Colchicine Oral Tablet Side Effects: How to Manage Them

If you have gout or an inherited condition called familial Mediterranean fever (FMF), you may be interested in learning more about colchicine. It’s a generic prescription drug used to:

• treat gout symptoms in adults
• help prevent flare-ups of gout symptoms in adults
• help prevent episodes of FMF in adults and some children

For gout, you may take colchicine on a short-term or long-term basis. For FMF, you’ll typically take colchicine as a long-term treatment.

Colchicine comes as tablets that you swallow. It also comes as capsules that you swallow. But this article only covers the tablet form of colchicine, not the capsules.

This article describes colchicine’s side effects (also called adverse effects). For more information about colchicine, including details about its uses, see this in-depth article.

Some people may experience mild to serious side effects during their colchicine treatment. Examples of colchicine’s more commonly reported side effects include:

• diarrhea*
• nausea and vomiting
• belly pain

* To learn more about this side effect, see the “Side effects explained” section below.

Examples of mild side effects that have been reported with colchicine include:

• diarrhea*
• nausea and vomiting
• belly pain
• fatigue (low energy)
• headache
• sore throat
• mild allergic reaction*†

* To learn more about this side effect, see the “Side effects explained” section below.
† An allergic reaction is possible after using colchicine. But this side effect wasn’t reported in studies.

In most cases, these side effects should be temporary. And some may be easily managed. But if you have any symptoms that are ongoing or bother you, talk with your doctor or pharmacist. And do not stop taking colchicine unless your doctor recommends it.

Colchicine may cause mild side effects other than the ones listed above. See the drug’s prescribing information for details.

Serious side effects that have been reported with colchicine include:

• nerve damage that causes numbness or tingling in your fingers or toes
• rhabdomyolysis*
• blood disorders*
• severe allergic reaction*†

If you develop serious side effects while taking colchicine, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.

* To learn more about this side effect, see the “Side effects explained” section below.
† An allergic reaction is possible after using colchicine. But this side effect wasn’t reported in studies.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you’d like to notify the FDA about a side effect you’ve had with colchicine, visit MedWatch.

Get answers to some frequently asked questions about colchicine’s side effects.

Does colchicine cause any side effects related to the kidneys or liver?

Yes, colchicine can cause certain side effects that could affect your kidneys or liver.

For example, if you have severe diarrhea or vomiting, you may become dehydrated. Dehydration can lead to kidney problems, which could raise your risk of side effects with colchicine.

Colchicine can also cause rhabdomyolysis, which is a breakdown of muscle cells. This side effect can lead to kidney damage if it’s not treated. To learn more about these side effects, see “Colchicine’s side effects explained” below.

There have also been reports of raised liver enzymes in people taking colchicine since the drug became available for use. Raised liver enzymes could be a sign of liver damage. But it’s unclear how often this has happened or whether colchicine was the cause.

Colchicine is cleared from your body by your liver and kidneys. If you have liver or kidney problems, colchicine could build up in your body. This could raise your risk of the side effects noted above, as well as other side effects of colchicine. If you have liver or kidney problems, your doctor may prescribe a lower dosage of colchicine for you.

If you’re concerned about how colchicine may affect your liver or kidneys, talk with your doctor.

Does the risk of side effects with colchicine vary depending on my dosage (such as 0.6 mg vs. 1.2 mg)?

It’s possible. As with many medications, higher dosages of colchicine may be more likely to cause side effects than lower dosages.

Other factors can also affect your risk of side effects with colchicine. These include your age, other conditions you have, and other medications you take.

If you’re concerned about your risk of side effects with the colchicine dosage you’ve been prescribed, talk with your doctor.

Does colchicine cause weight loss or weight gain?

No, colchicine isn’t known to cause weight loss or weight gain. These side effects weren’t reported in studies of the drug.

Colchicine can cause digestive side effects such as nausea, diarrhea, and belly pain. Your appetite may be reduced if you have these side effects, which in some cases could lead to weight loss.

If you’re concerned about changes in weight with colchicine, talk with your doctor.

Does colchicine cause any long-term side effects?

It’s possible, but this is rare. Most of colchicine’s side effects go away in a few days or weeks, or soon after you stop taking the medication.

But there have been some reports of rhabdomyolysis (breakdown of damaged muscle) in people taking colchicine. If you develop this side effect, it could take several months after stopping colchicine for your symptoms to get better. This side effect could also cause long-term kidney problems. Taking colchicine for a long period of time may raise your risk of rhabdomyolysis.

To learn more about rhabdomyolysis, see “Colchicine’s side effects explained” below.

If you’re concerned about long-term side effects with colchicine, talk with your doctor.

Is hair loss a side effect of colchicine?

It’s possible. Hair loss wasn’t reported in studies of colchicine. There have been some reports of hair loss since the drug became available for use, but it’s unclear how often this has happened or whether colchicine was the cause.

If you have hair loss or hair thinning that bothers you with colchicine, talk with your doctor. They can try to determine the cause and suggest ways to manage hair loss.

Learn more about some of the side effects colchicine may cause.

Diarrhea

Some people may have diarrhea while taking colchicine. In studies, diarrhea was a common side effect reported by people taking colchicine.

Diarrhea is usually mild, but it can sometimes be severe. And if you don’t replace the fluids you lose with diarrhea, this can lead to serious problems.

Losing more fluids than usual can make you dehydrated. Dehydration can lead to kidney problems. If you develop kidney problems while taking colchicine, the medication could build up in your body. This could raise your risk of side effects.

