Itch Wormer for Cats & Kittens 230/20mg Flavoured Tablets

Composition

Each film-coated tablet contains Pyrantel embonate 230 mg and

Praziquantel 20 mg

For the full list of excipients, see section 6.1.

6.1 List of excipients

Core tablet:

Maize starch

Microcrystalline cellulose

Crospovidone

Magnesium stearate

Colloidal anhydrous silica

Film coat

Grilled meat flavour

Opadry Complete Film Coating System 03F28415 White consisting of HPMC 2910/Hypromellose (E464), Macrogol/PEG 4000 (E1521), Titanium Dioxide (E171).

3

Pharmaceutical form

Film-coated tablets.

A white to off white round, biconvex coated tablet with a breakline on one side and plain on the other side.

The tablet can be divided in half.

3

Pharmacological properties

Pharmacotherapeutic group: Anthelmintics, praziquantel combinations. ATC vet code: QP52AA51

5.1 Pharmacodynamic properties

This product contains anthelmintics active against gastrointestinal roundworms and tapeworms. The product contains two active substances, as follows: 1. Pyrantel embonate (pamoate), a tetrahydropyrimidine derivative and 2. Praziquantel, a partially hydrogenated pyrazinoisoquinoline derivative.

Pyrantel acts as a cholinergic agonist. Its mode of action is to stimulate nicotinic cholinergic receptors of the parasite, induce spastic paralysis and thereby allow expulsion from the gastro-intestinal (GI) system by peristalsis.

Praziquantel is very rapidly absorbed and distributed throughout the parasite. Both in vitro and in vivo studies have shown that praziquantel causes severe damage to the parasite integument, resulting in contraction and paralysis. There is an almost instantaneous tetanic contraction of the parasite musculature and a rapid vacuolization of the syncytial tegument. This rapid contraction has been explained by changes in divalent cation fluxes, especially calcium.

In this fixed combination, pyrantel is active against the following ascarids: Toxocara cati, and Toxascaris leonina. Praziquantel is effective against tapeworms in particular Dipylidium caninum and Taenia taeniaeformis.

Since it contains praziquantel, the product is effective against Echinococcus multilocularis.

5.2 Pharmacokinetic particulars

Praziquantel is rapidly absorbed, metabolised and distributed in the body. It is also believed to be excreted back into the intestinal lumen by the mucous membrane.

Following administration of the product to cats, peak plasma concentrations of praziquantel were achieved by approximately 2 hours.

Pyrantel is poorly absorbed so it is expected that a large proportion of the administered dose remains in the GIT where it exerts its therapeutic effect and it is excreted largely unchanged in the faeces.

Following administration of the product to cats, peak plasma concentrations of pyrantel were achieved by approximately 3 hours.

3

Target species

Cats.

3

Indications

For the treatment of mixed infections caused by the following gastrointestinal roundworms and tapeworms:

Roundworms: Toxocara cati, Toxascaris leonina,

Tapeworms: Dipylidium caninum, Taenia taeniaeformis, Echinococcus multilocularis.

3

Dosage

To ensure administration of a correct dose, body weight should be determined as accurately as possible.

Dosage

The recommended dose is: 20 mg/kg pyrantel (57.5 mg/kg pyrantel embonate) and 5 mg/kg praziquantel. This is equivalent to 1 tablet per 4 kg bodyweight.

Administration and duration of treatment

Single oral administration.

The tablet should be given directly to the cat, but if necessary can be disguised in food.

In roundworm infestation, especially in kittens, complete elimination cannot be expected, so a risk of infection for humans can persist. Repeat treatments should, therefore, be carried out with a suitable roundworm product at 14 day intervals until 2-3 weeks after weaning.

If signs of disease persist or appear, consult a veterinary surgeon.

3

Contraindications

Do not use simultaneously with piperazine compounds as piperazine may block the action of pyrantel embonate contained in the product.

Other worming products may contain piperazine.

Do not use simultaneously with other deworming products without veterinary advice.

Do not use in kittens less than 6 weeks of age.

Do not use in animals with known hypersensitivity to the active substances or to any of the excipients.

Do not use during pregnancy.

3

Adverse reactions

Mild and short-lived digestive tract disorders such as excessive salivation and/or vomiting and mild and short-lived disorders of the nervous system such as loss of balance may be reported very rarely in spontaneous reports.

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

Not intended for use in cats weighing less than 1 kg bodyweight.

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

This veterinary medicinal product may be harmful when ingested, particularly for children.

Avoid accidental ingestion.

Any unused part tablets should be returned to the open blister, inserted back into the outer packaging, and always be used at the next administration. The product should be stored in a safe place out of the sight and reach of children. In the case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Wash hands after administering the veterinary medicinal product.

Other precautions

Echinococcosis represents a hazard for humans. As echinococcosis is a notifiable disease to the World Organisation for Animal Health (OIE), specific guidelines on the treatment and follow-up, and on the safeguard of persons, need to be obtained from the relevant competent authority.

3

Use during pregnancy, lactation or lay

Do not use during pregnancy but may be used during lactation.

3

Interactions

Do not use simultaneously with piperazine compounds (see section 4.3 above).

3

Overdose

After doses higher than 5 times the recommended dose, signs of intolerance such as vomiting have been observed.

3

Special warnings

Fleas serve as intermediate hosts for one common type of tapeworm – Dipylidium caninum. Tapeworm infestation is certain to reoccur unless control of intermediate hosts such as fleas, mice, etc. is undertaken.

Parasitic resistance to a certain class of anthelmintics can occur after frequent and repeated use of an anthelmintic from this class.

3

Withdrawal period

Not applicable.

3

Incompatibilities

Not Applicable

3

Immediate packaging

The product is presented in either:

Individual blisters made up of a PVC/PE/PCTFE white opaque copolymer and a 20µm heat seal lacquer/aluminium containing 1, 2or 4 tablets.

or

Individual blisters made up of 45µm PVC/aluminium/orientated polyamide and a 20µm heat seal lacquer/aluminium containing 1 or 2 tablets.

The blisters are packed into cartons containing 1, 2 or 4 tablets.

Not all pack sizes may be marketed.

3

Storage

This veterinary medicinal product does not require any special temperature storage restrictions.

Unused halved tablets should be discarded.

Do not remove tablets from strip packaging until required for use.

Keep blister 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 product should be disposed of in accordance with local requirements.

3

Additional information

Vm 08749/4068

9 DATE OF FIRST AUTHORISATION

13 May 2016

10 DATE OF REVISION OF THE TEXT

March 2024

3

Registration holder

Chanelle Pharmaceuticals Manufacturing Ltd.

Loughrea

Co. Galway

Ireland

3