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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. |
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