Summary of Product Characteristics

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Beaphar WORMclear tablets for dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains

Active substances:

Praziquantel	50mg
Pyrantel	50mg (equivalent to 144mg pyrantel embonate)
Febantel	150mg

Excipients:

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Tablet.

A pale yellow tablet with a cross breakline on one side.

The tablets can be divided into halves or quarters.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs.

4.2 Indications for use, specifying the target species

For the treatment of mixed infections with the following gastrointestinal tapeworms and roundworms in dogs and puppies

Roundworms (nematodes):

Ascarids: Toxocara canis, Toxascaris leonina(adult and late immature forms).

Hookworms: Uncinaria stenocephala, Ancylostoma caninum(adults).

Whipworms: Trichuris vulpis(adults).

Tapeworms (cestodes):

Echinococcusspecies (E. granulosus, E. multilocularis), Taeniaspecies (T. hydatigena, T. pisiformis, T. taeniformis), Dipylidium caninum(adult and immature forms).

4.3 Contraindications

Do not use simultaneously with piperazine compounds as piperazine may block the action of pyrantel embonate contained in this product. Other worming products may contain piperazine.

Do not use simultaneously with other deworming products without veterinary advice.

Do not use in animals with a known sensitivity to the active ingredients 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.

Development of parasite resistance to anthelmintics of a certain class can occur after frequent and repeated use of an anthelmintic from that class.

4.5 Special precautions for use

i) Special precautions for use in animals

Do not exceed the stated dose, especially when treating pregnant bitches.

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

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

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

Echinococcosis represents a hazard for humans. As echinococcosis is a notifiable disease to the World Organisation for Animal Health (OIE), specific guidelines on the treatment and follow-up, and on the safeguard of persons, need to be obtained from the relevant competent authority.

4.6 Adverse reactions (frequency and seriousness)

In very rare cases, gastrointestinal disorders (diarrhoea, emesis) have been observed.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)

- common (more than 1 but less than 10 animals in 100 animals)

- uncommon (more than 1 but less than 10 animals in 1,000 animals )

- rare (more than 1 but less than 10 animals in 10,000 animals)

- very rare (less than 1 animal in 10,000 animals, including isolated reports)

4.7 Use during pregnancy, lactation or lay

Consult a veterinary surgeon before treating pregnant animals.

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. It is recommended that the product is not used in dogs during the first 4 weeks of pregnancy.

The product may be used in lactating bitches from two weeks after giving birth (see Section 4.9 below).

4.8 Interaction with other medicinal products and other forms of interaction

Do not use simultaneously with piperazine compounds (see Section 4.3 above).

Concurrent use with other cholinergic compounds can lead to toxicity.

4.9 Amounts to be administered and administration route

Single dose: For oral administration only.

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

The recommended dose rates are: 15mg/kg bodyweight febantel, 5 mg/kg pyrantel (equivalent to 14.4 mg/kg pyrantel embonate) and 5 mg/kg praziquantel. This is equivalent to 1 tablet per 10 kg (22 lbs) bodyweight.

It is important to follow the treatment recommendations presented here. Do not deviate from these recommendations without the advice of your veterinary surgeon.

Puppies and Small Dogs:
3 up to 5 kg bodyweight	½ tablet
Greater than 5 up to 10 kg bodyweight	1 tablet
Medium Dogs:
Greater than 10 up to 15 kg bodyweight	1 ½ tablets
Greater than 15 up to 20 kg bodyweight	2 tablets
Greater than 20 up to 25 kg bodyweight	2 ½ tablets
Greater than 25 up to 30 kg bodyweight	3 tablets
Large Dogs:
Greater than 30 up to 35 kg bodyweight	3 ½ tablets
Greater than 35 up to 40 kg bodyweight	4 tablets

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

Not for use in dogs weighing less than 3 kg.

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

For routine worm control adult dogs should be treated every 3 months.

For routine treatment a single dose is recommended.

In case of suspected heavy roundworm infestation, please contact your veterinary surgeon for diagnosis and treatment recommendations.

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 doseor greater gave rise to occasional vomiting.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anthelmintic, praziquantel combinations.

ATC vet code: QP52AA51

5.1 Pharmacodynamic properties

This product contains anthelmintics active against gastrointestinal roundworms and tapeworms. The product contains three active substances, as follows:

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 stenocephala, Ancylostoma caninumand Trichuris vulpis.

This combination shows synergistic activity in the case of hookworms and febantel is effective against T. vulpis.

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 tegument. 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

Orally 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. Following administration of the product to dogs, peak plasma concentrations of praziquantel were achieved by approximately 2.5 hours.

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”. Following administration of the product to dogs, peak plasma concentrations of fenbendazole and oxfendazole were achieved by approximately 7-9 hours.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose monohydrate

Microcrystalline cellulose

Magnesium stearate

Colloidal anhydrous silica

Croscarmellose sodium

Sodium laurilsulfate

Pork flavour

6.2 Incompatibilities

None Known

6.3 Shelf life of the veterinary medicinal product as packaged for sale

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

6.4. Special precautions for storage

This veterinary medicinal product does not require any special storage conditions

Discard any unused divided tablets immediately.

6.5 Nature and composition of immediate packaging

The product is presented in either:

Individual strips composed of aluminium foil 30 µm/30 gsm extruded polythene, containing 2 and 4 tablets.

or

Individual blisters composed of 45 µm, soft temper aluminium foil and 25 µm hard temper aluminium foil, containing 2 tablets.

The strips or blisters are packed into cartons containing either 2 or 4 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, if appropriate

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

C&H Generics Ltd

c/o Michael McEvoy and Co

Seville House

New Dock Street

Galway

Ireland

8. MARKETING AUTHORISATION NUMBER

Vm 40162/4016

9. DATE OF FIRST AUTHORISATION

10 March 2015

10. DATE OF REVISION OF THE TEXT

June 2016

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.

Approved: 03 June 2016