Teva-Bosentan: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

ABOUT THIS MEDICATION

What the medication is used for:

TEVA-BOSENTAN tablets are prescribed for the treatment of pulmonary arterial hypertension (high blood pressure in the blood vessels between the heart and the lungs).

What it does:

TEVA-BOSENTAN reduces abnormally high blood pressure by relaxing these blood vessels. TEVA-BOSENTAN tablets belong to the class of medicines known as endothelin receptor antagonists.

Before you take TEVA-BOSENTAN: Tests your doctor will do before treatment:

• a blood test for liver function;

• a blood test for anemia (reduction in red blood

  cells);

• a pregnancy test.

When it should not be used:

Do not use TEVA-BOSENTAN if you:

• are hypersensitive (allergic) to bosentan or any

  other ingredients in the tablet (See What the important non-medicinal ingredients are);

• have liver problems;

• are pregnant or planning to become pregnant

  (hormonal contraceptives alone are not effective when you take TEVA-BOSENTAN);

• are a woman of childbearing age and not using

  adequate contraceptive methods;

• are being treated with cyclosporine A, or

  glyburide.

Tell your doctor immediately if you are pregnant or plan to become pregnant in the near future. This is because TEVA-BOSENTAN may harm your unborn baby and you must not take TEVA-BOSENTAN if

you are pregnant. You must also not become pregnant while taking TEVA-BOSENTAN. If you are a woman of childbearing age, your doctor or gynecologist will advise you about adequate contraceptive methods while taking TEVA-BOSENTAN. Because TEVA-BOSENTAN may make hormonal contraception (e.g., oral, injection, implant or skin patches) ineffective, this method on its own is not reliable. Therefore, if you use hormonal contraceptives you must also use a barrier method (e.g., female condom, diaphragm, contraceptive sponge or your partner must also use a condom). Monthly pregnancy tests are recommended while you are taking TEVA-BOSENTAN and you are of childbearing age.

Tell your doctor immediately if you are breastfeeding. You are advised to stop breastfeeding if TEVA-BOSENTAN is prescribed for you because it is not known if this drug passes into the milk in women who are taking TEVA-BOSENTAN.

If you feel dizzy while taking TEVA-BOSENTAN, do not drive or operate any tools or machines.

TEVA-BOSENTAN is not recommended for children.

What the medicinal ingredient is:

Bosentan monohydrate

What the important non-medicinal ingredients are:

TEVA-BOSENTAN contains: corn starch, sodium starch glycolate, povidone, glyceryl dibehenate and magnesium stearate. The film-coating is composed of: hypromellose, triacetin, talc, titanium dioxide, red ion oxide, yellow iron oxide and ethylcellulose.

What dosage forms it comes in:

TEVA-BOSENTAN is available as 62.5 mg film-coated tablets and 125 mg film-coated tablets, as follows:

62.5 mg: film-coated, round, biconvex, pink-orange tablets embossed with ‘TV’ on one side.

125 mg: film-coated, oval, biconvex, pink-orange tablets embossed with 'TV' on one side.

WARNINGS AND PRECAUTIONS

Warnings and Precautions Before you use TEVA-BOSENTAN talk to your doctor or pharmacist if you are:

• known to have liver problems;

• pregnant or thinking of becoming pregnant;

• a woman of childbearing age and not using adequate contraceptive methods;
• breastfeeding;

• hypersensitive (allergic) to bosentan or any other ingredients of TEVA-BOSENTAN.

Before starting TEVA-BOSENTAN treatment, tell your doctor and your pharmacist if you are taking or have recently taken any other medicines, even those you have bought yourself. It is especially important to tell your doctor if you are taking:

• hormonal contraceptives (as these may not be

  effective as the sole method of contraception when you take TEVA-BOSENTAN);

• glyburide (for diabetes);

• cyclosporine A (a medicine used after transplants

  and to treat psoriasis), or any other drugs used to prevent rejection of transplanted organs;

• fluconazole (to treat fungal infections);
• rifampicin (to treat tuberculosis).

