Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Trihexyphenidyl hydrochloride
Crescent Pharma Ltd
N04AA01
Trihexyphenidyl hydrochloride
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04090200; GTIN: 5017123285158
Artwork No. Customer Description Market Language Size Min. Font Size Page No. Version No. Date Software 121218/2 Ennogen Trihexyphenidy 2 /5 mg Leaflet UK English 160 x 300 mm 9 pt 1 of 1 3 03-01-19 Coreldraw 12 Packaging Development Quality Assurance (QA) Quality Control (QC) Production e-mail : artworkcd@yahoo.com Ph : +91-09845156610 Colours Used Black Keyline Trihexyphenidyl 2mg and 5mg Tablets [trihexyphenidyl 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, 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 Trihexyphenidyl Tablets are and what they are used for 2. What you need to know before you take Trihexyphenidyl Tablets 3. How to take Trihexyphenidyl Tablets 4. Possible side effects 5. How to store Trihexyphenidyl Tablets 6. Contents of the pack and other information 1. WHAT TRIHEXYPHENIDYL TABLETS ARE AND WHAT THEY ARE USED FOR Trihexyphenidyl Tablets contain the active substance trihexyphenidyl hydrochloride. This belongs to a group of medicines known as anticholinergics which are used in the treatment of Parkinson's disease. This particular medicine is used for treating Parkinson's disease and also to prevent and control side effects which are similar to Parkinson's disease and are caused by certain medicines. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRIHEXYPHENIDYL TABLETS DO NOT TAKE TRIHEXYPHENIDYL TABLETS: ! If you are allergic to trihexyphenidyl hydrochloride or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Tal Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Trihexyphenidyl 5mg Tablets BP 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of trihexyphenidyl hydrochloride BP. For excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White, flat bevel edged tablets with a breakline. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS 1. Treatment of parkinsonism 2. Prevention and control of drug-induced extrapyramidal symptoms (excluding tardive dyskinesia) 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral _Dosage _ Adults (only) _All forms of parkinsonism _ Initial dose: 1 – 2 mg gradually increased by 1 – 2 mg increment to 6 – 10 mg daily according to the patient’s response. Some patients may require 12 – 15 mg daily or more. The maximum daily dose is 20 mg. Postencephalitic patients tolerate and require larger doses. _Drug-induced parkinsonism _ Usual dose: 5 – 10 mg daily Some cases may be controlled with 1 mg daily. Elderly: Patients over 65 years of age may require a reduced dosage. The above dosage should be administered in 3 – 4 divided doses daily before or with meals. Antimuscarinic treatment of parkinsonism should never be terminated suddenly. When changing from one drug to another, withdraw the one in small amounts while gradually increasing the dose of the other. Trihexyphenidyl tablets may be given with other drugs employed for the relief of parkinsonism e.g. other antimuscarinic drugs, levodopa and amantadine. Dose reduction may be required. 4.3 CONTRA-INDICATIONS Known hypersensitivity to trihexyphenidyl hydrochloride or any of the ingredients. Incipient glaucoma may be precipitated. The following are not absolute contraindications, nevertheless caution must be observed in patients with hypertension,cardiac, liver or kidney dysfunction, obstructive disease of the gastrointestinal or genitourinary tracts, glaucoma, and in males with a prostatic hypertrophy. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Anticholinergic medication Đọc toàn bộ tài liệu