País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Biperiden hydrochloride
Lexon Pharmaceuticals (Ireland) Limited
N04AA; N04AA02
Biperiden hydrochloride
2 milligram(s)
Tablet
Tertiary amines; biperiden
2017-07-28
AKINETON 2 MG TABLETS biperiden hydrochloride PACKAGE LEAFLET: INFORMATION FOR THE USER 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 or pharmacist. * 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET What Akineton is and what it is used for What you need to know before you take Akineton How to take Akineton Possible side effects How to store Akineton Contents of the pack and other information WHAT AKINETON IS AND WHAT IT IS USED FOR The name of your tablets is Akineton 2mg tablets - called Akineton in this leaflet. The active ingredient in Akineton is biperiden hydrochloride. Each tablet contains 2 mg of biperiden hydrochloride. Akineton belongs to a group of medicines called anticholinergic agents. Akineton can be used to treat Parkinson’s disease by relaxing muscle spasms and controlling muscle twitching. It can also be used to control muscle twitching and spasms caused by some medicines. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AKINETON DO NOT TAKE AKINETON:_ _ * If you are allergic (hypersensitive) to biperiden hydrochloride or any of the other ingredients in Akineton (please see section 6). * If you suffer from glaucoma. * If you have an abnormal heartbeat or any other heart problems.. * If your doctor has told you that you have a narrowing of your stomach or bowels, or any other bowel problem. * If you are male, and you have benign tumour of the prostate. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Akineton: * If you suffer from thyroid problems. * Some people may be more sensitive to the effects of Akineton and may need closer moni Leer el documento completo
Health Products Regulatory Authority 04 February 2022 CRN00CS1H Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Akineton 2mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg of Biperiden Hydrochloride. Excipients with known effect: Each tablet also contains Lactose monohydrate For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet _Product imported from Czech Republic._ Circular, biplanar, white tablet with a bisecting score on one surface. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS As per PA1253/001/001 Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. 5 PHARMACOLOGICAL PROPERTIES As per PA1253/001/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Calcium hydrogen phosphate Copovidone Potato starch Lactose monohydrate Magnesium stearate Corn starch Microcrystalline cellulose Talc 6.2 INCOMPATIBILITIES Not applicable. Health Products Regulatory Authority 04 February 2022 CRN00CS1H Page 2 of 2 6.3 SHELF LIFE The shelf life expiry date for this product shall be the date shown on the blister and outer package of the product on the market in the country of origin. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25°C. Keep blister in the outer carton. 6.5 NATURE AND CONTENTS OF CONTAINER Supplied in packs of 100 tablets in a blister pack. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING No special requirements 7 PARALLEL PRODUCT AUTHORISATION HOLDER Lexon Pharmaceuticals (Ireland) Limited Block 3 Harcourt Centre Harcourt Road Dublin 2 Ireland 8 PARALLEL PRODUCT AUTHORISATION NUMBER PPA23176/010/001 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 th July 2017 10 DATE OF REVISION OF THE TEXT October 2021 Leer el documento completo