NAME OF THE MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION
25 mg cinnarizine per tablet.
For excipients, see List of
• 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.
• 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.
STUGERON is contraindicated in patients with known hypersensitivity to the
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
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
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.
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
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
Abdominal pain upper
Skin and Subcutaneous
General Disorders and
Administration Site Conditions