CINNARON Tablet Ref.[28181] Active ingredients: Cinnarizine

Cinnaron has not been found to reduce blood pressure significantly. However, the drug should be used with reasonable caution in hypotensive patients.

As with other antihistamines, Cinnaron may cause epigastric distress; taking it after meals may diminish gastric irritation.

In patients with Parkinson’s disease, Cinnaron should only be given if the advantages outweigh the possible risk of aggravating this disease.

Cinnaron may cause somnolence, especially at the start of the treatment. Therefore, caution should be taken when alcohol or CNS depressants or tricyclic antidepressants are used concomitantly (see section 4.5).

Use of Cinnaron should be avoided in porphyria.

There have been no specific studies in hepatic or renal dysfunction. Cinnaron should be used with care in patients with hepatic or renal insufficiency.

Diagnostic interference:
Because of its antihistamine effect, Cinnaron may prevent an otherwise positive reaction to dermal reactivity indicators if used within 4 days prior to testing.

This product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Alcohol/CNS depressants/Tricyclic Antidepressants

Concurrent use of may potentiate the sedative effects of either these drugs or of Cinnaron.

Diagnostic Interference

Because of its antihistamine effect, Cinnaron may prevent an otherwise positive reaction to dermal reactivity indicators if used within 4 days prior to skin testing.

Pregnancy

Although in animal studies cinnarizine has shown no teratogenic effects, as with all drugs, Cinnaron should be used during pregnancy only if the therapeutic benefits justify the potential risks for the fetus.

Breast-feeding

There are no data on the excretion of cinnarizine in human breast milk. Nursing should therefore be discouraged in women using Cinnaron.

Since somnolence may occur, especially at the start of treatment, caution should be taken during activities such as driving or operating machinery.

The safety of cinnarizine was evaluated in 372 cinnarizine-treated subjects who participated in 7 placebo-controlled trials for the indications peripheral circulatory disorders, cerebral circulatory disorders, vertigo and seasickness; and in 668 cinnarizine-treated subjects who participated in six comparator and thirteen open label clinical trials for the indications peripheral circulatory disorders, cerebral circulatory disorders and vertigo. Based on pooled safety data from these clinical trials, the most commonly reported (>2% incidence) Adverse Drug Reactions (ADRs) were: Somnolence (8.3) and Weight increased (2.1).

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), not known (cannot be estimated from the available data).

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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.

Cyprus, Pharmaceutical Services, Ministry of Health, CY-1475 Nicosia, Fax: +357 22608649, Website: www.moh.gov.cy/phs.

None known.