McNeil Healthcare (Ireland) Ltd

Stugeron 25mg Tablets

Each tablet contains 25mg cinnarizine.

For excipients, see section 6.1.

Tablet.

White tablets marked 'JANSSEN' on one side and 'S/25' on the other.

Stugeron is indicated in peripheral vascular disease when such symptoms as intermittent claudication and cold extremities exist and in vasospastic disorders.

Stugeron Tablets are for oral administration to adults.

Peripheral Vascular Disease:

The usual dose is 50 to 75 mg (2-3 tablets) two to three times daily.

Stugeron should preferably be taken after meals. These doses should not be exceeded.

Peripheral arterial disease is slow to improve with any form of drug treatment. Maximum benefits with Stugeron will not be seen until after several weeks of continuous treatment although significant improvement in blood flow has frequently been demonstrated after 1 week.

Stugeron Tablets are contra-indicated in patients with known hypersensitivity to cinnarizine.

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

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

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.

Concurrent use of alcohol, CNS depressants or tricyclic antidepressants may potentiate the sedative effects of either these drugs or of Stugeron.

Use in Pregnancy: 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.

Use in lactation: There are no data on the excretion of Stugeron in human breast milk; use of Stugeron is not recommended in nursing mothers.

Stugeron may cause drowsiness, especially at the start of treatment; patients affected in this way should not drive or operate machinery.

The safety of Stugeron 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 Stugeron. 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).

Symptoms

Acute cinnarizine overdoses have been reported with doses ranging from 90 to 2,250 mg. The most commonly reported signs and symptoms associated with overdose of cinnarizine include: alterations in consciousness ranging from somnolence to stupor and coma, vomiting, extrapyramidal symptoms, and hypotonia. In a small number of young children, seizures developed. Clinical consequences were not severe in most cases, but deaths have been reported after single and polydrug overdoses involving cinnarizine.

Treatment

There is no specific antidote. For any overdose, the treatment is symptomatic and supportive care. Within the first hour after ingestion, gastric lavage may be performed. Activated charcoal may be given if considered appropriate.

ATC Code N07CA02

Cinnarizine's action in the treatment of peripheral vascular disease is due to its anti-vasoconstrictor properties, its action on blood hyperviscosity and its anti-ischaemic effect. Anti-vasoconstriction is thought to be through a calcium blocker mechanism and is evident selectively in vascular smooth muscle. Increased peripheral muscle blood flow may be mediated by prevention of calcium entry into ischaemic erythrocytes, thereby preserving flexibility.

Absorption

The peak plasma levels of cinnarizine are obtained 1 to 3 hours after intake.

Distribution

The plasma protein binding of cinnarizine is 91%.

Metabolism

Cinnarizine is extensively metabolised mainly via CYP2D6 in the liver.

Distribution

The reported elimination half-life for cinnarizine ranges from 4 to 24 hours. The elimination of metabolites occurs as follows: about one third in the urine and two thirds in the faeces. Plasma elimination half life is 3 to 4 hours.

Nonclinical safety studies showed that effects were observed only after chronic exposures from approximately 5 to 72 times, on a mg/kg basis when compared to the maximum recommended human dose of 225 mg/day, calculated as 4.5 mg/kg as based on a 50 kg person.

Lactose

Maize starch

Sucrose

Talc

Cottonseed oil - hydrogenated

Polyvidone K90

Not applicable.

Five years.

Do not store above 30°C.

Blister packs of aluminium foil/PVC containing 50 tablets.

No special requirements.

McNeil Healthcare (Ireland) Ltd.

Airton Road

Tallaght

Dublin 24

Ireland

PA 823/55/2

1st April 1979/15th October 2005

February 2010