TRAVELEEZE 12.5 MG PASTILLES - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Traveleeze 12.5mg Pastilles

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Meclozine hydrochloride 12.5mg per pastille

For excipients, see 6.1.

3. PHARMACEUTICAL FORM

Pink, flat-cylindrical pastille.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

For the prevention of nausea and vomiting of sickness and in particular travel sickness.

4.2 Posology and method of administration

Oral

Adults and the Elderly and Children over 12 years         2 pastilles

Children 6 to 12 years                              1 pastille

Children 2 to 6 years                               ­Half a pastille

Take an hour before travelling.

4.3 Contraindications

Do not take if you are hypersensitive to any of the ingredients.

Severe hepatic disease.

Porphyria.

4.4 Special warnings and precautions for use

Keep out of reach and sight of children.

Meclozine may thicken or dry lung secretions and impair expectoration. It should therefore be used with caution in patients with asthma, bronchitis or bronchiectasis.

Use with care in patients with prostatic hypertrophy, urinary retention, glaucoma, pyloroduodenal obstruction, epilepsy or hepatic or renal insufficiency.

Meclozine may delay the early diagnosis of pregnancy, intestinal obstruction or raised intracranial pressure through suppression of vomiting.

Children and the elderly are more susceptible to the side effects of antihistamines.

Aspartame contains a source of phenylalanine. Harmful to people with phenylketonuria.

Contains maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Excessive use may cause diarrhoea.

4.5 Interaction with other medicinal products and other forms of interaction

Meclozine may have additive effects with alcohol and other central nervous system depressants e.g. hypnotics, tranquillisers, tricyclic antidepressants, monoamine oxidase inhibitors.

Because of its antimuscarinic activity, meclozine may enhance the side effects of other antimuscarinic agents e.g. antiemetics, antihistamines, antipsychotics, tricyclic antidepressants, monoamine oxidase inhibitors.

4.6 Pregnancy and lactation

Do not take if pregnant or breast-feeding.

May cause drowsiness or blurred vision. If affected, do not drive or operate machines.

4.8 Undesirable effects

May cause drowsiness.

Meclozine has antimuscarinic properties and may cause dry mouth, thickened respiratory secretions, blurred vision, urinary difficulty/re­tention, constipation and increased gastric reflux.

Traveleeze contains maltitol (a polyol). Diarrhoea may occur if the product is taken in excess of the stated dose.

4.9 Overdose

Symptoms of overdose due to gross abuse of the product in excess of the stated dose may include stomach upset and CNS effects. If overdose occurs seek medical advice.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Meclozine hydrochloride is an antihistamine with anti-emetic properties.

5.2 Pharmacokinetic properties

Meclozine hydrochloride, a piperazine derivative, is a sedating antihistamine with antimuscarinic and moderate sedating properties.

5.3 Preclinical safety data

There is no preclinical data available specific to the product.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Maltitol syrup (Maltidex 110)

Gelatin

Citric acid monohydrate

Microcrystalline cellulose/car­boxymethylcellu­lose sodium (Avicel RC 591)

Aspartame

Oleoresin ginger

Strawberry flavour (flavouring substances, propylene glycol)

Carmine E120

Silicone antifoam 1510 (dimethyl siloxane, glycerides, methyl cellulose, polyethylene glycol stearate, xantham gum, benzoic acid, polyethylene glycol, sorbic acid)

Vegetable oil Carnauba wax (Capol 4872UK) (vegetable oil, carnauba wax, alpha-tocopherol, citric acid)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

24 months

6.4 Special precautions for storage

Do not store above 25°C. Store in the original package.

6.5 Nature and contents of container

Blister packs of 250p white PVC coated with 40 gsm PVDC lidded with 20 li hard temper aluminium foil. Pack sizes of 10, 12, 20 or 24 pastilles contained in a carton. Not all pack sizes may be marketed.

6.6 Instructions for use and handling

None

7. MARKETING AUTHORISATION HOLDER

Ernest Jackson & Co Ltd

High Street

Crediton

Devon EX17 3AP

United Kingdom

8. MARKETING AUTHORISATION NUMBER

PL 00094/0042

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

15/12/2008