4.1. Therapeutic indications

Stugeron is effective in the control of motion sickness.

4.2. Posology and method of administration

Posology

Stugeron should preferably be taken after meals.

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.

Method of administration: Oral

4.3. Contraindications

Stugeron should not be given to patients with known hypersensitivity to cinnarizine or to any of the excipients listed in section 6.1

4.4. Special warnings and precautions for use

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

In patients with Parkinson's disease, Stugeron should only be given 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. Stugeron should be used with care in patients with hepatic or renal insufficiency.

Patients with rare hereditary problems of fructose or galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase- isomaltase insufficiency, should not take this medicine because it contains lactose and sucrose.

Stugeron may cause somnolence, especially at the start of treatment. Therefore caution should be taken when alcohol, central nervous system (CNS) depressants or tricyclic antidepressants are used concomitantly. Please also refer to section 4.5 Interactions with Other Medicinal Products and Other Forms of Interaction.

Diagnostic Interference

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

4.5. Interaction with other medicinal products and other forms of interaction

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

Diagnostic interference

Because of its antihistamine effect, Stugeron may prevent otherwise positive reactions to dermal reactivity indicators if used up to 4 days prior to skin testing. Also refer to section 4.4 Special Warnings and Precautions for Use.

4.6. Fertility, pregnancy and lactation

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.

Lactation

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

4.7. Effects on ability to drive and use machines

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

4.8. Undesirable effects

The safety of Stugeron (30-225mg/day) was evaluated in 601 subjects (of which 303 were treated with Stugeron, 298 were given placebo) who participated in 6 placebo-controlled, double-blind clinical trials; 2 in the treatment of peripheral circulatory disorders, 1 in the treatment of cerebral circulatory disorders, 1 in the treatment of vertigo, 1 in the prevention of motion sickness, and 1 in the treatment of both vertigo and cerebral circulatory disorders.

Six comparator trials and 13 open-label clinical trials were selected to determine the incidence of adverse reactions. In 19 studies, 937 subjects were treated with doses ranging from 25 to 450 mg/day Stugeron, in the treatment of peripheral circulatory disorders, cerebral circulatory disorders and vertigo.

Based on pooled safety data from these clinical trials, the most commonly reported (>1% incidence) Adverse Drug Reactions (ADRs) were: Somnolence (9.9%) and Weight Increased (1.5%).

Including the above-mentioned ADR, the following ADRs have been observed from clinical trials and post-marketing experiences reported with the use of Stugeron 15mg Tablets. 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).

System Organ Class

Adverse Drug Reactions

Frequency Category

Common

(≥ 1/100 to < 1/10)

Uncommon

(≥ 1/1,000 to < 1/100)

Not Known

Nervous System Disorders

Somnolence

Dyskinesia; Extrapyramidal Disorder; Parkinsonism; Tremor

Gastrointestinal disorders

Nausea; Dyspepsia

Vomiting; Abdominal Pain Upper

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

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 2,250mg. 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.

Management

There is no specific antidote. For any overdose, the treatment is symptomatic and supportive care. It is advisable to contact a poison control centre to obtain the latest recommendation for the management of an overdose.