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

Logo D-WORM 100 mg Chewable Tablets.

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

D-WORM 100 mg Chewable Tablets.

COMPOSITION:
Each chewable tablet contains 100 mg
Mebendazole.

PHARMACOLOGICAL CLASSIFICATION:
Category A. Classification 12: Anthelmintics, Bilharzia medicines, Filaricides, etc.

PHARMACOLOGICAL ACTION:
Mebendazole is an anthelmintic agent. Its action is independent of its systemic concentration. It causes selective disappearance of cytoplasmatic microtubules in the tegumental and intestinal cells of affected worms. Secretory substances accumulate in Golgi areas, secretion of acetylcholinesterase is impaired and uptake of glucose is also impaired and therefore glycogen and adenosine triphospate (ATP) are depleted resulting in depletion of the worm's energy sources and their slow death. These effects are not noticed in host cells.

INDICATIONS:
D-Worm
is effective in ascariasis, intestinal capillariasis, enterobiasis, trichuriasis, threadworm (Strongyloides stercoralis) and hookworm (Ancylostoma duodenale and Necator americanus) infection as single or mixed infections. The drug is active against both larval and adult stages of nematodes that cause these infections and it is ovicidal for Ascaris and Trichuris. It is also effective against Taenia species.

CONTRA-INDICATIONS:
D-Worm
should not be given during pregnancy. It should not be used in patients who have experienced sensitivity reactions to mebendazole.

DOSAGE AND DIRECTIONS FOR USE:
FOR ADULTS AND CHILDREN
For infections of all worms excluding Tapeworm, Threadworm, Capillaria philippinensis, enterobiasis and Hydatid disease:
One tablet (100 mg) to be chewed and swallowed with liquid twice daily (morning and evening) for three consecutive days.
If the patient is not cured within 3 weeks after treatment, a second course should be given.

For Tapeworm infections (Taenia species):
One tablet (100 mg) to be chewed and swallowed with liquid twice daily (morning and evening) for six consecutive days.

For Threadworm (Strongyloides stercoralis) infections:
Adults:
Two tablets (200 mg) to be chewed and swallowed with liquid twice daily (morning and evening) for three consecutive days.

Children:
One tablet (100 mg) to be chewed and swallowed with liquid twice daily (morning and evening) for three consecutive days. The tablets may also be crushed and given with liquid if the child is unable to chew the tablet. A second course of treatment should be given to those patients who are still infected weeks after the first course.
In worm-eradication campaigns the standard course for each specific species should be administered every quarter during the first year. If a helminth is not susceptible to the standard dosage, the treatment course should be increased and/or higher doses than the standard dosage for a specific species is recommended.
The efficacy of D-Worm is dependent upon the duration of physical contact between the medicine and the parasite. When gastro-intestinal transit time is accelerated e.g. in diarrhoea it is necessary to repeat the dose at more frequent intervals daily.

For Capillaria philippinensis infections:
Chew two 100 mg tablets (200 mg) twice daily and swallow with liquid for at least twenty days.

For infants under 2 years:
See "Side Effects and Special Precautions".

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal disturbances such as abdominal pain and diarrhoea. Usage in children below 2 years is not well documented and as there have been very exceptional reports of convulsions in this age group D-Worm should only be given to very young children if their worm infections interfere significantly with the nutritional status and the physical development.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment is symptomatic and supportive.

IDENTIFICATION:
A light cream, round tablet with bevelled edge, one breakline and one flat side. Sweet taste and banana flavour.

PRESENTATION:
D-Worm
tablets are packed in quantities of 6 in blister packs.

STORAGE INSTRUCTIONS:
Keep out of reach of children. Store below 25 degrees Celsius.

REGISTRATION NUMBER:
Z/12/198

NAME AND BUSINESS ADDRESS OF APPLICANT:
TRIOMED (Pty) Ltd
Parc du Cap, Cnr Willie van Schoor Ave and Mispel Road, Bellville 7530

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
January 20, 1993.

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