SUMMARY OF PRODUCT CHARACTERSISTICS

Wilko One Dose Worming Tablets for Dogs, 500 mg film-coated tablets

Active substance mg/tablet

Nitroscanate 500

Other ingredients

Titanium Dioxide (E171) 3.95

Ferric Oxide Yellow ( E172) 0.1306

Ferric Oxide Black (E172) 0.00013

Ferric Oxide Red (E172) 0.00013

For full list of excipients, see section 6.1.

Film-coated tablets

Round, convex, yellow coloured film coated tablets. Diameter 12.0 mm ±0.25 mm

4.1 Target species

Dogs

Wilko One Dose Worming Tablets for Dogs is a broad spectrum anthelmintic for use in adult dogs. Wilko One Dose Worming Tablets for Dogs are highly effective in the control of cestodes and common intestinal nematodes: Toxocara canis, Toxascaris leonina, Uncinaria stenocephala, Ancylostoma caninum, Taenia hydatigena, Taenia pisiformis andDipylidium caninum.Wilko One Dose Worming Tablets for Dogs give a limited level of control of Echinococcus granulosus.

4.3 Contra-indications

Do not repeat treatment if vomiting occurs shortly after dosing.

If a hypersensitive reaction occurs, treatment should be discontinued.

4.4 Special warnings for each target species

Wilko One Dose Worming Tablets for Dogs are not indicated for the treatment of Trichuris vulpis, the whipworm.It is recommended that adult dogs should be wormed routinely 2 – 4 times a year. Since the most common tapeworm of the dog (Dipylidium caninum)is transmitted by a flea and has a very short pre-patent period, it is important to pay attention to flea control to reduce the incidence of tapeworm in your pet.

i. Special precautions for use in animals

None.

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

This product can be an irritant to the skin and eyes.

Tablets are film-coated and should not be broken or divided.

Wash hands after use.

Wilko One Dose Worming Tablets for Dogs when administered as recommended are unlikely to cause vomiting.

4.7 Use during pregnancy, lactation or lay

Wilko One Dose Worming Tablets for Dogs can be used safely during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

The dose for the routine treatment of adult dogs is Nitroscanate 50 mg/kg bodyweight, which is equivalent to 1 x 500 mg tablet per 10 kg (22 lb) bodyweight. Adult dogs should be dosed 2 – 4 times a year. Wilko One Dose Worming Tablets for Dogs should be administered orally in the morning after overnight fasting with approximately one-fifth of the daily food ration. The remaining food ration should be withheld for at least 8 hours.

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

No information – treatment should be symptomatic.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anthelmintics

ATCvet code: QP52AX01

5.1 Pharmacodynamic properties

Nitroscanate is a broad spectrum anthelmintic effective against gastrointestinal nematodes and cestodes.

5.2 Pharmacokinetic particulars

None given.

6. PHARMACEUTICAL PARTICULARS

Titanium Dioxide (E171)

Ferric Oxide Yellow ( E172)

Ferric Oxide Black (E172)

Ferric Oxide Red (E172)

Sodium Starch Glycollate

Maize Starch

Microcrystalline Cellulose

Sodium Lauryl Sulphate

Magnesium Stearate

None known.

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

Store in a dry place.

Do not store above 25°C

Cardboard carton containing four tablets in an aluminium foil/low density polyethylene strip pack.

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

Sinclair Animal and Household Care Ltd.

Ropery Road

Gainsborough

Lincolnshire

DN21 2QB

8. MARKETING AUTHORISATION NUMBER

Vm 16516/4006

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 2 March 2001

Date of renewal of the authorisation: 2 March 2006

10. DATE OF REVISION OF THE TEXT

Date:July 2011