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PIRACETAM AL 800 mg. 30 tablets

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Pharmacotherapeutic group: Psihoanaleptitsi. Psychostimulants used in ADHD (concentration deficiency hyperactivity) and nootropic agents. Other Psychostimulants and Nootropic Remedies.

1. What Piracetam AL 800 is and what it is used for
Piracetam AL 800 is a nootropic agent that is used to treat psycho-organic syndrome, ischemic cerebrovascular (cerebrovascular) incidents and their consequences, especially aphasia (loss or impairment of the ability to produce linguistic production and / or to understand foreign speech ), Cortical myoclonus (hyperkinesia (rapid movements and inability to rest), manifested by single or repeated involuntary twitching of individual muscle groups), treatment of dyslexia (inability to read and understand brooks) and the treatment of vertigo (dizziness).

Piracetam AL 800 is used for the symptomatic treatment of:
Psycho-organic syndrome with the following manifestations: disturbance of memory and lack of motivation;
Treatment of ischemic cerebrovascular accidents and their consequences, in particular aphasia;
Treatment of cortical myoclonus, alone or in combination;
Treatment of dyslexia in children, combined with appropriate measures such as treatment by a speech therapist;
Treatment of vertigo and related balancing disorders, except dizziness of vasomotor or psychic origin.

2. Before you take Piracetam AL 800
Do not take Piracetam AL 800:
If you have an allergy to piracetam or to any of the other ingredients of this medicine;
If you have a cerebral hemorrhage;
If you suffer from severe kidney failure;
If you suffer from Huntington's chorea.
Take special care before taking Piracetam AL 800
Before initiating treatment with piracetam, it should always be excluded whether the symptoms are not due to any major disease with a specific treatment.

When you can take Piracetam AL 800 only after consulting your doctor
The situations described here refer to certain conditions under which Piracetam AL 800 should be taken with particular care. Please tell your doctor if any of the conditions described earlier have been reported to you.
Piracetam AL 800 can be used in psychomotor anxiety (mentally induced, uncoordinated motor activity) only after all necessary precautions have been taken.

What you should consider if you are pregnant or breast-feeding
Administration of Piracetam AL 800 during pregnancy and lactation is not recommended. If you become pregnant during treatment with this medicine, you should tell your doctor. Piracetam treatment can only be continued after consultation with your doctor who will assess the benefit / risk balance as there is insufficient experience with piracetam during pregnancy. It is not known whether piracetam is excreted in breast milk, so piracetam should not be taken during breast-feeding.

What should be considered when used by the elderly
Prolonged treatment in the elderly requires regular control of creatinine clearance in order to adjust the dose as necessary.

What should be considered when used by people with impaired hepatic or renal function
Piracetam does not break down in the liver. There is no indication of a change in dosage in patients with hepatic impairment. Since piracetam is mainly secreted by the kidneys, it is possible that its plasma concentration is increased with decreased renal function. It is recommended that half the therapeutic dose be administered in mild to moderate renal insufficiency. In the case of severe renal insufficiency, without the patient undergoing hemodialysis, 1/4 to 1/8 of the therapeutic dose should be used. In patients with severe renal insufficiency requiring hemodialysis the dose should not be reduced as piracetam is excreted during dialysis.
Piracetam is contraindicated in patients with severe renal insufficiency.
What else do you need to keep in mind
In patients with bleeding disorders, Piracetam AL 800 should be administered with caution after major surgical interventions or severe haemorrhage.
In patients with renal insufficiency, strict monitoring of serum creatinine and / or residual nitrogen is recommended.
The treatment of dyskinesia in children by administering piracetam should be performed by specialists who are sufficiently experienced in the diagnosis of the reading and writing disorders and only if this treatment is part of a general treatment plan including appropriate training programs and Education.

Drug interactions with other medicinal products
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Which medicines affect the action of Piracetam AL 800 and what you should have when taking other medicines at the same time
Please keep in mind that these warnings also apply to recently taken medicines.
Due to the fact that piracetam influences blood clotting, the action of coumarin derivatives (blood coagulation-lowering agents) may be increased when co-administered.
Stimulating the action of central nervous system stimulants of psychotic drugs as well as thyroid hormones in patients with reduced thyroid function (hypothyroidism).

What to consider when driving, using machines or working on unstable sites
Because patients can respond differently to this drug, some patients may need specific attention to attention and concentration monitoring at the beginning of treatment as well as at dose escalation.

3. How to take Piracetam AL 800
Dosage, route and duration of administration:
The instructions given below apply only if your doctor has not prescribed otherwise.
Please adhere to them and / or your doctor's instructions for effectiveness and safe treatment with Piracetam AL 800.
Dosage is based on the type and severity of the disease as well as the response of the patient to the therapy.

