Select from NVS Healthcare Prednisolone 5 mg Tablets for Dogs and Cats

Composition

Each tablet contains:

Active substance:

5 mg prednisolone

Excipients

7mm round flat uncoated white tablets with score line and marking ‘A620’ on one side and marking ‘5’ on the other side.

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Pharmacological properties

4.1 ATCvet code: QH02AB06

4.2 Pharmacodynamics

Prednisolone is a synthetic corticosteroid anti-inflammatory drug belonging to the glucocorticoid family. The main effects of prednisolone are the same as those of glucocorticoids:

Anti-inflammatory action:

The anti-inflammatory properties of prednisolone are expressed at a low dose and are explained by:

- the inhibition of phospholipase A2, which reduces the synthesis of arachidonic acid, a precursor of many proinflammatory metabolites. Arachidonic acid is released from the phospholipid component of the cell membrane by the action of phospholipase A2.

The corticosteroids indirectly inhibit this enzyme by inducing the endogenous synthesis of polypeptides, lipocortins, which have an anti-phospholipase action;

- by a membrane stabilising effect, particularly in relation to lysosomes, thus preventing enzymes from being released outside the lysosomal compartment.

Immunosuppressive action:

The immunosuppressive properties of prednisolone are expressed at a higher dose on both the macrophages (slower phagocytosis, decreased flow to inflammatory foci) and the neutrophils and lymphocytes. Administration of prednisolone reduces the production of antibodies and inhibits several complement components.

Antiallergic action:

Like all corticosteroids, prednisolone inhibits the release of histamine by mast cells. Prednisolone is active in all manifestations of allergy as a complement to the specific treatment.

4.3 Pharmacokinetics

Prednisolone is readily absorbed from the gastro-intestinal tract. Peak plasma concentrations are reached 0.5 to 1.5 hours after administration, with a plasma half- life of between 3 and 5 hours. It is distributed to all tissues and body fluids, even in the cerebrospinal fluid. It is extensively bound to plasma proteins, is metabolized in the liver and primarily excreted via the kidneys. It is excreted in the urine as free and conjugated metabolites and parent compound. It has a biological half-life of several hours, making it suitable for alternate-day therapy.

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Target species

Dogs and cats

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Indications

For the symptomatic treatment or as adjunct treatment of inflammatory and immune- mediated diseases in dogs and cats.

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Dosage

Oral use

The dose and total duration of treatment, among the authorized posology range, is determined by the veterinarian per individual case depending on the severity of symptoms. The lowest effective dose must be used. To ensure a correct dosage, body weight should be determined as accurately as possible. The break line can be used to divide tablets into equal doses. Check the tablet - look for a score line (a groove indicating where the tablet can be split).

Hold the tablet between your thumbs and forefingers with the scoreline towards you. Apply gentle, even pressure along the score line until it splits the tablet in two.

Starting dose: 0.5 - 2.0 mg per kg bodyweight once per day.

Administration for one to three weeks at the above dosage levels may be required. For longer term treatment: when after a period of daily dosing the desired effect has been achieved, the dose should be reduced until the lowest effective dose is reached. The reduction of the dose should be made by alternate day therapy and /or by halving the dose with intervals of 5-7 days until the lowest effective dose is reached.

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Contraindications

Do not use in animals with:

- Viral, mycotic or parasitic infections that are not controlled with an appropriate treatment

- Diabetes mellitus

- Hyperadrenocorticism

- Osteoporosis

- Heart failure

- Renal insufficiency

- Corneal ulceration

- Gastro-intestinal ulceration

- Glaucoma

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

See also sections 3.7 and 3.8.

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Adverse reactions

Target species: Dogs and Cats

Very common (>1 animal / 10 animals treated): Panting, Polyuria, polydipsia, polyphagia¹, Elevated triglyceride², hypocortisolaemia³

Common (1 to 10 animals / 100 animals treated): Vomiting, Diarrhoea; Opportunistic infection, delayed healing⁴

Uncommon (1 to 10 animals / 1 000 animals treated): Behavioural disorder (aggression, restlessness)

Rare (1 to 10 animals / 10 000 animals treated): Hyperadrenocorticism (iatrogenic), Cushing’s disease (iatrogenic), Diabetes mellitus; Hepatomegaly, elevated liver enzymes, elevated serum alkaline phosphatase (ALP), eosinopenia, lymphopenia, neutrophilia; Muscle wasting; Skin thinning, alopecia; Gastrointestinal ulceration⁵

Very rare (<1 animal / 10 000 animals treated, including isolated reports): Anaphylactic or hypersensitivity reactions, Pancreatitis

Undetermined frequency (cannot be estimated from available data): Elevated parathyroid (PTH) concentration, low thyroxine (T4), decreased lactate dehydrogenase (LDH), decreased aspartate aminotransferase (AST), hyperalbuminaemia, hypernatraemia, hypokalaemia⁶; Muscle weakness, osteoporosis, inhibition of longitudinal growth of bones; Increased weight, water retention, redistribution of body fat; Calcinosis cutis

¹ After systemic administration and particularly during the early stages of therapy.

