Страна: Мальта
мова: англійська
Джерело: Medicines Authority
TRIHEXYPHENIDYL HYDROCHLORIDE
Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus
N04AA01
TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg
TABLET
TRIHEXYPHENIDYL HYDROCHLORIDE 2 mg
POM
ANTI-PARKINSON DRUGS
Authorised
2007-02-15
page 1 of 4 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BENZHEXOL 2 MG TABLETS Trihexyphenidyl Hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THE 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. - Ιf 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 Benzhexol is and what it is used for 2. What you need to know before you take Benzhexol 3. How to take Benzhexol 4. Possible side effects 5. How to store Benzhexol 6. Contents of the pack and other information 1. WHAT BENZHEXOL IS AND WHAT IT IS USED FOR Benzhexol is an antispasmodic (muscle relaxing) drug. Benzhexol is used for the treatment of Parkinson’s disease. Benzhexol helps patients with Parkinson’s disease by improving muscle control and reducing stiffness so that they can move more naturally. Benzhexol can also be used to treat movement disorders (extreme restlessness, involuntary movements or muscle spasms) which may be caused by certain drugs. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BENZHEXOL DO NOT TAKE BENZHEXOL - if you are allergic (hypersensitive) to trihexyphenidyl hydrochloride or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Benzhexol • if you have glaucoma. • if you have heart, liver or kidney disease or suffer from high blood pressure. • if you have prostate problems. • if you have trouble passing urine. • if you have a stomach ulcer or suffer from severe heartburn or acid indigestion or any other digestive disorders. • if you suffer from a condition called myasthenia gravis. • if you suffer from tardive dy Прочитайте повний документ
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Benzhexol 2 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg trihexyphenidyl hydrochloride. Excipient(s) with known effect This product contains 62,5 mg lactose. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablet. White, round, flat, scored tablets. The score line is not intended for breaking the tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Benzhexol 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. Benzhexol is effective in reducing the rigidity of muscle spasm, tremor and excessive salivation associated with Parkinsonism. Benzhexol is also indicated to control extrapyramidal disorders (e.g. akathisia manifested by extreme restlessness and dyskinesia characterised by spastic contractions and involuntary movements) due to central nervous system drugs such as Reserpine and the phenothiazines. Page 2 of 7 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, Benzhexol dosage should be increased or decreased only by small increments over a period of several days. In initial therapy the dose should be 1 mg the first day, 2 Прочитайте повний документ