Summary of Product Characteristics (SmPC) - Traveleeze 12.5 mg pastilles
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.
4.7 Effects on ability to drive and use machines
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 250µ white PVC coated with 40 gsm PVDC lidded with 20µ 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
AUTHORISATION
15/12/2008
10 DATE OF REVISION OF THE TEXT
19/07/2012