SEA LEGS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MECLOZINE HYDROCHLORIDE

Available from:

GR Lane Health Products Ltd

ATC code:

R06AE05

INN (International Name):

MECLOZINE HYDROCHLORIDE

Dosage:

12.5 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product not subject to medical prescription

Therapeutic area:

meclozine

Authorization status:

Not Marketed

Authorization date:

2000-07-21

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sea-Legs Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 12.50mg Meclozine Hydrochloride.
Also contains 132.6 mg lactose monohydrate.
_For a full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Tablet.
White, round biconvex tablet with a scoreline on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The prevention and treatment of motion sickness.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral
Adults and Children over 12 years
Two tablets (25mg) per 24 hours.
The tablets may be taken one hour prior to commencement of journey or,
as Sea-
Legs can remain active for 24 hours after one dose, the previous
night.
Children 6-12 years of age
One tablet (12.5mg) per 24 hours.
Children 2-6 years of age
Half of one tablet (6.25mg) per 24 hours.
4.3 CONTRAINDICATIONS
Contraindicated in pregnancy.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
May cause drowsiness, if affected do not drive or operate machinery.
Avoid alcoholic drink.
Sea legs tablets contain Lactose and therefore should not
be taken by patients with rare hereditary problems of
galactose intolerance, the Lapp lactase deficiency or
glucose-galactose malabsorption.
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4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS