METROGYL

Metronidazole is indicated for the treatment of the following infections in adults and children:

· treatment of infections due to micro-organisms sensitive to metronidazole (peritonitis, cerebral abscess, osteomyelitis, puerperal fever, pelvic abscess, surgical wound infections);

· prevention of postoperative infections due to anaerobic bacteria;

· urogenital trichomoniasis;

· bacterial vaginosis;

· amoebiasis;

· giardiasis;

· acute periodontal infections, notably acute ulcerative gingivitis;

· Helicobacter pylori infection associated with a gastroduodenal ulcer, in association with other recommended medicines.

Official recommendations regarding the appropriate use of antibacterial agents should be taken into account.

Contraception in men and women

See section 4.5 "Contraceptives"

Pregnancy

The safety of metronidazole use during pregnancy has not been demonstrated with certainty. Data concerning use in early pregnancy in particular are contradictory. Some studies have shown an increase in the rate of malformations. Studies conducted in animals have not shown any teratogenic effect of metronidazole (see section 5.3).

The use of metronidazole is contraindicated in the first trimester of pregnancy. In the second and third trimesters, this medicine should be used only if the potential benefits of its use for the mother outweigh the risks of deleterious effects on the fetus.

Breastfeeding

Metronidazole is excreted in breast milk at concentrations close to plasma concentrations. This medicine should not be used during breastfeeding. However, if treatment proves necessary, breastfeeding must be discontinued.

Fertility

Studies conducted in animals only show a potential negative influence of metronidazole on the male reproductive system in the case of administration of high doses significantly higher than the maximum recommended dose in humans.

Patients must be warned of the risk of drowsiness, dizziness, disorientation, hallucinations, convulsions or transient visual disturbances. It is recommended that patients do not drive vehicles and do not use machines if they present these symptoms.