Krajina: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
BIPERIDEN HYDROCHLORIDE
RAFA LABORATORIES LTD
N04AA02
TABLETS
BIPERIDEN HYDROCHLORIDE 2 MG
PER OS
Required
RAFA LABORATORIES LTD, JERUSALEM
BIPERIDEN
BIPERIDEN
All types of Parkinson's disease.
2021-03-31
1 PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 This medicine is sold with a doctor's prescription only DEKINET TABLETS ACTIVE INGREDIENT: Each tablet contains: Biperiden Hydrochloride (HCl) 2 mg. For the list of the other ingredients, see section 6. See also 'Important information about some of the medicine's ingredients' in section 2. READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, please refer to your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. WHAT IS THE MEDICINE INTENDED FOR? This medicine is intended for relief of Parkinson’s disease symptoms in all its forms. THERAPEUTIC GROUP: the medicine belongs to the anticholinergic medicines group. The medicine acts by relaxing muscles and controlling spasms. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: • You are sensitive (allergic) to the active ingredient or to any of the other ingredients the medicine contains (for the list of the other ingredients, see section 6). • You suffer from narrow-angle glaucoma. • You suffer from an irregular heartbeat or any other heart problems or illnesses that could lead to tachycardia. • You have a narrowing of the stomach or bowels, intestinal obstruction, or any other bowel problems such as megacolon. • You have a benign tumor of the prostate gland. SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE: BEFORE (AND DURING) TREATMENT WITH DEKINET, TELL YOUR DOCTOR IF: • You suffer from thyroid gland problems. • You suffer from glaucoma - see 'Do not use the medicine if'. • You belong to any of the following groups which might be more sensitive to the effects of the medicine and therefore you may need to be monitored more closely: - The elderly, particularly those who suffer or have suffered from a disease, injur Prečítajte si celý dokument
1 Dekinet-DL-Feb 2022-01 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT DEKINET Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg of biperiden hydrochloride. Excipients with known effect: Each tablet contains about 38 mg of lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Almost white scored tablet, marked D/2. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS All types of Parkinson's disease. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Parkinsonism _ Dosage should be individualized. Begin with 1/2 a tablet twice daily, and gradually increase to 1 tablet, 3-4 times daily. Then decrease continuously to the lowest dosage regimen which adequately controls the symptoms. _Drug-induced Extrapyramidal Symptoms _ The oral dosage is 1 tablet, 1-3 times daily. _Special populations_ _Elderly_ Elderly patients, particularly those with cerebral lesions of a vascular or degenerative nature, may exhibit increased sensitivity even to therapeutic doses of the drug. Cautious dosing is recommended. Chronic use may predispose geriatric patients to glaucoma. 2 _Paediatric population_ Safety and effectiveness of use in children have not been established. Method of administration Oral use. Dekinet should be taken with a small amount of food to avoid gastric irritation. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Dekinet is contra-indicated in the presence of untreated narrow-angle glaucoma, mechanical stenoses in the gastrointestinal tract, paralytic ileus, megacolon, prostatic adenoma and diseases that can lead to perilous tachycardia. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Dekinet should only be used with caution in the elderly, and in patients with thyrotoxicosis, cardiac failure, tachycardia, prostatic adenoma or patients who show an increased tendency to convulsions. Central excitation effects are frequently seen in pati Prečítajte si celý dokument