SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the Veterinary Medicinal Product

Beaphar Worming Syrup, 9.4% w/v, oral solution.

2. Qualitative and Quantitative Composition

Active substance % w/v

Piperazine Citrate 9.4

Excipients

Methyl Parahydroxybenzoate 0.040% w/v

Ethyl Parahydroxybenzoate 0.010% w/v

Propyl Parahydroxybenzoate 0.005% w/v

Butyl Parahydroxybenzoate 0.015% w/v

For full list of excipients, see section 6.1

3. Pharmaceutical form

Oral solution.

Bright reddish brown, clear solution.

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 puppies and kittens.

4.3 Contra-indications

Do not exceed stated dose.

Do not repeat treatment if vomiting occurs shortly after dosing.

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 after use.

4.6 Adverse reactions (frequency and seriousness)

Overdosage (see section 4.10).

4.7 Use during pregnancy, lactation or lay

Consult a veterinary surgeon before treating pregnant animals.

Nursing female animals should be treated 2 weeks after giving birth and every two weeks at the same time as the puppies or kittens 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

For oral administration.

Administer directly into the corner of the mouth, or mixed with a little food. The rest of the meal should be offered afterwards to ensure all the syrup is taken.

Shake the bottle and prime dispenser before use by slowly depressing the plunger repeatedly, up to 5 times.

Animal Weight/kg Number of pumps

Up to 0.9 1 (1.1 ml)

0.91 - 1.8 2 (2.2 ml)

1.81 - 2.7 3 (3.3 ml)

2.71 - 3.6 4 (4.4 ml)

3.61 - 4.5 5 (5.5 ml)

4.51 - 5.4 6 (6.6 ml)

For every additional 0.9 kg bodyweight, an extra single pump volume should be administered.

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.

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

Symptoms: Vomiting and diarrhoea, depression, ataxia, 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

Methyl Parahydroxybenzoate

Ethyl Parahydroxybenzoate

Propyl Parahydroxybenzoate

Butyl Parahydroxybenzoate

Sorbitol Solution 70% w/w (Non-Crystallising)

Imitation Chocolate Flavour 1470

Caramel T6

Water Deionised

6.2 Incompatibilities

None known.

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 25°C.

6.5 Nature and composition of immediate packaging

Size: 45 ml

Container: Round, amber Type III glass bottle.

Closure: White, tamper-evident polypropylene cap (screw fit) with low-density polyethylene liner.

Dosing device: Pump dispenser nominally delivering 1.1 ml per stroke

Use Orientation: Upright

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

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

Beaphar UK Ltd.

Homefield Road

Haverhill

Suffolk

CB9 8QP

8. Marketing authorisation number

Vm13907/4008

9. Date of first authorisation/renewal of the authorisation

Date of first authorisation: 21 September 1994

10. Date of revision of the text

June 2010