Stomorgyl 10 Film-coated Tablets

Composition

Spiramycin 750,000 IU

Metronidazole 125mg

Colorants: Ponceau 4R 0.06mg

Titanium dioxide E171 0.20mg

For full list of excipients, see section 6.1.

6.1 List of excipients

Aluminium Oxide, hydrated

Sorbitol

Dextrin, white

Gelatin

Citric Acid Monohydrate

Magnesium Stearate

Wheat Starch

Film coating:

Ponceau 4R (E124)

Titanium Dioxide (E171)

Hypromellose 6 m Pa s

Polyethylene Glycol 20000

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Pharmaceutical form

Film-coated tablet. Pink circular convex scored tablet.

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Pharmacological properties

Pharmacotherapeutic group:

Antibacterials for systemic use, combinations of antibacterials

ATCVet code: QJ01RA04

Metronidazole has antimicrobial activity against most anaerobes, including Bacteroides, Fusobacterium and spirochaetes. Spiramycin has a therapeutic spectrum including Gram-positive aerobes such as staphylococci, streptococci and Bacillus, but also including anaerobes such as Actinomyces, Clostridium and Bacteroides. Antimicrobial synergy has been shown in vitro for many of these organisms.

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Target species

Dogs and cats.

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Indications

For the treatment of periodontal and related oral conditions in dogs and cats.

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Dosage

By oral administration. For dogs and cats, 23.4 mg spiramycin and 12.5 mg metronidazole/kg bodyweight, once daily for 5 to 10 days.

Equivalent to: 1 tablet/10 kg bodyweight once daily for 5-10 days. Do not break or crush the tablets.

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Contraindications

Do not use in animals with a known hypersensitivity to spiramycin or metronidazole.

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Adverse reactions

Digestive tract disorders (vomitus, diarrhoea, anorexia) may occur very rarely.

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).

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Warnings

i. Special precautions for use in animals

None.

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

In case of accidental ingestion obtain medical advice if needed. Wash hands after use. Should direct skin contact occur, wash affected area. Should accidental eye exposure occur, flush the eyes immediately with water and seek medical attention if needed.

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Use during pregnancy, lactation or lay

Safety in pregnant dogs and cats has not been demonstrated.

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Interactions

The product should not be used concurrently with other antibiotics of the macrolide group.

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Overdose

No signs of toxicity were seen in cats receiving 5 times the recommended dose, or in dogs receiving 8 times the recommended dose.

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Special warnings

None known.

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Withdrawal period

Not applicable.

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Incompatibilities

None known.

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Immediate packaging

Opaque, white, non-plasticised polyvinylchloride-acetochloride blister pack with aluminium foil backing containing 10 tablets per strip. Each box contains five blister strips.

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Storage

Do not store above 25°C. Store in a dry place. Protect from light.

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Shelf life

3 years.

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Disposal of unused product

Any unused product or waste material should be disposed of in accordance with national requirements.

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Additional information

Vm 08327/5062

9 DATE OF FIRST AUTHORISATION

30 June 1993

10 DATE OF REVISION OF THE TEXT

August 2025

ANY OTHER INFORMATION REQUIRED BY THE SECRETARY OF STATE

Not applicable.

Gavin Hall Approved: 19 August 2025

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Registration holder

Boehringer Ingelheim Animal Health UK Limited

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

United Kingdom

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