What PIRACETAM is and what it is used for
PIRACETAM belongs to the group of nootropic drugs, derivatives of gamma-aminobutyric acid. It acts on the central nervous system and improves blood supply and metabolism in the brain. Thanks to this action, it stimulates and facilitates neuro-psychic activity and restores mental and physical working capacity, without exhibiting a calming or psychostimulating effect. Beneficially affects memory disorders, attention concentration, speech, headaches and vertigo accompanying various brain diseases. PIRACETAM improves and restores cognitive abilities after various brain damages as a result of lack of oxygen (hypoxia), poisonings (intoxications), etc., as well as in cases of vascular dementia (forgetfulness as a result of vascular damage).
PIRACETAM is used to treat:
Adults:
symptomatic treatment of psycho-organic syndrome with the following manifestations: memory and attention disorders, lack of motivation;
consequences of ischemic cerebrovascular accidents, in particular aphasia (loss of speech), as well as transient ischemic disorders of cerebral circulation;
treatment of cortical myoclonus (sudden involuntary muscle contractions), alone or in combination with other drugs;
treatment of vertigo (dizziness and tinnitus) and related balance disorders, excluding dizziness of vasomotor or mental origin
for prevention and remission of sickle cell vaso-occlusive crisis.
Children:
treatment of dyslexia (disorders in the ability to read) in combination with speech therapy or other appropriate measures;
for prevention and remission of sickle cell vaso-occlusive crisis
What you should know before taking PIRACETAM HYMAX FARMA
Do not take PIRACETAM:
If you are allergic (hypersensitive) to Piracetam or to any of the other ingredients of Piracetam;
In case of cerebral hemorrhage;
If you have severe renal failure (renal failure with creatinine clearance values below 20 ml/min);
If you have Huntington's chorea.
Take special care when using PIRACETAM
because piracetam is eliminated from the body by the kidneys, the product should be used with caution in patients with kidney disease. If you have kidney problems, it may be necessary to reduce the dose depending on their severity. Your doctor will assess whether the dosage needs to be adjusted. With long-term treatment, your doctor will determine what laboratory tests need to be performed regularly. If you suffer from kidney failure it is necessary to inform your doctor;
in patients with myoclonus, abrupt discontinuation of treatment should be avoided, as this may cause isolated or generalized seizures;
with severe bleeding or risk of bleeding.
Other medicines and PIRACETAM
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those bought without a prescription. Single cases of confusion, irritability and sleep disturbances have been observed with simultaneous administration with drugs containing thyroid hormones. Concomitant treatment with anticoagulants or antiplatelet agents (including low-dose acetylsalicylic acid) increases the risk of bleeding.
There is no evidence of adverse drug interactions with products for the treatment of epilepsy: clonazepam, carbamazepine, phenytoin, phenobarbital, valproic acid.
PIRACETAM with food, drink and alcohol
There is no evidence of the need for a special diet or restrictions on certain types of food and drink during treatment with this medicinal product.
It is necessary to avoid taking alcohol during treatment.
Pregnancy, lactation and fertility
Pregnancy
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.
There is no evidence that piracetam causes harm or has any other adverse effects on the fetus. It is necessary to know that the drug passes through the placenta and enters the bloodstream of the fetus. Since its safe use in pregnant women has not been established with certainty, treatment with the product during pregnancy should not be undertaken unless absolutely necessary.
In the event of pregnancy, it is necessary to notify your doctor, who will evaluate the continuation of treatment according to the potential benefit for the mother and the possible risk for the fetus.
Breastfeeding
Piracetam is excreted in human milk. Do not use piracetam while breastfeeding or breast-feeding should be discontinued while treatment with piracetam is taking place.
Driving and using machines
The application of the medicinal product to drivers,
Breastfeeding
Piracetam is excreted in human milk. Do not use piracetam while breastfeeding or breast-feeding should be discontinued while treatment with piracetam is taking place.
Driving and using machines
The application of the medicinal product to drivers, persons working with machines or those carrying out activities requiring high concentration of attention and adequate coordination will be specified carefully by your doctor. PIRACETAM may affect the ability to drive and operate machinery as a result of some of the side effects, which should be taken into account.
Children and adolescents
PIRACETAM is administered to children in dosages and duration prescribed by the attending physician.
Elderly patients
It is recommended that elderly patients visit their doctor regularly to monitor the dose.
PIRACETAM contains aspartame (E951)
Aspartame is a source of phenylalanine. May be harmful to people with phenylketonuria.
