Pardale-V 400 mg/9 mg Tablets

Composition

Each tablet contains:

Active substances:

Paracetamol 400.0 mg

Codeine phosphate hemihydrate 9.0 mg

Excipients:

Qualitative composition of excipients and other constituents

Pregelatinised starch

Povidone (30K)

Maize starch

Magnesium stearate

White, flat tablets with a bevelled edge and a break-line.

3

Pharmacological properties

4.1 ATCvet code:

QN02BE71

4.2 Pharmacodynamics

Paracetamol is a para aminophenyl derivative with analgesic properties.

Codeine is an opioid analgesic.

4.3 Pharmacokinetics

Both paracetamol and codeine are readily absorbed from the gastrointestinal tract. They are metabolised in the liver (codeine to morphine and narcodeine).

Codeine and its metabolites are excreted almost entirely by the kidney, whilst less than 5 % of paracetamol is excreted unchanged.

3

Target species

Dogs.

3

Indications

For analgesic therapy in dogs only. The veterinary medicinal product is indicated for acute pain of traumatic origin, as a complementary treatment in pain associated with other conditions, and post operative analgesia.

3

Dosage

For oral administration - 1 tablet/12 kg bodyweight every 8 hours.

Small dogs (up to 6 kg bodyweight): ½ tablet every 8 hours

Medium dogs (6 – 18 kg bodyweight): ½ - 1½ tablets every 8 hours

Large dogs (18 - 42 kg bodyweight): 1½ - 3½ tablets every 8 hours

Treat for a maximum of 5 days.

3

Contraindications

Do not exceed stated dose or duration of treatment.

Use is contraindicated in animals suffering from cardiac, hepatic or renal disease, where there is a possibility of gastrointestinal ulceration or bleeding, or where there is evidence of a blood dyscrasia or hypersensitivity to the product.

Do not use this product for cats.

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

3

Adverse reactions

Dogs:

Very rare (<1 animal / 10,000 animals treated, including isolated reports): Constipationa, Vomitingb, Diarrhoeab, Lethargy, Anorexia

a Due to codeine content.

b Transient.

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

Warnings

Special precautions for safe use in the target species:

Use in animals less than 6 weeks of age or in aged animals may involve additional risk. If such use cannot be avoided, animals may require a reduced dosage and careful clinical management.

Avoid use in dehydrated, hypovolaemic or hypotensive animals, as there is a potential risk of increased renal toxicity.

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

This product may cause hypersensitivity (allergic) reactions in some people.

People with known hypersensitivity to codeine, paracetamol, or povidone should handle the product with care.

Allergic reaction to these substances may occasionally be serious. Do not handle this product if you know you are sensitive. If you develop symptoms following exposure, such as a skin rash, you should seek medical advice and show the physician this warning.

Accidental ingestion by children may lead to constipation, nausea, light-headedness, and/or sedation. Take care not to leave tablets within children’s reach while preparing to administer the product. In case of accidental ingestion, particularly by a child, seek medical advice and show the physician this warning.

Return any unused whole or half tablets to the packaging provided and store out of the sight and reach of children.

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:

There are no known contraindications for use during pregnancy.

3

Interactions

Concurrent administration of potentially nephrotoxic drugs should be avoided

3

Overdose

Immediately seek the advice of a veterinary surgeon and show him/her the product literature.

Carry out lavage and treat with intravenous injection of acetylcysteine (200 mg/ml) at a rate of 140 mg/kg every 6 hours for 7 treatments. Ascorbic acid (30 mg/kg) should also be given orally with each dose of acetylcysteine.

If necessary instigate fluid therapy using Ringers or bicarbonate solution.

Treat for codeine overdose with injection of Naloxone (1.0 mg/kg) repeated as necessary.

Provide oxygen support.

3

Special warnings

Seek veterinary advice if the treated condition does not improve or worsens during treatment, or if any side-effects or adverse reactions are experienced.

3

Withdrawal period

Not applicable.

3

Incompatibilities

Not applicable.

3

Immediate packaging

Polypropylene container with a low density polyethylene tamper evident lid, containing 100 or 500 plain white, flat tablets with bevelled edges and a break line on one side and DPL on the other.

Not all pack sizes may be marketed.

3

Storage

Do not store above 25 °C.

3

Shelf life

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

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

Vm 50406/5027

Vm 50406/3022

8 DATE OF FIRST AUTHORISATION

15 April 1993

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

October 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 09 December 2025

3

Registration holder

Dechra Regulatory B.V.

3