Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Trihexyphenidyl hydrochloride
Dr Reddy's Laboratories (UK) Ltd
N04AA01
Trihexyphenidyl hydrochloride
2mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04090200
PACKAGE LEAFLET: INFORMATION FOR THE USER TRIHEXYPHENIDYL HYDROCHLORIDE 2MG TABLETS 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. The name of your medicine is TRIHEXYPHENIDYL HYDROCHLORIDE 2mg TABLETS but will be referred to as Trihexyphenidyl Tablets or Trihexyphenidyl throughout this leaflet. IN THIS LEAFLET 1. What Trihexyphenidyl Tablets are and what they are used for 2. Before you take Trihexyphenidyl Tablets 3. How to take Trihexyphenidyl Tablets 4. Possible side effects 5. How to store Trihexyphenidyl Tablets 6. Further information 1. WHAT TRIHEXYPHENIDYL TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Trihexyphenidyl Tablets. Trihexyphenidyl is an antispasmodic (muscle relaxing) drug. Trihexyphenidyl is used to treat Parkinson’s disease. Trihexyphenidyl helps patients with Parkinson’s disease by improving muscle control and reducing stiffness so that they can move more naturally. Trihexyphenidyl can also be used to treat movement disorders (extreme restlessness, involuntary movements or muscle spasms) which may be caused by certain drugs. 2. BEFORE YOU TAKE TRIHEXYPHENIDYL TABLETS DO NOT TAKE TRIHEXYPHENIDYL TABLETS IF YOU: are ALLERGIC (HYPERSENSITIVE) to trihexyphenidyl or any other ingredient in the tablets (see section 6–‘Further information for details’) TAKE SPECIAL CARE WITH TRIHEXYPHENIDYL TABLETS IF YOU: have glaucoma have heart, liver or kidney disease or suffer from high blood pressure have prostate problems have trouble passing urine have a stomach ulcer or suffer from severe heartburn or acid indigestion or any other digestive disorders suffer from a Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Agitane Trihexyphenidyl 2 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Trihexyphenidyl Hydrochloride – 2.00 mg Excipient with known effect: Lactose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets White flat bevelled edge plain tablets, odourless. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Trihexyphenidyl is an antispasmodic drug which exerts a direct inhibitory effect on the parasympathetic nervous system. It also has a relaxing effect on smooth muscle. It is indicated in all forms of Parkinsonism (postencephalitic, arteriosclerotic and idiopathic) .It is often useful as adjuvant therapy when treating these forms of Parkinsonism with levodopa. Trihexyphenidyl is effective in reducing the rigidity of muscle spasm, tremor and excessive salivation associated with Parkinsonism. Trihexyphenidyl is also indicated to control extrapyramidal disorders (eg akathisia manifested by extreme restlessness and dyskinesia characterized by spastic contractions and involuntary movements) due to central nervous system drugs such as reserpine and the phenothiazines. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _POSOLOGY: _ _Adults Only: _ Optimal dosage should always be determined empirically, usually by initiating therapy at a relatively low level and by subsequent graduated increments The usual dosage for Parkinsonism is 6-10 mg per day although some patients chiefly in the post-encephalitic group may require an average total dose of 12- 15 mg daily. It should be given orally either three or four times a day at mealtimes. Normal dosage for drug-induced Parkinsonism is usually between 5 mg and 15 mg per day, although some cases have been controlled by 1 mg daily. In all cases, trihexyphenidyl dosage should be increased or decreased only be by small increments over a period of several days. In initial therapy the dose should be 1mg the first day, 2mg the second day with further increase of 2mg per da Đọc toàn bộ tài liệu