Summary of Product Characteristics

1 Name of the veterinary medicinal product

Dual Action Worming Tablets for Cats

2.Qualitative and quantiitative composition

Each roundworm tablet contains:

Active Substance(s) mg

Piperazine Citrate BP 500

Each tapeworm tablet contains:

Active substance mg

Dichlorophen 500

Excipients

Amaranth (E123) 0.055

For a full list of excipients see section 6.1

3. Pharmaceutical form.

Tablet

Roundworm- circular, biconvex, white tablets engraved on one side with a breakline

Tapeworm- circular, biconvex, pink tablets engraved on one side with a breakline.

4. Clinical particulars.

4.1 Target species;

Cats and Kittens

4.2 Indications for use, specifying the target species;

For the treatment of roundworms (Ascarids) and tapeworms in cats and kittens over 6 months old.

4.3 Contra indication;

Do not give Roundworm tablets and Tapeworm tablets on the same day.

Do not repeat the treatment if vomiting occurs shortly after dosing.

Do not administer to animals weighing less than 1.25Kg or under 6 months of age.

4.4 Special warnings for each target species;

Cats are particularly susceptible to CNS side effects of phenols which include vomiting, depression and incoordination.

4.5 Special precautions for use including special precautions to be taken by the person administering the medicinal product to the animals;

i) Special precautions for use in animals

Consult a veterinary surgeon before dosing animals with a history of epilepsy or severe renal dysfunction.

Do not use if your pet is sick or recovering from an illness

It is important to establish the bodyweight of the animal accurately before treatment to ensure correct dosage administration.

Animals weighing less than 1.25Kg should be treated with a suitable product authorised for this purpose.

Do not exceed the recommended dosage.

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

Ingredients in this product are known to cause allergic reactions in sensitive individuals, do not use this product if you have a known allergy to any of the ingredients in this product.

Wash hands immediately after administering the tablets.

Take care to avoid accidental eye contact. In case of contact with the eyes wash thoroughly with clean running water. If irritation persists/occurs seek medical advice.

4.6 Adverse reactions (frequency and seriousness);

Cats – Cats are particularly susceptible to CNS side effects of phenols which include vomiting, depression and in-coordination.

4.7 Use during pregnancy, lactation or lay;

Consult a veterinary surgeon before dosing pregnant animals.

4.8 Interaction with other medicinal products and other forms of interaction;

Interaction with medicinal products – None known.

Other - None known.

4.9 Amounts to be administered and administration route;

Roundworm Tablets

Treatment is one dose to be given immediately with a second equal dose two weeks later

The dosage given above is for cats up to 2.5Kg in weight. For larger cats, increase the dosage by ½ tablet for each additional 1.25Kg in bodyweight.

It is important that kittens are treated for roundworms, with a suitably approved product, at 2 weeks of age and every 2 weeks until 12 weeks of age. Thereafter they should be treated at 3 monthly intervals. It is advisable to treat the nursing female at the same time as the kittens.

Nursing female should be treated for roundworms 2 weeks after giving birth and every 2 weeks until weaning.

Tapeworm Tablets

Treatment consists of one single dose on day 7.

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

Symptoms include vomiting, depression and in-coordination. There is no known antidote. Treatment should be symptomatic.

4.11 Withdrawal period(s);

Not applicable

5.1 Pharmacodynamic properties;

ATCvet code QP52AG01

QP52AH01

Roundworm tablets

The antiparasitic properties of Piperazine Citrate and the other piperazine salts used as anthelmintics depends almost solely on the piperazine base. The material has a narcotising and paralytic effect on the worms which lose their mobility and thus their ability to maintain their position in the gastrointestinal tract. This allows them to be swept along and be voided in the faeces. This effect is evident after a few hours after dosing. The use of a purgative is not a recommended part of treatment as it may speed up the removal of piperazine from the intestinal tract allowing narcotised worms to recover and re-establish a position in the gut. Mature worms are more susceptible to the action of Piperazine than younger stages; hence the requirement to re-treat in 14 days to have an action on newly matured worms before they begin to lay eggs.

Tapeworm tablets

Dichlorophen has antimicrobial and anthelmintic properties which are effective against Taenia sppand Dipylidium sppbut not against Echinococcus spptapeworms.

Shortly after dosing the tapeworm detaches itself from the wall of the intestine and is killed, partially digested and excreted in the faeces. Dichlorophen reacts with drug receptors in the parasite and not with host receptors.

5.2 Pharmacokinetic properties;

Roundworm tablets

Piperazine salts are readily absorbed from the gastrointestinal tract. Up to 40% is excreted in the urine after 2 to 3 days. The majority is excreted in the bile.

Tapeworm tablets

There is little absorption of dichlorophen as it passes through the gastrointestinal tract leaving most of the drug to be available at the desired site of reaction. The drug is then flushed out of the body during normal bodily functions.

6 Pharmaceutical particulars

Roundworm tablets

Lactose monohydrate

Gelatin Hydrolysed

Magnesium Stearate

Hydrogenated Castor Oil

Talc Purified

Tapeworm tablets

Amaranth (E123)

Gelatin Hydrolysed

Magnesium Stearate

Maize starch

Talc Purified

6.2 Incompatibilities

Not applicable

6.3 Shelf life

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

6.4 Special precautions for storage.

Do not store above 25ºC

Protect from light.

Any part used tablets should be discarded.

6.5 Nature and composition of immediate packaging.

4 scored white roundworm tablets in a high-density polyethylene jar with a high-density polyethylene child resistant screw cap.

2 scored pink tapeworm tablets in a high-density polyethylene jar with a high-density polyethylene child resistant screw cap.

Packed together with a leaflet in a cardboard box.

6.6 Special precautions for disposal of unused veterinary medicinal products or waste materials derived from the use of such products -

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.

Battle, Hayward and Bower Ltd

Crofton Drive,

Lincoln.

LN3 4NP

8. Marketing Authorisation Number

Vm 00676/4105

9. Date of first authorisation

13^thDecember 1995

10. Date of revision of the text

January 2009