Name:
Phezam. Release formCapsules. MNN Piracetam + cinnarizine. FTGNnootropic agent. Composition Active substances in one capsule: piracetam 400 mg and cinnarizine 25 mg. Excipients: lactose monohydrate, colloidal silicon dioxide, magnesium stearate. Capsule composition: titanium dioxide (E 171), gelatin.
Description:
– Hard, cylindrical gelatin capsules; White color. Pharmacotherapeutic group ATC code N06BX. Other psychostimulants and nootropics. Pharmacological properties Phezam contains piracetam and cinnarizine. Piracetam is a nootropic agent, improves cognitive functions, improves microcirculation. Cinnarizine inhibits the contraction of vascular smooth muscle cells, improves microcirculation, inhibits stimulation of the vestibular system. Indications for use Symptomatic treatment of memory disorders, intellectual impairment in the absence of a diagnosis of dementia (symptomatic treatment of chronic psychoorganic syndrome); symptomatic treatment of labyrinth and vestibular disorders of vascular origin, Meniere’s syndrome. Information necessary for the correct use of the medicinal product Contraindications Individual intolerance to piracetam or pyrrolidone derivatives, as well as other components of the medicinal product; psychomotor agitation at the time of drug administration; chorea of Huntington; acute violation of cerebral circulation (hemorrhagic stroke); parkinsonism; terminal stage of chronic renal failure (with creatinine clearance less than 20 ml / min); pregnancy, lactation period. Precautions In cases of prescribing the drug to patients with impaired renal function, it is necessary to adjust the dose (see section “Method of application and doses”). This drug should be used with extreme caution in patients with hepatic impairment. In patients with impaired liver function, it is necessary to monitor the values of liver enzymes. Alcohol should be avoided during treatment. Caution should be used in conditions associated with increased intraocular pressure. In patients with Parkinson’s disease, the appointment of cinnarizine is possible only if the therapeutic benefits outweigh the possible risk of exacerbation of this disease. As with other antihistamines, cinnarizine may cause epigastric irritation, and taking the drug after meals may reduce gastric irritation. Cinnarizine can cause drowsiness, especially at the very beginning of treatment, so you should refrain from the simultaneous use of alcohol or CNS depressants. Cinnarizine should be avoided in porphyria. Since Phezam contains cinnarizine, the drug may cause a positive reaction in athletes during a doping test. Due to the antihistamine activity of cinnarizine, the drug may affect the results of skin allergy tests carried out within 4 days after taking Phezam. Due to the effect of piracetam on platelet aggregation, caution should be exercised when prescribing the drug to patients with impaired hemostasis, surgical intervention (including dental), risk factors for bleeding (for example, peptic ulcer of the stomach and duodenum), previous hemorrhagic stroke or intracerebral hemorrhage, taking anticoagulants or antiplatelet agents, including low doses of acetylsalicylic acid. Interactions with other medicinal products Please tell your doctor or pharmacist if you are taking or have recently taken other medicines, even if they have not been prescribed for you. With the simultaneous use of piracetam with thyroid hormones, there have been reports of confusion, irritability and sleep disturbance. According to the results of a study of patients with recurrent venous thrombosis, piracetam at a dose of 9.6 g / day increases the effectiveness of indirect anticoagulants. Taking piracetam at a dose of 20 g / day for 4 weeks did not change the maximum serum concentration of antiepileptic drugs (carbamazepine, phenytoin, phenobarbital, valproate) in patients with epilepsy who received piracetam at a stable dose. Simultaneous intake of alcohol, CNS depressants, tricyclic antidepressants may increase the sedative effects of these drugs or cinnarizine. Due to its antihistamine effect, cinnarizine may mask a positive skin test reaction and should therefore be discontinued 4 days before the test. If you are taking other medicines at the same time, you should consult your doctor. Phezam use and food and drink intake There is no evidence of the need for a special diet or restriction of certain types of food or drink during treatment with this drug. Alcohol should be avoided during treatment. Special instructions for certain groups of patients Before taking any medicines, consult your doctor or pharmacist. Use in children The use of the drug in children under 18 years of age is not recommended. Use during pregnancy and lactation The drug is contraindicated for the appointment of pregnant women and women who are breastfeeding. Influence on the ability to drive a car and work with machinery While taking the drug, it is recommended to refrain from driving a vehicle and working with potentially dangerous