Prazendo 50 mg Tablets for Dogs

Composition

Each tablet contains:

Active substance:

Praziquantel 50 mg

Excipients:

White round tablet scored on one side.

3

Pharmacological properties

4.1 ATCvet code:

QP 52 AA 01

4.2 Pharmacodynamics

The spectrum of action of praziquantel covers all the important species of cestodes in dogs. It specifically includes all Taenia species occurring in dogs, Multiceps multiceps, Joyeuxiella pasquali, Dipylidium caninum, Mesocestoides species, Echinococcus multilocularis and E. granulosus. Praziquantel is effective against all stages of development of these parasites occurring in the intestines of dogs.

Praziquantel impairs the normal tegument function of the parasite, making it permeable to excessive glucose loss and thereby more easily attacked by proteolytic enzymes. Because of this, whole tapeworms including the scolex are very rarely passed in the faeces following administration of the drug. Disintegrated and partially digested fragments may occasionally be seen in the faeces.

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.

3

Target species

Dogs

3

Indications

For the treatment of adult tapeworms of dogs. The tablets are effective against both immature and mature forms of adult tapeworms in dogs. The product is a highly effective treatment against all the common species of tapeworm infecting dogs in the United Kingdom including Echinococcus granulosus, Taenia ovis, Taenia pisiformis, Taenia multiceps, Taenia hydatigena, Taenia taeniaeformis, and Dipylidium caninum. The veterinary medicinal product is also effective against Echinococcus multilocularis (see 3.4).

3

Dosage

Oral use.

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

2.5 – 5 kg: ½ tablet

6 – 10 kg: 1 tablet

11 – 20 kg: 2 tablets

21 – 30 kg: 3 tablets

Over 30 kg: Pro rata

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

The tablets are administered 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.

A single dose is all that is required. However, for dogs in rural areas and for packs of hounds, this dose should be repeated every four weeks to ensure that newly acquired tapeworms are destroyed before reaching maturity. Dosing must be associated with strict control of the dog’s diet to ensure that uncooked offal is not eaten.

For infections with tapeworms, the need for and frequency of re-treatment(s) should be based on professional advice and should take into account the local epidemiological situation and the animal’s lifestyle.

3

Contraindications

Do not administer to dogs weighing less than 2.5 kg.

Do not administer to unweaned puppies and kittens, as such animals are rarely infected with tapeworms.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

3

Adverse reactions

None known.

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, its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

3

Warnings

Special precautions for safe use in the target species:

Any unused tablet parts should be discarded.

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

Avoid accidental ingestion. This veterinary medicinal product may be harmful when ingested, particularly for children. In the case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Any unused tablet parts should discarded. The product should be stored in a safe place out of the sight and reach of children.

Wash your hands after administering the veterinary medicinal product.

Special precautions for the protection of the environment:

Not applicable.

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.

3

Use during pregnancy, lactation or lay

Pregnancy and lactation:

The product may be administered to pregnant females. It is safe to the female herself, to the unborn foetus and to the new-born young.

3

Interactions

None known.

3

Overdose

Not applicable.

3

Special warnings

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. The decision to use the product should be based on confirmation of the parasitic species and burden, or of the risk of infection based on its epidemiological features, for each individual animal.

The possibility that other animals in the same household can be a source of re- infection with fleas and tapeworms should be considered, and these should be treated as necessary with an appropriate product.

The use of this product should take into account local information about susceptibility of the target parasites, where available.

As a precautionary measure to prevent the establishment of Echinococcus multilocularis in the UK, it is recommended that all dogs entering the country be treated with praziquantel.

3

Withdrawal period

Not applicable.

3

Incompatibilities

None known.

3

Immediate packaging

aluminium/aluminium blisters.

Pack sizes:

Carton containing 2 blisters of 10 tablets (20 tablets).

Carton containing 4 blisters of 10 tablets (40 tablets).

Not all pack sizes may be marketed.

3

Storage

Do not store above 25 C.

3

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf life after splitting tablet: use immediately.

3

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.

3

Additional information

Vm 60679/5000

8 DATE OF FIRST AUTHORISATION

06 March 2025

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

July 2026

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product not subject to prescription.

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

Approved: 03 August 2026

3

Registration holder

Ashish Life Science Holding B.V.

3