Active Ingredient: one film-coated tablet contains 800 mg piracetam.
Excipients/Inactive Ingredients: povidone K25, colloidal anhydrous silica, magnesium stearate, talc, hypromellose, propylene glycol, macrogol 6000, colouring agents titanium dioxide, iron oxide and hydroxides E172 ( yellow).
Pharmacotherapeutic group: Nootropics. ATC code: N06BX03.
Pharmacology: Pharmacodynamics: Experimental studies with humans revealed an increase of perfusion as well as an increase of the oxygen turnover rate such as oxygen extraction rate in ischemic cerebral areas. In primarily damaged ischemic cerebral areas, an increase of the glucose turnover rate could be found. Examinations carried out through an EEG revealed a reinforcement of the alpha components and showed simultaneously a decrease of the theta and delta components.
Piracetam affects the disturbed learning and memory function of the patient.
Furthermore, Piracetam has haemorheologic effects by improving the erythrocyte deformability, decrease of erythrocyte aggregation, reduction of plasma viscosity, decrease of flow stress as well as inhibition of thrombocyte aggregation.
Mechanism of Action: Piracetam is a substance out of the group of the nootropic agents. As a result of trials in man, an increase in blood circulation, oxygen turnover rate and oxygen extraction rate of ischaemic areas of the brain as well as an increased glucose turnover rate of primary ischaemically damaged areas of the brain were found. EEG-checks showed an intensification of the alpha-components with a simultaneous reduction of the theta- and the delta-components. Piracetam has influence on the disturbed function of learning and memorising. Furthermore, Piracetam shows haemostasiologic and haemorheologic effects caused by improvement of the red cell deformability, decrease in red cell aggregation, lowering of plasma viscosity, improved blood flow and inhibition of platelet aggregation.
Pharmacokinetics: Piracetam is rapidly and extensively absorbed following oral administration. In fasted subjects, the peak plasma concentrations are achieved 1 hour after dosing. The absolute bioavailability of piracetam oral formulations is close to 100 %.
Piracetam is not bound to plasma proteins and its volume of distribution is approximately 0.6 l/kg. Piracetam crosses the blood brain barrier as it has been measured in cerebrospinal fluid following intravenous administration. In cerebrospinal fluid, the tmax was achieved about 5 hours post-dose and the half-life was about 8.5 hours.
Piracetam is not known to be metabolised in the human body. The plasma half-life of piracetam in adults is about 5 hours following either intravenous or oral administration. The apparent total body clearance is 80-90 ml/min. The major route of excretion is via urine, accounting for 80 to 100 % of the dose.
Piracetam clearance is correlated to creatinine clearance. It is therefore recommended to adjust the daily dose of piracetam based on creatinine clearance in patients with renal impairment.
There are no adequate data from the use of piracetam in pregnant women. Piracetam crosses the placental barrier. Drug levels in the newborn are approximately 70% to 90% of maternal levels. Piracetam is excreted in human breast milk.
Symptomatic treatment of chronic cerebro-organically conditioned disturbances of functional capacity in the course of a therapeutic overall programme in case of syndromes of dementia becoming manifest as: impaired memory, lack of concentration, blocking of thought processes, premature fatigue and lack of drive and motivation, affective disturbances. The individual response to the medication cannot be forecast.
Hint: Before beginning the treatment with this product it should be clarified whether the symptoms are not due to a basic disease which has to be treated specifically.
The dosage depends on type and severity of the clinical picture and the patient's response to the therapy. Unless otherwise prescribed by the physician the following dosage guidelines apply: For adults: 3 times daily 1 f/c tablet of this product (equiv. to 2.4 g piracetam). On special medical prescription the dose can be raised to 3 times daily 2 f/c tablets of this product (equiv. to 4.8 g piracetam).
Dose adjustment in elderly patients:
In elderly patients with renal impairment, the dosage is determined by the attending physician. Periodic monitoring of creatinine clearance by the physician is required during long-term treatment of elderly patients to adjust the dose if needed.
Dose adjustment in patients with impaired renal function:
As piracetam is exclusively eliminated via the kidneys, increased plasma levels may be produced in case of reduced renal function. Piracetam is contraindicated in severe renal impairment (renal creatinine clearance of less than 20 ml per minute). The daily dose must be individualised according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of the patient's creatinine clearance (CLcr) in ml/min is needed. (See table). The CLcr in ml/min may be estimated from serum creatinine (mg/dl) determination using the following formula: (See equation and table).
Click on icon to see table/diagram/image
Click on icon to see table/diagram/image
Dose adjustment in patients with impaired liver function:
Piracetam is not metabolised in the liver. For patients with reduced liver function no other dosage guidelines apply. In patients with impaired liver as well as impaired renal function dosage is determined by the attending physician.
This product should be taken with one glass of liquid (e.g. water), for reasons of expediency together with or directly after the meals. The duration of treatment depends on the physician's decision. In case of a supporting treatment of syndromes of dementia it has to be verified after three months whether a further treatment is still indicated.
Mistakes in application and overdosing: There are no documented cases of further adverse reactions (listed as follows) which occurred after an overdose of Piracetam. If too large quantities of this product have been taken, inform the physician. He shall decide about further actions. If the patient has taken a too small quantity or forgotten an intake, continue the intake as prescribed. Do not take the double dose, in case the patient forgot the intake. Do not stop the treatment without having first talked to the physician.
