Package Leaflet: Information for the Patient

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

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 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 conditions

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 thickener.

Pregnancy and breastfeeding

Movicol can be taken during pregnancy and breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or intend 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 maximum daily sodium intake recommended for an adult.

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

Dissolve the contents of each sachet in 125 ml (1/2 glass) of water and take it.

Constipation:

A dose of Movicol corresponds to a sachet dissolved in 125 ml (1/2 glass) of water.

Take this amount of1 to3 times a day depending on the degree of constipation you have.

Fecal Impaction:

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

A dose of 8 sachets per day is required for the treatment of fecal impaction. Each sachet must be dissolved in 125 ml (1/2 glass) of water. The 8 sachets must be taken within a six-hour period and for 3 days if necessary. If you have a heart condition, do not take more than 2 sachets in an hour.

How to Prepare:

Open the sachet and pour the contents into a glass. Add 125 ml (1/2 glass) of water and stir well until the powder has completely dissolved, leaving a clear or slightly cloudy solution, and then drink it. If you are taking Movicol for fecal impaction, it will be easier to dissolve the 8 sachets in a liter of water.

Treatment Duration:

Constipation:

The treatment usually lasts for about 2 weeks. If you need to take Movicol for a longer period, 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 that you take 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, stop taking 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 Forget to Take Movicol:

Take your dose as soon as you remember.

Like all medications, this medication may produce adverse effects, although not everyone will 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, hand, foot, or ankle inflammation, headaches, and high or low levels of potassium in the blood.

You may also experience indigestion, stomach pain, or rumbling sounds.

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

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: 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.

This medication does not require special storage conditions.

Once you have dissolved Movicol in water, if you do not take it immediately, store the solution covered and in the refrigerator (between 2°C and8°C). Discard any solution that has not been used in 6 hours.

Medications should not be thrown down the drain or in the trash. Deposit the containers and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medications.This will help protect the environment.

Composition of Movicol

Each sachet of Movicol contains:

Macrogol 335013,125 g

Sodium Chloride0,3507 g

Sodium Bicarbonate0,1785 g

Potassium Chloride0,0466 g

The other components are:lemon-lime aroma and potassium acesulfame as a sweetener. The lemon-lime aroma 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 contains:

Sodium65 millimoles/litre

Chloride53 millimoles/litre

Potassium5.4 millimoles/litre

Bicarbonate17 millimoles/litre

Appearance of the product and contents of the packaging

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

Movicol is a white powder.

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

Only some sizes of packaging and sachets may be marketed.

Marketing Authorization Holder and Responsible for Manufacturing

Marketing Authorization Holder:

Norgine Healthcare B.V.

Antonio Vivaldistraat 150

1083 HP Amsterdam

Netherlands

Responsible for Manufacturing

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 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

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