What might help

If you have diarrhea while taking colchicine, it’s important to replace the fluids you’re losing. Drink plenty of fluids, especially after each bowel movement. You can drink plain water, but it can also be helpful to drink a rehydration solution, such as Pedialyte, or a sports drink, such as Gatorade. These help replace electrolytes (minerals such as sodium) that you can lose with diarrhea.

If you have diarrhea that’s severe or doesn’t go away in a few days, talk with your doctor or pharmacist. They may recommend taking a medication such as loperamide (Imodium) to treat the diarrhea. Your doctor may also have you stop taking colchicine.

Rhabdomyolysis

Colchicine may cause a serious, possibly life threatening side effect called rhabdomyolysis. With this condition, you have a breakdown of damaged muscles in your body. This can lead to a buildup of protein in your bloodstream, which may cause kidney damage.

It’s not known how often rhabdomyolysis occurs with colchicine. You may have a higher risk of this side effect if you’re age 65 years or older, have kidney or liver problems, or take certain medications with colchicine.

Symptoms of rhabdomyolysis can include:

• muscle pain or tenderness
• muscle weakness
• fatigue (low energy)
• feeling generally unwell
• nausea and vomiting
• dark-colored urine

What might help

Before taking colchicine, tell your doctor if you have a kidney or liver problem. They may prescribe a dosage of the drug that’s lower than usual. Doing so could help lower your risk of rhabdomyolysis.

To avoid interactions that can raise your risk of rhabdomyolysis, tell your doctor about any other medications, herbs, or supplements you take before starting colchicine. While taking colchicine, always check with your doctor or pharmacist before taking any new medications, herbs, or supplements.

You should avoid drinking grapefruit juice and eating grapefruit while taking colchicine. Consuming grapefruit can cause colchicine to build up in your body, which can raise your risk of rhabdomyolysis.

If you have symptoms of rhabdomyolysis while taking colchicine, speak with your doctor right away. This condition can be life threatening if it’s not treated quickly. Your doctor will likely have you stop taking colchicine.

Blood disorders

Colchicine may cause serious blood disorders. For example, it may cause low levels of red blood cells, white blood cells, or platelets (cells that help with blood clotting).

It’s not known how often blood disorders occur with colchicine, but they are rare.

Symptoms of blood disorders may include:

• fatigue
• dizziness
• frequent infections
• fever
• bruising easily
• unusual bleeding, such as nosebleeds, bleeding gums, or bleeding that takes longer than usual to stop

What might help

If you have any of the symptoms listed above while taking colchicine, speak with your doctor right away. They will likely do a blood test to check your blood cells. In some cases, they may have you stop taking colchicine.

Allergic reaction

Like most drugs, colchicine can cause an allergic reaction in some people. But this side effect wasn’t reported in studies.

Symptoms can be mild to serious and can include:

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)
• swelling under your skin, usually in your eyelids, lips, hands, or feet
• swelling of your mouth, tongue, or throat, which can make it hard to breathe

What might help

If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest a treatment to manage your symptoms. Examples include:

• an antihistamine you take by mouth, such as Benadryl (diphenhydramine)
• a product you apply to your skin, such as hydrocortisone cream

If your doctor confirms you’ve had a mild allergic reaction to colchicine, they’ll decide whether you should continue using it.

If you have symptoms of a severe allergic reaction, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms you’ve had a serious allergic reaction to colchicine, they may have you switch to a different treatment.

Keeping track of side effects

During your colchicine treatment, consider taking notes on any side effects you’re having. You can then share this information with your doctor. This is especially helpful when you first start taking new drugs or using a combination of treatments.

Your side effect notes can include things such as:

• what dose of the drug you were taking when you had the side effect
• how soon you had the side effect after starting that dose
• what your symptoms were
• how it affected your daily activities
• what other medications you were taking
• any other information you feel is important

Keeping notes and sharing them with your doctor will help them learn more about how colchicine affects you. They can then use this information to adjust your treatment plan if needed.

Colchicine may not be right for you if you have certain medical conditions. These are known as drug-condition interactions. Other factors may also affect whether colchicine is a good treatment option for you.

Talk with your doctor about your health history before starting colchicine. Factors to consider include those described below.

Kidney problems. Colchicine is removed from your body by your kidneys. If you have kidney problems, colchicine could build up in your body. This could raise your risk of serious side effects, especially rhabdomyolysis. (To learn more about this side effect, see “Colchicine’s side effects explained” above.)

Due to the risk of side effects, your doctor will likely prescribe a lower dosage of colchicine if you have kidney problems.

Liver problems. Colchicine is broken down by your liver. If you have liver problems, colchicine could build up in your body. This could raise your risk of serious side effects. Due to this risk, your doctor may prescribe a dosage of colchicine that’s lower than usual.

Other medications. Taking colchicine with certain other medications can cause colchicine to build up in your body, especially if you have liver or kidney problems. This can raise your risk of serious, even life threatening side effects.

Due to this risk, if you have liver or kidney problems and take certain medications, your doctor may not prescribe colchicine. Before starting colchicine treatment, tell your doctor about any other medications you take. While taking colchicine, always check with your doctor or pharmacist before starting any new medications.

Allergic reaction. If you’ve had an allergic reaction to colchicine or any of its ingredients, your doctor will likely not prescribe colchicine. Ask them what other medications are better options for you.

