Land: Europese Unie
Taal: Engels
Bron: EMA (European Medicines Agency)
tafamidis
Pfizer Europe MA EEIG
N07XX08
tafamidis
Other nervous system drugs
Amyloidosis
Vyndaqel is indicated for the treatment of transthyretin amyloidosis in adult patients with stage-1 symptomatic polyneuropathy to delay peripheral neurologic impairment.
Revision: 27
Authorised
2011-11-16
43 B. PACKAGE LEAFLET 44 PACKAGE LEAFLET: INFORMATION FOR THE USER VYNDAQEL 20 MG SOFT CAPSULES tafamidis meglumine This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, pharmacist or nurse. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Vyndaqel is and what it is used for 2. What you need to know before you take Vyndaqel 3. How to take Vyndaqel 4. Possible side effects 5. How to store Vyndaqel 6. Contents of the pack and other information 1. WHAT VYNDAQEL IS AND WHAT IT IS USED FOR Vyndaqel contains the active substance tafamidis. Vyndaqel is a medicine which treats a disease called transthyretin amyloidosis Transthyretin amyloidosis is caused by a protein called transthyretin (TTR) that does not work properly. TTR is a protein that carries other substances, such as hormones, through the body. In patients with this disease, TTR breaks up and may form fibres called amyloid. Amyloid can build up around your nerves (known as transthyretin amyloid polyneuropathy or ATTR-PN) and in other places in your body. The amyloid causes the symptoms of this disease. When this occurs, it prevents them from working normally. Vyndaqel, can prevent TTR from breaking up and forming amyloid. This medicine is used to treat adult patients with this disease whose nerves have been affected (people with symptomatic polyneuropathy) to delay further Lees het volledige document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Health care professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Vyndaqel 20 mg soft capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each soft capsule contains 20 mg of micronized tafamidis meglumine equivalent to 12.2 mg tafamidis. Excipient with known effect Each soft capsule contains no more than 44 mg of sorbitol (E 420). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Soft capsule. Yellow, opaque, oblong (approximately 21 mm) capsule imprinted with “VYN 20” in red. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vyndaqel is indicated for the treatment of transthyretin amyloidosis in adult patients with stage 1 symptomatic polyneuropathy to delay peripheral neurologic impairment. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated under the supervision of a physician knowledgeable in the management of patients with transthyretin amyloid polyneuropathy (ATTR-PN). Posology The recommended dose of tafamidis meglumine is 20 mg orally once daily. Tafamidis and tafamidis meglumine are not interchangeable on a per mg basis. If vomiting occurs after dosing, and the intact Vyndaqel capsule is identified, then an additional dose of Vyndaqel should be administered if possible. If no capsule is identified, then no additional dose is necessary, with resumption of dosing the next day as usual. Special populations _Elderly_ No dosage adjustment is required for elderly patients (≥ 65 years) (see section 5.2). 3 _Hepatic and renal impairment_ No dosage adjustment is required for patients with renal or mild and moderate hepatic impairment. Limited data are available in patients with severe renal impairment (creatinine clearance less than or equal to 30 mL/min). Tafamidis meglumine has not been studied Lees het volledige document