Glycerol 2g suppositories

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Glycerol

Available from:

Waymade Healthcare Plc

ATC code:

A06AX01

INN (International Name):

Glycerol

Dosage:

1400mg

Pharmaceutical form:

Suppository

Administration route:

Rectal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01060200

Patient Information leaflet

100MM MEASUREMENT VERIFICATION BAR
2922-G
WHAT IS IN THIS LEAFLET
1.
What Glycerol Suppositories are and what
they are used for
2.
What you need to know before you use
Glycerol Suppositories
3.
How to use Glycerol Suppositories
4.
Possible side effects
5. How to store Glycerol Suppositories
6.
Contents of the pack and other information
1. WHAT GLYCEROL SUPPOSITORIES ARE
AND WHAT THEY ARE USED FOR
Glycerol belongs to a group of medicines
called laxatives. A laxative is a medicine
which is used for the occasional treatment of
constipation.
Glycerol Suppositories act as a stimulant
laxative for short term treatment of
constipation and for emptying the bowels
2. WHAT YOU NEED TO KNOW BEFORE
YOU USE GLYCEROL SUPPOSITORIES
DO NOT USE GLYCEROL SUPPOSITORIES IF YOUR
CHILD:
• suffers from a blocked bowel or an
abdominal problem for which you have not
obtained a medical opinion
• is allergic (hypersensitive) to glycerol or any
of the other ingredients of this medicine
(listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using
Glycerol Suppositories
If your child is diabetic you should speak
to your doctor before using Glycerol
Suppositories as they may interfere with levels
of sugar in their body.
It is not recommended that you use Glycerol
Suppositories for long periods of time.
If your child needs laxatives every day you
should see your doctor.
PREGNANCY, BREAST-FEEDING AND FERTILITY
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice
before using this medicine.
Glycerol Suppositories should be avoided in
the first three months of pregnancy. Glycerol
Suppositories can be used during
breastfeeding.
Ask your doctor or pharmacist for advice
before taking any medication.
3. HOW TO USE GLYCEROL
SUPPOSITORIES
Always use this medicine exactly as described
in this leaflet or as your doctor or pharmacist
has told you. Check with your doctor or
pharmacist if you are not sure.
1. Wash hands before opening in

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Glycerol 2g Suppositories
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 1400mg Glycerol
For full list of excipients, see 6.1.
3
PHARMACEUTICAL FORM
Amber coloured suppository, of nominal weight 2g 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
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 performed
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
5.1
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