MICROLAX MICROENEMA TUBES 5ML N12

ATC code: A06AG11 

Active substances: Sorbitolum, Natrii Citras, Natrii Laurilsulfoacetas

Vendor, principal: Mcneil Consumer Healthcare,joh. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

MICROLAX 9MG/+625MG/+90MG/1ML N4

Package leaflet: Information for the user Microlax, 625 mg/90 mg/9 mg/mL rectal solution

Sorbitol, Sodium Citrate, Sodium Lauryl Sulfoacetate

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

Always use 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.

What is in this leaflet

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

1.   What Microlax is and what it is used for

For short-term relief of constipation or in a situation that requires bowel movement.
For emptying terminal part of the intestine prior to x-ray or rectoscopy.

2.   What you need to know before you use Microlax Do not use Microlax:

-   if you are allergic to active substances or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

-   if you have haemorrhoids, use Microlax with caution in order to avoid damage to intestine.
Seek medical advice if symptoms persist. Avoid prolonged use of this medicine.

Other medicines and Microlax

There is a risk of intestinal necrosis when using sorbitol and sodium polystyrene sulfonate (administered orally/rectally).

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 or pharmacist for advice before taking this medicine.
There are no adequate and well-controlled studies in pregnant women. As the active substances of the medicine are not systemically absorbed in the body, no harmful effects on the foetus/the neonate are to be expected upon recommended use during pregnancy and breast-feeding.
It is not known whether sodium citrate, sodium lauryl sulfoacetate or sorbitol are excreted in breast milk.

Driving and using machines

This medicine has no effect on the ability to drive or use machines.
This medicine contains sorbic acid which may cause local skin reactions, e.g. contact dermatitis.

3. How to use Microlax

Always use Microlax exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Adults and children 3 years and older
Administer the contents of 1 tube in the rectum, whereas the nozzle of the tube is inserted fully into the rectum. One drop of solution is enough to lubricate the nozzle.
Children under 3 years
Administer the contents of 1 tube in the rectum, whereas insert only half the length of the nozzle.
Instructions for use
Figure 1
1.   Twist the seal of the nozzle.
2.   To make insertion easier, smear the tip of tube with a drop of medicine.
3.   Insert the nozzle fully into the rectum. In children under 3 years of age, insert only half the length of the nozzle.
Figure 2
4.   Squeeze out all the contents of the tube.
5.   Gently withdraw the nozzle while still squeezing the tube.
Medicine is effective within 5...15 minutes after administration
Duration of treatment One dose is usually enough.

4. Possible side effects

Like all medicines, Microlax can cause side effects, although not everybody gets them.
Very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1,000 to <1/100), rare (>1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

System Organ Class	Frequency	Side effects
Gastrointestinal disorders	Not known	Abdominal paina, anal discomfort, diarrhoea

Immune system disorders Not known Hypersensitivity reactions (e.g. hives)

a abdominal discomfort, abdominal pain, upper abdominal pain

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via www.ravimiamet.ee. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Microlax

Do not store above 25C. Do not freeze.
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 package. The expiry date refers to the last day of that month.
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 Microlax contains
-   The active substances are sorbitol 625 mg/mL (corresponds to 893 mg/mL crystallising sorbitol solution), sodium citrate 90 mg/mL, sodium lauryl sulfoacetate 9 mg/mL.
1 tube (5 mL) contains 3.125 g sorbitol (corresponds to 4,465 g crystallising sorbitol solution), 450 mg sodium citrate and 45 mg sodium lauryl sulfoacetate.
-   Excipients are sorbic acid (E200), glycerol and water.

What Microlax looks like and contents of the pack

Colourless, opalescent and viscous liquid.
5mL of solution in plastic tubes with a white nozzle and a cap.
Each carton contains 4 or 12 tubes.

Marketing Authorisation Holder

McNeil AB
Norrbroplatsen 2, SE-25109 Helsingborg, Sweden

Manufacturers

Famar Orleans
5 avenue de Concyr, 45071 Orleans, Cedex 2, France McNeil AB
Norrbroplatsen 2, SE-25109 Helsingborg, Sweden

This leaflet was last revised in May 2013.