We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we'll assume that you are happy to receive all cookies on the medicines.ie website. Find out more

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: 21/01/2014
SPC Stugeron 25 mg



Go to top of the page
1. NAME OF THE MEDICINAL PRODUCT

Stugeron 25mg Tablets


Go to top of the page
2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 25mg cinnarizine.

Excipients: Contains Lactose monohydrate 158.8mg and Sucrose 15.0mg

For a full list of excipients, see section 6.1.


Go to top of the page
3. PHARMACEUTICAL FORM

Tablet.

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


Go to top of the page
4. CLINICAL PARTICULARS

Go to top of the page
4.1 Therapeutic indications

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


Go to top of the page
4.2 Posology and method of administration

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.

Use in elderly:

as above

Use in children:

not recommended


Go to top of the page
4.3 Contraindications

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


Go to top of the page
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.

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.

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 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.


Go to top of the page
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 these drugs or of Stugeron.

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.


Go to top of the page
4.6 Pregnancy and lactation

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.


Go to top of the page
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.


Go to top of the page
4.8 Undesirable effects

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).

System Organ Class

Adverse Drug Reactions

Frequency Category

Common

(≥ 1/100 to < 1/10)

Uncommon

(≥ 1/1000 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

 

Hyperhydrosis; Lichenoid keratosis

Lichens planus; Subacute cutaneous lupus erythematosus

Musculoskeletal and connective Tissue Disorders

  

Muscle rigidity

General Disorders and Administration Site Conditions

 

Fatigue

 

Investigations

Weight increased

  


Go to top of the page
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.


Go to top of the page
5. PHARMACOLOGICAL PROPERTIES

Go to top of the page
5.1 Pharmacodynamic properties

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.


Go to top of the page
5.2 Pharmacokinetic properties

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.


Go to top of the page
5.3 Preclinical safety data

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.


Go to top of the page
6. PHARMACEUTICAL PARTICULARS

Go to top of the page
6.1 List of excipient(s)

Lactose Monhydrate

Maize starch

Sucrose

Talc

Cottonseed oil - hydrogenated

Povidone K90


Go to top of the page
6.2 Incompatibilities

Not applicable.


Go to top of the page
6.3 Shelf life

Three years.


Go to top of the page
6.4 Special precautions for storage

Do not store above 30°C.


Go to top of the page
6.5 Nature and contents of container

Blister packs of aluminium foil/PVC containing 50 tablets.


Go to top of the page
6.6 Special precautions for disposal and other handling

No special requirements.


Go to top of the page
7. MARKETING AUTHORISATION HOLDER

McNeil Healthcare (Ireland) Ltd.

Airton Road

Tallaght

Dublin 24

Ireland


Go to top of the page
8. MARKETING AUTHORISATION NUMBER(S)

PA 823/55/2


Go to top of the page
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

1st April 1979/15th October 2005


Go to top of the page
10. DATE OF REVISION OF THE TEXT

January 2014



Link to this document from your website:
http://www.medicines.ie/medicine/2141/SPC/Stugeron+25+mg/

Document Links

 
  Link to this page
  View all medicines
from this company
Print this page
View document history
Bookmark and Share

Active Ingredients

 
   Cinnarizine