Adicetam 1200 mg. 20 sachets

What Adicetam is and what it is used for

This medicinal product belongs to the nootropic group. Improves impaired brain function by acting on the central nervous system without having a psycho-stimulating or calming effect.

Piracetam improves blood supply and metabolism in the brain, which restores physical and mental performance. Stimulates neuropsychiatric activity and acts as a memory, speech, vertigo and headache enhancer, as well as helping to concentrate attention.

Piracetam improves cognitive ability after various brain damage such as: poisoning, forgetting due to vascular damage, restoring oxygen deficiency.

The medicinal product is used in:
Adults:

Treatment of cortical myoclonus (sudden involuntary muscle contractions), alone or in combination;
Treatment of vertigo (tinnitus and vertigo) and related disorders of balance, except for dizziness of psychic origin.
Children:

Treatment of dyslexia (disorders in reading ability) in combination with speech therapy.
2. What you need to know before taking Adicetam

Do not take Adicetam:

if you are allergic to piracetam or any of the other ingredients of this medicine (listed in section 6);
if you suffer from severe kidney failure;
if you have cerebral hemorrhage;
if you have Huntington's disease (a genetic disorder of the nervous system).
Always consult your doctor or pharmacist when in doubt.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Adicetam.
The medicinal product should be taken with caution in patients with kidney disease. The recommended dose may be changed by your doctor.
Abrupt discontinuation of treatment should be avoided in patients with myoclonus as this may lead to the onset of generalized or myoclonic seizures.

Children and adolescents
The dosage and duration of administration of the medicinal product to children is prescribed by your doctor.

Other medicines and Adicetam
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In single cases of concomitant use of piracetam with thyroid extract - T3 and T4, sleep disturbance and irritability were observed. There are no data on other interactions with other medicines.
Consult a doctor immediately in case of overdose or accidental overdose.

Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

This medicinal product is not recommended during pregnancy and lactation unless clearly necessary. The drug crosses the placenta and reaches the fetus. Piracetam is excreted in human breast milk and, therefore, should be discontinued during breast-feeding.

Driving and using machines
People who drive or operate machinery are warned about the risk of drowsiness, depression or nervousness when using this medicine.

Use in the elderly:
In the elderly, it is advisable to see a regular physician to monitor the dose.

Adicetam contains mannitol (E421)
This medicinal product contains the excipient mannitol (E421). At a dose of 6.5 g or more piracetam daily, mannitol may have a slight laxative effect.

3. How to take Adicetam

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Adicetam can be taken before, during or after a meal.

Dosage
The recommended dose is:
Symptomatic treatment of psycho-organic syndromes (impaired mental activity)
Treatment begins with daily doses of 4.8 g. This dosage is taken for several weeks and then reduced to 1.2 g. The dose is divided into 2-3 separate doses.

Treatment of myoclonus (sudden involuntary muscle contractions)
The daily dose starts at 7.2 g and increases by 4.8 g every 3-4 days to a maximum of 24 g divided by 2-3 doses. If you are taking other such anti-myclonic drugs, treatment with them should be continued.

Treatment of vertigo
The recommended daily dose is 1.2 g to 4.8 g divided into 2-3 doses.

Treatment of consequences of ischemic cerebrovascular accident, especially aphasia
In chronic forms (established at least after 15 days) and in the subacute stage, the daily dose is from 4.8 g to 6 g.

Treatment of dyslexia with speech therapy in children from 8 to 13 years
The recommended daily dose for children over 8 years of age and adolescents is about 3.2 g divided by 2 doses.

Prevention of sickle cell crisis
The daily dose is 160 mg / kg given in 4 doses. With a lower dose or irregular administration, the crisis can be reversed.
In children over 3 years of age suffering from sickle cell anemia, piracetam may be given at the recommended daily dose (mg / kg).

Dosage in patients with renal insufficiency
In patients with severe renal insufficiency, intake and dosage are determined by your doctor. The interval between different receptions should not be less than 8 hours.

Application method
Dissolve the contents of the sachet in a glass of water and mix well. It is taken regardless of the time of eating.
Oral use.

Duration of treatment
The duration of treatment is determined by your doctor. The optimal effect in the treatment of chronic diseases is achieved after 6 to 12 weeks.
It is recommended that the daily dose be divided between two and four doses.

If you take more Adicetam than you should
If you accidentally or intentionally take a higher dose than this leaflet, please tell your doctor or pharmacist.

If you forget to take Adicetam
Do not take a double dose to make up for the missed dose, but take the next dose.

If you stop taking Adicetam
Piracetam treatment should be discontinued gradually - reducing the dose by 1.2 g every 2 days. Otherwise, complaints may resume.

If you need any further information on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The frequency of adverse reactions is categorized as:

Very common (affects more than 1 in 10 patients);
Common (affects 1-10 in 100 patients);
Uncommon (affects 1-10 per 1000 patients);
Rare (affecting 1-10 in 10,000 patients);
Very rare (less than 1 in 10,000 patients affected);
Not known (no data can be estimated from the available data).
Honor:

Metabolism and nutrition disorders: weight gain;
Mental disorders: nervousness;
Nervous system disorders: hyperkinesia (increased activity).
Rare:

Mental disorders: depression, drowsiness;
General disorders: weakness;
Sleepiness, low attention - more pronounced at the beginning of treatment;
In adult patients, side effects were observed with a daily dose of more than 1.2 g of piracetam. Controlled studies are below 2%. In the lowering of the dose, these symptoms in most cases disappear.

With unknown frequency:

Gastrointestinal disorders: pain in the upper abdomen as well as throughout the abdomen, nausea, vomiting, diarrhea;
Nervous system disorders: disturbances in balance, lack of coordination in movements, increased epilepsy, insomnia, drowsiness, headache;
Mental disorders: confusion, hallucinations, agitation, anxiety;
Ear disorders: vertigo (feeling dizzy or dizzy);
Immune system disorders: anaphylactoid reaction (severe allergic reaction causing difficulty in breathing or dizziness), hypersensitivity;
Skin and subcutaneous tissue disorders: skin rashes, swelling in the subcutaneous tissue, itching, hives

 How to store Adicetam

Keep out of the reach and sight of children.
Store below 25 ° C.

Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.

Do not dispose of medicines in sewage or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Adicetam contains

The active substance is piracetam.
The other ingredients are mannitol, sodium cyclamate, aroma of lemon (natural lemon oil, maltodextrin, gum arabic, sucrose), anhydrous citric acid and colloidal anhydrous silica.
What Adicetam looks like and contents of the pack:
Adicetam 1200 mg powder for oral solution is a white or off-white powder. Adicetam 1200 mg powder for oral solution is packaged in paper / aluminum / polyethylene sachets packed in cartons.

Each box contains 10, 20, 30, 50, 60 or 100 sachets and a leaflet for the patient. Not all pack sizes may be marketed.

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