MAXXVITON^® PLUS

COMPOSITION:

Each hard capsule contains:

Piracetam..................................................................... 400 mg

Cinnarizine..................................................................   25 mg

Excipients: Microcrystalline cellulose, Sodium starch glycolate, Magnesium stearate, Colloidal anhydrous silica q.s. 1 hard capsule.

INDICATIONS

• Vestibular disorders such as vertigo, tinnitus, nausea and vomiting in Ménière’s disease.
• Elderly suffering from loss of memory; vertigo, lack of concentration or alertness, changes of mood; deterioration in behaviour, personal negligence, dementia produced by multiple cerebral infarction.

DOSAGE AND ADMINISTRATION

MAXXVITON^® PLUS is administered orally, preferably after meals:

Adults and Children 12 Years and Older: The recommended dose is 1-2 capsules, 3 times daily.

Children 5 to 12 Years: 1 capsule, once or twice daily.

CONTRAINDICATIONS

• Patients with known hypersensitivity to piracetam, cinnarizine or any ingredient in the formulation.
• Patients with severe renal insufficiency (creatinine clearance < 20 ml/min).
• Patients with Huntington's disease.
• Patients with hepatic insufficiency.
• Patient with porphyria.
• Children under 5 years old.

WARNING AND PRECAUTIONS

Since piracetam is eliminated via the kidneys, the increase in half life is directly related to the decrease of renal function and creatinine clearance. Special care must be taken when treating patients with renal insufficiency. Monitoring of renal function is recommended in these patients and in elderly patients. When the creatinine clearance is < 60 ml/min or the
serum creatinine is > 1.25 mg/100 ml, the dosage should be adjusted:

Creatinine clearance 60-40 ml/min, serum creatinine 1.25-1.7 mg/100 ml (the half-life of piracetam is twice longer): 1/2 of normal dose.

Creatinine clearance 40-20 ml/min, serum creatinine 1.7-3.0 mg/100 ml (the half-life of piracetam is 25-42 hours): 1/4 of normal dose.

Cinnarizine may cause epigastric distress. Taking it after meals may diminish gastric irritation.

Prolonged use of cinnarizine in the elderly should be avoided because elderly people have been described to show an aggravation or an appearance of extrapyramide symptoms, sometimes associated with depressive feelings, during prolonged therapy.

Safety in pregnancy

It is not recommended for pregnant women.

Safety in breast feeding

It is not recommended for breast feeding mothers.

PRESENTATION:

Blister of 10 hard capsules; Box: 10 blisters/ aluminium pouch/ box.

Keep out of reach of children

Read the package insert carefully before use

Ask your doctor for further information

Use upon doctor’s prescription only

Manufactured and distributed by: AMPHARCO U.S.A - PJSC

Nhon Trach 3 Industrial Park, Hiep Phuoc Ward, Nhon Trach District, Dong Nai Province

Tel: 02513 566 202    -     Fax: 02513 566 203