MOVICOL POWDER FOR ORAL SOLUTION IN SACHET

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Movicol powder for oral solution in sachet

Macrogol 3350, Sodium chloride, Sodium bicarbonate, Potassium chloride

Read the entire 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 could 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.

Leaflet contents

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 adverse 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 powder for 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 you have 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.

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

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

• intestinal obstruction
• intestinal perforation
• severe 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 ingredients 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 normal fluid intake.

Heart conditions

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

Other medicines and Movicol

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

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

Other oral medicines should not be taken within one hour before or one hour after taking Movicol.

If you need to thicken liquids to swallow them safely, Movicol may counteract 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 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, or especially if you have been advised to follow a low-salt (low-sodium) diet.

Movicol contains 186.87 mg of sodium (main component of table/cooking salt) per sachet. This corresponds 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 and does not need to be taken with food.

Dissolve the contents of each sachet in 125 ml (½ glass) of water and drink it.

Constipation:

One dose of Movicol corresponds to one sachet dissolved in 125 ml (½ glass) of water.

Take this amount 1 to 3 times a day, depending on the severity of your constipation.

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. Each sachet must be dissolved in 125 ml (½ glass) of water. The 8 sachets should be taken within a six-hour period and continued for up to 3 days if necessary. If you have heart problems, do not take more than 2 sachets in one hour.

How to prepare:

Open the sachet and pour the contents into a glass. Add about 125 ml (½ glass) of water and stir well until the powder has completely dissolved, resulting in a clear or slightly cloudy solution, then drink it. If you are taking Movicol for faecal impaction, it may be easier to dissolve the 8 sachets in one litre of water.

Duration of treatment:

Constipation:

Treatment usually lasts about 2 weeks. If you need to take Movicol for longer, consult your doctor. If your constipation is caused by a condition 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 an extended period, consult your doctor.

For long-term treatment, the dose is usually 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 at 91 562 04 20, indicating the name of the medicine and the amount ingested.

If you forget to take Movicol:

Take the missed dose as soon as you remember.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody gets them.

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

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

Other adverse effects include:

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

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

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

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 the 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.

This medicine does not require any special storage conditions.

Once Movicol has been dissolved in water, if it is not taken immediately, store the solution covered and in the refrigerator (between 2°C and 8°C). Discard any solution not used within 6 hours.

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

6. Contents of the pack and other information

Composition of Movicol

Each sachet of Movicol contains:

Macrogol 3350 13.125 g

Sodium chloride 0.3507 g

Sodium bicarbonate 0.1785 g

Potassium chloride 0.0466 g

The other components are: lime-lemon flavour and potassium acesulfame as sweetener. The lime-lemon flavour consists of the following ingredients: acacia solids, maltodextrin, lime oil, lemon oil, citral, citric acid and water.

When one sachet is dissolved in 125 ml of water, the solution contains:

Sodium 65 millimoles/litre

Chloride 53 millimoles/litre

Potassium 5.4 millimoles/litre

Bicarbonate 17 millimoles/litre

Presentation of the product and contents of the pack

Movicol is available in rectangular sachets and in tubular sachets (sticks).

Movicol is a white powder.

Movicol is supplied in cartons containing 2, 6, 8, 10, 20, 30, 50, 60 or 100 sachets.

Only certain pack sizes and sachet types may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Norgine Healthcare B.V.

Antonio Vivaldistraat 150

1083 HP Amsterdam

The Netherlands

Manufacturer

Laboratoires Macors, Rue des Caillottes, ZI de la Plaine des Isles, F-89000, Auxerre, France.

Or

Sophartex, 21 rue du Pressoir, 28500, Vernouillet, France.

Or

Norgine BV, Antonio Vivaldistraat 150, 1083 HP Amsterdam, The Netherlands.

Or

Meribel Pharma Höganäs AB, Sporthallsvägen 6, 263 35 Höganäs, Sweden.

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Norgine de España, S.L.U.

Paseo de la Castellana, 91, 2ª Planta

28046 Madrid

Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: 03/2023

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