Nelio 5 mg Tablet for Dogs

Excipients:
Qualitative composition of excipients and
other constituents
Pig liver flavourYeastLactose monohydrate Croscarmellose sodiumAnhydrous colloidal silicaHydrogenated castor oilMicrocrystalline cellulose
Clover shaped scored beige tablet, divisible into halves or quarters.
3. CLINICAL INFORMATION
3.1 Target species
Dogs
3.2 Indications for use for each target species
Dogs:
- Treatment of congestive heart failure.
3.3 Contraindications
Do not use in case of hypersensitivity to the active substance or to any of the
excipients.
Do not use in cases of hypotension, hypovolaemia, hyponatraemia or acute renal
failure.
Do not use in cases of cardiac output failure due to aortic or pulmonary stenosis.
Do not use during pregnancy or lactation.
3.4 Special warnings
None.
3.5 Special precautions for use
Special precautions for safe use in the target species:
No evidence of renal toxicity of the veterinary medicinal product has been observed
during clinical trials, however, as is routine in cases of chronic kidney disease, it is
recommended to monitor plasma creatinine, urea and erythrocyte counts during
therapy.
The safety and efficacy of the product has not been examined in dogs weighing
less than 2.5 kg.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Wash hands after use.
In case of accidental oral ingestion, seek medical advice immediately and show the
label or the package leaflet to the physician.
Pregnant women should take special care to avoid accidental oral exposure,
because angiotensin converting enzyme (ACE) inhibitors have been found to affect
the unborn child during pregnancy in humans.
Special precautions for the protection of the environment:
Not applicable.
3.6 Adverse events
Dogs:
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Vomiting
Incoordination
Fatigue
Elevated creatinine
1
Transient
At the start of therapy. A moderate increase in plasma creatinine concentrations
following administration of ACE inhibitors is compatible with the reduction in
glomerular hypertension induced by these agents, and is therefore not necessarily a
reason to stop therapy in the absence of other signs.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
either the marketing authorisation holder or the national competent authority via the
national reporting system. See the package leaflet for respective contact details.
3.7 Use during pregnancy, lactation or lay
Do not use during pregnancy or lactation.
The safety of the product has not been established in breeding, pregnant or
lactating dogs. In dogs benazepril reduced the weight of the ovaries and the ovarian
ducts when given at a daily dose of 10 mg/kg for 52 weeks. Embryotoxic effects
(foetal urinary tract malformation) were seen in trials with laboratory animals (rats)
at maternally nontoxic doses.
3.8 Interaction with other medicinal products and other forms of interaction
In dogs with congestive heart failure, this product has been given in combination with
digoxin, diuretics, pimobendan and anti-arrhythmic veterinary medicinal products
without demonstrable adverse interactions.
In humans, the combination of ACE inhibitors and Non-Steroidal Anti-Inflammatory
Drugs (NSAIDs) can lead to reduced anti-hypertensive efficacy or impaired renal
function. The combination of the product and other anti-hypertensive agents (e.g.
calcium channel blockers, ß-blockers or diuretics), anaesthetics or sedatives may
lead to additive hypotensive effects. Therefore, concurrent use of NSAIDs or other
medications with a hypotensive effect should be considered with care. Renal
function and signs of hypotension (lethargy, weakness etc) should be monitored
closely and treated as necessary.
Interactions with potassium preserving diuretics like spironolactone, triamterene or
amiloride cannot be ruled out. It is recommended to monitor plasma potassium levels
when using the product in combination with a potassium sparing diuretic because of
the risk of hyperkalaemia.
3.9 Administration routes and dosage
The product should be given orally once daily, with or without food. The duration of
treatment is unlimited.
Dogs:
The product should be administered orally at a minimum dose of 0.25 mg
(range 0.25-0.5) benazepril hydrochloride/kg body weight once daily,
according to the following table:
Weight of dog (kg)Standard doseDouble dose2.5-50.25 tablet0.5 tablet>5-100.5 tablet1 tablet>10-150.75 tablet1.5 tablets>15-201 tablet2 tablets
The dose may be doubled, still administered once daily, to a minimum dose of 0.5
mg/kg (range 0.5-1.0), if judged clinically necessary and advised by the veterinary
surgeon.
In case of use of quarters or half tablets: Put the remaining quantity of the tablet
back into the blister pocket and use for the next administration.
The tablets are flavoured and may be taken spontaneously by dogs, but can also be
administered directly into the dog’s mouth or be given with food if necessary.
Instruction on how to divide the tablet: Put the tablet on an even surface, with its
scored side facing down (convex face up). With the tip of the forefinger, exert slight
vertical pressure on the middle of the tablet to break it along its width into halves.
Then, in order to obtain quarters, exert slight pressure on the middle of one half with
the forefinger to break it into two parts.
3.10 Symptoms of overdose (and where applicable, emergency procedures and
antidotes)
The product reduced erythrocyte counts in normal dogs when dosed at 10 mg/kg
body weight once daily for 12 months but this effect was not observed at the
recommended dose during clinical trials in dogs.
Transient reversible hypotension may occur in cases of accidental overdose. Therapy
should consist of intravenous infusion with warm isotonic saline.
3.11 Special restrictions for use and special conditions for use, including
restrictions on the use of antimicrobial and antiparasitic veterinary
medicinal products in order to limit the risk of development of resistance
Not applicable.
3.12 Withdrawal periods
Not applicable
4.