Nootropil Special Precautions

Effects on platelet aggregation: Due to the platelet antiaggregant effect of NOOTROPIL, caution is recommended in patients with severe haemorrhage, patients at risk of bleeding such as gastrointestinal ulcer, patients with underlying disorders of haemostasis, patients with a history of haemorrhagic CVA, patients undergoing major surgery including dental surgery, and patients using anticoagulants or platelet antiaggregant drugs including low dose aspirin.
Renal insufficiency: NOOTROPIL is eliminated via kidneys and care should thus be taken in cases of renal insufficiency.
Discontinuation: Abrupt discontinuation of treatment should be avoided in myoclonic patients as this may induce myoclonic or generalised seizures.
Sickle cell vaso-occlusive crises: For sickle cell indication, a dose lower than 160 mg/kg/day or irregular intake may result in relapse of crises.
Huntington's Disease: When administering high doses of NOOTROPIL to patients with Huntington's Disease a slight deterioration of spontaneous movements was observed.
Warnings related to the excipients: Mannitol (E421): May have a mild laxative effect from an intake of 6.5 g piracetam or more, daily.
Aspartame (E951): Contains a source of phenylalanine equivalent to 50 mg for a dose of 2.4 g piracetam. May be harmful for people with phenylketonuria.
Methyl parahydroxybenzoate and propylparahydroxybenzoate: May cause allergic reactions (possibly delayed) (see Adverse Reactions).
Glycerol: May cause headache, stomach upset and diarrhea (see Adverse Reactions).
Sodium: NOOTROPIL 800 mg film-coated tablets: This product contains about 2 mmol (or about 46 mg) sodium per 24 g piracetam.
Renal impairment: The daily dose must be individualised according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient's creatinine clearance (Clcr) in ml/min is needed. The Clcr in ml/min may be estimated from serum creatinine (mg/dl) determination using the following formula: See equation.

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For this reason, the daily dose will be changed according to the table as follows: See table.

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Ability to perform tasks that require judgement, motor or cognitive skills: Given the adverse events observed with the drug, an influence on driving and using machines is possible and should be taken into account.
Use in Elderly: For long-term treatment in the elderly, regular evaluation of the creatinine clearance is required to allow dosage adaptation if needed.