Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
galantamine hydrobromide, Quantity: 20.51 mg (Equivalent: galantamine, Qty 16 mg); galantamine, Quantity: 16 mg (Equivalent: galantamine hydrobromide, Qty 20.51 mg)
Janssen-Cilag Pty Ltd
Capsule, modified release
Excipient Ingredients: diethyl phthalate; ethylcellulose; hypromellose; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide; maize starch; sucrose; macrogol 400; titanium dioxide; sorbitan monolaurate; iron oxide red; Gelatin; sodium lauryl sulfate; ethanol absolute; sulfuric acid
Oral
56 capsules, 28 capsules, 84 capsules
(S4) Prescription Only Medicine
Indicated for the treatment of mild to moderately severe dementia of the Alzheimer type.
Visual Identification: Opaque, pink, size 2 capsule imprinted with 'G16' containing white to off-white pellets; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2004-05-19
REMINYL ® (210422) ACMI 1 REMINYL ® _MODIFIED RELEASE CAPSULES _ _Galantamine hydrobromide _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about REMINYL 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 REMINYL against the benefits this medicine is expected to have for you. If you have any concerns about taking REMINYL, ask your doctor or pharmacist. Keep this leaflet with your medicine. You may need to read it again. WHAT REMINYL IS USED FOR REMINYL 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. REMINYL 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 REMINYL for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you. BEFORE YOU TAKE REMINYL _WHEN YOU MUST NOT TAKE IT _ Do not take REMINYL if you have: • an allergy to REMINYL 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 REMINYL if the packaging is torn or shows signs of tampering. Do not use REMINYL beyond the expiry date (month and year) printed on the pack. _BEFORE YOU START TO TAKE IT _ You must tell your doctor if you are: • pregnant, or planning to become pregnant • breastfeeding, or planning to breastfeed • planning to undergo surgery which will require anaes Soma hati kamili
CCDS201023 Page 1 of 18 REMINYL(220315) API AUSTRALIAN PRODUCT INFORMATION REMINYL ® (GALANTAMINE) MODIFIED RELEASE CAPSULE 1 NAME OF THE MEDICINE Galantamine (as hydrobromide) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION REMINYL modified release capsules contain the active galantamine hydrobromide, equivalent to 8, 16, 24 mg galantamine base. Excipients with known effect: sugars For the full list of excipients, see 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM REMINYL 8 mg modified release capsules are white opaque, size 4 hard gelatin capsules with the inscription “G8”, containing white to off-white pellets. REMINYL 16 mg modified release capsules are pink opaque, size 2 hard gelatin capsules with the inscription “G16”, containing white to off-white pellets. REMINYL 24 mg modified release capsules are caramel opaque, size 1 hard gelatin capsules with the inscription “G24”, containing white to off-white pellets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS REMINYL is indicated for the treatment of mild to moderately severe dementia of the Alzheimer type. 4.2 DOSE AND METHOD OF ADMINSTRATION REMINYL modified release capsules should be administered once daily in the morning, preferably with food. Ensure adequate fluid intake during treatment. The dose of REMINYL 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. Product Information - Australia CCDS201023 Page 2 of 19 REMINYL(220315)API • 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 shou Soma hati kamili