Glycerol Suppositories BP for Adults

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Glycerol

Dostupné s:

Ethypharm

ATC kód:

A06AX; A06AX01

INN (Mezinárodní Name):

Glycerol

Dávkování:

4 gram(s)

Léková forma:

Suppository

Terapeutické oblasti:

Other drugs for constipation; glycerol

Stav Autorizace:

Marketed

Datum autorizace:

1991-10-18

Informace pro uživatele

IN THIS LEAFLET:
1. What Glycerol Suppositories are and what
they are used for.
2. Before you use Glycerol Suppositories.
3. How to use Glycerol Suppositories.
4. Possible side effects.
5. How to store Glycerol Suppositories.
6. Further 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 treatment of constipation.
Glycerol Suppositories act as a stimulant
laxative for short term treatment of
constipation and for emptying the bowels.
2. BEFORE YOU USE GLYCEROL
SUPPOSITORIES
DO NOT USE GLYCEROL SUPPOSITORIES IF:
• you suffer from a blocked bowel or an
abdominal problem for which you have
not obtained a medical opinion.
• you are allergic (hypersensitive) to glycerol
or any of the other ingredients of Glycerol
Suppositories, listed in section 6 of this leaflet.
TAKE SPECIAL CARE WITH GLYCEROL SUPPOSITORIES.
TELL YOUR DOCTOR IF:
• you are diabetic
If any of the above applies to you or your child,
please contact your doctor or pharmacist.
It is not recommended that you use Glycerol
Suppositories for long periods of time. If you need
laxatives every day you should see your doctor.
PREGNANCY AND BREAST-FEEDING
Glycerol Suppositories should be avoided in the
first three months of pregnancy. Ask your doctor
or pharmacist for advice before taking any
medication.
3. HOW TO USE GLYCEROL
SUPPOSITORIES
Always use Glycerol Suppositories exactly as
your doctor has told you. You should check
with your doctor or pharmacist if you are not
sure.
1. Wash hands before opening individual
packaging. If the suppository is too soft, it may
be chilled in the refrigerator or under cold
running water before unwrapping
2. To remove a suppository, tear one
from the strip along the perforations
then peel it from the plastic
wrapping by grasping the two
halves of the wrapping at the tip of
the suppository and pulling them
gently apart. The tip should be moistened with
a little cold water to aid insertion
3. Lie o

Charakteristika produktu

Health Products Regulatory Authority
11 June 2019
CRN008YGJ
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glycerol Suppositories BP for Adults
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains 2.8 grams of glycerol (equivalent to 70 %
w/w).
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suppository.
Amber-coloured suppository, of nominal weight 4 g.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For occasional use as astimulant laxative used for the treatment of
constipation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Suppositories for rectal insertion.
Adults, the elderly and children of 12 years and over
One suppository, to aid insertion the suppository tip should be
moistened with water before use.
Children under 12 and infants
Not recommended.
4.3 CONTRAINDICATIONS
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 use is not
recommended.
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
INTERACTIONS
None stated.
4.6 FERTILITY, PREGNANCY AND LACTATION
No evidence of harmful affects available. However, best avoided during
the first trimester of pregnancy.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None stated.
4.8 UNDESIRABLE EFFECTS
Health Products Regulatory Authority
11 June 2019
CRN008YGJ
Page 2 of 3
Use of the product may occasionally cause abdominal cramps.
4.9 OVERDOSE
Overdosage via rectal route is unlikely. However, if ingested treat
symptomatically.
5 PHARMACOLOGICAL PROPERTIES
5.1 PHARMACODYNAMIC PROPERTIES
Glycerol is an osmotic dehydrating agent with hygroscopic and
lubricating properties.
Glycerol acts by promoting peristalsis and evacuation of the lower
bowel by virtue of a mild irritant effect.
5.2 PHARMACOKINETIC PROPERTIES
Glycerol is readily absorbed fro