Stugeron^™ 15 mg.

Each tablet contains 15 mg cinnarizine.

White circular tablet with S/15 on one side and Janssen on the other side.

Stugeron is for the control of vestibular disorders such as vertigo, tinnitus, nausea and vomiting such as is seen in Meniere's Disease.

Stugeron is also effective in the control of motion sickness.

Route of administration

Oral. The tablets may be chewed, sucked or swallowed whole.

Dosage

Stugeron should preferably be taken after meals.

Vestibular symptoms

Adults, elderly and children over 12 years: 2 tablets three times a day.

Children 5 to 12 years: One half the adult dose.

These doses should not be exceeded.

Motion sickness

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.

Stugeron should not be given to patients with known hypersensitivity to cinnarizine.

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

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.

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.

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.

For all indications: Drowsiness and gastro-intestinal disturbances may occur. These are usually transient.

In rare cases, headache, dry mouth, perspiration or allergic reactions may occur.

For long term treatment, i.e. vestibular symptoms: Rare cases of weight gain and very rare cases of lichen planus, lupus-like skin reactions and cholestatic jaundice have been reported. Rare cases of aggravation or appearance of extrapyramidal symptoms (sometimes associated with depressive feelings) have been described, predominantly in elderly people during prolonged therapy. The treatment should be discontinued in such cases.

Symptoms

The signs and symptoms are mainly due to the anticholinergic (atropine-like) activity of cinnarizine.

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 provided that the airway is protected. However, the benefit of gastric lavage is uncertain.

Activated charcoal should only be considered in patients presenting within one hour of taking a potentially toxic overdose (ie more than 15mg/kg).

Cinnarizine has been shown to be a non-competitive antagonist of the smooth muscle contractions caused by various vasoactive agents including histamine.

Cinnarizine also acts on vascular smooth muscle by selectively inhibiting the calcium influx into depolarised cells, thereby reducing the availability of free Ca²⁺ ions for the induction and maintenance of contraction.

Vestibular eye reflexes induced by caloric stimulation of the labyrinth in guinea pigs are markedly depressed by cinnarizine.

Cinnarizine has been shown to inhibit nystagmus.

In animals, cinnarizine is extensively metabolised, N-dealkylation being the major pathway. Approx. two thirds of the metabolites are excreted with the faeces, the rest in the urine, mainly during the first five days after a single dose.

In man, after oral administration, absorption is relatively slow, peak serum concentrations occurring after 2.5 to 4 hours.

Cinnarizine undergoes extensive metabolism but there is considerable interindividual variation in the extent of metabolism. The drug is excreted in the urine unchanged as metabolites and glucuronide conjugates. The terminal elimination half life is about 3 hours.

No relevant information additional to that contained elsewhere in the Summary of Product Characteristics.

Lactose monohydrate

Maize starch

Sucrose

Talc

Magnesium stearate

0025Polyvidone K90

None known.

5 years

None.

PVC/Aluminium foil blisters

or

Polystyrene tubs with polyethylene caps

Each pack containing 15, 25, 100, 250 or 1000 tablets.

The tablets may be chewed, sucked or swallowed whole.

Janssen-Cilag Limited

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

UK

PL 0242/5009R

Date of First Authorisation: 14/09/89

Renewal of Authorisation: 23/03/95

28 April 2009