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McNeil Healthcare (Ireland) Ltd

Airton Road, Tallaght, Dublin 24, Ireland
Telephone: +353 1 466 5200
Fax: +353 1 466 5316

Summary of Product Characteristics last updated on medicines.ie: 19/04/2016
SPC Microlax

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Microlax Rectal Solution

Sodium Citrate 450 mg / 5 ml

Sodium Lauryl Sulphoacetate 45 mg / 5 ml

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Each 5ml unit dose contains sodium citrate 450mg and sodium lauryl sulphoacetate 45mg.

Excipients: Contains Sorbic acid (E200) 5 mg / 5 ml unit dose.

For a full list of excipients, see section 6.1.

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Rectal solution (enema).

A colourless, viscous liquid, containing small air bubbles, supplied in disposable 5ml white low density capped polyethylene microenema tubes with elongated nozzles.

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4.1 Therapeutic indications

The Microlax enema acts as a laxative through its faecal softening and lubricant properties.

For evacuation of the colon in constipation, or prior to surgical and diagnostic procedures or in obstetrics prior to delivery.

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4.2 Posology and method of administration


Recommended dosage schedules.

Adults - One Microenema administered as necessary.

Children - As adults unless below the age of 3, when the nozzle should be inserted only half its length.

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4.3 Contraindications

Hypersensitivity to the active substance or any of the excipients listed in section 6.1

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4.4 Special warnings and precautions for use

Prolonged usage of the microenema may lead to irritation of the anal canal.

When used in children under 3 years old, the nozzle should be inserted only to half its length.

When used in patients with inflammatory or ulcerative conditions of the large bowel, or with acute gastrointestinal conditions, extreme caution should be exercised.

Lubricate the nozzle tip with some of the contents to aid insertion.

Seek medical advice if symptoms persist and avoid prolonged use.

Microlax contains sorbic acid which may cause local skin reactions, e.g. contact dermatitis which is a local irritation at the site of use.

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4.5 Interaction with other medicinal products and other forms of interaction

Risk of intestinal necrosis with sorbitol and sodium polystyrene sulphonate (oral / rectal administration)

4.6 Fertility, pregnancy and lactation

As there is no relevant data available to evaluate the potential for foetal malformation or other foetotoxic effects when administered during pregnancy Microlax Rectal Solution should only be used as directed by a physician at the time of delivery

It is not known whether sodium citrate, sodium lauryl sulphoacetate are excreted in human milk.

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4.7 Effects on ability to drive and use machines

Microlax has no or negligible influence on the ability to drive or use machines.

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4.8 Undesirable effects

Adverse drug reactions identified during post-marketing experience with sodium citrate/ sodium lauryl sulfoacetate are included in the table below.

The frequencies are provided according to the following convention:

Very common ≥1/10

Common ≥1/100 and < 1/10

Uncommon ≥1/1,000 and <1/100

Rare ≥1/10,000 and <1/1,000

Very rare <1/10,000

Not known (cannot be estimated from the available data)

Table 1: Adverse Drug Reactions Identified During post-Marketing Experience with sodium citrate/sodium lauryl sulfoacetate by Frequency Category estimated from clinical trials or epidemiology studies

Body system


Reported adverse event

Gastrointestinal Disorders

Not known

Abdominal paina

Anorectal discomfort

Loose stool

Immune System Disorders

Not known

Hypersensitivity reactions (e.g. Urticaria)

a: Includes the PTs Abdominal discomfort, Abdominal pain, and Abdominal pain upper

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail:medsafety@hpra.ie.

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4.9 Overdose

No symptoms of overdose have been identified from post-marketing data and scientific literature for this product, when used intrarectally.

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5.1 Pharmacodynamic properties

Aided by the detergent effects of the sodium lauryl sulphoacetate, the sodium citrate produces a softening of hard faces by releasing bound water. In around 15 minutes evacuation should occur, taking with it the Microlax, thereby limiting its action.

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5.2 Pharmacokinetic properties

The ingredients contained in the preparation are not likely to be systemically absorbed, distributed or metabolised. The ingredients are excreted in faeces.

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5.3 Preclinical safety data

No preclinical data of clinical relevance are available.

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6.1 List of excipient(s)

Liquid Sorbitol(E420)

Glycerol (E422)

Sorbic Acid (E200)

Purified Water

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6.2 Incompatibilities

Not applicable

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6.3 Shelf life

Unopened: 5 years.

Once Opened: Use immediately and discard any unused solution.

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6.4 Special precautions for storage

Do not store above 25°C. Do not freeze.

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6.5 Nature and contents of container

The microenema tubes are 5ml, made from white low density polyethylene with a capped elongated nozzle.

Packs of 1,4,12 or 50 microenemas are provided.

Not all pack sizes may be marketed.

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6.6 Special precautions for disposal and other handling

No special requirements.

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McNeil Healthcare (Ireland) Limited

Airton Road


Dublin 24


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PA 823/46/1

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Date of first authorization: 23rd January 1998

Date of last renewal: 23rd January 2008

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April 2016

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Active Ingredients

   Sodium lauryl sulfoacetate
   Sodium Citrate