Telmisartan (Page 5 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Telmisartan tablets USP are available as follows:

Telmisartan tablets USP 20 mg: white to off-white circular shaped flat beveled edge tablets with ‘G’ engraved on one side and ‘199’ engraved on the other side.

Bottles of 100 (NDC 68462-199-01)

Carton of 30 Tablets (3 x 10 Unit-Dose) NDC 68462-199-13

Telmisartan tablets USP 40 mg: white to off-white capsule shaped tablets with ‘G’ engraved on one side and ‘200’ engraved on other side.

Bottles of 100 (NDC 68462-200-01)

Carton of 30 Tablets (3 x 10 Unit-Dose) NDC 68462-200-13

Telmisartan tablets USP 80 mg: white to off-white capsule shaped tablets with ‘G’ engraved on one side and ‘201’ engraved on other side.

Bottles of 100 (NDC 68462-201-01)

Carton of 30 Tablets (3 x 10 Unit-Dose) NDC 68462-201-13

Storage

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Tablets should not be removed from blisters until immediately before administration.

17 PATIENT COUNSELING INFORMATION

See FDA-approved Patient Labeling

17.1 Pregnancy

Female patients of childbearing age should be told about the consequences of exposure to telmisartan during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible [see Warnings and Precautions (5.1)].

Manufactured by:

Glenmark Generics Ltd.
Colvale-Bardez, Goa 403 513, India

Manufactured for:

Glenmark logo

Glenmark Generics Inc., USA
Mahwah, NJ 07430

Questions? 1 (888)721-7115www.glenmarkgenerics.com

January 2015

Patient Medication Information

Patient Information

Telmisartan Tablets USP

Read this Patient Information before you start taking telmisartan tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is the most important information I should know about telmisartan tablets?

Telmisartan tablets can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking telmisartan tablets, tell your doctor right away.

What are telmisartan tablets?

Telmisartan tablets are a prescription medicine used:

to treat high blood pressure (hypertension)

It is not known if telmisartan tablets are safe and effective in children.

Who should not take telmisartan tablets?

You should not take telmisartan tablets if you are allergic (hypersensitive) to the active ingredient (telmisartan) or any of the other ingredients listed at the end of this leaflet.

For patients with diabetes, if you are taking telmisartan you should not take aliskiren.

What should I tell my doctor before taking telmisartan tablets?

Before you take telmisartan tablets, tell your doctor if you:

have liver problems
have kidney problems
have heart problems
have any other medical conditions
are pregnant or are planning to become pregnant. See “What is the most important information I should know about telmisartan tablets?”
are breast-feeding or plan to breast-feed. It is not known if telmisartan passes into your breast milk. You and your doctor should decide if you will take telmisartan tablets or breast-feed. You should not do both. Talk with your doctor about the best way to feed your baby if you take telmisartan tablets.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

For patients with diabetes, if you are taking telmisartan you should not take aliskiren.

Telmisartan tablets may affect the way other medicines work, and other medicines may affect how telmisartan tablets work. Especially tell your doctor if you take:

aliskiren
digoxin (Lanoxin® , Lanoxicaps®)
lithium (Eskalith® , Lithobid®)
medicines used to treat pain and arthritis, called non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors
ramipril (Altace®) or other medicines used to treat your high blood pressure or heart problem
water pills (diuretic)

Know the medicines you take. Keep a list of them and show it to your doctor or pharmacist when you get a new medicine.

How should I take telmisartan tablets?

Take telmisartan tablets exactly as your doctor tells you to take it.
Your doctor will tell you how much telmisartan to take and when to take it.
Do not change your dose unless your doctor tells you to.
Take telmisartan tablets one time each day at the same time.
Take telmisartan tablets with or without food.
If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Take the next dose at your regular time.
If you take too much telmisartan, call your doctor, or go to the nearest hospital emergency room right away.
Read the “How to Open the Blister” at the end of this leaflet before you use telmisartan tablets. Talk with your doctor if you do not understand the instructions.

What are the possible side effects of telmisartan tablets?

Telmisartan tablets may cause serious side effects, including:

Injury or death to your unborn baby. See “What is the most important information I should know about telmisartan tablets?”
Low blood pressure (hypotension) is most likely to happen if you also:
take water pills (diuretics)
are on a low-salt diet
get dialysis treatments
have heart problems
get sick with vomiting or diarrhea

If you feel faint or dizzy, lie down and call your doctor right away.

Kidney problems , which may get worse if you already have kidney disease. You may have changes in your kidney test results, and you may need a lower dose of telmisartan tablets. Call your doctor if you get:
swelling in your feet, ankles, or hands
unexplained weight gain

Call your doctor right away if you get any of the symptoms listed above.

High potassium in the blood (hyperkalemia). Your doctor may check your potassium levels as needed.

Rare, serious allergic reactions may happen. Tell your doctor right away if you get any of these symptoms:

swelling of the face, tongue, throat
difficulty breathing
skin rash

The most common side effects of telmisartan tablets include:

sinus pain and congestion (sinusitis)
back pain
diarrhea

These are not all the possible side effects with telmisartan tablets. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store telmisartan tablets?

Store telmisartan tablets between 59°F to 86°F (15°C to 30°C).
Do not remove telmisartan tablets from blisters until right before you take them.

Keep telmisartan tablets and all medicines out of the reach of children.

General information about telmisartan tablets

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use telmisartan tablets for a condition for which it was not prescribed. Do not give telmisartan tablets to other people, even if they have the same condition you have. It may harm them.

This Patient Information leaflet summarizes the most important information about telmisartan tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about telmisartan tablets that is written for health professionals.

For more information, call Glenmark Generics Inc., USA at 1 (888)721-7115 or visit www.glenmarkgenerics.com.

What are the ingredients in telmisartan tablets USP?

Active Ingredient: telmisartan USP

Inactive Ingredients: crospovidone, lactose monohydrate, magnesium stearate, meglumine, povidone and sodium hydroxide pellets

What is High Blood Pressure (Hypertension)?

Blood pressure is the force in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too much. Telmisartan tablets can help your blood vessels relax so your blood pressure is lower. Medicines that lower your blood pressure lower your chance of having a stroke or heart attack.

High blood pressure makes the heart work harder to pump blood throughout the body and causes damage to the blood vessels. If high blood pressure is not treated, it can lead to stroke, heart attack, heart failure, kidney failure, and vision problems.

How to open the blister:

1. Tear (You may also use scissors to tear the blister apart)

step1
(click image for full-size original)

2. Peel (Peel off the paper layer from the aluminum foil)

step2
(click image for full-size original)

3. Push (Push the tablet through the foil)

step3
(click image for full-size original)

Manufactured by:

Glenmark Generics Ltd.
Colvale-Bardez, Goa 403 513, India

Manufactured for:

Glenmark logo

Glenmark Generics Inc., USA
Mahwah, NJ 07430

Questions? 1 (888)721-7115
www.glenmarkgenerics.com

January 2015

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