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

Logo METAZOL 200 mg TABLETS
METAZOL 400 mg TABLETS

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

METAZOL 200 mg TABLETS
METAZOL 400 mg TABLETS

COMPOSITION:
Metronidazole 200 mg and 400 mg per tablet respectively.

PHARMACOLOGICAL CLASSIFICATION:
A20.2.6 Medicines against protozoa.

PHARMACOLOGICAL ACTION:
Metronidazole has antiprotozoal and antibacterial actions and is directly trichomonacidal and amoebicidal and bactericidal in vitro for many anaerobic micro-organisms including Bacteroides species.

INDICATIONS:
1.        Trichomonas infections in both males and females.
2.        All forms of amoebiasis.
3.        Lambliasis and Vincent's infection.
4.        Treatment of infections in which anaerobic bacteria have been identified or are suspected as pathogens, particularly Bacteroides fragilis and other species of Bacteroides, and including other species for which metronidazole is bactericidal.
5.        Prevention of post operative infections due to anaerobic bacteria.

CONTRA-INDICATIONS:
Metronidazole should not be used in patients with blood dyscrasias or with active disease of the central nervous system. Its use should be avoided during pregnancy.

DOSAGE AND DIRECTIONS FOR USE:
Seven days treatment should be satisfactory for most patients. Prolonged treatment can be used if the physician considers it to be necessary.
1.        Treatment of anaerobic infections
Adults and children over 12 years:
        400 mg three times daily.
Children under 12 years:
        7,5 mg per kg body mass three times daily.

2.        Prevention of anaerobic infections
GYNAECOLOGICAL SURGERY
Adults:
        2 g as a single dose followed by 200 mg three times daily until pre-operative withholding of solids and liquids by mouth becomes necessary.
        Medication with 200 mg three times daily should be resumed after the operation and for up to seven days.

3.        Vincent's infection
Adults and children over 12 years:
        200 mg three times daily for three days
        or 400 mg orally morning and evening for three days.

4.        Treatment of trichomonas infections
        (To prevent re-infection the consort should receive similar courses of treatment concurrently.)
Adults and children over 12 years:
        Either 200 mg three times daily for seven day.
        Or 800 mg mornings and 1,2 g evenings for two days.
        Or a single 2 g oral dose.

5.        Treatment of Amoebic infections
Adults and children over 12 years:
        800 mg three times daily for 5 - 10 days.

6.        Treatment of Lambliasis
Adults and children over 12 years:
        2 g once daily for three days.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side effects of Metronidazole include gastro-intestinal discomfort, anorexia, nausea, coated tongue, dryness of mouth and unpleasant taste, headaches and skin rashes; vomiting, diarrhoea, weakness, vertigo, depression, insomnia, drowsiness, urethral discomfort and darkening of the urine. There may be a temporary decrease in the white-cell count. Peripheral neuropathy has been reported in patients on prolonged therapy. When given in conjunction with alcohol Metronidazole may provoke a disulfiram-like reaction. Metronidazole enhances the anti-coagulant effect of warfarin. Pseudomembranous colitis has been reported with the use of Metronidazole.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms:
Nausea, diarrhoea, epigastric pain, abdominal cramps, metallic taste and furry tongue. Dizziness, vertigo, ataxia.
Treatment: Supportive and symptomatic therapy.

CONDITIONS OF REGISTRATION:
Advertising to the professions only.

IDENTIFICATION:
A) 200 mg: White, round, biconvex, uncoated tablet with a dividing groove on one side with a diameter of 11,5 mm.
B) 400 mg: White, round, flat uncoated tablet with a dividing groove on one side and a "11/400" inscription on the other, with a diameter of 12,5 mm.

PRESENTATION:
200 mg:
Containers of 1000 tablets.
400 mg: Containers of 1000 tablets.

STORAGE INSTRUCTIONS:
Store in a cool place (Below 25°C)
Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
200 mg strength: W/20.2.6/63.
400 mg strength: W/20.2.6/64.

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Geo Schwulst Laboratories Limited
Needham Park
1 Manchester Road
Wadeville

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
October 1988

PSO-46-11/91
PSO-47-11/91

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