SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Micolette Micro-enema

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Sodium lauryl sulphoacetate    45mg )

Sodium citrate BP    450mg ) per 5 ml

Glycerol BP    625mg )

3. Pharmaceutical Form

Micro-enema

4.    CLINICAL PARTICULARS

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, paediatrics and obstetrics.

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.

Contra-Indications

Inflammatory or ulcerative bowel disease. Acute gastrointestinal conditions.

4.4.    Special Warnings and Special 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.

4.5.    Interaction with other Medicinal Products and other Forms of Interaction

Prolonged use may interfere with the absorption of some vitamins.

4.6.    Pregnancy and Lactation

Indicated for use in constipation in obstetrics.

4.7.    Effects on Ability to Drive and Use Machines

Not applicable.

4.8 Undesirable effects

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

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 the Yellow Card Scheme at www.mhra.gov.uk/yellowcard

4.9. Overdose

Not applicable.

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.

5.2.    Pharmacokinetic Properties

Not applicable

5.3.    Pre-clinical Safety Data

Not applicable

6. PHARMACEUTICAL PARTICULARS

6.1.    List of Excipients

Sorbitol solution BP    3.12 g

Potassium sorbate BP    6.2 mg

Water    6.25 g

6.2.    Incompatibilities

None known.

6.3.    Shelf-Life

60 months (unopened)

6.4.    Special Precautions for Storage

Store below 25°C.

6.5.    Nature and Content of Container

Disposable low density polyethylene tube with nozzle and removable cap. (Pack of 12 x 5ml tubes).

6.6.    Instructions for Use, Handling and Disposal

Not applicable.

7    MARKETING AUTHORISATION HOLDER

Pinewood Laboratories Limited

Ballymacarbry

Clonmel

Co. Tipperary

Ireland

8    MARKETING AUTHORISATION NUMBER

PL 04917/0064

9.    DATE OF FIRST AUTHORISATION / RENEWAL OF

AUTHORISATION

15 August 2003

10 DATE OF REVISION OF THE TEXT

24/06/2015