Alcohol and colchicine

Colchicine isn’t known to interact with alcohol. But drinking alcohol while taking colchicine could raise your risk of certain side effects, such as headache, nausea, or diarrhea.

Drinking alcohol can also worsen symptoms of gout, which colchicine is used to treat. If you have gout, your doctor will likely recommend avoiding alcohol.

If you drink alcohol, talk with your doctor about how much (if any), may be safe to consume while you’re taking colchicine.

Pregnancy and breastfeeding while taking colchicine

It’s not known if colchicine is safe to take during pregnancy. If you’re pregnant or planning to become pregnant, talk with your doctor about the possible risks and benefits of taking colchicine.

It’s not known whether colchicine is safe to take while breastfeeding. Colchicine can pass into breast milk. But side effects haven’t been reported in children exposed to the drug through breast milk. If you’re breastfeeding or planning to breastfeed, talk with your doctor before taking colchicine.

Most of colchicine’s side effects are mild and easily managed. But the medication can sometimes cause serious side effects.

If you have any questions about side effects that colchicine can cause, talk with your doctor. You can also ask them about Colcrys, which is the brand-name version of colchicine.

A generic drug and its brand-name version are expected to have the same side effects because they contain the same active ingredient. (An active ingredient is what makes a drug work.)

Examples of questions you may want to ask your doctor include:

• Is my risk of side effects higher when I first start taking colchicine?
• What are the side effects of taking colchicine off-label for pericarditis?
• Is it safe to take colchicine with my other medications?
• How do the side effects of colchicine compare with those of other drugs used to treat gout, such as nonsteroidal anti-inflammatory drugs (NSAIDs)?

To get information on different conditions and tips for improving your health, subscribe to any of Healthline’s newsletters. You may also want to check out the online communities at Bezzy. It’s a place where people with certain conditions can find support and connect with others.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Colchicine side effects and how to avoid them

Colchicine is commonly prescribed to treat gout and other conditions such as Familial Mediterranean Fever (FMF). Colchicine is not recommended for long-term use and can have many side effects.

Glipizide side effects | Diarrhea | Serious side effects |
Colchicine toxicity | Kidney injury | How long do side effects last? | Warnings | Interactions | How to avoid side effects

If you are one of the 9.2 million Americans that have suffered from a gout attack this year, your healthcare provider may have prescribed an antigout medication named colchicine to help ease your symptoms. This medication has been around since the ninth century and remains a popular option for patients and healthcare professionals.   

Colchicine is a U.S. Food and Drug Administration (FDA) approved drug that is safe for use in both adults and children. It is a plant-based alkaloid from the autumn crocus and glory lily. Although most commonly used for gout management and prevention, the medication can also be used for the treatment of the genetic condition Familial Mediterranean Fever (FMF) and helps to manage the symptoms of Behcet’s syndrome, pseudogout, and pericarditis.

Currently, colchicine can only be acquired by a prescription from a healthcare provider. There are many forms of colchicine available.  It can be prescribed in either a capsule (Mitigare), tablet (Colcrys), or liquid form. It is important to note that colchicine cannot cure any of the medical conditions that it treats and is only used to manage symptoms. This medication also is not recommended for long-term use for pain management.

Common side effects of colchicine

There are quite a number of side effects associated with the use of colchicine. Luckily most are related to symptoms of gastrointestinal distress, but all are usually short-lived. The most common symptoms to be aware of when using colchicine include: 

• Diarrhea
• Nausea
• Vomiting
• Cramping
• Abdominal pain
• Fatigue
• Headache
• Sore throat

Diarrhea

As previously discussed, gastrointestinal symptoms are quite common with the use of colchicine. Diarrhea tends to be the most prevalent complication seen with its use. Although colchicine has been available for centuries, there are not many studies available that evaluate its use. A systematic review was performed in 2017 that found diarrhea could be seen in as many as 3 out of 4 patients prescribed with the original recommended dosage for colchicine.  This dosage has since been studied and adjusted. Because of the potential gastrointestinal concerns associated with colchicine, the lowest effective dose is always recommended.

Serious side effects of colchicine

Although colchicine is considered a safe drug, one must note that there are some serious adverse effects associated with its use. If any of the following symptoms below occur while using colchicine, your medical provider should be contacted immediately for further medical attention. 

• Myelosuppression (decreased bone marrow activity)
• Leukopenia (reduced white blood cells)
• Thrombocytopenia (reduced platelets)
• Granulocytopenia (reduced granulocytes)
• Pancytopenia (reduced red blood cells)
• Aplastic anemia
• Severe diarrhea
• Myopathy (disease of muscle tissue)
• Rhabdomyolysis (serious condition of muscle fibers entering the bloodstream)
• Neuropathy (nerve damage)
• Hepatotoxicity (liver damage)
• Nephrotoxicity (kidney damage)
• Multiple organ failure
• Disseminated intravascular coagulation (abnormal blood clotting in the body)
• Hypersensitivity reaction
• Reversible azoospermia (absence of viable sperm in semen)

Colchicine toxicity

Since there is minimal room for error when dosing colchicine safely, one must be aware of certain symptoms that may represent signs of toxicity. Gastrointestinal symptoms, the most common side effects with the use of colchicine, are usually the first symptoms of toxicity. When these symptoms (usually diarrhea and vomiting) occur, the medication is frequently stopped. This is because it may be hard to judge if the medication is continued that there will be more serious adverse effects that occur. Less common symptoms usually involve multiorgan failure and lastly death.  

