Prednicare 5 mg Tablets

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Prednisolone

Available from:

Animalcare Ltd

ATC code:

QH02AB06

INN (International Name):

Prednisolone

Pharmaceutical form:

Tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Dogs

Therapeutic area:

Anti Inflammatory corticosteroid

Authorization status:

Authorized

Authorization date:

1997-12-22

Summary of Product characteristics

Revised: April 2020
AN: 01167/2019
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Prednicare 5 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Prednisolone 5mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
A white, biconvex tablet
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and Cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
As an anti-inflammatory and anti-allergic agent for use in dogs and
cats.
4.3
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

Severe renal insufficiency

Corneal ulceration
Revised: April 2020
AN: 01167/2019
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
Gastro-intestinal ulceration

Glaucoma
Do not use concomitantly with attenuated live vaccines.
Do not use during pregnancy (see section 4.7).
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
See also section 4.8.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Dosing should coincide with the endogenous cortisol peak (i.e., in the
morning
with regard to dogs and in the evening with regard to cats).
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Caution is necessary when prescribing corticosteroids in animals with
the
following conditions: epilepsy; hypertension; or previous steroid
myopathy.
Anti-inflammatory steroids, such as prednisolone, are known to exert a
wide
range of side-effects. Whilst single high doses are generally well
tolerated, they
may induce severe side-effects in long-term use and when esters
possessing a
long duration of action are administered. Dosage in medium to long
term should
therefore generally be kept to the minimum necessary to control
symptoms.
Consideration should therefore be given to means of minimising
problems of
adrenal insufficiency followi