mechanisms. Information about excipients Phezam capsules contain lactose as an excipient. Patients with rare hereditary problems such as galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Information on correct use Dosage and administration Always take Phezam according to your healthcare professional’s instructions. For adults, the drug is prescribed 1-2 capsules 3 times a day for 1-3 months, depending on the severity of the disease. The duration of the course of treatment is determined by the doctor, taking into account the characteristics of the disease, the effect achieved and the tolerability of the drug. Since piracetam is excreted from the body by the kidneys, when prescribing the drug to patients with renal insufficiency and elderly patients, the dose should be adjusted depending on the value of creatinine clearance (CC). Patients with renal insufficiency require dose adjustment of the drug in accordance with the following scheme: Degree of renal insufficiency CC (ml / min) Dose Norm > 80 Usual dose Mild 50-79 2/3 of the usual dose in 2-3 doses Average 30-49 1 / 3 usual doses in 2 doses Severe <30 1/6 usual dose, single dose End stage - contraindicated I In elderly patients, the dose is adjusted in the presence of renal insufficiency; with prolonged therapy, it is necessary to monitor the functional state of the kidneys. Use with caution in patients with impaired liver function. For patients with impaired renal and hepatic function, the drug is prescribed in the same way as for patients with impaired renal function. If you have the impression that Phezam is too weak or too strong, talk to your doctor or pharmacist. Overdose If you have taken a higher dose than you have been prescribed, seek medical attention immediately! Symptoms, change in consciousness from drowsiness to stupor and coma, vomiting, extrapyramidal symptoms, arterial hypotension, convulsions, dyspeptic symptoms in the form of diarrhea with blood and pain in the abdomen. Treatment: There is no specific antidote. During the first hour after ingestion, activated charcoal may be prescribed. Treatment is symptomatic. If you miss taking Phezam It is advisable not to miss taking the drug. If this happens, you should take the capsule immediately, however, if it is time for your next dose, you should not take the missed dose. If you have any further questions on the use of this medicine, please ask your doctor or pharmacist. Side effects Like all medicines, Phezam can cause side effects, although not everybody gets them. Adverse reactions are listed by organ system class according to the MedDRA Regulatory Dictionary of Medicine using the MedDRA frequency definitions: very common (≥1/10), common (≥1/100, <10), uncommon (≥1/1000, <100), rare (≥1/10000, <100), very rare (<1/10000), frequency unknown (cannot be estimated from the available data). On the part of the blood and lymphatic system: Frequency unknown: hemorrhagic disorders On the part of the immune system: Frequency unknown: anaphylactoid reactions, hypersensitivity. From the nervous system: Frequency unknown: hyperactivity, drowsiness, ataxia, imbalance, convulsions, exacerbation of epilepsy, headaches, insomnia, tremor, dyskinesia, extrapyramidal disorders, parkinsonism. On the part of the organ of hearing and balance: Frequency unknown: dizziness. From the digestive system: the frequency is unknown: abdominal pain, pain in the upper abdomen, diarrhea, vomiting, nausea. Diseases of the skin and subcutaneous tissue: Frequency unknown: Quincke's edema, dermatitis, pruritus, urticaria, hyperhidrosis, lichen keratosis, lichen planus, lupus-like reaction, photosensitivity. Disorders of the reproductive system and mammary glands: Frequency unknown: increased libido. General disorders: Frequency unknown: weight gain, asthenia, muscle stiffness. In the event of adverse reactions, including those not listed in this leaflet, you should stop taking the drug and consult a doctor. Storage conditionsAt a temperature not higher than 25°C. Keep out of the reach of children! Shelf life 3 (three) years. The drug should not be used after the expiration date indicated on the package! Terms of release By prescription. Buy Phezam capsules 400mg / 25mg No. 10x6 Price for Phezam capsules 400mg / 25mg No. 10x6
INN | PIRACETAM+CINNARIZINE |
---|---|
The code | 1 712 |
Barcode | 3 800 712 045 118 |
Dosage | 400mg/25mg |
Active substance | Piracetam, cinnarizine |
Manufacturer | Balkanpharma-Dupnitsa AD, Bulgaria |
Importer | Foreign unitary trade and manufacturing enterprise "Belinvestfarma", Minsk, Leshchinskogo st., 8/4-2; Komfarm LLC, Minsk, 220131 Minsk, Sosnovy Bor st., 4, office 1; Limited Liability Company "Farmiko", Minsk district, Senitsky s / s, Kolyadichi village, Lazurnaya st., 9; Additional Liability Company "Farmin", 220125 Minsk, Independence Avenue, 177, room 62; IOOO "Interfarmaks", Republic of Belarus, 223028, Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Zvezdnaya, 19A-5, pom. 5-2 |
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