Страна: Израиль
Язык: английский
Источник: Ministry of Health
PROCYCLIDINE HYDROCHLORIDE
PADAGIS ISRAEL AGENCIES LTD, ISRAEL
N04AA04
TABLETS
PROCYCLIDINE HYDROCHLORIDE 5 MG
PER OS
Required
ASPEN BAD OLDESLOE GMBH, GERMANY
PROCYCLIDINE
PROCYCLIDINE
Indicated in all forms of parkinson's disease: idiopathic (paralysis agitans), post encephalitic and arteriosclerotic.
2023-02-28
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 The medicine is dispensed with a doctor’s prescription only Kemadrin Tablets 5 mg The active ingredient and its quantity: Each tablet contains: Procyclidine Hydrochloride 5 mg Inactive ingredients and allergens in the medicine: see sections 2 “Important information regarding some of the ingredients of the medicine” and 6 “Further Information” in the leaflet. Read this leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. Kemadrin tablets are not intended for use in children. This medicine has been prescribed as treatment for you. Do not pass it on to others. It may harm them even if it seems to you that their ailment is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine Kemadrin is intended for the treatment of all forms of Parkinson’s disease: idiopathic )of unknown source), postencephalitic )after a viral inflammation of the brain) and arteriosclerotic )related to blood vessels). Therapeutic group: The active ingredient in Kemadrin is procyclidine, which belongs to the group of anticholinergic medicines that prevent the action of the substance acetylcholine in the body. 2. BEFORE USING THE MEDICINE Do not use the medicine if: • You are sensitive )allergic( to the active ingredient procyclidine or to any of the other ingredients contained in the medicine )see section 6). • You have problems passing urine )urinary retention(. • You suffer from a problem caused by excessive intraocular pressure called “closed angle glaucoma”. • You have stomach cramps and pains or constipation. Do not take the medicine if any of the conditions listed above apply to you. If you are uncertain, discuss this with the doctor or pharmacist before starting use of Kemadrin. Special warnings regarding use of the medicine Before starting treatment with Kemadrin, tell the doctor if Прочитать полный документ
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Kemadrin Tablets 5 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Procyclidine Hydrochloride BP, 5 mg per tablet Excipients with known effect: Lactose Monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, round, biconvex tablets, one face with a break-line and coded KT above the break-line and 05 below the break-line, with a score-line on the other face. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Kemadrin is indicated in all forms of Parkinson’s disease: idiopathic (paralysis agitans), postencephalitic and arteriosclerotic. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The variation in optimum dosage from one patient to another should be taken into consideration by the physician. _Dosage in adults: _ _ _ _Parkinson's disease: _ _ _ Treatment is usually started at 2.5 mg procyclidine three times per day, increasing by 2.5 to 5 mg per day at intervals of two or three days until the optimum clinical response is achieved. The usual maintenance dose to achieve optimal response is 15 to 30 mg procyclidine per day. Addition of a fourth dose before retiring has been seen to be beneficial in some patients. Doses up to 60 mg procyclidine have been well tolerated, and at the discretion of the attending physician dosing to this level may be appropriate. In general, younger patients or those with postencephalitic parkinsonism may require higher doses for a therapeutic response than older patients and those with arteriosclerotic parkinsonism. _Paediatric population _ _ _ The use of Kemadrin in this age group is not recommended. _ _ Page 2 of 6 _Older people _ _ _ Elderly patients may be more susceptible than younger adults to the anticholinergic effects of Kemadrin and a reduced dosage may be required (see section 4.4). _Method of administration _ Oral administration may be better tolerated if associated with a meal. Tablets can be divided into equal doses. Прочитать полный документ