How many tablets Piracetam AL 800 and how often should you take them
Treatment of psycho-organ syndrome, ischemic cerebrovascular accidents, vertigo
3 film-coated tablets Piracetam AL 800 (corresponding to 2.4 g piracetam per day) are given three times a day. With an explicit prescription, the dose may be increased 3 times daily by 2 film-coated tablets Piracetam AL 800 (corresponding to 4.8 g piracetam per day).

Treatment of ischemic stroke and its consequences
Piracetam is initially administered in the form of an intravenous infusion or injection, and then the treatment is continued as described above unless the treating physician has prescribed otherwise.

Treatment of cortical myoclonus
Piracetam is initially administered as an intravenous infusion or injection, which may last for a longer time. Piracetam film-coated tablets may then be included in the treatment as prescribed by the treating physician.

Treatment of a disorder in reading and writing
For children and adolescents, a daily dose of 3.2 g piracetam is recommended.
Two film-coated tablets Piracetam AL 800 twice daily (corresponding to 3.2 g piracetam per day) are taken.

How and when to take Piracetam AL 800
Piracetam AL should be taken with a glass of liquid (eg a glass of water) best during or shortly after a meal.

How long do you need to take Piracetam AL 800?
For the duration of treatment, your doctor will decide on your own.
In the treatment of dementia syndrome, ischemic stroke or post-traumatic syndrome, the need for continued treatment should be reassessed after 3 months. To treat interference with reading and writing, the recommended treatment time is 3 months.
For treatment of cortical myoclonus, the duration of treatment depends on the clinical course. If muscle spasms are missing, treatment may be phased out.
Do not forget to take your medicine. Check with your doctor or pharmacist if you have not been told how to take it.

What should be done if you have taken too much (deliberate or accidental overdose) from Piracetam AL 800
The active substance piracetam has been investigated and considered to be practically non-toxic.
It is possible to increase the side effects listed below. In this case, please contact your doctor. It will determine the need for specific measures.

If you forget to take Piracetam AL 800
If you forget to take a dose of Piracetam AL 800, do not take a double dose next time to make up for a missed dose. As soon as you remember, take the next dose at the scheduled time.
Please consult your doctor if you have forgotten to take Piracetam AL for more than a few days. He / she will advise on how to resume treatment.

What should be considered if you discontinue treatment with Piracetam AL 800 or prematurely stop it
There are no special requirements if Piracetam AL 800 is administered as prescribed.

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

4. Possible side effects
What are the possible side effects with Piracetam AL 800 and what measures you should take if they occur?
When treated with piracetam, it is sometimes possible to increase psychically induced uncoordinated motor activity (psychomotor activity), sleep disturbances and insomnia, nervousness, depressive disorders, anxiety, aggression, gastrointestinal complaints (nausea, vomiting, abdominal Pain, diarrhea), weight gain. Rarely, dizziness, weakness, decrease or increase in blood pressure, increased libido and increased sexuality may occur. Headache, ataxia (impaired coordination of movements), equilibrium, confusion, hallucinations, drowsiness and allergic reactions (such as anaphylactic reactions, hives, skin flushing, itching, sweating) have been reported in isolated cases.
Adverse effects in adults are reported at doses of about 5 g piracetam per day. Children have similar side effects at daily doses above 3 g of piracetam. In particularly predisposed patients, hyper-excitability of the nervous system may, exceptionally, lead to a reduction in the seizure threshold. Patients who need anti-convulsive drugs should continue this treatment even if piracetam therapy is subjective.
Some piracetam-containing products have been reported to rarely cause some cases of epilepsy.

If you experience side effects that are not listed in this patient leaflet, please tell your doctor or pharmacist.

What you should take in the event of an adverse drug reaction
If any of the side effects listed above occur with you, please inform the treating physician so that he / she can assess the severity of the illness and determine the need for specific measures. At the first signs of hypersensitivity to Piracetam AL 800, its intake should be discontinued.

Shelf life and stability of the product
The expiry date is printed on the blister and on the carton. Do not use the medicine after this date!

5. How to store Piracetam AL 800
Keep out of the reach and sight of children.

6. Additional Information
What Piracetam AL 800 contains
1 film-coated tablet contains 800 mg piracetam.
Excipients: Povidone, colloidal silicon dioxide, magnesium stearate, croscarmellose sodium, macrogol 6000, talc, titanium dioxide (E171), methylhydroxypropylcellulose, iron oxide (E172), simethicone emulsion, poly (ethylacrylate, methyl methacrylate).

What does Piracetam AL 800 contain?
Original pack of 30, 60 or 120 film-coated tablets.


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