SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the veterinary medicinal product

Propentofylline 100mg Film Coated Tablets for Dogs

2. Qualitative and quantitative composition

Active Substance:

Propentofylline 100.00mg/tablet

Excipients:

Opadry II Blue 85G30552 8.00mg/tablet

For a full list of excipients, see section 6.1

3. Pharmaceutical form

Film coated tablet.

A light blue oblong tablet, with a central score line on both faces which can be divided into equal halves.

4. Clinical Particulars

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

For improvement in dullness, lethargy and overall demeanour in dogs. Is particularly useful in older dogs, where it may increase willingness to exercise and exercise tolerance.

4.3 Contraindications

Do not administer to pregnant bitches or breeding animals.

4.4 Special Warnings for each target species

None

(i) Special precautions for use in animals

Specific diseases (e.g. kidney disease) should be treated accordingly.

Consideration should be given to rationalising the medication of dogs already receiving treatment for congestive heart failure or bronchial disease.

(ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals

Care should be taken to avoid accidental ingestion. In the event of accidental ingestion, seek immediate medical advice and show the package leaflet to the doctor. Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

In the rare event of allergic reactions, treatment with the product should be stopped.

4.7 Use during pregnancy, lactation or lay

Do not use in pregnant bitches as the product has not been evaluated in these animals.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

Half tablet per 10kg body weight twice a day.

The tablets should not be quartered. More accurate dosing may be achieved using a combination of 100mg and 50mg tablets. Dogs of less than 20kg can be given 50mg tablets.

The tablets can be administered directly onto the back of the dog’s tongue or can be mixed in a small ball of food and should be administered at least 30 minutes before feeding.

Any remaining halved tablet portions should be discarded.

Signs include cardiac and cerebral over stimulation. Treatment would be symptomatic.

Not applicable

5. pharmacological properties

Pharmacotherapeutic group:

ATC Vet Code: QC04AD90

5.1 Pharmacodynamic properties

Propentofylline has been shown to increase blood flow, particularly of the heart and skeletal muscle. It also increases the blood flow of the brain and therefore its oxygen supply, without increasing the brain’s glucose demand. It has modest positive chronotropic effect and a marked positive ionotropic effect. In addition, it has been shown to have an anti-arrhythmic effect in dogs with myocardial ischemia and a bronchodilator action equivalent to that of aminofylline.

Propentofylline inhibits platelet aggregation and improves the flow properties of erythrocytes. It has a direct effect on the heart and reduces peripheral vascular resistance thereby lowering cardiac load.

5.2 Pharmacokinetic properties

After oral administration propentofylline is fast and completely absorbed and quickly distributed in the tissues. Given orally to dogs, maximum plasma levels are reached already after 15 minutes.

The half-time is about 30 minutes and the bioavailability for the mother substance amounts to about 30%. There are a number of effective metabolites and the biotransformation takes place mainly in the liver. Propentofylline is excreted in the form of its metabolites in 80-90% via the kidneys. The rest is eliminated with the faeces. There is no accumulation.

6. Pharmaceutical particulars

6.1 List of excipients

Opadry ll Blue 85G30552

White Maize Starch

Lactose Monohydrate

Povidone K30

Croscarmellose Sodium

Purified Water

Talc

Silica Colloidal Anhydrous

Magnesium Stearate

Microcrystalline Cellulose

6.2 Incompatibilities

None known

Shelf-life of the veterinary medicinal product as packaged for sale: 18 months

Any remaining halved tablet portions should be discarded.

Do not store above 25°C. Store in a dry place. Keep blister packs in outer carton.

Polyvinylchloride/aluminium blister packs of 6 x 10 tablets per carton

Any unused product or waste materials should be disposed of in accordance with national requirements.

7. MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

Station Works

Newry

Co. Down, BT35 6JP

Northern Ireland

8. MARKETING AUTHORISATION NUMBER

Vm 02000/4301

9. DATE OF FIRST AUTHORISATION

14 November 2011

10. DATE OF REVISION OF THE TEXT

November 2011

PROHIBITION OF SALE, SUPPLY AND/OR USE

POM-V – To be supplied only on veterinary prescription