Χώρα: Ισραήλ
Γλώσσα: Αγγλικά
Πηγή: Ministry of Health
GALANTAMINE AS HYDROBROMIDE
J-C HEALTH CARE LTD
N06DA04
CAPSULES PROLONGED RELEASE
GALANTAMINE AS HYDROBROMIDE 16 MG
PER OS
Required
JANSSEN CILAG S.P.A., ITALY
GALANTAMINE
Reminyl is indicated for the smptomatic treatment of mild to moderately severe dementia of the Alzheimer type.
2011-12-31
Reminyl SH 10/19 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only REMINYL ® CAPSULES PRC 8 MG REMINYL ® CAPSULES PRC 16 MG REMINYL ® CAPSULES PRC 24 MG Active ingredient and its quantity: GALANTAMINE (AS HYDROBROMIDE) 8 MG GALANTAMINE (AS HYDROBROMIDE) 16 MG GALANTAMINE (AS HYDROBROMIDE) 24 MG INACTIVE AND ALLERGENIC INGREDIENTS IN THE PREPARATION – SEE SECTION 2 “IMPORTANT INFORMATION ABOUT SOME OF THE INGREDIENTS OF THE MEDICINE”, SECTION 6 “FURTHER INFORMATION”. 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. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. The medicine is not intended for children and adolescents. 1. WHAT IS THE MEDICINE INTENDED FOR? Reminyl is intended for the treatment of symptoms (of mild to moderate severity) of dementia associated with Alzheimer’s disease in adults. This disease affects brain function and is manifested by symptoms including gradual impairment of memory, increasing confusion and behavioral changes that impair day-to-day functioning. Reminyl contains the active ingredient galantamine and is a prolonged-release capsule. That is, the medicine is released slowly. THERAPEUTIC GROUP: Anti-dementia medicines 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 contained in the medicine. For a list of the other ingredients, see section 6 “Further Information”. • If you suffer from severe liver or kidney disease. • If you are breastfeeding. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE: Talk to your doctor before taking Reminyl. This medicine is used only in Alzheimer’s dis Διαβάστε το πλήρες έγγραφο
Page 1 of 13 Reminyl_PRC_SPC 09.19 1. NAME OF THE MEDICINAL PRODUCT REMINYL 8 mg prolonged-release capsules, REMINYL 16 mg prolonged-release capsules, REMINYL 24 mg prolonged-release capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 8 mg capsule contains 8 mg galantamine (as hydrobromide). Each 16 mg capsule contains 16 mg galantamine (as hydrobromide). Each 24 mg capsule contains 24 mg galantamine (as hydrobromide). Excipients with known effect: 8 mg capsule: sucrose 59 mg 16 mg capsule: sucrose 117 mg 24 mg capsule: sucrose 176 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release capsule, hard 8 mg capsule: White opaque, size 4 hard capsules with the inscription “G8”, containing white to off-white pellets. 16 mg capsule: Pink opaque, size 2 hard capsules with the inscription “G16”, containing white to off-white pellets. 24 mg capsule: Caramel opaque, size 1 hard capsules with the inscription “G24”, containing white to off-white pellets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Reminyl is indicated for the symptomatic treatment of mild to moderately severe dementia of the Alzheimer type. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults/Elderly _ _Before start of treatment _ The diagnosis of probable Alzheimer type of dementia should be adequately confirmed according to current clinical guidelines (see section 4.4). Page 2 of 13 Reminyl_PRC_SPC 09.19 _Starting dose _ The recommended starting dose is 8 mg/day for 4 weeks. _Maintenance dose _ The tolerance and dosing of galantamine should be reassessed on a regular basis, preferably within 3 months after start of treatment. Thereafter, the clinical benefit of galantamine and the patient’s tolerance of treatment should be reassessed on a regular basis according to current clinical guidelines. Maintenance treatment can be continued for as long as therapeutic benefit is favourable and the patient tolerates treatment with galantamine. Discontinuation of galantamine should be considered Διαβάστε το πλήρες έγγραφο