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Forest Laboratories UK Limited

Riverbridge House, Anchor Boulevard, Crossways Business Park, Dartford, Kent, DA2 6SL

Telephone: +44 (0)1322 421 800
Fax: +44 (0)1322 291 306
WWW: http://www.forestlabs.com
Medical Information e-mail: medinfo@forest-labs.co.uk

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Summary of Product Characteristics last updated on the eMC: 27/04/2012

SPC	Joy-rides Tablets

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

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1. NAME OF THE MEDICINAL PRODUCT

Joy-rides Tablets

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active constituent

Hyoscine hydrobromide 0.15 mg

For a full list of excipients, see section 6.1.

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3. PHARMACEUTICAL FORM

A raspberry flavoured chewed tablet for oral administration.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Anti-muscarinic. For the prevention of motion sickness.

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4.2 Posology and method of administration

Route of administration: Oral.

Adults over 13 years:

2 tablets 20 minutes before start of the journey. Maximum 4 tablets in 24 hours.

Children:

20 minutes before journey. 7 - 12 years: 1 -2 tablets. 4 - 7 years: 1 tablet. Maximum 2 tablets in 24 hours. 3 – 4 years: half a tablet. Maximum 1 tablet in 24 hours.

Not recommended under 3 years except on medical advice.

Ideally taken 20 minutes before the start of the journey. However, still effective if taken at onset of nausea or after the journey has begun.

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4.3 Contraindications

Glaucoma.

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4.4 Special warnings and precautions for use

Do not exceed the stated dose. Avoid alcoholic drink.

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4.5 Interaction with other medicinal products and other forms of interaction

The actions of Hyoscine Hydrobromide may be potentiated by concurrent phenothiazines, tricyclic antidepressants or alcohol. Aluminium hydroxide preparations may reduce absorption of Hyoscine Hydrobromide. The actions may of tricyclic antidepressants may be potentiated by concurrent Hyoscine Hydrobromide.

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4.6 Pregnancy and lactation

Safety in pregnancy has not been established, but the drug has been used widely for many years without apparent ill effect. However, the normal precautions of avoiding unnecessary medication especially in the first trimester of pregnancy should be observed.

Hyoscine hydrobromide can cross the placenta and appears in trace quantities in breast milk.

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4.7 Effects on ability to drive and use machines

May cause drowsiness, if affected do not drive or operate machinery.

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4.8 Undesirable effects

Some patients may experience dry mouth, dizziness, blurred vision and difficulty with micturition.

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4.9 Overdose

The main symptoms are sleepiness, dry mouth, rapid heart rate, palpitation, dilated pupils. Take measures to limit intestinal absorption immediately. Parasympathetic agents such as physotigmine should be used as necessary. Do not use phenothiazines.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

The Atropine like actions of Hyoscine hydrobromide are well known. The site of action in preventing motion sickness is thought to be either on the cortex or more peripherally on the vestibular apparatus.

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5.2 Pharmacokinetic properties

Hyoscine is rapidly absorbed from the gastro-intestinal tract. About 1 % of an oral dose is eliminated as such in the urine. Traces are found in various secretions, including milk.

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5.3 Preclinical safety data

None.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

Mannitol

Erythrosine (E.127) Lake

Povidone

Raspberry Flavour Trusil J7551

Microcrystalline cellulose

Magnesium stearate

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6.2 Incompatibilities

None known.

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6.3 Shelf life

3 years.

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6.4 Special precautions for storage

Store below 25°C in a dry place.

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6.5 Nature and contents of container

Tablets are individually sealed in strips of 12, or as 2 strips of 6, between 2 layers of 0.25 mm soft aluminium foil/0.25 mm polyethylene. Strips are packed in decorated, folding boxboard cartons.

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6.6 Special precautions for disposal and other handling

None.

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7. MARKETING AUTHORISATION HOLDER

Forest Laboratories UK Limited

Riverbridge House

Anchor Boulevard

Crossways Business Park

Dartford

Kent

DA2 6SL