Movicol oral solution in sachet

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Movicol oral solution in sachet

Macrogol 3350, Sodium chloride, Sodium bicarbonate, Potassium chloride

Read all of 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Movicol is and what it is used for

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

Movicol helps to achieve easy bowel movements, even if you have been 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 your condition worsens.

2. What you need to know before taking Movicol

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

• intestinal obstruction (blockage of the intestine, ileus)
• intestinal perforation (tear in the intestinal wall)
• a serious inflammatory bowel disease 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 medicine (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 usual fluid intake.

Heart problems

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

Other medicines and Movicol

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

Some medicines, such as antiepileptic drugs, may be less effective when taken together with Movicol.

Do not take other oral medicines within one hour before or one hour after taking Movicol.

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

Pregnancy and breastfeeding

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

Movicol contains sodium

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

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

3. How to take Movicol

This medicine can be taken at any time of day, without the need to accompany it with food or drink.

Take Movicol directly from the sachet. It is not necessary to dissolve it in water.

To maintain good health, including a healthy bowel, it is recommended to drink an adequate amount of fluids (generally 2 to 2.5 litres per day).

Always follow exactly the instructions for use given by your doctor or pharmacist. In case of doubt, please ask your doctor or pharmacist.

Constipation:

One dose of Movicol corresponds to one 25 ml sachet.

Take 1 to 3 sachets daily, divided into doses according to your response to Movicol.

Faecal impaction:

Before taking Movicol for faecal impaction, a doctor must confirm that you have this condition.

A dose of 8 sachets per day is required for the treatment of faecal 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 additional 1 litre of fluid per day if you have severe constipation (faecal impaction).

Duration of treatment:

Constipation:

Treatment with Movicol usually lasts about 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 disease or multiple sclerosis, or if you are taking medicines that may cause constipation, your doctor may recommend taking Movicol for longer than 2 weeks. If you need to take Movicol for a longer period, consult your doctor.

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

Faecal impaction:

Treatment may last up to 3 days.

If you take more Movicol than you should

You may experience excessive diarrhoea, which could 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Movicol:

Take your dose as soon as you remember.

4. Possible adverse effects

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

Immediately contact your doctor and stop treatment with Movicol if you:

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

Other adverse effects include:

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

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

You may also feel bloated, have gas, nausea, or vomiting. You may also experience pain around the anus and mild diarrhoea when you first start taking Movicol. These adverse effects usually improve if the dose of this medicine is reduced.

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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Movicol

Keep this medicine out of sight and reach of children.

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

Do not store above 30°C.

Do not refrigerate or freeze.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their packaging should be taken to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Movicol

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

Macrogol 3350 13.125 g

Sodium chloride 0.3508 g

Sodium hydrogen carbonate 0.1786 g

Potassium chloride 0.0502 g

Movicol also contains sucralose, purified water and strawberry-banana flavouring,
containing natural flavouring substances (including strawberry and banana fruit extracts), flavouring 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

Hydrogen carbonate 2.125 mmol

Appearance of the product and contents of the pack

Movicol is a clear, colourless to pale yellow liquid.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Norgine Healthcare B.V.

Antonio Vivaldistraat 150,

1083 HP Amsterdam,

The Netherlands

Manufacturer

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

For further information about this medicinal product, 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 review of this leaflet: 03/2023

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