SUMMARY OF PRODUCT CHARACTERISTICS

Vivitonin 100mg tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:

Propentofylline 100.00mg/tablet

Film coating ingredients:

Yellow ferric oxide (E172) (colouring) 0.258mg/tablet

Titanium Dioxide (E171) (colouring) 0.856mg/tablet

For full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Ochre, biconvex, oblong filmcoated tablets.

4. CLINICAL PARTICULARS

Dogs

4.2 Indications for use, specifying the target species

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

4.3 Contra-indications

Not to be administered to pregnant bitches or breeding animals.

Do not use in animals with known hypersensitivity to the active substance or any of the excipients

4.4 Special warning for each target species

None

4.5 Special precautions for use

i. Special precautions for use in animals

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

In the case of renal failure, the dose should be reduced.

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 medicinal product to the animals

Care should be taken to avoid accidental ingestion.

Wash hands after use.

Vomiting has been observed on rare occasions, particularly at the commencement of therapy.

In rare cases allergic reactions (e.g. urticaria) may occur and these necessitate discontinuation of the treatment.

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

- very common (more than 1 in 10 animals displaying adverse reaction(s)

during the course of one treatment)

- common (more than 1 but less than 10 animals in 100 animals)

- uncommon (more than 1 but less than 10 animals in 1,000 animals )

- rare (more than 1 but less than 10 animals in 10,000 animals)

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

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 a 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 50 mg 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.

Divide the tablets in halves with a knife or with a tablet splitter.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Symptoms of cardiac and cerebral overstimulation have been observed. In such cases, animals should be treated symptomatically.

4.11 Withdrawal period

Not applicable

5. PHARMACOLOGICAL PROPERTIES

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 a modest positive chronotropic effect and a marked positive inotropic 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.

ATC Vet Code:QC04AD90

5.2 Pharmacokinetic particulars

After oral administration, propentofylline is rapidly and completely absorbed and quickly distributed into the tissues. Maximum plasma levels are reached by 15 minutes following oral dosing in dogs.

The half-life is approximately 30 minutes and the bioavailability of the parent compound is approximately 30%.

There are a number of effective metabolites and biotransformation takes place mainly in the liver.

80-90% of propentofylline is excreted in the form of metabolites via the kidneys. The rest is eliminated with the faeces.

There is no bioaccumulation.

6. PHARMACEUTICAL PARTICULARS

Lactose monohydrate

Maize Starch

Crospovidone

Talc

Magnesium Stearate

Colloidal Anhydrous silica

Film Coating:

Methylhydroxpropylcellulose 5mPa’s

Talc

Titanium dioxide (E171)

Yellow ferric oxide (E172)

Macrogol 8000

6.2 Incompatibilities

None known

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

6.4 Special precautions for storage

Do not store above 25^oC. Store in a dry place. Return any half tablets to the original packaging. Keep blister packs in outer carton.

6.5 Nature and composition of immediate packaging

Polyvinylchloride/aluminium blister packs of 6 x 10 tablets.

6.6 Special precautions for disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate

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

7. MARKETING AUTHORISATION HOLDER

Intervet UK Ltd

Walton Manor

Walton

Milton Keynes

Buckinghamshire

MK7 7AJ

8. MARKETING AUTHORISATION Number

Vm01708/4446

9. Date of first AUTHORISation

Date:30 September 1994.

10. Date of Revision of text

Date:November 2013.

14 November 2013