Telmisartan

IMPORTANT WARNING:

Tell your doctor if you are pregnant or plan to become pregnant. Do not take telmisartan if you are pregnant. If you become pregnant while you are taking telmisartan, stop taking telmisartan and call your doctor immediately. Telmisartan may cause death or serious injury to the fetus when taken in the last 6 months of pregnancy.

WHY is this medicine prescribed?

Telmisartan is used alone or in combination with other medications to treat high blood pressure. Telmisartan is also used to decrease the chance of heart attack, stroke, or death in people 55 years of age or older who are at high risk for cardiovascular disease. Telmisartan is in a class of medications called angiotensin II receptor antagonists. It works by blocking the action of certain natural substances that tighten the blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently.

High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.

Are there OTHER USES for this medicine?

Telmisartan is also used sometimes to treat heart failure (condition in which the heart is unable to pump enough blood to the rest of the body) and diabetic nephropathy (kidney disease in people with diabetes and high blood pressure). Talk to your doctor about the possible risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Telmisartan comes as a tablet to take by mouth. It is usually taken once a day with or without food. To help you remember to take telmisartan, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take telmisartan exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Telmisartan tablets come in individual blister packs that can be opened by peeling back the paper layer from the foil and pushing the tablet through the foil. Do not open a blister pack until you are ready to swallow the tablet it contains.

Your doctor may start you on a low dose of telmisartan and gradually increase your dose.

Telmisartan controls high blood pressure but does not cure it. Your blood pressure may decrease during the first 2 weeks of your treatment, but it may take 4 weeks for you to notice the full benefit of telmisartan. Continue to take telmisartan even if you feel well. Do not stop taking telmisartan without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking telmisartan,

• tell your doctor and pharmacist if you are allergic to telmisartan, any other medications, or any of the ingredients in telmisartan tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor if you have diabetes (high blood sugar) and you are taking aliskiren (Tekturna, in Amturnide, Tekamlo, Tekturna HCT). Your doctor will probably tell you not to take telmisartan if you have diabetes and you are also taking aliskiren.

• some medications should not be taken with telmisartan. Other medications may cause dosing changes or extra monitoring when taken with telmisartan. Make sure you have discussed any medications you are currently taking or plan to take before starting telmisartan with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking telmisartan, please get the advice of your doctor or pharmacist .

• the following nonprescription or herbal products may interact with telmisartan: aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); potassium supplements. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking telmisartan. Do not start any of these medications while taking telmisartan without discussing with your healthcare provider.

• tell your doctor if you have or have ever had heart failure; blockage of the bile duct (condition when bile can not flow from the liver to the gallbladder and small intestine, which can occur with gallstones, tumors, or injury); or kidney or liver disease.

• tell your doctor if you are breast-feeding.

• you should know that telmisartan may cause drowsiness, dizziness, lightheadedness, or fainting. Do not drive a car or operate machinery until you know how this medication affects you.

• you should know that diarrhea, vomiting, not drinking enough fluids, and sweating a lot can cause a drop in blood pressure, which may cause lightheadedness and fainting. Tell your doctor if you have any of these problems or develop them during your treatment.

What SPECIAL DIETARY instructions should I follow?

Do not use salt substitutes containing potassium without talking to your doctor. If your doctor prescribes a low-salt or low-sodium diet, follow these directions carefully.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Telmisartan may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• back pain
• sinus pain and congestion
• diarrhea

Some side effects can be serious. If you experience any of these symptoms, or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately:

• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• difficulty breathing or swallowing
• pain and cramping in the lower leg that comes and goes during walking or exercise
• blistering of the skin or rash

Telmisartan may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the blister pack it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• dizziness
• fainting
• fast or slow heartbeat

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your blood pressure should be checked regularly to determine your response to telmisartan.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.