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 Aniracetam (Ampamet ®) - Manufacturer's Insert

INGREDIENTS

1 sachet of AMPAMET ® 750 granules for oral use contains:
Active ingredient: aniracetam 750 mg
Excipients: Sodium amide glycolate, methyldroxy propyl cellulose, dioctyl sodium sulfosuccinate, sodium cyclamate, sodic saccharine, sorbitol, balsamic aroma, saccharose.

1 sachet of AMPAMET ® 1500 granules for oral use contains:
Active ingredient: aniracetam 1500 mg
Excipients: Sodium amide glycolate, methyldroxy propyl cellulose, dioctyl sodium sulfosuccinate, aspartame, sodic saccharine, fructose, banana aroma, mint aroma, grapefruit aroma, xylitol.

1 coated tablet of AMPAMET ® 750 contains:
Active ingredient: aniracetam 750 mg
Excipients: Sodium amide glycolate, methyldroxy propyl cellulose, dioctyl sodium sulfosuccinate, magnesium stearate, talc, titanium dioxide, E 172.

AVAILABLE IN

Granules to be taken by mouth

PHARMACEUTICAL CATEGORY

AMPAMET ® belongs to the category of psychostimulants and nootropics.
AMPAMET ® 750 granules to be taken by mouth and AMPAMET ® 1500 granules to be taken by mouth.

THERAPEUTICAL INDICATIONS

Attention and memory disorders of degenerative or vascular origin in the elderly.

CONTRAINDICATIONS

Proven individual hypersensitivity to the pharmaceutical product.

PRECAUTIONS

In the case of symptoms such as restlessness, anxiety, agitation at night or insomnia, it is preferable either to administer the second dose in the early afternoon, or opt for a single 1500-mg dose in the morning.
Although studies on animals have not shown teratogenic effects, patients are nonetheless advised not to take this pharmaceutical product if pregnant or breast-feeding.
Patients with serious renal failure (creatinine clearance < 10 mL/min) are advised to reduce the daily dosage by half.

INTERACTIONS

Clinical experience concerning the interaction of AMPAMET ® with other pharmaceutical products has not been released.

SPECIAL WARNING

Pregnancy and breast-feeding
Studies on animals have not shown teratogenic effects. Although studies on animals have not shown teratogenic effects, patients are nonetheless advised not to take this pharmaceutical product if pregnant or breast-feeding.
Driving or operating machinery
AMPAMET ® does not interfere with the patient's capacity to drive or operate machinery.

DIRECTIONS FOR USE

The recommended complete daily dosage is 1,500 mg to be taken in 1-2 doses.
Tablets are to be swallowed whole with a sip of water. The contents of the sachets are to be mixed in a glass of water and swallowed.
The therapeutic effects of aniracetam are shown after some 60 days and become more noticeable after four months of treatment.

OVERDOSE

Cases of overdose of this pharmaceutical product have not been reported.

ADVERSE EFFECTS

AMPAMET ® is well tolerated by all patients, even the very elderly.
Occasional cases have been reported of agitation, anxiety, restlessness, and insomnia. These adverse effects are reduced if the dosage is modified. See PRECAUTIONS.
Should symptoms occur that are not described in this leaflet, consult a doctor as soon as possible.
Regarding patients who may be hypersensitive to this product:
Any symptom other than those described should be reported to the patient's doctor.

Keep out of the reach of children.

EXPIRY DATE

Check the expiry date shown on the box. This period applies for the product in its proper state, correctly stored.
Warning: Do not use this medicine once the displayed expiry date has elapsed.

STORAGE

This pharmaceutical product should be stored in normal atmospheric conditions.

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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