DOXIUM® tablets

INDICATIONS CONTRA-INDICATIONS DOSAGE SIDE-EFFECTS PREGNANCY OVERDOSE IDENTIFICATION PATIENT INFORMATION

DOXIUM® tablets

SCHEDULING STATUS:
Schedule 2

PROPRIETARY NAME
(and dosage form):

DOXIUM^® tablets

COMPOSITION:
One tablet contains 250 mg of the active substance calcium dobesilate.

PHARMACOLOGICAL CLASSIFICATION:
A. 8.1 Coagulants, haemostatics.

PHARMACOLOGICAL ACTION:
DOXIUM tablets act selectively on the capillary walls regulating their physiological functions of resistance and permeability. This action is beneficial in all cases of capillary fragility due to metabolic disturbances (constitutional or acquired), to surgical stress or induced by certain medicines.

INDICATIONS:
DOXIUM tablets are recommended as the vascular treatment of choice indiabetic retinopathy.

It has been used with good effect as a haemostatic during surgical procedures in otorhinolaryngology, ophthalmology and dentistry.

CONTRA-INDICATIONS:
There are no known contra-indications but on general principles DOXIUM tablets should not be administered during the first trimester of pregnancy.

DOSAGE AND DIRECTIONS FOR USE:
The usual daily dose is 2 to 3 tablets of 250 mg swallowed whole at meals. Duration of treatment may be from one week to several months or longer depending upon the disease condition. Half the above dose is recommended for infants.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Rarely in sensitive persons some nausea or gastric discomfort may occur but this rapidly disappears if the dose is decreased.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
This has not been encountered. In view of the extremely low toxicity of the medicines no symptoms can be predicted but if poisoning or overdosage is suspected it is recommended on general principles that vomiting be induced or gastric lavage be performed, and such symptomatic supportive therapy be administered as appears indicated.

CONDITIONS OF REGISTRATION:
None.

IDENTIFICATION:
A white, smooth biconvex tablet of 11,0 mm diameter with the mark "d." engraved on one side.

PRESENTATION:
DOXIUM tablets are supplied in bottles of 100 tablets. Each tablet contains 250 mg calcium dobesilate.

STORAGE INSTRUCTIONS:
Keep out of reach of children.
Store below 30°C.

REGISTRATION NUMBER:
E/8.1/39.

APPLICANT:
Johnson & Johnson Professional Products (Pty) Ltd
(Reg. No. 83/13283/07)
New Road
HALFWAY HOUSE, Transvaal

DATE OF PUBLICATION:
12 October 1972.

MANUFACTURED BY:
OM Laboratories Ltd.,
Meyrin –Geneva,
Switzerland.

Code No.: 020040
86B0188