Vetmedin Chew: Product Information

VETMEDIN CHEW- pimobendan tablet, chewable
Boehringer Ingelheim Animal Health USA Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Client Information Sheet

Client Information Sheet for Vetmedin® Chew (pimobendan)

Replacement product for Vetmedin® (pimobendan) chewable tablets

Contact your Veterinarian BEFORE administering this product to your dog.

This Client Information Sheet contains important information about VETMEDIN CHEW, a product used as a temporary replacement for US FDA-approved VETMEDIN chewable tablets.

VETMEDIN CHEW is authorized for marketing in the United Kingdom and Ireland to treat congestive heart failure in dogs. You should read this information before you start giving VETMEDIN CHEW and review it each time the prescription is refilled as there may be new information.

This information sheet is provided only as a summary and does not take the place of instructions from your veterinarian. If you have received this product from a pharmacy and not directly from your veterinarian, you should contact your veterinarian to inform them that you have received this replacement product. Talk with your veterinarian if you do not understand any of this information or if you want to know more about VETMEDIN CHEW.

Note to prescribing veterinarians

The dose administered should be as stated in the FDA approved VETMEDIN chewable tablets package insert, accessible at: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5441e5b2-cdc0-477a-bd9a-ec5f8d912281

Why did I receive VETMEDIN CHEW?

Because of a shortage in the supply of the FDA-approved VETMEDIN chewable tablets, the FDA is allowing temporary use of VETMEDIN CHEW in the United States.

Is VETMEDIN CHEW the same as VETMEDIN chewable tablets?

The active ingredient in VETMEDIN CHEW is pimobendan, just like in Vetmedin chewable tablets, the US-approved product.
Both VETMEDIN CHEW and VETMEDIN chewable tablets are brownish, oval tablets that are scored in half so that the tablet can be divided in two equal parts.
Both VETMEDIN CHEW and VETMEDIN chewable tablets manage the signs of congestive heart failure.
You will notice the instructions for use in the VETMEDIN CHEW packaging to be slightly different than the instructions for the VETMEDIN chewable tablets. However, both VETMEDIN CHEW and VETMEDIN chewable tablets contain the same amount of pimobendan and the dose should be same.

Talk to your veterinarian if you have any questions about your dog’s congestive heart failure and the use of VETMEDIN CHEW.

Are there differences between VETMEDIN CHEW and VETMEDIN chewable tablets?

Size – the VETMEDIN CHEW is smaller, about half the size of the FDA approved VETMEDIN chewable tablet.
Strength — VETMEDIN CHEW is not available in 2.5 mg strength. The number and strength of VETMEDIN CHEW administered may be different than for VETMEDIN chewable tablets.
Inactive ingredients – some of the additional ingredients that make up or hold the tablets together are different between the two.
Packaging – VETMEDIN CHEW is packaged in cardboard boxes containing blister cards with 10 individually sealed tablets per card. VETMEDIN chewable tablets are packaged in bottles.

How do I give VETMEDIN CHEW to my dog?

VETMEDIN CHEW should be given to your dog in their mouth (orally) twice a day, about 12 hours apart as directed by your veterinarian. VETMEDIN CHEW should be given about 1 hour before feeding. If you have any questions about administration, please contact your veterinarian.

If a tablet is divided and only a half tablet is given to your dog, the remaining half should be returned to the open blister pocket and placed back in the cardboard box for storage. The remaining half tablet should be used within 3 days after opening the blister.

If your dog vomits after being given VETMEDIN CHEW, please contact your veterinarian and unless directed otherwise, do not give additional tablets again until the next scheduled dose.

What are some of the possible side effects of VETMEDIN Chew?

VETMEDIN CHEW may cause side effects similar to those seen with VETMEDIN chewable tablets, even at the prescribed dose. Contact your veterinarian immediately if your dog develops a serious or concerning medical problem or side effect while taking VETMEDIN CHEW.

The most common side effects of pimobendan containing products administration are:

poor appetite
lethargy
diarrhea
difficulty breathing or coughing
weakness or difficulty walking
a rise in heart rate
vomiting

There are other side effects which may occur with either VETMEDIN CHEW or VETMEDIN chewable tablets. For a complete list, ask your veterinarian.

To report a suspected adverse drug event (side effect) or a product quality problem contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-4251. Adverse drug events and product quality problems may also be reported directly to FDA by completing the online form available at http://www.fda.gov/reportanimalae or by requesting a hard copy of the form at 1-888-FDA-VETS.

What if my dog receives more VETMEDIN Chew than what is prescribed?

Contact your veterinarian immediately.

What else should I know about VETMEDIN CHEW?

VETMEDIN CHEW is not for use in humans.

You should keep VETMEDIN CHEW in a secure storage area out of the reach of children, as well as dogs, cats and other animals to prevent accidental ingestion or overdose.

If VETMEDIN CHEW is accidentally ingested by a person, contact a physician. It is important to show the treating physician a copy of the VETMEDIN CHEW package insert, label, or this information sheet. VETMEDIN CHEW is a non-sympathomimetic, non-glycoside inotropic drug with vasodilatative properties.

This information sheet contains a summary of important information about VETMEDIN CHEW. For more detailed information about VETMEDIN CHEW, talk with your veterinarian.

Storage Statement: VETMEDIN CHEW should not be stored at temperatures above 25°C (77°F).

Updated 02/2021

Marketing authorisation holder

Marketing authorisation holder in the UK

Boehringer Ingelheim Animal Health UK Ltd

Bracknell, RG12 8YS, UK.

Marketing authorisation holder in Ireland

Boehringer Ingelheim Vetmedica GmbH

55216 Ingelheim/Rhein, Germany

Manufacturer responsible for batch release

Lavet Pharmaceuticals Ltd.,

Kistarcsa, 2143 Batthyány u. 6., Hungary

Active substance

One chewable tablet contains:

Pimobendan: 1.25 mg

Pimobendan: 5 mg

Pimobendan: 10 mg

Brownish, oval, divisible tablet, scored on both sides.

The tablet can be divided into two equal parts.

Indications

For the treatment of canine congestive heart failure originating from dilated cardiomyopathy or valvular insufficiency (mitral and/or tricuspid valve regurgitation). (See also section “Dosage, routes and method of administration”).

For the treatment of dilated cardiomyopathy in the preclinical stage (asymptomatic with an increase in left ventricular end-systolic and end-diastolic diameter) in Doberman Pinschers following echocardiographic diagnosis of cardiac disease (see section “Special warnings” and “Precautions for use in animals”).

For the treatment of dogs with myxomatous mitral valve disease (MMVD) in the preclinical stage (asymptomatic with a systolic mitral murmur and evidence of increased heart size) to delay the onset of clinical symptoms of heart failure (see section “Special warnings” and “Special precautions for use in animals”).

Contraindications

Do not use pimobendan in hypertrophic cardiomyopathies or in diseases in which an improvement in cardiac output cannot be achieved for functional or anatomical reasons (e.g. aortic stenosis).

Since pimobendan is metabolised mainly via the liver, it should not be used in dogs with severe impairment of liver function (see also section “Pregnancy and lactation”). Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

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