MYLAN TRAVEL SICKNESS

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

Posology Adults, elderly and children over 12 years:

Two tablets two hours before travel and one tablet every eight hours during journey if necessary.

Paediatric population (children 5 to 12 years):

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

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 ADR, 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), 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 Gastrointesti nal disorders Nausea, Vomiting, Upper abdominal pain Dyspepsia; 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.

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 the MHRA Yellow Card in the Google Plat 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.

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

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