Glycerol Suppositories BP Infants

국가: 몰타

언어: 영어

출처: Malta Medicines Authority

유효 성분:

GLYCEROL

제공처:

Macarthys Laboratories Limited Bampton Road, Harold Hill, Romford Essex, RM3 8UG, United Kingdom

ATC 코드:

A06AX01

INN (국제 이름):

GLYCEROL

약제 형태:

SUPPOSITORY

구성:

GLYCEROL

처방전 유형:

OTC

치료 영역:

DRUGS FOR CONSTIPATION

승인 상태:

Withdrawn

승인 날짜:

2006-12-19

제품 특성 요약

Page 1 of 3 
SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 
Glycerol 1g Suppositories  

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each suppository contains 700mg Glycerol  

For full list of excipients, see 6.1. 

3 
PHARMACEUTICAL FORM 
Amber coloured suppository, of nominal weight
1g 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 

Infants_ _
One 1g 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 

Page 2 of 3 
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 A0