How does lamotrigine work to treat epilepsy and bipolar disorder. What are the common side effects of lamotrigine. How should lamotrigine be taken properly. What are the off-label uses of lamotrigine. Who should not take lamotrigine.

What is Lamotrigine and How Does it Work?

Lamotrigine, sold under the brand name Lamictal, is an anticonvulsant medication primarily used to treat epilepsy and bipolar disorder. It was developed by GlaxoSmithKline and approved by the FDA in 1994. Lamotrigine works by stabilizing electrical activity in the brain and prolonging the inactive state of voltage-gated sodium channels.

This mechanism of action helps prevent the rapid firing of neurons that can lead to seizures. In bipolar disorder, lamotrigine’s mood-stabilizing effects are thought to result from its ability to modulate neurotransmitters like glutamate and gamma-aminobutyric acid (GABA).

FDA-Approved Uses of Lamotrigine

• Treatment of partial seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients aged 2 years and older
• Maintenance treatment to delay mood episodes in adults with bipolar I disorder

Off-Label Uses of Lamotrigine

While lamotrigine is only FDA-approved for epilepsy and bipolar I disorder maintenance, some healthcare providers prescribe it off-label for other conditions. Off-label use refers to the practice of prescribing medications for conditions not approved by the FDA.

Common Off-Label Uses Include:

• Panic disorder
• Anxiety disorders
• Migraine prevention
• Rapid-cycling bipolar depression
• Binge eating disorder
• Borderline personality disorder
• Posttraumatic stress disorder (PTSD)

It’s important to note that while these off-label uses may be beneficial for some patients, the evidence supporting their efficacy varies. Patients should discuss the potential risks and benefits with their healthcare provider before using lamotrigine for off-label purposes.

Proper Administration of Lamotrigine

Lamotrigine is available in several formulations to accommodate different patient needs and preferences. These include:

• Regular tablets
• Extended-release tablets
• Orally disintegrating tablets
• Chewable dispersible tablets

The dosage and administration of lamotrigine can vary depending on the specific formulation, the condition being treated, and individual patient factors. Generally, lamotrigine is taken orally with or without food.

Key Points for Proper Administration:

1. Follow prescription instructions carefully
2. Take lamotrigine at the same time(s) each day
3. Do not stop taking lamotrigine abruptly without consulting your doctor
4. If using chewable dispersible tablets, they can be swallowed whole, chewed, or dissolved in liquid
5. Orally disintegrating tablets should be placed on the tongue to dissolve before swallowing
6. Extended-release tablets should be swallowed whole and not crushed or chewed

Is it safe to split lamotrigine tablets? It’s generally not recommended to split, crush, or chew regular or extended-release lamotrigine tablets. Doing so can affect the drug’s release profile and potentially lead to improper dosing. If you have difficulty swallowing the tablets, consult your healthcare provider about alternative formulations or administration methods.

Common Side Effects of Lamotrigine

Like all medications, lamotrigine can cause side effects. While not everyone experiences side effects, it’s important to be aware of potential adverse reactions.

Frequently Reported Side Effects Include:

• Dizziness
• Headache
• Double vision or blurred vision
• Nausea
• Vomiting
• Tremor
• Rash
• Fatigue
• Insomnia
• Dry mouth

Can lamotrigine cause weight gain or loss? Unlike some other mood stabilizers and anticonvulsants, lamotrigine is generally considered weight-neutral. This means it’s less likely to cause significant weight changes. However, individual responses can vary, and some patients may experience minor weight fluctuations.

Serious Side Effects and Warnings

While most side effects of lamotrigine are mild and manageable, some can be serious and require immediate medical attention.

Potentially Serious Side Effects Include:

• Severe skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis
• Hemophagocytic lymphohistiocytosis (HLH)
• Aseptic meningitis
• Suicidal thoughts or behaviors
• Multiorgan hypersensitivity reactions

When should you seek immediate medical attention while taking lamotrigine? If you experience any of the following symptoms, contact your healthcare provider or seek emergency medical care immediately:

• Severe rash or blistering of the skin, mouth, eyes, or genitals
• Fever accompanied by swollen lymph nodes
• Severe headache with stiff neck and sensitivity to light
• Unusual changes in mood, behavior, or thoughts of self-harm
• Yellowing of the skin or eyes (jaundice)

Drug Interactions and Precautions

Lamotrigine can interact with various medications, supplements, and even certain medical conditions. These interactions can affect the efficacy of lamotrigine or increase the risk of side effects.

Common Drug Interactions:

• Valproic acid and valproate products: May increase lamotrigine levels
• Carbamazepine: May decrease lamotrigine levels
• Oral contraceptives: May decrease lamotrigine levels
• Rifampin: May decrease lamotrigine levels
• Atazanavir/ritonavir: May decrease lamotrigine levels

How can you minimize the risk of drug interactions with lamotrigine? Always inform your healthcare provider and pharmacist about all medications, supplements, and herbal products you’re taking. Keep an up-to-date list of your medications and share it at each medical appointment. Don’t start or stop any medications without consulting your doctor, as dosage adjustments may be necessary.

Special Precautions:

• Pregnancy: Lamotrigine may increase the risk of cleft lip and palate in newborns
• Breastfeeding: Lamotrigine can pass into breast milk
• Kidney or liver disease: May require dosage adjustments
• History of heart problems: Lamotrigine may affect heart rhythm
• History of depression or suicidal thoughts: Increased monitoring may be necessary

Lamotrigine Dosage and Titration

The dosage of lamotrigine varies depending on the condition being treated, age of the patient, and other medications being taken concurrently. It’s crucial to follow the prescribed dosage and titration schedule carefully.

General Dosing Guidelines:

• Starting dose is typically low and gradually increased over several weeks
• Maintenance doses usually range from 100 to 400 mg per day for adults
• Dosing may be once or twice daily, depending on the formulation
• Patients taking valproic acid may require lower doses of lamotrigine
• Patients taking enzyme-inducing antiepileptic drugs may require higher doses

Why is gradual dose titration important for lamotrigine? Gradual titration helps reduce the risk of serious skin reactions and other adverse effects. Rapid dose escalation has been associated with a higher incidence of severe rashes, including potentially life-threatening conditions like Stevens-Johnson syndrome.

Titration Schedule Example (for Bipolar Maintenance in Adults):

1. Weeks 1-2: 25 mg once daily
2. Weeks 3-4: 50 mg once daily
3. Week 5: 100 mg once daily
4. Week 6 and onwards: 200 mg once daily (target maintenance dose)

It’s important to note that this is just an example, and individual titration schedules may vary based on specific patient factors and concomitant medications.

Monitoring and Follow-up

Regular monitoring is essential for patients taking lamotrigine to ensure its effectiveness and safety. Your healthcare provider will likely schedule follow-up appointments to assess your response to the medication and monitor for any potential side effects.

Aspects of Monitoring May Include:

• Regular blood tests to check lamotrigine levels
• Liver function tests
• Kidney function tests
• Mood and behavior assessments (for bipolar disorder patients)
• Seizure frequency and severity monitoring (for epilepsy patients)

How often should lamotrigine levels be checked? The frequency of lamotrigine level monitoring can vary depending on individual circumstances. Initially, levels may be checked more frequently, especially during dose adjustments. Once a stable dose is achieved, monitoring may be done less often, typically every 6 to 12 months or as recommended by your healthcare provider.

Signs That May Indicate a Need for Dose Adjustment:

• Increased seizure frequency or severity
• Worsening of mood symptoms
• Emergence of new or worsening side effects
• Changes in other medications that may interact with lamotrigine

Always consult your healthcare provider before making any changes to your lamotrigine dosage. Abrupt discontinuation or dose changes can lead to serious consequences, including increased seizure risk or mood destabilization.

Long-term Use and Considerations

Lamotrigine is often prescribed for long-term use in managing chronic conditions like epilepsy and bipolar disorder. While it can be effective in controlling symptoms over extended periods, there are some considerations to keep in mind for long-term use.

