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Details for: TARO-BOSENTAN

Company: TARO PHARMACEUTICALS INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02483130TARO-BOSENTANBOSENTAN (BOSENTAN MONOHYDRATE)62.5 MGTABLETORAL
02483149TARO-BOSENTANBOSENTAN (BOSENTAN MONOHYDRATE)125 MGTABLETORAL
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

Taro-Bosentan (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

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

Before you take Taro-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 Taro-Bosentan if you:

  • are hypersensitive (allergic) to bosentan or any other ingredients in the tablet (See What the important nonmedicinal ingredients are);
  • have liver problems;
  • are pregnant or planning to become pregnant (hormonal contraceptives alone are not effective when you take Taro-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 Taro-Bosentan may harm your unborn baby and you must not take Taro-Bosentan if you are pregnant. You must also not become pregnant while taking Taro-Bosentan. If you are a woman of childbearing age, your doctor or gynecologist will advise you about adequate contraceptive methods while taking Taro-Bosentan. Because Taro-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 Taro-Bosentan and you are of childbearing age.

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

If you are a man taking Taro-Bosentan, it is possible that this medicine may lower your sperm count. It cannot be excluded that this may affect your ability to father a child. Talk to your doctor if you have any questions or concerns about this.

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

Taro-Bosentan is not recommended for children.

What the medicinal ingredient is

Bosentan monohydrate.

What the non-medicinal ingredients are

corn starch, glyceryl behenate, magnesium stearate, povidone, pregelatinized starch, and sodium starch glycolate The Film coating is composed of ethylcellulose, hypromellose, iron oxide red, iron oxide yellow, talc, titanium dioxide and triacetin.

What dosage form it comes in

Taro-Bosentan 62.5 mg film-coated bosentan (from bosentan mononydrate) tablets are orange-white, round and embossed with '62,5' on one side. Taro-Bosentan is also available as orange-white, oval, film-coated tablets containing 125 mg bosentan and embossed with '125' on one side.

Warnings and precautions

Serious Warnings and Precautions

Before you use Taro-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 Taro-Bosentan.

Before starting Taro-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 Taro-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).
  • vasodilators (drugs used to treat high blood pressure)

Tests during treatment:

Some patients taking Taro-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 Taro-Bosentan. When your blood test results for liver function return to normal, your doctor may decide to restart treatment with Taro-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 Taro-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 Taro-Bosentan.

Interactions with this medication

Drugs that may interact with Taro-Bosentan include: warfarin, simvastatin and other statins, glyburide, ketoconazole, cyclosporine A, tacrolimus, sirolimus and hormonal contraceptives.

Proper use of this medication

Always take Taro-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. Swallow the tablet with water. 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 Taro-Bosentan.

Overdose

If you take more tablets than you have been told to take, see a doctor or go to a hospital immediately.

Missed Dose

If you forget to take Taro-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 Taro-Bosentan may lead to a worsening of your symptoms. Do not stop taking Taro-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

Like all medicines, Taro-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, nasal congestion, 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 Taro-Bosentan or if any of the side effects mentioned above worries you, please inform your doctor or pharmacist.

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and call your doctor or pharmacist
Common
Abdominal pain    
Itching    
Nausea    
Other signs of fluid retention    
Swelling of the legs and ankles    
Tiredness    
Vomiting    
Uncommon
Rash    
Swelling of the face, throat or tongue    
Rare
Asthma like symptoms (wheezing)    
Yellowing of the skin and eyes (jaundice)  
Call your doctor immediately
 

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

How to store

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 side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

  • Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
  • Calling toll-free at 1-866-234-2345

NOTE: Contact your health professional if you need information about how to manage your side effects. 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 at:
www.taro.ca

or by contacting the sponsor,
Taro Pharmaceuticals Inc., at: 1-800-268-1975

This leaflet was prepared by:
Taro Pharmaceuticals Inc.
130 East Drive
Brampton, Ontario L6T 1C1

TARO is a registered trademark of Taro Pharmaceuticals Inc.

Last revised: November 22, 2018

Date modified: