Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
sitaxentan sodium
Pfizer Ltd.
C02KX03
sitaxentan sodium
Antihypertensives,
Hypertension, Pulmonary
Treatment of patients with pulmonary arterial hypertension (PAH) classified as WHO functional class III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and in pulmonary hypertension associated with connective tissue disease.
Revision: 13
Withdrawn
2006-08-10
25 B. PACKAGE LEAFLET Medicinal product no longer authorised 26 PACKAGE LEAFLET: INFORMATION FOR THE USER THELIN 100 MG FILM-COATED TABLETS Sitaxentan sodium 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, 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 side effect becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Thelin is and what it is used for 2. Before you take Thelin 3. How to take Thelin 4. Possible side effects 5. How to store Thelin 6. Further information 1. WHAT THELIN IS AND WHAT IT IS USED FOR Thelin is used to help lower blood pressure in the blood vessels when this pressure is raised in pulmonary arterial hypertension (PAH). Pulmonary arterial hypertension is the term used when the heart struggles to pump blood to the lungs. Thelin lowers the blood pressure by widening these vessels, so your heart can pump blood more effectively. This will make it easier for you to do more activities. 2. BEFORE YOU TAKE THELIN DO NOT TAKE THELIN: If you are ALLERGIC (hypersensitive) to sitaxentan sodium or any of the other ingredients in these tablets; If you have or have had a SERIOUS LIVER PROBLEM; If you have RAISED LEVELS OF SOME LIVER ENZYMES (detected by blood tests); If you are taking CICLOSPORIN A (used to treat psoriasis and rheumatoid arthritis, and to prevent rejection of liver or kidney transplants); If you are BREAST-FEEDING (please read the section ‘Pregnancy and breast-feeding’ below); If you are A CHILD OR ADOLESCENT under 18 years old. TAKE SPECIAL CARE WITH THELIN: If you could get PREGNANT or are pregnant (please read the section “Pregnancy and breast-feeding” below); If you DEVELOP LIVER PROBLEMS or symptoms that migh Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Thelin 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg sitaxentan sodium. Excipients: Also contains 166.3mg of lactose monohydrate. For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Film-coated tablet Capsule shaped yellow-to-orange film-coated tablets, debossed with T-100 on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of patients with pulmonary arterial hypertension (PAH) classified as WHO functional class III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and in pulmonary hypertension associated with connective tissue disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH. Thelin is to be taken orally as a dose of 100 mg once daily. It may be taken with or without food and without regard to the time of day. In the case of clinical deterioration despite Thelin treatment for at least 12 weeks, alternative therapies should be considered. However, a number of patients who showed no response by week 12 of treatment with Thelin responded favourably by week 24, so an additional 12 weeks of treatment may be considered. Higher doses did not confer additional benefit sufficient to offset the increased risk of adverse reactions, particularly liver injury (see section 4.4). Discontinuation of treatment There is limited experience with abrupt discontinuation of sitaxentan sodium. No evidence for acute rebound has been observed. Dosage in hepatic impairment: Studies in patients with pre-existing liver impairment have not been conducted. Thelin is contraindicated in patients with elevated liver aminotransferases prior to initiation of treatment (> 3 x Upper Limit of Normal (ULN)) or with elevated direct bilirubin > 2 x ULN prior to initiation of treatment (see sect Lesen Sie das vollständige Dokument