Zipyran XL 175 mg/175 mg/525 mg tablets for dogs

Composition

Each tablet contains:

Active substances:

Praziquantel ..............................................................................175 mg

Pyrantel.....................................................................................175 mg

(equivalent to 504.43 mg of pyrantel embonate)

Febantel ....................................................................................525 mg

Excipients:

Qualitative composition of excipients and other constituents

Povidone

Cellulose, microcrystalline

Silica, colloidal anhydrous

Sodium laurilsulfate

Crospovidone

Saccharin sodium

Magnesium stearate

Maize starch

Beef flavour

Yellowish oblong scored tablet, divisible into two equal parts.

Beef flavoured tablets.

3

Pharmacological properties

4.1 ATCvet code: QP52AA51

4.2 Pharmacodynamics

In this fixed combination pyrantel and febantel act against nematodes (ascarids, hookworms) in dogs. In particular the activity spectrum covers Toxocara canis, Toxascaris leonina, Uncinaria stenocephala and Ancylostoma caninum. This combination shows synergistic activity in the case of hookworms.

Praziquantel is effective against a number of cestodes. Activity of praziquantel against adult and immature forms of these parasites has been described in literature. Praziquantel is very rapidly absorbed through the parasite’s surface and distributed throughout the parasite. Both in vitro and in vivo studies have shown that praziquantel causes severe damage to the parasite integument, resulting in the contraction and paralysis of the parasites. There is an almost instantaneous tetanic contraction of the parasite musculature and a rapid vacuolisation of the syncytial tegument. This rapid contraction has been explained by changes in divalent cation fluxes, especially calcium.

Pyrantel acts as a cholinergic agonist. Its mode of action is to stimulate nicotinic cholinergic receptors of the parasite, induce spastic paralysis of the nematodes and thereby allow removal from the gastro- intestinal (GI) system by peristalsis. Within the mammalian system febantel undergoes ring closure forming fenbendazole and oxfendazole. It is these chemical entities which exert the anthelmintic effect by inhibition of tubulin polymerisation. Formation of microtubules is thereby prevented, resulting in disruption of structures vital to the normal functioning of the helminth. Glucose uptake, in particular is affected, leading to a depletion in cell ATP. The parasite dies upon exhaustion of its energy reserves, which occurs 2-3 days later

4.3 Pharmacokinetics

After the oral administration praziquantel is nearly completely absorbed in the digestive tract. The maximum concentration is reached approximately 60 minutes after the administration.

Praziquantel is widely metabolized in the liver. Praziquantel is found in the urine as metabolites (40% after 8 hours).

After oral administration, the maximum plasmatic concentrations of Febantel are reached approximately after 3 hours. Febantel is metabolized as Fenbendazole and its derivates oxides and hydroxides. Febantel traces are found in faeces and as metabolites in the urine.

The embonate salt of Pyrantel has low aqueous solubility and is poorly absorbed from the intestinal tract in dogs. It is found as active substance in the faeces (50 to 60%). Following absorption, pyrantel embonate is quickly and almost completely metabolized into inactive components which are rapidly excreted in the urine.

3

Target species

Dogs.

3

Indications

Treatment of mixed infections by adult cestodes and nematodes of the following species:

Nematodes:

Hookworms: Ancylostoma caninum

Uncinaria Stenocephala

Ascarids: Toxocara canis

Toxascaris leonina

Cestodes:

Tapeworms: Taenia spp

Dipylidium caninum

3

Dosage

Oral use.

Dosage: the recommended dose is 5 mg of Praziquantel, 5 mg of Pyrantel (embonate) and 15 mg of Febantel per kg of body weight (equivalent to one tablet/35 kg bw) in accordance with the following table:

To ensure a correct dosagee, body weight should be determined as accurately as possible.

For single oral treatment only.

The tablets are administered by placing whole and/or divided tablets at the back of the tongue for forced swallowing.

In cases of confirmed single infestation by cestodes or nematodes, a monovalent veterinary medicinal product containing a cestocide or a nematocide alone should be used.

3

Contraindications

See section ”Use during pregnancy, lactation or lay”.

Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

3

Adverse reactions

Dogs:

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

3

Warnings

Special precautions for safe use in the target species:

In debilitated or heavily infested animals, the veterinary medicinal product should be used only after evaluation of the risk / benefit by the veterinarian

Digestive haemorrhages (diarrhoea, bloody stools and even deaths) provoked by worm lysis may result from anthelminthic treatment in cases of heavy infestations.

In dogs less than 6 weeks old, tapeworm infections are highly uncommon. Treatment of animals less than 6 weeks old with a fixed combination veterinary medicinal product against cestodes and nematodes may, therefore, not be necessary.

The active substances are not known to cause particular adverse effects in young animals. Nevertheless the safety of the formulation has not been established in dogs less than 5 months of age.

Roundworm and hookworm infections: In some animals, Ancylostoma caninum and Toxocara canis may not be 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 nematocidal veterinary medicinal product may be carried out, if necessary. - To minimise the risk of re-infestation and new infestation, excreta should be collected and properly disposed out of for 24 hours following treatment

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

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

In case of accidental contact wash hands thoroughly

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

Wash hands after use.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

3

Use during pregnancy, lactation or lay

Pregnancy and lactation:

Teratogenic effects attributed to high doses of febantel administered during early pregnancy have been reported in rats, sheep and dogs.

The safety of the veterinary medicinal product has not been investigated during the 1st and 2nd half of pregnancy.

Do not use in pregnant bitches during the first four weeks of gestation.

The veterinary medicinal product may be used during lactation

3

Interactions

Do not use simultaneously with piperazine, as the anthelmintic effects of pyrantel and piperazine may be antagonized.

Plasma concentrations of praziquantel may be decreased by concomitant administration with drugs that increase the activity of cytochrome P-450 enzymes (e.g. dexamethasone, phenobarbital).

Concurrent use with other cholinergic compounds can lead to toxicity.

3

Overdose

Doses higher than 3 times the recommended dose can cause digestive disorders (vomiting and diarrhea).

3

Special warnings

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 and source of infection for one common type of tapeworm – Dipylidium caninum.

Tapeworm infestation may reoccur unless control of intermediate hosts as well as the environment is undertaken concurrently to the treatment.

3

Withdrawal period

Not applicable.

3

Incompatibilities

Not applicable.

3

Immediate packaging

Blisters of PVC and aluminium in a cardobaord box.

Pack sizes:

Cardboard box with 1 blister of 2 tablets

Cardboard box with 2 blisters of 2 tablets

Cardboard box with 5 blisters of 2 tablets

Cardboard box with 12 blisters of 2 tablets

Cardboard box with 16 blisters of 2 tablets

Cardboard box with 24 blisters of 2 tablets

Cardboard box with 30 blisters of 2 tablets

Not all pack sizes may be marketed.

3

Storage

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

3

Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 36 months

Shelf life of the divided tablet after first opening the immediate packaging: any divided tablet portion should be immediately discarded and not stored

3

Disposal of unused product

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

3

Additional information

7 MARKETING AUTHORISATION NUMBER

Vm 20634/4008

8 DATE OF FIRST AUTHORISATION

12 May 2014

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

July 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Approved 20 October 2025

3

Registration holder

Laboratorios Calier, S.A.

3