Spironolactone Ceva

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

spironolactone

Available from:

Ceva Santé Animale

ATC code:

QC03DA01

INN (International Name):

spironolactone

Therapeutic group:

Dogs

Therapeutic area:

Diuretics

Therapeutic indications:

For use in combination with standard therapy (including diuretic support, where necessary) for the treatment of congestive heart failure caused by valvular regurgitation in dogs.

Product summary:

Revision: 7

Authorization status:

Withdrawn

Authorization date:

2007-06-20

Patient Information leaflet

22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET
Spironolactone Ceva 10 mg tablets for dogs
Spironolactone Ceva 40 mg tablets for dogs
Spironolactone Ceva 80 mg tablets for dogs
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
Ceva Santé Animale
10, av. de La Ballastière
33500 Libourne
France
Tel: + 33 (0) 5 57 55 40 40
Fax : + 33 (0) 5 57 55 41 98
Manufacturers for batch release:
Ceva Santé Animale
Z.I. Très le Bois
22600 Loudéac
France
Catalent Germany
Schorndorf GmbH
Steinbeistrasse 2
D-73614 Schorndorf
Germany
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Spironolactone Ceva 10 mg tablets for dogs
Spironolactone Ceva 40 mg tablets for dogs
Spironolactone Ceva 80 mg tablets for dogs
Spironolactone
3.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT
Spironolactone Ceva 10 mg contains 10 mg spironolactone
Spironolactone Ceva 40 mg contains 40 mg spironolactone
Spironolactone Ceva 80 mg contains 80 mg spironolactone
4.
INDICATION
Spironolactone Ceva tablets are used in combination with standard
therapy (including diuretic support,
where necessary) for the treatment of congestive heart failure caused
by valvular regurgitation in dogs.
24
5.
CONTRAINDICATIONS
Do not use in dogs suffering from hypoadrenocorticism, hyperkalaemia
or hyponatraemia.
Do not use in conjunction with Non-Steroidal Anti-Inflammatory Drugs
(NSAIDs) in dogs with renal
insufficiency (kidney impairment/dysfunction).
Do not use during pregnancy or lactation.
Do not use in animals used for, or intended for use in breeding.
6.
ADVERSE REACTIONS
A reversible prostatic atrophy (reduction in size) is often observed
in entire male dogs.
If you notice any serious effects or other effects not mentioned in
this leaflet, please inform your
veterinary surgeon.
7.
TARGET SPECIES
Dogs.
8.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Oral use.
Administer 2 mg/kg of body weight of spironolactone once daily.
NUMBER

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Spironolactone Ceva 10 mg tablets for dogs
Spironolactone Ceva 40 mg tablets for dogs
Spironolactone Ceva 80 mg tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:_ _
Spironolactone Ceva 10 mg contains 10 mg spironolactone
Spironolactone Ceva 40 mg contains 40 mg spironolactone
Spironolactone Ceva 80 mg contains 80 mg spironolactone
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Spironolactone Ceva 10 mg : Brown bisected oval tablet of 10 mm
length.
Spironolactone Ceva 40 mg : Brown bisected oval tablet of 17 mm length
Spironolactone Ceva 80 mg : Brown quadrisected oval tablet of 20 mm
length
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 valvular regurgitation
in dogs.
4.3
CONTRAINDICATIONS
Do not use in dogs suffering from hypoadrenocorticism, hyperkalaemia
or hyponatraemia.
Do not use in conjunction with Non-Steroidal Anti-Inflammatory Drugs
(NSAIDs) in dogs with renal
insufficiency (kidney impairment/dysfunction).
Do not use during pregnancy or lactation.
Do not use in animals used for, or intended for use in breeding.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Kidney function and serum potassium levels should be evaluated before
initiating combined treatment
with spironolactone and Angiotensin Converting Enzyme (ACE)
inhibitors. Unlike in humans, an
increased incidence of hyperkalaemia was not observed in clinical
trials performed in dogs with this
3
combination. However, in dogs with renal impairment regular monitoring
of renal function and serum
potassium levels is recommended as there may be an increased risk of
hyperkalaemia.
Dogs treated concomitantly with spironolactone and NSAI