Bosentan Oral tablet

What is this medicine?

BOSENTAN (boe SEN tan) is used to treat a serious heart and lung disorder called primary pulmonary hypertension. This medicine may help to increase your ability to exercise and improve your breathing.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• liver disease

• an unusual or allergic reaction to bosentan, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take this medicine with or without food. Take your doses at regular intervals. Do not take more often than directed. Do not stop taking except on your doctor's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• cyclosporine

• female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections

• glyburide

• ritonavir

This medicine may also interact with the following medications:

• amiodarone

• amprenavir

• certain medicines for fungal infections like fluconazole, itraconazole or ketoconazole

• certain medicines for high cholesterol like atorvastatin, cerivastatin, lovastatin, simvastatin

• diltiazem

• erythromycin

• rifampicin

• sildenafil

• tacrolimus

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for checks on your progress. Despite receiving this medicine, your condition may worsen and you may need your dose adjusted. Call your doctor or health care professional if your conditions gets worse.

Pregnancy must be avoided while taking this medicine due to the potential for serious side effects to an unborn child. If you are female of child-bearing potential, you will have to have pregnancy tests regularly (at least monthly) while you are taking this medicine. Discuss options to prevent pregnancy with your physician. This medicine may reduce the effectiveness of hormonal birth control methods, including birth control pills, patches, implanted hormonal products, or injections.

This medicine has caused reduced sperm counts in some men. This may interfere with the ability to father a child. You should talk to your doctor or health care professional if you are concerned about your fertility.

Your health care professional will have to check blood tests regularly (at least monthly) to check the effect of this medicine on your liver.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• cool, pale skin

• dark urine

• fast, irregular heartbeat

• feeling faint or lightheaded, falls

• fever

• swelling of the ankles or legs

• stomach pain, nausea, vomiting

unusual bleeding or bruising

• unusually weak or tired

• yellowing of eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• flushing of the skin

• headache

• itching of the skin

• runny nose or sore throat

• stomach upset

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.