MOLAXOLE

Patient information leaflet

Molaxole powder for oral solution

macrogol 3350
sodium chloride
sodium bicarbonate
potassium chloride
equivalent medicine
Please read all of this leaflet carefully before you take this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms seem identical to yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Molaxole is and what it is used for
2. What you need to know before taking Molaxole
3. How to take Molaxole
4. Possible side effects
5. How to store Molaxole
6. Contents of the pack and other information

1. What Molaxole is and what it is used for

Molaxole helps you achieve adequate bowel movement even if you have experienced a prolonged period of constipation. After consulting your doctor, you may also use Molaxole for the treatment of persistent constipation (called fecal impaction).
Macrogol 3350 increases stool volume by binding water, leading to normalization of colonic motility. The physiological effects are improved propulsive movement of softened stools and easier defecation. The salts present in the formulation help maintain the body's normal fluid and electrolyte balance.
You should consult your doctor if you do not feel better or if you feel worse after 2 weeks of constipation. If you are being treated for very severe constipation (called fecaloma), you must follow your doctor's instructions.

2. What you need to know before using Molaxole

Do not take Molaxole

• if you are allergic to any of 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 disease of the intestinal tract such as ulcerative colitis, Crohn's disease, ileus or toxic megacolon.

Warnings and precautions
Talk to your doctor or pharmacist before using Molaxole.
While taking Molaxole, you must continue to drink plenty of fluids. The fluid content of Molaxole should not replace your normal daily fluid intake.
If you develop side effects such as swelling, shortness of breath, fatigue, dehydration (symptoms include increased thirst, dry mouth and weakness) or heart problems, stop taking Molaxole and speak to your doctor immediately.
If, for example, you are taking medicines that cause constipation, or if you suffer from diseases causing constipation such as Parkinson’s disease or multiple sclerosis (MS), do not take Molaxole for longer than recommended unless specifically instructed by your doctor.
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, such as antiepileptics, may not work effectively during treatment with Molaxole. Therefore, you should not take any other oral medicines at the same time as Molaxole, or within one hour before or one hour after taking Molaxole.
Molaxole may interact with starch-based food thickeners, causing liquefaction of preparations that should remain thickened for people with swallowing difficulties. Molaxole should be used with caution when taken together with starch-based thickeners.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Molaxole can be used during pregnancy and breastfeeding.
Driving and using machines
There are no effects on the ability to drive or operate machinery.
Molaxole contains sodium
This medicine contains 187 mg of sodium (a main component of table salt) per sachet. This corresponds to 9.5% of the maximum daily recommended dietary intake of sodium for an adult.

3. How to use Molaxole

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose for constipation is:
1 sachet 1-3 times daily. The usual dose for most patients is 1-2 sachets daily. Depending on individual
response, up to 3 sachets daily may be required. The dose depends on the severity of your constipation.
The dose may be reduced to the lowest effective dose after a few days. The usual duration of treatment is
normally 2 weeks. If symptoms persist after 2 weeks of treatment, consult your doctor.
Dissolve the contents of one sachet in half a glass of water (approximately 125 ml). Mix until the powder has
dissolved and drink. If desired, you may add fruit juice or fruit syrup just before drinking.
Children (under 12 years of age): not recommended.
The recommended dose for faecal 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 required. A treatment cycle for faecal impaction normally does not exceed 3 days. If you are using Molaxole for the treatment of faecal impaction, dissolve 8 sachets in one litre of water. The solution may then be stored in the refrigerator.
Patients with impaired cardiovascular function:
For the treatment of faecal impaction, the dose should be divided so that no more than two sachets are taken within one hour.
Patients with renal impairment:
Dose adjustment is not necessary for the treatment of either constipation or faecal impaction.
If you take more Molaxole than you should
If you take too much Molaxole and experience severe diarrhoea or begin to vomit, stop taking Molaxole until these symptoms resolve, then you may restart at a lower dose. If you are concerned, contact your doctor or pharmacist.
If you forget to take Molaxole
Do not take a double dose to make up for a forgotten dose.
Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Molaxole can cause side effects, although not everyone experiences them.
Very common (may affect more than 1 in 10 people): Stomach ache and cramps, diarrhoea, vomiting,
nausea, stomach rumbling and gastrointestinal gas problems.
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 reactions, digestive disorders and bloated stomach.
Very rare (may affect up to 1 in 10,000 people): Severe allergic reactions causing breathing difficulties, or swelling of the face, lips, tongue or throat. If you experience any of these symptoms, contact your doctor immediately and stop taking Molaxole. Allergic reactions (for example, skin reactions and runny nose), high or low blood potassium levels, and anal discomfort.
Not known (frequency cannot be estimated from available data): Changes in body fluid or electrolyte levels (low sodium levels).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 the carton after "Exp.".
The expiry date refers to the last day of that month.
This product does not require any special storage temperature conditions.
Store in the original packaging to protect from moisture. The reconstituted solution may be stored covered in the refrigerator (2°C – 8°C). Discard any unused solution after 6 hours.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Molaxole contains

• 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 ingredients are: acesulfame potassium (E950) (sweetener) and lemon flavour (flavouring).

Description of the appearance of Molaxole and pack contents
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.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Cooper Consumer Health B.V.
Verrijn Stuartweg 60 – 1112 AX Diemen
(The Netherlands)

Manufacturers
Klocke Pharma-Service GmbH, Strassburger Strasse 77, D-77762 Appenweier (Germany)
Lamp San Prospero S.p.A., Via Della Pace 25/a, San Prospero, 41030, Italy

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Denmark, Norway, Finland, Hungary, Iceland and Sweden: Moxalole
Austria, Belgium, Cyprus, Ireland, Italy, Luxembourg, Portugal, Spain, The Netherlands and United Kingdom: Molaxole
Poland: Duphagol