NOOTROPIL Film-coated tablet / Oral solution / Solution for injection (2020)

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Περιεχόμενα

Name of the medicinal product

NOOTROPIL (piracetam) 800 mg film-coated tablet. NOOTROPIL (piracetam) 1200 mg film-coated tablet. NOOTROPIL (piracetam) 200 mg/ml oral solution. NOOTROPIL (piracetam) 1 g/5 ml solution for injection. ...

Qualitative and quantitative composition

Each film-coated tablet of NOOTROPIL 800 mg contains 800 mg of piracetam. Each film-coated tablet of NOOTROPIL 1200 mg contains 1200 mg of piracetam. Each ml of NOOTROPIL oral solution contains 200 mg ...

Pharmaceutical form

NOOTROPIL 800 and 1200 mg film-coated tablet: white, oblong, film-coated tablet, with a bisect line, marked N/N. NOOTROPIL 200 mg/ml oral solution: clear colourless solution. NOOTROPIL ...

Therapeutic indications

In adults: Treatment of cortical myoclonus, should be used in combination with other anti-myoclonic therapies.

Posology and method of administration

Method of Administration Piracetam will be administered orally, and may be taken with or without food. The tablet(s) should be swallowed with liquid. It is recommended to take the daily dose in two to ...

Contraindications

Hypersensitivity to piracetam or other pyrrolidone derivatives or any of the excipients. Piracetam is contra-indicated in patients with cerebral haemorrhage. Piracetam is contra-indicated in End Stage ...

Special warnings and precautions for use

Effects on platelet aggregation Due to the effect of piracetam on platelet aggregation (see section 5.1), caution is recommended in patients with severe haemorrhage, patients at risk of bleeding such as ...

Interaction with other medicinal products and other forms of interaction

Pharmacokinetics Interactions The drug interaction potential resulting in changes of piracetam pharmacokinetics is expected to be low because approximately 90% of the dose of piracetam is excreted in the ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate data from the use of piracetam in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, ...

Effects on ability to drive and use machines

Given the adverse events observed with the drug, an influence on driving and using machines is possible and should be taken into account.

Undesirable effects

a. Summary of safety profile Double-blind placebo-controlled clinical or pharmacoclinical trials, of which quantified safety data are available (extracted from the UCB Documentation Data Bank on June 1997), ...

Overdose

Symptoms No additional adverse events specifically related to overdose have been reported with piracetam. The highest reported overdose with piracetam was oral intake of 75g. Bloody diarrhoea with abdominal ...

Pharmacodynamic properties

Pharmacotherapeutic group: Nootropics ATC code: N06BX03 The active substance, piracetam, is a pyrrolidone (2-oxo-1-pyrrolidine-acetamide), a cyclic derivative of gamma-aminobutyric acid (GABA). ...

Pharmacokinetic properties

The pharmacokinetic profile of piracetam is linear and time-independent with low inter-subject variability over a large range of doses. This is consistent with the high permeability, high solubility, and ...

Preclinical safety data

The preclinical data indicate that piracetam has a low toxicity potential. Single dose studies showed no irreversible toxicity after oral doses of 10 g/kg in mice, rats and dogs. No target organ for toxicity ...

List of excipients

NOOTROPIL 800 mg and 1200 mg film-coated tablet: Core (current formulation): Macrogol 6000 Colloidal anhydrous silica Magnesium stearate Sodium croscarmellose White film-coating: Hydroxypropylmethylcellulose ...

Incompatibilities

None known. Piracetam is compatible (physico-chemical compatibility) with the perfusions of: Glucose 5%, 10%, 20% Fructose 5%, 10%, 20% Sodium chloride 0.9% Dextran 40 (10% in a 0.9% NaCl solution) Ringer ...

Shelf life

NOOTROPIL 1 g/5 ml, 3 g/15 ml solution for injection: 5 years. NOOTROPIL 800 mg and 1200 mg film-coated tablet: 4 years. NOOTROPIL 20% oral solution: 3 years.

Special precautions for storage

None.NOOTROPIL Tabs 1200mg: No special storage conditions. NOOTROPIL Tabs 800mg: No special storage conditions. NOOTROPIL Amps 1g/5ml: No special storage conditions. NOOTROPIL Amps 3g/15ml: No special ...

Nature and contents of container

Blister pack in an outer cardboard carton (60 tablets per carton). NOOTROPIL Tabs 1200mg: Thermoformed PVC/aluminium blister strips. Pack size of 20 or 60 tablets. NOOTROPIL Tabs 800mg: Thermoformed ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

UCB Pharma S.A., 60, Allee de la Research, 1070 Brussels, Belgium

Marketing authorization number(s)

NOOTROPIL Tabs 1200mg: 17692 NOOTROPIL Tabs 800mg: 7086 NOOTROPIL Amps 1g/5ml: 4139 NOOTROPIL Amps 3g/15ml: 13874 NOOTROPIL Solution 20%: 7087

Date of first authorization / renewal of the authorization

NOOTROPIL Tabs 1200mg: 22-04-98 NOOTROPIL Tabs 800mg: 14-8-79 NOOTROPIL Amps 1g/5ml: 8-5-73 NOOTROPIL Amps 3g/15ml: 29-10-92 NOOTROPIL Solution 20%: 14-8-79

Date of revision of the text

09/03/2020

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