Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Betahistine dihydrochloride
PCO Manufacturing Ltd.
N07CA; N07CA01
Betahistine dihydrochloride
16 milligram(s)
Tablet
Antivertigo preparations; betahistine
2021-11-12
PACKAGE LEAFLET: INFORMATION FOR THE USER SERC ® 16 MG TABLETS betahistine dihydrochloride 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 of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. WHAT IS IN THIS LEAFLET: 1. What Serc is and what it is used for 2. What you need to know before you take Serc 3. How to take Serc 4. Possible side effects 5. How to store Serc 6. Contents of the pack and other information 1. WHAT SERC IS AND WHAT IT IS USED FOR Serc contains betahistine. Serc is a type of medicine called a “histamine analogue”. Serc is used for: Ménière’s disease – the signs of this include: feeling dizzy (vertigo) ringing in the ears (tinnitus) hearing loss or hearing difficulty This medicine works by improving blood flow in the inner ear. This lowers the build up of pressure. 2. BEFORE YOU TAKE SERC DO NOT TAKE SERC IF: you are allergic (hypersensitive) to betahistine or any of the other ingredients in the tablets (see section 6 for further details) you have high blood pressure due to an adrenal gland tumour (phaeochromocytoma) If any of the above applies to you, do not take this medicine and talk to your doctor. TAKE SPECIAL CARE AND TELL YOUR DOCTOR IF: you have ever had a stomach ulcer you have asthma you are pregnant or planning to become pregnant you are breast-feeding. If any of the above applies to you, talk to your doctor or pharmacist before taking Serc. Your doctor may want to monitor you more closely while you take Serc. Your doctor will tell you whether it is safe for you to start taking this medicine. CHILDREN Serc is not recommended for those under 18 years old. TAKI Đọc toàn bộ tài liệu
Health Products Regulatory Authority 09 January 2024 CRN00F1RL Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Serc 16 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 16 mg betahistine dihydrochloride, equivalent to 10.42 mg betahistine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. _Product imported from Spain:_ Round, biconvex, scored, white to almost white tablets imprinted `267' on one face. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS As per PA23355/014/002 5 PHARMACOLOGICAL PROPERTIES As per PA23355/014/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Microcrystalline cellulose Mannitol (E421) Citric acid monohydrate Colloidal anhydrous silica Talc 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expirydate of this product shall be the date shown on the blister and outer packageof the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE This medicinal product does not require any special temperature storage conditions. Store in the original package. 6.5 NATURE AND CONTENTS OF CONTAINER Blister strips of 15 tablets. The blister strips are made of PVC/PVDC film with a covering aluminium foil. Each carton contains 90 tablets. Health Products Regulatory Authority 09 January 2024 CRN00F1RL Page 2 of 2 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCT AND OTHER HANDLING OF THE PRODUCT No special requirements. 7 PARALLEL PRODUCT AUTHORISATION HOLDER PCO Manufacturing Ltd. Unit 10, Ashbourne Business Park Rath Ashbourne Co. Meath Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA0465/482/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 th November 2021 10 DATE OF REVISION OF THE TEXT January 2024 Đọc toàn bộ tài liệu