SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Austria Belgium Cyprus Malta Czech Republic Netherlands Greece Portugal Slovakia Hungary Slovenia Germany Finland	Dolpac medium dogs tablets
France Luxembourg	Dolpac 10 comprimé
UK-Ireland-Italy	Dolpac Tablets for Medium Dogs
Spain Poland	Dolpac medium dogs tablets for 5-20 kg
Denmark Sweden	Dolpac vet medium dogs tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains :

Active substances

Oxantel 200.28 mg (equivalent to 559 mg of oxantel embonate)

Pyrantel 49.94 mg (equivalent to 144 mg of pyrantel embonate)

Praziquantel 50.00 mg

Excipient to one 950 mg divisible tablet

Excipients

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Tablet

Pale yellow to yellow oblong tablet with breaking line.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

For curative treatment of dogs harbouring mixed parasitic infestations with the following adult stages of nematode and cestode species:

Nematodes:

Toxocara canis

Toxascaris leonina

Ancylostoma caninum

Uncinaria stenocephala

Trichuris vulpis

Cestodes:

Dipylidium caninum

Taenia spp

Echinococcus multilocularis

Echinococcus granulosus

4.3 Contraindications

See section 4.8

4.4 Special warnings for each target species

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class

Fleas serve as intermediate hosts for one of the common tapeworms – Dipylidium caninum. Tapeworm infestation may reoccur unless control of intermediate hosts (fleas) is undertaken.

4.5 Special precautions for use

i) Special precautions for use in animals

Roundworm and Hookworm infection:

In some animals, Ancylostoma caninumand Toxocara canismay not be totally eradicated by the treatment, resulting in a continued risk of egg shedding into the environment. Follow-up examinations of the faeces are advisable and according to the results of these examinations, treatment with a nematodicidal product may be carried out if necessary.

The product is not recommended for use in pups younger than two months oldor weighing less than 1 kg.

In debilitated or heavily infested animals, the product should be used only according to a benefit/risk assessment by the responsible veterinarian

Do not use in animals with known hypersensitivity to any of the components of the product.

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

Some constituents of this product may cause allergic reactions or skin irritation.

Avoid contact with the skin.

People with known hypersensitivity to any of the ingredients should avoid contact with this product.

Wash hands after use.

In case of accidental ingestion, seek medical advice and show the package leaflet to the physician.

4.6 Adverse reactions (frequency and seriousness)

Vomiting and diarrhoea may be observed following the treatment.

Despite not being observed in studies performed with the product, anorexia can occur as it is a common adverse effect of products containing praziquantel.

4.7 Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. The use is not recommended during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Do not use simultaneously with levamisole, piperazine or choline esterase inhibitors

4.9 Amounts to be administered and administration route

The recommended dose rate is 20 mg oxantel / 5 mg pyrantel / 5 mg praziquantel per kg bodyweight, ie one tablet per 10 kg bodyweight in a single intake, by oral route.

Administer the required number of tablets, according to bodyweight, orally, in a single administration. Preferably, dogs should be fasted prior to treatment. Food may be given one hour or more after treatment.

The tablet can be divided into halves.

Dogs kept together or in kennels should be treated at the same time.

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

Administration of the product to healthy dogs at 5 times the recommended dosage for 6 consecutive weeks had no adverse consequences.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Praziquantel, combinations

ATCvet Code: QP52AA51

5.1 Pharmacodynamic properties

The product contains three active ingredients, pyrantel embonate, oxantel embonate and praziquantel. The spectrum of activity of the product is wide, directed towards gastro-intestinal roundworms (ascaris, whipworm and hookworms) and tapeworms.

Pyrantel has a paralysing effect on roundworm muscles, by activating acetylcholine receptors. Its activity is more particularly directed against Toxocara canis, Toxascaris leonina, Uncinaria stenocephala andAncylostoma caninum. Its activity against Trichuris vulpisis negligible.

Oxantel is an m-oxyphenolic derivate of pyrantel, that has been developed for its activity against whipworms.

Praziquantel leads to muscular contractions, paralysis and altered parasite tegument integrity. It is active against adults and larval stages of dog tapeworms, Echinococcus, Taenia andDipylidium.

5.2 Pharmacokinetic particulars

After oral administration, the absorption of oxantel embonate is negligible. Pyrantel is quickly absorbed but in small quantities (T_max = 1.38 h, C_max= 0.048 µg/ml) and is very quickly eliminated. Praziquantel is quickly absorbed (T_max = 1.28 h, C_max= 0.4 µg/ml) and eliminated (elimination half-life 1.5 h).

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Dextrates

Povidone K30

Sodium lauryl sulphate

Bacon flavour

Crospovidone

Sodium stearyl fumarate

6.2 Incompatibilities

Not applicable

6.3 Shelf life

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

Discard any unused half tablet

6.4. Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Polyamide-aluminium-PVC/aluminium blister or polychlorotrifluoroethylene-PVC/aluminium blister.

Cardboard box with 1 strip of 3 tablets

Cardboard box with 6 strips of 3 tablets

Cardboard box with 10 strips of 3 tablets

Cardboard box with 20 strips of 3 tablets

Cardboard box with 1 strip of 6 tablets

Cardboard box with 3 strips of 6 tablets

Cardboard box with 5 strips of 6 tablets

Cardboard box with 10 strips of 6 tablets

Not all pack sizes may be marketed

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

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

7. MARKETING AUTHORISATION HOLDER

Vétoquinol UK Limited

Vétoquinol House

Great Slade

Buckingham Industrial Park

Buckingham

MK18 1PA

8. MARKETING AUTHORISATION NUMBER

Vm08007/4120

9. DATE OF FIRST AUTHORISATION

14 January 2008

10. DATE OF REVISION OF THE TEXT

October 2011