SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Droncit Tablets 50 mg

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

2.1	Active Constituents	mg per tablet
	Praziquantel	50

For full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Tablet

White tablets

4. CLINICAL PARTICULARS

4.1 Target species

Dogs and cats.

4.2 Indications for use, specifying the target species

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

The product is a highly effective treatment against all the common species of tapeworm infecting dogs and cats in the United Kingdom and Ireland including Echinococcus granulosus, Taenia ovis, Taenia pisiformis, Taenia multiceps, Taenia hydatigena, Taenia taeniaeformis, andDipylidium caninum. Droncit 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 puppies and kittens, 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 and Ireland, it is recommended that all dogs and cats entering the country be treated with praziquantel.

4.5 Special precautions for use

i) Special precautions for use in animals

Any part used tablets should be discarded.

ii) Special precautions to be taken by the person administering the 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 Amount(s) to be administered and administration route

Dosage

The recommended dosage 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 - 20 kg 2 tablets

21 - 30 kg 3 tablets

Over 30 kg pro rata

Cats Adults ½ tablet

Administration and Duration of Treatment

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

Praziquantel is a pyrazino-isoquinolin derivative, with anthelmintic activity.

ATC Vet Code: QP 52 AA 01

5.1 Pharmacodynamic properties

The spectrum of action of praziquantel covers all the important species of cestodes in dogs and cats. It specifically includes all Taeniaspecies occurring in dogs and cats, 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 dogs and cats.

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

Container material:	Aluminium foil blister or polyethylene coated aluminium blister
Container colour :	Silver or white coloured

Pack sizes:	UK Only	IE Only
	Cartons containing 2 x 10 tablet blisters or 10 x 10 tablet blisters	Cartons containing 2 x 10 tablet blisters

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product 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 00010/4097

9. DATE OF FIRST AUTHORISATION

22 June 1994

10. DATE OF LAST REVISION OF THE TEXT

September 2013

Approved:13/09/2013