MOVICOL Chocolate 13.9g, sachet powder for oral solution

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MOVICOL Chocolate 13.9g, sachet powder for oral solution

Please read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take MOVICOL Chocolate carefully to get the best results from it.

Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. You must contact a doctor if your symptoms worsen or do not improve If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What is MOVICOL Chocolate and what is it used for? 2. Before you take MOVICOL Chocolate. 3. How to take MOVICOL Chocolate. 4. Possible side effects. 5. How to store MOVICOL Chocolate. 6. Further information. What is MOVICOL Chocolate and what is it used for?

The name of this product is MOVICOL Chocolate 13.9 g sachet, powder for oral solution. It is a laxative for the treatment of constipation in adults, adolescents and elderly. It is not recommended for children below 12 years of age.

MOVICOL Chocolate helps you to have a comfortable bowel movement even if you have been constipated for a long time. MOVICOL Chocolate also works in very bad constipation known as faecal impaction.

Before you take Movicol Chocolate

Do not take MOVICOL Chocolate if your doctor has told you that you have:

A blockage in your intestine (gut obstruction, ileus) A perforated gut wall Severe inflammatory bowel disease like ulcerative colitis, Crohn’s disease or toxic megacolon An allergy to any of the ingredients Take special care with MOVICOL Chocolate

Heart conditions

Follow the special instructions in section 3 if you are taking MOVICOL Chocolate for faecal impaction.

Taking other medicines

Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines including medicines obtained without a prescription.

Taking MOVICOL Chocolate with food and drink

This medicine can be taken any time with or without food and drink.

Pregnancy and breast feeding

If you are pregnant or breast feeding talk to your doctor before taking MOVICOL Chocolate.

Driving and using machines

MOVICOL Chocolate does not affect your ability to drive or use machines.

How to take MOVICOL Chocolate Constipation:

A dose of MOVICOL Chocolate is 1 sachet.

Take this 1-3 times a day according to the severity of your constipation.

Faecal Impaction:

A dose of 8 sachets a day of MOVICOL Chocolate is needed for the treatment of faecal impaction. The 8 sachets should be taken within 6 hours for up to 3 days if required. If you have a heart condition, do not take more than 2 sachets in any one hour.

How to mix:

Open the sachet and pour the contents into a glass. Add about 125 ml or quarter pint of water to the glass. Stir well until all the powder has dissolved and the MOVICOL Chocolate solution is clear or slightly hazy, then drink it. If you are taking MOVICOL Chocolate for faecal impaction it may be easier to dissolve 8 sachets in 1 litre of water.

Duration of treatment

Constipation:

Treatment with MOVICOL Chocolate usually lasts for about 2 weeks.

If your constipation is caused by an illness such as Parkinson’s disease or multiple sclerosis (MS), or if you take medicines that cause constipation your doctor may recommend that you take MOVICOL Chocolate for longer than 2 weeks.

Usually for long term treatment the dose can be lowered to either 1 or 2 sachets a day.

Faecal impaction:

Treatment with MOVICOL Chocolate can be for up to 3 days.

If you take more MOVICOL Chocolate than you should

You may develop diarrhoea. Stop taking MOVICOL Chocolate until it clears, and then start again at a lower dose.

If you are worried contact your doctor or pharmacist.

If you forget to take MOVICOL Chocolate

Take the dose as soon as you remember to take it.

Possible side effects

Like all medicines, MOVICOL Chocolate can have side effects.

Tell your doctor immediately and stop taking MOVICOL Chocolate if: You feel weak, increasingly tired, breathless, very thirsty with a headache or get puffy ankles. You have a skin rash or itching which may be signs of an allergic reaction. Other possible signs of an allergic reaction include difficulty in breathing or dizziness. Other side effects that you may have include:

Very rare side effects (less than 1 person in 10,000)

Stomach pain or diarrhoea but this will usually improve when the dose is reduced Feeling sick or actually being sick or suffering from wind

If any of the above become serious or last more that a few days or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

How to store Movicol Chocolate

Keep out of the reach and sight of children.

Do not use MOVICOL Chocolate after the expiry date shown on the sachet.

Do not store sachet above 25°C. Once you have made up MOVICOL Chocolate in water, if you cannot drink it straight away, keep it covered and in the fridge (2-8°C).

Throw away any solution not used within a 6 hour period.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

Each 13.9g sachet of MOVICOL Chocolate contains the following:

Macrogol 3350: 13.125g
Sodium Chloride: 0.3507g
Sodium Hydrogen Carbonate: 0.1785g
Potassium Chloride: 0.0317g

MOVICOL Chocolate also contains chocolate flavour, and acesulfame potassium as a sweetener. Chocolate flavour contains the following ingredients maltodextrin (potato), gum arabic/acacia gum E414, vegetable oils and fats (palm/coconut oil), propylene glycol E1520 and ethyl alcohol.

When it is made into a drink with 125 millilitres of water each sachet gives the equivalent of:

Sodium: 65 millimoles/litre
Chloride: 51 millimoles/litre
Potassium: 5.4 millimoles/litre
Hydrogen Carbonate: 17 millimoles/litre

What MOVICOL Chocolate looks like and the contents of the pack

MOVICOL Chocolate is a white to light brown powder.

MOVICOL Chocolate is available in boxes of 20 or 30 sachets.

Marketing Authorisation Holder Norgine Ltd. Moorhall Road Harefield Middlesex UB9 6NS UK Manufacturer: Norgine Ltd. New Road Hengoed Mid Glamorgan CF82 8SJ UK

MOVICOL Chocolate is available in Europe. In Ireland and Finland it is known as MOVICOL Chocolate, in Austria MOVICOL Schoko, in Belgium MOVICOL Chocoladesmaak/MOVICOL Go?t chocolat/MOVICOL Schokoladengeschmack and in Sweden MOVICOL Choklad.

Date revised: April 2008

MOVICOL Chocolate 13.9g sachet powder for oral solution

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