Movicol flavor-free powder for oral solution in sachet

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Movicol Neutral Flavour 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 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.

Leaflet contents

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

1. What Movicol Neutral Flavour is and what it is used for

The name of this medicine is Movicol Neutral Flavour 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 Neutral Flavour helps achieve proper bowel movements even when constipation is long-standing. Movicol Neutral Flavour is also effective in the treatment of severe constipation, also known as faecal impaction.

2. What you need to know before starting to take Movicol Neutral Flavor

Do not take Movicol Neutral Flavor if your doctor has diagnosed you with:

• intestinal obstruction (blockage of the intestine, intestinal paralysis (ileus)),

• perforation of the intestinal wall,

• a severe inflammatory bowel disease such as ulcerative colitis, Crohn's disease, 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 Neutral Flavor, you should continue to drink plenty of fluids. The liquid content of Movicol does not replace your normal fluid intake.

Heart conditions

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

Other medicines and Movicol Neutral Flavor

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 administered together with Movicol Neutral Flavor.

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

If you need to thicken liquids to swallow them safely, Movicol Neutral Flavor may neutralize the effect of the thickening agent.

Pregnancy and breastfeeding

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

Movicol Neutral Flavor contains sodium

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

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

3. How to take Movicol Neutral Flavour

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

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

Constipation:

The dose of Movicol Neutral Flavour is 1 sachet dissolved in 125 ml (½ glass) of water.

Take 1 sachet 1–3 times a day, depending on the severity of constipation.

Faecal impaction:

Before taking Movicol Neutral Flavour for faecal impaction, it must be confirmed that you actually have this condition.

For the treatment of faecal impaction, it is necessary to take 8 sachets per day. Each sachet must be dissolved in 125 ml (½ glass) of water. The 8 sachets should be taken within 6 hours, over 3 days if necessary. If you have any cardiac disorder, do not take more than 2 sachets per hour.

How to prepare

Open the sachet and pour the contents into a glass. Add approximately 125 ml of water to the glass. Stir well until the powder has dissolved and the Movicol Neutral Flavour solution is clear or slightly cloudy, then drink the solution. If you are taking Movicol Neutral Flavour for faecal impaction, it may be easier to dissolve the 8 sachets in 1 litre of water.

Duration of treatment:

Constipation:

Treatment with Movicol Neutral Flavour normally lasts about 2 weeks. If you need to take Movicol Neutral Flavour for a longer period, please consult your doctor. If your constipation is caused by a disease such as Parkinson's disease or multiple sclerosis, or if you are taking other medicines that cause constipation, your doctor may advise you to take Movicol Neutral Flavour for longer than 2 weeks.

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

Faecal impaction:

Treatment with Movicol Neutral Flavour may last up to 3 days.

If you take more Movicol Neutral Flavour than you should:

You may develop excessive diarrhoea, which could lead to dehydration. If this occurs, stop treatment with Movicol Neutral Flavour until symptoms resolve, 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 Neutral Flavour:

Take the dose as soon as you remember.

4. Possible adverse effects

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

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

Experience a severe allergic reaction causing difficulty breathing, dizziness, 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, headaches, and high or low blood potassium levels.

In some cases, you may experience stomach pain or noises. You may also feel bloated, have gas, nausea or vomiting. You may also experience pain in the anus (bottom) and may have mild diarrhoea when you start taking Movicol Sabor Neutro. These adverse effects usually improve if the dose of Movicol Sabor Neutro is reduced.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Movicol Neutral Flavour

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 the 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 Neutral Flavour has been dissolved in water, if it is not taken immediately, store the solution covered and in the refrigerator (between 2ºC and 8ºC). Discard any solution not used within 24 hours.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials should be handed over to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Movicol Neutral Flavour:

Each sachet of Movicol Neutral Flavour contains:

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

Pharmaceutical form and contents of the packaging of Movicol Neutral Flavour

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

Movicol Neutral Flavour is a white powder.

Movicol Neutral Flavour is a powder for oral solution. Movicol Neutral Flavour is available in packs of 6, 8, 10, 20, 30, 40, 50, 60 or 100 sachets.

Only certain pack sizes and sachet types may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Norgine Healthcare B.V.

Antonio Vivaldistraat 150

1083 HP Amsterdam

The Netherlands

Manufacturer:

SOPHARTEX, 21 rue du Pressoir, 28500 Vernouillet, France

Or

Norgine B.V., Antonio Vivaldistraat 150, 1083 HP Amsterdam, The Netherlands.

For further information on this medicinal product, please 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 European Economic Area member states under the following names:

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

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