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 large dogs tablets
France Luxembourg	Dolpac 25 comprimé
UK-Ireland-Italy	Dolpac Tablets for Large Dogs
Poland Spain	Dolpac large dogs tablets for 20-75 kg
Denmark Sweden	Dolpac vet large dogs tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains :

Active substances

Oxantel 500.70 mg (equivalent to 1397.5 mg of oxantel embonate)

Pyrantel 124.85 mg (equivalent to 360 mg of pyrantel embonate)

Praziquantel 125.00 mg

Excipient to one 2375 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 25 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.