Cinnarizine NAN
Producer: RPUP "Akademfarm" Republic of Belarus
Code of automatic telephone exchange: N07CA02
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active ingredient: 25 mg of cinnarizine.
Excipients: lactose monohydrate, potato starch, povidone, silicon dioxide colloid anhydrous, magnesium stearate.
Pharmacological properties:
Drug has vasodilating effect (especially concerning brain vessels), without having significant effect on the ABP. Shows moderate antihistaminic activity, reduces excitability of a vestibular mechanism.
Indications to use:
- A maintenance therapy at symptoms of labyrinth frustration which include a syncope, a sonitus, a nystagmus, nausea and vomiting.
- Prevention of a disease of the movement.
- Prevention of migraine.
- The maintenance therapy at symptoms of a cerebrovascular origin which include a syncope a sonitus, a headache of a vascular origin, irritability, loss of memory and inability will concentrate.
- A maintenance therapy at symptoms of peripheral vascular frustration which include a Raynaud's disease, a Crocq's disease, the alternating lameness, trophic disturbances, trophic and varicose ulcers, paresthesia, night spasms of extremities, cold extremities.
Route of administration and doses:
For prevention sea and aeroembolism the adult - on 25 mg in 1 hour before the forthcoming trip, if necessary reception is repeated in the same dose by each 6 h. To the persons especially susceptible to sea and aeroembolism, it is recommended on the eve of long trips (for example, cruises), to begin reception of cinnarizine a day before departure, on 25 mg 3 times a day.
At vestibular disturbances by the adult - on 25 mg 3 times a day.
At disturbances of peripheric circulation by the adult - on 50-75 mg 2-3 times a day. At diseases of peripheral arteries the therapeutic effect is reached slowly, and the maximum effect of cinnarizine is noted after several weeks of continuous treatment, however considerable improvement of a blood-groove is reached in 1 week.
It is not recommended to exceed a dose of cinnarizine of 150 mg a day, the maximum daily dose – 225 mg. At high sensitivity to cinnarizine treatment is begun about 1/2 doses, gradually increasing a drug dose.
For achievement of optimum and long-term therapeutic effect drug should be accepted it is continuous, long (from several weeks to several months).
Dosing in special cases. Patients with damage of a liver: in order to avoid cumulation correction of a dose at patients with a liver failure is recommended.
Elderly people: change of the mode of dosing is not required.
Children and teenagers: to children from 5 years the dose is reduced twice.
Features of use:
Use at pregnancy and during breastfeeding. Despite of what at a cinnarizine research on animals of teratogenic effects is not revealed, use of drug during pregnancy, as well as other medicines it can be justified only under conditions if therapeutic advantages exceed possible potential risk for fetation.
There are no data concerning a possibility of hit of cinnarizine in breast milk. Therefore, women should avoid treatment by cinnarizine during feeding by a breast.
Children. Age from 5 to 12 years it is recommended to children to appoint a half of the dose recommended to adults.
Due to the content of lactose of monohydrate reception of this medicine is not recommended to patients with rare inborn intolerance of a galactose, deficit of Lapp of lactase or malabsorption of glucose galactose.
Due to the existence of antihistaminic effect cinnarizine can affect result at anti-doping control of athletes (false positive result), and also to level positive reactions when conducting skin diagnostic tests (in 4 days prior to a research treatment should be cancelled).
It is necessary to be careful at purpose of cinnarizine to patients with heavy arterial hypotension.
At prolonged use carrying out control inspection of function of a liver, kidneys, pictures of peripheral blood is recommended.
Feeding is not recommended to the women accepting cinnarizine by a breast.
As well as other antihistaminic drugs, cinnarizine can cause pains in epigastric area, for the purpose of reduction of their expressiveness it is recommended to accept drug after food.
It is necessary to avoid purpose of cinnarizine to patients with a porphyria.
Influence on ability to drive the car and potentially dangerous mechanisms. During treatment it is necessary to be careful during the driving of motor transport and occupation other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions. Especially in an initiation of treatment there can be a drowsiness, reduction in the rate of reaction and level of attention.
With extra care it is necessary to apply the cinnarizine (having the oppressing effect on TsNS) along with alcohol or anesthetics.
The patients having Parkinson's disease should appoint cinnarizine only when advantages of its appointment exceed possible risk of an aggravation of symptoms. It is necessary to control emergence at the elderly patients accepting cinnarizine, extrapyramidal symptoms and a depression; if necessary drug it is necessary to cancel and appoint the corresponding therapy.
Side effects:
For assessment of frequency of undesirable effects the following categories are used: very often (≥ 1/10); often (≥ 1/100 and <1/10); infrequently (≥ 1/1000 and <1/100); seldom (≥ 1/10000 and <1/1000); very seldom (<1/10000) and frequency is not known (according to the available data frequency cannot be determined).
The side reactions revealed in clinical trials:
Central nervous system: very often: drowsiness (14,97%), it is frequent: headache (2,1%), dizziness (8,3%), infrequently (<1%): slackness.
Digestive tract: often: the general - nausea (1,5%), dryness in a mouth (1,35%), infrequently (<1%): gastrointestinal discomfort, vomiting, abdominal pains, dyspepsia; frequency is unknown - cholestatic jaundice.
"General" symptoms: increase in body weight (2,1%), infrequently (<1%): feeling of fatigue.
Diseases of skin and hypodermic cellulose: infrequently (<1%): the increased sweating.
The side effects revealed in post-market researches:
Central nervous system: very seldom: dyskinesia, extrapyramidal frustration (tremor of extremities and increase in a muscle tone, hypokinesia), parkinsonism; frequency is unknown - a depression.
Diseases of skin and hypodermic cellulose: very seldom: a lichenoid keratosis, red flat deprive, a volchanochnopodobny syndrome.
Diseases of a musculoskeletal system, connecting fabric and bones: very seldom: muscle tension.
Allergic reactions: frequency is unknown - skin rash.
Others: frequency is unknown - a lowering of arterial pressure.
Interaction with other medicines:
At simultaneous use with tricyclic antidepressants, hypnotic drugs and sedative medicines, ethanol, etanolsoderzhashchy drugs (mutually) braking action on the central nervous system (CNS) amplifies.
At simultaneous use with vasodilators – perhaps mutual strengthening of effect of cinnarizine and vasodilators.
Contraindications:
Hypersensitivity, pregnancy, the lactation period, children's age up to 5 years, extrapyramidal symptoms, Parkinson's disease, a depression in the anamnesis, recently postponed myocardial infarction.
Overdose:
Symptoms: vomiting, drowsiness, a stupor, a tremor, an excessive lowering of arterial pressure, a coma, extrapyramidal symptoms, spasms (at children).
Treatment: the specific antidote does not exist, a gastric lavage in the first hour after overdose, absorbent carbon, a symptomatic and maintenance therapy.
Storage conditions:
In the place protected from light and moisture, at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity 2 years.
Issue conditions:
According to the recipe
Packaging:
25 tablets in a blister strip packaging. 1 or 2 planimetric packagings together with the instruction on a medical use in a pack cardboard.