Summary of Product Characteristics (SmPC) - Sea-legs tablets
1 NAME OF THE MEDICINAL PRODUCT
Sea-Legs Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Meclozine Hydrochloride 12.5mg
3 PHARMACEUTICAL FORM
Tablets for oral administration
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the prevention and treatment of motion sickness. Sea-Legs are for oral administration
4.2 Posology and method of administration
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 one dose can be taken the previous night.
Children 6-12 years:
One tablet (12.5mg) per 24 hours
Children 2-6 years:
Half a tablet (6.25mg) per 24 hours
4.3 Contraindications
Pregnancy
4.4 Special warnings and precautions for use
Avoid alcoholic drink
4.5 Interaction with other medicinal products and other forms of interaction
None known.
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. Avoid alcoholic drink.
4.8 Undesirable effects
None known
4.9 Overdose
No specific statement
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Meclozine hydrochloride is a piperazine derivative with the properties of anti-histamines.
It is used for its anti-emetic action, which may last for up to 24 hours. Sedative effects are not marked.
It is used for the prevention and treatment of motion sickness.
5.2 Pharmacokinetic properties
In general, anti-histamines are readily absorbed from the gastro-intestinal tract, metabolised in the liver and excreted usually mainly as metabolites in the urine.
5.3 Preclinical safety data
None stated.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose
Maize starch
Sodium starch glycolate
Magnesium stearate
Povidone powder
Industrial methylated spirits
Purified water
6.2 Incompatibilities
None stated
6.3 Shelf life
36 months unopened
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
A cellulose/ aluminium foil/ polythene laminate carrying 12 or 28 tablets over-wrapped with a cardboard envelope or (a) purelay-pharm 100E white opaque (polypropylene) and (b) purelay-lid (polypropylene) or Pentapharm foil /laminate blister pack carrying 12 or 28 tablets over-wrapped with a cardboard envelope.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Risolv Health Limited
Clifton House
Bunnian Place
Basingstoke
RG21 7JE
8 MARKETING AUTHORISATION NUMBER(S)
PL 58255/0003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
16/02/1994 / 26/03/1999
10 DATE OF REVISION OF THE TEXT
12/09/2024