Country: Ավստրալիա
language: անգլերեն
source: Department of Health (Therapeutic Goods Administration)
galantamine hydrobromide, Quantity: 20.504 mg (Equivalent: galantamine, Qty 16 mg)
Arrotex Pharmaceuticals Pty Ltd
Galantamine hydrobromide
Capsule, modified release
Excipient Ingredients: Gelatin; ethylcellulose; titanium dioxide; microcrystalline cellulose; iron oxide red; magnesium stearate; hypromellose
Oral
28
(S4) Prescription Only Medicine
Galantamine is indicated for the treatment of mild to moderately severe dementia of the Alzheimer type
Visual Identification: opaque flesh-flesh size 2 hard gelatin capsule containing two round biconvex tablets; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2012-01-20
GAMINE XR – Consumer Medicine Information Page 1 of 4 GAMINE XR CAPSULES _galantamine hydrobromide _ _ _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Gamine XR modified release capsules. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits this medicine is expected to have for you. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY CONCERNS ABOUT TAKING GAMINE XR. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT GAMINE XR IS USED FOR Gamine XR is used to treat mild to moderately severe dementia of the Alzheimer’s type. The symptoms of Alzheimer’s disease include confusion, memory loss or other changes in behaviour. As the disease progresses, patients find it more and more difficult to carry out their normal daily activities. The symptoms of Alzheimer’s disease are thought to be due to lack of acetylcholine, a substance which transmits messages between brain cells. Gamine XR increases the amount of this substance to help improve or stabilise the symptoms and therefore slow the progress of Alzheimer’s disease. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE GAMINE XR IF YOU HAVE: • an allergy to Gamine XR or any of the ingredients. See PRODUCT DESCRIPTION at the end of this leaflet for a list of ingredients • severe liver and/or kidney disease. DO NOT TAKE THIS MEDICINE IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. DO NOT USE IT BEYOND THE EXPIRY DATE (MONTH AND YEAR) PRINTED ON THE PACK. _BEFORE YOU TAKE IT _ YOU MUST TELL YOUR DOCTOR IF YOU ARE: • pregnant, or planning to become pregnant • breastfeeding, or planning to breastfeed • planning to underg read_full_document
AUSTRALIAN PRODUCT INFORMATION – GAMINE XR (GALANTAMINE (AS HYDROBROMIDE)) MODIFIED RELEASE CAPSULES 1 NAME OF THE MEDICINE Galantamine (as hydrobromide). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Galantamine modified release capsules contain the active galantamine hydrobromide, equivalent to 8, 16, 24 mg galantamine base. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM GALANTAMINE 8 mg modified release capsules are opaque white-white, size 2 hard gelatin capsules containing one round biconvex tablet. GALANTAMINE 16 mg modified release capsules are opaque flesh-flesh, size 2 hard gelatin capsules containing two round biconvex tablets. GALANTAMINE 24 mg modified release capsules are opaque orange-orange, size 2 hard gelatin capsules containing three round biconvex tablets. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Galantamine is indicated for the treatment of mild to moderately severe dementia of the Alzheimer type. 4.2 D OSE AND METHOD OF ADMINISTRATION Galantamine modified release capsules should be administered once daily in the morning, preferably with food. Ensure adequate fluid intake during treatment. The capsule must be swallowed whole. The contents should not be crushed and sprinkled on food. The dose of galantamine should be gradually increased to the maintenance dose to minimise side effects. STARTING DOSE The recommended starting dose is 8 mg a day for four weeks. MAINTENANCE DOSE The initial maintenance dose is 16 mg a day and patients should be maintained on this dose for at least 4 weeks. An increase to the maximum recommended maintenance dose of 24 mg a day should be considered after appropriate assessment including evaluation of clinical benefit and tolerability. There is no rebound effect after abrupt discontinuation of treatment, for example, prior to surgery. RE-INITIATION OF THERAPY If treatment is interrupted for longer than several days, treatment should be re-initiated with the lowest daily dose and gradually increased to the maximum t read_full_document