Molaxole powder for oral solution EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Molaxole powder for oral solution EFG
Macrogol 3350, Sodium chloride, Sodium bicarbonate, Potassium chloride
Read the entire 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 questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Molaxole is and what it is used for
- What you need to know before taking Molaxole
- How to take Molaxole
- Possible side effects
- How to store Molaxole
- Contents of the pack and other information
1. What Molaxole is and what it is used for
Molaxole helps achieve regular intestinal transit, even if you have suffered from constipation for a long time. After consulting a doctor, Molaxole may also be used in the treatment of severe constipation (also called fecal impaction).
Macrogol 3350 increases stool volume by retaining water in the intestine, thereby normalizing intestinal movement in the colon. The physiological effect is an increased passage of softened stools, which facilitates defecation. The electrolytes in the formulation help maintain the body's normal balance of salts and water.
You should consult a doctor if your condition worsens or does not improve after 2 weeks. If you are being treated for severe constipation (also called fecal impaction), you must follow your doctor's instructions.
2. What you need to know before starting to take Molaxole
Do not take Molaxole
- if you are allergic to the active substances (macrogol, sodium chloride, potassium chloride, or sodium bicarbonate) or to any of the other ingredients of this medicine (listed in section 6),
- if you have intestinal obstruction, intestinal wall perforation, or a severe inflammatory bowel disease such as ulcerative colitis, Crohn's disease, toxic megacolon, or ileus (intestinal paralysis).
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Molaxole.
When taking Molaxole, you should continue drinking plenty of fluids. The liquid content of Molaxole should not replace your regular fluid intake.
If you develop adverse effects such as swelling, shortness of breath, feeling tired, dehydration (symptoms include increased thirst, dry mouth, and weakness), or heart problems, stop taking Molaxole and contact your doctor immediately.
Do not take Molaxole for prolonged periods unless your doctor advises otherwise, for example, if you are taking medications that may cause constipation or if you have a condition that may 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 need to take any other medicines.
Some medicines, for example antiepileptics, may not work as effectively when taken with Molaxole. Other oral medicines should not be taken within one hour before or one hour after taking Molaxole.
Molaxole may interact with starch-based food thickeners, causing thickened preparations to liquefy. These preparations are intended to remain thick for people with swallowing difficulties. Use Molaxole with caution when using starch-based thickeners.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
Molaxole may be used during pregnancy and breastfeeding.
Driving and using machines
Molaxole does not affect the ability to drive or operate machinery.
Molaxole contains sodium
This medicine contains 187 mg of sodium (main component of table/cooking salt) per sachet. This is equivalent to 9.5% of the maximum daily recommended intake of sodium for an adult.
3. How to take Molaxole
Follow exactly the instructions for use of this medicine as given 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 daily. The usual dose for most patients is 1 to 2 sachets per day. Depending on individual response, up to 3 sachets per day may be required. The dose depends on the severity of your constipation. After a few days, the dose may be reduced to the lowest effective dose. 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 it. If desired, you may 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 within a 6-hour period each day, for up to 3 days if necessary. The treatment period for fecal impaction is normally no longer than 3 days.
If you are using Molaxole for the treatment of fecal impaction, you may mix 8 sachets in one liter of water. The solution can be stored in the refrigerator.
Patients with impaired cardiovascular function:
For the treatment of fecal impaction, the dose should be divided so that no more than two sachets are taken within one hour.
Patients with renal insufficiency:
Dose adjustment is not necessary for the treatment of either constipation or fecal impaction.
If you take more Molaxole than you should
If you take an excessive amount of Molaxole and experience severe diarrhea or begin to vomit, stop using Molaxole until symptoms subside, then restart treatment at a lower dose. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone 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 use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed. Consult your doctor or pharmacist if you are unsure.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Very common (may affect more than 1 in 10 people): stomach pain and cramps, diarrhoea, vomiting, nausea, stomach rumbling 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.
Very rare (may affect up to 1 in 10,000 people): severe allergic reactions causing difficulty breathing, or swelling of the face, lips, tongue or throat. If you experience any of these effects, please inform your doctor immediately and discontinue treatment with Molaxole. Allergic reactions (e.g. skin reactions and nasal mucous discharge), high or low blood potassium levels, and anal discomfort.
Frequency not known (frequency cannot be estimated from available data): changes in fluid or electrolyte levels in your body (low sodium levels).
Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse 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 expiry date stated on the sachet and carton after CAD or EXP. The expiry date is the last day of the month indicated.
This medicine does not require any special storage temperature. Store in the original container to protect it from moisture. The freshly prepared solution for use may be stored, well covered, in the refrigerator (2°C to 8°C). Discard any unused solution after six hours.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Molaxole
- The active substances 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 components (excipients) are: acesulfame potassium (E950) (sweetener) and lemon flavour (flavouring).
Appearance of Molaxole and contents of the pack
White powder for oral solution.
13.8 g sachets in packs of 2, 6, 8, 10, 20, 30, 40, 50, 60 and 100 or 2x50 sachets.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Mylan Pharmaceuticals, S.L.
C/ Plom, 2-4, 5th floor
08038 - Barcelona
Spain
This medicinal product is authorised in the European Economic Area countries 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, the Netherlands, Portugal and the United Kingdom: Molaxole.
Poland: Duphagol.
Date of the most recent revision of this leaflet: April 2025
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/