Company: Actavis Ireland Ltd.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Memantine hydrochloride 10mg.
Description: White, capsule-shaped, biconvex film-coated tablet scored and marked M10 on one side. Can be divided into equal halves.
Presentation: 28, €19.86; 56, €39.71.
Indication: Treatment of moderate to severe Alzheimer’s disease.
Pharmacology: Memantine is a voltage-dependent, moderate-affinity uncompetitive antagonist at glutamatergic NMDA receptors. It modulates the effects of pathologically elevated tonic levels of glutamate that may lead to neuronal dysfunction.
Dosage: Adult: Take once daily at same time each day. Week 1: 5mg daily. Week 2: 10mg daily. Week 3: 15mg daily. From week 4 onwards: 20mg daily. Maintenance: 20mg daily (maximum dose). Moderate renal impairment: 10mg daily, can be increased to 20mg using standard titration if well tolerated after 7 days. Severe renal impairment: 10mg daily. Elderly: Over 65 years, 20mg daily. Children: Under 18 years, not recommended.
Contraindications: Hypersensitivity to the active ingredient or to any of the excipients. Pregnancy (unless clearly necessary), lactation.
Special precautions: Not recommended: Severe hepatic impairment. Caution: Epilepsy, former history of convulsions or predisposing factors for epilepsy. Conditions in which urine pH is elevated e.g. change from carnivore to vegetarian diet, massive ingestion of alkalising gastric buffers, renal tubulary acidosis or severe infections of the urinary tract with Proteus bacteria. Closely supervise patients with recent myocardial infarction, uncompensated congestive heart failure or uncontrolled hypertension (limited data). Driving/using machines. Contains lactose.
Drug interactions: Avoid: Amantadine, ketamine, dextromethorphan. Caution: L-dopa, dopaminergic agonists, anticholinergics, barbiturates, neuroleptics, dantrolene, baclofen, cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine, HCTZ, oral anticoagulants.
Adverse drug reactions: Drug hypersensitivity, somnolence, dizziness, balance disorders, hypertension, dyspnoea, constipation, elevated liver function test, headache.
Full prescribing information and references available from Actavis Ireland Ltd. Telephone: 1890 333231. Fax: (021) 4619049. E-mail: contact@actavis.ie