Cinnarizin Sopharma (Tablets) Instructions for Use

Marketing Authorization Holder

Sopharma, JSC (Bulgaria)

ATC Code

N07CA02 (Cinnarizine)

Active Substance

Cinnarizine (Rec.INN registered by WHO)

Dosage Form

Cinnarizine Sopharma

Tablets 25 mg: 50 pcs.

Dosage Form, Packaging, and Composition

Tablets from white to almost white, round, biconvex.

Excipients: lactose monohydrate – 63.12 mg, wheat starch – 50.57 mg, microcrystalline cellulose (type 101) – 3.85 mg, povidone K25 – 5.66 mg, colloidal silicon dioxide – 0.77 mg, magnesium stearate – 1.03 mg.

50 pcs. – blisters (1) – cardboard packs.

Clinical-Pharmacological Group

Calcium channel blocker with a predominant effect on cerebral vessels

Pharmacotherapeutic Group

Other agents for the treatment of nervous system diseases; medications for the treatment of dizziness

Pharmacological Action

Cinnarizine improves cerebral and peripheral circulation by inhibiting the action of a number of endogenous vasoconstrictors and the flow of calcium ions into cells by blocking “slow” voltage-dependent calcium channels.

It has a vasodilating effect, especially on the cerebral vessels, without significantly affecting blood pressure.

It increases the elasticity of erythrocyte membranes, their ability to deform, reduces blood viscosity, and increases muscle resistance to hypoxia.

It exhibits moderate antihistamine activity, reduces the excitability of the vestibular apparatus, and lowers the tone of the sympathetic nervous system.

Pharmacokinetics

It is absorbed relatively slowly from the gastrointestinal tract.

C_max in blood plasma is reached 1-3 hours after oral administration.

It is 80% bound to plasma proteins and 13% to erythrocytes.

Distribution in tissues is more intensive within 4 hours after administration.

It is completely metabolized in the liver, mainly by N-dealkylation.

T_1/2 is 3-6 hours, excreted as metabolites: 1/3 – by the kidneys and 2/3 – with feces.

Indications

Adults and children over 12 years

• Prevention and treatment of peripheral circulation disorders (obliterating endarteritis, obliterating thromboangiitis, Raynaud’s disease, diabetic angiopathy, thrombophlebitis, trophic disorders (trophic and varicose ulcers), paresthesia, night cramps and cold extremities);
• Prevention of motion sickness (“travel sickness” – seasickness and airsickness);
• Symptomatic treatment of labyrinthine and vestibular disorders of vascular origin, Meniere’s disease.

ICD codes

Dosage Regimen

Adults and children over 12 years

Orally, with plenty of fluid, after meals.

For peripheral circulation disorders – 50-75 mg (2-3 tablets) 3 times/day.

In case of high sensitivity to the drug, treatment begins with 1/2 dose, gradually increasing it. To achieve the optimal therapeutic effect, the drug should be taken continuously, for a long time – from several weeks to several months.

For vestibular disorders – 25 mg 3 times/day.

For motion sickness – 25 mg 30 minutes before the upcoming journey (if necessary, a repeated dose of 25 mg after 6-8 hours).

For labyrinthine disorders – 25 mg 3 times/day. The maximum daily dose should not exceed 225 mg.

Adverse Reactions

The most frequently encountered adverse reactions are drowsiness, gastrointestinal discomfort, which in most cases are transient and disappear when the dose is reduced.

Other less frequently encountered adverse reactions

From the cardiovascular system: decreased blood pressure.

From the nervous system: headache, increased fatigue; in patients taking Cinnarizine in high doses for a long time, extrapyramidal symptoms may appear (limb tremor and increased muscle tone, hypokinesia, disorientation, balance disorder), including Parkinson’s syndrome, depression.

From the digestive system: dry mouth, pain in the epigastric region, dyspepsia; extremely rarely – cholestatic jaundice.

From the skin: increased sweating; in extremely rare cases – lichen planus and lupus-like reactions.

Allergic reactions: skin rash.

Other: increased body weight.

Contraindications

• Pregnancy;
• Lactation period;
• Children under 12 years of age;
• Lactase deficiency, galactosemia or glucose-galactose malabsorption syndrome;
• Celiac disease (gluten enteropathy);
• Hypersensitivity to the components of the drug.

With caution: Parkinson’s disease.

Use in Pregnancy and Lactation

Due to the lack of well-controlled clinical studies regarding the safety of use in pregnant women, the use of cinnarizine during pregnancy is not recommended.

Due to the lack of data regarding excretion into breast milk, the use of cinnarizine during breastfeeding is undesirable. If it is necessary to use the drug, breastfeeding should be discontinued.

Pediatric Use

Contraindicated in children under 12 years of age.

Geriatric Use

Patients over 65 years of age with a family history or clinical symptoms of extrapyramidal disorders should be under constant medical supervision.

Special Precautions

Cinnarizine may cause gastric discomfort. Taking the tablets after meals reduces irritation of the gastric mucosa.

Cinnarizine should be prescribed to patients suffering from Parkinson’s disease only if its benefits outweigh the possible risk of worsening the condition.

Patients over 65 years of age with a family history or clinical symptoms of extrapyramidal disorders should be under constant medical supervision.

In persons prone to decreased blood pressure (hypotension), blood pressure values should be monitored during treatment.

Cinnarizine may cause a false positive reaction when conducting anti-doping tests in athletes.

With long-term use, it is recommended to conduct a control examination of liver function, kidney function, and peripheral blood picture.

Due to its antihistamine effects, Cinnarizine may lead to false negative results in skin tests for hypersensitivity. Treatment with cinnarizine should be discontinued 4 days before the tests.

Effect on the ability to drive vehicles and mechanisms

During the treatment period, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Symptoms: vomiting, drowsiness, decreased blood pressure, tremor, coma.

Treatment: in case of overdose – gastric lavage, activated charcoal. Symptomatic agents are used. There is no specific antidote.

Drug Interactions

It enhances the effect of ethanol (alcohol) and sedative medications.

When used concomitantly with nootropic, hypotensive, and vasodilating agents, it enhances their effect.

It reduces the effect of hypertensive medications.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.