Quốc gia: Vương quốc Anh
Ngôn ngữ: Tiếng Anh
Nguồn: MHRA (Medicines & Healthcare Products Regulatory Agency)
Trihexyphenidyl hydrochloride
Accord-UK Ltd
N04AA01
Trihexyphenidyl hydrochloride
2mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04090200; GTIN: 5012617018878
the enclosed leaflet use. Also t s leaflet for fur er information). For oral administration as ec doctor. Store a dry Licence ol r: Cre t Lt , Over , Hants 3ED If you forget to take Trihexyphenidyl Tablets If you forget to take a dose of this medicine, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take the next dose at the usual time. DO NOT TAKE TWO DOSES AT THE SAME TIME. 4 . POSSIBLE SIDE EFFECTS 30 – 50% of patients may experience dry mouth, constipation, blurred vision, dizziness and stomach upset. If any of the following occur STOP TAKING the tablets IMMEDIATELY and contact your doctor, as they may be signs of an allergic reaction: • shortness of breath, blocked nose, rash, itching, swollen face or lips (could happen to more than 1 in 100 people, but less than 1 in 10) The following other side-effects have been reported with trihexyphenidyl: Uncommon effects (that could happen to more than 1 in 100 people, but less than 1 in 10): • difficulty in passing urine • faster heart beat • nervousness • high doses of this medicine may cause excitement, feeling of great happiness, agitation or confusion, hallucinations, restlessness, difficulty sleeping, change in your mental Like all medicines, this medicine can cause side effects, although not everybody gets them. 6 . 5. HOW TO STORE TRIHEXYPHENIDYL TABLETS KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN. FURTHER INFORMATION Ingredients Each Trihexyphenidyl 2mg Tablet contains 2mg of trihexyphenidyl hydrochloride. Other ingredients are magnesium stearate, maize starch, pregelatinised maize starch and lactose. W hat Trihexyphenidyl Tablets look like The tablets are round and white with a breakline on one side. They are available in pack sizes of 28, 30, 42, 50, 56, 60, 84, 90, 100, 112, 250, 500 and 1000 tablets. (Not all pack sizes may be marketed). W ho makes this medicine and holds the Product Licence: The Product Licence Holder is Crescent Pharma Limited, Units 3 & 4, Quidhampton Đọc toàn bộ tài liệu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Trihexyphenidyl 2mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2mg of trihexyphenidyl hydrochloride Excipient(s) with known effect Lactose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM 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 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 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 increases of 2mg per day at three to five-day intervals until the optimum dose is reached. If patients are already being treated with other parasympathetic inhibitors, trihexyphenidyl should be substituted as part of the therapy. When trihexyphenidyl is used concomitantly with levodopa the usual dose of each may need to be reduced. Careful adjustment is necessary, depending on side effects and the degree of symptom control. Trihexyphenidyl dosage of 3-6mg daily in divided doses, is usually adequate. Trihexyphenidyl may be taken before or after meals according to the way the patient reacts. If trihexyphenidyl tends to dry the mouth excessively, it may be better to take it before mea Đọc toàn bộ tài liệu