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McNeil Healthcare (Ireland) Ltd

Airton Road, Tallaght, Dublin 24, Ireland
Telephone: +353 1 466 5200
Fax: +353 1 466 5316


Summary of Product Characteristics last updated on medicines.ie: 14/12/2017
SPC Stugeron 15mg Tablets


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1. NAME OF THE MEDICINAL PRODUCT

Stugeron 15 mg Tablets


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains cinnarizine 15 mg.

Excipients: each tablet contains 160mg lactose monohydrate and 15mg sucrose.

For a full list of excipients, see section 6.1.


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3. PHARMACEUTICAL FORM

Tablet

A biconvex, circular, white tablet engraved “S|15” on one side and “Janssen” on the other.


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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the prevention and control of motion sickness.


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4.2 Posology and method of administration

For oral use.

Adults:

2 tablets 2 hours before travelling, then 1 tablet every 8 hours during the journey.

Children 5 - 12 years:

Half the adult dose.


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4.3 Contraindications

Stugeron tablets are contra-indicated in patients with known hypersensitivity to the drug.


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4.4 Special warnings and precautions for use

As with other antihistamines, Stugeron may cause epigastric upset, which may be diminished if taken after meals.

Cinnarizine is a vasodilator. While it has not been found to reduce blood pressure significantly, it should be used with caution in those with coronary artery disease or in patients with hypotension.

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

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

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.

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 galactose intolerance, fructose intolerance, LAPP lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Avoid alcoholic drink.

Warning: Do not exceed the stated dose.


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4.5 Interaction with other medicinal products and other forms of interaction

Stugeron may potentiate the sedative effect of CNS depressants, tricyclic antidepressants and alcohol, especially at the start of treatment. Alcoholic drink should be avoided.

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.


4.6 Fertility, pregnancy and lactation

Stugeron tablets should not be taken during pregnancy unless considered essential by the physician. It is not known whether cinnarizine is excreted in breast milk. Use of Stugeron is not recommended in nursing mothers.


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4.7 Effects on ability to drive and use machines

This product may cause drowsiness. If affected, do not drive or operate machinery.


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4.8 Undesirable effects

The safety of Stugeron was evaluated in 372 cinnarizine-treated subjects who participated in 7 placebo-controlled, double-blind clinical trials for the indications peripheral circulatory disorders, cerebral circulatory disorders, vertigo and seasickness; and in 668 cinnarizine treated subjects who participated in 6 comparator and 13-open label clinical trials for the indications of 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 ADR, 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).

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

Hypersomnia; Lethargy

Dyskinesia; Extrapyramidal Disorder; Parkinsonism; Tremor

Gastrointestinal disorders

Nausea

Stomach Discomfort; Vomiting; Abdominal Pain Upper; Dyspepsia

Skin and subcutaneous tissue disorders

Hyperhidrosis; Lichenoid Keratosis

Lichen Planus; Subacute Cutaneous Lupus Erythematosus

Musculoskeletal and Connective Tissue Disorders

Muscle rigidity

General Disorders and Administration Site Conditions

Fatigue

Investigations

Weight Increased

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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.


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4.9 Overdose

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. Activated charcoal may be given if considered appropriate.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

ATC Code N07CA02

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.


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5.2 Pharmacokinetic properties

In animals, cinnarizine is extensively metabolised, N-dealkylation being the major pathway. Approximately 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.

Absorption

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

Distribution

The plasma protein binding of cinnarizine is 91%.

Metabolism

Cinnarizine is extensively metabolised mainly via CYP2D6, but there is considerable interindividual variation in the extent of metabolism.

Elimination

The reported elimination half-life for cinnarizine ranges from 4 to 24 hours.

The elimination of metabolites occurs as follows: one third in the urine drug is excreted in the urine (unchanged as metabolites and glucuronide conjugates) and two thirds in the faeces.


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5.3 Preclinical safety data

Nonclinical safety studies showed that effects were observed only after chronic exposures from approximately 7 to 35 times the recommended maximum daily human dose of 90 mg/day calculated on a body surface area basis. Cinnarizine blocked the cardiac hERG channel in vitro, however in isolated cardiac tissue and following intravenous application in guinea-pigs, no QTc prolongation or proarrhythmic effects were observed at substantially higher exposures than those expected clinically.

In reproductive studies in the rat, rabbit, and dog, there was no evidence of adverse effects on fertility and no teratogenicity. At high doses associated with maternal toxicity in the rat there was a decreased litter size, an increase in resorptions and a decrease in fetal birth weight.

In vitro mutagenicity studies indicated that the parent compound is not mutagenic however, after reacting with nitrite and forming the nitrosation product, a weak mutagenic activity was observed. Carcinogenicity studies have not been conducted however, no pre-neoplastic changes were evident during chronic 18-month oral administration in rats up to approximately 35 times the maximum human dose level.


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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipient(s)

Lactose monohydrate

Maize starch

Sucrose

Talc

Magnesium stearate

Povidone K90


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6.2 Incompatibilities

Not applicable.


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6.3 Shelf life

3 years.


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6.4 Special precautions for storage

Do not store above 25°C.


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6.5 Nature and contents of container

Blister packs of aluminium foil/PVC, containing 15 tablets.


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6.6 Special precautions for disposal and other handling

No special requirements.


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7. MARKETING AUTHORISATION HOLDER

McNeil Healthcare (Ireland) Ltd.

Airton Road

Tallaght

Dublin 24

Ireland


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8. MARKETING AUTHORISATION NUMBER(S)

PA 823/55/1


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

19 April 1993 / 19 April 2008


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10. DATE OF REVISION OF THE TEXT

06 December 2017



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Active Ingredients

 
   Cinnarizine