- bosentan monohydrate
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 17780/0610.
Bosentan Zentiva 62.5mg and 125mg film-coated tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Bosentan 62.5 mg film-coated tablets
Bosentan 125 mg film-coated tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet:
1. What bosentan is and what it is used for
2. What you need to know before you take bosentan
3. How to take bosentan
4. Possible side effects
5. How to store bosentan
6. Contents of the pack and other information
1. WHAT BOSENTAN IS AND WHAT IT IS USED FOR
The name of your medicine is Bosentan 62.5 mg film-coated tablets or Bosentan 125 mg film-coated tablets (called bosentan throughout this leaflet). Bosentan tablets contain bosentan, which blocks a naturally occurring hormone called endothelin-1 (ET-1), which causes blood vessels to narrow. Bosentan therefore causes blood vessels to expand and belongs to the class of medicines called “endothelin receptor antagonists”.
Bosentan is used to treat:
Bosentan is used to treat patients with class III PAH to improve exercise capacity (the ability to carry out physical activity) and symptoms. The “class” reflects the seriousness of the disease: “class III” involves marked limitation of physical activity. Some improvements have also been shown in patients with class II PAH. “Class II” involves slight limitation of physical activity. The PAH for which bosentan is indicated can be:
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BOSENTAN
Do not take bosentan
If any of these apply to you, tell your doctor.
Warnings and precautions
Tests your doctor will do before treatment
Some patients taking bosentan have been found to have abnormal liver function tests and anaemia (low haemoglobin).
Tests your doctor will do during treatment
During treatment with bosentan, your doctor will arrange for regular blood tests to check for changes in your liver function and haemoglobin level.
For all these tests please refer also to the Patient Alert Card (inside your pack of bosentan tablets). It is important that you have these regular blood tests as long as you are taking bosentan. We suggest you write the date of your most recent test and also of your next test (ask your doctor for the date) on the Patient Alert Card, to help you remember when your next test is due.
Blood tests for liver function
These will be done every month for the duration of treatment with bosentan. After an increase in dose an additional test will be done after 2 weeks.
Blood tests for anaemia
These will be done every month for the first 4 months of treatment, then every 3 months after that, as patients taking bosentan may get anaemia.
If these results are abnormal, your doctor may decide to reduce your dose or stop treatment with bosentan and to perform further tests to investigate the cause.
Children and adolescents
Bosentan is not recommended in paediatric patients with systemic sclerosis and ongoing digital ulcer disease. Please see also section 3. How to take Bosentan.
Other medicines and bosentan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. It is especially important to tell your doctor if you are taking:
Driving and using machines
Bosentan has no or negligible influence on the ability to drive and use machines. However, bosentan can induce hypotension (decrease of your blood pressure) which can make you feel dizzy, affect your vision and affect your ability to drive and use machines. Therefore, if you feel dizzy or that your vision is blurred while taking bosentan, do not drive or operate any tools or machines.
Bosentan with food and drink
Bosentan can be taken with or without food.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking bosentan.
Women of childbearing age
Do NOT take bosentan if you are pregnant or planning to become pregnant.
Bosentan may harm unborn babies conceived before starting or during treatment. If you are a woman who could become pregnant, your doctor will ask you to take a pregnancy test before you start taking bosentan, and regularly while you are taking bosentan.
If it is possible that you could become pregnant, use a reliable form of birth control (contraception) while you are taking bosentan. Your doctor or gynaecologist will advise you about reliable contraceptive methods while taking 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).
Inside your pack of bosentan tablets you will find a Patient Alert Card. You should complete this card and take it to your doctor at your next visit so that your doctor or gynaecologist can assess whether you need additional or alternative reliable contraceptive methods. Monthly pregnancy tests are recommended while you are taking bosentan and are of childbearing age.
Tell your doctor immediately if you become pregnant while you are taking bosentan, or plan to become pregnant in the near future.
Tell your doctor immediately if you are breast-feeding. You are advised to stop breast-feeding if bosentan is prescribed for you, because it is not known whether this medicine passes into breast milk.
If you are a man taking 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.
Bosentan contains sodium
This medicine contains less than 1 mmol sodium (23mg) per tablet, that is to say essentially "sodium free".
3. HOW TO TAKE BOSENTAN
Treatment with bosentan should only be started and monitored by a doctor who has experience in the treatment of PAH or systemic sclerosis. Always take this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
The treatment in adults is usually started for the first 4 weeks with 62.5 mg twice daily (morning and evening), from then your doctor will usually advise you to take a 125 mg tablet twice daily, depending on how you react to bosentan.
Children and adolescents
The dose recommendation in children is only for PAH. For children aged 1 year and older, treatment with bosentan is usually started with 2 mg per kg bodyweight twice daily (morning and evening). Your doctor will advise you on your dosing. Bosentan should not be administered to children with a body weight below 31 kg, and an alternative product containing bosentan should be used.
If you have the impression that the effect of bosentan is too strong or too weak, talk to your doctor in order to find out whether your dose needs to be changed.
How to take bosentan
Tablets should be taken (morning and evening), swallowed with water. The tablets can be taken with or without food.
If you take more bosentan than you should
If you take more tablets than you have been told to take, contact your doctor immediately.
If you forget to take bosentan
If you forget to take bosentan, take a dose as soon as you remember, then continue to take your tablets at the usual times.
Do not take a double dose to make up for forgotten tablets.
If you stop taking bosentan
Suddenly stopping your treatment with bosentan may lead to your symptoms getting worse. Do not stop taking bosentan unless your doctor tells you to. Your doctor may tell you to reduce the dose over a few days before stopping completely.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious side effects with bosentan are:
Signs that your liver may not be working properly include:
If you notice any of these signs tell your doctor immediately.
Your liver and blood values will be monitored during treatment with bosentan (see section 2). It is important that you have these tests as ordered by your doctor.
Other side effects:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Blurred vision has also been reported at an unknown frequency (frequency cannot be estimated from the available data).
Side effects in children and adolescents
The side effects that have been reported in children treated with bosentan are the same as those in adults.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE BOSENTAN
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Bosentan film-coated tablets contain
The active substance is bosentan.
Each 62.5 mg tablet contains 62.5 mg of bosentan (as monohydrate).
Each 125 mg tablet contains 125 mg of bosentan (as monohydrate).
The other ingredients are maize starch, povidone (K-30), sodium starch glycolate (type A), pregelatinized maize starch, glycerol dibehenate, magnesium stearate, opadry II 85F230061 orange (a mixture consisting of polyvinyl alcohol, titanium dioxide, macrogol 3350, talc , iron oxide yellow (E 172) and iron oxide red (E 172)).
What Bosentan film-coated tablets look like and contents of the pack
Bosentan 62.5 mg film-coated tablets are round, biconvex-shaped, light orange coloured film-coated tablets with the diameter approx. 6.1 mm.
Bosentan 125 mg film-coated tablets are oval, biconvex-shaped, light orange coloured film-coated tablets with length approx. 11.1 mm and width approx. 5.1 mm.
Size of packing: 14, 56 and 112 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
This leaflet was last updated in June 2020