Movicol Orange oral solution concentrate

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Movicol Orange Flavour oral solution concentrate

Macrogol 3350, Sodium chloride, Sodium hydrogen carbonate, Potassium chloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Movicol Orange Flavour is and what it is used for

The name of this medicine is Movicol Orange Flavour oral solution concentrate.

It is a laxative for the treatment of chronic constipation in adults, adolescents and the elderly. It is not recommended for children under 12 years of age.

Movicol Orange Flavour helps you achieve good intestinal transit, even if you have been constipated for a long time.

Do not use Movicol Orange Flavour if you suffer from severe constipation known as fecal impaction.

2. What you need to know before taking Movicol Orange Flavour

Do not take Movicol Orange Flavour if your doctor has told you that you:

• have intestinal blockage (intestinal obstruction, ileus)
• have intestinal perforation
• have a severe inflammatory bowel disease such as ulcerative colitis, Crohn's disease, or toxic megacolon
• are allergic to the active substances or to any of the other ingredients of Movicol Orange Flavour Solution (listed in section 6).

Warnings and precautions

When taking Movicol Orange Flavour, you should continue to drink plenty of fluids. The liquid content of Movicol does not replace your normal fluid intake.

Other medicines and Movicol Orange Flavour

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

Some medicines, such as antiepileptics (medicines for epilepsy), may not work as effectively when used with Movicol Orange Flavour.

Other oral medicines should not be taken within one hour before or one hour after taking Movicol Orange Flavour.

If you need to thicken liquids to swallow them safely, Movicol Orange Flavour may neutralize the effect of the thickening agent.

Pregnancy and breastfeeding

Movicol Orange Flavour may be taken during pregnancy and breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Movicol Orange Flavour does not affect your ability to drive or operate machinery.

Movicol Orange Flavour contains ethyl parahydroxybenzoate (E-214), methyl parahydroxybenzoate (E-218), alcohol (ethanol), benzyl alcohol (E-1519), and sodium.

This medicine may cause allergic reactions (possibly delayed) because it contains ethyl parahydroxybenzoate (E-214) and methyl parahydroxybenzoate (E-218).

This medicine contains 74.6 mg of alcohol (ethanol) in 25 ml of oral solution concentrate, equivalent to 3.0 mg of alcohol (ethanol) per ml. The amount in 25 ml of oral solution concentrate is equivalent to less than 2 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine has no appreciable effect.

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

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you have liver or kidney disease, are pregnant, or are breastfeeding. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (metabolic acidosis).

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

This medicine contains 186.87 mg of sodium (a main component of table/cooking salt) per 25 ml dose. This corresponds to 9.3% of the maximum daily sodium intake recommended for an adult.

Do not exceed the stated dose.

3. How to take Movicol Orange Flavour

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

This product must be diluted before use.

One dose of Movicol Orange Flavour is 25 ml of liquid diluted in 100 ml of water.

Take this amount 1–3 times a day, depending on the severity of constipation.

How to prepare the mixture:

Open the bottle and measure 25 ml or five 5 ml teaspoonfuls. Pour the liquid into a glass and then add 100 ml (approximately half a glass) of water. Shake well until the liquid is uniformly mixed and the diluted Movicol Orange Flavour solution becomes clear, then drink it.

Wash the measuring cup after use and return it to the bottle.

Duration of treatment:

Treatment with Movicol Orange Flavour usually lasts about two weeks. If you need to take Movicol Orange Flavour for longer, consult your doctor. If your constipation is caused by a condition such as Parkinson's disease or multiple sclerosis (MS), or if you are taking medicines that cause constipation, your doctor may recommend taking Movicol Orange Flavour for longer than two weeks.

In long-term treatment, the dose can usually be reduced to one or two doses per day.

If you take more Movicol Orange Flavour than you should

You may experience severe diarrhoea, which could lead to dehydration. If this occurs, stop taking Movicol Orange Flavour and drink plenty of fluids.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Movicol Orange Flavour

Take the missed dose as soon as you remember.

If you stop taking Movicol Orange Flavour

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

If you have a severe allergic reaction causing difficulty breathing or swelling of the face, lips, tongue or throat, inform your doctor immediately and stop taking Movicol Orange Flavour.

Other allergic reactions may also occur, which can cause a skin rash, itching, redness of the skin or hives, swelling of the hands, feet or ankles, and headache.

Other possible adverse effects include indigestion, stomach pain, and stomach rumbling, as well as high or low blood potassium levels. When starting to take Movicol Orange Flavour, you may also feel bloated, experience flatulence, discomfort or vomiting, anal pain, and mild diarrhoea. These symptoms usually improve if you reduce the dose of Movicol Orange Flavour.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Movicol Orange Flavour

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

Do not use this medicine after the expiry date stated on the bottle after EXP. The expiry date refers to the last day of the month indicated.

Do not refrigerate or freeze.

Discard any remaining product 30 days after the original opening of the bottle.

Once Movicol Orange Flavour has been diluted in water, if it cannot be consumed immediately, store it covered. Discard any unused solution after 24 hours.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Movicol Orange Flavour

The active ingredients in each 25 ml of Movicol Orange Flavour are:

The other ingredients are: purified water, orange flavour, and the sweeteners potassium acesulfame (E-950) and sucralose (E-955).

It also contains the preservative benzyl alcohol (E-1519), methyl parahydroxybenzoate (E-218), and ethyl parahydroxybenzoate (E-214). See section 2: "Movicol Orange Flavour contains ethyl parahydroxybenzoate (E-214), methyl parahydroxybenzoate (E-218), alcohol (ethanol), benzyl alcohol (E-1519), and sodium".

The orange flavour contains the following components: flavouring substances, flavouring preparations, and a small amount of alcohol (ethanol).

When each 25 ml is made up into a drink with 100 ml of water, it provides:

Appearance of the medicinal product and contents of the container

Movicol Orange Flavour is a clear, colourless liquid.

Each pack consists of a carton containing a plastic bottle of Movicol Orange Flavour with 500 ml of solution and a plastic measuring cup.

Marketing Authorisation Holder and Manufacturer

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Norgine de España, S.L.U.

Paseo de la Castellana, 91, 2nd Floor

28046 Madrid

Spain

This medicinal product is authorised in the member states of the European Economic Area under the following names:

Date of the last revision of this leaflet: 07/2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/