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Stugeron

NAME OF THE MEDICINAL PRODUCT

STUGERON

QUALITATIVE AND QUANTITATIVE COMPOSITION

25 mg cinnarizine per tablet.

For excipients, see List of Excipients.

PHARMACEUTICAL FORM

Tablets.

CLINICAL PARTICULARS

Therapeutic Indications
• Maintenance therapy for symptoms of labyrinthine disorders, including vertigo, dizziness, tinnitus, nystagmus, nausea and vomiting.
• Prophylaxis of motion sickness.
• Prophylaxis of migraine.
• Maintenance therapy for symptoms of cerebrovascular origin, including dizziness, ear buzzing (tinnitus), vascular headache, unsociability and irritability disorders, loss of memory and lack of concentration.
• Maintenance therapy for symptoms of peripheral circulatory disorders, including Raynaud's phenomenon, acrocyanosis, intermittent claudication, trophic disturbances, trophic and varicose ulcers, paraesthesia, nocturnal cramps, cold extremities.

Posology and Method of Administration
Cerebral circulatory disorders: 1 tablet of 25 mg t.i.d.
Peripheral circulatory disorders: 2 - 3 tablets of 25 mg t.i.d.

Disorders of balance: 1 tablet of 25 mg t.i.d.
Motion sickness:
• in adults :1 tablet of 25 mg half an hour before travelling; to be repeated every 6 hours;
• in children : half of the adult dose is recommended.

STUGERON should preferably be taken after meals. The maximum recommended dosage should not exceed 225 mg daily. As the effect of STUGERON on vertigo is dose dependent, the dosage should be increased progressively.

Contraindications
STUGERON is contraindicated in patients with known hypersensitivity to the drug.

Special Warnings and Special Precautions for Use
As with other antihistamines STUGERON may cause epigastric distress; taking it after meals may diminish gastric irritation.

In patients with Parkinson's disease STUGERON should only be given if the advantages outweigh the possible risk of aggravating this disease.

STUGERON may cause somnolence, especially at the start of treatment. Therefore caution should be taken when alcohol or CNS depressants are used concomitantly.

Interactions with Other Medicinal Products and Other Forms of Interaction
Alcohol/CNS Depressants/Tricyclic Antidepressants: Concurrent use may potentiate the sedative effects of either of these medications or of STUGERON.

Diagnostic Interference: Because of its antihistamine effect, STUGERON may prevent otherwise positive reactions to dermal reactivity indicators if used up to 4 days prior to skin testing.

Pregnancy and Lactation
Use during Pregnancy
Although in animal studies, STUGERON has shown no teratogenic effects, as with all drugs, STUGERON should be used during pregnancy only if the therapeutic benefits justify the potential risks for the fetus.

Use during Lactation
There are no data on the excretion of STUGERON in human breast milk: nursing should therefore be discouraged in women using STUGERON.

Effects on Ability to Drive and Use Machines
Since somnolence may occur, especially at the start of treatment, caution should be taken during activities such as driving or operating machinery.

Undesirable Effects

Clinical Trial Data

Placebo-Controlled Double-Blind Data -Adverse Drug Reactions Reported at ≥ 1 % Incidence

The safety of STUGERON (30 to 225 mg/day) was evaluated in 740 subjects (of which 372 were treated with STUGERON, 368 were given placebo) who participated in 7 placebo-controlled, double-blind clinical trials: three in the treatment of peripheral circulatory disorders, one in the treatment of cerebral circulatory disorders, two in vertigo, and one in seasickness.

ADRs reported by ≥ 1 % of STUGERON-treated subjects noted in the double-blind clinical trials are shown in Table 1.

Table 1. Adverse Drug Reactions Reported by ≥ 1% of STUGERON-treated Subjects in 7 Double-Blind Placebo-Controlled Clinical Trials of STUGERON

Comparator and Open-Label Data - Adverse Drug Reactions Reported at ≥ 1 % Incidence

Six comparator trials and thirteen open label trials were selected to determine the incidence of ADRS. In these 19 studies, 668 subjects were treated with doses ranging from 50 to 225 mg/day STUGERON, in the treatment of peripheral circulatory disorders, cerebral circulatory disorders, and vertigo.

ADRs reported by ≥1 % of STUGERON-treated subjects noted in the comparator and open label clinical trials are shown in Table 2.

Table 2. Adverse Drug Reactions Reported by ≥1% of STUGERON-treated Subjects in 6 Comparator and 13 Open Clinical Trials of STUGERON

Placebo, Comparator, and Open-Label Data-Adverse Drug Reactions Reported at < 1% Incidence

Additional ADRs that occurred in < 1 % of STUGERON-treated subjects in the above 2 clinical datasets are listed below in Table 3.

Table 3. Adverse Drug Reactions Reported by < 1% of STUGERON-treated Subjects in Either the Placebo- or Comparator-controlled or Open Clinical Trials

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