Medine.co.uk

Beaphar Multiwormer For Dogs, Tablets

Revised: 09 June 2010

AN: 00310/2010

SUMMARY OF PRODUCT CHARACTERISTICS


Name of the Veterinary Medicinal Product


Beaphar Multiwormer for Dogs, Tablets


Qualitative and Quantitative Composition

Tapeworm tablets (fawn)


Active substance mg/tablet

Dichlorophen 750.00

Excipients mg/tablet

Caramel 15712 (E150) 12.15


For full list of excipients, see section 6.1


Roundworm tablets (pink)


Active substance mg/tablet

Piperazine Citrate 375.00


Excipients mg/tablet

Erythrosine Lake (E127) 1.425


For full list of excipients, see section 6.1


Pharmaceutical form


Tablets

Roundworm tablet: Slightly mottled pink, circular bi-convex tablet embossed with a break-line on one face.

Tapeworm tablet: Mottled fawn to off-white, circular flat faced bevel edged tablet.


Clinical Particulars


Target species


Dogs over 6 months of age


Indications for use, specifying the target species


For the treatment of roundworm (Ascarids) and tapeworm infections in dogs over six months old


Contra-indications


Do not treat dogs under 1.9 kg (4lb) or less than 6 months old.

4.4 Special warnings for each target species


Do not treat dogs under 1.9 kg (4 lb), or less than 6 months old.

Do not repeat treatment if dog vomits after administration.

Do not administer more than 6 tablets in a single dose. If no vomiting occurs, the remaining dose may be administered after 3 hours.


Special precautions for use


Special precautions for use in animals


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

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

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


Wash hands thoroughly after handling tablets.

Accidental eye contact – rinse thoroughly with clean running water.

If irritation persists seek medical advice.

Accidental ingestion by humans – drink plenty of water and seek medical advice.


Adverse reactions (frequency and seriousness)

Dichlorophen may cause vomiting in sensitive dogs.

Large numbers of tablets given concurrently may cause vomiting in some dogs.


Use during pregnancy, lactation or lay

Consult a veterinary surgeon before treating pregnant animals.


Interaction with other medicinal products and other forms of interaction

None known


Amounts to be administered and administration route


For oral administration

Treatment consists of three doses given at weekly intervals. Administer one pink tablet per 3.8 kg (8.5 lb) bodyweight on day 1, then one fawn tablet per 3.8 kg on day 8, and one pink tablet per 3.8 kg on day 15. Tablets may be taken whole, or crushed and sprinkled on the dog’s food. Do not remove tablets from strip until required for treatment.

Dogs should be treated every 3 months.


4.10 Overdose (symptoms, emergency procedures, antidotes) if

necessary


Piperazine Citrate Dichlorophen


Symptoms: Vomiting and diarrhoea Vomiting

Depression General weakness

Ataxia and muscle weakness Ataxia

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 codes:QP52AG01, QP52AH01


5.1 Pharmacodynamic properties


Piperazine acts as an anthelmintic by causing nerve paralysis of the worm, with subsequent expulsion.

Dichlorophen is effective against most common cestodes, and also has antibacterial and antifungal properties.


5.2 Pharmacokinetic particulars


The citrate is quickly absorbed in the dog and excreted in the urine.


6. Pharmaceutical particulars


List of excipients


Tapeworm tablets (fawn)

Caramel 15712 (E150)

Pregelatinised Starch

Maize Starch

Magnesium Stearate


Roundworm tablets (pink)

Erythrosine Lake (E127)

Cellulose Microcrystalline

Magnesium Stearate

Silica Colloidal Anhydrous


Incompatibilities


None known.


Shelf life


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


Special precautions for storage


Do not store above 25ºC.

Do not remove tablets from strip until required for treatment

Any part-used tablets should be discarded.


Nature and composition of immediate packaging


8 or 24 pink roundworm tablets and 4 or 12 fawn tapeworm tablets in the following packs:

Container: PVC – aluminium foil blister strip

Closure: Heat – seal

Secondary pack: One blister of 8 roundworm tablets with one blister of 4 fawn tapeworm tablets per carton

One blister of 24 roundworm tablets with one blister of 12 fawn tapeworm tablets per carton

OR

Three blisters of 8 roundworm tablets with three blisters of 4 fawn tapeworm tablets per carton


Not all pack sizes may be marketed.


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


Vm13907/4011


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


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