Colchicine toxicity is commonly divided into three stages. Stage one involves the common and initial symptoms of diarrhea, nausea, and vomiting. These symptoms may cause severe dehydration resulting in low blood pressure and an irregular amount of blood cells in the body. This stage typically lasts anywhere from 1-12 hours. Stage two usually lingers for 1-7 days and involves more catastrophic complications such as bone marrow suppression, multi-organ failure, kidney failure, altered mental status, and heart attack. Finally, stage three includes hair loss and rebound elevated blood count that will last 1-2 weeks for those individuals that survive stage two.   

Because the stages of colchicine toxicity may overlap, close monitoring is vital if any symptoms begin to occur—even minor ones. Early intervention may be required to prevent fatalities associated with its use.

Kidney injury

Although not common, there are some studies showing direct toxicity of the kidneys due to the use of colchicine. They report kidney damage as well as the potential for kidney failure from the direct toxic effect of colchicine on the kidney tubules. Most studies show acute kidney damage from colchicine use is reversible. Typically kidney damage related to colchicine is a direct result of chronic use of the medication at high doses. Because kidney damage is always a concern with any medication, colchicine management should be monitored closely by a medical professional.

How long do side effects last?

The majority of side effects from colchicine are considered minor and short-lived. These usually include gastrointestinal side effects like abdominal pain, nausea, vomiting, and diarrhea that can start as early as two hours after initiating treatment. The symptoms may linger for a few days or up to a couple of weeks. Some of the more serious side effects like multiorgan failure may start around 8-72 hours after consumption. Symptoms may not fully go away for 7-10 days. Long-term side effects like numbness are less common with colchicine utilization. The quicker onset of symptoms appears to be found more with the use of intravenous colchicine versus the oral formulation.  

Colchicine contraindications & warnings

Abuse and dependence

Colchicine is not a habit-forming drug and does not pose any risk of dependency with the use of this medication. Additionally, there are no withdrawal symptoms documented with the discontinuation of the medicine.

Overdose

It is recommended that no more than 0.5 mg/kg of colchicine be prescribed to prevent a fatal overdose of the medication. Understanding how to properly use this medication is important as there is no antidote to reverse the effects of the medication. This may be fatal. Currently, activated charcoal and saline flushing is the traditional treatment for an overdose and should be started as quickly as possible.

Colchicine restrictions

 Do not use colchicine if you have:

• Known allergic reaction to the medication
• Known liver disease especially when preventative management is needed
• Known kidney disease especially when preventative management is needed

Colchicine should be avoided, if another option is available, in seniors and individuals with blocked bile ducts.

Pregnancy and breastfeeding

Colchicine has been shown to be safe for use during pregnancy with no adverse effects noted to the fetus or mother. However, it is advised that colchicine be avoided while breastfeeding. Currently, there is no human data to support damage to breast milk production or harm to the infant, so caution has been recommended at this time. When deciding to take colchicine under these circumstances, the potential benefits should always outweigh the risks.

Children

Colchicine has been approved for use in pediatric patients as young as four years old. This is only for the treatment of the genetic condition Familial Mediterranean Fever (FMF). Gout prophylaxis can be used only for those over the age of 16.

Seniors

Close monitoring is needed when prescribing colchicine to seniors. Kidney function may not work as well which causes colchicine to not be processed in the body adequately. This increases the risk for side effects with this medication. To counteract this possibility, a lower dose of colchicine may be considered or a different medication altogether.  

Colchicine interactions

There is a wide range of medications that should be monitored closely or avoided when there is a consideration for prescribing colchicine.

Contraindications

Colchicine is absolutely contraindicated with certain HIV/antivirals, macrolide antibiotics, cancer medications, antifungals, and heart prescription drugs. They have the potential to increase the amount of colchicine levels in the body which results in colchicine toxicity and other serious adverse effects. This is especially true if there is liver or kidney disease present. Some of these medications include:

• Atazanavir
• Clarithromycin
• Cyclosporine
• Itraconazole
• Ketoconazole
• Lopinavir/Ritonavir
• Ribociclib
• Ritonavir
• Saquinavir
• Voriconazole
• Voxilaprevir

Other drug interactions

• Statins. This includes popular cholesterol medications such as atorvastatin, fluvastatin, lovastatin, pravastatin, and simvastatin.
• Antibiotics. Antibiotics such as ciprofloxacin and erythromycin should be avoided as they pose a risk of muscle pain and damage when combined with colchicine.
• NSAIDs. Certain anti-inflammatories should also be closely monitored. Examples include indomethacin and naproxen.

Other interactions

If supplements such as vitamin B12, turmeric, milk thistle, or ginkgo are being used, they should always be disclosed to your healthcare provider due to potential interactions when added with colchicine. Additionally, any products containing grapefruit should be avoided as they may cause unwanted side effects with colchicine use.

How to avoid colchicine side effects

1. Provide your healthcare provider with a current list of all medications 

Information should be provided that includes all prescription and over-the-counter medications, vitamins, and herbal supplements.

2. Supply your healthcare provider with a complete medical history 

Because colchicine toxicity poses a higher risk for those with certain medical conditions, a complete history should be provided so that it can be determined if you are a good candidate to take this medication. Disclosure of liver disease, kidney disease, pregnancy, or if you are breastfeeding is important.

3. Medication should only be given to those who are 4 years old and older. 

Colchicine has only been FDA approved for those who are 4 years old or older. Infants and toddlers should not be given colchicine.  

