SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Bob Martin Clear Wormer 20/230 mg Tablets for Cats & Kittens

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

2.1	Active Constituents	mg per tablet
	Pyrantel Embonate	230.0
	Praziquantel	20.0
2.2	Relevant Constituents of the Excipients
	Titanium Dioxide (E171)	1.8 mg	Colouring agent

For the full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

White to yellowish scored coated tablet. The tablet can be divided into equal halves.

4. CLINICAL PARTICULARS

4.1 Target species

Cats

4.2 Indications for use, specifying the target species

For the treatment of gastrointestinal roundworms and tapeworms:

Toxocara cati, Toxascaris leonina, Dipylidium caninum, Taenia taeniaeformis.

4.3 Contraindications

Do not use simultaneously with piperazine compounds.

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

Not intended for use in kittens less than 12 weeks of age.

Do not use during pregnancy.

4.4 Special warnings for each target species

There is no permanent treatment for worms. Veterinarians recommend that weaned kittens over 12 weeks old and adult cats should be wormed every 3 months as a routine measure. It is also important to remove sources of possible re-infection such as fleas and mice. If more frequent treatment is required, or for advice on worming kittens less than 12 weeks old, consult a veterinary surgeon or suitably qualified person.

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

Not intended for use in cats weighing less than 1 kg bodyweight.

If signs of disease persist or appear, consult a veterinary surgeon.

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 a cat, or by adding them to the cat’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

Not to be used during pregnancy but may be used during lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Do not use simultaneously with piperazine compounds.

4.9 Amount to be administered and administration route

Dosage

The recommended dose rates are: 57.5 mg/kg pyrantel embonate and

5 mg/kg praziquantel. This is equivalent to 1 tablet per 4 kg bodyweight.

Dosing bands are:

Weight of cat
1 - 2 kg:	½ tablet
greater than 2 kg up to 4 kg:	1 tablet
greater than 4 kg up to 6 kg:	1½ tablets
greater than 6 kg:	2 tablets

Administration and Duration of Treatment

Single oral administration. The tablet should be given directly to the animal, but if necessary can be disguised in food.

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

No information.

4.11 Withdrawal period

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

An anthelmintic active against gastrointestinal roundworms and tapeworms. The product contains two active ingredients:

and

ATC Vet Code:QP52 AA51

5.1 Pharmacodynamic properties

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 expulsion from the gastrointestinal (GI) system by peristalsis.

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.

In this fixed combination product pyrantel is active against the following ascarids: Toxocara catiand Toxascaris leonina. Praziquantel is effective against tapeworms in particular Dipylidium caninumand Taenia taeniaeformis.

The product has also been shown to be efficacious in the control of hookworms, Ancylostoma tubaeformeand A. brazilienseand the tapeworm Joyeuxiella pasqualei, none of which occur naturally in the UK or Ireland but may occasionally be found in imported animals. Since it contains praziquantel, the product is effective against Echinococcus multilocularis, which does not occur in the UK or Ireland but is becoming more common in some European countries.

5.2 Pharmacokinetic particulars

Praziquantel is very rapidly absorbed into and distributed throughout the parasite.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Titanium dioxide (E171)

Maize starch

Microcrystalline cellulose

Povidone K25

Magnesium stearate

Silica colloidial anhydrous

Hypromellose 15mPa

Macrogol 400

6.2 Incompatibilities

None.

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.

Unused halved tablets should be disposed of in the household refuse and not stored.

Do not remove tablets from strip packaging until required for use.

6.5 Nature and composition of immediate packaging

Container material:	White polyethylene coated aluminium foil blister pack or silver aluminium foil blister pack.
Closure:	Heat seal
Container sizes:	Cartons containing 2 tablets.

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:00010/4145

9. DATE OF FIRST AUTHORISATION

Date:09 January 2007

10. DATE OF REVISION OF TEXT

Date: July 2014

APPROVED 29/07/14