Tracleer 62.5 mg film-coated tablets
Bosentan
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, please ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What Tracleer is and what it is used for
- 2. Before you take Tracleer
- 3. How to take Tracleer
- 4. Possible side effects
- 5. How to store Tracleer
- 6. Further information
What Tracleer Is And What It Is Used For
Tracleer tablets contain bosentan and belong to the class of medicines called “endothelin receptor antagonists”.
Tracleer is used to treat pulmonary arterial hypertension (PAH). PAH is high blood pressure in the blood vessels (the pulmonary arteries) that carry blood from the heart to the lungs. Tracleer widens the pulmonary arteries, making it easier for the heart to pump blood through them. This lowers the blood pressure and relieves the symptoms.
Tracleer is also used to treat digital ulcers (ulcers of the fingers) in people with a condition called scleroderma. Tracleer reduces the number of new finger ulcers that appear.
Before You Take Tracleer
Do not take Tracleer…
if you are allergic (hypersensitive) to bosentan or any of the other ingredients of the tablet
if you have liver problems (ask your doctor)
if you are pregnant, or could get pregnant because you are not using reliable contraceptive methods (hormonal contraceptives alone are not effective when you take Tracleer)
if you are taking cyclosporine A (a medicine used after a transplant or to treat psoriasis)
If any of these apply to you, tell your doctor.
Take special care with Tracleer
Tests your doctor will do before treatment
- Blood tests to check your liver function
- Blood test to monitor anaemia (low haemoglobin)
- Pregnancy tests if you are a woman of child-bearing potential
Some patients taking Tracleer have been found to have abnormal liver function tests and anaemia (low haemoglobin). During treatment with Tracleer, 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 Reminder Card. It is important that you have these regular blood tests as long as you are taking Tracleer. 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 reminder card, to help you remember when your next test is due.
Your doctor will give this card to you before you start taking Tracleer.
Blood tests for liver function:
These will be done every month for the duration of treatment with Tracleer. After an increase in dose an additional test will be done after 2 weeks.
Tracleer may affect your liver. Signs that your liver may not be working properly include:
- Nausea (feeling sick)
- Vomiting, (being sick)
- Fever (high temperature)
- Pain in your stomach (abdomen)
- Jaundice (yellowing of your skin or the whites of your eyes)
- Dark-coloured urine
- Itching of your skin
- Lethargy or fatigue (unusual tiredness or exhaustion)
- Flu-like syndrome (joint and muscle pain with fever)
If you notice any of these signs:
Tell your doctor immediately
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 Tracleer may get anaemia.
If these results are abnormal, your doctor may decide to reduce your dose or stop treatment with Tracleer and to perform further tests to investigate the cause.
Pregnancy tests for women of child-bearing age:
Tracleer 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 Tracleer, and regularly while you are taking Tracleer.
- Don’t take Tracleer if you are pregnant or planning to become pregnant.
- If it is possible that you could become pregnant, use a reliable form of birth control (contraception) while you are taking Tracleer. Your doctor or gynaecologist will advise you about reliable contraceptive methods while taking Tracleer. Because Tracleer 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 Tracleer tablets you will find a Patient Reminder 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 Tracleer and are of child-bearing age.
- Tell your doctor immediately if you become pregnant while you are taking Tracleer, or plan to become pregnant in the near future.
Breast-feeding:
Tell your doctor immediately if you are breast-feeding. You are advised to stop breast-feeding if Tracleer is prescribed for you, because it is not known whether this medicine passes into breast milk.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It is especially important to tell your doctor if you are taking:
- hormonal contraceptives (as these are not effective as the sole method of contraception when you take Tracleer). Inside your pack of Tracleer tablets you will find a patient reminder card which you should read carefully. Your doctor and/or gynaecologist will establish the contraception which is appropriate for you.
- glibenclamide (for diabetes) (as this combination may increase the risk of side effects)
- cyclosporine A (a medicine used after transplants and to treat psoriasis), or any other drugs used to prevent rejection of transplanted organs (as these drugs may increase the concentrations of Tracleer in your blood)
- fluconazole (to treat fungal infections) (as this drug may increase the concentrations of Tracleer in your blood)
- rifampicin (to treat tuberculosis) (as this drug may reduce the efficacy of Tracleer)
- medicines for the treatment of HIV infection
Taking Tracleer with food and drink
Tracleer can be taken with or without food.