4. Always take your medication on time

Keep a record of when you should take your medication. If there is a missed dose, take it as soon as you remember. If the missed dose is close to your next scheduled dose, take that one instead.

5. Take medication as directed by your healthcare professional

Do not take more or less of this medication without the guidance of your physician. Even small increases of colchicine can be life-threatening and may not improve symptoms. Taking colchicine will vary based on your age, the medical condition being treated, medical history, and how you react to the medication. If your symptoms are not improving, do not take more medication or take them for longer than recommended.   

• Acute gout: When taking colchicine for an acute gout flare, usually larger doses are prescribed initially. The medication should be discontinued as soon as the pain has cleared up. If any acute symptoms of diarrhea, vomiting, nausea, or stomach pain occur, the medication should be discontinued immediately.
• Gout prevention: When taking colchicine for an extended time for gout prevention, smaller dosages will be given but for longer periods of time. This medication may be given in addition with other gout medications like allopurinol. Depending on other medical conditions that may need to be treated, colchicine may be prescribed for the rest of someone’s life. Close monitoring may be required in this scenario along with laboratory testing.  

6. Monitor symptoms closely

Overdose of colchicine can be fatal. Contact your physician immediately if you notice any of the following:

• Diarrhea
• Vomiting
• Stomach pain
• Muscle weakness
• Little or no urinating
• Numbness or tingling
• Weak pulse
• Slow heart rate
• Weak or shallow breathing
• Fainting

7. Avoid grapefruit juice

Grapefruit products of any kind should be avoided while taking colchicine as they may lead to some of the side effects discussed above by increasing the levels of colchicine in the body.

Related Resources for colchicine side effects

• Colchicine, Epocrates
• Colchicine Overdose-Induced Acute Renal Failure and Electrolyte Imbalance, Renal Failure
• Diarrhea in Adults, Merck Manual
• Diagnosis and Treatment of Colchicine Poisoning, California Poison Control System
• Gout and hyperuricaemia in the USA: prevalence and trends, Rheumatology
• Hepatotoxicity and nephrotoxicity of colchicine prolonged use in the rats, International Journal of Advanced Research
• Lessons from the Courtroom: Colchicine Toxicity, Emergency Medicine News
• Management of Gout: A Systematic Review in Support of an American College of Physicians Clinical Practice Guideline, Annals of Internal Medicine
• The Ugly Side of Colchicine,  Journal of Investigative Medicine High Impact Case Reports

Arpimed

What Colchicine is and what it is used for

Colchicine tablets contain colchicine as the active ingredient. Colchicine is an anti-gout medication and is used to prevent and treat gout attacks.

Gout attacks in adults

Colchicine is used for the short-term treatment of gout attacks.

Colchicine is also used to prevent the recurrence of gout attacks. The concentration of uric acid in the blood is increased in gout. Excess uric acid in the blood can lead to the formation and accumulation of uric acid crystals in and around the joints. Colchicine inhibits the development of the inflammatory response.

Familial Mediterranean fever (periodic illness)

In addition, colchicine is used to treat familial Mediterranean fever (periodic illness) to prevent attacks of fever and amyloidosis (abnormal precipitation of proteins in tissues and organs).

You should consult your doctor if you do not get better or get worse.

What you need to know before using Colchicine

Do not take Colchicine:

• if you are allergic to colchicine or any of the other ingredients of this drug
• if you have a serious blood disorder
• if you have severe kidney problems
• if you have severe liver problems
• during pregnancy
• while breastfeeding
• if you are a woman of childbearing age and are not using effective contraception while taking this medicine
• if you are on hemodialysis because colchicine cannot be removed by dialysis or exchange transfusion
• if you suffer from kidney or liver failure and are taking P-glycoprotein inhibitors or strong inhibitors of CYP3A4

Warnings and Precautions

There is little difference between the effective dose of colchicine and the dose that produces symptoms of intoxication, meaning that even a slight increase in dose can cause acute symptoms of drug intoxication. If you experience symptoms such as nausea, vomiting, abdominal pain, and diarrhea, stop taking colchicine and contact your doctor immediately.

Talk to your doctor or pharmacist before using this medicine. if one or more of the following conditions are present or have happened to you in the past.

• if you have liver and kidney problems
• if you have cardiovascular disease
• if you have gastrointestinal problems
• if you are an elderly and weak person
• if you have a blood disorder.

Colchicine can cause acute bone marrow depression (loss of some white blood cells (agranulocytosis), a deficiency in platelets (thrombocytopenia), a decrease in the number of red blood cells and hemoglobin due to insufficient production of red blood cells (aplastic anemia).

You need regular blood tests,

If you have symptoms such as fever, sore throat, sore throat, prolonged bleeding, bruising or skin problems, stop taking this medicine and call your doctor right away. blood problems and your doctor may refer you for immediate blood tests.0003

Long-term use of colchicine can lead to vitamin B12 deficiency.

Children and adolescents under 18 years of age

Colchicine should only be administered to children under the supervision of a medical specialist. There are no data on the effect of long-term use of colchicine on the body of children.

Other medicines and Colchicine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In case of long-term treatment, check blood counts regularly. If you suffer from liver or kidney problems, talk to your doctor before taking this medicine.

