


Ask a doctor about a prescription for MOVICOL NEUTRAL FLAVOR ORAL SOLUTION POWDER IN SACHETS
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.
Contents of the Package Leaflet
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.
Do not take Movicol Neutral Flavor if your doctor has diagnosed you with:
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.
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.
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.
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.
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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Discuss dosage, side effects, interactions, contraindications, and prescription renewal for MOVICOL NEUTRAL FLAVOR ORAL SOLUTION POWDER IN SACHETS – subject to medical assessment and local rules.