Glycerol 4g Suppositories
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glycerol 4g Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 2800mg Glycerol For full list of excipients , see 6.1.
3 PHARMACEUTICAL FORM
Amber coloured suppository, of nominal weight 4g intended for rectal administration.
4 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.
Adults and the elderly
One 4g suppository, to aid insertion the suppository tip should be moistened with water before use. No reduction in adult dosage is necessary for elderly patients.
Infants and Children Not recommended
4.3. Contraindications
• Hypersensitivity to the active substance 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. Interactions with other medicinal products and other forms of interaction
None stated.
4.6. 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.
5 PHARMACOLOGICAL PROPERTIES
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC code A06AX01
Glycerol 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
No additional pre-clinical data of relevance to the prescriber.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Gelatin
Purified Water
6.2. Incompatibilities
None stated
Shelf life
6.3.
3 years (36 Months)
6.4. Special precautions for storage
Store below 25 °C in a dry place
6.5 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. Instructions for use, handling and disposal
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.
7 MARKETING AUTHORISATION HOLDER
Martindale Pharmaceuticals Ltd Bampton Road Romford RM3 8UG
8. MARKETING AUTHORISATION NUMBER
PL 00156/0053
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
18/05/2004
10 DATE OF REVISION OF THE TEXT
02/10/2013