Stugeron tablets 25 mg No. 50

Instructions Stugeron tablets 25 mg No. 50

Composition

active ingredient: cinnarizine. 1 tablet contains cinnarizine 25 mg;

Excipients: colloidal anhydrous silicon dioxide, potato starch, magnesium stearate, povidone, talc, corn starch, lactose monohydrate.

Dosage form

Pills.

Main physicochemical properties: white or almost white flat disc-shaped tablets with a bevel, practically odorless, engraved with “STUGERON” on one side and a score on the other.

Pharmacotherapeutic group

Drugs used in vestibular disorders. Cinnarizine. ATX code N07C A02.

Pharmacological properties

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 leads to a decrease in vasoconstriction without affecting blood pressure and heart rate.

Cinnarizine can further improve poor microcirculation by increasing the elasticity of the erythrocyte membrane and reducing blood viscosity. When using cinnarizine, cellular resistance to hypoxia increases.

Cinnarizine inhibits stimulation of the vestibular system, which leads to suppression of nystagmus and other autonomic disorders. Cinnarizine prevents the appearance or reduces acute attacks of dizziness.

Pharmacokinetics.

Absorption: Peak plasma levels of cinnarizine are reached 1-3 hours after oral administration.

Distribution: Plasma protein binding is 91%.

Metabolism: Cinnarizine is metabolized primarily by CYP2D6.

Elimination: The plasma half-life is 4 to 24 hours. ⅓ of the metabolites are excreted in the urine and ⅔ in the feces.

Indication

Cerebral circulatory disorders:

symptomatic treatment of cerebrovascular disorders, including dizziness, ringing in the ears (tinnitus), vascular headache, irritability, memory loss and inability to concentrate;

migraine prevention.

Peripheral circulatory disorders:

symptomatic treatment of peripheral vascular disorders, including Raynaud's disease, acrocyanosis, intermittent claudication, trophic disorders, trophic and varicose ulcers, paresthesia, nocturnal limb spasms, cold extremities.

Disequilibrium:

symptomatic treatment of labyrinth disorders, including dizziness, tinnitus, nystagmus, nausea and vomiting.

Motion sickness:

prevention of motion sickness.

Contraindication

Hypersensitivity to the active substance or to any of the excipients.

Interaction with other medicinal products and other types of interactions

Alcohol/CNS depressants/tricyclic antidepressants: Concomitant use may enhance the sedative effects of these agents or Stugeron.

Diagnostic intervention: due to its antihistamine properties, Stugeron may mask positive reactions to skin reactivity factors during skin testing, therefore its use should be discontinued 4 days before the test.

Application features

Like other antihistamines, Stugeron may cause irritation in the epigastric region; taking the drug after meals may reduce the effects of irritation of the gastric mucosa.

Stugeron should only be prescribed to patients with Parkinson's disease if the benefits of treatment outweigh the possible risk of worsening the course of the disease.

Since Stugeron may cause drowsiness, especially at the beginning of treatment, the simultaneous use of alcohol, CNS depressants or tricyclic antidepressants should be avoided.

Stugeron should be avoided in patients with porphyria.

Stugeron should be used with caution in patients with hepatic or renal insufficiency.

Excipients: the drug contains lactose (175 mg of lactose monohydrate in 1 tablet), therefore patients with rare hereditary forms of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption syndrome should not use this drug.

Use during pregnancy or breastfeeding

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

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

Ability to influence reaction speed when driving vehicles or other mechanisms

Since the use of the drug, especially at the beginning of treatment, may cause drowsiness, you should refrain from driving or operating other mechanisms while taking the drug.

Method of administration and doses

Cerebral circulation disorders

Adults and children over 12 years of age: 1 tablet 3 times a day.

Adults and children over 12 years of age: 2-3 tablets 3 times a day. The maximum recommended dose should not exceed 225 mg (9 tablets) per day. Since the effect on dizziness is dose-dependent, the dosage should be increased gradually.

Disequilibrium

Adults and children over 12 years of age: 1 tablet 3 times a day.

Motion sickness

adults and children over 12 years of age: 1 tablet half an hour before travel; the dose can be repeated every 6 hours;

Children aged 5-12 years: half the dose prescribed for adults may be recommended.

Method of application

For oral use. It is preferable to take Stugeron after meals.

Children.

Stugeron should not be used in children under 5 years of age.

Overdose

Symptoms: In isolated cases of acute overdose (from 90 to 2250 mg), the following manifestations were observed: change in consciousness from drowsiness to stupor and coma, vomiting, extrapyramidal symptoms, arterial hypotension. In a small number of children, convulsions were observed. In most cases, the clinical outcome was not severe, but fatalities were noted 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.

Side effects

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. In very rare cases, Wilson's disease and lupus-like symptoms have been reported.

A single case of obstructive jaundice has been reported in the medical literature. In elderly patients, during long-term treatment, 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.

In addition to the above adverse reactions, the following adverse reactions have been observed with Stugeron in clinical trials and post-marketing experience. The frequency is defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); frequency unknown (cannot be estimated from the available data).

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

Expiration date

5 years.

Storage conditions

Store at a temperature not exceeding 30 °C.

Keep out of reach of children.

Packaging

25 tablets in a blister, 2 blisters in a cardboard box.

Vacation category

According to the recipe.

Producer

Gedeon Richter OJSC, Hungary.

Manufactured under license from JANSSEN PHARMACEUTICA, Belgium.

Address

H-1103, Budapest, Demrei Street 19-21, Hungary.

Applicant

Gedeon Richter OJSC, Hungary.