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Joy-Rides Tablets

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FRONT


| Forest La

iboratories |

2540867

Forest Job No.:

JO/UK/LFT/1/A

■ ■■

100% 95% 50%

5%

Product Name

Joy-Rides Tablets

Market

UK

Component

Leaflet

Asset No.

141

No. of Colours

1 (One)

Profile

L142

Dimensions

139.7 x 209.55 mm

Point of Sale Code

N/A

Pharmacode

1248

Production Site No

2540867

Production Site

Perrigo

Pasara UIC No.

9gQaX3

Originated on

17/07/2014

Originated by

Operator 003

Originated at

ARK

Proof Status

P3/M3

Amended by

Operator 003

Date Completed

27/11/2014

TEXT SIZES

Main Body Text

9pt

Line Spacing

9pt

Smallest Text

9pt

FONTS USED

Frutiger

ARK Pharma Graphics Ltd.

Crown House Business Centre, Home Gardens,

Dartford, Kent, DA1 1DZ.

Tel +44(0)1322 424656


Forest Version 4 - June 2014


n


Package leafletrinformation for+fie patient-

150 microgram Tablets Hyoscine hydrobromide


head all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor, or pharmacist has told you.

Keep this leaflet. You may need to read it again.

I- If you have any further questions, ask your doctor or pharmacist.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible

Lside effects not listed in this leaflet. See section 4. hat is in this leaflet

What Joy-Rides Tablets are and what they are used for What you need to know before you take Joy-Rides Tablets How to use Joy-Rides Tablets Possible side effects How to store Joy-Rides Tablets Contents of the pack and other information

What Joy-Rides Tablets are and what they are used for

oy-Rides Tablets are used for the prevention of travel sickness. The active ingredient is hyoscine hydrobromide which acts on the brain to prevent messages of travel sickness reaching the stomach.

I2. What you need to know before you take Joy-Rides Tablets Do not take Joy-Rides Tablets

if you/your child are allergic to hyoscine hydrobromide or any of the other ingredients of this medicine (listed in section 6), if you/your child have glaucoma (raised pressure in the eye), if your child is under 3 years unless your doctor tells you to.

Warnings and precautions

|lf you/your child are epileptic, you/they might suffer from increased seizure frequency. Talk

to your doctor or pharmacist before taking Joy-Rides Tablets.

piildren

Do not give Joy-Rides Tablets to children under the age of 3 years unless your doctor tells you to. Since it may cause drowsiness, children taking this medicine should not be left unattended. Other medicines and Joy-Rides Tablets

Tell your doctor or pharmacist if you/your child are taking, have recently taken or might take any other medicines, and in particular:

if you/your child are taking phenothiazines which belong to two groups of medicines called neuroleptics such as chlorpromazine, and antihistaminics, such as promethazine, if you/your child are taking tricyclic antidepressants used to treat depression.

,- if you/your child are taking medicines for heartburn containing aluminium hydroxide. Joy-Rides Tablets with alcohol

Do not drink alcohol (e.g. wine, beer, spirits) while taking this medicine, pregnancy and breast-feeding

Do not take Joy-Rides if you are pregnant or breast-feeding unless your doctor says it is afe to do so.


i.


I



Driving and using machines

,lt is possible while using Joy-Rides Tablets that you/your child may experience drowsiness.

|Do not drive or use any machines if the tablets make you feel drowsy.

3. How to use Joy-Rides Tablets

Always take this medicine exactly as described in this leaflet or as your doctor has told you Check with your doctor or pharmacist if you are not sure.

Lhewzthe tahlets_h£fore_swaliowing,_    _ _ _ _ _ _ _ _ J


BACK


ITf is best tdTake Joy-Rides"Tablets 2CTminutes before you startyour journey.    “I

Dosage

3-4 years

4-7 years

7-12 years

Adults 13+& Elderly

First dose (tablet)

1/2

1

1-2

2

Repeat dose after 6 hours

f needed.

Maximum number of tablets in 24 hours

1

2

2

4

Do not take more than the recommended dose.

Ilf you/your child take more Joy-Rides Tablets than you/they should

Tell your doctor or contact the nearest Accident and Emergency Department.

|lf you have any further questions on the use of this medicine, ask your doctor or pharmacist.


4.    Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some people may experience hallucinations, confusion or irregular heartbeat (slower heartbeat, faster heartbeat, palpitations). If you get any of these effects, stop taking the tablets and tell your doctor immediately.

You may also get dry mouth, dizziness, blurred vision, widening of pupils with loss of ability to focus, eyes becoming sensitive to light, difficulty in passing urine or sudden compelling urge to urinate, reduced sputum production, flushing and dryness of the skin, constipation, [feeling sick or being sick.

Less frequently, there have been reports of an increased body temperature due to decreased sweating and increased pressure in the eye (very rare).

(These symptoms may occur in all patient groups although certain populations including children and the elderly are more susceptible.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side [effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme atwww.mhra.gov.uk/yellowcard. By reporting side effects you can help provide |more information on the safety of this medicine.

5.    How to store Joy-Rides Tablets

keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the outer carton and the blister after EXP. The expiry date refers to the last day of that month. Store below 25°C in a dry place. Do not throw away [any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

b- Contents of the pack and other information What Joy-Rides Tablets contain

|- The active substance is hyoscine hydrobromide. Each tablet contains 150 micrograms of 1 hyoscine hydrobromide.

The other ingredients are mannitol, erythrosine (E 127), povidone, raspberry flavour, microcrystalline cellulose and magnesium stearate.

What Joy-Rides Tablets look like and contents of the pack

[joy-Rides Tablets are supplied as small pink tablets with a break-line on one side.

The tablets are packed in aluminium blister packs supplied in cartons containing 12 tablets [(strips of 12, or 2 strips of 6). Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

[The Marketing Authorisation Holder is Forest Laboratories UK Ltd, Dartford, Kent,

DA2 6SL, UK and all enquiries should be sent to this address.

The Manufacturer is Wrafton Laboratories Ltd, Exeter Road,

Wrafton, Braunton, North Devon EX33 2DL, UK    /$(•■■>ForCSt'

This leaflet was last revised in December 2014. _ _ _ _ 2540867 JO/UK/LFT/1/AI