SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Panacur Granules 222 mg/g

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each gram contains:

Active substance: Fenbendazole 222.22 mg Excipients:

Qualitative composition of excipients and other constituents

Maize starch

Lactose monohydrate

Povidone 25000 (synonym: Povidone K25)

White or yellowish-white granular powder.

3. CLINICAL INFORMATION

3.1 Target species

Dogs, cats, puppies and kittens.

3.2 Indications for use for each target species

For the treatment of domestic dogs and cats infected with immature and mature stages of nematodes of the gastrointestinal and respiratory tracts.

Adult dogs and cats: For the treatment of adult dogs and cats infected with gastrointestinal nematodes and cestodes:

Ascarid spp. (Toxocara canis, Toxocara cati, Toxascaris leonina) Ancylostoma spp.

Trichuris spp.

Uncinaria spp. Taenia spp.

Puppies and kittens: For the treatment of weaned puppies and kittens infected with gastrointestinal nematodes and puppies infected with protozoa (Giardia spp).

Pregnant dogs: For the treatment of pregnant dogs to reduce prenatal infections with Toxocara canis and the transfer of T. canis and Ancylostoma caninum to their pups via the milk.

For the treatment of dogs infected with lungworm Oslerus (Filaroides) osleri or protozoa Giardia spp. and cats infected with lungworm Aelurostrongylus abstrusus.

The veterinary medicinal product also has an ovicidal effect on nematode eggs.

3.3 Contraindications None.

3.4 Special warnings

Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy:

• Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.

• Underdosing, which may be due to underestimation of bodyweight or misadministration of the product.

3.5 Special precautions for use

Special precautions for safe use in the target species:

Assess bodyweight as accurately as possible before calculating the dosage.

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

Avoid inhalation of granule dust.

Direct contact with the skin should be kept to a minimum.

Wash hands after use.

Avoid contact with skin, eyes and mucous membranes. In case of accidental skin, eye or mucosal contact, wash skin thoroughly with soap and water and rinse eyes and mucous membranes with plenty of water.

If irritation persists, seek medical advice and show the package leaflet or the label to the doctor.

Special precautions for the protection of the environment: Not applicable.

3.6 Adverse events

Dogs, cats, puppies and kittens:

Very rare (< 1 animal / 10 000 animals treated, including isolated reports):

Gastrointestinal disorders (e.g. vomiting and diarrhoea).

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 its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

3.7 Use during pregnancy, lactation or lay

Pregnancy and lactation:

Can be used during pregnancy.

Teratogenic effects in dogs and cats cannot be completely ruled out in very rare cases.

Treatment during the first two trimesters of pregnancy should be based on a benefitrisk assessment by a responsible veterinarian.

3.8 Interaction with other medicinal products and other forms of interaction

None known.

3.9 Administration routes and dosage

Oral use.

Assess bodyweight as accurately as possible and then administer one or a combination of sachets which most closely treats this bodyweight. The dose should be administered by mixing the granules into the feed.

Routine treatment of adult dogs and cats:

Administer 100 mg fenbendazole per kg bodyweight as a single dose.

Practical dosage recommendations:

Each 1 g sachet treats 2 kg bodyweight (1.1 – 2.2 kg).

Each 1.8 g sachet treats 4 kg bodyweight (2.2 – 4.4 kg).

Each 4.5 g sachet treats 10 kg bodyweight (5 – 10 kg).

For dogs weighing over 10 kg, additional sachets are required according to the additional bodyweight.

Treatment should be repeated when natural re-infection with parasitic worms occurs. Routine treatment of adult animals with minimal exposure to infection is advisable 2 to 4 times per year. More frequent treatment, at 6 to 8 weekly intervals is advisable for dogs in kennels.

Weaned puppies and kittens under six months of age:

Administer 50 mg fenbendazole per kg bodyweight daily for 3 consecutive days.

Practical dosage recommendations:

Each 1 g sachet treats 4 kg bodyweight (minimum weight 2.2 kg), administer daily for 3 consecutive days (2.2 – 4.4 kg).

Each 1.8 g sachet treats 8 kg bodyweight; administer daily for 3 consecutive days (4.5 – 8 kg).

