COMPOSITION Tablets 1 tablet contains: Active substance: Piracetam 1200 mg. Excipients: Core: Polyethylene glycol 6000, Colloidal silica, Magnesium stearate, Croscarmellose sodium. Coating: Opadry Y-1-7000, comprising: Hydroxypropylmethylcellulose, Titanium dioxide, Macrogol 400; Opadry OY-S-29019, comprising: Hydroxypropylmethylcellulose and Macrogol 6000. PHARMACEUTICAL FORM AND CONTENT Film-coated tablets. Box of 40 tablets in a blister pack. THERAPEUTIC INDICATIONS Mild cognitive decline in the elderly. CONTRAINDICATIONS Hypersensitivity to the active substance or to one of the excipients. PRECAUTIONS FOR USE The product is not contraindicated during pregnancy and lactation and can be administered to children. In case of renal impairment, the product should be administered with caution and at reduced dosages. INTERACTIONS There are no known interactions with other commonly used drugs. SPECIAL WARNINGS Nootropil does not affect the ability to drive or operate machinery. DOSE, METHOD AND TIME OF ADMINISTRATION Tablets: 1 tablet 3-4 times daily at intervals throughout the day. The dosage can be doubled. Due to the high bioavailability of the substance, the therapeutic effects of piracetam administered orally and parenterally are identical. For this reason, in patients receiving prolonged therapy and with potential intravenous administration problems, the oral route may be recommended. The duration and dosage should be adjusted by the physician on a case by case basis. OVERDOSE There have been no reported cases of overdose. If in doubt, suspension of the treatment is recommended. UNDESIRABLE EFFECTS In some rare cases where excessive patient reactivity to the product may be observed, a reduction in dosage is sufficient. Compliance with the instructions in this leaflet will reduce the risk of undesirable effects. It is important to tell your doctor or pharmacist if you experience any undesirable effect, even if not described in the leaflet. EXPIRY AND STORAGE IMPORTANT: do not use the medicine after the expiry date printed on the pack. Store at ambient temperature. To open, hold the vial upright, ensuring that the coloured tip is in the position shown in the diagram. Apply pressure to the coloured tip with the thumb as shown in the diagram. | The above information is the translation of the manufacturer's insert. It is provided under the supplying company's terms and conditions and should not replace the advice of your personal physician. |
|