Therapeutic indications
Stugeron is for the control of vestibular disorders such as vertigo, tinnitus, nausea and vomiting such as is seen in Meniere's Disease.
Stugeron is also effective in the control of motion sickness.
Posology and method of administration
Route of administration
Oral. The tablets may be chewed, sucked or swallowed whole.
Dosage
Stugeron should preferably be taken after meals.
Vestibular symptoms
Adults, elderly and children over 12 years: 2 tablets three times a day.
Children 5 to 12 years: One half the adult dose.
These doses should not be exceeded.
Motion sickness
Adults, elderly and children over 12 years: 2 tablets 2 hours before you travel and 1 tablet every 8 hours during your journey.
Children 5 to 12 years: One half the adult dose.
Contraindications
Stugeron should not be given to patients with known hypersensitivity to cinnarizine
Special warnings and precautions for use
As with other antihistamines, Stugeron may cause epigastric discomfort; taking it after meals may diminish the gastric irritation.
In patients with Parkinson's Disease, Stugeron should only be given if the advantages outweigh the possible risk of aggravating this disease.
Because of its antihistamine effect, Stugeron may prevent an otherwise positive reaction to dermal reactivity indicators if used within 4 days prior to testing.
Use of cinnarizine should be avoided in porphyria.
There have been no specific studies in hepatic or renal dysfunction. Stugeron should be used with care in patients with hepatic or renal insufficiency.
Patients with rare hereditary problems of fructose or galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency, should not take this medicine because it contains lactose and sucrose.
Interaction with other medicinal products and other forms of interaction
Concurrent use of alcohol, CNS depressants or tricyclic antidepressants may potentiate the sedative effects of either these drugs or of Stugeron
Pregnancy and lactation
The safety of Stugeron in human pregnancy has not been established although studies in animals have not demonstrated teratogenic effects. As with other drugs it is not advisable to administer Stugeron in pregnancy.
There are no data on the excretion of Stugeron in human breast milk. Use of Stugeron is not recommended in nursing mothers.
Effects on ability to drive and use machines
Stugeron may cause drowsiness, especially at the start of treatment; patients affected in this way should not drive or operate machinery.
Undesirable effects
For all indications: Drowsiness and gastro-intestinal disturbances may occur. These are usually transient.
In rare cases, headache, dry mouth, perspiration or allergic reactions may occur.
For long term treatment, i.e. vestibular symptoms: Rare cases of weight gain and very rare cases of lichen planus, lupus-like skin reactions and cholestatic jaundice have been reported. Rare cases of aggravation or appearance of extrapyramidal symptoms (sometimes associated with depressive feelings) have been described, predominantly in elderly people during prolonged therapy. The treatment should be discontinued in such cases.
