Microlax gel 4 unidoses of 5ml

Therapeutic indications

MICROLAX is a laxative. It softens the stool and triggers the evacuation reflex (defecation).

It is used to treat occasional constipation.

This medicine is for adults only.

2. WHAT YOU SHOULD KNOW BEFORE USING MICROLAX SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in single dose container

List of information needed before taking the medicine

Not applicable.

Contraindications

Never use MICROLAX :

If you suffer from abdominal pain for which you do not know the cause.

If you are allergic (hypersensitive) to any of the active ingredients (sorbitol, sodium citrate or sodium laurilsulfoacetate) or to any of the other components of this medication. For a list of ingredients, see section 6.

Precautions for use; special warnings

Be careful with MICROLAX :

You should not use this medicine without asking your doctor if any of the following apply to you:

• - You have a hemorrhoidal attack,
• - you have an anal fissure (a lesion in the anus that is more or less painful during the passage of stool and lasts for several hours),
• - you have haemorrhagic rectocolitis (a disease with an inflammation of the rectum and sometimes of the large intestine manifested by stomach pains, diarrhoea with mucus, blood and often fatigue).

In combination with Catioresin sulfo sodium (oral and rectal).

Interactions with other drugs

Taking or using other drugs

MICROLAX is not recommended in combination with Catioresin Sulfate Sodium (oral and rectal).

Talk to your doctor or pharmacist if you are taking or have recently taken any other medication, including over-the-counter medications.

Interactions with food and drink

Not applicable.

Interactions with herbal products or alternative therapies

Not applicable.

Use during pregnancy and lactation

Pregnancy

This medicine should only be used during pregnancy on the advice of your doctor.

If you discover that you are pregnant during treatment, consult your doctor, as only he/she can decide whether it is necessary to continue treatment.

Ask your doctor or pharmacist for advice before taking any medicine.

Breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

Sportsmen

Not applicable.

Effects on ability to drive and use machines

Not applicable.

List of excipients with a known effect

Not applicable.

3. HOW TO USE MICROLAX SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in single dose container

Instructions for proper use

Not applicable.

Dosage, Method and/or route of administration, Frequency of administration and Duration of treatment

Dosage

The dose to be used is 1 tube per day.

Method of administration

This medicine is used rectally. You do not need to lie down to administer this product or wait for it to take effect.

This medication usually takes effect in 5 to 20 minutes.

A longer delay (more than 1 hour) may be observed in people who lie down for a long time.

Duration of treatment

You should not use this medication for a prolonged period of time without consulting your doctor.

Symptoms and instructions in case of overdose

If you have used more MICROLAX SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in a single dose container than you should have : prolonged use may result in anal burning and, exceptionally, congestive rectitis.

Instructions in case of missed dose(s)

Not applicable.

Risk of withdrawal syndrome

Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Description of side effects

Like all medicines, MICROLAX may have side effects, although not everyone is likely to have them.

The following side effects may occur with prolonged use of this medication:

• - Burning sensation in the anus,
• - exceptionally, inflammation of the rectum.

If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please tell your doctor or pharmacist.

5. HOW TO USE MICROLAX SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in single dose container

Keep out of sight and reach of children.

Expiry date

Do not use MICROLAX after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.

Conditions of storage

No special storage precautions.

If necessary, warnings against certain visible signs of deterioration

Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help protect the environment.

6. ADDITIONAL INFORMATION

Complete list of active ingredients and excipients

What it contains MICROLAX SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in a single-dose container

The active ingredients are :

Sorbitol 70% crystallizable ........................................................................................................... 4.4650 g

Sodium citrate ........................................................................................................................... 0.4500 g

Sodium lauryl sulfoacetate 70% ................................................................................................ 0.0645 g

For a single-dose container.

Other components are:

Sorbic acid, glycerol, purified water.

6,45 g = 5 ml rectal solution

Pharmaceutical form and content

What is MICROLAX SORBITOL CITRATE AND SODIUM LAURILSULFOACETATE, rectal solution in a single-dose container and contents of the pack

This medicine is presented as a rectal solution in a single-dose container (PE). Boxes of 4, 6, 12, 50 or 200.

Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different

Holder

JOHNSON & JOHNSON SANTE BEAUTE FRANCE

1, rue Camille Desmoulins

92130 ISSY LES MOULINEAUX