UpCard - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET: 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

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF

THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder and manufacturer responsible for batch release:

Vetoquinol SA

Magny-Vernois

70200 Lure

FRANCE

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

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

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS

Each tablet contains:

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

UpCard 0.75 mg tablets are oblong white to off-white tablets with 1 break-line on each side. The tablets can be divided into equal halves.

UpCard 3 mg, 7.5 mg and 18 mg tablets are oblong white to off-white tablets with 3 break-lines on each side. The tablets can be divided into equal quarters.

• 4. INDICATION(S)

For treatment of clinical signs, including oedema and effusion, related to congestive heart failure.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Do not use in cases of renal failure.

Do not use in cases of severe dehydration, hypovolaemia or hypotension.

Do not use concomitantly with other loop diuretics.

Increase in renal blood parameters and renal insufficiency are very commonly observed during treatment.

As a result of the diuretic action of torasemide, haemoconcentration and, very commonly, polyuria and/or polydipsia are observed.

In case of prolonged treatment, electrolyte deficiency (including hypokalaemia, hypochloraemia, hypomagnesaemia) and dehydration may occur.

Gastrointestinal signs which include emesis, reduced or absent faeces and, in rare cases, soft faeces may be observed. Occurrence of soft faeces is transient, mild, and does not necessitate the withdrawal of the treatment.

Erythema of the inner pinnae may be observed.

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s))

• – common (more than 1 but less than 10 animals in 100 animals treated)

• – uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

• – rare (more than 1 but less than 10 animals in 10,000 animals treated)

• – very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicines has not worked, please inform your veterinary surgeon.

• 7. TARGET SPECIES

Dogs

• 8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Oral use.

The recommended dose of torasemide is 0.1 to 0.6 mg per kg bodyweight, once daily. The dosage should be titrated to maintain patient comfort with attention to renal function and electrolyte status. If the level of diuresis requires alteration, the dose may be increased or decreased within the recommended dose range by increments of 0.1 mg/kg bodyweight. Once signs of congestive heart failure have been controlled and the patient is stable, if long term diuretic therapy with this product is required it should be continued at the lowest effective dose.

Frequent re-examination of the dog will enhance the establishment of an appropriate diuretic dose. The daily schedule of administration can be timed to control the period of micturition according to need.

• 9. ADVICE ON CORRECT ADMINISTRATION

UpCard tablets can be administered with or without food.

• 10. WITHDRAWAL PERIOD(S)

Not applicable.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

This veterinary medicinal product does not require any special storage conditions.

Any part tablet should be stored in the blister pack or in a closed container for a maximum of 7 days.

Do not use this veterinary medicinal product after the expiry date which is stated on the carton. The expiry dates refers to the last day of that month.

• 12. SPECIAL WARNING(S)

Special precautions for use in animals:

In dogs presenting in acute crisis with pulmonary oedema, pleural effusion and/or ascites requiring emergency treatment, the use of injectable drugs should be considered first before commencing oral diuretic therapy.

Renal function, hydration status and serum electrolytes status should be monitored: – at treatment initiation

• – 24 hours to 48 hours after treatment initiation

• – 24 hours to 48 hours after dose change

• – in case of adverse events.

While the animal is on treatment, these parameters should be monitored at very regular intervals according to the benefit-risk assessment performed by the responsible veterinarian (see contraindications and adverse reactions sections).

Torasemide should be used with caution in cases of diabetes mellitus, and in dogs with previously prescribed high doses of an alternative loop diuretic. In dogs with pre-existing electrolyte and/or water imbalance, this should be corrected prior to treatment with torasemide.

Torasemide treatment should not be initiated in dogs already clinically stable on an alternative diuretic for treatment of the signs of congestive heart failure, except where this has been justified taking into account the risk of de-stabilising the clinical condition and of adverse reactions as indicated in section 6.

Special precautions to be taken by the person administering the veterinary medicinal product to animals: People with known hypersensitivity to torasemide or other sulphonamides should administer the veterinary medicinal product with caution.

This product may cause increased urination and/or gastrointestinal disturbances if ingested. Keep tablets in the blister packs until required, and keep the blisters in the outer carton.

In case of accidental ingestion, particularly in the case of children, seek medical advice immediately and show the package leaflet or the label to the physician.

Pregnancy and lactation :

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.

Interaction with other medicinal products and other forms of interaction :

Co-administration of loop diuretics and non-steroidal anti-inflammatory drugs (NSAIDs) can result in a decreased natriuretic response.

Concomitant use with veterinary medicinal products affecting electrolyte balance (corticosteroids, amphotericin B, cardiac glycosides, other diuretics) requires careful monitoring.

Concurrent use of veterinary medicinal products that increase the risk of renal injury or renal insufficiency should be avoided. Concomitant use with aminoglycosides or cephalosporins may increase the risk of nephrotoxicity and ototoxicity.

Torasemide may increase the risk of sulfonamide allergy.

Torasemide can reduce the renal excretion of salicylates, leading to an increased risk of toxicity. Care should be exercised when administering torasemide with other highly plasma protein-bound drugs. Since protein binding facilitates the renal secretion of torasemide, a decrease in binding due to displacement by another drug may be a cause of diuretic resistance.

Concomitant administration of torasemide with other veterinary medicinal products metabolised by cytochrome P450 isoforms such as 3A4 (e.g. enalapril, buprenorphine, doxycycline, cyclosporine) and 2E1 (isoflurane, sevoflurane, theophylline) may decrease their clearance from the systemic circulation.

The effect of antihypertensive medicinal products, especially angiotensin converting enzyme (ACE)-inhibitors, may be potentiated when co-administered with torasemide.

When used in combination with cardiac treatments (e.g. ACE-inhibitors, digoxin), the dose regimen may need to be modified depending upon the animal’s response to therapy.

Overdose (symptoms, emergency procedures, antidotes) :

Doses greater than 0.8 mg/kg/day have not been evaluated in the target animal safety or controlled clinical studies. However, it is anticipated that overdose increases the risk of dehydration, electrolyte imbalance, renal insufficiency, anorexia, weight loss and cardiovascular collapse.

Treatment should be symptomatic.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE

MATERIALS, IF ANY

Medicines should not be disposed of via wastewater or household waste.

Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the

European Medicines Agency

• 15. OTHER INFORMATION