SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of Veterinary Medicinal Product

Pardale-V Oral Tablets

2. Qualitative and Quantitative Composition

Each tablet contains:

Active ingredients

Paracetamol 400.0 mg

Codeine phosphate hemihydrate 9.0 mg

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Tablet.

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

4. Clinical Particulars

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

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

4.3 Contraindications

Do not exceed stated dose or duration of treatment.

Do not administer other NSAIDs concurrently or within 24 hours of each other.

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.

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

NSAIDs can cause inhibition of phagocytosis and hence, in the treatment of inflammatory conditions associated with bacterial infections, appropriate concurrent antimicrobial therapy should be instigated.

i) Special precautions for use in animals

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.

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

Wash hands after use.

iii) Other precautions

None.

4.6 Adverse reactions (frequency and seriousness)

Occasional constipation may occur due to codeine content.

4.7 Use during pregnancy, lactation or lay

There are no known contraindications for use during pregnancy.

4.8 Interaction with other medicinal products and other forms of interaction

Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs to produce an increase in non-bound pharmacologically active concentrations, which can lead to toxic effects.

Concurrent administration of potentially nephrotoxic drugs should be avoided.

4.9 Amounts to be administered and administration route

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.

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

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.

4.11 Withdrawal periods

Not applicable.

5. Pharmacological Particulars

Pharmacotherapeutic group: Analgesics, Other analgesics and antipyretics, Anilides

ATC Vet Code: QN02BE71

5.1 Pharmacodynamic properties

Paracetamol is a para aminophenyl derivative with analgesic properties.

Codeine is an opioid analgesic.

5.2 Pharmacokinetic properties

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.

6. Pharmaceutical Particulars

6.1 List of excipients

Pregelatinised starch

Povidone (30K)

Maize starch

Magnesium stearate

6.2 Incompatibilities

None known.

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

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of 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.

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

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

Dechra Limited

Snaygill Industrial Estate

Keighley Road

Skipton

North Yorkshire

BD23 2RW

United Kingdom

8. MARKETING AUTHORISATION NUMBER

Vm 10434/4034

15 April 1993

January 2016

Approved: 26 January 2016