SEA LEGS 12.5 Milligram Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
14-03-2015
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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:
Piperazine derivatives
Authorization status:
Authorised
Authorization date:
2015-02-27
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 27/02/2015_
_CRN 2158609_
_page number: 1_
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
None stated.
4.6 FERTILITY, PREGNANCY AND LACTATION
Contraindicated in pregnancy.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
May cause drowsiness, if affected do not drive or operate machinery.
4.8 UNDESIRABLE EFFECTS
None known.
4.9 OVERDOSE
No specific statement.
5 PHARM
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