Patient Medication Information: uses, side effects, how to take - Accel-Bosentan
ABOUT THIS MEDICATION
What the medication is used for:
Accel-Bosentan is prescribed for the treatment of pulmonary arterial hypertension (high blood pressure in the blood vessels between the heart and the lungs).
What it does:
Bosentan reduces abnormally high blood pressure by relaxing these blood vessels. Accel-Bosentan belongs to the class of medicines known as endothelin receptor antagonists.
Before you take Accel-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 Accel-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 Accel-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 Accel-Bosentan may harm your unborn baby and you must not take Accel-Bosentan if you are pregnant. You must also not become pregnant while taking Accel-Bosentan. If you are a woman of childbearing age, your doctor or gynecologist will advise you about adequate contraceptive methods while taking Accel-Bosentan. Because 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 Accel-Bosentan and you are of childbearing age.
Tell your doctor immediately if you are breastfeeding. You are advised to stop breastfeeding if Accel-Bosentan is prescribed for you because it is not known if this drug passes into the milk in women who are taking bosentan.
If you feel dizzy while taking Accel-Bosentan, do not drive or operate any tools or machines.
Accel-Bosentan is not recommended for children.
What the medicinal ingredient is:
Bosentan monohydrate.
What the important nonmedicinal ingredients are:
Maize starch, magnesium stearate, povidone, pregelatinized starch and sodium starch glycolate. The film-coating is composed of hypromellose, iron oxide red, iron oxide yellow, talc, titanium dioxide and triacetin.
What dosage forms it comes in:
Accel-Bosentan 125 mg tablets are also available as orange-white, oval, biconvex, film-coated tablets, debossed with “IB2” on one side and plain on other.
WARNINGS AND PRECAUTIONS
Warnings and Precautions Before you use Accel-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 Accel-Bosentan.
Before starting 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 Accel-Bosentan);
- glyburide (for diabetes);
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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).
Tests during treatment:
Some patients taking Accel-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 Accel-Bosentan. When your blood test results for liver function return to normal, your doctor may decide to restart treatment with Accel-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 Accel-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 bosentan.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with bosentan include: warfarin, simvastatin and other statins, glyburide, ketoconazole, cyclosporine A, tacrolimus, sirolimus and hormonal contraceptives.
PROPER USE OF THIS MEDICATION
Always take Accel-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 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 Accel-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 bosentan may lead to a worsening of your symptoms. Do not stop taking Accel-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, Accel-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 Accel-Bosentan or if any of the side
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effects mentioned above worries you, please inform your doctor or pharmacist.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate emergency medical attention | |||
Only if severe | In all cases | ||||
| 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 Accel-Bosentan, contact your doctor or pharmacist.
HOW TO STORE IT
Keep out of reach and sight of children. Store at room temperature between 15°C and 30°C. Do not use after the expiry date stated on the blister.
Reporting Side Effects
We encourage you to report serious or unexpected side effects to Health Canada. The information is used to check for new safety concerns about health products. As a consumer, your report contributes to the safe use of health products for everyone.
3 ways to report:
- Online at MedEffect;
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
Mail to: Canada Vigilance Program Health Canada, Postal Locator 0701E Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at 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, Accel Pharma Inc. at:
Accel Pharma Inc. 99 Place Frontenac, Pointe-Claire
Quebec, Canada
H9R 4Z7
www.accelpharma.com
Tel: 1-877-827-1306