Glycerin Suppositories Bp 2g Childrens Size
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glycerin Suppositories BP 2g Children’s Size.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Glycerol BP 70% w/w.
3. PHARMACEUTICAL FORM
Suppositories.
4 CLINICAL PARTICULARS
4.1. Therapeutic Indications
For the relief of occasional constipation.
4.2. Posology and Method of Administration
Route of administration: Rectal.
Dose: One suppository.
Dosage Schedule: As required.
The suppository should be dipped in water before insertion.
The suppositories are defined as children’s size, therefore there is no infants’ or adults’ recommendation
4.3. Contra-Indications
Contraindicated in patients with known hypersensitivity to glycerol.
Children’s Suppositories are not suitable for use by infants (under 1 year).
4.4. Special Warnings and Special Precautions for Use
Keep all medicines away from children. Not to be swallowed.
Suppositories must not be taken by mouth.
4.5. Interactions with other Medicinal Products and other Forms of Interaction
None known.
4.6. Pregnancy and Lactation
Not applicable.
4.7. Effects on Ability to Drive and Use Machines
None.
4.8 Undesirable effects
Gastrointestinal Disorders: May cause irritation and occasionally abdominal
cramps.
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
Glycerol has a mildly laxative action, however, if the product is accidentally swallowed it is unlikely to cause such effects and it is unlikely that active measures will be required. Accidental ingestion of a large number of suppositories may cause headache, nausea and vomiting; less frequently diarrhoea, thirst; dizziness, mental confusion and cardiac arrhythniias can occur.
5
PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic Properties
Glycerol by the rectal route promotes peristalsis and evacuation of the lower bowel by virtue of its irritant action.
5.2. Pharmacokinetic Properties
No information available.
5.3. Pre-clinical Safety Data
None.
6 PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Gelatin
Purified Water
6.2. Incompatibilities
None known.
6.3. Shelf Life
18 months unopened.
6.4. Special Precautions for Storage
Store below 25°C in a dry place.
6.5. Nature and Content of Container
12’s: Sealed, PVC/PE laminate inside a cardboard carton.
None.
7 MARKETING AUTHORISATION HOLDER
Thornton & Ross Ltd.
Linthwaite Laboratories
Huddersfield
HD7 5QH.
8. MARKETING AUTHORISATION NUMBER
PL: 00240/6101R
OF
9. DATE OF FIRST AUTHORISATION/RENEWAL AUTHORISATION
1st August 1986 / 22nd April 1993, 25th November 1998
10 DATE OF REVISION OF THE TEXT
26/11/2014