MENTINO

Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’s dementia. Posology Therapy should only be started if a caregiver is available who will regularly monitor the intake of the medicinal product by the patient.

Diagnosis should be made according to current guidelines. The tolerance and dosing of Mentino should be reassessed on a regular basis, preferably within three months after start of treatment. Thereafter, the clinical benefit of Mentino 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 Mentino. Discontinuation of Mentino should be considered when evidence of a therapeutic effect is no longer present or if the patient does not tolerate treatment.

Adults Dose titration The recommended starting dose is 5 mg per day which is stepwise increased over the first 4 weeks of treatment reaching the recommended maintenance dose as follows: Week 1 (day 1-7) The patient should take one 5 mg tablet per day (light pink round, flat, speckled tablets with beveled edges, a diameter of 7 mm and engraved with “5” on one side) for 7 days.

Week 2 (day 8-14) The patient should take one 10 mg tablet per day (light pink, round, flat, speckled tablets with beveled edges, a diameter of 9 mm and engraved with “10” on one side) for 7 days. Week 3 (day 15-21) The patient should take one 15 mg tablet per day (light pink, round, flat, speckled tablets with beveled edges, a diameter of 11 mm and engraved with “15” on one side) for 7 days.

Week 4 (day 22-28) The patient should take one 20 mg tablet per day (light pink, round, flat, speckled tablets with beveled edges, a diameter of 12 mm and engraved with “20” on one side) for 7 days. The maximum daily dose is 20 mg per day.

Maintenance dose The recommended maintenance dose is 20 mg per day. Elderly On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (20 mg once a day) as described above. Renal impairment In patients with mildly impaired renal function (creatinine clearance 50 – 80 ml/min) no dose adjustment is required.

In patients with moderate renal impairment (creatinine clearance 30 – 49 ml/min) daily dose should be 10 mg per day. If tolerated well after at least 7 days of treatment, the dose could be increased up to 20 mg/day according to standard titration scheme.

In patients with severe renal impairment (creatinine clearance 5 – 29 ml/min) daily dose should be 10 mg per day. Hepatic impairment In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B), no dose adjustment is needed.

No data on the use of Mentino in patients with severe hepatic impairment are available. Administration of Mentino is not recommended in patients with severe hepatic impairment. Paediatric population No data are available. Method of administration Mentino should be administered orally once a day and should be taken at the same time every day.

The tablets can be taken with or without food. The tablet should be placed on the tongue and allowed to disintegrate before swallowing with or without water, according to patient preference.

Summary of the safety profile In clinical trials in mild to severe dementia, involving 1,784 patients treated with Mentino and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with Mentino did not differ from those with placebo; the adverse reactions were usually mild to moderate in severity.

8%). Tabulated list of adverse reactions The following Adverse Reactions listed in the Table below have been accumulated in clinical studies with Mentino and since its introduction in the market. Adverse reactions are ranked according to system organ class, using the following convention: very common (≥1/10), common (≥1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. SYSTEM ORGAN CLASS FREQUENCY ADVERSE REACTION Infections and infestations Uncommon Fungal infections Immune system disorders Common Drug hypersensitivity Psychiatric disorders Common Uncommon Uncommon Not known Somnolence Confusion Hallucinations1 Psychotic reactions2 Nervous system disorders Common Common Uncommon Very rare Dizziness Balance disorders Gait abnormal Seizures Cardiac disorders Uncommon Cardiac failure Vascular disorders Common Uncommon Hypertension Venous thrombosis/thromboembolism Respiratory, thoracic and mediastinal disorders Common Dyspnoea Gastrointestinal disorders Common Uncommon Not known Constipation Vomiting Pancreatitis2 Hepatobiliary disorders Common Not known Elevated liver function test Hepatitis General disorders and administration site conditions Common Uncommon Headache Fatigue 1 Hallucinations have mainly been observed in patients with severe Alzheimer’s disease.

2 Isolated cases reported in post-marketing experience. Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. In post-marketing experience these reactions have been reported in patients treated with Memantine.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Caution is recommended in patients with epilepsy, former history of convulsions or patients with predisposing factors for epilepsy. Concomitant use of N-methyl-D-aspartate (NMDA)-antagonists such as amantadine, ketamine or dextromethorphan should be avoided.

5). 2 “Elimination”) may necessitate careful monitoring of the patient. g. from a carnivore to a vegetarian diet, or a massive ingestion of alkalising gastric buffers. Also, urine pH may be elevated by states of renal tubulary acidosis (RTA) or severe infections of the urinary tract with Proteus bacteria.

In most clinical trials, patients with recent myocardial infarction, uncompensated congestive heart failure (NYHA III-IV), or uncontrolled hypertension were excluded. As a consequence, only limited data are available and patients with these conditions should be closely supervised.

Mentino contains Sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. Mentino contains Lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Mentino contains Aspartame Aspartame is hydrolysed in the gastrointestinal tract when orally ingested. One of the major hydrolysis products is phenylalanine.

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