What Adicetam is and what it is used for This medicinal product belongs to the nootropic group. It enhances impaired brain function by acting on the central nervous system without having a psycho-stimulating or sedative 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 abilities 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). When in doubt, always consult your doctor or pharmacist. Warnings and precautions Talk to your doctor, pharmacist, or nurse before taking Adicetam. • The medicinal product should be administered with caution to patients with kidney disease. The recommended dose may be changed by your doctor. • In patients with myoclonus, abrupt discontinuation of treatment should be avoided as this may lead to the onset of generalized or myoclinic 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 Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In isolated 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 administration of an 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 medicine is not recommended during pregnancy and lactation unless it is absolutely necessary. The drug crosses the placenta and reaches the fetus. Piracetam is excreted in human breast milk and therefore during breast-feeding it should be discontinued. 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 doctor regularly to monitor the dose. Adicetam contains mannitol (£ 421) This medicinal product contains the excipient mannitol (E421). When administered 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 about a negro, 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. Treatment begins with daily doses of 4.8 g. This dosage is taken for several weeks and then reduced to 2.4 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 until the maximum intake of 24 g is divided into 2-3 doses. If you are taking other such anti-myclonic medicines, treatment with them should be continued. Treatment of vertigo The recommended daily dose is 2.4 g to 4.8 g divided into 2-3 doses. Treatment of the effects of ischemic gastro-vascular accidents, especially aphasia In chronic forms (established at least after 15 days) and in the acute stage, the daily dose is 4.8 g to 6 g. Treatment of dyslexia with speech therapy in children aged 8 to 13 years The recommended daily dose in children over 8 years of age and adolescents is about 3.2 g divided into 2 doses. Prevention of sickle cell crisis 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 medicine at the next dose. If you stop taking Adicetam Piracetam treatment should be discontinued gradually - dose reduction by 2.4 g every 2 days. Otherwise, complaints may resume If you need 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 in 1000 patients) Rare (affecting 1-10 in 10,000 patients) Very rare (less than 1 in 10,000 patients affected) Frequency not known (cannot be estimated from available data) Honor: • Metabolic and nutritional disorders: weight gain; • Mental disorders: nervousness; • Nervous system disorders: hyperkinesia (increased activity). Rare: • Mental disorders: depression, drowsiness • Common 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 2.4 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: imbalances, lack of coordination in movement, 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 If you get any side effects, talk to your doctor, pharmacist or nurse. This includes all possible side effects not listed in this leaflet. 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 throw away 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 is a white or off-white powder. Adicetam 2400 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 pieces of sachets and a leaflet for the patient. Not all pack sizes may be marketed..