Johnson’s One Dose Wormer for Puppies & Small Dogs 100mg Film-coated Tablets

Composition

Each tablet contains:

Excipients:

Titanium Dioxide (E171) 0.778

Iron Oxide Yellow (E172) 0.0257

Iron Oxide Black (E172) 0.00003

Iron Oxide Red (E172) 0.00003

For the full list of excipients, see section 6.1

6.1 List of excipients

Titanium Dioxide (E171)

Iron Oxide Yellow (E172)

Iron Oxide Black (E172)

Iron Oxide Red (E172)

Maize starch

Sodium starch glycolate (Type A)

Microcrystalline cellulose

Sodium laurel sulfate

Magnesium stearate

HPMC 2910

Polydextrose FCC

Macrogol 4000

3

Pharmaceutical form

Film-coated Tablet.

Smooth yellow coloured film coated tablets, convex shaped (plain round concave)

3

Pharmacological properties

Pharmacotherapeutic group: Anthelmintic, Other anthelmintic agents, nitroscanate

ATCvet code: QP52AX01

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 particulars

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.

3

Target species

Dog.

3

Indications

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

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

Cestodes:Taenia hydatigena, Taenia pisiformis, and Dipylidium caninum.

3

Dosage

Dose: For treatment of roundworm and tapeworm in small dogs and puppies give 1 x 100mg tablet per 2kg (4.4lb) bodyweight, equivalent to 50mg nitroscanate/kg bodyweight.

For dogs weighing more than 8kg (17.5lb) use Johnson’s One Dose Wormer for Dogs 500mg Film-Coated Tablets.

Directions for use: The product should be administered orally in the morning after overnight fasting with approximately one-fifth of the daily food ration. To reduce the risk of vomiting, it is recommended that the remaining food ration is withheld for at least 8 hours afterwards.

3

Contraindications

Do not use in dogs weighing less than 2 kg.

When administered as recommended is unlikely to cause vomiting.

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.

3

Adverse reactions

During the post-marketing surveillance, 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).

3

Warnings

Special precautions for use in animals

The product should not be administered to puppies less than 12 weeks 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

3

Use during pregnancy, lactation or lay

Can be safely used during pregnancy and lactation.

3

Interactions

None known.

3

Overdose

No treatment specified.

3

Special warnings

It is recommended that adult dogs should be wormed routinely 2-4 times a year. 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.

It is important to worm young puppies very regularly for roundworm with a suitable product. Johnson’s One Dose Wormer for Puppies & Small Dogs 100mg can be used at 12, 16 and 24 weeks of age. An alternative worming product must be used in younger puppies.

Nursing bitches should be treated at 2, 4, 6, 8 and 12 weeks after whelping.

If symptoms of disease persist or appear, consult your veterinary surgeon.

3

Withdrawal period

Not applicable.

3

Incompatibilities

Not applicable.

3

Immediate packaging

Aluminium foil strips, low density polyethylene strip packs with heat sealed closure containing 3, 4 or 6 x 100 mg tablets in a cardboard box.

Blister foil made up of a hard tempered aluminium lidding foil and a cold formable PA/Alu/PVC film, containing 3, 4 or 6 x 100 mg tablets in a cardboard box.

Not all pack sizes will be marketed.

3

Storage

Store in a dry place. Do not store above 25°C. Keep blister strip in outer carton.

3

Shelf life

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

3

Disposal of unused product

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

3

Additional information

Vm 08749/5110

9 DATE OF FIRST AUTHORISATION

16 April 2002

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

October 2025

Gavin Hall Approved: 01 October 2025

3

Registration holder

Chanelle Pharmaceuticals Manufacturing Ltd

Loughrea

Co. Galway

H62 FH90

Ireland

3