Endobloc 5 mg Tablets (Ambrisentan)
What is ambrisentan?
What is the most important information I should know about ambrisentan?
– Ambrisentan can harm an unborn baby or cause birth defects. Do not use if you are pregnant.
– If you are a woman of child-bearing potential, you will be required to use two forms of birth control to prevent pregnancy during your treatment, and for at least 1 month after your treatment ends (unless you have had a tubal ligation or are using a copper IUD).
– You should not use this medication if you have idiopathic pulmonary fibrosis (IPF).
– Ambrisentan is available only from a certified pharmacy under a special program.
What should I discuss with my healthcare provider before taking ambrisentan?
You should not use this medication if you are allergic to ambrisentan, or if you have idiopathic pulmonary fibrosis (IPF).
To make sure ambrisentan is safe for you, tell your doctor if you have:
• anemia (low red blood cell counts);
• liver disease; or
• if you are pregnant or plan to become pregnant while taking ambrisentan.
This medicine can harm an unborn baby or cause birth defects. Do not use if you are pregnant, and tell your doctor right away if you become pregnant.
If you are a woman of child-bearing potential, you will need to have a negative pregnancy test before you start treatment with ambrisentan. You will also be re-tested each month during your treatment.
You must use two forms of birth control to prevent pregnancy during your treatment, and for at least 1 month after your last dose. If you have had a tubal ligation or use a copper IUD (intrauterine device) or progesterone implant, you will not need to use a second form of birth control.
Recommended combinations of birth control forms include:
• one hormone form (birth control pill, skin patch, implant, vaginal ring, or injection) plus 1 barrier form (condom, diaphragm with spermicide, or cervical cap with spermicide);
• a condom and a female barrier form together (diaphragm with spermicide, or cervical cap with spermicide); or
• a partner’s vasectomy plus 1 hormone form or 1 barrier form.
Talk with your doctor about the use of emergency contraception if you have unprotected s** or if you believe your form of contraception has failed.
It is not known whether ambrisentan passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using ambrisentan.
Ambrisentan may lower a man’s sperm count and could affect fertility (your ability to have children).
How should I take ambrisentan?
Before you start treatment with ambrisentan, your doctor may perform blood tests to make sure it is safe for you to take this medicine. Your blood will need to be tested often during treatment. Ambrisentan is usually taken once daily. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Ambrisentan can be taken with or without food. Take the medicine at the same time each day. Do not crush, chew, or split the tablet. Swallow the pill whole. Store at room temperature away from moisture and heat. Keep this medicine in its original container.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using ambrisentan?
Follow your doctor’s instructions about any restrictions on food, beverages, or activity.
Common side effects
Nausea, Palpitations, Peripheral edema, Liver transaminases increased, Abdominal pain, Anemia, Constipation, Dizziness, Shortness of breath, Flushing, Nasal congestion, Nasopharyngitis, Sinus inflammation, Vomiting
Expert advice for Endobloc
• Inform your doctor before taking the medicine if you have liver problems, peripheral edema (swelling in the hands and legs due to fluid retention), anemia (low hemoglobin or red blood cells in the blood), pulmonary veno-occlusive disease (blockage of the veins in the lungs), intolerance to some sugars, or soya allergy.
• Do not drive or operate heavy machinery after taking this medicine as the drug or your condition may cause dizziness and tiredness.
• Inform your doctor if you are taking other medicines such as cyclosporine A, rifampicin or other medicines such as epoprostenol, sildenafil etc.
• Ambrisentan is not recommended for children under 18 years of age.
• Inform your doctor if you intend to father a child, as ambrisentan may lower your sperm count.