Joy-Rides Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Joy-rides Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active constituent
Hyoscine hydrobromide 0.15 mg
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
A raspberry flavoured chewed tablet for oral administration.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Anti-muscarinic. For the prevention of motion sickness.
4.2 Posology and method of administration
Route of administration: Oral.
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Adults over 13 years: |
2 tablets 20 minutes before start of the journey. Maximum 4 tablets in 24 hours. |
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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.
4.3 Contraindications
Glaucoma.
4.4 Special warnings and precautions for use
Do not exceed the stated dose. Avoid alcoholic drink.
If you are epileptic, you may suffer from increased seizure frequency.
4.5. Interactions with other Medicaments 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 of tricyclic antidepressants may be potentiated by concurrent hyoscine hydrobromide.
4.6 Fertility, 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.
4.7 Effects on ability to drive and use machines
May cause drowsiness, if affected do not drive or operate machinery.
4.8 Undesirable effects
Some patients may experience cholinergic signs and symptoms such as dry mouth, dizziness, blurred vision, dilatation of the pupils with loss of accommodation, photophobia, closed angle glaucoma (very rare), urinary disturbances (urinary emergency and retention), reduced bronchial secretions, transient bradycardia (followed by tachycardia, palpitation and arrhythmias), flushing and dryness of the skin, constipation, nausea and vomiting.
Other signs and symptoms may include hallucination, high temperature (due to decreased sweating) and confusion. These may occur in all patient groups although certain populations (children and the elderly) are more susceptible to anticholinergic toxicity.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
The main symptoms are sleepiness, dry mouth, rapid heart rate, palpitation, dilated pupils. Other signs and symptoms may include hallucination, high temperature and confusion. These may occur in all patient groups although certain populations (children and the elderly) are more susceptible of anticholinergic toxicity. Take measures to limit intestinal absorption immediately. Parasympathetic agents such as physotigmine should be used as necessary. Do not use phenothiazines.
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.
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.
5.3 Preclinical safety data
None.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Mannitol
Erythrosine (E.127) Lake Povidone
Raspberry Flavour Trusil J7551 Microcrystalline cellulose
Magnesium stearate
6.2 Incompatibilities
None known.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Store below 25°C in a dry place.
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.
6.6 Special precautions for disposal
None.
7 MARKETING AUTHORISATION HOLDER
Forest Laboratories UK Limited,
Whiddon Valley,
Barnstaple,
North Devon,
EX32 8NS,
United Kingdom.
8 MARKETING AUTHORISATION NUMBER(S)
PL 00108/0333
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
28/05/2008
10 DATE OF REVISION OF THE TEXT
14/07/2015