Labels

Chemical:

Piracetam, to be taken by mouth

Each tablet contains: Main ingredient: Piracetam (I.N.N) 800 mg. Excipients: Polyethylene glycol 6000, colloidal silica, magnesium stearate, hypromellose (E464), orange yellow, S (E 110), titanium dioxide (E 171), Polyethylene glycol 400, talc.

ACTIVITY:

Piracetam acts on the central nervous system by means of different mechanisms. It modulates cerebral neurotransmission, is a neuronal protector improving metabolic conditions at the cell level and, although not a vasodilator, improves microcirculation on account of its haemorrheological properties.

INDICATIONS:

Attention and memory disorders, problems affecting day-to-day activity and adaptation to the environment accompanying states of mental deterioration owing to:

Degenerative vascular cerebral pathology related to age.

Ischemic cerebrovascular pathology.

Cortical myoclonias.

CONTRAINDICATIONS:

Nootropil should not be taken by patients with serious renal insufficiency (creatinine clearance lower than 20 ml/min).

PRECAUTIONS:

Since Piracetam is eliminated in urine, patients with renal insufficiency should take this drug with caution.

Abrupt suspension of treatment should be avoided, since this can cause a myoclonic or general crisis in certain myoclonic patients.

INTERACTIONS:

A single case has been reported in which the concomitant use of Piracetam and thyroid hormone extracts (T3 + T4) has produced confusion, irritability and sleeping disorders. Its interaction with other drugs has not been described.

WARNING:

Pregnancy and breast-feeding

The safety of using this product during pregnancy has not been sufficiently established. Although studies in animals have not shown teratogenic effects or effects on fertility, using this drug during pregnancy is not recommended except under a doctor’s strict supervision and only when the benefits justify possible risks. Likewise, breast-feeding is not recommended.

Effects on driving

Unknown.

Warning concerning excipients

This pharmaceutical product contains Orange Yellow S as an excipient. This may cause allergic reactions, including asthma, especially in patients allergic to acetylsalicylic acid.

DIRECTIONS FOR USE:

The daily dosage (to be broken down into 2 or 3 doses) and length of treatment are to be established by the doctor, depending on the state and clinical evolution of the patient.

States of mental deterioration

Administer a daily dosage of 4.8 g of Piracetam (6 tablets per day) for the first few weeks. Then lower the daily dosage to 2.4 g (3 tablets per day).

Cortical Myoclonias

Because the therapeutic response is quite variable, the dosage should be adjusted to the patient’s own needs. A recommended protocol would be to begin treatment with 7.2 g of Piracetam daily, increasing this dosage by 4.8 g per day, every 3 or 4 four days until obtaining a satisfactory response or a maximum dose of 24 g daily. Subsequently and depending on the results obtained, the dosage of other anti-myoclonic treatments should be reduced if possible. When adjusting the posology, follow your doctor’s instructions.

Once treatment with Piracetam has begun, it should be continued for as long as the cerebral pathology persists. Nonetheless, every 6 months an effort should be made to reduce or stop treatment. To prevent the sudden reappearance of the disorder, withdrawal should be carried out by reducing the dosage by ½ g every 2 days.

OVERDOSE:

Piracetam is non-toxic even in high doses. Massive accidental overdose can be treated either orally or intravenously with forced diuresis or dialysis in the case of renal insufficiency.

In the event of overdose or accidental swallowing, consult a doctor.

ADVERSE REACTIONS:

Cases have been reported of nervousness, irritability, insomnia, anxiety, trembling and agitation and, in certain patients, fatigue and drowsiness. Occasional dryness of the mouth, increased libido, weight gain and hypersensitive skin reactions. These side effects are generally shown in elderly patients. In the majority of cases, such symptoms subside with a reduced dosage. If any other adverse reaction not described in this leaflet should occur, consult your doctor or chemist.

EXPIRY:

This drug should not be used once the expiry date shown on the box has elapsed.

KEEP ALL PHARMACEUTICAL PRODUCTS OUT OF THE REACH OF CHILDREN.

MADE IN EU

NOOTROPIL 20% Syrup

In this insert:

What Nootropil 20% solution is and what it is used for. Before taking Nootropil 20% solution. How to take Nootropil 20% solution. Possible side effects. Storing Nootropil 20% solution.

The active ingredient is Piracetam (I.N.N.) 800 mg /4 ml. The other ingredients are: glycerol (E422), sodium saccharine, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), apricot aroma, caramel aroma, sodium acetate, acetic acid, purified water.

1. WHAT NOOTROPIL 20% SOLUTION IS AND WHAT IT IS USED FOR

Nootropil 20% solution is a Nootropic substance and has no sedative or psychostimulating effects. It is recommended for the treatment of attention and memory disorders, difficulties in daily activity and adaptation to one’s environment, states which accompany mental deterioration owing to an age-related neurodegenerative illness.

2. BEFORE TAKING NOOTROPIL 20% SOLUTION

Do not take Nootropil 20% solution:

If you are hypersensitive to Piracetam or any of the ingredients in this preparation.

If you are suffering from a brain hemorrhage.

If you are suffering from terminal kidney failure.

