Tradjenta oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

How to use Tradjenta

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking linagliptin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily.

The dosage is based on your medical condition, response to treatment, and other medications you may be taking.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Carefully follow the medication treatment plan, meal plan, and exercise program your doctor has recommended.

Check your blood sugar regularly as directed by your doctor. Keep track of the results, and share them with your doctor. Tell your doctor if your blood sugar measurements are too high or too low. Your dosage/treatment may need to be changed.

Side Effects

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: joint pain, unusual skin blisters, signs of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain).

Although linagliptin by itself usually does not cause low blood sugar (hypoglycemia), low blood sugar may occur if this drug is prescribed with other diabetes medications. Talk with your doctor or pharmacist about whether the dose of your other diabetes medication(s) needs to be lowered.

Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don’t have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor about the reaction right away. Low blood sugar is more likely if you drink large amounts of alcohol, do unusually heavy exercise, or do not consume enough calories from food. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor right away. Your doctor may need to adjust your diabetes medication(s).

Get medical help right away if you have any very serious side effects, including: signs of disease of the pancreas (such as nausea/vomiting that doesn’t stop, severe stomach/abdominal pain which may spread to the back).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking linagliptin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: disease of the pancreas (pancreatitis), stones in your gallbladder (gallstones), heart failure.

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while taking this medication because it can increase your risk of developing low blood sugar.

It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because increased stress may require a change in your treatment plan, medications, or blood sugar testing.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy. Discuss the risks and benefits of different treatments (such as diet, exercise, and medications including insulin).

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Consult your pharmacist or physician.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

A product that may interact with this drug is: rifampin.

Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are unaffected by these drugs.

Many drugs can affect your blood sugar levels, making it more difficult to control your blood sugar. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed by your doctor. Tell your doctor about the results and of any symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Does Tradjenta interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

Lab and/or medical tests (such as blood glucose, hemoglobin A1c) should be done while you are taking this medication. Keep all medical and lab appointments.

Attend a diabetes education program to learn more about how to manage your diabetes with medications, diet, exercise, and regular medical exams.

Learn the symptoms of high and low blood sugar and how to treat low blood sugar. Check your blood sugar regularly as directed and share the results with your doctor.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Images

Tradjenta 5 mg tablet

Color: light redShape: roundImprint: D5 logo

This medicine is a light red, round, film-coated, tablet imprinted with “D5” and “logo”.

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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Trajenta (linagliptin) Drug / Medicine Information

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Tablets

linagliptin

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about Trajenta.

It does not contain all the available information.

It does not take the place of talking to your doctor, pharmacist or diabetes educator.

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

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

This leaflet was last updated on the date at the end of this leaflet. More recent
information may be available. The latest Consumer Medicine Information is available
from your pharmacist, doctor, or from www.medicines.org.au (Australia) and www.medsafe.govt.nz/
Consumers/cmi/CMIForm.asp (New Zealand) and may contain important information about
the medicine and its use of which you should be aware.

Keep this leaflet with the medicine.

You may need to read it again.

What Trajenta is used for

Trajenta is used to lower blood sugar levels in patients with type 2 diabetes mellitus.

It may be used when diet plus exercise do not provide adequate blood sugar level control
either:

alone as a single medicine, or

in combination with certain other anti-diabetic medicines such as:

metformin, or

sulfonylurea medicines such as glimepiride and glibenclamide, or

insulin (with or without metformin), or

metformin plus sulfonylurea medicines, or

metformin plus sodium-glucose transporter 2 inhibitor medicines such as empagliflozin.

Type 2 diabetes mellitus is also called non-insulin-dependent diabetes mellitus or
NIDDM. Type 2 diabetes develops if the body does not make enough insulin, or if the
insulin that your body makes does not work as well as it should.

Insulin is a substance that helps to lower the level of sugar in your blood, especially
after meals.

When the level of sugar builds up in your blood, this can cause damage to the body’s
cells and lead to serious problems with your heart, brain, eyes, circulation, nerves
or kidneys.

How Trajenta works

Trajenta contains the active ingredient linagliptin, which is a member of a class
of medicines you take by mouth called DPP-4 (dipeptidyl peptidase-4) inhibitors that
lowers blood sugar levels in patients with type 2 diabetes mellitus.

Trajenta helps to improve the levels of insulin after a meal and lowers the amount
of sugar made by your body.

Lowering and controlling blood sugar may help prevent or delay complications of diabetes,
such as heart disease, kidney disease, blindness and foot amputation.

Along with diet and exercise, this medicine helps lower your blood sugar.

Your doctor will prescribe Trajenta alone, or in combination with another anti-diabetic
medicine if that medicine alone is not sufficient to control your blood sugar level.
It is important that you continue to follow the diet and/or exercises recommended
for you while you are on treatment with Trajenta.

