Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
galantamine hydrobromide
Southern Cross Pharma Pty Ltd
Galantamine hydrobromide
Registered
________________________________________________________________________________ C: Products/Galant/CMI AN 27february2015 Page 1 of 4 GALANTAMINE AN SR CAPSULES _Galantamine hydrobromide _ _ _ CONSUMER MEDICINE INFORMATION _ _ What is in this leaflet This leaflet answers some common questions about Galantamine AN SR 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 Galantamine AN SR against the benefits this medicine is expected to have for you. If you have any concerns about taking Galantamine AN SR, ask your doctor or pharmacist. Keep this leaflet with your medicine. You may need to read it again. What Galantamine AN SR is used for Galantamine AN SR 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 AN SR 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 Galantamine AN SR for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Before you take Galantamine AN SR _When you must not take it _ Do not take Galantamine AN SR if you have: an allergy to Galantamine AN SR 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 Galantamine AN SR if the packaging is torn or shows signs of tampering. Do not use Galantamine AN SR beyond the expiry date (month and year) printed Đọc toàn bộ tài liệu
C:Products/Galantamine/PI AN Page 1 of 19 PRODUCT INFORMATION GALANTAMINE AN SR MODIFIED RELEASE CAPSULES NAME OF THE MEDICINE PROPRIETARY NAME: Galantamine AN SR galantamine (as hydrobromide) modified release capsules NON PROPRIETARY NAME: Galantamine (as hydrobromide) Galantamine modified release capsules contain the active galantamine hydrobromide, equivalent to 8, 16, 24 mg galantamine base. Inactive ingredients include microcrystalline cellulose, hypromellose, ethylcellulose and magnesium stearate. The capsules contain gelatin and titanium dioxide (8, 16 and 24 mg), iron oxide red (16 and 24 mg) indigo carmine, erythrosine and iron oxide yellow (24 mg). The chemical structure of galantamine is: C 17 H 21 NO 3. HBr CAS number: 1953-04-4 MW: 368.27 DESCRIPTION Chemical name: Galantamine hydrobromide, (4a_S_, 6_R_, 8a_S_)-4a,5,9,10,11,12- hexahydro-3-methoxy-11-methyl-6_H_benzofuro[3a,3,2-_ef_][2]benzazepin-6-ol hydrobromide, is a white to almost white powder with a solubility in water at 25 o C of 3.69 g/100 mL. It is slightly soluble in methanol and very slightly soluble in ethanol and acetonitrile. The pK a is 8.2 with a pH of 5.2. Galantamine hydrobromide contains three chiral centres and is presented as a single enantiomer. PHARMACOLOGY Galantamine is a cholinomimetic with a dual mechanism of action. Galantamine is a reversible inhibitor of the enzyme acetylcholinesterase, and enhances the intrinsic action of acetylcholine on nicotinic receptors. C:Products/Galantamine/PI AN Page 2 of 19 PHARMACODYNAMICS The cognitive dysfunction (memory, attention, learning) in dementia of the Alzheimer type is related to the profound dysfunction of the cholinergic neurotransmission system in the brain. Galantamine, a tertiary alkaloid, enhances the efficacy of the physiologically available acetylcholine through a dual mechanism of action: acetylcholinesterase inhibition and nicotinic receptor modulation. Galantamine is a selective, competitive and reversible inhibitor of acetylcholinesterase, the enzyme responsible for t Đọc toàn bộ tài liệu