Long-term Benefits:

• Sustained seizure control in epilepsy patients
• Reduced frequency and severity of mood episodes in bipolar disorder
• Generally well-tolerated compared to some other mood stabilizers
• Potential neuroprotective effects

Does long-term use of lamotrigine cause cognitive impairment? Unlike some other antiepileptic drugs, lamotrigine is generally not associated with significant cognitive impairment. In fact, some studies suggest it may have a positive impact on cognitive function in certain patients. However, individual responses can vary, and any concerns about cognitive effects should be discussed with your healthcare provider.

Long-term Considerations:

• Potential for decreased effectiveness over time (tolerance)
• Need for periodic reassessment of treatment goals and medication efficacy
• Possible long-term effects on bone health
• Interactions with age-related changes in metabolism and organ function
• Planning for pregnancy and adjusting treatment if necessary

Regular follow-ups with your healthcare provider are crucial for long-term lamotrigine use. These appointments allow for ongoing assessment of the medication’s benefits and risks, as well as making any necessary adjustments to your treatment plan.

Patient Education and Support

Proper education and support are essential for patients taking lamotrigine to ensure safe and effective use of the medication. Healthcare providers play a crucial role in providing this information, but patients should also be proactive in seeking out reliable resources and asking questions.

Key Points for Patient Education:

• Importance of adhering to the prescribed dosage and schedule
• Recognition of potential side effects and when to seek medical attention
• Proper storage and handling of lamotrigine
• Interactions with other medications, alcohol, and certain foods
• The need for regular follow-up appointments and monitoring

Where can patients find reliable information about lamotrigine? Reputable sources for patient education include:

• Official medication guides provided by the manufacturer
• Educational materials from epilepsy and bipolar disorder support organizations
• Trusted online health resources like MedlinePlus or the Epilepsy Foundation
• Consultations with pharmacists or medication therapy management services

Support Resources:

• Patient support groups for epilepsy or bipolar disorder
• Medication reminder apps to help with adherence
• Mental health hotlines for crisis support
• Financial assistance programs for medication costs

Empowering patients with knowledge about their medication can improve treatment outcomes and overall quality of life. Don’t hesitate to ask your healthcare provider or pharmacist if you have any questions or concerns about lamotrigine or your treatment plan.

Lamotrigine: MedlinePlus Drug Information

Lamotrigine comes as a tablet, an extended-release tablet, an orally disintegrating tablet (dissolves in the mouth and can be swallowed without water), and a chewable dispersible (can be chewed or dissolved in liquid) tablet to take by mouth with or without food. The extended-release tablets are taken once a day. The tablets, orally disintegrating tablets, and chewable dispersible tablets are usually taken once or twice a day, but may be taken once every other day at the beginning of treatment. Follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any part you do not understand.

There are other medications that have names similar to the brand name for lamotrigine. You should be sure that you receive lamotrigine and not one of the similar medications each time you fill your prescription. Be sure that the prescription your doctor gives you is clear and easy to read. Talk to your pharmacist to be sure that you are given lamotrigine. After you receive your medication, compare the tablets to the pictures in the manufacturer’s patient information sheet. If you think you were given the wrong medication, talk to your pharmacist. Do not take any medication unless you are certain it is the medication that your doctor prescribed.

Swallow the tablets and extended-release tablets whole; do not split, chew, or crush them.

If you are taking the chewable dispersible tablets, you may swallow them whole, chew them, or dissolve them in liquid. If you chew the tablets, drink a small amount of water or diluted fruit juice afterward to wash down the medication. To dissolve the tablets in liquid, place 1 teaspoon (5 mL) of water or diluted fruit juice in a glass. Place the tablet in the liquid and wait 1 minute to allow it to dissolve. Then swirl the liquid and drink all of it immediately. Do not try to divide a single tablet to be used for more than one dose.

To take an orally disintegrating tablet, place it on your tongue and move it around in your mouth. Wait a short time for the tablet to dissolve, and then swallow it with or without water.

If your medication comes in a blisterpack, check the blisterpack before you take your first dose. Do not use any of the medication from the pack if any of the blisters are torn, broken, or do not contain tablets.

If you were taking another medication to treat seizures and are switching to lamotrigine, your doctor will gradually decrease your dose of the other medication and gradually increase your dose of lamotrigine. Follow these directions carefully and ask your doctor or pharmacist if you have questions about how much of each medication you should take.

Lamotrigine may control your condition, but it will not cure it. It may take several weeks for you to feel the full benefit of lamotrigine. Continue to take lamotrigine even if you feel well. Do not stop taking lamotrigine without talking to your doctor, even if you experience side effects such as unusual changes in behavior or mood. Your doctor will probably decrease your dose gradually. If you suddenly stop taking lamotrigine, you may experience seizures. If you do stop taking lamotrigine for any reason, do not start taking it again without talking to your doctor.

Uses, Dosages, Common Side Effects, and Interactions

GlaxoSmithKline developed Lamictal, and the U.S. Food and Drug Administration approved it in 1994.

Even though it’s only approved for epilepsy and as maintenance medicine to delay mood episodes in people with bipolar I, some medical providers prescribe it to treat other conditions off-label — uses not approved by the FDA.

Off-label uses include:

• Panic disorder
• 
  Anxiety
• 
  Migraines and headaches
• 
  Rapid-cycling bipolar depression
• 
  Binge eating disorder
• 
  Borderline personality disorder
• 
  Posttraumatic stress disorder (PTSD)

Lamictal XR, the extended-release version of Lamictal, is not approved for patients younger than 13. It’s only approved for treating certain types of seizures.

In January 2020, Taro Pharmaceuticals, a manufacturer of generic Lamictal, issued a recall for one lot of lamotrigine because it was contaminated with a small amount of enalapril maleate — a blood pressure and heart failure drug that may cause birth defects.

How It Works

Researchers believe Lamictal works by slowing down electrical signals and inhibiting certain chemicals in the brain that cause brain cells to signal too quickly. When brain cells work too fast, it causes seizures. By slowing down these brain signals, lamotrigine may help to reduce seizure episodes.

In people with bipolar disorder, the medication helps to reduce mood swings, though researchers aren’t sure how the drug actually works.

Recommended Dosages

Lamictal comes in several forms and strengths. Depending on the reason for treatment, the recommended dosage is different.

Forms and Strengths

• Tablets: 25 mg, 100 mg, 150 mg, and 200 mg
• 
  Tablets for oral suspension: 2 mg, 5 mg, and 25 mg
• 
  Orally disintegrating tablets: 25 mg, 50 mg, 100 mg, and 200 mg
• 
  Extended release tablets: 5 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg

Patients typically take Lamictal once or twice a day, and it can be taken with or without food. If taking Lamictal XR, make sure to take the pills whole and don’t crush, cut or chew them.

The medication starts at a low dose. Then, the dose gets higher over the course of several weeks. People who are taking the drug with other drugs for seizures take lower doses. They may take it every other day when beginning treatment.

Common Side Effects

Researchers studied Lamictal in clinical trials that included thousands of patients in several groups. Across these studies, researchers defined common side effects as those that occurred in 10 percent or more of patients using the drug for epilepsy and five percent or more of patients using the drug for bipolar disorder.

Common side effects of Lamictal (lamotrigine) include:

• Ataxia (impaired balance or coordination)
• 
  Back pain, abdominal pain
• 
  Blurred vision
• 
  Diarrhea
• 
  Diplopia (double vision)
• 
  Dizziness
• 
  Fatigue
• 
  Headache
• 
  Insomnia
• 
  Nausea
• 
  Pharyngitis
• 
  Rash
• 
  Rhinitis (inflammation of membranes in the nose)
• 
  Somnolence (drowsiness)
• 
  Vomiting
• 
  Xerostomia (dry mouth)

The most common side effects in children were infection, vomiting, diarrhea, accidental injury, fever, abdominal pain and tremor.

