CODALAX 200mg/25mg Milligram Capsules Hard
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
06-05-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
DANTRON POLOXALCOL
Available from:
Mundipharma Pharmaceuticals Limited
INN (International Name):
DANTRON POLOXALCOL
Dosage:
200mg/25mg Milligram
Pharmaceutical form:
Capsules Hard
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Authorised
Authorization date:
0000-00-00
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Codalax 200mg/25mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 200mg Poloxamer 188 and 25mg Dantron.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard (Capsule)
Opaque orange/light brown, size 3, hard gelatin capsule marked ‘CX’ and NAPP in white.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Use only in the treatment of analgesic induced constipation in the terminally ill patient.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Recommended dosage:
Adults
One or two capsules at bedtime.
Children under 12 years
CODALAX capsules - one at bedtime or as recommended by the physician.
Elderly
As recommended by the physician.
4.3 CONTRAINDICATIONS
1.
In common with other gastro-intestinal evacuants, CODALAX capsules should not be given when acute or
painful conditions of the abdomen are present or when the cause of the constipation is thought to be intestinal
obstruction.
2.
Pregnancy and lactation.
3.
Hypersensivity to any of the constituents of the product.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 25/07/2013_
_CRN 2135022_
_page number: 1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
1.
Oral administration of dantron has been reported to cause liver or intestinal tumours in rats and mice. There is
no sound evidence to conclude a no effect dose and therefore there may be a risk of such effects in humans.
CODALAX use should therefore be restricted to the licensed indications.
2.
In babies, children and patients wearing nappies there may be staining of the buttocks. This may lead to
superficial sloughing of the skin. Therefore, CODALAX should not be given to inf
Read the complete document
