STUGERON

Posology Stugeron should preferably be taken after meals. 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.

Method of administration:

Oral

The safety of Stugeron (30-225mg/day) was evaluated in 601 subjects (of which 303 were treated with Stugeron, 298 were given placebo) who participated in 6 placebo- controlled, double-blind clinical trials; 2 in the treatment of peripheral circulatory disorders, 1 in the treatment of cerebral circulatory disorders, 1 in the treatment of vertigo, 1 in the prevention of motion sickness, and 1 in the treatment of both vertigo and cerebral circulatory disorders.

Six comparator trials and 13 open-label clinical trials were selected to determine the incidence of adverse reactions. In 19 studies, 937 subjects were treated with doses ranging from 25 to 450 mg/day Stugeron, in the treatment of peripheral circulatory disorders, cerebral circulatory disorders and vertigo.

5%). Including the above-mentioned ADR, the following ADRs have been observed from clinical trials and post-marketing experiences reported with the use of Stugeron 15mg Tablets.

Frequencies displayed use the following convention:

Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). Adverse Drug Reactions Frequency Category System Organ Class Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Not Known Nervous System Disorders Somnolence Dyskinesia; Extrapyramidal Disorder; Parkinsonism; Tremor Gastrointestinal disorders Nausea; Dyspepsia Vomiting; Abdominal Pain Upper Hepatobiliary disorders Cholestatic Jaundice Skin and subcutaneous tissue disorders Hyperhidrosis; Lichenoid Keratosis including Lichen Planus Subacute Cutaneous Lupus Erythematosus Musculoskeletal and Connective Tissue Disorders Muscle rigidity General Disorders and Administration Site Conditions Fatigue Investigations Weight Increased Cases of hypersensitivity, headache and dry mouth have been reported.

As with other antihistamines, Stugeron may cause epigastric discomfort; 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.

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, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase- isomaltase insufficiency, should not take this medicine because it contains lactose and sucrose.

Stugeron may cause somnolence, especially at the start of treatment. Therefore caution should be taken when alcohol, central nervous system (CNS) depressants or tricyclic antidepressants are used concomitantly. Please also refer to section

1.