² The significant increase in triglycerides noticed can be a part of possible iatrogenic hyperadrenocorticism (Cushing’s disease) involving significant alteration of fat, carbohydrate, protein and mineral metabolism.

³ The significant dose related cortisol suppression noticed during therapy is a result of effective doses suppressing the hypothalamic-pituitary-adrenal-axis. Following cessation of treatment, signs of adrenal insufficiency can arise and this may render the animal unable to deal adequately with stressful situations.

⁴ Corticosteroid use may delay wound healing and the immunosuppressant actions may weaken resistance to or exacerbate existing infections.

⁵ May be exacerbated by steroids in animals given non-steroidal anti-inflammatory drugs and in animals with spinal cord trauma.

⁶ With long term use.

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.

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Warnings

Special precautions for safe use in the target species:

In cases where a bacterial infection is present the product should be used in association with suitable antibacterial therapy. Pharmacologically-active dose levels may result in adrenal insufficiency. This may become apparent particularly after withdrawal of corticosteroid treatment. The treatment should not be suddenly withdrawn. This effect may be minimised by institution of alternate-day therapy if practical. The dosage should be reduced and withdrawn gradually to avoid precipitation of adrenal insufficiency. Corticoids such as prednisolone, exacerbate protein catabolism. Consequently, the product should be carefully administered in old or malnourished animals. Corticoids such as prednisolone should be used with caution in patients with hypertension, epilepsy, burns, previous steroid myopathy, in immunocompromised animals and in young animals as corticosteroids may induce a delayed growth. Treatment with the veterinary medicinal product may interfere with vaccination efficacy. (See section 3.8)

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

Prednisolone or other corticosteroids may cause hypersensitivity (allergic reactions). People with known hypersensitivity to prednisolone or other corticosteroids, should avoid contact with the veterinary medicinal product.

Prednisolone may lead to gastrointestinal effects (nausea, vomiting, diarrhoea), headache, and/or hyperactivity if accidentally ingested, particularly in children. To avoid accidental ingestion, particularly by a child, unused tablets and unused half- tablets should be returned to the container.

In case of accidental ingestion, especially by a child, seek medical advice immediately and show the package leaflet or the label to the physician.

Corticosteroids can cause foetal malformations. Pregnant women should avoid contact with the veterinary medicinal product.

Immediately wash hands thoroughly after handling the tablets.

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.

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Use during pregnancy, lactation or lay

Pregnancy and lactation Do not use during pregnancy. Laboratory studies have shown evidence of foetal abnormalities during early pregnancy and abortion or early parturition during the later stages of pregnancy.

Glucocorticoids are excreted in the milk and may result in growth impairment in suckling young animals. Use only according to the benefit-risk assessment by the responsible veterinarian in lactating bitches and queens.

Fertility The safety of the veterinary medicinal product has not been established in males intended for breeding.

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Interactions

Phenytoin, barbiturates, ephedrine and rifampicin may accelerate the metabolic clearance of corticosteroids resulting in decreased blood levels and reduced physiological effect.

The concomitant use of this veterinary medicinal product with non-steroidal anti- inflammatory drugs may exacerbate gastrointestinal tract ulceration.

Administration of prednisolone may induce hypokalaemia and hence increase the risk of toxicity from cardiac glycosides. The risk of hypokalaemia may be increased if prednisolone is administered together with potassium depleting diuretics.

Precautions need to be taken when combining use with insulin.

Treatment with the veterinary medicinal product may interfere with vaccination efficacy. When vaccinating with attenuated live vaccines, a two week interval should be observed before or after treatment. Do not use concomitantly with attenuated live vaccines.

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Overdose

An overdose will not cause other effects than those stated in section 3.6. There is no specific antidote. Signs of overdosage should be treated symptomatically.

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Special warnings

Glucocorticoids can produce symptomatic improvements without treating the underlying disease. Where appropriate, use of the product should be combined with treatment of the underlying disease and/or management of the affected animal’s environment.

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Withdrawal period

Not applicable.

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Incompatibilities

Not applicable

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Immediate packaging

Cardboard box containing a white 100 ml PE bottle with a white PP twist-off cap and 3g desiccant.

Pack size: Single bottle containing 500 tablets

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Storage

This product does not require any special temperature storage conditions. Store in the original container in order to protect from light.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 24 months

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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.

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Additional information

Vm 42153/5009

8 DATE OF FIRST AUTHORISATION

12 August 2026

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

August 2026

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

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

Gavin Hall Approved: 25 August 2026

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Registration holder

Accord Healthcare B.V

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