MOVICOL Ready to Take oral solution in sachet

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have 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 within 2 weeks or if you feel worse.

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

• a blockage in your intestine (gut obstruction, ileus)
• a perforated gut (a hole in the 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 Ready to Take (listed in section 6).

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

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

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 Ready to Take.

You should not take any other medicines by mouth together with Movicol Ready to Take and for one hour before and for one hour after taking Movicol Ready to Take.

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

Movicol Ready to Take 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 Ready to Take.

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

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 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.

A dose of Movicol Ready to Take is one 25 mL sachet. Take 1–3 sachets a day in divided doses according to your response to Movicol Ready to Take.

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

Eight sachets a day of Movicol Ready to Take are needed for the treatment of faecal impaction. The 8 sachets should be taken within 6 hours. If you have a heart condition, do not take more than 2 sachets in any one hour.

It is recommended to drink an extra 1.0 litre of fluid per day if you have severe constipation (called faecal impaction).

Constipation:

Treatment with Movicol Ready to Take usually lasts for about 2 weeks. If you need to take Movicol Ready to Take 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 Ready to Take 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 Ready to Take can be for up to 3 days.

You may develop excessive diarrhoea, which can lead to dehydration. If this occurs, stop taking Movicol Ready to Take and drink plenty of fluids. If you are worried contact your doctor or pharmacist.

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

Get a serious allergic reaction which causes difficulty in breathing, or swelling of the face, lips, 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 and 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 also experience soreness of the anus (bottom) and may have mild diarrhoea when starting to take Movicol Ready to Take. These side effects generally get better if you reduce the amount that you take of this medicine.

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.

Each 25 mL sachet of Movicol Ready to Take contains the following active ingredients:

Macrogol 3350 13.125 g

Sodium Chloride 0.3508 g

Sodium Hydrogen Carbonate 0.1786 g

Potassium Chloride 0.0502 g

Movicol Ready to Take also contains sucralose, purified water and strawberry banana flavouring which contains natural flavouring substances (including extracts from strawberry and banana fruit), flavouring preparations (including celery) and propylene glycol.

Each 25 mL sachet gives the equivalent of:

Sodium 8.125 mmol

Chloride 6.675 mmol

Potassium 0.675 mmol

Hydrogen Carbonate 2.125 mmol

Movicol Ready to Take is a clear, colourless to light yellow liquid.

Movicol Ready to Take is available in boxes of 10, 20, 30 and 50 sachets.

Not all pack sizes may be marketed.

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Belgium MOVICOL Unidose

Denmark MOVICOL Go

Finland MOVICOL Ready to Take

Germany Macrogol Norgine trinkfertig Lösung zum Einnehmen im Beutel

Ireland MOVICOL Ready to Take

Italy MOVICOL

Luxembourg MOVICOL Unidose

Norway MOVICOL

Portugal MOVICOL

Spain MOVICOL solución oral en sobre

Sweden Movicol oral lösning i dospåse

United Kingdom (Northern Ireland) MOVICOL Ready to Take