Leaflet: information for the user

Movicol Orange Flavour concentrated oral solution

Macrogol 3350, Sodium Chloride, Sodium Hydrogenocarbonate, Potassium Chloride

Read this 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, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

The name of this medication is Movicol Orange Flavor concentrated oral solution.

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 Flavor helps you have good intestinal transit even when you have been constipated for a long time.

Do not useMovicol Orange Flavorif you have a severe constipation condition called fecal impaction.

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

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

Warnings and precautions

When taking Movicol Orange Flavor, you should continue to drink plenty of liquids. The liquid content of Movicol does not replace your usual intake of liquids.

Other medicines and Movicol Orange Flavor

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

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

Do not take other oral medicines from one hour before to one hour after taking Movicol Orange Flavor.

If you need to thicken liquids to safely swallow them, 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, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machines

Movicol Orange Flavordoes not affect your ability to drive or operate machines.

Movicol Orange Flavorcontains ethyl parahydroxybenzoate (E-214), methyl parahydroxybenzoate (E-218), 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 ethanol in 25 ml of concentrated oral solution, which is equivalent to 3.0 mg of ethanol per ml. The amount in 25 ml of concentrated 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 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 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 need 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 (main component of table salt/for cooking) per dose of 25 ml. This is equivalent to 9.3% of the maximum daily sodium intake recommended for an adult.

Do not exceed the stated dose.

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

This product must be diluted before use.

A dose ofMovicol Orange Flavouris 25 ml of liquid diluted in 100 ml of water.

Take this amount 1-3 times a day, according to the severity of constipation.

How to make the mixture:

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

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

Treatment duration:

The treatment withMovicol Orange Flavourusually lasts for about two weeks. If you need to takeMovicol Orange Flavourfor longer, consult your doctor. If your constipation is caused by a disease such as Parkinson's or multiple sclerosis (MS), or if you are taking medications that cause constipation, your doctor may recommend that you takeMovicol Orange Flavourfor 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 Flavourthan you should

You may experience severe diarrhea, which can cause dehydration. If this occurs, stop takingMovicol Orange Flavourand drink large amounts of liquids.

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

If you forgot to takeMovicol Orange Flavour

Take the dose as soon as you remember to do so.

If you interrupt the treatment withMovicol Orange Flavour

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

Like all medications,this medicationcan produce adverse effects, although not all people will experience them.

If you experience a severe allergic reaction that causes difficulty breathing or swelling of the face, lips, tongue, or throat, notify your doctorimmediatelyandstop takingMovicol Orange Flavor.

Other allergic reactions may occur, causing a skin rash, itching, skin redness, or urticaria, swelling of the hands, feet, or ankles, and headache.

Other adverse effects may also beindigestion, stomach pain, and stomach noise and high or low levels of potassium in the blood. When starting to takeMovicol Orange Flavoryou may also feel bloated, experience gas, discomfort, or vomiting, experience anal pain and mild diarrhea, which usually improve if you reduce the amount ofMovicol Orange Flavoryou take.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the bottle after EXP. The expiration date is the last day of the month indicated.

Do not refrigerate or freeze.

Dispose of 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 a 24-hour period.

Medications should not be thrown down the drain or in the trash. Deposit empty containers and unused medications at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition ofMovicol Orange Flavour

The active ingredients per 25 ml of Movicol Orange Flavour are:

The other components are:purified water, orange flavour and potassium acesulfame (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 Flavour contains ethyl parahydroxybenzoate (E-214), methyl parahydroxybenzoate (E-218), ethanol, benzyl alcohol(E-1519)and sodium”.

The orange flavour contains the following components: aromatic substances, aromatic preparations and a small amount of ethanol.

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

Appearance of the product and contents of the package

Movicol Orange Flavour is a clear and colourless liquid.

Each package consists of a box with a plastic bottle ofMovicol Orange Flavourcontaining 500 ml of solution and a plastic measuring cup.

Holder of the marketing authorisation and responsible for manufacturing

Holder of the Marketing Authorisation:

Norgine Healthcare B.V.

Antonio Vivaldistraat 150

1083 HP Amsterdam

Netherlands

Responsible for Manufacturing:

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

You can request more information about this medicine by contacting 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 medicine is authorised in the member states of the European Economic Area with the following names:

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

The detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/