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

Your doctor may have prescribed it for another reason.

This medicine is only available with a doctor’s prescription. It is not addictive.

Before you take Trajenta

When you must not take it

Do not take Trajenta if you have an allergy to:

any medicine containing linagliptin (the active ingredient in Trajenta)

any of the other ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

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.

Do not give this medicine to a child or adolescent under the age of 18 years.

Safety and effectiveness in children and adolescents less than 18 years old have not
been established.

Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives
or dyes.

Tell your doctor if you are pregnant or intend to become pregnant.

Your doctor will discuss the possible risks and benefits involved.

Tell your doctor if you are breast-feeding or planning to breast-feed.

Trajenta is usually not recommended while you are breast-feeding. It is not known
if the active ingredient of Trajenta will pass into human breast milk and could affect
your baby.

Tell your doctor if you have or have had any of the following medical conditions:

type 1 diabetes (also known as ‘juvenile onset’ or ‘insulin-dependent’ diabetes mellitus
or ‘IDDM’), a condition where your body does not produce any insulin

diabetic ketoacidosis, a condition where chemicals called ketones build up in the
body or urine due to very low insulin levels, and results in high blood sugar, rapid
weight loss, nausea or vomiting.

Trajenta is not a substitute for insulin. Trajenta should not be used to treat type
1 diabetes or diabetic ketoacidosis.

If you are not sure whether any of the above conditions apply to you, your doctor
can advise you.

Alcohol, diet, exercise, and your general health all strongly affect the control of
your diabetes.

Discuss these things with your doctor.

If you have not told your doctor, pharmacist or diabetes educator about any of the
above, tell them before you take Trajenta.

Your doctor may want to take special precautions if you have any of the above conditions.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any
that you get without a prescription from your pharmacy, supermarket or health food
shop.

Some medicines and Trajenta may interfere with each other. These include:

rifampicin (an antibiotic medicine used to treat certain infections such as tuberculosis)

carbamazepine, phenobarbital or phenytoin (medicines used to control fits (seizures)
or chronic pain).

These medicines may be affected by Trajenta or may affect how well it works. You may
need different amounts of your medicines, or you may need to take different medicines.
Your doctor, pharmacist or diabetes educator can tell you what to do if you are taking
any of these medicines. They also have more information on medicines to be careful
with or avoid while taking this medicine.

How to take Trajenta

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist
for help.

How much to take

The usual dose is one 5 mg tablet once daily.

Take Trajenta exactly as your doctor or pharmacist has told you.

Your doctor will prescribe Trajenta alone, or in combination with another anti-diabetic
medicine, if that medicine alone is not sufficient to control your blood sugar level.

How to take it

Swallow the tablet with a full glass of water.

When to take it

Take your medicine at about the same time each day.

Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.

It does not matter if you take this medicine before or after food.

How long to take it

Continue taking Trajenta for as long as your doctor tells you to. Make sure you keep
enough Trajenta to last over weekends and holidays.

Trajenta will help control your diabetes, but will not cure it. Therefore, you may
have to take it for a long time.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your medicine
as you would normally.

Do not take a double dose to make up for the dose that you missed.

This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (in Australia telephone
13 11 26; in New Zealand telephone 0800 764 766) for advice, or go to Emergency at
the nearest hospital, if you think that you or anyone else may have taken too much
Trajenta. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

While you are taking Trajenta

Things you must do

If you are about to be started on any new medicine, tell your doctor or pharmacist
that you are taking Trajenta.

Tell all doctors, dentists and pharmacists who are treating you that you are taking
Trajenta.

If you become pregnant while taking this medicine, tell your doctor immediately.

Keep all of your doctor’s appointments so that your progress can be checked.

Your doctor may do some tests from time to time to make sure the medicine is working
and to prevent unwanted side effects.

Carefully follow your doctor’s and/or dietician’s advice on diet, drinking alcohol
and exercise.

Diet and exercise can help your body use its blood sugar better. It is important to
stay on the diet and exercise program recommended by your doctor while taking Trajenta.

Make sure you check your blood glucose levels regularly.

This is the best way to tell if your diabetes is being controlled properly. Your doctor
or diabetes educator will show you how and when to do this.

Tell your doctor if you become ill or experience stress, injury, fever, infection
or need surgery.

Your blood glucose may become difficult to control at these times.

Make sure that you, your friends, family and work colleagues can recognise the symptoms
of hypoglycaemia and hyperglycaemia and know how to treat them.

HYPOGLYCAEMIA

Trajenta does not normally cause hypoglycaemia, although you may experience it if
you take certain other medicines.

Signs of hypoglycaemia may include:

weakness, trembling or shaking

sweating

light-headedness, dizziness, headache or lack of concentration

irritability, tearfulness or crying

hunger

numbness around the lips and tongue.

