Carporal 160 mg Tablets for Dogs

Composition

Each tablet contains:

Active substance:

Carprofen 160 mg

Excipient(s):

For the full list of excipients, see section 6.1.

6.1 List of excipients

Lactose Monohydrate

Sodium Starch Glycolate (Type A)

Maize Starch

Talc

Cellulose, powdered

Starch, pregelatinised

Silica, colloidal anhydrous

Calcium Behenate

Yeast, deactivated

Artificial beef flavour

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Pharmaceutical form

Tablet.

Light brown with brown spots, round and convex flavoured tablet with a cross-shaped break line on one side.

Tablets can be divided into 2 or 4 equal parts.

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Pharmacological properties

Pharmacotherapeutic group: Anti inflammatory and antirheumatic products, non- steroids. Propionic acid derivatives, Carprofen.

ATC Vet Code: QM01AE91

5.1 Pharmacodynamic properties

Carprofen is NSAID. It is derived from phenylpropionic acid and belongs to the 2- arylpropionic acid class of NSAIDs. It contains a chiral center at the C2 of the propionic half and therefore exists in two stereo isomeric forms, the (+)-S and (-)-R enantiomers. In dogs there is no chiral inversion between the enantiomers in-vivo.

Carprofen possesses anti-inflammatory, analgesic and antipyretic activity. Like most other NSAID’s, carprofen is an inhibitor of the enzyme cyclo-oxygenase of the arachidonic acid cascade.

However, the inhibition of prostaglandin synthesis by carprofen is slight in relation to its anti-inflammatory and analgesic potency. The precise mode of action of carprofen is not clear.

5.2 Pharmacokinetic particulars

In dogs the absorption of carprofen is rapid (Tmax =2.0 h) after oral administration. Cmax is 28.67 µg/ml. The volume of distribution is small and carprofen is highly bound to plasma proteins. The biotransformation of carprofen takes place in the liver the ester glucuronide and two 1-O-acyl-β-D-glucuronide diastereoisomers are formed. These are secreted into the bile duct and excreted in the faeces.

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Target species

Dogs.

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Indications

Reduction of inflammation and pain caused by musculoskeletal disorders and degenerative joint disease. As a follow up to parenteral analgesia in the management of post-operative pain.

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Dosage

Oral use.

To ensure a correct dosage body weight should be determined as accurately as possible to avoid overdosing.

Dosage 2-4 mg carprofen per kg bodyweight per day.

For reduction of inflammation and pain caused by musculoskeletal disorders and degenerative joint disease: an initial dose of 4 mg carprofen per kg bodyweight per day given as a single daily dose or in two equally divided doses may, subject to clinical response, be reduced to 2 mg carprofen/kg bodyweight/day given as a single dose. Duration of treatment depends on the response observed in the patient. For treatment beyond 14 days the dog should be regularly examined by a veterinarian. Do not exceed the recommended dosage.

To extend analgesic and anti-inflammatory cover post-operatively, parenteral preoperative treatment with an injectable carprofen veterinary medicinal product may be followed by carprofen tablets at 4 mg/kg bw/day for up to 5 days.

The following table is intended as a guide to dispensing the veterinary medicinal product at the dose rate of 4 mg per kg bodyweight per day.

Number of tablets for a dose rate of 4 mg/kg bw

Table key (pictograms in the PDF): ¼ = ¼ Tablet, ½ = ½ Tablet, ¾ = ¾ Tablet, 1 = 1 Tablet. Each pictogram of the PDF is written here as the fraction it stands for; "+" separates the pictograms in one cell; the two cells under Twice daily are the two daily doses.

Tablets can be divided into 2 or 4 equal parts to ensure accurate dosing. Place the tablet on a flat surface, with its scored side facing up and the convex (rounded) side facing the surface.

Halves: press down with your thumbs on both sides of the tablet.

Quarters: press down with your thumb in the middle of the tablet.

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Contraindications

Do not use in cats.

Do not use in pregnant or lactating bitches.

Do not use in dogs less than 4 months of age.

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

Do not use in dogs 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.

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Adverse reactions

Dogs:

Rare (1 to 10 animals / 10,000 animals treated): Renal disorder, Hepatic disorder b

Very Rare (<1 animal / 10,000 animals treated, including isolated reports): Vomitinga, Loose Stoola, Diarrhoeaa, Blood in faecesa, Lethargya, Appetite Lossa

a These adverse reactions occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.

b Idiosyncratic effect

If adverse reactions occur, use of the veterinary medicinal product should be stopped and the advice of a veterinarian should be sought.

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.

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Warnings

Special precautions for use in animals Use in aged dogs may involve additional risk.

If such a use cannot be avoided, dogs may require careful clinical management. Avoid use in any dehydrated, hypovolaemic or hypotensive dog, as there is a potential risk of increased renal toxicity.

NSAIDs (non-steroidal anti-inflammatory drugs) can cause inhibition of phagocytosis and hence in the treatment of inflammatory conditions associated with bacterial infection, appropriate concurrent antimicrobial therapy should be instigated. The tablets are flavoured. In order to avoid any accidental ingestion, store tablets out of reach of the animals.

See section 4.8.

Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Wash hands after handling the product.

Special precautions for the protection of the environment Not applicable.

Other Precautions Not applicable.

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Use during pregnancy, lactation or lay

Laboratory studies in rats and rabbits have shown evidence of foetotoxic effects of carprofen at doses close to the therapeutic dose. The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

See section 4.3.

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Interactions

Do not administer other NSAIDs and glucocorticoids concurrently or within 24 hours of administration of the veterinary medicinal product. Carprofen is highly bound to plasma proteins and may compete with other highly bound drugs, which can lead to toxic effects.

Concurrent administration of potential nephrotoxic drugs should be avoided.

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Overdose

No signs of toxicity appeared when dogs were treated with carprofen at levels up to 6 mg/kg bw twice daily for 7 days (3 times the highest recommended dose rate of 4 mg/kg bw) and 6 mg/kg bw once daily for a further 7 days (1.5 times the highest recommended dose rate of 4 mg/kg bw).

There is no specific antidote for carprofen overdose but general supportive therapy, as applied to clinical overdose with NSAIDs should be applied.

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Special warnings

None.

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Withdrawal period

Not applicable.

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Incompatibilities

Not applicable.

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Immediate packaging

Aluminium - PA/ALU/PVC blister Cardboard box of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 25 or 50 blisters of 10 tablets Not all pack sizes may be marketed.

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Storage

Any unused tablet portions should be returned to the open blister in order to protect from light.

The unopened blister does not require any special storage condition.

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Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years. A divided tablet should be used within 3 days.

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Disposal of unused product

Medicines should not be disposed of via wastewater.

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

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Additional information

Vm 41821/5010

9 DATE OF FIRST AUTHORISATION

05 August 2015

10 DATE OF REVISION OF THE TEXT

February 2024

11 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

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

Veterinary medicinal product subject to prescription.

Approved: 27 December 2024

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Registration holder

Le Vet. Beheer B.V.

Wilgenweg 7

3421 TV Oudewater

The Netherlands

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