Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
* Keep this leaflet. You may need to read it again.
* If you have any further questions, ask your doctor or
pharmacist.
* This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
* If you get any side effects talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
5-INDICATIONS
-Trichomoniasis.
-Intestinal and hepatic lambliasis.
-Giardiasis (lamblasis).
-Acute ulcerative gingivitis (Vincent’s gingivitis).
-Prevention and treatment of infections due to anaerobic bacteria.
-Pre- and post-operative prophylaxis in gynecological and
gastro-intestinal surgery.
6-POSOLOGY
Amoebiasis
Children: 30 to 40 mg/kg per day.
The daily dose should be taken as three divided doses preferably
during meals.
The treatment generally lasts 7 consecutive days.
Giardiasis
Children:
• From 2 to 5 years old: 250 mg (10 mL) per day.
• From 5 to 10 years old: 375 mg (15 mL) per day.
• From 10 to 15 years old: 500 mg (20 mL) per day.
The daily dose should be taken as a single dose or 2 divided doses,
preferably during meals for 5 consecutive days.
Anaerobic infections
Children: 20 to 30 mg/kg per day.
7-ADVERSE REACTIONS
Mild gastro-intestinal disorders such as nausea, vomiting, diarrhea,
abdominal cramps, metallic taste in the mouth, loss of appetite
may appear but such effects are temporary and rapidly
disappear. Moderate leukopenia may occur during treatment;
during long-term treatment regular blood formula controls are
recommended.
Exceptionally, allergic reactions (itching, flushing, urticaria, fever,
angioedema, anaphylactic shock, peripheral and central nervous
system disorders, reversible cases of pancreatitis).
At high dosage and/or during prolonged treatment: hematological
disorders, in particular leukopenia, peripheral sensory
neuropathies, decreasing after discontinuation of treatment.
8-WARNINGS AND PRECAUTIONS
Oral treatment with metronidazole should be avoided during
breast-feeding.
Throughout treatment patients should abstain from drinking
alcoholic beverages which could give rise to vomiting and to
stomach cramps.
Interactions with other drugs may occur, particularly with
Disulfiram, oral anticoagulants (warfarin type), lithium and
cyclosporin.
9-CONTRAINDICATIONS
Anomalies of the blood formula.
Central nervous system disorders.
METRODAZ-UBSA
®
is contra-indicated during the first three months
of pregnancy; during the following months, oral administration
should be limited to those cases in which local application has
proved inadequate.
10-STORAGE CONDITIONS
Store below 30 C.
All medicines should be kept out of children’s reach.
Manufacturer, Marketing Authorization Holder:
®
Metronidazole benzoate
125 mg/5 mL oral suspension
Date of Revision: June 12, 2026
1-FORMS and PRESENTATION
METRODAZ-UBSA
®
is an oral suspension with orange taste.
100ml vial and a measuring spoon ( 5ml).
2-COMPOSITION
Active ingredient
Metronidazole BP………………….2.5g
(as metronidazole benzoate :4g)
Excipients:
Sorbitol solution 70%, glycerin, propylene glycol, aerosil 200,
sodium citrate, citric acid monohydrate, sodium benzoate,
sodium methyl paraben, sodium propyl paraben, disodium
edetate, sucralose, xanthan gum, polysorbate 80, orange flavor,
purified water.
3-PHARMACOTHERAPEUTIC CLASS
Antiparasitic, anti-infective
4-PROPERTIES
Metronidazole, a synthetic drug, is considered the drug of choice
for treatment of infections due to various protozoa such as:
amoeba, giardia lamblia and trichomonas vaginalis. It is
therefore particularly indicated for treatment of intestinal and
hepatic amoebiasis and forms of urethritis and vaginitis caused
by trichomonas vaginalis. In the latter case, the simultaneous
treatment of patient and partner is strongly recommended.
Metronidazole is also very active against a wide range of obligate
anaerobic bacteria such as Fusobacterium, Clostridium and
various strains of bacteroides. It has however no effect on
facultative aerobic bacteria and its use therefore does not affect
the normal population of these organisms in man.
Cases of resistance to metronidazole are rather rare. Metronida-
zole is absorbed rapidly and nearly completely from the
gastro-intestinal tract. The maximum concentrations in the blood
are achieved about four hours after administration. About half the
dose administered is metabolised and 50% is rapidly eliminated
via the kidneys. The drug passes the placenta and is found in the
breast milk in concentrations corresponding to those in the
mother’s serum.
125 mg/5 mL Suspension Reg. N°:06526/1
PI084/01