In clinical trials, the most common side effects that caused people to drop out of the trial included: rash, headache, dizziness and impaired balance or coordination.

Serious Side Effects

There have been reports of serious side effects linked to Lamictal, but these side effects are rare, according to the drug’s label. These range from serious skin rashes to death.

Skin Rashes

In clinical trials, 11 of 3,348 adults with epilepsy who received Lamictal had a serious rash that led to hospitalization and discontinuation. Researchers received postmarketing reports of rash-related deaths, but the numbers were too few to estimate the exact rate.

Serious rashes that led to hospitalization were: Stevens-Johnson syndrome — a serious, blistering rash — angioedema, toxic epidermal necrolysis and rashes associated with multiorgan hypersensitivity.

Hemophagocytic Lymphohistiocytosis (HLH)

HLH is a potentially life-threatening syndrome caused by overactivation of the immune system. The overactivation causes severe inflammation throughout the body. In April 2018, the FDA released a warning that Lamictal can cause HLH.

HLH usually starts with a high fever and rash. It causes problems with blood cells and internal organs such as the lungs, kidneys and liver. It usually starts within 8 to 24 days after starting treatment.

Multiorgan Hypersensitivity Reactions and Organ Failure

Multiorgan hypersensitivity reactions, also known as drug reaction with eosinophilia and systemic symptoms (DRESS), have occurred. This is a potentially fatal drug reaction.

Symptoms include fever, rash, and other organ problems. It sometimes resembles a viral infection. Report these symptoms to your medical provider right away.

Blood Problems

Some people who took Lamictal had abnormal blood cell counts such as neutropenia, leukopenia, anemia, thrombocytopenia, pancytopenia, and, rarely, aplastic anemia and pure red cell aplasia.

Suicidal Thoughts or Behaviors

Taking Lamictal may increase the risk of suicidal thoughts or behaviors. In studies of anti-epileptic drugs (AED) such as Lamictal, patients who took one type of drug had about twice the risk of suicidal thoughts and behaviors compared to people who took a placebo. These symptoms may start as early as one week after starting treatment.

Aseptic Meningitis

Taking Lamictal increases the risk of aseptic meningitis — inflammation of the membrane covering the spinal cord and brain. Symptoms include rash, fever, vomiting, nausea and stiffness and soreness in the neck. Symptoms usually appear anywhere from one day to about a month after starting therapy.

Withdrawal Seizures

Patients taking Lamictal should not abruptly stop treatment. Patients with epilepsy may experience an increase in seizure frequency and people with bipolar disorder may develop seizures. Slowly weaning off the drug for at least two weeks is recommended.

Drug Interactions

Lamictal’s drug label lists several drugs that may increase or decrease the drug’s blood concentration. This could lead to less effective medication or an increase in side effects if the concentration is too high.

This is not a complete list of potential drug interactions. Make sure you tell your medical provider about all medications, supplements and herbs you take.

Drugs that interact with Lamictal include:

• Oral contraceptives with ethinylestradiol and levonorgestrel decrease lamotrigine concentration and decrease levonorgestrel.
• 
  Carbamazepine and carbamazepine epoxide decreases lamotrigine concentration and may increase carbamazepine epoxide levels.
• 
  Lopinavir/ritonavir decreases lamotrigine concentration.
• 
  Atazanavir/ritonavir decreases lamotrigine concentration.
• 
  Phenobarbital/primidone decreases lamotrigine concentration.
• 
  Phenytoin decreases lamotrigine concentration.
• 
  Rifampin decreases lamotrigine concentration.
• 
  Valproate increases lamotrigine concentration two fold. Some studies suggest taking these drugs together increases the risk of potentially fatal drug-induced skin rashes.

Special Precautions

Make sure you talk to your medical provider about any allergies you have, medications you take or preexisting health conditions. Lamictal might not be safe or effective for everyone.

Before taking Lamictal:

• Tell your doctor and pharmacist if you are allergic to lamotrigine or any ingredients in the tablets. For example, some formulas may include lactose.
• 
  Tell your doctor or pharmacist about the medications you take, especially drugs in the interactions list or other drugs used to treat epilepsy.
• 
  Tell your doctor if you use medications that contain female hormones such as birth control or hormone replacement therapy (HRT).
• 
  Tell your doctor if you have or have ever had lupus or any other autoimmune disease in which the immune system attacks healthy tissues and organs; a blood disorder; mental health conditions or kidney or liver disease.
• 
  Tell your doctor if you plan to be pregnant or are pregnant. Call your doctor right away if you become pregnant while taking lamotrigine.
• 
  Tell your doctor if you are breastfeeding or plan to breastfeed. Lamotrigine may pass to your baby through breast milk. Tell your doctor if your baby has interrupted breathing, poor sucking or unusual sleepiness.
• 
  Know that this medication can cause sleepiness and/or dizziness. Don’t operate machinery or drive until you know how Lamictal affects you.
• 
  Know that you may experience changes in your mental health. This medication may cause thoughts of suicide, panic attacks, agitation, new or worsening irritability, restlessness, anxiety, dangerous impulses, depression, insomnia, aggressive behavior, abnormally excited moods and other unusual changes in mood. Tell another person close to you about these symptoms so they can help you look out for them. Tell your doctor right away if you experience changes in mood or mental health.

Please seek the advice of a medical professional before making health care decisions.

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APO-Lamotrigine – NPS MedicineWise

What is in this leaflet

Read this leaflet carefully before taking your medicine.
This leaflet answers some common questions about lamotrigine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available.

Ask your doctor or pharmacist:

• if there is anything you do not understand in this leaflet,
• if you are worried about taking your medicine, or
• to obtain the most up-to-date information.

You can also download the most up to date leaflet from www.apotex.com.au.

All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.

Pharmaceutical companies cannot give you medical advice or an individual diagnosis.

Keep this leaflet with your medicine. You may want to read it again.

What this medicine is used for

The name of your medicine is APO-Lamotrigine. It contains the active ingredient lamotrigine.

Lamotrigine belongs to a group of medicines called “anti-epileptic drugs”.

It is used to treat epilepsy in adults and children aged 2 years and over.

Usually lamotrigine is used in addition to other medicines for the treatment of epilepsy. Lamotrigine is used in partial seizures (seizures that affect only one part of the brain) or generalised seizures (seizures that affect the whole brain), including Lennox-Gastaut Syndrome (a severe form of epilepsy characterised by several seizure types).

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason.

This medicine is available only with a doctor’s prescription.

There is no evidence that this medicine is addictive.

Use in children

This medicine may be used to treat epilepsy in children 2 years of age and over.

Before you take this medicine

When you must not take it

Do not take this medicine if:

• You are hypersensitive to, or have had an allergic reaction to, lamotrigine or any of the ingredients listed at the end of this leaflet.
  
  Symptoms of an allergic reaction may include: cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting; or hay fever-like symptoms.
  If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.
• It has passed the expiry date (EXP) printed on the pack.
• The packaging is torn, shows signs of tampering or it does not look quite right.

Before you start to take it

Tell your doctor if:

1. You have allergies to:

• any other medicines
• any other substances, such as foods, preservatives or dyes.

2. You have or have had any medical conditions, especially the following:

• kidney disease
• liver disease
• bipolar disorder
• Parkinson’s disease
• history of allergy or rash to other antiepileptic drugs.
• you have ever developed meningitis after taking lamotrigine.

3. You are currently pregnant or you plan to become pregnant. Do not take this medicine whilst pregnant until you and your doctor have discussed the risks and benefits involved.

It is recommended that women on antiepileptic drugs, including lamotrigine receive pre-pregnancy counselling regarding the risk to their unborn child.
Studies have shown that lamotrigine can decrease the levels of folic acid during pregnancy. It is therefore recommended that you take a daily 5 mg folate supplement before becoming pregnant and during the first 12 weeks of your pregnancy.

4. You are currently breastfeeding or you plan to breastfeed.

Lamotrigine can pass into breast milk and may affect your baby. Do not take this medicine whilst breastfeeding until you and your doctor have discussed the risks and benefits involved.

