SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Metrocare Flavour 250 mg tablets for dogs and cats

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

Active substance: Metronidazole 250 mg

Excipients:

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Tablet

White to off-white, round and convex tablet with a cross-shaped break line on one side.

Tablets can be divided into 2 or 4 equal parts.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs and cats

4.2 Indications for use, specifying the target species

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.

4.3 Contraindications

Do not use in cases of hepatic disorders.

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

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals

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 antimicrobial policies should be taken into account when the veterinary medicinal product is used.

In very rare cases, neurological signs may occur especially after prolonged treatment with metronidazole.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

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.

Impervious gloves should be worn during administration of the product to avoid skin and hand-to-mouth contact with the product.

To avoid accidental ingestion, particularly by a child, unused part-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. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Wash hands thoroughly after handling the tablets. Metronidazole may cause hypersensitivity reactions. In case of known hypersensitivity to metronidazole, avoid contact with the veterinary medicinal product.

4.6 Adverse reactions (frequency and seriousness)

The following adverse reactions may occur after administration of metronidazole:

vomiting, hepatotoxicity, neutropenia and neurological signs.

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

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

-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).

4.7 Use during pregnancy, lactation or lay

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.

4.8 Interaction with other medicinal products and other forms of interaction

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.

4.9 Amounts to be administered and administration route

For oral administration.

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

To ensure administration of the correct dosage, bodyweight should be determined as accurately as possible.

Bodyweight	Metrocare 250 mg Tablets (daily dose)	or	Metrocare 500 mg Tablets (daily dose)
1.25 kg	¼
2.5 kg	½		¼
3.75 kg	¾
5 kg	1		½
7.5 kg	1 ½		¾
10 kg	2		1
15 kg	3		1 ½
20 kg	4		2
25 kg			2 ½
30 kg			3
35 kg			3 ½
40 kg			4

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 or fingers on both sides of the tablet.

Quarters: press down with your thumb or a finger in the middle of the tablet. The remaining portion(s) should be given at the next administration(s).

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

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.

4.11 Withdrawal period(s) Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: (nitro) imidazole derivatives

ATCvet code: QP51AA01

5.1 Pharmacodynamic properties

After metronidazole has penetrated the bacteria the molecule is reduced by the sensitive bacteria (anaerobe). The metabolites that are created have a toxic effect on the bacteria through binding to the bacterial DNA. In general metronidazole is bactericidal for sensitive bacteria in concentrations equal to or a little higher than the minimum inhibiting concentration (MIC).

Clinically metronidazole does not have any relevant effect on facultative anaerobes, obligate aerobes and microaerophilic bacteria.

5.2 Pharmacokinetic particulars

Metronidazole is immediately and well absorbed after oral administration. The peak plasma concentration, C_max was reached in dogs at between 0.75 and 2 hours after dosing and in cats at between 0.33 and 2 hours after dosing. The average terminal half life was 6.35 hours in dogs and 6.21 hours in cats. Metronidazole penetrates well into the tissues and bodily fluids, such as saliva, milk, vaginal secretions and semen. Metronidazole is primarily metabolised in the liver. Within 24 hours after oral administration, 35-65% of the administered dose (metronidazole and the metabolites thereof) is excreted in the urine.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Cellulose, microcrystalline

Sodium starch glycolate (type a)

Yeast extract

Hydroxypropylcellulose Magnesium stearate

6.2 Major Incompatibilities

Not applicable

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 30 months

6.4 Special precautions for storage

Return any divided tablet to the blister and store protected from light.

6.5 Nature and composition of immediate packaging

PVC/Aluminium/Oriented polyamide /Aluminium blister packs

Cardboard box of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 25 or 50 blisters of 10 tablets giving pack sizes of 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 250 or 500 tablets

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Ecuphar NV

Legeweg 157-i

B-8020

Oostkamp

Belgium

8. MARKETING AUTHORISATION NUMBER

Vm 32742/4016

9. DATE OF FIRST AUTHORISATION

23 September 2019

10. DATE OF REVISION OF THE TEXT

23 September 2019

Approved 23 September 2019