PraziTape 50 mg Film-Coated Tablets for Dogs and Cats

Composition

Each tablet contains:

Active substances:

Praziquantel 50.0 mg

Excipients:

A white to off white film-coated tablet with a breakline on one side.

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Pharmacological properties

4.1 ATCvet code: QP52AA01

4.2 Pharmacodynamics

Praziquantel is a pyrazinoisoquinoline derivative effective against the cestodes (tapeworms) Echinococcus granulosus, E. multilocularis, Taenia ovis, T. pisiformis, T. multiceps, T. hydatigena, T. taeniaeformis, and Dipylidium caninum. Praziquantel is rapidly adsorbed via the surface of the parasites and acts primarily by changing the Ca++ permeability of the parasite membranes. This results in severe damage to the parasite integument, contraction and paralysis, disruption of metabolism and finally leads to the death of the parasite.

4.3 Pharmacokinetics

Praziquantel is rapidly absorbed by the animal and metabolised by the liver. It is excreted, entirely as metabolites, in the urine and faeces

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Target species

Dogs and cats.

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Indications

In dogs and cats: treatment of adult tapeworms (immature and mature forms) of the following species:

Echinococcus granulosus

Echinococcus multilocularis

Taenia ovis

Taenia pisiformis

Taenia multiceps

Taenia hydatigena

Taenia taeniaeformis

Dipylidium caninum

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Dosage

Oral use.

Dosage:

The minimum recommended dose rate is 5 mg/kg body weight. This corresponds to 1 tablet per 10 kg body weight.

To ensure a correct dosage, body weight should be determined as accurately as possible. Underdosing could result in ineffective use and may favour resistance development.

Dogs:

Cats:

Weight and Number of Tablets:

Equal to/greater than 2.5 up to 5.0 kg: ½ tablet

Greater than 5.0 up to 10.0 kg: 1 tablet

Greater than 10.0 kg: pro rata

The tablets are administered as a single dose orally, by opening the animal’s mouth and pushing the tablet over the back of the tongue so that it cannot be rejected. Alternatively, a tablet can be wrapped in a piece of meat or butter and offered to the animal or crushed and mixed with the food.

The need for and frequency of re-treatment should be based on professional advice and should take into account individual risk factors (the local epidemiological situation and the animal’s lifestyle).

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Contraindications

Do not use in dogs or cats weighing less than 2.5 kg.

Do not administer to unweaned puppies and kittens.

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

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

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Adverse reactions

Dogs and cats:

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.

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Warnings

Special precautions for safe use in the target species:

Any part used tablets should be discarded.

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

Special precautions for the protection of the environment:

See section 5.5.

Other precautions:

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

If the animal has visited areas where Echinococcus spp. are prevalent, a veterinary surgeon should be consulted.

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.

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Use during pregnancy, lactation or lay

The product can be used during pregnancy and lactation.

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Interactions

Plasma concentrations of praziquantel may be decreased by concomitant administration with drugs that increase the activity of cytochrome P-450 enzymes (e.g. dexamethasone, phenobarbital).

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Overdose

Praziquantel is well tolerated with a wide safety margin. Doses higher than recommended may cause vomiting.

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Special warnings

In order to develop an effective worm control programme local epidemiological information and the risk of exposure of the animal should be taken into account, and it is recommended to seek professional advice, e.g. from a veterinary surgeon or Suitably Qualified Person (registered animal medicines advisor).

It is recommended to treat all the animals living in the same household concomitantly.

Fleas serve as intermediate hosts for one common type of tapeworm-Dipylidium caninum. To avoid reinfection with this parasite, flea control of the animal and its housing should be carried out at the same time. Unless flea control is complete an infected flea population may survive: i.e. re-treatment of the animal may be necessary.

Unnecessary use of antiparasitics or use deviating from the instructions given in the SPC may increase the resistance selection pressure and lead to reduced efficacy.

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Withdrawal period

Not applicable.

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Incompatibilities

None known.

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Immediate packaging

Blister packs made up of a cold form laminate of OPA/ALU/PVC of thickness 25µm/47µm/60µm with a 20μm hard tempered aluminium foil.

Available pack sizes:

Cardboard box containing 1 tablet. (1 blister strip of 1)

Cardboard box containing 10 tablets. (1 blister strip of 10)

Cardboard box containing 20 tablets. (2 blister strips of 10)

Cardboard box containing 24 tablets. (3 blister strips of 8)

Cardboard box containing 48 tablets. (6 blister strips of 8)

Cardboard box containing 100 tablets. (10 blister strips of 10)

Cardboard box containing 104 tablets. (13 blister strips of 8)

Not all pack sizes may be marketed.

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Storage

This veterinary medicinal product does not require any special storage conditions.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years

Shelf life after first opening the immediate packaging: use immediately.

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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.

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Additional information

UK(GB) Vm 08749/5058 UK(NI) Vm 08749/3021

8 DATE OF FIRST AUTHORISATION

25 August 2026

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

August 2026

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product not subject to prescription.

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

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Registration holder

Chanelle Pharmaceuticals Manufacturing Ltd

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