Be especially careful with Nootropil 20% solution:

If you suffer from kidney problems, take a lower dose in accordance with the seriousness of these problems. Your physician will tell you what dosage to take.

Abrupt suspension of treatment should be avoided in myoclonic patients since this can cause a myoclonic or generalized crisis.

Pregnancy: Consult your physician or pharmacist before taking any pharmaceutical drug. Even though no side effects have been reported in animal studies, do not take Nootropil 20% solution during pregnancy. Should you accidentally swallow Nootropil 20% solution, it is not expected that the fetus will be harmed.

Breast-feeding: Consult your physician or pharmacist before taking any pharmaceutical drug. Avoid using Nootropil 20% solution during breast-feeding or refrain from breast-feeding during treatment.

Driving and operating machinery: Taking into account the possible side effects reported with Nootropil 20% solution, remember that these may affect your capacity for driving and operating machinery.

The elderly: Elderly patients are advised to see their physician on a regular basis to monitor their dosage.

Important information concerning some of the ingredients in Nootropil 20% solution:

Because this medicine contains glycerol as an excipient, it may be harmful in high dosages, causing headaches, upset stomach or diarrhea.

When taking other pharmaceutical drugs:

Inform your physician or pharmacist if you are taking or have recently taken other pharmaceutical drugs, including those sold without prescription.

A single case has been reported in which the concomitant use of Piracetam and thyroid hormone extracts (T3 and T4) has caused confusion, irritability and sleeping disorders.

No further interactions with other medicines have been reported to date.

3. HOW TO TAKE NOOTROPIL 20% SOLUTION

Always follow the dosage of Nootropil 20% solution that your physician has prescribed for you. If you have any doubts or questions, consult your physician or pharmacist. Nootropil 20% solution is taken orally, with or without food. The usual dosage is:

For the symptomatic treatment of states of mental deterioration: Start treatment by taking 4.8 g of Piracetam (6 x 4-ml doses of the solution) daily during the first few weeks, decreasing the dosage to 2.4 g of Piracetam (3 x 4-ml doses of the solution) daily. This should be taken in 2-3 doses.

For the treatment of cortical myoclonias: Start treatment with a daily dosage of 7.2 g of Piracetam (9 x 4-ml doses of the solution) and increase the daily dosage by 4.8 g of Piracetam (6 x 4-ml of the solution), every 3-4 days until obtaining a satisfactory response, or up to a maximum daily dosage of 24 g of Piracetam.

The daily dosage should be broken down into 2-3 doses, continuing the regular dosage of other anti-myoclonic treatments. Later, depending on the clinical response obtained, reduce the dosage of the other anti-myoclonic drugs if possible.

Once treatment with Nootropil 20% solution has begun, it should be continued for as long as the cerebral pathology persists. Nonetheless, every 6 months an effort should be made to reduce or stop treatment.

Note: Patients suffering from kidney problems should take a lower dosage (see- Be especially careful with Nootropil 20% solution).

The length of treatment depends on the type, duration and evolution of the symptoms.

If you believe that the effect of Nootropil 20% solution is too severe or too mild, consult your physician or pharmacist.

Directions for use:

The dose of the solution can be taken alone or diluted with a little water.

If you take more Nootropil 20% solution than you should: If you or another person takes an overdose of Nootropil 20% solution, inform your physician, who will inform you of the measures to be taken.

In the case of overdose or accidental ingestion, consult a physician or local toxicology office.

If you forgot to take Nootropil 20% solution: Do not take a double dose to compensate for the forgotten dose. Continue your usual dosage as scheduled.

Effects to expect when interrupting the dosage of Nootropil 20% solution: To prevent the abrupt reappearance of the disorder, gradually reduce the dosage by 1.2 g of Piracetam (6 ml of solution) every 2 days.

4. POSSIBLE SIDE EFFECTS

In addition to the beneficial effects of Nootropil 20% solution, unpleasant side effects may also be produced, even when the medicine is properly used.

The adverse side-effects reported with Nootropil 20% solution are trembling, weight gain, nervousness, drowsiness, depression and fatigue.

The incidence of side effects in controlled studies is under 2% and these have generally occurred with a daily dosage of over 2.4 g of Piracetam (3 x 4-ml doses of solution) in elderly patients. In the majority of cases, such symptoms subside with a lowered dosage.

Occasional cases have also reported of dizziness, intestinal disorders (nausea, vomiting, diarrhea, upset stomach), hypersensitive reactions, lack of coordination, loss of balance, aggravation of epilepsy, headache, insomnia, jumpiness, anxiety, confusion, hallucinations and skin reactions.

Very rare cases have been reported of localized pain, thrombophlebitis, fever and lowered blood pressure.

If you notice any of these unpleasant side effects, inform your physician so that he or she can assess the severity of the side effect and decide if it is necessary to take any measure should be taken.

If you notice unpleasant side effects not mentioned in this insert, report it to your physician or pharmacist.

5. STORING NOOTROPIL 20% SOLUTION

Keep Nootropil 20% solution out of children’s reach and sight.

No special storage conditions are required.

Do not use this pharmaceutical drug after the expiry date shown on the box and bottle.

MADE IN EU