Prilactone Next 100 mg chewable tablets for dogs

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Spironolactone

Saatavilla:

Ceva Santé Animale

ATC-koodi:

QC03DA01

INN (Kansainvälinen yleisnimi):

Spironolactone

Annos:

100 mg/tablet

Lääkemuoto:

Chewable tablet

Prescription tyyppi:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeuttinen ryhmä:

Dogs

Terapeuttinen alue:

spironolactone

Käyttöaiheet:

Neurological Preparations

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2016-04-22

Valmisteyhteenveto

Health Products Regulatory Authority
06 May 2021
CRN009XNY
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Prilactone Next 100 mg chewable tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains
ACTIVE SUBSTANCE:
Spironolactone
.......................................................... 100 mg
EXCIPIENT(S):
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet.
Clover-shaped scored beige tablet. The tablet can be divided into four
equal parts.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For use in combination with standard therapy (including diuretic
support, where necessary) for the treatment of congestive
heart failure caused by degenerative mitral valve disease in dogs.
4.3 CONTRAINDICATIONS
Do not use in animals used for or intended for use in breeding.
Do not use in dogs suffering from hypoadrenocorticism, hyperkalaemia
or hyponatraemia.
Do not administer spironolactone in conjunction with NSAIDs to dogs
with renal insufficiency.
Do not use in cases of hypersensitivity to spironolactone or any of
the excipients.
See section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Kidney function and plasma potassium levels should be evaluated before
initiating combined treatment with spironolactone
and ACE inhibitors. Unlike in humans, an increased incidence of
hyperkalaemia was not observed in clinical trials performed in
dogs with this combination. However, in dogs with renal impairment,
regular monitoring of renal function and plasma
potassium levels is recommended as there may be an increased risk of
hyperkalaemia.
Dogs treated concomitantly with spironolactone and NSAIDs should be
correctly hydrated. Monitoring of their renal function
and plasma potassium levels is recommended before initiation and
during treatment with combined therapy (see 4.3).
As spironolactone has an antiand