What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL15142/0108.

Molaxole powder for oral solution

PACKAGE LEAFLET: INFORMATION FOR THE USER

Molaxole® powder for oral solution

Macrogol 3350, Sodium chloride, Sodium hydrogen carbonate

Potassium chloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

  • Keep this leaflet. You may need to read it again.
  • Ask your pharmacist if you need more information or advice.
  • If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
  • You must talk to a doctor if you do not feel better or if you feel worse after 2 weeks of constipation. If you are treated for very bad constipation (called faecal impaction) you should follow your doctors instruction.

What is in this leaflet:

1. What Molaxole is and what it is used for
2. What you need to know before you take Molaxole
3. How to use 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 to have a comfortable bowel movement even if you have been constipated for a long time. After consulting a doctor, Molaxole can also be used for treatment of very bad constipation (called faecal impaction).

Macrogol 3350 increases the volume of faeces by binding water leading to a normalisation of motility in the colon. The physiological consequences are an increased movement of the softened stools and easing of defecation. The salts in the formulation help maintain the body's normal salt and waterbalance.

You must talk to a doctor if you do not feel better or if you feel worse after 2 weeks of constipation. If you are treated for very bad constipation (called faecal impaction) you should follow your doctors instruction.

2. What you need to know before you take Molaxole

Do not take Molaxole:

  • if you are allergic to any of the active substances macrogol, sodium chloride, potassium chloride or sodium hydrogen carbonate or any of the other ingredients of this medicine (listed in section 6).
  • if you have an obstruction in the intestine (gut), a perforated gut wall or severe inflammatory bowel disease like ulcerative colitis, Crohn's disease, toxic megacolon or ileus.

Warnings and Precautions

Talk to your doctor or pharmacist before taking Molaxole:

  • If you feel weak, breathless, very thirsty with a headache, have cardiac failure or get puffy ankles stop taking Molaxole and tell your doctor immediately.

Do not take Molaxole for longer periods of time unless you have been instructed to do so by your doctor for example if you take drugs that can cause constipation or if you have a disease which cause constipation for example Parkinson's disease or multiple sclerosis (MS).

Children

Do not give this medicine to children below 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.

Pregnancy, breast-feeding and fertility

If you are pregnant, or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

There is no effect on the ability to drive or use machines.

3. How to take Molaxole

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose for constipation is:

1 sachet one to three times daily. Normal dose for most patients is 1-2 sachets per day. Depending on the individual response 3 sachets per day might be needed. The dose depends on the severity of your constipation. The dose can be adjusted down to the lowest effective dose after a couple of days. The time of the treatment is normally 2 weeks. If the symptoms persist after 2 weeks treatment contact your doctor.

Mix the content of 1 sachet with a ½ glass of water (about 125 ml). Stir until the powder is dissolved and drink. If you wish you can add fruit juice or fruit syrup immediately before drinking.

Children (below 12 years of age):

not recommended.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose for Faecal impaction is:

Adults: The usual dose is 8 sachets a day.

The 8 sachets should be taken within a 6 hour period each day for up to 3 days if required. A course of treatment for faecal impaction does not normally exceed 3 days.

If you use Molaxole for treatment of faecal impaction you can mix 8 sachets in one litre of water. The solution can 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 in any one hour.

Patients with renal insufficiency:

No dosage change is necessary for treatment of either constipation or faecal impaction.

If you take more Molaxole than you should

If you take too much Molaxole and get bad diarrhoea or start vomiting, stop taking Molaxole until it clears, then start again at a lower dose. If you are worried, contact your doctor or pharmacist.

If you forget to take Molaxole

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

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

If you have any further questions on 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 ache and cramp, diarrhoea, vomiting, nausea, stomach rumbles and gastrointestinal gas problems.

Common (may affect up to 1 in 10 people): Itching, headache, swollen hands, feet or ankles.

Uncommon (may affect up to 1 in 100 people): Skin rash, indigestion and bloated stomach.

Very rare (may affect up to 1 in 10,000 people): Serious allergic reactions which cause difficulty in breathing, or swelling of the face, lips, tongue or throat. If any of these symptoms occur, tell your doctor immediately and stop taking Molaxole. Allergic reactions (e.g. skin reaction and runny nose), high and low levels of potassium in the blood and anal discomfort.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

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 which is 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 temperature storage conditions. Store in original package in order to protect from moisture. Ready mixed solution can be stored well covered in refrigerator (2 °C to 8 °C). Throw away any solution not used within a six hour period.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack 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 hydrogen carbonate 178.5 mg, potassium chloride 46.6 mg.
  • The other ingredients (excipients) are acesulfame potassium (E950) (sweetener) and lemon flavour (flavouring).

What Molaxole looks like and contents of the pack

White powder for oral solution.

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Meda Pharmaceuticals Ltd
Skyway House
Parsonage Road
Takeley
Bishiop's Stortford
CM22 6PUUnited Kingdom

Recipharm Höganäs AB
Sporthallsvägen 6
SE-263 34 Höganäs
Sweden

alternatively

Klocke Pharma-Service GmbH
Strassburger Strasse 77
D-77767 Appenweier
Germany

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

Meda 01748 828 810

This medicinal product is authorised in the Member States of the EEA under the following names:

Denmark, Norway, France, Finland, Hungary, Iceland, Poland and Sweden: Moxalole

Austria, Belgium, Bulgaria, Cyprus, Estonia, Germany, Greece, Italy, Ireland, Latvia, Lithuania, Luxembourg, Romania, Slovak Republic, Slovenia, Spain, The Netherlands, Portugal and UK: Molaxole

This leaflet was last revised in

January 2016.

60008613