MOVICOL CHOCOLATE 13.9G SACHET POWDER FOR ORAL SOLUTION - patient leaflet, side effects, dosage

MOVICOL

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.
• The name of this medicine is Movicol®Chocolate 13.9g sachet, powder for oral solution but it will be referred to as Movicol Chocolate throughout the remainder of this leaflet.

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

1. what movicol chocolate is and what it is used for

The name of this product is Movicol Chocolate 13.9g 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.

2. what you need to know 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 the active substances or any of the other ingredients of Movicol Chocolate (listed in section 6).

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.

Pregnancy and breast feeding

Movicol Chocolate can be taken during pregnancy and whilst breast feeding. If you are pregnant, trying to become pregnant or breast feeding, 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 14.1mg of benzyl alcohol per sachet.

Benzyl alcohol may cause allergic reactions.

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

3. how to take movicol chocolate

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

Dissolve the content of each sachet in 125ml (A pint) of water and drink.

Constipation:

A dose of Movicol Chocolate is 1 sachet dissolved in 125ml (A 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 125ml (A 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 125ml or A 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.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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.

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

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 Website: 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.

5. how to store movicol chocolate

• Keep out of the sight and reach of children.
• Do not store above 25oC.
• Store the reconstituted solution at 2oC to 8oC (in a refrigerator and keep covered).
• Throw away any solution not used within a 6 hour period.
• Do not use this medicine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.
• If your medicine becomes discoloured or shows any signs of deterioration, return it to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. This will help to protect the environment.

6. contents of the pack and other information

What Movicol Chocolate contains

Each sachet contains:

macrogol 3350 – 13.125g

sodium chloride – 0.3507g

sodium hydrogen carbonate – 0.1785g

potassium chloride – 0.0317g

On reconstitution in 125ml of water each sachet provides:

sodium 65mmol/l

chloride 51mmol/l

potassium 5.4mmol/l

hydrogen carbonate 17mmol/l

Also contains acesulfame potassium E950 and chocolate flavour. Composition of chocolate flavour: maltodextrin (potato), gum arabic, vegetable oils and fats (coconut), propylene glycol and benzyl alcohol.

What Movicol Chocolate looks like and contents of the pack

Movicol Chocolate is a free flowing white to light brown powder.

Movicol Chocolate is available in cartons containing 20 or 30 sachets.

Manufactured by

Norgine B.V., Antonio Vivaldistraat 150, 1083 HP, Amsterdam, Netherlands.

Procured from within the EU by the Product Licence Holder: MPT Pharma Ltd, Westgate Business Park, Unit 5–7 Tintagel Way, Aldridge, Walsall, WS9 8ER.

Repackaged by MPT Pharma Ltd.

PL 33532/0725

Leaflet dated 10th June 2019

Leaflet coded xxxxxxxxx

MOVICOL® is a registered trademark of Velinor AG.

To request a copy of this leaflet in Braille, large print or audio please call 01922 745 645 and ask for the Regulatory Department.