- Approval Id
- 901c68902d30bec7
- Drug Approval Emc Name
- Glycerol 2g Suppositories
- Drug Name
- Glycerol 2g Suppositories
- Company Name
- Martindale Pharma, an Ethypharm Group Company
- Company Address
- Jupiter House, Mercury Park, Wooburn Green, High Wycombe, Buckinghamshire, HP10 0HH, UK
- Company Website
- http://ethypharm.co.uk/
- Company Telephone
- +44 (0) 1277 266 600
- Company Medical Info Email
- medinfo@ethypharm.com
- Atc Code
- A06AX01
- Legal Category
- General Sales List
- Authorisation Holder
- Martindale Pharmaceuticals Ltd.Bampton Road,Romford,RM3 8UGUnited Kingdom
- Authorisation Number
- PL 00156/0120
- Authorisation Date
- 13/07/2009
- Instruction Authorisation Holder
- Martindale Pharmaceuticals Ltd.Bampton Road,Romford,RM3 8UGUnited Kingdom
- Instruction Authorisation Number
- PL 00156/0120
- Instruction Authorisation Date
- 13/07/2009
- Instruction Composition
- Each suppository contains 1400mg GlycerolFor full list of excipients, see 6.1.
- Instruction Dosage Form
- Amber coloured suppository, of nominal weight 2g intended for rectal administration.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
For occasional use as a stimulant laxative for the treatment of constipation.4.2 Posology and method of administration
For rectal use
\*\*Children\*\*
One 2g suppository, to aid insertion the suppository tip should be moistened with water before use.4.3 Contraindications
• Hypersensitivity to the active substance(s) or to any of the excipients.• The product is contraindicated if there is intestinal obstruction or blockage.4.4 Special warnings and precautions for use
The product is intended for occasional use only. Prolonged or excessive use of the product is not recommended as this may cause diarrhoea. Use of this product may interfere with glucose control in diabetic patients. If symptoms persist consult a doctor.4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed4.6 Pregnancy and lactation
No evidence of harmful affects available. However, best avoided during the first trimester of pregnancy. May be used during breast feeding.4.7 Effects on ability to drive and use machines
None stated.4.8 Undesirable effects
Use of the product may occasionally cause abdominal cramps. Glycerol can cause irritation when given rectally.4.9 Overdose
Overdosage via rectal route is unlikely. However, if ingested treat symptomatically.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
ATC code A06AX01Glycerol is commonly classified as an osmotic laxative but may act additionally or alternatively by promoting peristalsis and evacuation of the lower bowel by virtue of a mild irritant effect. Glycerol suppositories possess also lubricating and faecal softening actions.5.2 Pharmacokinetic properties
Glycerol following rectal administration is poorly absorbed.5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
GelatinPurified Water6.2 Incompatibilities
Not applicable6.3 Shelf life
3 years6.4 Special precautions for storage
Store below 25°C in a dry place6.5 Nature and contents of container
Heat sealed cavities composed of Polyvinyl Chloride (PVC) coated with Polyvinylidene Chloride (PVDC) and laminated with polyethylene (PE), each containing 1x 4g suppository in strips of 6. The strips and a patient leaflet are packed into cardboard cartons. Pack size available: 12 x 4g\*\*.\*\*6.6 Special precautions for disposal and other handling
Wash hands before opening individual packaging. The suppository is shaped for rectal insertion, ensure the tip of the suppository is inserted first. The tip should be moistened with a little cold water to aid insertion.
- Instruction Content
- ## Composition
Each suppository contains 1400mg GlycerolFor full list of excipients, see 6.1.
## Pharmaceutical Form
Amber coloured suppository, of nominal weight 2g intended for rectal administration.
## Clinical Particulars
4.1 Therapeutic indications
For occasional use as a stimulant laxative for the treatment of constipation.4.2 Posology and method of administration
For rectal use
\*\*Children\*\*
One 2g suppository, to aid insertion the suppository tip should be moistened with water before use.4.3 Contraindications
• Hypersensitivity to the active substance(s) or to any of the excipients.• The product is contraindicated if there is intestinal obstruction or blockage.4.4 Special warnings and precautions for use
The product is intended for occasional use only. Prolonged or excessive use of the product is not recommended as this may cause diarrhoea. Use of this product may interfere with glucose control in diabetic patients. If symptoms persist consult a doctor.4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed4.6 Pregnancy and lactation
No evidence of harmful affects available. However, best avoided during the first trimester of pregnancy. May be used during breast feeding.4.7 Effects on ability to drive and use machines
None stated.4.8 Undesirable effects
Use of the product may occasionally cause abdominal cramps. Glycerol can cause irritation when given rectally.4.9 Overdose
Overdosage via rectal route is unlikely. However, if ingested treat symptomatically.
## Pharmacological Properties
5.1 Pharmacodynamic properties
ATC code A06AX01Glycerol is commonly classified as an osmotic laxative but may act additionally or alternatively by promoting peristalsis and evacuation of the lower bowel by virtue of a mild irritant effect. Glycerol suppositories possess also lubricating and faecal softening actions.5.2 Pharmacokinetic properties
Glycerol following rectal administration is poorly absorbed.5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC
## Pharmaceutical Particulars
6.1 List of excipients
GelatinPurified Water6.2 Incompatibilities
Not applicable6.3 Shelf life
3 years6.4 Special precautions for storage
Store below 25°C in a dry place6.5 Nature and contents of container
Heat sealed cavities composed of Polyvinyl Chloride (PVC) coated with Polyvinylidene Chloride (PVDC) and laminated with polyethylene (PE), each containing 1x 4g suppository in strips of 6. The strips and a patient leaflet are packed into cardboard cartons. Pack size available: 12 x 4g\*\*.\*\*6.6 Special precautions for disposal and other handling
Wash hands before opening individual packaging. The suppository is shaped for rectal insertion, ensure the tip of the suppository is inserted first. The tip should be moistened with a little cold water to aid insertion.
