Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Tizanidine
PCO Manufacturing Ltd.
M03BX; M03BX02
Tizanidine
4 milligram(s)
Tablet
Other centrally acting agents; tizanidine
2021-05-21
PACKAGE LEAFLET: INFORMATION FOR THE USER ZANAFLEX ® 2 MG TABLETS ZANAFLEX ® 4 MG TABLETS TIZANIDINE 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, pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Zanaflex is and what it is used for 2. What you need to know before you take Zanaflex 3. How to take Zanaflex 4. Possible side effects 5. How to store Zanaflex 6. Contents of the pack and other information 1. WHAT ZANAFLEX IS AND WHAT IT IS USED FOR • Tizanidine belongs to a group of medicines called skeletal muscle relaxants. • Your medicine is used to relieve the stiffness and restriction of muscles resulting from multiple sclerosis, injury or diseases of the spinal cord. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZANAFLEX DO NOT TAKE ZANAFLEX: • if you are ALLERGIC to tizanidine or any of the other ingredients of this medicine (listed in section 6). • if you have SEVERELY IMPAIRED LIVER FUNCTION. • if you are TAKING medicines such as FLUVOXAMINE (for depression) or CIPROFLOXACIN (an antibiotic) (see also ‘Other medicines and Zanaflex’, below) WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Zanaflex • if you have HEART PROBLEMS such as coronary artery disease. Your doctor will check your heart function regularly using ECG. • if you suffer from SEVERE WEAKNESS OF CERTAIN MUSCLES (myasthenia gravis, leading to difficulty speaking, chewing and swallowing as well as drooping eyelids) • if you suffer from epilepsy. Your disease must be well- controlled with medication. • if you have kidney problems. Y Pročitajte cijeli dokument
Health Products Regulatory Authority 24 November 2022 CRN00D72L Page 1 of 2 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zanaflex 4 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 4 mg of tizanidine (as hydrochloride). Excipient(s) with known effect Each tablet contains lactose, anhydrous. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. _Product imported from Germany:_ White to off-white, biconvex, round, tablets, 9 mm in diameter, debossed "T4" on one side and quadrisected by score lines on the other. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS As per PA0749/054/002 5 PHARMACOLOGICAL PROPERTIES As per PA0749/054/002 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Lactose Cellulose, microcrystalline Stearic acid Silica, colloidal anhydrous 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of 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 30 °C. Health Products Regulatory Authority 24 November 2022 CRN00D72L Page 2 of 2 6.5 NATURE AND CONTENTS OF CONTAINER Blister PVC/PVDC/Aluminium. Blister packs of 120 tablets in outer carton. 6.6 SPECIAL PRECAUTIONS FOR DISPOSAL 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 PPA0465/474/002 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 21 st May 2021 10 DATE OF REVISION OF THE TEXT November 2022 Pročitajte cijeli dokument