SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Bayer Praziquantel 50 mg Tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance

Praziquantel 50 mg per tablet

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Tablet.

White tablets.

4. CLINICAL PARTICULARS

4.1 Target species

Cats and dogs.

4.2 Indications for use, specifying the target species

For the treatment of adult tapeworms of cats and dogs. The tablets are effective against both immature and mature forms of adult tapeworms in both cats and dogs.

The product is a highly effective treatment against all the common species of tapeworm infecting cats and dogs in the United Kingdom including Echinococcus granulosus, Taenia ovis, Taenia pisiformis, Taenia multiceps, Taenia hydatigena, Taenia taeniaeformis, andDipylidium caninum. The product is also effective against Echinococcus multilocularis (see 4.4)

4.3 Contraindications

Do not administer to dogs weighing less than 2.5 kg.

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

4.4 Special warnings for each target species

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.

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

4.5 Special precautions for use

Special precautions for use in animals

Any part-used tablets should be discarded.

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

In the interests of good hygiene, persons administering the tablets directly to an animal or adding them to the animal’s food should wash their hands afterwards.

4.6 Adverse reactions (frequency and seriousness)

None known.

4.7 Use during pregnancy, lactation or lay

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,

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

Dosage

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

Dogs	2.5 – 5.0 kg	½ tablet
	6.0– 10.0 kg	1 tablet
	11.0 – 20.0 kg	2 tablets
	21.0 – 30.0 kg	3 tablets
	Over 30 kg	pro rata
Cats	Adult	½ tablet

Administration and Duration of Treatment

For oral administration.

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.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Not applicable.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Pyrazino-isoquinoline derivative, with anthelmintic activity.

ATCvet code: QP52AA01

5.1 Pharmacodynamic properties

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

5.2 Pharmacokinetic particulars

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

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose monohydrate

Microcrystalline cellulose

Povidone K-25

Sodium lauryl sulphate

Magnesium stearate

Silica colloidal anhydrous

Maize starch

6.2 Incompatibilities

None known.

6.3 Shelf life

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

6.4. Special precautions for storage

Do not store above 25 C.

Store in a dry place.

6.5 Nature and composition of immediate packaging

Aluminium foil blister or polyethylene coated aluminium blister; silver or white coloured.

Cartons containing 100 tablets (10 x 10 tablet blisters).

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

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

7. MARKETING AUTHORISATION HOLDER

Bayer plc

Animal Health Division

Bayer House

Strawberry Hill

Newbury

Berkshire

RG14 1JA

8. MARKETING AUTHORISATION NUMBER

Vm 00010/4209

9. DATE OF FIRST AUTHORISATION

25 September 2014

10. DATE OF REVISION OF THE TEXT

September 2014

Approved: 25/09/2014