Movicol Liquid Orange Flavour

 Package Leaflet: Information for the patient

Movicol^® Liquid Orange flavour, Concentrate for oral solution

(Macrogol 3350, Sodium Chloride, Sodium Hydrogen Carbonate, Potassium Chloride)

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

- Keep this leaflet. You may need to read it again.

- If you have any further questions, ask your doctor, pharmacist or nurse.

- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

- 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.

What is in this leaflet:

1.                 What Movicol Liquid Orange flavour is and what it is used for

2.                 What you need to know before you take Movicol Liquid Orange flavour

3.                 How to take Movicol Liquid Orange flavour

4.                 Possible side effects

5.                 How to store Movicol Liquid Orange flavour

6.                 Contents of the pack and other information

1.       What Movicol Liquid Orange flavour is and what it is used for

The name of this medicine is Movicol Liquid Orange flavour concentrate for oral solution. It is a laxative for the treatment of chronic constipation in adults, adolescents and elderly. It is not recommended for children below 12 years of age.

Movicol Liquid Orange flavour helps you to have a comfortable bowel movement even if you have been constipated for a long time. 

You must not use Movicol Liquid Orange flavour if you have a very bad constipation called faecal impaction.

2.       What you need to know before you take Movicol Liquid Orange flavour

Do not take Movicol Liquid Orange flavour 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 Liquid Orange flavour (listed in section 6).

Warnings and precautions

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

Other medicines and Movicol Liquid Orange flavour

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

Some medicines, e.g. anti-epileptics (medicines for epilepsy), may not work as effectively during use with Movicol Liquid Orange flavour.

You should not take any other medicines by mouth together with Movicol Liquid Orange flavour and for one hour before and for one hour after taking Movicol Liquid Orange flavour.

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

Pregnancy and breast-feeding

Movicol Liquid Orange flavour 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 Liquid Orange flavour.

Driving and using machines

Movicol Liquid Orange flavour does not affect your ability to drive or use machines.

Movicol Liquid Orange flavour contains ethyl parahydroxybenzoate, methyl parahydroxybenzoate, alcohol (ethanol), benzyl alcohol and sodium

This medicine contains ethyl and methyl parahydroxybenzoate which may cause allergic reactions, possibly delayed.

This medicine contains 74.6 mg of alcohol (ethanol) in 25 mL concentrate for oral solution, which is equivalent to 3.0 mg of alcohol (ethanol) per mL. The amount in 25 mL concentrate for oral solution of this medicine is equivalent to less than 2 mL of beer or 1 mL of wine. The small amount of alcohol in this medicine will not have any noticeable effects.

 This medicine contains 45.6mg of benzyl alcohol in each diluted dose of 125ml.

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”).

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

Movicol Liquid Orange flavour contains 186.87 mg sodium (main component of cooking/table salt) per 25 ml dose. This is equivalent to 9.3% of the recommended maximum daily dietary intake of sodium for an adult.

Do not exceed the stated dose.

3.       How to take Movicol Liquid Orange flavour

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

This product must be diluted before use.

A dose of Movicol Liquid Orange flavour is 25 ml liquid diluted in 100 ml of water.

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

How to mix:

Open the bottle and measure 25 ml or five 5 ml teaspoonfuls. Pour the liquid into a glass and then add 100ml (about half a glassful) of water. Stir well until all the liquid has been evenly mixed and the diluted Movicol Liquid Orange flavour solution is clear, then drink it. Please rinse the dosing cup after use and replace on the bottle.

Duration of treatment:

Treatment with Movicol Liquid Orange flavour usually lasts for about 2 weeks. If you need to take Movicol Liquid Orange flavour 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 Liquid Orange flavour for longer than 2 weeks.

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

If you take more Movicol Liquid Orange flavour than you should

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

If you forget to take Movicol Liquid Orange flavour

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.

