MOVICOL Powder for Oral Solution in Sachet

Introduction

Patient Information Leaflet

Movicol Powder for 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 further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

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

1. What is Movicol and what is it used for

The name of this medicine is Movicol Powder for 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 you have an easy bowel movement even when 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 take 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 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 fecal impaction

Other Medicines and Movicol

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

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

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

If you need to thicken fluids 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and Using Machines

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

Movicol Contains Sodium

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

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

3. How to Take Movicol

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

Dissolve the contents of one sachet in 125 ml (half a glass) of water and take it.

Constipation:

One dose of Movicol is equivalent to one sachet dissolved in 125 ml (half a glass) of water.

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

Fecal Impaction:

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

A dose of 8 sachets a day is needed for the treatment of fecal impaction. Each sachet should be dissolved in 125 ml (half a glass) of water. The 8 sachets should be taken over a period of 6 hours and 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 approximately 125 ml (half a glass) of water and stir well until the powder has dissolved completely, resulting in a clear or slightly cloudy solution, and then drink it. If you are taking Movicol for fecal impaction, it may be easier to dissolve the 8 sachets in 1 liter of water.

Duration of Treatment:

Constipation:

Treatment usually lasts for up to 2 weeks. If you need to take Movicol for longer, talk to 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 can cause constipation, your doctor may recommend that you take Movicol for more than 2 weeks. If you need to take Movicol for a longer period, talk to your doctor.

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

Fecal Impaction:

Treatment can 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 happens, stop taking Movicol and drink plenty of fluids. If you are concerned, talk to your doctor or pharmacist.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, stating the medicine and the amount taken.

If You Forget to Take Movicol:

Take your dose as soon as you remember.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor immediately and stop taking 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, headache, 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 or have mild diarrhea when you start taking Movicol. These side effects usually improve if you reduce the amount of Movicol you take.

Reporting Side Effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Movicol

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

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

This medicine does not require any special storage conditions.

Once you have dissolved Movicol in water, if you do not take it immediately, store the solution in the refrigerator (between 2°C and 8°C) and cover it. Discard any solution that has not been used within 6 hours.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the Pack and Further 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 ingredients are: lemon and lime flavor and acesulfame potassium as a sweetener. The lemon and lime flavor is composed of the following ingredients: acacia solids, maltodextrin, lemon oil, lime oil, citral, citric acid, and water.

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

Sodium 65 millimoles/liter

Chloride 53 millimoles/liter

Potassium 5.4 millimoles/liter

Bicarbonate 17 millimoles/liter

Appearance and Packaging of the Product

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

Movicol is a white powder.

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

Not all pack sizes and sachet types may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Norgine Healthcare B.V.

Antonio Vivaldistraat 150

1083 HP Amsterdam

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, Netherlands.

Or

Recipharm Höganäs AB, Sporthallsvägen 6, Höganäs, 263 35, Sweden.

Or

Delpharm Orléans, 5 Avenue de Concyr, Orléans Cedex 2, 45071, France

You can obtain further information on this medicine by contacting 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Date of Last Revision of this Leaflet:03/2023

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