Dogs and cats

Treatment of gastrointestinal tract infections caused by Giardia spp. and Clostridia spp. (i.e. C. perfringens or C. difficile).

Treatment of infections of the urogenital tract, oral cavity, throat and skin caused by obligate anaerobic bacteria (e.g. Clostridia spp.) susceptible to metronidazole.

Do not use in case of hepatic disorders.

Do not use in case of hypersensitivity to the active substance or to any of the excipients.

Due to the likely variability (time, geographical) in the occurrence of metronidazole resistant bacteria, bacteriological sampling and susceptibility testing are recommended.

Whenever possible, the product should only be used based on susceptibility testing. Official, national and regional anitmicrobial policies should be taken into account when the veterinary medicinal product is used.

The tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of the animals.

Especially after prolonged treatment with metronidazole neurological signs could occur.

Metronidazole has confirmed mutagenic and genotoxic properties in laboratory animals as well as in humans. Metronidazole is a confirmed carcinogen in laboratory animals and has possible carcinogenic effects in humans. However, there is inadequate evidence in humans for the carcinogenicity of metronidazole.

Metronidazole may be harmful for the unborn child.

Avoid contact with the skin or mucous membranes including hand-to-mouth contact. To avoid such contact wear impervious gloves when handling the product and/or for direct administration into the animal's mouth.

Do not allow treated dogs to lick persons immediately after intake of the medication.

In case of skin contact, wash thoroughly the affected area.

To avoid accidental ingestion, particularly by a child, unused parts of the tablets should be returned to the open blister space, inserted back into the outer packaging and kept in a safe place out of the sight and reach of children. The remaining part should be used at the time of next administration.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Wash hands thoroughly after use. Metronidazole may cause hypersensitivity reactions. People with known hypersensitivity to metronidazole should avoid contact with the veterinary medicinal product.

The following adverse reactions may occur after administration of metronidazole: vomiting, hepatotoxicity, neutropenia. In very rare cases neurologic signs may cccur.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

Studies in laboratory animals have shown inconsistent results with regard to teratogenic/embryotoxic effects of metronidazole. Therefore, use of this product during pregnancy is not recommended. Metronidazole is excreted in milk and use during lactation is therefore not recommended.

Metronidazole may have an inhibitory effect on the degradation of other drugs in the liver, such as phenytoin, cyclosporine and warfarin.

Cimetidine may decrease the hepatic metabolism of metronidazole resulting in increased serum concentration of metronidazole.

Phenobarbital may increase hepatic metabolism of metronidazole resulting in decreased serum concentration of metronidazole.

For oral use.

The recommended dose is 50 mg metronidazole per kg body weight per day, for 5-7 days. The daily dose may be divided equally for twice daily administration (i.e. 25 mg/kg body weight twice daily).

To ensure administration of the correct dosage body weight should be determined as accurately as possible.

Tablets can be divided into 2 or 4 equal parts to ensure accurate dosing. Place the tablet on a flat surface, with its scored side facing up and the convex (rounded) side facing the surface.

Halves: press down with your thumbs on both sides of the tablet.

Quarters: press down with your thumb in the middle of the tablet.

Adverse events are more likely to occur at doses and treatment durations in excess of the recommended treatment regimen. If neurological signs occur, treatment should be discontinued and the patient should be treated symptomatically.