IMPORTANT: PLEASE READ

Tests during treatment:

Some patients taking bosentan were found to have abnormal liver function values (increase in liver enzymes) and some patients developed anemia (reduction in red blood cells). Because these findings may not cause symptoms you can feel or observe yourself, your doctor will do regular blood tests to assess any changes in your liver function and hemoglobin level.

Liver function:

This blood test will be done:

• every month or more frequently, if needed.

If you develop abnormal liver function, your doctor may decide to reduce your dose or stop treatment with TEVA-BOSENTAN. When your blood test results for liver function return to normal, your doctor may decide to restart treatment with TEVA-BOSENTAN.

Anemia:

This blood test will be done:

• after 1 month and after 3 months of treatment;
• every 3 months during treatment thereafter.

If you develop anemia, your doctor may decide to perform further tests to investigate the cause.

Your regular blood tests, both for liver function and anemia, are an important part of your treatment. We suggest you write in a diary the date of your most recent test and also that of your next test (ask your doctor for the date) to help you remember when your next test is due.

Pregnancy tests for women of childbearing age:

Due to the risk of failure of hormonal contraception when taking TEVA-BOSENTAN and the risk in

patients with pulmonary hypertension of rapid and severe deterioration of the disease, monthly pregnancy tests are recommended before and during treatment with TEVA-BOSENTAN.

INTERACTIONS WITH THIS MEDICATION

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with TEVA-BOSENTAN include: warfarin, simvastatin and other statins, glyburide, ketoconazole, cyclosporine A, tacrolimus, sirolimus and hormonal contraceptives. PROPER USE OF THIS MEDICATION

PROPER USE OF THIS MEDICATION

Always take TEVA-BOSENTAN exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

Usual dose:

The usual dose is one tablet, swallowed twice daily (morning and evening), consistently with or without food. For the first 4 weeks, you will take a 62.5 mg tablet twice daily, from then on, your doctor will advise you to take a 125 mg tablet twice daily, depending on how you react to TEVA-BOSENTAN.

Overdose:

If you take more tablets than you have been told to take, see a doctor or go to a hospital immediately. In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Center immediately, even if there are no symptoms.

Missed Dose:

If you forget to take TEVA-BOSENTAN, take a dose as soon as you remember, then continue to take your tablets at the usual time. Do not take a double dose to make up for forgotten tablets.

Stopping treatment:

Suddenly stopping your treatment with TEVA-BOSENTAN may lead to a worsening of your symptoms. Do not stop taking TEVA-BOSENTAN unless your doctor tells you to. Your doctor may tell you to reduce the dose over a few days before stopping completely.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

TO DO ABOUT THEM

Like all medicines, TEVA-BOSENTAN can have side effects even when used as directed.

If you notice yellowing of the skin or eyes (jaundice) or other symptoms such as nausea, vomiting, fever, abdominal pain or unusual

tiredness, see your doctor immediately because this may be related to abnormal liver function.

Headaches were the most common side effect in clinical studies.

You may also notice one or more of the following side effects

• flushed appearance, inflammation of the throat

  and nasal passages, swelling of the legs and ankles, or other signs of fluid retention, low blood pressure, irregular heartbeat, heartburn, tiredness, itching, nausea. If these side effects become bothersome, contact your doctor.

Other less common side effects that you might notice:

• vomiting, abdominal pain, diarrhea, skin rash.

If you notice any other side effects or signs of allergic reaction (e.g. swelling of the face or tongue, rash, pruritus) while you are taking TEVA-BOSENTAN or if any of the side effects mentioned above worries you, please inform your doctor or pharmacist.

This is not a complete list of side effects. For any unexpected effects while taking TEVA-BOSENTAN, contact your doctor or pharmacist.

HOW TO STORE IT

HOW TO STORE IT

Keep out of reach and sight of children. Store at room temperature; between 15ºC and 30ºC. Do not use after the expiry date stated on the blister.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program Health Canada

    Postal Locator 0701E Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at

www.healthcanada.gc.ca/medeffect

Note: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Teva Canada Limited at: 1-800-268-4127 ext. 5005 (English)

or druginfo@tevacanda.com

or 1-877-777-9117 (French)

Teva Canada Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Last revised: December 10, 2012