MOVICOL ORAL SOLUTION IN SACHET

Introduction

Package Leaflet: Information for the Patient

Movicol Oral Solution in Sachet

Macrogol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride

Read this entire leaflet carefully before starting to take this medication, as 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 medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Movicol and what is it used for
2. What you need to know before taking Movicol
3. How to take Movicol
4. Possible side effects
5. Storage of Movicol
6. Package Contents and Additional Information

1. What is Movicol and what is it used for

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 an easy bowel movement, even when constipated for a long time. Movicol is also effective in resolving fecal impaction, a complication of severe constipation.

Talk to your doctor if you do not feel better within 2 weeks or if you get worse.

2. What you need to know before taking Movicol

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

• intestinal obstruction (obstruction of the intestine, 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 substances 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 fluids. The liquid content of Movicol does not replace your normal fluid intake.

Heart Problems

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

Other Medications and Movicol

Tell your doctor or pharmacist if you are taking, have recently taken, or may 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 swallow them safely, Movicol may neutralize the effect of the thickener.

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 Using Machines

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

Movicol Contains Sodium

Consult your doctor or pharmacist if you need to take 3 or more sachets per day for an extended period or especially if you have been advised to follow a low-salt diet (sodium).

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

3. How to Take Movicol

This medication can be taken at any time without the need for food or drink.

Take Movicol directly from the sachet. It does not need to be diluted with water.

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

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Constipation:

A dose of Movicol corresponds to one 25 ml sachet.

Take 1 to 3 sachets per day in divided doses depending on your response to Movicol.

Fecal Impaction:

Before taking Movicol for fecal impaction, your doctor must confirm that you have this condition.

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

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

Duration of Treatment:

Constipation:

Treatment with Movicol usually lasts for 2 weeks. If you need to take Movicol for longer, 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 can 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:

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, stop treatment with Movicol and drink plenty of fluids. 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Movicol:

Take your dose as soon as you remember.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Tell your doctor immediately and stop treatment with Movicol if you:

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

Other side effects include:

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

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

Additionally, you may feel bloated, have gas, nausea, or vomiting, and you may also experience anal pain and may have mild diarrhea when you start taking Movicol. These side effects usually improve if you reduce the amount you take of this medication.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Movicol

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

Do not use this medication after the expiration date shown on the sachet and carton after EXP. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Do not refrigerate or freeze.

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

6. Package Contents and Additional Information

Composition of Movicol

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

Macrogol 3350 13.125 g

Sodium Chloride 0.3508 g

Sodium Bicarbonate 0.1786 g

Potassium Chloride 0.0502 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 25 ml sachet is equivalent to:

Sodium 8.125 mmol

Chloride 6.675 mmol

Potassium 0.675 mmol

Bicarbonate 2.125 mmol

Appearance of the Product and Package Contents

Movicol is a clear, colorless to light yellow liquid.

Movicol is available in cartons of 10, 20, 30, and 50 sachets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Norgine Healthcare B.V.

Antonio Vivaldistraat 150,

1083 HP Amsterdam,

Netherlands

Manufacturer

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

You can request more information about this medication 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 medication is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Leaflet:03/2023

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