Leaflet: information for the user

Molaxole powder for oral solution EFG

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 or pharmacist.

-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 or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Molaxole and what it is used for

2. What you need to know before starting to take Molaxole

3. How to take Molaxole

4. Possible side effects

5. Storage of Molaxole

6. Contents of the pack and additional information.

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

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

You should consult a doctor if it worsens or does not improve after 2 weeks. If you are being treated due to severe constipation (also known as fecal impaction) you should follow your doctor's instructions.

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 medication (listed in section 6),

−if you have an intestinal obstruction, intestinal wall perforation, or a severe inflammatory intestinal disease such as ulcerative colitis, Crohn's disease, toxic megacolon, or ileus (intestinal paralysis).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Molaxole.

While taking Molaxole, you must continue to take many liquids. The liquid content of Molaxole should not replace your regular intake of liquids.

If you develop adverse effects such as swelling, shortness of breath, feeling of fatigue, dehydration (symptoms include increased thirst, dry mouth, and weakness) or cardiac problems, discontinue taking Molaxole and inform your doctor immediately.

Do not take Molaxole for prolonged periods of time, unless your doctor advises you to do so, 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 administer this medication to children under 12 years of age.

Other medications and Molaxole

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

Some medications, for example, antiepileptics, may not work as effectively during use with Molaxole.

Molaxole may interact with starch-based thickeners, making preparations that should remain thick for individuals with swallowing problems 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 intend to become pregnant, consult your doctor before using this medication.

Molaxole may be used during pregnancy and breastfeeding.

Driving and operating machinery

Molaxole does not affect the ability to drive or operate machinery.

Molaxole contains sodium

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

Follow exactly the administration instructions of this medication 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, up to 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 two 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 desired, 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 in a period of 6 hours each day, for a period of 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 a 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, discontinue use of Molaxole until symptoms disappear, and restart treatment at a lower dose. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service at telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Molaxole

Do not take a double dose to compensate for missed doses.

Take this medication exactly as described in this leaflet or as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you are unsure.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience 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, hand, foot, or ankle inflammation.

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

Very 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 discontinue treatment with Molaxole. Allergic reactions (e.g., skin reactions and nasal mucositis), high or low levels of potassium in the blood, and anal discomfort.

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

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 Medicines for Human Use:http://www.notificaram.es.By reporting adverse effects, you will be contributing to providing more information about 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 that appears on the packaging and on the box after CAD or EXP..The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature. Store in its original packaging to protect it from moisture. The freshly prepared and ready-to-use solution can be stored well sealed in the refrigerator (2°C to 8°C). Discard any solution that has not been used within a period of six hours.

Medications should not be disposed of through drains or in the trash. Deposit the containers and unused medications at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of the containers and unused medications if you are unsure. By doing so, you will help protect the environment.

Composition of Molaxole

− The active principles 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: potassium acesulfame (E950) (sweetener) and lemon flavor (flavoring agent).

Appearance of Molaxole and content of the container

White powder for oral solution.

Blister packs of 13.8 g in containers of 2, 6, 8, 10, 20, 30, 40, 50, 60, and 100 or 2 x 50 blister packs.

It may only be commercially available in some sizes of containers.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Meda Pharma SL

C/ General Aranaz, 86

28027 Madrid

Spain

Responsible for manufacturing:

Klocke Pharma-Service GmbH

Strassburger Strasse 77, D-77767 Appenweier

Germany

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

Mylan Pharmaceuticals, S.L.

C/ Plom, 2-4, 5th floor

08038 - Barcelona

Spain

This medication is authorized in the member states of the European Economic Area with 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 review of this leaflet: October 2022

The detailed information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es /