Introduction

Company name: Dechra Veterinary Products

Address: (A business unit of Dechra Pharmaceuticals PLC)

Cartmel Drive

Harlescott

Shrewsbury SY1 3TB

Telephone: 01743 441632

Fax: 01743 462111

Email: info@dechra-uk.com

Website: www.dechra-uk.com

Presentation

A clear liquid containing Phenylpropanolamine Hydrochloride 50 mg/ml.

Uses

Phenylpropanolamine is a sympathomimetic agent, which acts by direct stimulation of the smooth muscle of the urethral sphincter. It is indicated in the management of urinary incontinence associated with urethral sphincter incompetence in the bitch.

The efficacy of Phenylpropanolamine has only been demonstrated in ovariohysterectomised bitches.

Dosage and administration

For oral administration. The recommended dose of Phenylpropanolamine is 1 mg/kg bodyweight three times daily.

1 mg/kg bodyweight three times daily in the feed, corresponding to 0.1 ml Urilin Syrup/5 kg bodyweight three times daily.

One drop (2.34 mg) for every 2.34 kg bodyweight three times daily in feed.

Do not shake the bottle, simply invert it over the food and count the required number of drops.

Contra-indications, warnings, etc

Aggressiveness and restlessness have been noted in some dogs following treatment.

Not to be used in pregnant or lactating bitches.

It is not appropriate to use the product for the behavioural cause of inappropriate urination.

In some dogs, loose stools, liquid diarrhoea, a decrease in appetite, arrhythmia and collapse have been reported following treatment with Phenylpropanolamine.

Occasional nausea and vomiting have also been reported.

As Phenylpropanolamine is a sympathomimetic it is possible to produce a wide range of effects, most of which mimic the symptoms of excess stimulation of the sympathetic nervous system.

Because Phenylpropanolamine is a sympathomimetic drug it may affect the cardiovascular system, especially blood pressure and heart rate and therefore should be used with caution in animals with cardiovascular diseases.

Care should be exercised in treating animals with severe renal or hepatic insufficiency, diabetes mellitus, hyperadrenocorticism, glaucoma or other metabolic disorders.

In bitches less than one year old the possibility of anatomical disorders contributing to incontinence should be considered prior to treatment.

Care should be exercised in administering the product with other sympathomimetic drugs, anticholinergic drugs, tricyclic antidepressants or specific type B Monoamine Oxidase.

The product should not be administered to patients treated with non-selective Monoamine Oxidase inhibitors.

Signs of overdose could produce signs of excessive stimulation of the sympathetic nervous system. Treatment should be symptomatic.

Lethargy and inappetance have been reported in a dog following an overdose (2.5 mg/kg 3 times daily).

Headaches, hypotension and dizziness have been reported in man.

Operator warnings: In the event of accidental skin contact, wash the contaminated area with soap and water. Wash hands after use of the product.

In the event of accidental eye contact, rinse the eye with clean water for about 15 minutes and seek medical advice.

To avoid accidental ingestion, the product must be used and kept out of the reach of children.

Always replace the cap securely after use.

In the event of accidental ingestion, seek immediate medical attention showing the doctor the package leaflet.

General precautions: For animal treatment only.

Pharmaceutical precautions

Do not store above 25°C. Keep out of the reach of children.

Disposal: Dispose of unused packaging in the household refuse. Unused product should be returned to the veterinary surgeon.

Legal category

POM-V

Packaging Quantities

45 ml and 100 ml contained in 50 ml and 100 ml glass bottles.

Further information

Urinary incontinence in the dog may be due to several underlying mechanisms.

Urilin is most effective in the control of urinary incontinence due to urethral sphincter incompetence in the bitch, particularly that associated with ovariohysterectomy.

Urilin is not effective in all cases and may be of limited effectiveness in other forms of urinary incontinence.

Marketing authorisation number

Vm 10434/4003.