5. You are planning to have surgery or an anaesthetic.
6. You are currently receiving or are planning to receive dental treatment.
7. You are taking or are planning to take any other medicines, including vitamins and supplements that are available from your pharmacy, supermarket or health food shop.

Some medicines may interact with lamotrigine. These include:

• sodium valproate (“Epilim”, “Valpro”), used to treat epilepsy
• other anti-epileptic drugs including carbamazepine, phenobarbitone and primidone
• any form of hormonal contraception (e. g. “the pill”) or HRT
• OCT 2 substrates such as dofetilide
• rifampicin, which is often used to treat infections including tuberculosis
• a combination of lopinavir and ritonavir, which is used to treat Human Immunodeficiency Virus (HIV) infection.
• risperidone, which is used to treat schizophrenia and bipolar disorder. You may be more likely to feel sleepy or drowsy if you take risperidone and lamotrigine together.

If you are taking any of these medicines you may need a different dose or you may need to take different medicines.

Other medicines not listed above may also interact with lamotrigine.

How to take this medicine

Follow carefully all directions given to you by your doctor. Their instructions may be different to the information in this leaflet.

You may notice you feel dizzy, tired or unsteady in the first few weeks of treatment with lamotrigine. During this time, you may also notice slight problems with your vision. As your reactions may be slower during this period, you should not operate any machinery or drive a car. If any of these effects do not go away or are troublesome, you should see your doctor.

How much to take

Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.

Do not stop taking your medicine or change your dosage without first checking with your doctor.

Usually your doctor will prescribe a low dose to start and gradually increase the dose during the first few weeks of treatment. The dose that your doctor prescribes will often depend on other anti-epileptic medications you are taking and your response to lamotrigine.

Hormonal Contraceptives:

If you start or stop taking hormonal contraceptives (e.g. “the pill”) while taking lamotrigine, your doctor may need to adjust the dose of lamotrigine depending on how well your condition is being treated.

You should tell your doctor if there are any changes in your menstrual pattern, such as breakthrough bleeding.

If you become pregnant your doctor may need to change your dose of lamotrigine or switch you to a different medicine.

Use in children

The dosage for children usually depends on their weight. Children’s weight should be checked and the dose reviewed as weight changes occur.

How to take it

The tablets may be swallowed whole, chewed or dispersed in a glass of water (at least enough water to dissolve the whole tablet).

When to take it

Take this medicine at the same time each day. Taking your medicine at the same time each day will have the best effect and it will also help you remember when to take it.

This medicine can be taken with or without food.

How long to take it for

Continue taking your medicine for as long as your doctor tells you to.

Make sure you have enough to last over weekends and holidays.

Do not stop taking your tablets or change the dose without first checking with your doctor.

If you forget to take it

Contact your doctor immediately if you have forgotten to take your dose of lamotrigine. Do not take a double dose to make up for the dose that you missed.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.

If you take too much (Overdose)

If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively go to the Accident and Emergency Department at your nearest hospital.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you take too much you may be more likely to have serious side effects which may be fatal.

Symptoms of overdose can include rapid, uncontrollable eye movements, clumsiness and lack of coordination affecting your balance, impaired or loss of consciousness, fits or coma.

While you are taking this medicine

Your doctor will tell you if there are any special instructions while you are taking lamotrigine tablets.

Things you must do

If you develop any skin rash (e.g. hives or spots) while being treated with lamotrigine, contact your doctor immediately.
There have been reports of severe, potentially life-threatening skin rashes associated with lamotrigine treatment, particularly in children. Lamotrigine should be discontinued at the first sign of rash unless the rash is clearly not drug related.

Tell your doctor that you are taking this medicine if:

• you are about to be started on any new medicine
  Lamotrigine may interfere with some laboratory tests to detect other drugs. If you require a laboratory test, tell your doctor or hospital that you are taking lamotrigine.
• you are pregnant or are planning to become pregnant.
  There may be an increased risk of babies developing a cleft lip or cleft palate if lamotrigine is taken during the first few months of pregnancy.
• you are breastfeeding or are planning to breastfeed.
  Lamotrigine passes into breast milk and may affect your baby.
• you are about to have any blood tests.
• you are going to have surgery or an anaesthetic or are going into hospital.

Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects. Go to your doctor regularly for a check-up.

Things you must not do

Do not:

• Give this medicine to anyone else, even if their symptoms seem similar to yours
• Take your medicine to treat any other condition unless your doctor tells you to
• Stop taking your medicine, or change the dosage, without first checking with your doctor.
• Take any other prescription or non-prescription medicines without first telling your doctor.

Do not stop taking lamotrigine or change the dose because you are feeling better.
If you stop taking lamotrigine tablets abruptly your epilepsy may worsen or come back. This is known as “rebound seizures”.

Your doctor will advise you if you need to stop taking lamotrigine and, if so, how to do this safely. If you are unsure whether you should stop taking lamotrigine talk to your doctor.

Things to be careful of

Be careful driving or operating machinery until you know how lamotrigine affects you.
Lamotrigine may cause dizziness and drowsiness, and affect alertness in some people.

Make sure you know how lamotrigine affects you before you drive a car, operate machinery, or do anything else that could be dangerous if you are dizzy or light-headed. If this occurs do not drive. If you drink alcohol, your dizziness or light-headedness may be worse. If any of these effects do not go away or are troublesome you should see your doctor.

Children should not ride a bike, climb trees or do anything else that could be dangerous if they are feeling dizzy or sleepy.

Possible side effects

Tell your doctor as soon as possible if you do not feel well while you are taking lamotrigine or if you have any questions or concerns.

Do not be alarmed by the following lists of side effects. You may not experience any of them. All medicines can have side effects. Sometimes they are serious but most of the time they are not.

Tell your doctor or pharmacist if you notice any of the following.

This list includes the more common side effects. Mostly, these are mild:

• dizziness, unsteadiness
• headache
• drowsiness
• feeling sick (nausea)
• vomiting
• feeling weak
• double vision
• blurred vision
• rapid, uncontrollable eye movements
• tremor (shakiness)
• trouble sleeping
• loss of memory
• confusion
• irritability, aggression
• agitation
• increased activity in children
• joint or back pain

Other reported side effects include:

• diarrhoea
• liver problems
• tiredness or feeling sleepy
• movement problems such as tics,unsteadiness and jerkiness
• hallucinations.

Some people may have changes in their blood count, which may make them feel tired, short of breath and more susceptible to infections. They may also bleed or bruise very easily or have mouth ulcers or a sore throat.

In general these side effects usually happen only during the first few weeks of treatment with Lamotrigine. If any of these side effects persist, or are troublesome, see your doctor.

Anti-epileptic medicines are used to treat several conditions, including epilepsy and bipolar disorder. Information from a large number of studies in patients being treated with anti-epileptic medicines such as lamotrigine has shown a small number of reports of suicidal behaviour (including suicidal thoughts and suicide attempts).

Tell your doctor immediately if you experience any of the following:

• suicidal thoughts
• suicide attempts.

Tell your doctor immediately or go to the Accident and Emergency department of your nearest hospital if you, or someone you know, has any suicidal thoughts or other mental/mood changes whilst taking lamotrigine.
All mentions of suicide or violence must be taken seriously. Families and caregivers of children and adolescents who are taking lamotrigine should be especially watchful for any changing behaviour. Anti-epileptic medicines such as lamotrigine may increase the risk of suicidal behaviour, including suicidal thoughts and suicide attempts.

Potentially Serious Skin Reaction

A small number of people taking lamotrigine get an allergic reaction or potentially serious skin reaction, which may develop into more serious problems if they are not treated. Severe allergic reactions are rare.

