Molaxole® powder for oral solution

Macrogol 3350, Sodium chloride, Sodium hydrogen carbonate Potassium chloride

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take Molaxole carefully to get the best results from it.

-    Keep this leaflet. You may need to read it again.

-    Ask your pharmacist if you need more information or advice.

-    You must contact a doctor if your symptoms worsen or do not improve after 2 weeks.

-    If any of the side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor.

In this leaflet:

1.    What Molaxole is and what it is used for

2.    Before you use Molaxole

3.    How to use Molaxole

4.    Possible side effects

5.    How to store Molaxole

6.    Further 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. Molaxole also works in 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 water balance.

2.    BEFORE YOU TAKE MOLAXOLE®

Do not take Molaxole

-    if you are allergic (hypersensitive) to any of the active substances macrogol, sodium chloride, potassium chloride or sodium hydrogen carbonate or any of the other ingredients of Molaxole.

-    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.

Take special care with 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 consti-pation for example Parkinson’s disease or multiple sclerosis (MS).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy, and breast-feeding and fertility

If you are pregnant, or breast feeding or planning to have a baby, talk to your doctor before you take Molaxole.

Driving and using machines

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

3. HOW TO TAKE MOLAXOLE®

Always take Molaxole exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Common 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 he 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 'A 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.

Faecal impaction:

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 he stored in the refrigerator.

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

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