When you use colchicine with the following medicines, side effects are more likely to occur and can be severe. You should talk to your doctor or pharmacist if you are taking:

• treatment of bacterial infections). The use of these antibiotics during treatment with colchicine can cause intoxication. If possible, do not take these antibiotics during treatment with colchicine. If treatment with other drugs is not possible, the doctor should reduce the dose of colchicine and constantly monitor your condition,
• ketoconazole, itraconazole, voriconazole (antifungals). You should not use these drugs while on colchicine,
• ritonavir, atazanavir, amprenavir, saquinavir, nelfinavir, fosamprenavir, and indinavir (protease inhibitors used to treat HIV infection). You should not use these medicines while on colchicine,
• verapamil, quinidine and diltiazem (medicines used to treat heart disease).
• cyclosporine (immunosuppressant).

Tell your doctor or pharmacist if you are taking any of the following drugs: and red-brown urine color (rhabdomyolysis):

• simvastatin, fluvastatin, or pravastatin (statins, medicines used to lower cholesterol)
• fibrates (drugs that lower cholesterol and some blood fats)
• digoxin (a medicine used to treat heart failure and arrhythmias).
• cimetidine (used to treat intestinal or stomach ulcers) and tolbutamide (used to lower blood sugar). They may enhance the effects of colchicine.
• vitamin B ₁₂ (cyanocobalamin). Colchicine may reduce the absorption of vitamin B ₁₂ from the gastrointestinal tract.

Colchicine with food and drink

Do not drink grapefruit juice during colchicine treatment.

Pregnancy, breast-feeding and fertility

If you are pregnant or breastfeeding, think you are pregnant or are planning to become pregnant, talk to your doctor or pharmacist before using this medicine.

Women of childbearing age

Treatment of gout

Women of childbearing potential should use effective contraception for at least 3 months after stopping colchicine treatment for gout. If, however, pregnancy occurs during this period of time, genetic counseling should be carried out.

Pregnancy

Treatment of gout:

You should not use colchicine if you are pregnant or planning to become pregnant. If, however, pregnancy occurs during treatment with colchicine or within 3 months of stopping treatment, genetic counseling should be performed.

Treatment of familial Mediterranean fever (periodic illness):

colchicine during pregnancy should be weighed against potential risks and may be considered in case of special clinical need.

Breastfeeding

Colchicine passes into breast milk.

Nursing mothers with gout should not take colchicine.

A decision should be made whether to stop breastfeeding or stop colchicine therapy, taking into account the benefits of breastfeeding for the baby and the benefits of colchicine therapy for the woman.

Fertilization

Gout Treatment:

Male patients should not have a child during and for at least 6 months after the treatment of colchicin. If a woman does become pregnant during this period of time, genetic counseling should be performed.

Treatment of familial Mediterranean fever (periodic illness):

ii, the use of colchicine must be weighed against the potential risks and may be considered in case of special clinical need.

Driving and operating machinery

There are no data on the effect of colchicine on the ability to drive vehicles and mechanisms.

However, the possibility of drowsiness and dizziness should be considered.

Important information about some of the ingredients in Colchicine.

The preparation contains sucrose. Talk to your doctor before taking this medicine if you have been told by your doctor that you have an intolerance to some sugars. Colchicine 1 mg tablets contains the dye E124, which can cause allergic reactions.

This medicine contains less than 1 mmol (39 mg) of sodium per tablet, i. e. essentially “sodium free.”

How to take Colchicine

Colchicine should be taken exactly as directed by your doctor. If you have any doubts about taking the drug, you should consult your doctor or pharmacist.

Colchicine can be toxic in too high doses, so it is important not to exceed the dose prescribed by your doctor.

Talk to your doctor or pharmacist if you think the effect of colchicine is too strong or not strong enough.

Adults

Use for gout

Treatment of acute gout attack: 9 0010

The recommended dose is 0.5 mg two to three times a day. Your doctor may decide to prescribe an additional 1 mg on the first day of treatment. Treatment should be discontinued if there are complaints from the gastrointestinal tract or if there is no effect after 2-3 days.

You should not take more than 6 mg of colchicine during your course of treatment. You should not start a new course for at least 3 days after finishing your course of colchicine treatment.

Prevention of a gout attack:

The recommended dose is 0.5-1 mg per day and should be taken in the evening. Your doctor will tell you how long your colchicine treatment will be.

If you have liver or kidney problems

If you have liver or kidney problems, the recommended dose is 0.5 mg colchicine per day and you should be closely monitored. If you have severe liver or kidney dysfunction, do not take this medicine.

Children and adolescents

The medicine should not be used to treat gout in children and adolescents.

Use in familial Mediterranean fever (periodic illness)

The recommended dose is 1-3 mg per day. The daily dose may be single or divided into two doses per day (for doses greater than 1 mg/day).

If you do not feel better, your doctor may gradually increase your colchicine dose to a maximum of 3 mg per day. Each time you increase your dose of colchicine, your doctor should monitor you closely for side effects.

Use in children and adolescents under 18 years of age

For children with familial Mediterranean fever (periodic illness), the recommended dosage depends on age.

Children under 5 years: 0.5 mg daily. Children 5 to 10 years of age: 1 mg daily.

Children over 10 years: 1.5 mg daily.

In children with amyloid nephropathy, the dose may be increased to 2 mg daily.

Dosage for impaired liver or kidney function

If you have impaired liver or kidney function, the recommended dose is halved. If you have severe liver or kidney dysfunction, do not take this medicine (see section “Do not take Colchicine”).

Directions for use

Colchicine tablets should be swallowed whole with a glass of water.

For children under 1 year of age, colchicine oral solution is recommended

If you have taken more colchicine than prescribed, or if, for example, a child accidentally swallows these tablets, there is a risk of toxicity. Contact your doctor, pharmacist or the nearest hospital emergency department immediately.

