MOVICOL Chocolate 13.9g sachet, powder for oral solution

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

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

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet:

1. What Movicol Chocolate is and what it is used for
2. What you need to know before you take Movicol Chocolate
3. How to take Movicol Chocolate
4. Possible side effects
5. How to store Movicol Chocolate
6. Contents of the pack and other information

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 the active substances or any of the other ingredients of Movicol Chocolate (listed in section 6).

Warnings and precautions

When taking Movicol Chocolate you should continue to take plenty of fluids. The fluid content of Movicol should not replace your regular liquid intake.

Heart conditions

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

Other medicines and Movicol Chocolate

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines e.g. anti-epileptics may not work as effectively during use with Movicol Chocolate.

If you need to thicken fluids in order to swallow them safely, Movicol Chocolate may counteract the effect of the thickener.

Pregnancy and breast feeding

Movicol Chocolate can be taken during pregnancy and whilst breastfeeding. If you are pregnant, trying to become pregnant or breastfeeding, ask your pharmacist or doctor for advice before taking Movicol Chocolate.

Driving and using machines

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

Movicol Chocolate contains benzyl alcohol

Movicol Chocolate contains 14.1 mg of benzyl alcohol per sachet. Benzyl alcohol may cause allergic reactions.

Ask your doctor or pharmacist for advice if you have a liver or kidney disease, are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).

Movicol Chocolate contains sodium

Talk to your doctor or pharmacist if you need 3 or more sachets daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.

Movicol Chocolate contains 186.87 mg sodium (main component of cooking/table salt) per sachet. This is equivalent to 9.3% of the recommended maximum daily dietary intake of sodium for an adult.

Constipation:

A dose of Movicol Chocolate is 1 sachet dissolved in 125 ml (1/4 pint) of water.

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

Faecal Impaction:

Before you take Movicol Chocolate for faecal impaction, it should be confirmed that you have this condition.

A dose of 8 sachets a day of Movicol Chocolate is needed for the treatment of faecal impaction. Each sachet dissolved in 125 ml (1/4 pint) of water. 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 ¼ 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 you need to take Movicol Chocolate for longer, please see your doctor.

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. If you need to take Movicol Chocolate for longer, please see your doctor.

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 excessive diarrhoea, which can lead to dehydration. If this occurs, stop taking Movicol Chocolate and drink plenty of fluids. 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.

Tell your doctor immediately and stop taking Movicol Chocolate if you:

• Get a serious allergic reaction which causes difficulty in breathing or dizziness or swelling of the face, lips and tongue or throat.

Other side effects include:

Allergic reactions which may cause a skin rash, itching, reddening of the skin or a nettle rash, swollen hands, feet or ankles, headaches and high or low levels of potassium in the blood.

Sometimes you may have indigestion, stomach ache or rumbles. You may also feel bloated, suffer from wind, feel sick or vomit, may experience soreness of the anus (bottom) and you may have mild diarrhoea when starting to take Movicol Chocolate. These side effects generally get better if you reduce the amount of Movicol Chocolate you take.

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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

What Movicol Chocolate contains

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 E950 as a sweetener. Chocolate flavour contains the following ingredients maltodextrin (potato), gum arabic/acacia gum E414, vegetable oils and fats (coconut), propylene glycol E1520 and benzyl alcohol E1519 (see section 2 “Movicol Chocolate contains benzyl 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

Manufacturer:

Or

Or