Prilenal 1 mg, Tablets

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Enalapril Maleate

Available from:

Ceva Animal Health Ltd

ATC code:

QC09AA02

INN (International Name):

Enalapril Maleate

Pharmaceutical form:

Tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Cardio Vascular ACE inhibitor

Authorization status:

Expired

Authorization date:

2005-09-28

Summary of Product characteristics

Revised: October 2022
AN: 01731/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
PRILENAL 1 mg, tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
ACTIVE SUBSTANCE:
Enalapril maleate
1 mg
(Which corresponds to 0.764 mg of enalapril base)
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Brown spotted white round tablet.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment
of
mild,
moderate
or
severe
congestive
heart
failure,
caused
by
mitral
regurgitation
or
dilated
cardiomyopathy,
as
an
adjunctive
therapy
with
diuretics
(furosemide, whether associated or not with digoxin).
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to enalapril or to any of the
excipients.
Do not use in dogs with evidence of cardiac output failure (e.g.
aortic stenosis, mitral
stenosis, obstructive cardiomyopathy).
See section 4.7.
4.4
SPECIAL WARNINGS
Pre renal azotemia generally results from hypotension due to
cardio-vascular insufficiency.
Substances that deplete blood volume, such as diuretics, or with a
vasodilator effect, such
as ACE inhibitors, may contribute to lowering systemic blood pressure.
Revised: October 2022
AN: 01731/2022
Page 2 of 5
This may create a hypotensive state or exacerbate an existing
hypotensive situation and
result in pre renal azotemia.
Dogs with no detectable renal disease may develop mild and transient
increases in blood
urea nitrogen or serum creatinine when the product is administered
concomitantly with a
diuretic.
The diuretic and/or enalapril dose should be reduced if clinical signs
of hypotension or
azotemia appear or if the blood concentration of urea nitrogen and/or
creatinine increases
significantly above the values observed before treatment.
Should clinical signs of overdose occur (azotemia) after the dose is
increased from once
daily to twice daily, the dose should be decreased to once daily.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIA