CINNARIZINE

Cinnarizine is for oral administration to both adults and children according to the following dosage regime.

Posology Vestibular symptoms:

Adults, elderly and children over 12 years: Two tablets three times a day.

Children 5-12 years:

One tablet three times a day. The stated doses should not be exceeded.

Motion sickness:

Adults, elderly and children over 12 years: Two tablets two hours before travel and one tablet every eight hours during journey if necessary.

Children 5-12 years:

One tablet two hours before travel and half a tablet every eight hours during journey if necessary. Method of administration For oral use. Cinnarizine should preferably be taken after meals. The tablets may be sucked, chewed or swallowed whole with water.

The safety of cinnarizine was evaluated in 303 cinnarizine-treated subjects who participated in 6 placebo-controlled trials for the indications peripheral circulatory disorders, cerebral circulatory disorders, vertigo and control of motion sickness ; and in 937 cinnarizine-treated subjects who participated in six comparator and 13 open label clinical trials for the indications peripheral circulatory disorders, cerebral circulatory disorders and vertigo.

5). Including the above mentioned ADRs, the following ADRs have been observed from clinical trials and post-marketing experiences reported with the use of cinnarizine.

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) and 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) Rare (≥ 1/10,000 to <1/1,000) Not known Nervous system disorders Somnolence Hypersomnia Dyskinesia, extrapyramidal disorder,, Parkinsonism, Tremor Gastrointestinal disorders Nausea, Vomiting Upper abdominal pain, Dyspepsia Hepatobiliary disorders Cholestatic jaundice Skin and subcutaneous tissue disorders Hyperhidrolysis, Lichenoid keratosis including lichen planus Subacute cutaneous lupus erythematosus Musculoskeletal and connective tissue disorders Muscle rigidity General disorders and administrative site conditions Fatigue Investigations Weight increased Cases of hypersensitivity, headache and dry mouth have also been reported.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA yellow card in the Google Play or Apple App Store.

As with other antihistamines, cinnarizine may cause epigastric discomfort; taking it after meals may diminish gastric irritation. Cinnarizine should only be given to patients with Parkinson's disease if the advantages outweigh the possible risk of aggravating this disease.

Because of its antihistamine effect, cinnarizine 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.

Cinnarizine should be used with care in patients with hepatic or renal insufficiency. Cinnarizine Tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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