Leaflet: information for the patient

Movicol oral solution in sachet

Macrogol 3350, Sodium chloride, Sodium bicarbonate, 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.

1. What is Movicol and what it is used for

2. What you need to know before you start taking Movicol

3. How to take Movicol

4. Possible side effects

5. Storage of Movicol

6. Contents of the pack and additional information

The name of this medication is Movicol oral solution in sachet. It is a laxative for the treatment of constipation in adults, adolescents, and the elderly. It is not recommended for children under 12 years of age.

Movicol helps to have easy intestinal transit even when constipated for a long time. Movicol is also effective in resolving fecal impaction, a complication of severe constipation.

Speak with your doctor if you do not feel better within 2 weeks or if you get worse.

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

• intestinal obstruction (intestinal blockage, ileus)
• intestinal perforation (perforation of the intestinal wall)
• a severe inflammatory disease of the intestine such as Crohn's disease, ulcerative colitis, or toxic megacolon.
• if you are allergic to the active ingredients or to any of the other components of this medication (listed in section 6).

Warnings and precautions

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

Heart problems

Follow the instructions in section 3 if you are taking Movicol for fecal impaction.

Other medications and Movicol

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

Some medications, such as antiepileptics, may not be as effective when taken with Movicol.

Do not take other oral medications from one hour before to one hour after taking Movicol.

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

Pregnancy and breastfeeding

Movicol can be taken during pregnancy and breastfeeding.

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

Driving and operating machines

Movicol does not affect the ability to drive or operate machines.

Movicol contains sodium

Consult your doctor or pharmacist if you need 3 or more packets per day for a prolonged period, especially if you have been recommended a low-sodium diet.

Movicol contains 186.87 mg of sodium (main component of table salt/for cooking) per packet. This is equivalent to 9.3% of the recommended daily maximum sodium intake for an adult.

This medication can be taken at any time without the need to accompany it with food or drink.

Take Movicol directly from the sachet. It is not necessary to dilute it with water.

To maintain good health, including a healthy intestine, it is recommended to drink a sufficient amount of liquids (usually 2 to 2.5 liters per day).

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Constipation:

A dose of Movicol corresponds to a sachet of 25 ml.

Take 1 to 3 sachets per day in divided doses according to your response to Movicol

Fecal impaction:

Before taking Movicol for fecal impaction, it must be confirmed by the doctor that you have this condition.

A dose of 8 sachets per day is required for the treatment of fecal impaction. The 8 sachets should be taken within a six-hour period. If you have heart problems, do not take more than 2 sachets in one hour.

It is recommended to drink an extra 1 liter of liquid per day if you have severe constipation (fecal impaction).

Treatment duration:

Constipation:

The treatment with Movicol usually lasts for about 2 weeks. If you need to take Movicol for more time, consult your doctor. If your constipation is caused by a disease such as Parkinson's or multiple sclerosis, or if you are taking medications that may cause constipation, your doctor may recommend taking Movicol for more than 2 weeks. If you need to take Movicol for a longer period, consult your doctor.

For long-term treatments, the dose can usually be reduced to 1 or 2 sachets per day.

Fecal impaction:

The treatment may last up to 3 days.

If you take more Movicol than you should

You may experience excessive diarrhea, which can lead to dehydration. If this occurs, interrupt the treatment with Movicol and drink plenty of liquid. If you are concerned, consult your doctor or pharmacist.

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 medication and the amount ingested.

If you forgot to take Movicol:

Take your dose as soon as you remember.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Inform your doctor immediately and discontinue treatment with Movicol if you:

Experience a severe allergic reaction that causes difficulty breathing or swelling of the face, lips, tongue, or throat.

Other adverse effects include:

Allergic reactions that may cause skin rash, itching, skin redness, or urticaria, swelling of hands, feet, or ankles, headaches, and high or low levels of potassium in the blood.

In some cases, you may experience indigestion, stomach pain, or rumbling sounds.

You may also feel bloated, have gas, nausea, or vomiting, and may experience pain in the anus and have mild diarrhea when starting to take Movicol. These adverse effects usually improve if you reduce the amount you take of this medication.

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 for Pharmacovigilance of Medicinal Products 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 packaging and the box after EXP..The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Do not refrigerate or freeze.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need.This will help protect the environment.

Composition of Movicol

Each sachet of 25 ml of Movicol contains the following active ingredients:

Macrogol 335013,125 g

Sodium chloride0,3508 g

Sodium hydrogen carbonate0,1786 g

Potassium chloride0,0502 g

Movicol also contains sucralose, purified water and strawberry banana flavor

containing natural flavoring substances (including strawberry and banana fruit extracts), flavoring preparations (including celery) and propylene glycol.

Each sachet of 25 ml is equivalent to:

Sodium8,125 mmol

Chlorine6,675 mmol

Potassium0,675 mmol

Hydrogen carbonate2,125 mmol

Appearance of the product and contents of the packaging

Movicol is a clear, colorless to light yellow liquid.

Movicol is presented in packs of 10, 20, 30 and 50 sachets.

Only some sizes of packaging may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Norgine Healthcare B.V.

Antonio Vivaldistraat 150,

1083 HP Amsterdam,

Netherlands

Manufacturer responsible

Norgine Pharma, 29 Rue Ethé Virton, 28100 Dreux Cedex, France

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Norgine de España, S.L.U.

Paseo de la Castellana, 91, 2nd Floor

28046 Madrid

Spain

This medicine is authorized in themember states of the European Economic Area with the following names:

Last review date of this leaflet:03/2023

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