Symptoms of intoxication

• After taking too much colchicine, the first symptoms of overdose appear within a few hours. These symptoms include burning in the throat, stomach, and skin, nausea, vomiting, abdominal cramps, and bloody diarrhea, which can lead to low blood pH, fluid loss, low blood pressure, and shock.
• Subsequently, the following life-threatening complications may occur 24 to 72 hours after taking too high a dose of colchicine: impaired consciousness with possible delusions (delirium), coma, symptoms of paralysis, respiratory depression, fluid retention in the lungs, kidney damage, circulatory failure, and heart failure.
• Approximately 7 days after taking too high a dose of colchicine, a temporary increase in the number of white blood cells (leukocytosis) and hair loss may occur.

If you forget to take Colchicine:

If you forget to take your next dose, take it as soon as you remember. If it is time for the next dose, the missed dose should not be taken.

Do not take a double dose to make up for a missed dose. If you are not sure, always check with your doctor or pharmacist.

If you stop taking Colchicine:

If you suddenly stop taking colchicine, the symptoms you had before treatment may return. If you are thinking about stopping colchicine, always check with your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Colchicine can cause side effects, although not everybody gets them.

If any of the following adverse reactions occur, stop taking Colchicine and contact your doctor or the nearest hospital and emergency department immediately:

• Nausea, vomiting, abdominal cramps and diarrhea. These side effects are very common (may affect up to 1 in 10 people)
• Muscle weakness (myopathy), red to brown urine color (rhabdomyolysis), muscle pain, fatigue. These side effects are uncommon (may affect up to 1 in 100 people)
• Infection with symptoms such as high fever, severe sore throat and mouth pain, and a severe form of anemia (aplastic anemia). These side effects are rare (may affect up to 1 in 1,000 people)

In addition, the following side effects are observed:

Frequency unknown (cannot be estimated from the available data):

• Hair loss, rash
• Decrease in the number of spermatozoa in seminal fluid or complete absence of spermatozoa in seminal fluid
• Sore throat
• Neuropathy (nerve disease), inflammation of the nerves that can cause pain, numbness, and sometimes nerve dysfunction
• Absence of menstruation for 6 months or more and pain and/or cramps during menstruation
• Vitamin B12 deficiency
• Liver dysfunction

Children and adolescents under 18 years of age

There are no data on the effects of long-term use of colchicine on children and adolescents under 18 years of age.

Reporting side effects:

If you notice any side effects, tell your doctor, pharmacist or pharmacist, including any side effects not listed in this leaflet. . You can also report side effects to Arpimed LLC by going to the website www.arpimed.com and filling out the appropriate form “Report a side effect or ineffectiveness of a drug” and to the Scientific Center for Expertise of Drugs and Medical Technologies named after. Academician E.Gabrielyan by going to the website www.pharm.am in the section – Report a side effect of a drug and fill out the form – Reporting a side effect of a drug. Scientific center hotline: +37410200505; +37496220505. By reporting side effects, you help gather more information about the safety of this drug.

How to store Colchicine

• Do not use Colchicine after the expiry date which is stated on the package. When specifying the expiration date, the last day of the specified month is meant.
• Do not take Colchicine if you notice signs of deterioration in appearance such as discoloration.
• Store at a temperature not exceeding 25 ⁰ C, in a dry and dark place.
• Keep out of reach of children.

Shelf life – 3 years.

Do not dispose of medicines in wastewater or sewers. Ask your pharmacist how to dispose of a medicine you no longer need. These measures are aimed at protecting the environment.

Contents of the pack and additional information

What Colchicine

contains Active ingredient: colchicine – 1 mg per tablet;

Other ingredients: Sugar, povidone, sodium starch glycolate, magnesium stearate, microcrystalline cellulose, dye E-124.

What Colchicine looks like and contents of the pack

Colchicine 1 mg tablet , with chamfer and risk on one side.

Description of packaging

Carton containing 96 tablets in a blister pack (PVC/aluminum) 4 blister packs of 24 tablets, together with a leaflet, are placed in a carton box.

What are the conditions for dispensing Colchicine from pharmacies

Available by prescription.

Colchicine – description of the substance, pharmacology, use, contraindications, formula

Contents

• Structural formula

• Russian name

• English name

• Latin name

• chemical name

• Gross formula

• Pharmacological group of the substance Colchicine

• Nosological classification

• CAS code

• pharmachologic effect

• Characteristic

• Pharmacology

• The use of the substance Colchicine

• Contraindications

• Side effects of Colchicine

• Interaction

• Overdose

• Dosage and administration

• Precautionary measures

• special instructions

• Trade names with the active ingredient Colchicine

Structural formula

Russian name

Colchicine

English name

Colchicine

Latin name

74 Colchicini)

Chemical name

(S)-N-(5,6,7 ,9-Tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo[a]heptalen- 7-yl)acetamide

Gross formula

C ₂₂ H ₂₅ NO ₆

Pharmacological group of the substance Colchicine

Drugs affecting the metabolism of uric acid

Nosological classification

ICD-10 code list

• E85 Amyloidosis

• M10 Gout

• M34 Systemic sclerosis

• M35. 2 Behçet’s disease

CAS code

64-86-8

Pharmacological action

Pharmacological action –

painkiller , antigout .

Characteristics

Corm alkaloid of colchicum splendid (Colchicum Speciosum Stev.) of the lily family. White or white with a yellowish tint fine crystalline powder, darkening in the light. 1 g dissolves in 25 ml of water and 220 ml of ether, easily soluble in ethanol and chloroform.

