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MOVICOL NEUTRAL FLAVOR ORAL SOLUTION POWDER IN SACHETS

MOVICOL NEUTRAL FLAVOR ORAL SOLUTION POWDER IN SACHETS

Ask a doctor about a prescription for MOVICOL NEUTRAL FLAVOR ORAL SOLUTION POWDER IN SACHETS

This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use MOVICOL NEUTRAL FLAVOR ORAL SOLUTION POWDER IN SACHETS

Introduction

Package Leaflet: Information for the Patient

MovicolNeutral Flavor Powder for Oral Solution in Sachet

Macrogol 3350, Sodium Chloride, Sodium Bicarbonate, Potassium Chloride

Read this entire leaflet carefully before starting to take this medication, as 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 medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

  1. What is Movicol Neutral Flavor and what is it used for
  2. What you need to know before taking Movicol Neutral Flavor
  3. How to take Movicol Neutral Flavor
  4. Possible side effects
  5. Storage of Movicol Neutral Flavor
  6. Package Contents and Additional Information

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

The name of this medication is Movicol Neutral Flavor 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 Neutral Flavor helps with proper intestinal movement even when constipation is long-lasting. Movicol Neutral Flavor is also effective in the treatment of severe constipation, also known as fecal impaction.

2. What you need to know before taking Movicol Neutral Flavor

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

  • intestinal obstruction (obstruction of the intestine, intestinal paralysis),
  • perforation of the intestinal wall,
  • a 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 Neutral Flavor, you should continue to drink plenty of fluids. The liquid content of Movicol does not replace your usual fluid intake.

Cardiac Conditions

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

Other Medications and Movicol Neutral Flavor

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Some medications, such as antiepileptics, may not be as effective when taken with Movicol Neutral Flavor.

Do not take other oral medications from one hour before to 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 thickener.

Pregnancy and Breastfeeding

Movicol Neutral Flavor 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 Using Machines

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

Movicol Neutral Flavor Contains Sodium

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

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

3. How to Take Movicol Neutral Flavor

This medication 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 Neutral Flavor is 1 sachet dissolved in 125 ml (1/2 glass) of water.

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

Fecal Impaction:

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

For the treatment of fecal impaction, it is necessary to take 8 sachets per day. Each sachet should be dissolved in 125 ml (1/2 glass) of water. The 8 sachets should be taken over 6 hours for 3 days, if necessary. If you have any cardiac conditions, 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. Shake well until the powder is dissolved and the Movicol Neutral Flavor solution is clear or slightly cloudy, then drink the solution. If you are taking Movicol Neutral Flavor for fecal impaction, it may be easier to dissolve the 8 sachets in 1 liter of water.

Duration of Treatment:

Constipation:

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

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

Fecal Impaction:

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

If You Take More Movicol Neutral Flavor Than You Should:

You may develop excessive diarrhea, which can lead to dehydration. If this happens, stop treatment with Movicol Neutral Flavor until it disappears and drink plenty of fluids. 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Movicol Neutral Flavor:

Take the dose as soon as you remember you need to take it.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

Tell your doctor immediately and stop treatment with Movicol Neutral Flavor if you:

Experience a severe allergic reaction that causes difficulty breathing or dizziness 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, headaches, and high or low potassium levels in the blood.

In some cases, you may experience stomach pain or rumbling. You may also feel bloated, have gas, nausea, or vomiting, and you may experience anal pain (lower part) and may have mild diarrhea when you start taking Movicol Neutral Flavor. These side effects usually improve if you reduce the amount of Movicol Neutral Flavor you take.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Movicol Neutral Flavor

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

Do not use this medication after the expiration date shown on the sachet and carton 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 Neutral Flavor in water, if you do not take it immediately, store the solution covered and in the refrigerator (between 2°C and 8°C). Discard any solution that has not been used within 24 hours.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Movicol Neutral Flavor:

Each sachet of Movicol Neutral Flavor contains:

Macrogol 3350

13.125 g

Sodium Chloride

0.3508 g

Sodium Bicarbonate

0.1786 g

Potassium Chloride

0.0502 g

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

Sodium

65 mmol/liter

Chloride

53 mmol/liter

Potassium

5.4 mmol/liter

Bicarbonate

17 mmol/liter

Appearance of the Product and Package Contents of Movicol Neutral Flavor

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

Movicol Neutral Flavor is a white powder.

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

Not all pack sizes and sachet sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Norgine Healthcare B.V.

Antonio Vivaldistraat 150

1083 HP Amsterdam

Netherlands

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 medication from 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 medication is authorized in the member states of the European Economic Area under the following names:

Belgium

MOVICOL Neutral

Spain

MOVICOL Neutral Flavor

Finland

MOVICOL Plain

Ireland

MOVICOL Plain

Italy

MOVICOL 13.7 g powder for oral solution, Without Aroma

Sweden

Movicol Neutral

Date of the Last Revision of this Leaflet:03/2023

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

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