Driving and using machines
If you feel dizzy while taking Tracleer, do not drive or operate any tools or machines.
How To Take Tracleer
Always take Tracleer exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
If you have the impression that the effect of Tracleer is too strong or too weak, talk to your doctor in order to find out whether your dose needs to be changed.
Usual dose
Adult
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 Tracleer.
Children and patients with low body weight
For children and patients with low body weight, treatment with Tracleer is usually started with 2 mg per kg bodyweight twice daily (morning and evening). Your doctor will advise you on your dosing.
Tablets should be taken (morning and evening), swallowed with water. The tablets can be taken with or without food.
If you take more Tracleer than you should
If you take more tablets than you have been told to take, contact your doctor at once.
If you forget to take Tracleer
If you forget to take Tracleer, 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 Tracleer
Suddenly stopping your treatment with Tracleer may lead to your symptoms getting worse. Do not stop taking Tracleer 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 product, ask your doctor or pharmacist.
Possible Side Effects
Like all medicines, Tracleer can cause side effects, although not everybody gets them.
These side effects may occur with certain frequencies, which are defined as follows:
- very common: affects more than 1 user in 10
- common: affects 1 to 10 users in 100
- uncommon: affects 1 to 10 users in 1,000
- rare: affects 1 to 10 users in 10,000
- very rare: affects less than 1 user in 10,000
When Tracleer was taken for pulmonary arterial hypertension in clinical studies, the following side effects occured:
Very common side effects
- Headache
- Oedema (swelling of the legs and ankles or other signs of fluid retention)
- Liver function tests abnormal
Common side effects
- Inflammation of the throat and nasal passages (a runny or blocked nose), respiratory tract infection, sinusitis (congestion or pain in the sinuses)
- Anaemia (low number of red blood cells)
- Syncope (fainting)
- Palpitations (fast or irregular heart beats)
- Low blood pressure, flushed appearance
- Joint pain
- Chest pain
When Tracleer was taken for digital ulcers in scleroderma in clinical studies, the following side effects occured:
Very common side effects
- Elevated liver function tests
- Oedema (swelling of the legs and ankles or other signs of fluid retention)
Common side effects
- Infected skin ulcer, urinary tract infection
- Anaemia (low number of red blood cells)
- Flushed appearance
- Heartburn, diarrhoea, constipation, stomach ache
- Skin redness
- Back pain, pain in limbs
The following side effects have occurred during the marketed use of Tracleer:
Common
- Nausea (feeling sick)
- Anaemia (low number of red blood cells) or haemoglobin decreases, sometimes requiring blood transfusion
Uncommon
- Vomitting (being sick), abdominal pain, diarrhoea
- Elevated liver function tests with hepatitis (inflammation of the liver) and/or jaundice (yellowing of the skin or the whites of the eyes)
- Hypersensitivity reactions including dermatitis, pruritis (itch) and rash
- Thrombocytopenia (low number of blood platelets)
Rare
- Cirrhosis (scarring) of the liver, liver failure (serious disturbance of liver function)
- Anaphylaxis (general allergic reaction), angioedema (swelling, most commonly around the eyes, lips, tongue or throat)
- Neutropenia/Leukopenia (low number of white blood cells)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet or signs of allergic reaction (e.g. swelling of the face or tongue, rash, itch) while you are taking Tracleer, or if any of the side effects mentioned above worry you, please tell your doctor or pharmacist.
How To Store Tracleer
Keep out of the reach and sight of children.
Do not use Tracleer after the expiry date which is stated on the carton and on the blister after "EXP".
Do not store above 30°C.
Further Information
What Tracleer contains
The active substance is bosentan monohydrate. Each tablet contains 62.5 mg of bosentan (as monohydrate).
The other ingredients in the tablet core are maize starch, pregelatinised starch, sodium starch glycollate, povidone, glycerol dibehenate and magnesium stearate. The film-coat contains hypromellose, glycerol triacetate, talc, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172) and ethylcellulose.
What Tracleer looks like and contents of the pack
Tracleer 62.5 mg film-coated tablets are orange-white, round film-coated tablets with “62,5” on one side.
PVC/PE/PVDC/aluminium-blisters containing 14 film-coated tablets. Cartons contain 14, 56 or 112 film-coated tablets.
Not all pack sizes may be marketed.
Marketing authorisation holder:
Manufacturer:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
United Kingdom
This leaflet was last approved in April 2010
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/.
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