- Approval Id
- 4a0cfb5fba98bb77
- Drug Approval Emc Name
- Micolette Micro-enema
- Drug Name
- Micolette Micro-enema
- Company Name
- Pinewood Healthcare
- Company Address
- Ballymacarby, Clonmel, Co. Tipperary, Co. Tipperary, Ireland
- Company Website
- http://www.pinewood.ie
- Company Telephone
- +353 52 6186000
- Company Medical Info Direct Line
- +353 52 6186000
- Company Medical Info Email
- drug.safety@pinewood.ie
- Company Medical Info Fax
- +353 52 6136311
- Legal Category
- Pharmacy
- Authorisation Holder
- Pinewood Laboratories LimitedBallymacarbry,Clonmel,Co. TipperaryIreland.
- Authorisation Number
- PL 04917/0064
- Authorisation Date
- 15 August 2003/ 09 March 2009
- Instruction Authorisation Holder
- Pinewood Laboratories LimitedBallymacarbry,Clonmel,Co. TipperaryIreland.
- Instruction Authorisation Number
- PL 04917/0064
- Instruction Authorisation Date
- 15 August 2003/ 09 March 2009
- Instruction Composition
- | | |
| --- | --- |
| Sodium lauryl sulphoacetate | 45 mg ) |
| Sodium citrate BP | 450 mg ) per 5 ml |
| Glycerol BP | 625 mg ) |
- Instruction Dosage Form
- Micro-enema
- Instruction 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, pediatrics 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.4.3 Contraindications
Inflammatory or ulcerative bowel disease. Acute gastrointestinal conditions.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.4.5 Interaction with other medicinal products and other forms of interaction
Prolonged use may interfere with the absorption of some vitamins.4.6 Fertility, 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.
- Instruction Pharmacology
- 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 Preclinical safety data
Not applicable.
- Instruction 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 known6.3 Shelf life
60 months (unopened).6.4 Special precautions for storage
Store below 25° C6.5 Nature and contents of container
Disposable low density polyethylene tube with nozzle and removable cap.(Pack of 12 x 5 ml tubes).6.6 Special precautions for disposal and other handling
Not applicable.
- Instruction Content
- ## Composition
| | |
| --- | --- |
| Sodium lauryl sulphoacetate | 45 mg ) |
| Sodium citrate BP | 450 mg ) per 5 ml |
| Glycerol BP | 625 mg ) |
## Pharmaceutical Form
Micro-enema
## 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, pediatrics 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.4.3 Contraindications
Inflammatory or ulcerative bowel disease. Acute gastrointestinal conditions.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.4.5 Interaction with other medicinal products and other forms of interaction
Prolonged use may interfere with the absorption of some vitamins.4.6 Fertility, 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.
## Pharmacological Properties
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 Preclinical safety data
Not applicable.
## 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 known6.3 Shelf life
60 months (unopened).6.4 Special precautions for storage
Store below 25° C6.5 Nature and contents of container
Disposable low density polyethylene tube with nozzle and removable cap.(Pack of 12 x 5 ml tubes).6.6 Special precautions for disposal and other handling
Not applicable.
