FASIGYNE

They derive from the antiparasitic and antibacterial activity of tinidazole and its pharmacokinetic characteristics. They take into account both the clinical studies conducted for this medicine and its place within the range of anti-infective products currently available.

In adults, they are limited to infections caused by germs defined as sensitive.

· Urogenital trichomoniasis.

· Non-specific vaginitis.

· Lambliasis.

· Amoebiasis.

· Preventive treatment of infections caused by sensitive anaerobic germs during surgical interventions involving a high risk of occurrence of this type of infection.

N.B: In the treatment of Trichomonas infections and non-specific vaginitis, it is necessary to treat the partner in parallel.

In children, they are limited to the treatment of lambliasis.

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

Special warnings

· Given that imidazole group derivatives may, at high doses, cause some neurological disorders, the observation of phenomena such as obnubilation, dizziness, incoordination of movements, ataxia, peripheral neuropathy and, rarely, convulsions, should lead to discontinuation of the medication.

· Avoid taking alcoholic beverages and medicines containing alcohol during treatment, (see section 4.5).

Precautions for use

· In patients presenting with blood dyscrasia or abnormalities of the blood count, tinidazole must be used with caution.

· Hematological monitoring must be carried out during the treatment of amoebiasis.

Pregnancy

Tinidazole has not shown any teratogenic effect on two species (rat, mouse).

In the absence of an epidemiological study, the low number of exposed pregnancies does not allow for a conclusion regarding its safety in terms of malformation.

Consequently, the use of tinidazole will only be considered after a careful evaluation of the expected therapeutic benefit.

Breastfeeding

Avoid administration of tinidazole during lactation, due to passage into milk.

Draw the attention of vehicle drivers and machine users to the risk of dizziness.

Adverse effects are rare, moderate and limited. The following have been reported:

· Gastrointestinal disorders: nausea, vomiting, abdominal pain, anorexia, diarrhea, taste disturbance (metallic), coated tongue.

· Hypersensitivity reactions with skin rash, pruritus, urticaria and angioedema. These reactions are only exceptionally severe.

· Headaches, fatigue, dizziness, peripheral neuropathies and, rarely, convulsions, dark urine.

· Possibility of transient leukopenia as with compounds of the same family.

· "Antabuse" effect.

Reporting of suspected adverse effects

Reporting of suspected adverse effects after authorization of the medicine is important. It allows continuous monitoring of the benefit/risk ratio of the medicine. Healthcare professionals report any suspected adverse effect via the national reporting system: French National Agency for Medicines and Health Products Safety (ANSM) and network of Regional Pharmacovigilance Centres - Website: www.ansm.sante.fr .