Metrotab Vet. Flavoured 1000 mg Tablets for Dogs

Composition

Each tablet contains:

Active substances:

Metronidazole 1000 mg

Excipients:

Qualitative composition of excipients and other constituents

Microcrystalline cellulose

Sodium starch glycolate (Type A)

Hydroxypropylcellulose

Silica, colloidal hydrated

Magnesium stearate

Chicken flavour

Off-white to light brown with brown spots, round and convex flavoured tablet with a cross-shaped break line on one side. The tablets can be divided into 2 or 4 equal parts.

3

Pharmacological properties

4.1 ATCvet code :

QJ01XD01

4.2 Pharmacodynamics

Metronidazole has antiprotozoal and antibacterial activity.

After metronidazole has penetrated the bacteria the molecule is reduced by the susceptible 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 susceptible bacteria in concentrations equal to or slightly higher than the minimum inhibiting concentration (MIC).

4.3 Pharmacokinetics

Metronidazole is immediately and well absorbed after oral administration. After 1 hour a plasma concentration of 10 micrograms/ml was reached with a single dose of 50 mg. The bioavailability of metronidazole is almost 100% and the half life in the plasma is approximately 8 - 10 hours. 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.

3

Target species

Dogs

3

Indications

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.

3

Dosage

Oral use.

The recommended dose is 50 mg metronidazole per kg bodyweight (one 1000 mg tablet/20 kg bodyweight) per day, for 5 - 7 days. The daily dose should preferably be divided in two equal doses for twice daily administration (i.e. 25 mg/kg bodyweight twice daily).

To ensure a 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 or fingers on both sides of the tablet. Quarters: press down with your thumb or a finger in the middle of the tablet.

Divided tablets should be used at the next administration. Any divided tablets remaining after the last administration of the product should be discarded.

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.

3

Adverse reactions

Dogs:

Very rare (<1 animal / 10 000 animals treated, including isolated reports):

Neurological signs (e.g. ataxia1,2, nystagmus1,3)

Undetermined frequency (cannot be estimated from the available data):

Vomiting

Hepatic toxicosis

Neutropenia

1 Amongst the most frequently reported neurological signs

2 Cerebellovestibular

3 Vertical

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

3

Warnings

Special precautions for safe use in the target species:

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.

Especially after prolonged treatment with metronidazole neurological signs could occur.

As tablets are flavoured, store tablets out of reach of the animals in order to avoid accidental ingestion.

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.

Pregnant women should be careful when handling this veterinary medicinal product. 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.

Metronidazole may cause hypersensitivity reactions. People with known hypersensitivity to metronidazole should avoid contact with the veterinary medicinal product.

Wash hands thoroughly after handling the tablets.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

3

Use during pregnancy, lactation or lay

Pregnancy 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.

Lactation Metronidazole is excreted in milk and use during lactation is therefore not recommended.

3

Interactions

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.

3

Overdose

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.

In literature, incidental cases of dogs suffering from metronidazole toxicosis have been described that were successfully treated with diazepam, resulting in a reduced recovery time.

3

Special warnings

None.

3

Withdrawal period

Not applicable.

3

Incompatibilities

Not applicable.

3

Immediate packaging

Aluminium - PVC/PE/PVDC blister in cardboard box, containing 10 tablets each.

Package sizes:

Cardboard box with 1, 2, 3, 5 or 10 blisters of 10 tablets.

Not all pack sizes may be marketed.

3

Storage

This veterinary medicinal product does not require any special storage conditions. Return any divided tablet to the blister.

3

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 4 years.

3

Disposal of unused product

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

3

Additional information

Vm 20916/4041

8 DATE OF FIRST AUTHORISATION

20 May 2021

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

June 2026

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Gavin Hall Approved: 01 July 2026

3

Registration holder

CP Pharma Handelsgesellschaft mbH

3