Prilactone Next 10 mg Chewable Tablets for Dogs

None

Special precautions for safe use in the target species:
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 3.3).
As spironolactone has an antiandrogenic effect, it is not recommended to administer
the product to growing dogs.
As spironolactone undergoes extensive hepatic biotransformation, care should be
taken when using the product to treat dogs with hepatic dysfunction.
The chewable tablets are flavoured. In order to avoid accidental ingestion, store
these tablets out of the reach of animals.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
The product may cause skin sensitisation. Persons known to be allergic to
spironolactone or other components of the final formulation should not handle this
product.
Handle this product with great care to avoid unnecessary exposure, taking all
recommended precautions.
Wash hands after use.
If you develop symptoms following exposure such as a skin rash, you should seek
medical advice and show the doctor this warning. Swelling of the face, lips or eyes or
difficulty with breathing are more serious symptoms and require urgent medical
attention.
In case of accidental ingestion, seek medical advice immediately and show the
package leaflet or the label to the physician.
Special precautions for the protection of the environment:
Not applicable.