UPCARD 3MG 100 TABLETS | FOR THE TREATMENT OF CONGESTIVE HEART FAILURE

3. PHARMACEUTICAL FORM
pills.
UpCard 0,75 mg tablets: white to off-white oblong tablets with a
groove on each face. The tablets can be divided into equal halves.
UpCard 3 mg, 7,5 mg and 18 mg tablets: white to off-white oblong tablets
with 3 grooves on each side. The tablets can be divided into equal thirds.

4. CLINICAL DATA
4.1 Target species
Dogs

4.2 Indications for use, specifying the target species
For the treatment of clinical signs, including edema and effusion, associated with congestive heart failure.

4.3 Contraindications
Do not use in cases of renal failure.
Do not use in case of severe dehydration, hypovolemia or hypertension.
Do not use concomitantly with other loop diuretics.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.

4.4 Special warnings for each target species
None.

4.5 Special precautions for use
Special precautions for use in animals

In dogs presenting with acute crisis with pulmonary edema, pleural effusion, and/or ascites requiring emergency treatment, the use of injectable medications should be considered prior to initiation of oral diuretic therapy.

Renal function, hydration status, and serum electrolytes should be monitored:
– At the start of treatment
– From 24 hours to 48 hours after the start of treatment
– From 24 hours to 48 hours after the dose change
– In case of adverse reactions
While the animal is being treated, these parameters will be monitored at very regular intervals in accordance with the benefit-risk assessment carried out by the responsible veterinarian. Torasemide should be used with caution in cases of diabetes mellitus, and in dogs in which
previously prescribed high doses of an alternative loop diuretic. In dogs with pre-existing electrolyte and/or water imbalance, this situation should be corrected prior to treatment with Torasemide.
Torasemide treatment should not be initiated in already clinically stable dogs with an alternative diuretic for the treatment of signs of congestive heart failure, except when justified and taking into account the risk of destabilizing the clinical situation and causing adverse reactions as indicated. in section 4.6.

4.6 Adverse reactions (frequency and seriousness)
During treatment, an increase in renal blood parameters and renal failure have been observed very frequently.
As a result of the diuretic action of torsemide, hemoconcentration and very frequently polyuria and/or polydipsia are observed.
In case of prolonged treatment, electrolyte deficiency (including hypokalemia, hypochloremia, hypomagnesemia) and dehydration may occur.
Gastrointestinal signs including vomiting, decreased or absent stools, and rarely loose stools may be seen. The appearance of loose stools is transient, mild and does not require withdrawal of treatment.

Erythema can be seen on the inner auricle.
The frequency of adverse reactions should be classified according to the following groups:
– Very frequently (more than 1 animal in 10 presents adverse reactions during a treatment)
– Frequently (more than 1 but less than 10 animals per 100)
– Infrequently (more than 1 but less than 10 animals per 1.000)
– Rarely (more than 1 but less than 10 animals per 10.000)
– Very rarely (less than 1 animal per 10.000, including isolated cases).

4.7 Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy or lactation.
The use of UpCard is not recommended during pregnancy, lactation and in breeding animals.

UpCard 0,75 mg tablets for dogs
UpCard 3 mg tablets for dogs
UpCard 7,5 mg tablets for dogs
UpCard 18 mg tablets for dogs