MICROLAX

MICROLAX Rectal Solution Enemas

Important notes (mandatory information)

microlax rectal solution. Areas of application: for short-term use in case of constipation (obstipation) as well as in diseases that require easier bowel movements (defecation); for bowel evacuation during diagnostic or therapeutic measures in the rectal area.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist!


PACKAGE LEAFLET: INFORMATION FOR THE USER

microlax rectal solution 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% (crystallising) (Ph. Eur.) 4,465 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 package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse, talk to your doctor.

What this package leaflet contains

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

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

Microlax is a laxative (laxans) for short-term use in case of constipation (obstipation) as well as in diseases that require easier bowel movements (defecation); for bowel evacuation during diagnostic or therapeutic measures in the rectal area.

2. WHAT SHOULD YOU CONSIDER BEFORE USING MICROLAX?

Microlax must not be used:

• if you are allergic to sodium citrate, dodecyl (sulfoacetate), sodium salt 70%, sorbitol solution 70% (crystallising) (Ph. Eur.) or any of the other ingredients of this medicine listed in section 6.
• in case of intestinal obstruction (ileus).
• in 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 discontinue treatment and seek medical advice.

Children

Please note the section "3. How to use Microlax?" for children under 3 years of age.

Use of Microlax together 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 elevated potassium levels in the blood because of its sorbitol content.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. You can use Microlax as intended during pregnancy and breast-feeding.

Driving and using machines

No special precautions are required.

Microlax contains sorbic acid

Sorbic acid (Ph. Eur.) can cause irritation of the mucous membranes.

3. HOW TO USE MICROLAX?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

• for adults and children, 1 micro enema as needed,
• for infants and toddlers under 3 years of age, half a micro enema. One dosage unit (1 micro enema or half a micro enema) is usually sufficient.

Microlax is a single-use enema for rectal use. It should be used 5 to 20 minutes before the desired effect. If only part of the enema content is used, the remaining rectal solution must be discarded. In infants and toddlers under 3 years of age, the tube neck should only be inserted halfway (marking on the tube neck). Please talk to your doctor or pharmacist if you have the impression that the effect of Microlax is too strong or too weak.

How to use Microlax correctly

1. Hold the tube, twist the cap and pull it off.
2. Carefully squeeze out 1 drop to make the tip slippery for insertion.
3. Insert the tube neck into the rectum. In children under 3 years of age, only insert the tube neck halfway (marking on the tube neck)!
4. Empty the contents by squeezing the tube. In infants and toddlers, only empty the tube halfway!
5. Remove the tube neck from the rectum. Keep the tube squeezed while doing so.
6. After use, even if only part of the tube has been used, the tube is discarded.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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
• mild burning in the anal area
• loose stools

Reporting of side effects

If you get any side effects, talk to 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. of 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 TO STORE MICROLAX?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and the tube after "Use by". The expiry date refers to the last day of the month indicated. Storage conditions: Do not store above 25°C. Medicines should be disposed of in accordance with local requirements. Ask your pharmacist how to dispose of the medicine when you no longer use it. You thus help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Microlax contains

The active ingredients are: sodium citrate, dodecyl (sulfoacetate), sodium salt 70% and sorbitol solution 70% (crystallising) (Ph. Eur.). 1 micro enema with 5 ml (corresponding to 6400 mg) rectal solution (solution for rectal use) contains: sodium citrate 450 mg, dodecyl (sulfoacetate), sodium salt 70% 64.5 mg, sorbitol solution 70% (crystallising) (Ph. Eur.) 4,465 mg. The other ingredients are: glycerol, sorbic acid (Ph. Eur.), purified water.

What Microlax looks like and contents of the pack:

• Pack of 4 micro enemas with 5 ml rectal solution each.
• Pack of 9 micro enemas with 5 ml rectal solution each.
• Pack of 10 micro enemas with 5 ml rectal solution each.
• Pack of 12 micro enemas with 5 ml rectal solution each.
• Pack of 50 micro enemas with 5 ml rectal solution each.

Not all pack sizes may be marketed.

Pharmaceutical entrepreneur and manufacturer

Johnson & Johnson GmbH
Johnson & Johnson Platz 2
41470 Neuss
Tel.: 00800 260 260 00 (toll-free)

This package leaflet was last revised in January 2019.

Source: Information from the package leaflet
Status: 10/2019
Areas of application: for short-term use in case of constipation (obstipation) as well as in diseases that require easier bowel movements (defecation); for bowel evacuation during diagnostic or therapeutic measures in the rectal area.