מדינה: אוסטרליה
שפה: אנגלית
מקור: 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: iron oxide red; hypromellose; titanium dioxide; magnesium stearate; microcrystalline cellulose; ethylcellulose; Gelatin
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: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2012-01-20
APO-GALANTAMINE MR CAPSULES 1 APO-GALANTAMINE MR CAPSULES _Contains the active ingredient galantamine (as galantamine hydrobromide) _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. 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 they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is APO- Galantamine MR. It contains the active ingredient galantamine (as hydrobromide). It 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 a lack of acetylcholine, a substance which transmits messages between brain cells. Galantamine increases the amount of this substance, to help improve or stabilise the symptoms and therefore slow the progress of Alzheimer’s disease. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. There is no evidence that this medicine is addictive. This medicine should not be used in children. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • any medicine containing galantamine • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic r קרא את המסמך השלם
1 AUSTRALIAN PRODUCT INFORMATION APO-GALANTAMINE MR (GALANTAMINE 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. EXCIPIENTS WITH KNOWN EFFECT Contains traces of galactose. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM APO-GALANTAMINE 8 MG MODIFIED RELEASE CAPSULES Opaque white-white, size 2 hard gelatin capsules containing one round biconvex tablet. APO-GALANTAMINE 16 MG MODIFIED RELEASE CAPSULES Opaque flesh-flesh, size 2 hard gelatin capsules containing two round biconvex tablets. APO-GALANTAMINE 24 MG MODIFIED RELEASE CAPSULES Opaque orange-orange, size 2 hard gelatin capsules containing three round biconvex tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Galantamine is indicated for the treatment of mild to moderately severe dementia of the Alzheimer type. 4.2 DOSE AND METHOD OF ADMINISTRATION APO-Galantamine modified release capsules are intended for oral administration. Galantamine modified release capsules should be administered once daily in the morning, preferably with food. Ensure adequate fluid intake during treatment. 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. DOSAGE STARTING DOSE The recommended starting dose is 8 mg a day for four weeks. 2 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 longe קרא את המסמך השלם