Glycerol 2g Suppositories

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Glycerol

Tersedia dari:

Ethypharm

Kode ATC:

A06AX; A06AX01

INN (Nama Internasional):

Glycerol

Dosis:

2 gram(s)

Bentuk farmasi:

Suppository

Area terapi:

Other drugs for constipation; glycerol

Status otorisasi:

Marketed

Tanggal Otorisasi:

1993-02-25

Karakteristik produk

Health Products Regulatory Authority
11 June 2019
CRN008YGJ
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Glycerol 2g Suppositories
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each suppository contains: 1400mg Glycerol
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Suppository
Amber coloured suppository, of nominal weight 2 g.
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
Suppositories for rectal insertion.
Children
One suppository, to aid insertion the suppository tip should be
moistened with water before use.
4.3 CONTRAINDICATIONS
§ The product is contraindicated if there is intestinal obstruction
or blockage.
§ Hypersensitivity to the active substance or to any of the
excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The product is intended for occasional use only. Prolonged use is not
recommended, as it can 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
INTERACTIONS
None stated.
4.6 FERTILITY, PREGNANCY AND LACTATION
No evidence of harmful effects 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 cause abdominal cramps. Glycerol can cause
irritation when given rectally.
REPORTING OF SUSPECTED ADVERSE REACTIONS
Health Products Regulatory Authority
11 June 2019
CRN008YGJ
Page 2 of 3
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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL -
Dublin 2; Tel: [phone]