Երկիր: Իռլանդիա
Լեզու: անգլերեն
Աղբյուրը: HPRA (Health Products Regulatory Authority)
Biperiden hydrochloride
Laboratorio Farmaceutico S.I.T.
N04AA; N04AA02
Biperiden hydrochloride
4 milligram(s)
Prolonged-release tablet
Product subject to prescription which may be renewed (B)
Tertiary amines; biperiden
Marketed
1979-04-01
1 PACKAGE LEAFLET: INFORMATION FOR THE USER AKINETON RETARD 4 MG PROLONGED RELEASE TABLETS BIPERIDEN HYDROCHLORIDE 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 1. What Akineton Retard is and what it is used for 2. What you need to know before you take Akineton Retard 3. How to take Akineton Retard 4. Possible side effects 5. How to store Akineton Retard 6. Contents of the pack and other information 1. WHAT AKINETON RETARD IS AND WHAT IT IS USED FOR The name of your tablets is Akineton Retard 4 mg prolonged release tablets called Akineton Retard tablets in this leaflet. The active ingredient in Akineton Retard is biperiden hydrochloride in a prolonged release formulation. The tablets are designed to release biperiden slowly into your bloodstream throughout the day. Akineton Retard belongs to a group of medicines called anticholinergic agents. Akineton Retard 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. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AKINETON RETARD TABLETS _ _ DO NOT TAKE AKINETON RETARD: If you are allergic (hypersensitive) to biperiden hydrochloride or any of the other ingredients of this medicine (listed in 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 m Կարդացեք ամբողջական փաստաթուղթը
Health Products Regulatory Authority 17 December 2020 CRN009SX3 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Akineton Retard 4 mg prolonged release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4 mg of biperiden hydrochloride. Excipients with known effect: Each tablet contains 252 mg of lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release, film-coated tablets Yellowish oblong tablets, scored on both sides. The score line is not intended for breaking the tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Akineton Retard is indicated in adults for the management of: - Parkinsonian syndromes, especially to counteract muscular rigidity and tremor; - Extrapyramidal symptoms such as early dyskinesia, akathisia and parkinsonism provoked by neuroleptics and similarly acting drugs. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Treatment with Akineton is normally initiated with small incremental doses, depending on the therapeutic effect and side effects. Unless otherwise prescribed by the physician, treatment is normally initiated with Akineton Tablets, gradually incremented to determine the most suitable dosage for each individual; patients are then switched to Akineton Retard 4 mg prolonged release tablets. _Adults_ Experience has shown that the average dose for adults is 4-8 mg (one to two tablets), to a maximum of 12 mg (three tablets) daily. The total daily dose should be spread over the day, with the first tablet always being taken in the morning. The tablets should be taken whole with some liquid, either with or immediately after meals. _Special Populations_ Elderly Cautious dosing is necessary in elderly patients, especially those with symptoms of organic brain disease. Paediatric population The safety and efficacy of Akineton Retard in children and adolescents have not been established. No data are available. Health Products Regulatory Authority 17 December 2020 CRN009SX3 Page 2 of 5 M Կարդացեք ամբողջական փաստաթուղթը