Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
memantine hydrochloride, Quantity: 20 mg
Lundbeck Australia Pty Ltd
memantine hydrochloride
Tablet, film coated
Excipient Ingredients: colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; croscarmellose sodium; titanium dioxide; hypromellose; iron oxide yellow; iron oxide red; macrogol 400
Oral
28 tablets
(S4) Prescription Only Medicine
Treatment of the symptoms of moderately severe to severe Alzheimer's disease.
Visual Identification: Pink, oval film-coated tablets with engravings '20' on one side and 'MEM' on the other side.; Container Type: Blister Pack; Container Material: PP/Al; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2009-09-10
EBIXA ® _(EE-BIC-SA)_ _Memantine hydrochloride (meh-MAN-teen high-dro-CLOR-ride)_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet contains answers to some common questions about Ebixa. It does not contain all the information that is known about Ebixa. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT EBIXA IS USED FOR Ebixa is used to treat moderately severe to severe Alzheimer's disease (AD). AD can be described as a general decline in all areas of mental ability. Ebixa belongs to a group of medicines called N-methyl-D- aspartate (NMDA) receptor antagonists. It is thought to work by protecting NMDA receptors in the brain against high levels of the chemical glutamate, which could be the cause of brain degeneration. NMDA receptors are involved in the transmission of nerve signals within the brain, e.g. in learning and memory. Ebixa should improve your thinking capacity and your ability to remember. Your doctor, however, may prescribe Ebixa for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. This medicine is only available with a doctor's prescription. Ebixa is not addictive. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE EBIXA IF YOU ARE ALLERGIC TO IT OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, or rash, itching or hives on the skin. DO NOT TAKE EBIXA IF YOU HAVE A SEIZURE DISORDER OR ANY HISTORY OF SEIZURES (FITS OR EPILEPSY). DO NOT TAKE IT AFTER THE EXPIRY DATE PRINTED ON THE PACK. If you take it after the expiry date ha Przeczytaj cały dokument
EBIXA ® (memantine hydrochloride) 1 of 16 AUSTRALIAN PRODUCT INFORMATION – EBIXA (MEMANTINE HYDROCHLORIDE) FILM-COATED TABLETS 1 NAME OF THE MEDICINE Memantine hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Film-coated tablets containing 10 mg memantine hydrochloride. Film-coated tablets containing 20 mg memantine hydrochloride. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Ebixa 10 mg tablets are pale yellow to yellow, oval shaped film-coated tablets with break line and engravings ‘M’ on both parts right and left of the break line and on the other side, ‘1’ left and ‘0’ right of the break line. Ebixa 20 mg tablets are pink to grey-red oval biconvex film-coated tablets with ’20’ embossed on one side and ‘MEM’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of the symptoms of moderately severe to severe Alzheimer's disease (see Section 5 Pharmacological properties; Section 4.4 Special warnings and precautions for use). 4.2 DOSE AND METHOD OF ADMINISTRATION Ebixa should be administered once a day and should be taken at the same time every day. Tablets should be taken with a little liquid, with or without food. The tolerance and dosing of memantine should be reassessed on a regular basis, preferably within three months after start of treatment. Thereafter, the clinical benefit of memantine 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 a therapeutic benefit is favourable and the patient tolerates treatment with memantine. Discontinuation of memantine should be considered when evidence of a therapeutic effect is no longer present or if the patient does not tolerate treatment. EBIXA ® (memantine hydrochloride) 2 of 16 Adults The recommended maintenance dose is 20 mg per day. This is achieved by upward titration of 5 mg per week. The 10 mg tablet is required for titration as follo Przeczytaj cały dokument