SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Wellplus Flavoured tablets for Dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

Praziquantel 50 mg

Pyrantel embonate 144 mg

Febantel 150 mg

Excipients:

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Tablets.

Yellowish round tablets with brown dots.

The tablets can be divided into equal halves or equal quarters.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use,specifying the target species

For the treatment of mixed infestations with 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)

Tapeworms: Echinococcus granulosus, Echinococcus multilocularis, Dipylidium caninum, Taenia spp., Multiceps multiceps(adult and immature forms)

4.3 Contraindications

Do not use simultaneously with piperazine compounds.

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

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 reoccur unless control of intermediate hosts such as fleas, mice, etc. is undertaken.

Tapeworm infestation is unlikely in pups less than 6 weeks of age.

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.

4.5 Special precautions for use

Special precautions for use in animals

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

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

None known.

4.7 Use during pregnancy, lactation or lay

Teratogenic effects attributed to high doses of febantel have been reported in sheep and rats.

No studies have been performed in dogs during early pregnancy.

Use of the product during pregnancy should be in accordance with a benefit risk assessment by the responsible veterinarian.

Use of the product is not recommended during the first 4 weeks of pregnancy.

Do not exceed the stated dose when treating pregnant bitches.’

4.8 Interaction with other medicinal products and other forms of interaction

Concurrent use with other cholinergic compounds can lead to toxicity. The effect of the active substances with acetylcholine esterase activity (e.g. organophosphate compounds) may be increased. The specific properties of piperazine (neuromuscular paralysis of the parasites) can antagonise the effect of pyrantel (spastic paralysis of the parasites).

4.9 Amounts to be administered and administration route

Oral use.

Dosage

The recommended dose rates are:15 mg febantel, 14.4 mg pyrantel embonate and 5 mg praziquantel per kg bodyweight. This is equivalent to 1 tablet per 10 kg bodyweight.

Tablets may be halved/quarteredas required.

To ensure administration of a correct dose, body weight should be determined as accurately as possible.

For example, a dog weighing

- 2.5 kg bodyweight receives ¼ of the tablet

- 5.0 kg bodyweight receives ½ of the tablet

- 10 kg bodyweight receives 1 tablet

- 15 kg bodyweight receives 1 ½ tablets

- 20 kg bodyweight receives 2 tablets

- 30 kg bodyweight receives 3 tablets

etc.

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 2.5 kg.

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

The tablets can be given directly to the dog or disguised in food. No starvation is needed before or after treatment.

If there is a risk for re-infestation, the advice of a veterinarian should be sought regarding the need for and the frequency of repeat administration.

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

The combination of praziquantel, pyrantel embonate and febantel is well tolerated in dogs. In safety studies, a single dose of 5 times the recommended dose or greater gave rise to occasional vomiting.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anthelmintics

ATCvet code: QP52AC55

5.1 Pharmacodynamic properties

This product contains anthelmintics active against gastrointestinal roundworms and tapeworms.

The product contains three active substances, as follows:

1. Febantel, a probenzimidazole

2. Pyrantel embonate (pamoate), a tetrahydropyrimidine derivative

3. Praziquantel, a partially hydrogenated pyrazinoisoquinoline derivative

In this fixed combination, pyrantel and febantel act against all relevant nematodes (ascarids, hookworms, and whipworms) in dogs. In particular, the activity spectrum covers Toxocara canis, Toxascaris leonina, Uncinaria stenocephalaand Ancylostoma caninum. This combination shows synergistic activity in the case of hookworms.

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

Praziquantel is very rapidly absorbed through the parasite’s surface and distributed throughout the parasite. Both in vitro and in vivo studies have shown that praziquantel causes severe damage to the parasite integument, resulting in the contraction and paralysis of the parasites. There is an almost instantaneous tetanic contraction of the parasite musculature and a rapid vacuolization of the syncytial tequment. This rapid contraction has been explained by changes in divalent cation fluxes, especially calcium.

Pyrantel acts as a cholinergic agonist. Its mode of action is to stimulate nicotinic cholinergic receptors of the parasite, induce spastic paralysis of the nematodes and thereby allow removal from the gastrointestinal 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 polymerisation. Formation of microtubules is thereby prevented, resulting in disruption of 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

Perorally administered praziquantel is absorbed almost completely from the intestinal tract. After absorption, the drug is distributed to all organs. Praziquantel is metabolized into inactive forms in the liver and secreted in bile. It is excreted within 24 hours to more than 95% of the administered dosage. Only traces of non-metabolised praziquantel are excreted.

The pamoate salt of pyrantel has low aqueous solubility, an attribute that reduces absorption from the gut and allows the drug to reach and be effective against parasites in the large intestine. Following absorption, pyrantel pamoate is quickly and almost completely metabolized into inactive metabolites that are excreted rapidly in the urine.

Febantel is absorbed relatively rapidly and metabolized to a number of metabolites including fenbendazole and oxfendazole, which have anthelmintic activity.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Maize starch

Lactose monohydrate

Microcrystalline cellulose

Povidone K29/32

Magnesium stearate

Sodium laurilsulfate

Silica, Colloidal Anhydrous

Meat flavour

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

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

Shelf-life after first opening the immediate packaging: 15 days

Shelf-life after dividing the tablet into halves or quarters: 15 days

6.4. Special precautions for storage

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

Return any part tablet to the opened blister pack.

6.5 Nature and composition of immediate packaging

Carton box containing 1 PVC/PVDC aluminium blister of 2 tablets.

Carton box containing 1 PVC/PVDC aluminium blister of 10 tablets.

Carton box containing 2 PVC/PVDC aluminium blisters of 10 tablets, with a total of 20 tablets.

Carton box containing 5 PVC/PVDC aluminium blisters of 10 tablets, with a total of 50 tablets.

Carton box containing 10 PVC/PVDC aluminium blisters of 10 tablets, with a total of 100 tablets.

Carton box containing 30 PVC/PVDC aluminium blisters of 10 tablets, with a total of 300 tablets.

Not all pack sizes may be marketed.

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 product should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Divasa - Farmavic S.A.

Ctra. Sant Hipòlit, km 71

08503 - Gurb-Vic

Barcelona

Spain

8. MARKETING AUTHORISATION NUMBER

Vm 33229/4003

9. DATE OF FIRST AUTHORISATION

20 December 2013

10. DATE OF REVISION OF THE TEXT

December 2013

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

Approved: 20/12/2013