Pharmacology

Has antimitotic activity, inhibits leukopoiesis and lymphopoiesis, reduces the utilization of glucose by phagocytic and non-phagocytic leukocytes, stabilizes the membranes of neutrophil lysosomes, prevents the formation of amyloid fibrils. Violates neuromuscular transmission, stimulates the functions of the gastrointestinal tract, depresses the respiratory center, constricts blood vessels and increases blood pressure, lowers body temperature.

Rapidly absorbed in the gastrointestinal tract, undergoes enterohepatic recirculation. It practically does not bind to plasma proteins and does not linger in the systemic circulation. In high concentrations accumulates in the kidneys, liver and spleen. Excreted mainly with bile and through the kidneys.

Highly effective for the relief of acute gouty attacks. The anti-gout effect depends on the level in leukocytes, and not in plasma, and is due to a decrease in the release of lysosomal enzymes from neutrophils, a decrease in lactate formation, stabilization of tissue fluid pH and limitation of uric acid crystallization. The anti-inflammatory effect is manifested only in gouty arthritis: it affects the primary inflammatory reaction, incl. local inflammatory infiltration with granulocytes that phagocytize urate crystals, so the best result is obtained when treatment is started early (shortly after the onset of symptoms). In the first 12 hours of therapy, the condition improves significantly in more than 75% of patients. In 80%, it causes adverse reactions from the gastrointestinal tract, which may occur before clinical improvement or simultaneously with it. With intravenous application, side effects from the gastrointestinal tract do not develop and the patient’s condition improves faster. After a single injection, the level in leukocytes increases and does not change for 24 hours. In a daily dose of 1–2 mg, taken daily in 3/4 patients with gout, it reduces the likelihood of recurrent acute attacks. Prevents acute attacks in patients with familial Mediterranean fever (decreased activity of dopamine-beta-hydroxylase). Increases the life expectancy of patients with primary AL-amyloidosis. It has a positive effect on the skin (softening, reducing dryness) with progressive systemic sclerosis (scleroderma). Effective in mild Behcet’s syndrome, primary biliary cirrhosis. Slows down the progression of neurological disorders in multiple sclerosis.

Use of the substance Colchicine

Acute gouty attack, prevention of recurrence of acute gouty attacks, especially in the first 2 years after the start of hypouricemic drugs, systemic scleroderma, amyloidosis, Behçet’s disease, familial Mediterranean fever.

Contraindications

Hypersensitivity, lesions of the gastrointestinal tract, bone marrow, neutropenia, impaired liver and kidney function, cardiovascular pathology, purulent infections, alcoholism, pregnancy, old age.

Side effects of the substance Colchicine

Dyspeptic symptoms (nausea, vomiting, anorexia, diarrhea, etc.) that occur when high doses are taken orally, myelosuppression (leukopenia, agranulocytosis, aplastic anemia, thrombocytopenia – usually with long-term treatment), temporary alopecia, liver failure, increased levels of alkaline phosphatase and gamma-glutamyl transpeptidase, impaired renal function, depression, myopathy, peripheral neuritis, reversible aspermia, malabsorption syndrome, manifested, in particular, by vitamin B deficiency ₁₂ , skin allergic reactions, local irritation with intravenous administration and extravasation – sharp pain, necrosis.

Interaction

Enhances the effect of depriming and sympathomimetic agents. Violates the absorption of vitamin B ₁₂ . NSAIDs and other drugs that cause myelodepression increase the risk of leukopenia and thrombocytopenia. Antigout activity is reduced by cytostatics (increase the concentration of uric acid).

Overdose

Symptoms: nausea, vomiting, severe diarrhea, abdominal and oral pain, hemorrhagic gastroenteritis, skin burning, severe dehydration with hypotension and hypovolemic shock, decreased myocardial contractility and ST segment elevation on ECG, hematuria, oliguria, convulsions, ascending paralysis, respiratory depression. Perhaps the development of hepatocellular damage, acute renal failure, pulmonary infiltrates. 5 days after an overdose, severe bone marrow suppression with leukopenia, thrombocytopenia, and coagulopathy may occur.

Treatment: is carried out in a poison center. There is no specific antidote. Hemodialysis is ineffective. It is necessary to control the patency of the respiratory tract, assisted ventilation, monitor and maintain vital functions, normalize blood gas composition, electrolyte balance, and conduct anti-shock measures.

Dosage and administration

Inside. In acute attacks of gout and inflammatory processes: on the 1st day – 1 mg 3 times a day (morning, afternoon and evening), on the 2nd and 3rd day – 1 mg 2 times a day (morning and evening ), on the 4th and subsequent days – 1 mg per day (in the evening). According to the 2nd scheme: the initial dose is 1 mg, then 0.5-1.5 mg with an interval of 1-2 hours until the pain disappears. The maximum daily dose is 6 mg. For the prevention of gout attacks – 1 mg in the evening; course — 3 months. In case of periodic illness complicated by amyloidosis – long-term (up to 5 years or more) 1-1.5 mg per day

Precautions

If severe gastrointestinal side effects occur, reduce the dose or discontinue the drug. When the level of leukocytes is below 3 10 ⁹ /l and platelets below 100 10 ⁹ /l, the intake is stopped until the blood picture is restored. Treatment should be carried out under careful clinical and hematological control, periodically examine the feces for occult blood.