If not treated quickly, these symptoms may progress to:

loss of co-ordination

slurred speech

confusion

fits or loss of consciousness.

At the first signs of hypoglycaemia, you need to raise your blood glucose quickly.

You can do this by taking one of the following:

5 -7 jelly beans

3 teaspoons of sugar or honey

half a can of non-diet soft drink

2-3 concentrated glucose tablets.

Unless you are within 10 to 15 minutes of your next meal or snack, follow up with
extra carbohydrates such as plain biscuits, fruit or milk.

Taking this extra carbohydrate will prevent a second drop in your blood glucose level.

HYPERGLYCAEMIA

If you notice the return of any signs of hyperglycaemia, contact your doctor immediately.
The risk of hyperglycaemia is increased in the following situations:

uncontrolled diabetes

illness, infection or stress

taking less Trajenta than prescribed

taking certain other medicines

too little exercise

eating more carbohydrates than normal.

Things you must not do

Do not take Trajenta to treat any other complaints unless your doctor tells you to.

Do not give this medicine to anyone else, even if they have the same condition as
you.

Things to be careful of

Be careful driving or operating machinery while you are taking Trajenta until you
know how it affects you.

You may experience dizziness when taking Trajenta.

If your blood sugar level becomes too low, you may feel dizzy, weak or tired and your
reaction time may be slower than usual. Other symptoms of low blood sugar are listed
under Side effects.

If you have any of these symptoms, do not drive, operate machinery or do anything
else that could be dangerous.

Be careful when doing any of the following things, which increase the risk of your
blood glucose becoming too low:

drinking alcohol

not eating enough

doing unexpected or vigorous exercise.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking Trajenta.

This medicine helps most people with type 2 diabetes mellitus, but it may have unwanted
side effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time
they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by this list of possible side effects. You may not experience any
of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

swelling of the nose or throat (nasopharyngitis)

mouth ulceration

cough

painful, swollen joints

back pain

headache

aching muscles, muscle tenderness or weakness not caused by exercise

symptoms of urinary tract infection (such as an urge to urinate frequently and in
small amounts, painful burning when passing urine).

Urinary tract infections may occur in patients who already take another medication
to treat diabetes, such as a sulfonylurea.

constipation.

Constipation may occur in patients who already take another medication to treat diabetes,
such as insulin.

Tell your doctor as soon as possible if you notice any of the symptoms of low blood
sugar such as:

sweating

weakness

hunger

dizziness

trembling

headache

flushing or paleness

numbness

a fast, pounding heartbeat.

Low blood sugar may occur in patients who already take another medication to treat
diabetes, such as a sulfonylurea or insulin. The dose of your sulfonylurea or insulin
medicine may need to be reduced while taking Trajenta.

Tell your doctor immediately if you develop blisters or the breakdown of the outer
layer of your skin (erosion).

These may be signs of a skin reaction called bullous pemphigoid. Your doctor may tell
you to stop taking Trajenta.

Tell your doctor immediately or go to Emergency if you notice any of the following:

sudden onset of hives, itching or skin rash

swelling of the face, lips or tongue which may lead to difficulty swallowing or breathing

severe upper stomach pain radiating to the back, nausea, vomiting, or fever (which
may be symptoms of an inflamed pancreas – pancreatitis).

Tell your doctor or pharmacist if you notice anything else that is making you unwell.

Other side effects not listed above may also occur in some people.

Some of these side effects can only be found when your doctor does tests from time
to time to check your progress.

After taking Trajenta

Storage

Keep your tablets in the original blister strip until it is time to take them.

Keep your tablets in a cool dry place where the temperature stays below 30°C.

Do not store Trajenta or any other medicine in the bathroom or near a sink. Do not
leave it in the car or on a window sill.

Heat and dampness can destroy some medicines.

Keep it 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 tells you to stop taking this medicine or the expiry date has passed,
ask your pharmacist what to do with any medicine that is left over.

Product Description

What it looks like

Trajenta is the brand name of your medicine.

Trajenta tablets are light red, round, biconvex, bevel-edged film-coated tablets,
marked with the BI company logo on one side and ‘D5’ on the other.

Trajenta tablets are available in blister packs of 10 (sample) and 30 tablets.

Ingredients

Each Trajenta tablet contains 5 mg of linagliptin as the active ingredient.

Inactive ingredients:

mannitol

pregelatinised maize starch

maize starch

copovidone

magnesium stearate

Opadry Pink 02F34337 (as colouring agent).

Supplier

Trajenta tablets are supplied in Australia by:

Boehringer Ingelheim Pty Limited

ABN 52 000 452 308

78 Waterloo Road

North Ryde NSW 2113

They are supplied in New Zealand by:

Boehringer Ingelheim (N.Z.) Limited

Auckland

This Consumer Medicine Information was updated in July 2017.