These symptoms are more likely to happen during the first few months of treatment with lamotrigine, especially if the dose is too high or if the dose is increased too quickly, or if lamotrigine is taken with a medicine called valproate. Serious skin reactions are more common in children. Symptoms of these serious allergic reactions include:

• any skin reaction, e.g. rash or ‘hives’
• wheezing, difficulty in breathing
• swelling of the face, lips or tongue
• sore mouth or sore eyes
• fever
• swollen glands.

Tell your doctor immediately if you notice any of the above symptoms.

Liver and Blood Problems

Tell your doctor immediately if you notice any of the following:

• any skin reactions (e.g. rash or ‘hives’)
• swelling of the face, lips or tongue
• sore mouth or sore eyes
• high temperature (fever)
• swollen glands
• abdominal pain or tenderness
• drowsiness
• easy bruising or unusual bleeding
• yellow skin (jaundice).

Your doctor may decide to carry put tests on your liver, kidneys or blood and ay tell you to stop taking lamotrigine if you experience these symptoms.

If you are taking Lamotrigine for epilepsy, rarely, you may start to experience more seizures than usual. Tell your doctor as soon as possible if your seizures get worse or if you have a new type of seizure.

These are all very serious side effects and you may need urgent medical attention or hospitalisation.

Serious side effects are rare.

Another rare side effect is “Lupus-like reactions” which can cause symptoms such as fever, pain in the joints and general ill health.

A very rare side effect is meningitis which may present as a group of symptoms consisting of fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light. This may be caused by an inflammation of the membranes that cover the brain and spinal cord.

Tell your doctor if you are female and your menstrual periods change.

This is not a complete list of all possible side-effects. Others may occur in some people and there may be some side-effects not yet known.

Allergic reactions

If you think you are having an allergic reaction to lamotrigine, tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.

Symptoms of an allergic reaction may include some or all of the following:

• cough, shortness of breath, wheezing or difficulty breathing.
• swelling of the face, lips, tongue, or other parts of the body
• rash, itching or hives on the skin
• fainting
• hayfever-like symptoms

Storage and disposal

Storage

Keep your medicine in its original packaging until it is time to take it.

If you take your medicine out of its original packaging it may not keep well.

Keep your medicine in a cool dry place where the temperature will stay below 25 degrees Celsius.

Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep this medicine where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor or pharmacist tells you to stop taking this medicine or it has passed its expiry date, your pharmacist can dispose of the remaining medicine safely.

Product description

What APO-Lamotrigine looks like

APO-Lamotrigine 25 mg:

White to off-white, uncoated, circular flat bevelled tablets debossed with “LI2” on one side, plain on the other side having a characteristic fruity odour.

APO-Lamotrigine 50 mg:

White to off-white, uncoated, circular flat bevelled tablets debossed with “LI3” on one side, plain on the other side having a characteristic fruity odour.

APO-Lamotrigine 100 mg:

White to off-white, uncoated, circular flat bevelled tablets debossed with “LI4” on one side, plain on the other side having a characteristic fruity odour.

APO-Lamotrigine 200 mg:

White to off-white, uncoated, circular flat bevelled tablets debossed with “LI5” on one side, plain on the other side having a characteristic fruity odour.

APO-Lamotrigine tablets are available in blister packs of 56 tablets.

Ingredients

Each tablet contains lamotrigine as the active ingredient.

It also contains the following inactive ingredients:

• aspartame
• calcium carbonate
• microcrystalline cellulose
• crospovidone
• hyprolose
• purified talc
• magnesium stearate
• povidone
• colloidal anhydrous silica
• mixed berries 501161 AP0551.

This medicine is gluten-free, lactose-free, tartrazine-free and free of other azo dyes.

Australian Registration Numbers

APO-Lamotrigine 25 mg (blister pack): AUST R 167520.

APO-Lamotrigine 50 mg (blister pack): AUST R 167521.

APO-Lamotrigine 100 mg (blister pack): AUST R 167523.

APO- Lamotrigine 200 mg (blister pack): AUST R 167524.

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113

Apotex Pty Ltd is the licensee of the registered trademarks APO and APOTEX from the registered proprietor, Apotex Inc.

This leaflet was prepared in: April 2020.

Published by MIMS May 2020

Uses, Side Effects, Dosages, Precautions

Lamictal is used as a mood stabilizer for people with bipolar disorder and as an anticonvulsant for people with epilepsy. When used to treat bipolar disorder, the drug helps reduce the occurrence of mood episodes. For people with epilepsy, Lamictal prevents seizures, and it may be used alone or together with another anticonvulsant.

Lamictal belongs to the phenyltriazine class of anticonvulsants. It’s not known exactly how it works, but it may stabilize mood by acting on sodium channels in the brain.

Lamictal is taken orally as a tablet that should be swallowed whole, a chewable, or a disintegrating tablet placed on the tongue. The generic form of Lamictal is called lamotrigine.

Uses

When used for bipolar disorder, Lamictal is indicated for the maintenance treatment of bipolar disorder in those 18 years and older to delay the time to occurrence of mood episodes. Although not formally indicated, Lamictal may also be prescribed for other aspects of bipolar disorder and other mood disorders.

Lamictal is also used to control seizures in people with epilepsy. For children age 2 and older, it’s often prescribed together with another anticonvulsant medication, but it may be used alone for adolescents and adults age 16 and up.

Off-Label Uses

While Lamictal is indicated as a maintenance drug, some research shows it may also help someone who is experiencing an acute bipolar depression. Lamictal may also sometimes be prescribed to treat unipolar depression.

Before Taking

Before your doctor considers prescribing Lamictal, they will need to evaluate you for bipolar disorder. Your doctor will check to see if you’re experiencing symptoms like:

• Agitation
• Delusions or hallucinations
• Difficulty concentrating or remembering things
• Distractibility
• Excessive fatigue
• Excessive talking
• Guilt or hopelessness
• Impulsive risk-taking
• Inappropriate behavior
• Increased sexual desire
• Irritability, hostility, or aggression
• Loss of interest in activities that usually give you pleasure
• Loss of interest in your health, nutrition, or physical appearance
• Prolonged periods of sadness
• Racing thoughts
• Sleep disturbances, either sleeping less than usual or too much
• Suicidal thoughts

If you or a loved one is currently experiencing suicidal thoughts or an impulse to self-harm, contact the National Suicide Prevention Lifeline at 1-800-273-8255 for help. If you believe the danger is immediate, call 911.

Your doctor will also determine whether you fit the criteria for bipolar I or II and rule out other similar conditions.

Since Lamictal is a maintenance drug, your doctor will likely ensure that you’re not currently experiencing an acute manic or depressive episode before beginning treatment with this medication. Your doctor should also reassess you periodically to make sure you still need maintenance treatment for bipolar disorder.

Precautions and Contraindications

There are some situations where you should not take Lamictal based on your preexisting conditions and other medications you’re currently taking.

If you’ve ever experienced hypersensitivity to Lamotrigine in the past, you should not take Lamictal, as this medication carries a risk of a serious, potentially life-threatening rash.

You should talk with your doctor if you’re pregnant or trying to conceive. Lamictal is a Category C medication, meaning that data from animal studies show a risk to the fetus, but those results haven’t been observed in people. Caution is warranted, but you should discuss the issue with your doctor. In some cases, the benefits of taking Lamictal might outweigh the potential risks.

Lamictal does appear to travel through breastmilk, so breastfeeding while taking this medication isn’t recommended.

Let your doctor know if you have a history of liver and/or kidney problems. Caution may be warranted in these cases, and your doctor may need to adjust your Lamictal dosage.

Talk to your doctor about all medications, supplements, and vitamins that you currently take. While some drugs pose minor interaction risks, others may outright contraindicate use or prompt careful consideration as to whether the pros of treatment outweigh the cons in your case.

Certain drugs may cause problems with Lamictal, like:

• Specific anticonvulsants that can reduce the concentration of Lamictal in your blood, like Dilantin (phenytoin), Mysoline (primidone), phenobarbital, and Tegretol (carbamazepine)
• Oral estrogen-containing contraceptives, which can also reduce Lamictal concentration
• Valproate, which may increase your blood level of Lamictal, can increase the risk of developing a life-threatening rash

In some cases, your doctor may need to adjust your dosage, while in others, they may recommend another medication instead of Lamictal.

