SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Drontal Plus Flavour Bone Shaped Tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

	Active Constituents	mg/tablet
	Febantel	150.0
	Pyrantel embonate	144.0
	Praziquantel	50.0
	Relevant Constituents of the Excipients
	Artificial beef flavour Irradiated	116.5

For full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Tablet.

A pale brown to brown, bone shaped tablet scored on both sides for oral administration to dogs.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

For the control of the following roundworms and tapeworms in dogs and puppies :

Ascarids :	Toxocara canis, Toxascaris leonina (adult and late immature forms)
Hookworms :	Uncinaria stenocephala, Ancylostoma caninum (adults)
Whipworms :	Trichuris vulpis (adults)
Tapeworms :	Echinococcus spp. Taenia spp. and Dipylidium caninum (adult and immature forms).

4.3 Contraindications

Do not use simultaneously with piperazine compounds

Do not exceed the stated dosage when treating pregnant bitches.

4.4 Special warnings for each target species

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

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 tablet directly to a dog or by adding it to the dog’s food, should wash their hands afterwards.

iii. Other precautions

None.

4.6 Adverse reactions (frequency and seriousness)

None known

4.7 Use during pregnancy, lactation or lay

Consult a veterinary surgeon before treating pregnant animals for roundworms (see also Section 4.3 above).

The tablets may be used during lactation (see Section 4.8 below).

4.8 Interaction with other medicinal products and other forms of interaction

Piperazine (see Section 4.3 above).

4.9 Amount(s) to be administered and administration route

For oral administration only.

Dosage

The recommended dose rates are:15 mg/kg bodyweight febantel,

14.4 mg/kg pyrantel and 5 mg/kg praziquantel. This is equivalent to 1 tablet per 10 kg bodyweight

Puppies and Small Dogs:
3-5 kg bodyweight	= ½ tablet
6-10 kg bodyweight	1 tablet
Medium Dogs:
11-15 kg bodyweight	= 1 ½ tablets
16-20 kg bodyweight	= 2 tablets
21-25 kg bodyweight	= 2 ½ tablets
26-30 kg bodyweight	= 3 tablets
Large Dogs:
31-35 kg bodyweight	= 3 ½ tablets
36-40 kg bodyweight	= 4 tablets

Administration and Duration of Treatment

Oral administration, the tablet(s) can be given directly to the dog or disguised in food. Access to normal diet does not need to be limited before or after treatment.

Puppies should be treated at 2 weeks of age and every 2 weeks until 12 weeks of age. Thereafter they should be treated at 3 month intervals. It is advisable to treat the bitch at the same time as the puppies. Not for use in dogs weighing less than 3 kg.

For the control of Toxocara, nursing bitches should be dosed 2 weeks after giving birth and every 2 weeks until weaning.

For routine control adult dogs should be treated every 3 months. In the event of a heavy roundworm infestation, a repeat dose should be given after 14 days.

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

Benzimidazoles possess a wide safety margin. Pyrantel is not absorbed systemically to any extent. Praziquantel has a wide safety margin of up to five times the normal dose.

4.11 Withdrawal period(s)

Not applicable

5. PHARMACOLOGICAL PROPERTIES

The product contains anthelmintics active against roundworms and tapeworms. The product contains three active substances:

1) Febantel

and

ATC Vet Code: QP52AC55

5.1 Pharmacodynamic properties

In this fixed combination product pyrantel and febantel act synergistically against all relevant nematodes (ascarids, hookworms and whipworms) in dogs. In particular, the activity spectrum covers Toxocara canis, Toxascaris leonina, Uncinaria stenocephala, Ancylostoma caninum and Trichuris vulpis.

The spectrum of activity of praziquantel covers all important cestode species in dogs, in particular all Taenia spp, Dipylidium caninum, Echinococcus granulosus and Echinococcus multilocularis. Praziquantel acts against adult and immature forms of these parasites.

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 removal from the gastro-intestinal (GI) system by peristalsis.

Within the mammalian system febantel undergoes ring closure forming fenbendazole and oxfendazole. It is these chemical entities which exert the anthelmintic effect by inhibition of tubulin polymerization. Formation of microtubules is thereby prevented, resulting in disruption to structures vital to the normal functioning of the helminth. Glucose uptake, in particular, is affected, leading to a depletion in cell ATP. The parasite dies upon exhaustion of its energy reserves, which occurs 2-3 days later.

5.2 Pharmacokinetic particulars

Praziquantel is very rapidly absorbed and distributed throughout the parasite. Both in vivo and in vitro 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 vacuolisation of the syncytial tegument. This rapid contraction has been explained by changes in divalent cation fluxes, especially calcium.

Since it contains praziquantel, the product is effective against Echinococcus multilocularis whichdoes not occur in the UK but is becoming more common in some European countries.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Maize starch

Lactose monohydrate

Microcrystalline cellulose

Povidone

Magnesium stearate

Sodium laurilsulfate

Colloidal anhydrous silica

Artificial beef flavour irrad.

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 25ºC.

6.5 Nature and composition of immediate packaging

Container material :	Polypropylene-coated aluminium foil
Container colour :	White.
Container sizes :	Cartons containing 2, 6, 24, 102 and 108 tablets. Not all pack sizes may be marketed.

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

7. MARKETING AUTHORISATION HOLDER

UK Only	IE Only
Bayer plc, Animal Health Division, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA	Bayer Ltd, Animal Health Division, The Atrium, Blackthorn Road, Dublin 18, Ireland

8. MARKETING AUTHORISATION NUMBER(S)

UK Only	IE Only
Vm 00010/4115	VPA 10021/14/4

9. DATE OF FIRST AUTHORISATION

UK Only	IE Only
08 June 2000	21 October 2005

10. DATE OF LAST REVISION OF THE TEXT

UK Only	IE Only
June 2011	TBC