Summary of Product Characteristics

Wilko Vinyl Dog Flea and Tick Collar, 15% w/w.

Active substance % w/w mg/collar

Dimpylate (as dimpylatestabilised) 15.0 3,600

Excipients % w/w mg/collar

Brown collar: Ferric oxide red (E172) 0.08 19.2

Charcoal, vegetable (E153) 0.02 4.8

Blue collar: Coomassie Brilliant Blue G 0.012 2.8

Copper Phthalocyanine 0.012 2.8

OB (CAS No. 67210-66-6) 0.005 1.2

Red collar: Rhodamine 6G 0.013 3.2

Basic Violet 11 0.005 1.2

Yellow collar: Solvent Yellow 135 0.013 3.2

Green collar: Solvent Yellow 135 0.013 3.2

Copper Phthalocyanine Green 0.010 2.4

Orange collar: Disperse Yellow 11 0.010 2.4

Rhodamine 6G 0.015 3.6

Rhodamine B 0.005 1.2

For full list of excipients, see section 6.1

Collar

Coloured flea collar fitted with safety buckle

4.1 Target species

Dogs

Treatment of dogs infested with fleas (Ctenocephalides felis and C. canis) and ticks (Ixodes ricinus).

No other insecticide should be used with the collar or within 7 days of removal.

Do not allow the collar to come into contact with nursing females.

Do not use the collar on dogs younger than 12 weeks.

4.4 Special warnings for each target species

Remove collar if any sign of skin irritation occurs.

Check the collar is not too tight, to ensure against irritation.

Do not allow animals to chew the collar.

Remove collar from dog immediately should any signs of drowsiness, listlessness or respiratory difficulties develop soon after fixing the collar.

For external use only.

Remove fleas from young puppies and nursing females by careful use of a flea comb.

Do not remove collar from pack until ready to use.

Do not allow children to play with the collar.

Do not allow children to suck or chew the collar.

Do not smoke, eat or drink while handling collar.

Do not sleep with pets wearing collars.

Dimpylate / Diazinon is an organophosphorus compound: DO NOT handle if under medical advice not to work with ANTICHOLINESTERASES.

Avoid excessive handling of the collar.

Cut off any excess collar with scissors and dispose of safely.

If you feel unwell after handling the collar, seek medical advice. Wash hands thoroughly after handling the collar.

To help prevent reinfestation, animals’ bedding and regular resting areas, including carpets and soft furnishings, should be treated with a suitable insecticide and vacuumed regularly.

After fitting the collar, do not allow dogs to swim in ponds or other small bodies of water. This will not adversely affect the activity of the collar but is potentially

dangerous to aquatic life.

Typical adverse reactions to organophosphorus compounds are rare.

4.7 Use during pregnancy, lactation or lay

Do not allow contact with nursing females.

Do not combine with other organophosphorus compounds or medicines which are not compatible with organophosphorus compounds.

One collar per animal to be fastened around the neck. Fasten the collar around the dog’s neck, ensuring a comfortable fit; two fingers should fit easily under the collar. Loosen the collar as the dog grows bigger. Cut off excess collar extending beyond buckle and dispose of with the household refuse. Replace collar after 4 months if flea and tick re-infestation is a risk.

Symptoms: Tearing, salivation, muscle twitches, vomiting, loss of reflexes, coma, cyanosis.

Emergency procedure: Remove collar.

Antidote: Atropine.

Not applicable

Pharmacotherapeutic group: Ectoparasiticides for topical use, incl. insecticides

ATC Vet Code: QP53AF03

5.1 Pharmacodynamic properties

The collar is applied around the dog’s neck. The collar constantly releases dimpylateover a four month period. Fleas and ticks on the skin of the animal come into contact with the dimpylateand are killed.

5.2 Pharmacokinetic particulars

Dimpylateis an organophosphorus compound with a non-systemic action.

Brown collar: Charcoal Vegetable (E153)

Ferric Oxide Red (E172)

Blue collar: Coomassie Brilliant Blue G

Copper Phthalocyanine

OB (CAS No. 67210-66-6)

Red collar: Rhodamine 6G

Basic Violet 11

Yellow collar: Solvent Yellow 135

Green collar: Solvent Yellow 135

Copper Phthalocyanine Green

Orange collar: Disperse Yellow 11

Rhodamine 6G

Rhodamine B

Polyvinyl chloride

Dibutyl Phthalate

Epoxidised Soya Bean Oil

Calcium Stearate

Morphine, theophylline, aminophylline, large amounts of intravenous fluids, phenothiazine drugs, pyrantelpalmoate.

Shelf life of the veterinary medicinal product as packaged for sale: 2 years

Protect from direct sunlight.

Do not store above 25°C.

Do not remove the collar from the pack until you are ready to fit it.

Clear, colourless high-density polyethylene blister, containing one PVC collar, heat sealed on varnished fibreboard/aluminium foil/fibreboard laminate backing card.

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

EXTREMELY DANGEROUS to fish and aquatic life.

Do not contaminate ponds, waterways or ditches with the collar or empty packaging.

Beaphar Ltd.

Homefield Road

Haverhill

Suffolk

CB9 8QP

Vm 05496/4027

Date: 13 September 2001

Date:November 2013

Approved:01/11/2013