MOVICOL ORANGE FLAVORED CONCENTRATE FOR ORAL SOLUTION

Introduction

Leaflet: Information for the user

Movicol Orange Flavor concentrated 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

Contents of the pack

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

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

The name of this medicine is Movicol Orange Flavor concentrated for oral solution

This 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 Flavor helps you have a good bowel movement even if you have been constipated for a long time

Do not useMovicol Orange Flavor if you have a very severe constipation called fecal impaction

2. What you need to know before you take Movicol Orange Flavor

Do not takeMovicol Orange Flavorif your doctor has told you that you have:

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

Warnings and precautions

When taking Movicol Orange Flavor, 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 Flavor

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

Some medicines, such as antiepileptics (medicines for epilepsy), may not work as well when used with Movicol Orange Flavor

Do not take other medicines by mouth from one hour before to one hour after taking Movicol Orange Flavor

If you need to thicken liquids to be able to swallow them safely, Movicol Orange Flavor may neutralize the effect of the thickener

Pregnancy and breastfeeding

Movicol Orange Flavor can be taken during pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine

Driving and using machines

Movicol Orange Flavor does not affect your ability to drive or use machines

Movicol Orange Flavorcontains ethyl parahydroxybenzoate (E-214), methyl parahydroxybenzoate (E-218), ethanol, and 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 ethanol (alcohol) in 25 ml of concentrated solution for oral use, which is equivalent to 3.0 mg of ethanol (alcohol) per ml. The amount in 25 ml of concentrated solution for oral use 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 has no noticeable effect

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

Benzyl alcohol may cause allergic reactions

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

Ask your doctor or pharmacist for advice if you need to take 3 daily doses for a prolonged period or especially if you have been recommended a low-sodium diet

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

Do not exceed the stated dose

3. How to take Movicol Orange Flavor

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

This product must be diluted before use

A dose of Movicol Orange Flavor 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 make the mixture:

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

Wash the measuring cup after use and put it back in the bottle

Duration of treatment:

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

Normally, in long-term treatment, the dose can be reduced to one or two doses a day

If you take moreMovicol Orange Flavorthan you should

You may get severe diarrhea, which can cause dehydration. If this happens, stop taking Movicol Orange Flavor and drink plenty of fluids

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested

If you forget to takeMovicol Orange Flavor

Take the dose as soon as you remember

If you stop takingMovicol Orange Flavor

If you have any further questions on the use of this product, ask your doctor or pharmacist

4. Possible side effects

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

If you have a severe allergic reaction with difficulty breathing or swelling of the face, lips, tongue, or throat, tell your doctor immediatelyand stoptaking Movicol Orange Flavor

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

Other side effects may also beindigestion, stomach pain, and stomach noise, and high or low potassium levels in the blood. When you start taking Movicol Orange Flavor, you may also feel bloated, have gas, discomfort, or vomit, experience anal pain, and have mild diarrhea, which usually improves if you reduce the amount of Movicol Orange Flavor 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 through the Spanish Medicines Vigilance System for Human Use: https://www.notificaram.es

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

5. Storage of Movicol Orange Flavor

Keep this medicine out of the sight and reach of children

Do not use this medicine after the expiry date which is stated on the bottle after EXP. The expiry date is the last day of the month stated

Do not refrigerate or freeze

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

Once you have diluted Movicol Orange Flavor in water, if you cannot drink it immediately, keep it covered. Discard any unused solution within 24 hours

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment

6. Contents of the pack and other information

Composition ofMovicol Orange Flavor

The active substances per 25 ml of Movicol Orange Flavor are:

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

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

The orange flavor contains the following components: flavoring substances, flavoring preparations, and a small amount of ethanol (alcohol)

When each 25 ml is converted into a drink with 100 ml of water, it is equivalent to:

Appearance of the product and contents of the pack

Movicol Orange Flavor is a clear, colorless liquid

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

Marketing authorization holder and manufacturer

Marketing authorization holder:

Norgine Healthcare B.V.

Antonio Vivaldistraat 150

1083 HP Amsterdam

Netherlands

Manufacturer:

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

You can ask for more information about this medicine from the local representative of the marketing authorization holder:

Norgine de España, S.L.U.

Paseo de la Castellana, 91, 2ª Planta

28046 Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:07/2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/