If you have a serious allergic reaction which causes difficulty in breathing, or swelling of the face, lips, tongue or throat, tell your doctor immediately and stop taking Movicol Liquid Orange flavour.

Other allergic reactions may occur which may cause a skin rash,itching, reddening of the skin or a nettle rash, swollen hands, feet or ankles and headache.

Other side effects may also include indigestion, stomach ache and rumbles and high and low levels of potassium in the blood. You may also feel bloated, suffer from wind, feel sick or vomit, may also experience soreness of the anus (bottom) and may have mild diahorrea when starting to take Movicol Liquid Orange flavour which generally gets better if you reduce the amount of Movicol Liquid Orange flavour 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 HPRA Pharmacovigilance Website: www.hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine.

5.       How to store Movicol Liquid Orange Flavour

Keep this medicine out of the sight and reach of children.

Do not use Movicol Liquid Orange flavour after the expiry date which is stated on the bottle. The expiry date refers to the last day of that month.

Do not refrigerate or freeze.

Discard any remaining product 30 days after first opening the bottle.

Once you have diluted Movicol Liquid Orange flavour in water, if you cannot drink it straight away keep it covered. Throw away any solution not used within a 24 hour period.

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 Movicol Liquid Orange flavour contains

Each 25 ml of Movicol Liquid Orange flavour contains the following:

Macrogol 3350

13.125 g

Sodium Chloride

0.3507 g

Sodium Hydrogen Carbonate

0.1785 g

Potassium Chloride

0.0466 g

Movicol Liquid Orange flavour also contains purified water, orange flavour, and acesulfame potassium (E950) and sucralose (E955) as sweeteners.

It also contains a preservative which contains benzyl alcohol (E1519), methyl parahydroxybenzoate (E218) and ethyl parahydroxybenzoate (E214). See section 2 “Movicol Liquid Orange flavour contains ethyl parahydroxybenzoate, methyl parahydroxybenzoate, alcohol (ethanol), benzyl alcohol and sodium”.

Orange flavour contains the following ingredients: flavouring substances, flavouring preparations and a small amount of alcohol (ethanol).

When each 25 ml is made into a drink with 100 millilitres of water, it gives the equivalent of:

Sodium

65 millimoles/litre

Chloride

53 millimoles/litre

Potassium

5.4 millimoles/litre

Hydrogen Carbonate

17 millimoles/litre

What Movicol Liquid Orange flavour looks like and contents of the pack

Movicol Liquid Orange flavour is a clear, colourless liquid.

Each pack consists of a carton with a plastic bottle of Movicol Liquid Orange flavour containing 500 ml of solution and a plastic dosing cup.

Marketing Authorisation Holder

Norgine Healthcare B.V.

Antonio Vivaldistraat 150

1083 HP Amsterdam

The Netherlands

Manufacturer:

Norgine Pharma Dreux, 29, Rue Ethé Virton, 28109 Dreux Cedex, France.

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

Austria

MOVICOL Liquid Orange

Belgium

MOVICOL Vloeibaar Sinaasappelsmaak /

MOVICOL Liquide Goût orange /

MOVICOL Flüssig Orangengeschmack

Germany

Macrogol Norgine Orangengeschmack Konzentrat zur Herstellung einer Lösung zum Einnehmen

Finland

MOVICOL Appelsiini

Ireland

MOVICOL Liquid Orange flavour

Italy 

MOVICOL 13,9 g/25 ml concentrato per soluzione orale, gusto Arancio

Luxembourg

Netherlands

Portugal

MOVICOL Liquide Goût orange

Movicolon Liquid Orange

MOVICOL Laranja

Spain

Movicol Sabor Naranja concentrado para solución oral

Sweden

Movicol Apelsin

United Kingdom (Northern Ireland)

MOVICOL Liquid Orange flavour

This leaflet was last revised in 05/2023.

Other sources of information

If you need the information on this leaflet in an alternative format, such as large print, please ring 00 44 1895 826 606.