Treatment of Overdose: In case of acute and significant overdose it is possible to empty the stomach by gastric irrigation or by causing vomiting. There is no specific antidote for piracetam. The treatment is only symptomatic and may also include hemodialysis. The extraction coefficient of the dialyser for piracetam is 50 - 60%.
This product must not be applied in case of known hypersensitivity to piracetam, other pyrrolidone derivates or to one of the other ingredients; in case of cerebral haemorrhage (e.g. stroke); in case of severe renal insufficiency (renal insufficiency at terminal stage); in case of suffering from the genetic disease Huntington's chorea. In case of psychomotor agitation, also if it occurred formerly, the physician has to be consulted first.
Caution is advised when this product is applied in case of patients with disturbed blood coagulation, major operations (including dental surgeries) or severe haemorrhages (e.g. gastric ulcer). Caution is also advised for patients who had an event in the past that affected the brain vessels and that was associated with a bleeding and patients who are taking medicines to prevent blood clotting or the aggregation of platelets (platelet aggregation), including low-dose acetylsalicylic acid. Patients with renal insufficiency should be supervised carefully as far as the rest-N- and creatinine-values are concerned.
In elderly patients who take Cebrotonin for a longer period, it is necessary that the physician regularly checks the values of creatinine clearance to adjust the dose if needed.
Patients who are taking medicines for seizures (anticonvulsants), should keep the treatment with anticonvulsants, even if they think their condition has improved since taking CEBROTONIN.
Doping Note: The use of CEBROTONIN 800 mg can lead to positive results in doping controls.
Hints regarding road traffic, operation of machines and works without secure hold: Due to observed adverse reactions a possible impairment of reactivity cannot be excluded. This should be bore in mind when driving a car or using machines.
Use in pregnancy and lactation: There is not enough experience concerning the application of piracetam during pregnancy. If a patient becomes pregnant during the treatment with this product, the physician has to be informed at once, in order for him to decide whether to continue or to stop therapy. Piracetam passes over to the mother's milk. This product should therefore not be applied during lactation period or alternatively breast-feeding should be interrupted during CEBROTONIN treatment. It is up to the physician to decide whether breastfeeding or CEBROTONIN treatment should be interrupted, after having weighed out the risks and benefits for the mother and the child.
There is not enough experience concerning the application of piracetam during pregnancy. If a patient becomes pregnant during the treatment with this product, the physician has to be informed at once, in order for him to decide whether to continue or to stop therapy. Piracetam passes over to the mother's milk. This product should therefore not be applied during lactation period or alternatively breast-feeding should be interrupted during CEBROTONIN treatment. It is up to the physician to decide whether breastfeeding or CEBROTONIN treatment should be interrupted, after having weighed out the risks and benefits for the mother and the child.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The assessment of side effects is based on the following frequencies: Very common: may affect more than 1 in 10 people / Common: may affect up to 1 in 10 people / Uncommon: may affect up to 1 in 100 people / Rare: may affect up to 1 in 1,000 people / Very rare: may affect up to 1 in 10,000 people / Not known: frequency cannot be estimated from the available data.
Blood and lymphatic system disorders: not known: hemorrhagic disease.
Immune system disorders: very rare: allergic reactions such as anaphylactic reactions; not known: hypersensitivity.
Metabolism and nutrition disorders: Common: weight gain.
Psychiatric disorders: Common: increased psychomotor activity, nervousness, aggressiveness, disturbed sleep, insomnia, depressive mood, anxiety, Uncommon: depression; very rare: states of confusion, hallucinations.
Nervous system disorders: Common: Excessive motor activity (hyperkinesia); uncommon: drowsiness (somnolence); very rare: headaches, disturbances in the interaction of movements (ataxia), impaired balance; not known: exacerbation of epilepsy, sleeping disorders.
Ear and labyrinth disorders: uncommon: Dizziness.
Vascular disorders: uncommon: blood pressure reduction or enhancement.
Gastrointestinal disorders: Common: gastrointestinal discomfort (abdominal discomfort), diarrhea, nausea, vomiting; not known: abdominal pain, upper abdominal pain, dry mouth, increased salivation.
Skin and subcutaneous tissue disorders: very rare: Skin redness and flushing, sweating, itching, hives (urticaria); not known: Painful swelling of the skin and mucous membranes (Oedema Quincke's), inflammatory skin reaction (dermatitis).
General disorders and administration site conditions: uncommon: Weakness or loss of strength (asthenia), increased sex drive (libido increase), increased sexuality.
Hint: The desired synchronisation and support of the electric activity of the brain can in exceptional cases lead to a decrease in the convulsion threshold in specially disposed patients (neuronal hyperexcitability). It should be taken care that patients who need anticonvulsants maintain this therapy even if the treatment with this product results in a subjective improvement.
At the first sign of a hypersensitivity reaction CEBROTONIN 800 mg must not be taken once again.
The following information also goes for medicaments recently applied. Because of the influence of piracetam on blood coagulation, the effect of coumarin derivatives (certain anticoagulants) may possibly be reinforced. The effect of medicaments stimulating the central nervous system, neuroleptics as well as of thyroid hormones in case of hypothyrosis may be reinforced.
To be stored in a dry place below 30°C, protected from light.
N06BX03 - piracetam ; Belongs to the class of other psychostimulants and nootropics.
Tab 800 mg (light-yellow, oblong film coated, smooth, with a score) x 30's.