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SPC, UK: Stugeron 15 mg (2011)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Janssen-Cilag Ltd
Διεύθυνση :
50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG
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Name of the medicinal product

Stugeron™ 15 mg.

Qualitative and quantitative composition

Each tablet contains 15 mg cinnarizine.

Pharmaceutical form

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

Therapeutic indications

Stugeron is for the control of vestibular disorders such as vertigo, tinnitus, nausea and vomiting such as is seen in Menieres Disease. Stugeron is also effective in the control of motion sickness.

Posology and method of administration

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: ...

Contraindications

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

Special warnings and precautions for use

As with other antihistamines, Stugeron may cause epigastric discomfort; taking it after meals may diminish the gastric irritation. In patients with Parkinsons Disease, Stugeron should only be given if ...

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.

Pregnancy and lactation

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 ...

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.

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, ...

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 2,250 mg. The ...

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 ...

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 ...

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 ...

List of excipients

Lactose monohydrate Maize starch Sucrose Talc Magnesium stearate Polyvidone K90

Incompatibilities

None known.

Shelf life

3 years.

Special precautions for storage

None.

Nature and contents of container

PVC/Aluminium foil blisters or Polystyrene tubs with polyethylene caps. Each pack containing 15, 25, 100, 250 or 1000 tablets.

Special precautions for disposal and other handling

The tablets may be chewed, sucked or swallowed whole.

Marketing authorization holder

Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG UK

Marketing authorization number(s)

PL 0242/5009R

Date of first authorization / renewal of the authorization

Date of First Authorisation: 14/09/89 Renewal of Authorisation: 23/03/95

Date of revision of the text

22 June 2011