Details for: TARO-BOSENTAN
Company: TARO PHARMACEUTICALS INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02483130 | TARO-BOSENTAN | BOSENTAN (BOSENTAN MONOHYDRATE) | 62.5 MG | TABLET | ORAL |
| 02483149 | TARO-BOSENTAN | BOSENTAN (BOSENTAN MONOHYDRATE) | 125 MG | TABLET | ORAL |
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.
| 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