3. How to take PIRACETAM
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is:
Symptomatic treatment of psycho-organic syndromes
Usually, treatment starts with a daily dose of 2.4 - 4.8 g, divided into 2 or 3 separate doses.
Treatment of myoclonus of cortical origin
The starting daily dose is 7.2 g, which is increased by an average of 4.8 g every 3 to 4 days until a maximum daily dose of 24 g is reached. The daily dose is divided into 2 or 3 doses. Treatment of consequences of ischemic cerebrovascular accidents, in particular aphasia. Recommended daily dose in the subacute stage and in chronic forms 4.8 - 6 g (established at least after 15 days).
Treatment of vertigo
The recommended daily dose is 2.4 - 4.8 g, divided into two or three doses.
Treatment of dyslexia in combination with speech therapy
Recommended daily dose for children over 8 years of age and adolescents is 3.2 g, divided into two doses.
Prevention of crises in patients with sickle cell vaso-occlusive crisis The recommended daily dose is 160 mg/kg divided into 4 doses.
Application in adults and patients with kidney and liver disorders A change in the daily dose and the dosage regimen is possible after the judgment of your doctor. In cases of severe renal insufficiency, your doctor will assess the dose and the interval between individual intakes, which should not be shorter than 8 hours.
The duration of treatment with PIRACETAM is determined by your doctor. In chronic diseases, the optimal effect is usually achieved after 6-12 weeks.
Dissolve the contents of the sachet in a glass of water and mix well until a homogeneous solution is obtained. The medicinal product is taken regardless of meal times.
If you have the impression that the effect of PIRACETAM is stronger than expected or insufficient, contact your doctor.
If you have taken more than the required dose of PIRACETAM
There are no reports of acute overdose with piracetam, but nevertheless consult your doctor or pharmacist.
If you forget to take PIRACETAM
Do not take a double dose to make up for a missed dose. Take the medicine at the time of the next regular intake.
If you have stopped using PIRACETAM
If you have any further questions related to the use of this medicine, please ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, PIRACETAM can cause side effects, although not everybody gets them. If you notice any of the above or such reactions that are not described in this leaflet, tell your doctor or pharmacist.
Piracetam is a drug with proven low toxicity and is generally well tolerated when used in doses as directed by the physician.
The frequency of possible adverse drug reactions listed below is determined according to the following convention:
Very common (affects more than 1 in 10 patients)
Common (affects 1 to 10 in 100 patients)
Uncommon (affects 1 to 10 patients in 1,000)
Rare (affects 1 to 10 in 10,000 patients)
Very rare (affects less than 1 in 10,000 patients)
Not known (frequency cannot be estimated from the available data)
Common:
Nervous system disorders: hyperkinesia (increased activity);
Studies: weight gain;
Mental disorders: nervousness;
Uncommon:
Mental disorders: depression;
Nervous system disorders: drowsiness;
General disorders: asthenia (weakness)
Uncommon:
Mental disorders: depression;
Nervous system disorders: drowsiness;
General disorders: asthenia (weakness)
Not known frequency:
Blood disorders: hemorrhagic disorders;
Disorders of the ear and labyrinth: vertigo (feeling of dizziness);
Gastrointestinal disorders: abdominal pain, upper abdominal pain, diarrhoea, nausea, vomiting
Immune system disorders: anaphylactoid reaction, hypersensitivity.
Nervous system disorders: ataxia (lack of coordination of movements), balance disorders, worsening of epilepsy, headache, insomnia
Psychiatric disorders: agitation, anxiety, confusion, hallucinations.
Skin and subcutaneous tissue disorders: angioedema, dermatitis, pruritus, urticaria.
The last intake of the product is recommended to be no later than 4:00 PM - 5:00 PM, as the nervousness and excitement caused in some cases can lead to sleep disturbances when the drug is taken late.
5. How to store PIRACETAM
To be stored below 25 °C, in the original packaging.
Keep out of the reach of children.
Do not use PIRACETAM after the expiry date which is stated on the carton and sachet after EXP or EXP. The expiration date corresponds to the last day of the specified month.
Do not use PIRACETAM if you notice a change in the appearance of the medicine.
Medicines should not be disposed of down the drain or in the household waste container. Ask your pharmacist how to dispose of your unwanted medicines. These measures will help protect the environment.
6. Contents of the package and additional information
What PIRACETAM 1.2 g contains
The active substance is piracetam 1.2 g in one sachet (3 g)
The other ingredients are: mannitol, aspartame, sodium cyclamate, lemon flavor.
What PIRACETAM looks like and contents of the pack
3.0 g of powder for oral solution is packed in a three-layer foil sachet;
20 sachets in a cardboard package.