MOLAXOLE powder for oral solution

Introduction

Leaflet: Information for the user

Molaxole powder for oral solution EFG

Macrogol 3350, Sodium chloride, Sodium bicarbonate, Potassium chloride

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine 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 or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Molaxole and what is it used for
2. What you need to know before taking Molaxole
3. How to take Molaxole
4. Possible side effects
5. Storage of Molaxole
6. Package contents and additional information.

1. What is Molaxole and what is it used for

Molaxole helps to have an adequate intestinal transit even if you have been suffering from constipation for a long time. After consulting a doctor, Molaxole can also be used in the treatment of severe constipation (also called fecal impaction).

Macrogol 3350 increases the volume of the stool thanks to the reabsorption of water in the intestine, which produces a normalization of the intestinal movement in the colon. The physiological consequences are an increased movement of the softened stool, which facilitates defecation. The salts in the formulation help maintain the normal balance of salts and water in the body.

You should consult a doctor if your symptoms worsen or do not improve after 2 weeks. If you are being treated for severe constipation (also called fecal impaction), you should follow your doctor's instructions.

2. What you need to know before taking Molaxole

Do not take Molaxole

• if you are allergic to the active ingredients (macrogol, sodium chloride, potassium chloride, or sodium bicarbonate) or to any of the other components of this medicine (listed in section 6),
• if you have an intestinal obstruction, perforation of the intestinal wall, or a severe inflammatory intestinal disease such as ulcerative colitis, Crohn's disease, toxic megacolon, or ileus (paralysis of the intestine).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Molaxole.

When taking Molaxole, you should continue to drink plenty of fluids. The liquid content of Molaxole should not replace your regular fluid intake.

If you develop side effects such as bloating, shortness of breath, feeling of tiredness, dehydration (symptoms include increased thirst, dry mouth, and weakness), or heart problems, stop taking Molaxole and inform your doctor immediately.

Do not take Molaxole for prolonged periods of time, unless your doctor tells you to, for example, if you are taking medications that can cause constipation or if you have a disease that can cause constipation, such as Parkinson's disease or multiple sclerosis (MS).

Children

Do not give this medicine to children under 12 years of age.

Other medicines and Molaxole

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some medicines, for example, antiepileptics, may not work as effectively during use with Molaxole. No other oral medicines should be taken from one hour before to one hour after taking Molaxole.

Molaxole may interact with starch-based food thickeners, causing the preparations that should remain thick for people with swallowing problems to liquefy. Molaxole should be used with caution when used with starch-based thickeners.

Pregnancy, breastfeeding, and fertility

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

Molaxole can be used during pregnancy and breastfeeding.

Driving and using machines

Molaxole does not affect the ability to drive or use machines.

Molaxole contains sodium

This medicine contains 187 mg of sodium (a major component of table/cooking salt) in each sachet. This is equivalent to 9.5% of the maximum recommended daily sodium intake for an adult.

3. How to take Molaxole

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose for constipation is:

1 sachet, one to three times a day. The normal dose for most patients is 1 to 2 sachets per day. Depending on the individual response, 3 sachets per day may be needed. The dose depends on the severity of your constipation. The dose can be reduced to the lowest effective dose after a couple of days. The treatment period is normally two weeks.

If symptoms persist after 2 weeks of treatment, contact your doctor.

Mix the contents of 1 sachet with half a glass of water (approximately 125 ml). Shake until the powder is dissolved and drink. If you wish, you can add fruit juice or nectar immediately before drinking.

Children (under 12 years of age): not recommended.

The recommended dose for fecal impaction is:

Adults: The usual dose is 8 sachets per day. The 8 sachets should be taken over a period of 6 hours each day, for up to 3 days if necessary. The treatment period for fecal impaction is normally not more than 3 days.

If you use Molaxole for the treatment of fecal impaction, you can mix 8 sachets in 1 liter of water. The solution can be stored in the refrigerator.

Patients with altered cardiovascular function:

For the treatment of fecal impaction, the dose should be divided so that no more than two sachets are taken in one hour.

Patients with renal insufficiency:

No dose adjustment is necessary for the treatment of constipation or fecal impaction.

If you take more Molaxole than you should

If you take an excessive amount of Molaxole and experience intense diarrhea or start vomiting, stop using Molaxole until the symptoms disappear, and restart the treatment afterwards at a lower dose. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service phone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Molaxole

Do not take a double dose to make up for forgotten doses.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has indicated. Consult your doctor or pharmacist if you are unsure.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Very common (may affect more than 1 in 10 people):stomach pain and cramps, diarrhea, vomiting, nausea, stomach noises, and flatulence (gas).

Common (may affect up to 1 in 10 people): itching, headache, swelling of hands, feet, or ankles.

Uncommon (may affect up to 1 in 100 people):skin rash (exanthema), indigestion, and stomach bloating.

Rare (may affect up to 1 in 10,000 people):severe allergic reactions that cause difficulty breathing or swelling in the face, lips, tongue, or throat. If you experience any of these effects, please inform your doctor immediately and stop the treatment with Molaxole. Allergic reactions (e.g., skin and mucous membrane reactions), high or low potassium levels in the blood, and anal discomfort.

Frequency not known (frequency cannot be estimated from the available data):change in the levels of fluids or electrolytes in your body (low sodium levels).

Reporting of side effects:

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

5. Storage of Molaxole

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

Do not use this medicine after the expiration date stated on the sachet and carton after CAD or EXP.The expiration date is the last day of the month indicated.

This medicine does not require any special storage temperature. Store in the original package to protect from moisture. The freshly prepared solution ready for use can be stored tightly closed in the refrigerator (2°C to 8°C). Discard any solution that has not been used within six hours.

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

6. Package contents and additional information

Composition of Molaxole

• The active ingredients are: macrogol 3350 (also known as polyethylene glycol 3350) 13.125 g, sodium chloride 350.7 mg, sodium bicarbonate 178.5 mg, potassium chloride 46.6 mg.
• The other ingredients (excipients) are: potassium acesulfame (E950) (sweetener) and lemon flavor (flavoring agent).

Appearance of Molaxole and package contents

White powder for oral solution.

Sachets of 13.8 g in packages of 2, 6, 8, 10, 20, 30, 40, 50, 60, and 100 or 2x50 sachets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

Lamp San Prospero S.p.A.

Via della Pace, 25/A

41030 - San Prospero (MO)

Italy

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Mylan Pharmaceuticals, S.L.

C/ Plom, 2-4, 5th floor

08038 - Barcelona

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Denmark, Norway, Finland, Hungary, Iceland, and Sweden: Moxalole.

Austria, Belgium, Bulgaria, Cyprus, Estonia, Spain, Italy, Ireland, Latvia, Lithuania, Luxembourg, Romania, Slovenia, Netherlands, Portugal, and United Kingdom: Molaxole.

Poland: Duphagol.

Date of the last revision of this leaflet:April 2025

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