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Pinewood Healthcare

Ballymacarby, Clonmel, Co. Tipperary, Co. Tipperary, Ireland

Telephone: +353 61 86000
Fax: +353 61 36311
WWW: http://www.pinewood.ie
Medical Information Direct Line: +353 52 61 86000

Medical Information e-mail: Medicalinfo@pinewood.ie
Customer Care direct line: +353 61 86000
Medical Information Fax: +353 52 61 36820

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Summary of Product Characteristics last updated on the eMC: 15/04/2011

SPC	Micolette Micro-enema

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

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1. NAME OF THE MEDICINAL PRODUCT

Micolette Micro-enema

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Sodium lauryl sulphoacetate	45 mg )
Sodium citrate BP	450 mg ) per 5 ml
Glycerol BP	625 mg )

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3. PHARMACEUTICAL FORM

Micro-enema

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

Micolette is indicated whenever an enema is necessary for chronic and acute constipation in the rectum and sigmoid colon. Also indicated for use in constipation in geriatrics, pediatrics and obstetrics.

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4.2 Posology and method of administration

Route of administration: Rectal

Adults and children aged 3 years and over:

Lubricate the nozzle with one drop of the contents; insert full length of nozzle into the rectum and squeeze tube until total contents have been administered. Two tubes may be necessary in severe cases. When used in children the nozzle should be inserted to half its length only.

Children under 3 years: Not recommended.

Elderly: There are no special requirements for elderly patients but as with all medicines the lowest effective dose should be used.

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4.3 Contraindications

Inflammatory or ulcerative bowel disease. Acute gastrointestinal conditions.

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4.4 Special warnings and precautions for use

Excessive use of Micolette micro-enema may cause diarrhoea and fluid loss. In such cases, Micolette should be discontinued and appropriate therapy instituted.

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4.5 Interaction with other medicinal products and other forms of interaction

Prolonged use may interfere with the absorption of some vitamins.

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4.6 Pregnancy and lactation

Indicated for use in constipation in obstetrics.

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4.7 Effects on ability to drive and use machines

Not applicable.

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4.8 Undesirable effects

Very occasionally, a slight cramp may occur. Prolonged use may lead to irritation of the anal canal.

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4.9 Overdose

Not applicable.

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

Sodium citrate is a 'peptizing' agent which liberates water present in the faeces. Sorbitol enhances this action. Sodium lauryl sulphoacetate is a wetting agent. Glycerol promotes peristalsis and evacuation of the lower bowel.

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5.2 Pharmacokinetic properties

Not applicable.

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5.3 Preclinical safety data

Not applicable.

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients