Cinnarizine forte tablets 75 mg blister No. 20

Instructions for use Cinnarizine forte tablets 75 mg blister No. 20

Composition

active ingredient: cinnarizine;

1 tablet contains cinnarizine in terms of 100% substance 75 mg;

excipients: lactose monohydrate; montan glycol wax; ammonium methacrylate copolymer (type A); ammonium methacrylate copolymer dispersion; calcium stearate.

Dosage form

Pills.

Main physicochemical properties: biconvex tablets of white with a cream tint with a score.

Pharmacotherapeutic group

Drugs used in vestibular disorders. ATX code N07C A02.

Pharmacological properties

Pharmacodynamics

Cinnarizine inhibits the contraction of vascular smooth muscle cells by blocking calcium channels. In addition to direct calcium antagonism, cinnarizine reduces the contractile effect of vasoactive substances such as norepinephrine and serotonin by blocking receptor-gated calcium channels. The blockade of calcium entry into cells is tissue-selective and results in a reduction in vasoconstriction without affecting blood pressure and heart rate.

Cinnarizine can further improve poor microcirculation by increasing the deformability of erythrocytes and reducing blood viscosity. Its administration increases cellular resistance to hypoxia.

Cinnarizine inhibits stimulation of the vestibular system, which leads to suppression of nystagmus and other autonomic disorders. With the help of cinnarizine, acute attacks of dizziness can be prevented or reduced.

Pharmacokinetics

Peak plasma levels of cinnarizine are reached 1-3 hours after administration. The half-life of cinnarizine from blood plasma is 4 to 24 hours.

Cinnarizine is completely metabolized in the body and excreted as metabolites: about 1/3 in urine and 2/3 in feces.

Approximately 91% of the drug binds to blood plasma proteins.

Indication

Symptomatic treatment:

labyrinth disorders, including dizziness, tinnitus, nystagmus, nausea and vomiting; cerebrovascular disorders, including dizziness, tinnitus, vascular headache, irritability, impaired memory and concentration; peripheral vascular disorders, including Raynaud's disease, acrocyanosis, intermittent claudication, trophic disorders, trophic and varicose ulcers, paresthesia, nocturnal limb cramps, feeling of coldness in the limbs.

Contraindication

Hypersensitivity to cinnarizine and/or any other components of the drug.

Interaction with other medicinal products and other types of interactions

Alcohol/CNS depressants/tricyclic antidepressants: Concomitant use may enhance the sedative effect of any of these drugs or Cinnarizine forte.

Diagnostic procedures: due to its antihistamine action, Cinnarizine forte may mask positive reactions to skin reactivity factors during skin testing, therefore its use should be discontinued 4 days before the test.

Application features

Cinnarizine forte may cause irritation in the epigastric region; taking the drug after meals will reduce irritation of the gastric mucosa.

Cinnarizine forte is recommended for patients with Parkinson's disease only if the benefits of treatment outweigh the possible risk of worsening the course of this disease.

Since Cinnarizine forte may cause drowsiness, especially at the beginning of treatment, you should refrain from simultaneous consumption of alcohol and the use of drugs that suppress the activity of the central nervous system (CNS depressants).

The use of Cinnarizine forte should be avoided in porphyria.

Cinnarizine forte should be used with caution in patients with hepatic and/or renal insufficiency.

The drug contains lactose, therefore patients with rare hereditary forms of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption syndrome should not take this medicine.

Ability to influence reaction speed when driving vehicles or other mechanisms

Considering that sensitive patients may experience drowsiness when using the drug (especially at the beginning of treatment), while taking the drug, you should refrain from driving vehicles and performing other work that requires concentration.

Use during pregnancy or breastfeeding

Despite the fact that no teratogenic effects were observed in animal studies of cinnarizine, the drug is not recommended for use during pregnancy.

There is no information on the possibility of cinnarizine passing into breast milk. Therefore, treatment with Cinnarizine forte should be avoided in women during breastfeeding.

Method of administration and doses

Adults should take Cinnarizine forte orally, preferably after meals.

The maximum dose should not exceed 225 mg (3 tablets) per day. Since the effect on dizziness is dose-dependent, the dosage should be increased gradually.

Children

This dosage form is not intended for the treatment of children.

Overdose

Symptoms. In isolated cases of acute overdose (from 90 mg to 2250 mg), the following manifestations were observed: change in consciousness from drowsiness to stupor and coma; vomiting, extrapyramidal symptoms, arterial hypotension. Convulsions were observed in a small number of children. In most cases, the clinical outcome was not severe, but fatalities are known after overdose with simultaneous use with other drugs, including cinnarizine.

Treatment. There is no specific antidote. Gastric lavage should be performed within the first hour after ingestion. Activated charcoal may be administered if indicated.

Adverse reactions

Drowsiness and gastrointestinal disturbances may occur. These symptoms are usually transient and disappear as the optimal dose is gradually reached. Symptoms such as headache, dry mouth, weight gain, sweating or allergic reactions may occur occasionally. Wilson's disease and lupus-like symptoms have been reported in very rare cases.

A single case of obstructive jaundice has been reported in the medical literature. In elderly patients, during long-term treatment with cinnarizine, cases of exacerbation or appearance of extrapyramidal symptoms, sometimes in combination with depressive states, have been observed. In such cases, the use of this drug should be discontinued.

The following adverse reactions have been observed with cinnarizine in clinical trials and in the post-marketing period. The frequency is defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10000 to <1/1000); frequency unknown (cannot be estimated from the available data).

Additionally, cases of hypersensitivity reactions, headache and dry mouth have been reported.

Expiration date

3 years.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 ºС.

Keep out of reach of children.

Packaging

10 tablets in a blister, 2 blisters in a pack.

Vacation category

According to the recipe.

Producer

PJSC "Kyivmedpreparat".

Location of the manufacturer and its business address

Ukraine, 01032, Kyiv, Saksaganskoho St., 139.