MICROLAX Rectal Solution Enemas for Constipation relief

Microlax rectal solution. Indications: For short-term use in cases of constipation and conditions requiring easier bowel movements. For bowel movements during diagnostic or therapeutic procedures in the rectum. Warning: Microlax contains sorbic acid.

For risks and side effects, read the package insert and ask your doctor or pharmacist.

Constipation relief, MICROLAX Rectal Solution Enemas

PACKAGE LEAFLET: INFORMATION FOR THE USER

Microlax rectal solution for short-term use in constipation for use in infants, children and adults
Active ingredients: Sodium citrate 450 mg/5 ml, Dodecyl (sulfoacetate) sodium salt 70% 64.5 mg/5 ml, Sorbitol solution 70% (crystallizing) (Ph. Eur.) 4465 mg/5 ml

Read the entire package leaflet carefully before you start using this medicine because it contains important information. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may want to read it again later.
• Ask your pharmacist if you need further information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If you do not feel better or if you feel worse, consult your doctor.

What is in this leaflet:

1. WHAT IS MICROLAX AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING MICROLAX?
3. HOW SHOULD MICROLAX BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD MICROLAX BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION.

1. WHAT IS MICROLAX AND WHAT IS IT USED FOR?

Microlax is a laxative:

• for short-term use in cases of constipation (obstipation) and in diseases that require easier bowel movements (defecation).
• for bowel emptying during diagnostic or therapeutic procedures in the rectum area.

2. WHAT SHOULD YOU CONSIDER BEFORE USING MICROLAX?

Microlax should not be used

• if you are allergic to sodium citrate%%% dodecyl(sulfoacetate), sodium salt 70%%%% sorbitol solution 70% (crystallizing) (Ph. Eur.) or any of the other ingredients of this medicine listed in section 6.
• in case of intestinal obstruction (ileus).
• in the case of diagnosed hereditary fructose intolerance (intolerance to certain sugars).

Warnings and precautions:
Please talk to your doctor or pharmacist before using Microlax.

If your symptoms persist, please stop treatment and seek medical advice.

Children:
For children under 3 years of age, please see section ###3. How to use Microlax?###.

Using Microlax with other medicines:
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

Due to the risk of damage to the intestinal wall, Microlax should not be used at the same time as orally or rectally administered exchange resins for the treatment of high blood potassium levels because of its sorbitol content.

Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine. You can use Microlax during pregnancy and breastfeeding if used as directed.

Driving and operating machinery:
No special precautions are required.

Microlax contains sorbic acid.
Sorbic acid (Ph. Eur.) may cause mucous membrane irritation.

3. HOW TO USE MICROLAX

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

The recommended dose is:

• for adults and children if necessary 1 mini enema,
• For infants and toddlers under 3 years of age, half a mini enema.

One dosage unit (1 mini-enema or half a mini-enema) is usually sufficient.

Microlax is a single-use enema for use in the rectum (rectal application). It should be used 5 to 20 minutes before the desired effect. If only part of the enema contents is used, discard the remaining rectal solution. Microlax is available as a mini-enema with a long and a short tube neck.

Mini-enema with a long tube neck:
For infants and small children under 3 years of age, the long tube neck may only be inserted halfway (mark on the tube neck, Figure 1). For children aged 3 and over and adults, the tube neck is inserted completely.

Mini-enema with a short tube neck for infants and children up to 6 years of age:
For infants and children up to 6 years of age, a mini-enema with a short tube neck is available as an alternative. The short tube neck is inserted completely for infants and small children.

Please also read the information on correct use at the end of this leaflet.

Microlax should be administered to infants and young children by an adult or a doctor.

Please talk to your doctor or pharmacist if you think the effect of Microlax is too strong or too weak.
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.

Possible side effects:

Not known (frequency cannot be estimated from the available data):

• Hypersensitivity reactions (e.g. hives)
• abdominal pain
• slight burning in the anal area
• loose stool

Reporting of side effects:
If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, Website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD MICROLAX BE STORE?

Keep this medicine out of the sight and reach of children. Do not store above 25°C.

Do not use this medicine after the expiry date which is stated on the carton and tube. The expiry date refers to the last day of that month.

Never dispose of medicines via wastewater (e.g. not down the toilet or sink). Ask your pharmacist how to dispose of medicines no longer required. In doing so, you are contributing to protecting the environment. Further information can be found at: www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION.

What Microlax contains:
The active ingredients are:
sodium citrate 70%, sodium dodecyl sulfoacetate 70%, and sorbitol solution 70% (crystallizing) (Ph. Eur.).

1 mini-enema with 5 ml (equivalent to 6400 mg) of rectal solution (solution for application in the rectum) contains:
sodium citrate 450 mg, sodium dodecyl sulfoacetate 70% 64.5 mg, sorbitol solution 70% (crystallizing) (Ph. Eur.) 4465 mg.

The other ingredients are:
glycerol, sorbic acid (Ph. Eur.), purified water.

What Microlax looks like and contents of the pack:
Pack of 4, 9, 10, 12 or 50 mini-enemas with a long neck tube, each containing 5 ml of rectal solution. Pack of 4 mini-enemas with a short neck tube, each containing 5 ml of rectal solution.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Johnson & Johnson GmbH
Johnson & Johnson Platz 2
41470 Neuss


Manufacturer:
Delpharm Orleans
5, avenue de Concyr
45071 Orleans Cedex 2 France

or

Manufacturer:
JNTL Consumer Health (France) SAS
Domaine de Maigremont
27100 Val-de-Reuil
France

This leaflet was last revised in February 2025.

Source: Information from the package leaflet
as of: 06/2025

Indications: For short-term use in cases of constipation and in conditions requiring easier bowel movements. For bowel evacuation during diagnostic or therapeutic procedures in the rectum. Warning: Microlax contains sorbic acid.

Constipation relief, MICROLAX Rectal Solution Enemas