Glycerin Suppositories Bp 4g
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glycerin Suppositories BP 4g
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 70% w/w Glycerol PhEur.
3 PHARMACEUTICAL FORM
Semi-clear to opaque, torpedo-shaped suppositories.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Constipation.
4.2 Posology and method of administration
To aid insertion the suppository should be moistened with water before use. Adults, elderly and children of 12 years and above: One 4g suppository to be inserted rectally as required.
Children under 12: Not recommended for use Method of Administration For rectal administration.
4.3 Contraindications
In patients with intestinal obstruction or blockage In patients with known hypersensitivity to glycerol.
4.4 Special warnings and precautions for use
Caution should be used in patients with intestinal obstruction or blockage Prolonged use of the product can precipitate onset of an atonic nonfunctioning colon.
The following warnings are also included on the product labelling:
For rectal use only
If symptoms persist for more than 3 days, consult your doctor Keep out of the reach and sight of children.
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Pregnancy and lactation
No special precautions are considered necessary.
4.7 Effects on ability to drive and use machines
None known
4.8 Undesirable effects
Gastrointestinal Disorders: May cause irritation and occasionally abdominal cramps.
4.9 Overdose
No special requirements are anticipated.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC CODE A06A X01
Glycerin is commonly classified as an osmotic laxative but may act additionally or alternatively through its local irritant effects; it may also have lubricating and faecal softening actions. Glycerin suppositories usually work within 15 to 30 minutes.
5.2 Pharmacokinetic properties
No information has been found on the pharmacokinetics of glycerol administered rectally.
5.3 Preclinical safety data
Not applicable.
6.1 List of excipients
Also contains: gelatin.
6.2 Incompatibilities
None known
6.3 Shelf life
Shelf-life
We propose a shelf-life of two years from the date of manufacture, to be extended when further stability testing becomes available.
Shelf-life after dilution/reconstitution Not applicable.
Shelf-life after first opening Not applicable.
6.4 Special precautions for storage
Store in a cool place
6.5 Nature and contents of container
The product will be supplied in strip packs contained in cartons:
a) Carton: White-backed folding box board printed on white.
b) Strip packs: Aluminium foil, lacquer laminated to 20p polypropylene foil on one side, coated with polythene (20mg/M2) on the reverse.
As an alternative, strip packs may be composed of PVC/PE material (thermoplastic film or laminated PVC 95p and PE 27-30p).
Pack sizes: 6s, 12s, 14s, 15s, 24s, 28s, 30s, 56s, 60s, 84s, 90s, 100s.
6.6 Special precautions for disposal and other handling
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Actavis UK Limited (Trading style: Actavis)
Whiddon Valley Barnstaple North Devon
EX32 8NS
8 MARKETING AUTHORISATION NUMBER
PL 00142/0332
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29/01/2007
10 DATE OF REVISION OF THE TEXT
20/09/2007