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Document: leaflet MAH BRAND_PL 00108-0333 change

• label-leaflet MAH BRAND_PL 00108-0333
• leaflet MAH BRAND_PL 00108-0333

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Package leaflet: Information for the patient

150 microgram Tablets .wWiqg3jr~ /IwCOCZSE Hyoscine hydrobromide

Read 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.

-    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 side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

2.    What you need to know before you take Joy-Rides Tablets

3.    How to use Joy-Rides Tablets

4.    Possible side effects

5.    How to store Joy-Rides Tablets

6.    Contents of the pack and other information

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

Joy-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.

2.    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

If you/your child are epileptic, you/they might suffer from increased seizure frequency. Talk to your doctor or pharmacist before taking Joy-Rides Tablets.

Children

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 safe to do so.

Driving and using machines

It 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.

Chew the tablets before swallowing.

It is best to take Joy-Rides Tablets 20 minutes before you start your journey.

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 if needed.
Maximum number of tablets in 24 hours	1	2	2	4

Do not take more than the recommended dose.

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

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

If 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 moresusceptible.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.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.

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

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