Each 4.5 g sachet treats 20 kg bodyweight; administer daily for 3 consecutive days (10 – 20 kg).

For dogs/puppies weighing over 20 kg, additional sachets are required according to the additional bodyweight.

Puppies should be treated at 2 weeks of age, 5 weeks of age and again before leaving the breeder's premises. Treatment may also be required at 8 and 12 weeks of age. Thereafter, frequency of treatment can be reduced unless the pups remain in kennels where re-infestation occurs more readily.

Pregnant dogs:

Administer 25 mg fenbendazole per kg bodyweight daily from day 40 of pregnancy continuously to 2 days post-whelping (approximately 25 days).

Practical dosage recommendations:

Each 1 g sachet treats 8 kg bodyweight; administer daily for approx. 25 days.

Each 1.8 g sachet treats 16 kg bodyweight; administer daily for approx. 25 days.

Each 4.5 g sachet treats 40 kg bodyweight; administer daily for approx. 25 days. For bitches weighing over 40 kg, additional sachets are required according to the additional bodyweight.

Increased dosing for specific infections:

- For the treatment of clinical worm infestations in adult dogs and cats or Giardia spp. infections in dogs, administer 50 mg/kg daily for 3 consecutive days.

- For the control of lungworm Oslerus (Filaroides) osleri in dogs, administer 50 mg/kg daily for 7 consecutive days. A repeat course of treatment may be required in some cases.

- For the control of lungworm Aelurostrongylus abstrusus in cats, administer 50 mg/kg daily for 3 consecutive days.

3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)

Benzimidazoles have a high margin of safety.

No specific overdose symptoms are known. No specific actions is required.

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.

3.12 Withdrawal periods

Not applicable.

4. PHARMACOLOGICAL INFORMATION

4.1 ATCvet code: QP52AC13

4.2 Pharmacodynamics

Fenbendazole is an anthelmintic belonging to the benzimidazole carbamates group.

It acts by interfering in the energy metabolism of the nematode.

The anthelmintic efficacy is based on inhibition of the polymerisation of tubulin to microtubuli. The anthelmintic affects both adult and immature stages of gastrointestinal and respiratory nematodes.

4.3 Pharmacokinetics

Fenbendazole is only partly absorbed from the intestine and reaches maximum plasma concentration in dogs 6 - 24 hours after oral administration. In cats, the mean maximum serum concentration of fenbendazole was reached about 4 hours after treatment. Administration of fenbendazole in food did significantly increase its bioavailability compared to the administration on an empty stomach.

Fenbendazole is metabolised mainly by enzymes of the cytochrome P-450 system in the liver. The major oxidative metabolite is fenbendazole sulfoxide which is further metabolised to fenbendazole sulfone.

Fenbendazole and its metabolites are distributed throughout the body, but highest concentrations are found in the liver.

The elimination half-life from plasma is about 15 hours after oral administration.

Fenbendazole and its metabolites are predominantly excreted via the faeces.

5. PHARMACEUTICAL PARTICULARS

5.1 Major incompatibilities

None known.

5.2 Shelf life

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

5.3 Special precautions for storage

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

5.4 Nature and composition of immediate packaging

Low density polyethylene/aluminium foil/paper laminated sachet. Sachets contain 1 g, 1.8 g or 4.5 g.

Pack sizes:

Cardboard box containing 100 x 1 g sachets.

Cardboard box containing 3 x 1.8 g sachets.

Cardboard box containing 10 x 3 x 1.8 g sachets.

Cardboard box containing 90 x 1.8 g sachets.

Cardboard box containing 3 x 4.5 g sachets.

Cardboard box containing 10 x 3 x 4.5 g sachets. Cardboard box containing 60 x 4.5 g sachets.

Not all pack sizes may be marketed.

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

Medicines should not be disposed of via wastewater.

The veterinary medicinal product should not enter water courses as fenbendazole may be dangerous for fish and other aquatic organisms.

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.

6. NAME OF THE MARKETING AUTHORISATION HOLDER

Intervet International B.V.

7. MARKETING AUTHORISATION NUMBER

Vm 06376/4075

8. DATE OF FIRST AUTHORISATION

23 January 1998

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

April 2026

10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product not subject to prescription.

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

Gavin Hall

Approved: 28 April 2026