Sea-Legs Tablets

1. Name Of The Medicinal Product

Sea-Legs Tablets

2. Qualitative And Quantitative Composition

Meclozine Hydrochloride BP 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 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 antihistamines. 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, antihistamines are readily absorbed from the gastrointestinal 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 known.

6.3 Shelf Life

36 months.

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 overwrapped with a cardboard envelope; or (a) purelay-pharm 100E white opaque (polypropylene) and (b) purelay-lid (polypropylene).

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Seton Products Limited, Tubiton House, Oldham, OL1 3HS.

8. Marketing Authorisation Number(S)

PL 11314/0011.

9. Date Of First Authorisation/Renewal Of The Authorisation

16/02/94 / 26/03/99

10. Date Of Revision Of The Text

December 2003