Other Anticonvulsants

Anticonvulsants, also known as antiepileptic drugs or AEDs, are sometimes used as mood stabilizers for people with bipolar disorder. Other common anticonvulsants used in bipolar disorder treatment include:

Lamictal Dosage

Lamictal is offered in a tablet form and available in a number of different formulations and strengths:

• Lamictal tablets, available in 25-, 100-, 150-, and 200-milligram (mg) strengths
• Lamictal orally disintegrating tablets (ODT), available in 25-, 50-, 100-, and 200-mg strengths
• Lamictal chewable dispersible tablets (CDT), available in 2-, 5-, and 25-mg strengths

To avoid the risk of a hypersensitivity reaction, Lamictal is usually started at a lower dose and gradually increased over a period of several weeks. The target dose of Lamictal is typically 200 mg daily, though this may vary, particularly if you’re taking certain other medications.

Starter kits are available for both Lamictal and Lamictal ODT. These kits provide instructions on how and when to increase dosages, and the instructions vary based on whether you are taking Lamictal alone or with other drugs. The starter kit may be useful if you are starting Lamictal for the first time.

All listed dosages are according to the drug manufacturer. Check your prescription and talk to your doctor to make sure you are taking the right dose for you.

Modifications

You can disperse Lamictal CDT in liquid to make them easier to take. To do this, simply:

1. Add the tablets to enough liquid to cover the medication (around 1 teaspoon).
2. Wait one minute, or until the medication is dissolved.
3. Swirl the mixture to make sure the medication is evenly dispersed.

Then you should take the entire mixture (don’t take a partial quantity).

How to Take and Store

Lamictal tablets should be swallowed whole. They can be taken with or without water or food, but if you have side effects like nausea, taking your medication with a small snack may help.

Lamictal CDT can be swallowed whole, chewed, or diluted in water or fruit juice. If you chew these tablets, you may want to drink a small amount of water or diluted fruit juice to help you swallow.

Lamictal ODT should be placed on your tongue and moved around in your mouth until they dissolve. They will dissolve quickly and can be swallowed with or without water. They can also be taken with or without food.

If you miss a dose of this medication, take it as soon as you remember. If it’s almost time for your next dose, however, do not double up. Simply wait for your next dose.

It may take several weeks before you start feeling positive effects from this medication. Be sure to keep taking your recommended dosage; don’t stop because you haven’t noticed any change.

It is possible to overdose on Lamictal. If you or your loved one suspect an overdose of this medication, call the Poison Control Center at 1-800-222-1222 or 911 immediately for help. Lamictal is rapidly absorbed, so it’s important to act quickly.

Side Effects

Common

For people with bipolar disorder, the most common side effects of Lamictal are:

• Abdominal pain
• Back pain
• Dry mouth
• Fatigue
• Insomnia
• Nausea
• Sleepiness
• Stuffy, runny nose

Severe

Lamictal very rarely has been associated with severe, even life-threatening conditions, like:

• Acute multi-organ failure
• Blood disorders like anemia
• Fever or enlarged lymph nodes, which may be signs of hypersensitivity
• Serious rash
• Suicidal behavior and ideation
• Worsening of bipolar symptoms or the emergence of new symptoms

Signs of a Lamictal overdose can include:

• Abnormalities in the electrocardiogram, or ECG
• Coma
• Impaired coordination, slurred speech, stumbling, and falling
• Loss of consciousness
• Uncontrolled, repetitive eye movements

Warnings and Interactions

Lamictal carries a black box warning regarding a potentially life-threatening hypersensitivity drug rash. In some cases, a severe rash can develop and lead to conditions known as Stevens-Johnson syndrome (SJS) or toxic epidermal necrosis (TEN), both of which require emergency medical treatment.

The risk of developing a serious rash may be increased if:

• You’re currently taking a valproate medication (like Depacon, Depakote, Depakene, or Stavzor)
• You have a history of hypersensitivity to other anticonvulsants
• You take more than the recommended dose of Lamictal or increase the dosage more quickly than recommended

Children may also face a higher risk of developing a serious rash than adults.

If you notice any type of rash while taking this medication, you should seek immediate medical attention. Severe cases require hospitalization, and once a hypersensitivity reaction has occurred, no matter how mild, Lamictal treatment should never be restarted.

Other potential problems with Lamictal include:

• Blood problems and acute organ failure: Lamictal can lead to potentially life-threatening blood and organ disorders. Liver failure, blood clots, muscle breakdown, and blood abnormalities like anemia may be possible.
• Increased risk of suicidal thoughts and/or behavior: This warning accompanies the whole category of antiepileptic drugs. If you notice any signs of worsening depression, unusual mood changes, worsening bipolar symptoms, or the emergence of suicidal thoughts, seek help immediately.
• Other signs of hypersensitivity: While a rash is typically a clear sign of hypersensitivity, it’s not the only one. Fever and enlarged lymph nodes can also indicate an adverse reaction.
• Problems operating machinery: Because Lamictal can cause dizziness and drowsiness, you should be cautious about operating a vehicle or heavy machinery while taking this medication.

You should remain under the close care of your doctor while taking Lamictal. If you decide to stop the medication, you may need to wean off slowly as withdrawal symptoms are possible.

Lamotrigine | Health Navigator NZ

Lamotrigine is used to treat epilepsy and to control some mood disorders such as bipolar disorder. Find out how to take it safely and possible side effects.

What is lamotrigine?

Lamotrigine is used to treat epilepsy by preventing seizures and to control some mood disorders such as bipolar disorder. Lamotrigine blocks certain kinds of nerve activity and in this way reduces seizures and helps with mood disorders. In New Zealand, lamotrigine is available in different strength tablets (2 mg, 5 mg, 25 mg, 50 mg, 100 mg, 200 mg). 

Dose

• The dose of lamotrigine is different for different people.
• Your doctor will start you on a low dose, and increase your dose slowly over a few weeks to avoid side effects.
• Lamotrigine is usually taken once or two times a day but sometimes when starting lamotrigine it is taken every other day. 
• Always take your lamotrigine exactly as your doctor has told you. The pharmacy label on your medicine will tell you how much to take, how often to take it, and any special instructions.

How to take lamotrigine

• Swallow your lamotrigine tablets with a glass of water, milk or juice.
• If you have swallowing problems, you can chew the tablets or put the tablet in a small amount of water or fruit juice and mix well so it dissolves. This may take a few minutes. Then swallow all of the solution straight away.
• Take lamotrigine at the same times each day, to help you to remember to take it. 
• You can take lamotrigine with or without food.
• If you forget to take your dose, take it as soon as you remember; do not take double the dose.
  • If you are taking lamotrigine once every other day: take your missed dose as soon as you remember, as long as it is at least 12 hours before the next dose is due.
  • If you are taking lamotrigine once a day: take your missed dose as soon as you remember, if it is at least 12 hours before the next dose is due.
  • If you are taking lamotrigine two times a day: take it as soon as you remember if it is within 4 hours of when your dose was due. But, if it is more than 4 hours since the dose was due, just take the next dose at the right time. Do not take double the dose

• Keep taking lamotrigine every day (see tips to help you remember to take your medicines regularly. It may take a few weeks before you notice the full benefits of lamotrigine. Do not stop taking lamotrigine suddenly, especially if you are taking it for epilepsy; speak to your doctor or nurse before stopping.

Precautions – before starting lamotrigine

• Are you pregnant or trying for a baby?
• Are you breastfeeding?
• Do you have any problems with the way your kidneys or liver work?
• Do you have Parkinson’s disease?

If so, it’s important that you tell your doctor before you start lamotrigine. Sometimes a medicine isn’t suitable for a person with certain conditions, or it can only be used with extra care.

