STUGERON

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT STUGERON (STUGERON)

Composition:

Active substance: cinnarizine. Each tablet contains 25 mg of cinnarizine.

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

Pharmaceutical form. Tablets.

Main physicochemical properties: white or almost white flat disc-shaped tablets with bevelled edges, practically odorless, marked with the engraving "STUGERON" on one side and a score line on the other.

Pharmacotherapeutic group. Agents used in vestibular disorders. Cinnarizine. ATC code N07CA02.

Pharmacological properties.

Cinnarizine inhibits contractions of vascular smooth muscle cells by blocking calcium channels. In addition to direct calcium antagonism, cinnarizine reduces the contractile effects of vasoactive substances such as noradrenaline and serotonin by blocking receptor-operated calcium channels. The blockade of calcium influx into cells is tissue-selective and leads to a reduction in vasoconstriction without affecting arterial pressure and heart rate.

Cinnarizine may additionally improve impaired microcirculation by increasing erythrocyte membrane elasticity and reducing blood viscosity. When cinnarizine is administered, cellular resistance to hypoxia increases.

Cinnarizine suppresses stimulation of the vestibular system, resulting in suppression of nystagmus and other vegetative disturbances. Cinnarizine prevents the occurrence of or alleviates acute attacks of vertigo.

Pharmacokinetics.

Absorption. Maximum plasma concentrations of cinnarizine are reached within 1–3 hours after oral administration.

Distribution. Plasma protein binding is 91%.

Metabolism. Cinnarizine is metabolized primarily via CYP2D6.

Elimination. The elimination half-life from plasma ranges from 4 to 24 hours. Approximately ⅓ of metabolites are excreted in urine and ⅔ in feces.

Clinical characteristics.

Indications.

Cerebral circulation disorders:

• symptomatic treatment of cerebrovascular disorders, including dizziness, tinnitus, vascular headache, irritability, memory loss, and inability to concentrate;
• migraine prophylaxis.

Peripheral circulation disorders:

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

Balance disorders:

• symptomatic treatment of labyrinthine disorders, including vertigo, tinnitus, nystagmus, nausea, and vomiting.

Motion sickness:

• prevention of motion sickness.

Contraindications.

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

Interaction with other medicinal products and other forms of interaction.

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

Diagnostic procedures: due to the antihistaminic properties of Stugeron, it may mask positive skin reactivity responses during skin testing; therefore, its use should be discontinued at least 4 days prior to such testing.

Special precautions for use

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

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

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

Stugeron should not be used in patients with porphyria.

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

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

Use during pregnancy or breast-feeding

Although teratogenic effects were not observed in animal studies with Stugeron, the drug is not recommended for use during pregnancy.

There is no information available on the ability of Stugeron to pass into breast milk. Therefore, treatment with Stugeron should be avoided in nursing women.

Ability to influence the speed of reactions while driving or operating machinery

Since the use of the drug, particularly at the beginning of treatment, may cause drowsiness, patients should refrain from driving or operating machinery during treatment.

Dosage and Administration

Cerebral circulation disorders

Adults and children aged 12 years and older: 1 tablet three times daily.

Peripheral circulation disorders

Adults and children aged 12 years and older: 2–3 tablets three times daily. The recommended maximum dose should not exceed 225 mg (9 tablets) per day. Since the effect in vertigo is dose-dependent, dosage should be gradually increased.

Balance disorders

Adults and children aged 12 years and older: 1 tablet three times daily.

Motion sickness

• Adults and children aged 12 years and older: 1 tablet taken half an hour before travel; the dose may be repeated every 6 hours;
• Children aged 5–12 years: half the adult dose may be recommended.

Administration method

For oral use. Stugeron should preferably be taken after meals.

Children

Stugeron must 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 symptoms were observed: altered consciousness ranging from drowsiness to stupor and coma, vomiting, extrapyramidal symptoms, and arterial hypotension. Seizures were observed in a small number of children. In most cases, the clinical outcome was not severe, but fatal cases have been reported following overdose when used concomitantly with other medicinal products, 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.

Somnolence and gastrointestinal disturbances may occur. These symptoms are usually temporary and disappear with gradual attainment of the optimal dose. Rarely, symptoms such as headache, dry mouth, weight gain, sweating, or allergic reactions may occur. In very rare cases, Wilson's syndrome 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 emergence of extrapyramidal symptoms, sometimes associated with depressive states, have been observed. In such cases, the use of this medicinal product should be discontinued.

Considering the above-mentioned adverse reactions, the following adverse reactions have been observed during clinical studies and in the post-marketing period with the use of the medicinal product Stugeron. 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); very rare (<1/10000); frequency not known (cannot be estimated from the available data).

Additional cases of hypersensitivity reactions, headache, and dry mouth sensation have also been reported.

Shelf life.

5 years.

Storage conditions.

Store at a temperature not exceeding 30 °C.

Keep out of reach of children.

Packaging.

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

Prescription status.

Prescription only.

Manufacturer.

Gedeon Richter Plc., Hungary.

Manufactured under license from JANSSEN PHARMACEUTICA, Belgium.

Manufacturer's address.

H-1103 Budapest, Demreai ut 19-21, Hungary.

Marketing authorization holder.

Gedeon Richter Plc., Hungary.

Address of the marketing authorization holder.

H-1103 Budapest, Demreai ut 19-21, Hungary.