Beaphar One Dose Small Dog Wormer 100 mg Nitroscanate Film-coated Tablets

Composition

Active substances:

Nitroscanate 100 mg

Excipient(s):

Titanium Dioxide (E171) 0.8038 mg

Ferric Oxide Yellow (E172) 0.0257 mg

Ferric Oxide Black (E172) 0.00003 mg

Ferric Oxide Red (E172) 0.00003 mg

As constituents of Opadry OY-GM 7900

For the full list of excipients, see section 6.1.

6.1 List of excipients

Opadry-Oy_Gm 7900 Consisting of:

Titanium Dioxide (E171)

Ferric Oxide Yellow (E172)

Ferric Oxide Black (E172)

Ferric Oxide Red (E172)

Maize Starch

Microcrystalline Cellulose

Sodium Starch Glycollate

Sodium Lauryl Sulphate

Magnesium Stearate

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Pharmaceutical form

Film-coated tablets.

Round convex tablets, yellow coloured, film coated.

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Pharmacological properties

Pharmacotherapeutic group: Anthelmintic

ATC vet code: QP52AX01

Nitroscanate is a broad spectrum anthelmintic effective against gastrointestinal nematodes and cestodes.

5.1 Pharmacodynamic Properties

The mode of action of nitroscanate has not been well established. However, there is some evidence that nitroscanate decreases the ATP/ADP ratio affecting energy producing pathways within the target parasites. This leads to the death of the parasite. The concentration of unabsorbed nitroscanate in contact with the helminths appears to be more important for efficacy than absorption into the blood.

5.2 Pharmacokinetic Properties

Pharmacokinetic data from dogs are not available. In other species (mice and sheep), the drug is only partly absorbed from the gastrointestinal tract when administered orally, with the majority of the dose being eliminated in the faeces.The remainder of the dose is metabolised and excreted in the urine.

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Target species

Dogs.

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Indications

For the treatment of the following nematodes (roundworms) and cestodes (tapeworms):

Nematodes: Toxocara canis, Toxascaris leonina, Uncinaria stenocephala, Ancylostoma caninum

Cestodes: Taenia hydatigena, Taenia pisiformis, Dipylidium caninum .

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Dosage

The dose of the product for the treatment of dogs is nitroscanate 50 mg/kg bodyweight, which is equivalent to 1 x 100 mg tablet per 2 kg (4.4 lb) bodyweight.

Should be administered orally in the morning after overnight fasting with approximately one-fifth of the daily food ration. The remaining food ration should be withheld for at least 8 hours.

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Contraindications

Do not repeat treatment if vomiting occurs shortly after dosing.

Do not administer if your pet is sick or recovering from an illness.

Do not use in known cases of hypersensitivity to the active substance or to any of the excipients. If a hypersensitivity reaction occurs treatment should be discontinued. Do not use in dogs weighing less than 2 kg.

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Adverse reactions

Transient gastrointestinal signs (vomiting and diarrhoea); systemic sign (lethargy) and neurological sign (ataxia) have been observed 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

Special precautions for use in animals

Is irritant, tablet should not be broken.

The product should not be administered to puppies less than 6 months old, owing to the need to restrict food intake at the time of administration. See also section 4.9.

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

This product can be an irritant to the skin and eyes. Tablets are film-coated and should not be broken or divided.

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Use during pregnancy, lactation or lay

Can be safely used during pregnancy and lactation.

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Interactions

None known

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Overdose

See section 4.6. Adverse events are more likely to occur if the product is overdosed.

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Special warnings

Is not indicated for the treatment of Trichuris vulpis

Since the most common tapeworm of the dog (Dipylidium caninum) is transmitted by a flea and has a very short pre-patent period, it is important to pay attention to flea control to reduce the incidence of tapeworm in your pet. If symptoms of disease persist or appear, consult your veterinary surgeon.

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Withdrawal period

Not applicable

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Incompatibilities

None known

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Immediate packaging

Aluminium foil, low density polyethylene strips in outer carton

or

Aluminium Foil blisters comprising:

Hard tempered aluminium lidding foil and cold formable aluminium bottom foil

Cartons containing

100 tablets (for sale to veterinary surgeons only)

1 x 6 tablets for OTC sale

1 x 4 tablets for OTC sale

1 x 3 tablets for OTC sale

Not all pack sizes may be marketed.

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Storage

Store in a dry place.

Do not store above 25°C

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 5 years.

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Disposal of unused product

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

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Additional information

Vm 08749/5107

9 DATE OF FIRST AUTHORISATION

27 January 1994

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

October 2025

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Registration holder

Chanelle Pharmaceuticals Manufacturing Ltd

Loughrea

Co. Galway

H62 FH90

Ireland

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