Possible side effects

Like all medicines, lamotrigine can cause side effects, although not everyone gets them. Often side effects improve as your body gets used to the new medicine.

Skin rash

• Skin rash is a common side effect of lamotrigine and is most likely to happen in the first 8 weeks of treatment; let your doctor know if this happens. It can affect the body, face or mouth. Some people may also feel unwell and have a fever with the rash.
• The rash is more likely to happen if you are also taking sodium valproate or another anti-epileptic medicine and if you have other allergies. It is less likely to happen if lamotrigine is started at a low dose and increased slowly.
• The rash is usually mild and goes away on its own but in some people it can become a severe skin reaction. Serious skin reactions have been reported in:
• 1 in 500 adults taking lamotrigine for epilepsy
• 1 in 100-300 children taking lamotrigine for epilepsy
• 1 in 1000 people taking lamotrigine for bipolar disorder.

• The risk of severe skin reactions is higher in people who have autoimmune disorders such as rheumatoid arthritis and lupus. 
• If you get a rash, let your doctor know about this as soon as possible.

Other possible side effects

Interactions

Lamotrigine interacts with some other medications and herbal supplements, so check with your doctor or pharmacist before starting lamotrigine or before starting any new medicines. This is especially important if you are taking the oral contraceptive pill (‘The pill’) or hormone replacement therapy (HRT), or other anti-epileptic medicines.

Learn more

Medsafe Consumer Information Sheet

Lamictal
Arrow-Lamotrigine
Logem

For children: Lamotrigine New Zealand Formulary for Children

References

1. Lamotrigine New Zealand Formulary Patient Information
2. Lamotrigine New Zealand Formulary for Children
3. Managing patients with neuropathic pain BPAC, May 2016
4. Bipolar disorder: identifying and supporting patients in primary care BPAC, July 2014
5. Lamotrigine safe prescribing – does the dose fit? SafeRx Waitematā DHB, 2016

Lamotrigine for preventing seizures | Medicines for Children

Lamotrigine for preventing seizures

This leaflet is about the use of lamotrigine to prevent epileptic seizures. (Seizures may also be called convulsions or fits.)

This leaflet is for parents and carers about how to use this medicine in children. Our information sometimes differs from that provided by the manufacturers, because their information is usually aimed at adults. Please read this leaflet carefully. Keep it somewhere safe so that you can read it again.

Do not stop giving lamotrigine suddenly as your child may have more seizures.

Name of drug

Lamotrigine

Brand name: Lamictal®

Why is it important for my child to take this medicine?

It is important that your child takes lamotrigine regularly so that they have fewer seizures.

What is lamotrigine available as?

• Tablets: 25 mg, 50 mg, 100 mg, 200 mg; contain lactose
• Dispersible tablets: 2 mg, 5 mg, 25 mg, 100 mg

When should I give lamotrigine?

You will usually start by giving lamotrigine once a day, or every other day, while your child gets used to the medicine. This can be in the morning OR evening.

When your child is used to lamotrigine, you will usually give it twice a day: once in the morning and once in the evening. Ideally, these times are 10–12 hours apart, for example sometime between 7am and 8 am and between 7pm and 8 pm.

How much should I give?

Your doctor will work out the amount of lamotrigine (the dose) that is right for your child, and gradually increase it. The dose will be shown on the medicine label. If you are not sure how much to give, check with your doctor, epilepsy nurse or pharmacist.

How should I give it?

Tablets should be swallowed whole with a glass of water, milk or juice. Your child should not chew the tablet.

You can crush the tablets and mix them with about 2 tablespoons of fruit juice or soft food (e.g. yogurt, honey or mashed potato). Make sure your child swallows it all straight away.

Dispersible tablets: Disperse the tablet(s) in water or fruit juice. Mix it vigorously – it will make a cloudy mixture. Give the mixture to your child straight away. You can give it using a medicine spoon or oral syringe. 

• Occasionally, the only way to provide the correct dose of lamotrigine for your child will be to give part of a tablet or to disperse a tablet in a small amount of water and give some of the mixture. Your doctor,  pharmacist or epilepsy nurse will let you know if this is necessary and explain what to do.
• This method should only be used when there is no other option and you have been told to do it. 
• Any unused mixture should be poured into a paper towel and put in the bin. Do not pour it down the sink.

Your child can chew the dispersible tablets. They should then drink a glass of water, milk or fruit juice.

When should the medicine start working?

It may take up to 6 weeks for lamotrigine to work properly, so your child may still have seizures during this time. This is because the amount of medicine has to be increased slowly. Continue to give the medicine in the way you have been told to by your doctor or epilepsy nurse. Lamotrigine may not stop your child’s seizures completely. If you are worried about whether it is helping, contact your doctor but continue to give the medicine.

What if my child is sick (vomits)?

• If your child is sick less than 30 minutes after taking a dose of lamotrigine, give the same dose again.
• If your child is sick more than 30 minutes after taking a dose of lamotrigine, you do not need to give them another dose. Wait until the next normal dose.

If your child is sick again, seek advice from your family doctor, pharmacist or hospital. 

What if I forget to give it?

If you are giving it once every other day: Give the missed dose when you remember, as long as this is at least 12 hours before the next dose is due.

If you usually give it once a day in the morning: Give the missed dose when you remember during the day, as long as this is at least 12 hours before the next dose is due.

If you usually give it once a day in the evening: If you remember before bedtime, give the missed dose. You do not need to wake up a sleeping child to give a missed dose. You can give the missed dose in the morning, as long as this is at least 12 hours before the evening dose is due.

If you usually give it twice a day: If you remember up to 4 hours after you should have given a dose, give your child the missed dose. For example, if you usually give a dose at about 7 am, you can give the missed dose at any time up to 11 am. If you remember after that time, do not give the missed dose. Just give the next dose as usual.

Never give a double dose of lamotrigine.

What if I give too much?

If you think you may have given your child too much lamotrigine, contact your doctor or local NHS services (see details at end of leaflet) or take your child to hospital.

Take the medicine packaging with you, even if it is empty. This will be useful to the doctor. Have the packaging with you if you telephone for advice.

Are there any possible side-effects?

We use medicines to make our children better, but sometimes they cause effects that we don’t want (side-effects).

Side-effects that you must do something about

If your child develops a blotchy red skin rash, contact your doctor straight away, as your child may be allergic to lamotrigine. The rash may be anywhere on the body, and you may also see blisters in the mouth. This reaction is most likely to be seen during the first 8 weeks of taking lamotrigine. It is more likely if your child is already taking another medicine for epilepsy called sodium valproate.

If your child has such a rash and is also generally unwell and has a fever (high temperature above 38°C) or unusual bruises or bleeding, take them to your doctor or hospital straight away, as this may indicate a more serious reaction.

• Your child’s skin may become more sensitive to sunlight. Keep them out of strong sun. When outdoors, they should wear a long-sleeved top, trousers and a hat and should use a high-factor sun screen (at least SPF 30).

Other side-effects you need to know about

• Your child may be drowsy (sleepy) when they first start taking lamotrigine. This should get better after a few days as your child gets used to the medicine. If it doesn’t, contact your doctor but continue to give lamotrigine.
• They may develop a tremor (shakiness), their coordination may be affected (they may seem clumsy) or they may have blurred vision. They may also have changes in mood and may be aggressive or hyperactive (more active than usual and finding it hard to relax). They may have sleep disturbances, such as difficulty getting to sleep. If you are worried contact your doctor.

If you notice any other side-effects and are concerned, contact your doctor. You can report any suspected sideeffects to a UK safety scheme at http://www.mhra.gov.uk/yellowcard.

Can other common medicines be given at the same time as lamotrigine?

• You can give your child medicines that contain paracetamol or ibuprofen, unless your doctor has told you not to.
• Check with your doctor or pharmacist before giving any other medicines to your child. This includes herbal and complementary medicines.

