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Memantine Hydrochloride Oral Solution Abbreviated Prescribing Information

Abbreviated Prescribing Information: Memantine Hydrochloride 10mg/ml Oral Solution. Consult Summary of Product Characteristics before prescribing. Presentation: A clear and colourless to light yellowish solution containing 10mg Memantine Hydrochloride/ml. Therapeutic Indications: Treatment of patients with moderate to severe Alzheimer’s disease. Posology and Method of Administration: Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’s dementia. Memantine Oral Solution should be taken once daily at the same time each day. The solution can be taken with or without food. Adults: Dose titration, the maximum daily dose is 20 mg once daily. The maintenance dose is achieved by upward titration of 5 mg per week over the first 3 weeks. The recommended maintenance dose is 20 mg per day. Elderly: As above. Paediatric population: Not recommended for use in children below 18 years. Renal impairment: Depending on the severity of the impairment the daily dose should be reduced. Hepatic impairment: Not recommended in patients with severe hepatic impairment. Contraindications: Hypersensitivity to the active substance or to any of the excipients. Excipient warnings: Each millilitre of solution contains 100 mg sorbitol and 0.5 mg potassium. . Drug interactions: The effects of L-dopa, dopaminergic agonists and anticholinergics may be enhanced. Effects of barbiturates and neuroleptics may be reduced. Dose adjustment may be necessary with dantrolene or baclofen. Use with amantadine, ketamine, dextromethorphan and phenytoin should be avoided. Cimetidine, ranitidine, procainamide, quinidine, quinine and nicotine may possibly interact with memantine leading to increased plasma levels. Memantine may reduce serum levels of hydrochlorothiazide. Close monitoring of prothrombin time or INR is advisable for patients concomitantly treated with oral anticoagulants. Special Warnings and Precautions for use: Caution is recommended in patients with epilepsy, former history of convulsions or patients with predisposing factors for epilepsy. Concomitant use of other N-methyl-D-aspartate -antagonists should be avoided. Factors that may raise urine pH may need careful monitoring of the patient.  Patients with recent myocardial infarction, uncompensated congestive heart failure (NYHA III-IV), or uncontrolled hypertension should be closely supervised. Fertility, Pregnancy and Lactation: Memantine should not be used during pregnancy unless clearly necessary. Women taking Memantine should not breast-feed. Effects on Ability to Drive and Use Machines: Outpatients should be warned to take special care. Undesirable Effects: Uncommon: Fungal infections, confusion, hallucinations, , gait abnormal, cardiac failure, venous thrombosis/thromboembolism vascular disorders, , vomiting, fatigue. Common: Drug hypersensitivity, somnolence, dizziness, balance disorders, hypertension, dyspnoea, constipation, elevated liver function test, and headache. Very rare: Seizures. Not known: Psychotic reactions, pancreatitis, hepatitis. Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. Overdose: In the event of an overdose treatment should be symptomatic. Shelf Life and storage: 24 months before opening. Once opened used within 3 months. Do not store above 30 Deg C. Legal Category: POM Pack Size and NHS Price: 50ml £54 or 100ml £108 -. Marketing Authorisation Number: PL 00427/0226. Marketing Authorisation Holder: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK. Date of Preparation: Feb – 2021.

Adverse Drug Events

Information about adverse event reporting can be found at www.mhra.gov.uk/yellowcard
Adverse events should also be reported to Rosemont Pharmaceuticals Ltd on 0113 244 1400