Leaflet: information for the patient

MovicolNeutral Taste 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 Movicol Sabor Neutro is and what it is used for

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

3.How to take Movicol Sabor Neutro

4.Possible side effects

5.Storage of Movicol Sabor Neutro

6.Contents of the pack and additional information

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

Movicol Sabor Neutro helps with adequate intestinal movement even when constipation is of long duration. Movicol Sabor Neutro is also effective in the treatment of severe constipation, also known as fecal impaction.

Do not take Movicol Sabor Neutro if your doctor has diagnosed you with:

• intestinal obstruction (intestinal blockage, intestinal paralysis (ileus)),
• intestinal wall perforation,
• severe inflammatory intestinal disease such as ulcerative colitis, Crohn's disease, or toxic megacolon,

• if you are allergic to the active ingredients or any of the other components of this medication (listed in section 6).

Warnings and precautions

When taking Movicol Sabor Neutro, you should continue to drink plenty of liquids. The liquid content of Movicol does not replace your usual intake of liquids.

Cardiac conditions

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

Other medications and Movicol Sabor Neutro

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 Sabor Neutro.

Do not take other oral medications from one hour before to one hour after taking Movicol Sabor Neutro.

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

Pregnancy and breastfeeding

Movicol Sabor Neutro can be taken during pregnancy and breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

Movicol Sabor Neutro does not affect the ability to drive or operate machines.

Movicol Sabor Neutro contains sodium

Consult your doctor or pharmacist if you need to take 3 doses per day for a prolonged period or especially if you have been recommended a low-sodium diet.

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

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

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

Constipation:

The dose of Movicol Sabor Neutro is 1 sachet dissolved in 125 ml (1/2 glass) of water.

Take 1 sachet 1 – 3 times a day according to the severity of constipation.

Fecal impaction:

Before taking Movicol Sabor Neutro for fecal impaction, it is necessary to confirm that you actually suffer from this disease.

For the treatment of fecal impaction, it is necessary to take 8 sachets a day. Each sachet should be dissolved in 125 ml (1/2 glass) of water. The 8 sachets must be taken in 6 hours over 3 days, if necessary. If you have any heart condition, 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 Sabor Neutro solution is clear or slightly turbid, then drink the solution. If you are taking Movicol Sabor Neutro for fecal impaction, it may be easier to dissolve the 8 sachets in 1 liter of water.

Duration of treatment:

Constipation:

The treatment with Movicol Sabor Neutro usually lasts for about 2 weeks. If you need to take Movicol Sabor Neutro for a longer period, please consult your doctor. If constipation is caused by a disease such as Parkinson's or multiple sclerosis or you are taking other medications that cause constipation, your doctor may advise you to take Movicol Sabor Neutro for more than 2 weeks.

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

Fecal impaction:

The treatment with Movicol Sabor Neutro may last up to 3 days.

If you take more Movicol Sabor Neutro than you should:

You may develop excessive diarrhea, which can lead to dehydration. If this occurs, discontinue treatment with Movicol Sabor Neutro until it disappears 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 forgot to take Movicol Sabor Neutro:

Take the dose as soon as you remember that you have to take it.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Inform your doctor immediately and discontinue treatment with Movicol Sabor Neutro if you:

Experience a severe allergic reaction that causes difficulty breathing or dizziness 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.

In some cases, you may experience stomach pain or rumbling sounds. You may also feel bloated, have gas, nausea, or vomiting, and may experience anal pain and mild diarrhea when starting to take Movicol Sabor Neutro.These adverse effects generally improve if you reduce the amount of Movicol Sabor Neutro 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: https://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 usethis medicationafter the expiration date that appears onthe packaging and the boxafter 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 SaborNeutroin 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 24 hours.

Medications should not be thrown away through the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE point of the pharmacy.If in doubtask your pharmacist how to dispose of the containers and medications you no longer need.This will help protect the environment.

Composition of Movicol Sabor Neutro:

Each sachet of Movicol SaborNeutrocontains:

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

Appearance of the productand contents of the packaging of Movicol Sabor Neutro

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

Movicol Sabor Neutro is a white powder.

Movicol SaborNeutrois an oral powder solution. Movicol SaborNeutrois available in boxes of 6, 8, 10, 20, 30, 40, 50, 60 or 100 sachets.

Only some sizes of packaging and sachets may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Norgine Healthcare B.V.

Antonio Vivaldistraat 150

1083 HP Amsterdam

Netherlands

Responsible manufacturer:

SOPHARTEX, 21 rue du Pressoir, 28500 Vernouillet, France

Or

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

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 the member states of the European Economic Area with the following names:

Last review date of this leaflet:03/2023

More 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