Epilepsy and pregnancy

• Pregnancy presents a risk to both the mother with epilepsy and her unborn baby. If your daughter has sex, it is essential that she uses adequate contraception to prevent an unplanned pregnancy.
• If your daughter is worried that she may be pregnant, it is important that she sees your family doctor as early as possible. Your daughter should keep taking her medication until she sees her doctor.

Lamotrigine and pregnancy

• Lamotrigine may harm an unborn baby.
• The oral contraceptive pill may not work properly in women or girls who are taking a high dose of lamotrigine.
• Lamotrigine may not work properly in those taking the oral contraceptive pill or in pregnancy.

General advice about medicines for seizures

Do not suddenly stop giving any of these medicines to your child, as they may have a seizure. If you are worried, talk to your doctor but carry on giving the medicine to your child as usual.

If your child seems to have more seizures than usual, contact your doctor or epilepsy nurse.

• If your doctor decides to stop a particular medicine, they will discuss this with you. You will usually reduce the dose bit by bit.

Do not change the dose of any drug without talking to your doctor first.

• It is best that your child always has the same brand of each medicine, as there may be differences between brands. Keep a record of which medicines your child has.
• Try to give medicines at about the same times every day, to help you remember.
• Only give the medicine(s) to your child. Never give them to anyone else, even if their condition appears to be the same, as this could do harm.

If you think someone else may have taken the medicine by accident, contact your doctor straight away.

• Make sure that you always have enough medicine. Order a new prescription at least 2 weeks before you will run out.
• Make sure that the medicines you have at home have not reached the ‘use by’ date on the packaging. Give old medicines to your pharmacist to dispose of.

Where should I keep this medicine?

• Keep the medicine in a cupboard, away from heat and direct sunlight.
• Make sure that children cannot see or reach the medicine.
• Keep the medicine in the container it came in

Who to contact for more information

Your child’s hospital doctor, epilepsy nurse or pharmacist will be able to give you more information about lamotrigine and other medicines used to treat epilepsy.

Lamotrigine for epilepsy. Side effects, dosage of lamotrigine.

About lamotrigine

Having epilepsy means that you have had more than one unexplained fit, or seizure. A seizure is a short episode of symptoms caused by a burst of abnormal electrical activity in your brain. Different parts of the brain control different functions of your body, so the symptoms that occur during a seizure will depend on where the abnormal burst of electrical activity occurs. Symptoms that may occur during a seizure can affect your muscles, sensations, behaviour, emotions, and consciousness, or a combination of these. The seizures can be prevented in most people by suitable antiepileptic medication. Lamotrigine is a commonly used medicine. It works by stabilising the electrical activity of your brain, which helps to prevent the seizures from occurring.

Lamotrigine is also prescribed as a treatment for bipolar disorder, which is a condition where there can be extreme mood swings. It is helpful in preventing the periods of depression that occur in people with this disorder.

Before taking lamotrigine

Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking lamotrigine it is important that your doctor knows:

• If you are pregnant, trying for a baby or breastfeeding.
• If you have any problems with the way your kidneys work, or with the way your liver works.
• If you have Parkinson’s disease.
• If you are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.
• If you have ever had an allergic reaction to a medicine.

How to take lamotrigine

• Before you start the treatment, read the manufacturer’s printed information leaflet from inside the pack. It will give you more information about lamotrigine and will provide you with a full list of the side-effects which you may experience from taking it.
• Take lamotrigine exactly as your doctor tells you to. Your dose will be printed on the label of the pack to remind you about what the doctor said. It is usual to start treatment on a low dose, and then for the dose to be increased gradually to a regular maintenance dose. It is usual to take either one or two doses every day. Doses for children are tailored to their age and weight.
• Try to take your doses at the same times of day, each day. Having a routine will help you to remember to take your doses regularly. You can take lamotrigine either before or after meals.
• Swallow the tablet with a drink of water. If you have been supplied with lamotrigine dispersible/chewable tablets, you can stir the tablet into a little water to help you swallow, or you can chew the tablet before swallowing it.
• If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose, in which case leave out the missed dose. Do not take two doses together to make up for a forgotten dose. 

Getting the most from your treatment

• When you first start a new treatment for epilepsy there may be a change in the number or type of seizures you experience. Your doctor will advise you about this.
• Try to keep your regular appointments with your doctor. This is so your doctor can check on your progress.
• Different formulations and makes of lamotrigine can act in a slightly different way in your body. Because of this, your doctor may recommend that you continue to take lamotrigine from the same manufacturer each time you obtain a new supply. If so, each time you collect a prescription, check to make sure your supply looks the same and that the name is the same. If you are unsure, or if you have any questions about your prescription, please ask your pharmacist to advise you.
• If you buy any medicines, check with a pharmacist that they are suitable for you to take.
• While you are being treated for epilepsy there is a small risk that you may develop mood changes, distressing thoughts and feelings about suicide. If this happens, you must tell your doctor about it straightaway.
• People with epilepsy must stop driving at first. Your doctor will advise you about when it may be possible for you to start driving again. This will usually be after a year free of seizures.
• Antiepileptic medicines can harm an unborn child. If you are a woman, make sure you have discussed with your doctor which types of contraception are suitable for you and your partner. If you want to have a family, discuss this with your doctor so that you can be given advice from a specialist before you become pregnant.
• You need to take lamotrigine regularly every day. Do not stop taking it unless your doctor tells you to stop. Stopping treatment suddenly can cause problems and your doctor will probably want you to reduce your dose gradually if this becomes necessary.
• If you drink alcohol, ask your doctor for advice. Your doctor may advise you not to drink alcohol while you are on this medicine.

Can lamotrigine cause problems?

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with lamotrigine. You will find a full list in the manufacturer’s information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.

Important: your doctor will discuss with you the possibility that lamotrigine can cause blood disorders and allergic skin reactions. Although these occur much less commonly than the side-effects listed above, it is important that you contact your doctor straightaway if you experience any of the following symptoms:

• A high temperature (fever) or swollen glands.
• Extreme tiredness.
• Unexplained bruising or bleeding.
• A severe skin rash.

If you experience any other symptoms which you think may be due to lamotrigine, speak with your doctor or pharmacist for further advice.

How to store lamotrigine

• Keep all medicines out of the reach and sight of children.
• Store in a cool, dry place, away from direct heat and light.

Important information about all medicines

Lamotrigine instructions for use: indications, contraindications, side effects – description Lamotrigine tab. 25 mg: 10, 20, 25, 30, 40, 50, 60, 75, 90, 100, 125, 150, 250 or 500 pcs. (46099)

Side effects of second generation antiepileptic drugs | Belousov

Introduction

This article discusses side effects and their incidence in six modern second-generation antiepileptic drugs (PEP-II):

• gabapentin (GBP) – Neurontin, Pfizer and other generics;
• lamotrigine (LTD) – Lamictal, GlaxoSmithKline and other generics;
• levetiracetam (LEV) – Keppra, Pliva;
• Oxcarbazepine (OKS) – Trileptal, Novartis;
• pregabalin (PHB) – Lyrica, Pfizer;
• topiramate (TPM) – Topamax, Janssen-Silag and other generics.

All data on side effects of AED-II are obtained from controlled clinical trials.

Compared to the first generation drugs (PEP-I): phenobarbital (PB), primidone (PRD), phenytoin (PNT), carbamazepine (KBZ), valproic acid (VPA), most PEP-II have much fewer side effects, associated with the stimulation or inhibition of enzyme activity, for example, cognitive, hormonal and others. This simplifies therapy and improves patient compliance, which is absolutely necessary for the successful management of patients with partial or generalized epilepsy [25].PEP-IIs expand the treatment arsenal and represent a new step in optimizing individualized therapy for epilepsy.

Although these drugs are safer and better tolerated, most of them do cause adverse side effects. The table summarizes the incidence of the most common side effects of some AED-II.

Table. Frequency of side effects of some new antiepileptic drugs, modified from [7]

9000 T 900

n = 711 (%)

Heads 9000

10 (1.8)

Headache

9000 (4.4)