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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: 09/09/2008
SPC Microlax



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1. NAME OF THE MEDICINAL PRODUCT

Microlax Rectal Solution

Sodium Citrate 450 mg / 5 ml

Sodium Lauryl Sulphoacetate 45 mg / 5 ml


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

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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3. PHARMACEUTICAL FORM

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. CLINICAL PARTICULARS

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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, prior to surgical and diagnostic procedures and in obstetrics prior to delivery.


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4.2 Posology and method of administration

Rectal.

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 any of the ingredients


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4.4 Special warnings and precautions for use

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

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

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

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


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4.5 Interaction with other medicinal products and other forms of interaction

None Known


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4.6 Pregnancy and lactation

No problems have been reported.


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4.7 Effects on ability to drive and use machines

N/A


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4.8 Undesirable effects

Occasionally, slight rectal burning has been observed. Individual cases of hypersensitivity have been reported.


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4.9 Overdose

Overdose is unlikely given the physical limitations of the route of administration.


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5. PHARMACOLOGICAL PROPERTIES

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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. PHARMACEUTICAL PARTICULARS

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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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7. MARKETING AUTHORISATION HOLDER

McNeil Healthcare (Ireland) Limited

Airton Road

Tallaght

Dublin 24

Ireland


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8. MARKETING AUTHORISATION NUMBER(S)

PA 823/46/1


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorization: 23rd January 1998

Date of last renewal: 23rd January 2008


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10. DATE OF REVISION OF THE TEXT

September 2008



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Active Ingredients

 
   Sodium Lauryl Sulphoacetate
   Sodium Citrate