Summary of Product Characteristics

1. Name of the Veterinary Medicinal Product

Beaphar Worming Cream, 25% w/w, oral suspension

2. Qualitative and Quantitative Composition

Active substance % w/w

Piperazine Citrate 25.00

Excipients % w/w

Titanium Dioxide 3.00

Methyl Parahydroxybenzoate 0.15

For full list of excipients, see section 6.1

3. Pharmaceutical form

Oral suspension

A soft, white to off-white cream.

4. Clinical Particulars

4.1 Target species

Dogs and cats.

4.2 Indications for use, specifying the target species

For the treatment of roundworms (Ascarids) in dogs and cats.

4.3 Contra-indications

None

4.4 Special warnings for each target species

Consult a veterinary surgeon before treating pregnant animals or those with a history of epilepsy or severe renal disfunction.

4.5 Special precautions for use

i. Special precautions for use in animals

Do not exceed the recommended dosage.

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

Following accidental skin or eye contact, wash the affected area with plenty of water. If irritation persists, seek medical advice.

Following accidental ingestion, drink plenty of water and seek medical attention.

Wash hands and exposed skin after use.

4.6 Adverse reactions (frequency and seriousness)

Overdosage. See Section 4.10.

4.7 Use during pregnancy, lactation or lay

Nursing female animals should be treated two weeks after giving birth and every two weeks until weaning.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

The cream may be administered either by dabbing the required amount (see table below) onto the nose or mouth, from where the animal will lick it off, or given on a biscuit, or added to a small amount of the animal’s daily meal (give the remainder afterwards). If your household has more than one dog or cat, feed them separately to ensure that each receives the correct dosage.

Each graduation of the syringe will dispense the correct volume of Worming Cream for 1.0 kg bodyweight, e.g.

Animal Weight Number of graduations

kg (lb)

1.0 (2.2) 1

2.0 (4.4) 2

3.0 (6.6) 3

4.0 (8.8) 4

5.0 (11.0) 5

10.0 (22.0) 10

The syringe is marked with guidelines for each 1 kg bodyweight dose.

To administer the correct volume, depress plunger the required number of graduations for the weight of the animal.

Puppies and kittens should be treated for roundworms at 2 weeks of age.

They should be re-treated at 4, 6, 8, 10 and 12 weeks of age, and thereafter at 2 to 3 monthly intervals.

Adult dogs and cats should be treated at 3 monthly intervals.

Female animals should be wormed at the same time and as frequently as their puppies or kittens until weaning.

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

Symptoms: Vomiting and diarrhoea, depression, ataxia and muscle weakness, and fits.

Emergency Procedures: Consult a veterinary surgeon. Treat symptomatically and supportively. Keep animal warm and calm. Symptoms reverse in 24-48 hours.

4.11 Withdrawal period(s)

Not applicable

5. Pharmacological properties

ATCvet code:QP52AH01

5.1 Pharmacodynamic properties

Worms are killed in the gastro-intestinal tract and may be expelled in the faeces or digested in their passage through the tract.

5.2 Pharmacokinetic particulars

None given.

6. Pharmaceutical particulars

6.1 List of excipients

Titanium Dioxide

Methyl Parahydroxybenzoate

Xanthan Gum

Glycerol

Yeatex CY

Silica Colloidal Anhydrous

Water Deionised

6.2 Incompatibilities

None known.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 18 months.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and composition of immediate packaging

Pack size: 18 g

Container: Graduated syringe with high density polyethylene barrel and low density polyethylene piston.

Closure: Low density polyethylene cap (push fit).

Secondary pack: One carton containing one syringe.

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

Beaphar UK Ltd.

Homefield Road

Haverhill

Suffolk

CB9 8QP

8. Marketing authorisation number

Vm13907/4004

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation: 21 September 1994

10. Date of revision of the text

February 2010