Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Phenylpropanolamine hydrochloride
Vetoquinol Ireland Limited
QG04BX91
Phenylpropanolamine hydrochloride
50 milligram(s)/millilitre
Syrup
POM: Prescription Only Medicine as defined in relevant national legislation
phenylpropanolamin
Authorised
1993-07-14
1. NAME OF THE VETERINARY MEDICINAL PRODUCT PROPALIN Syrup 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE Phenylpropanolamine Hydrochloride 50mg EXCIPIENTS : For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Syrup. A clear syrup. The colour of the product may change from clear to yellow/brown over time. This does not adversely affect the quality of the product. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Phenylpropanolamine is a sympathomimetic agent which acts by direct stimulation of the smooth muscle of the internal urethral sphincter. It is indicated in the management of urinary incontinence associated with urethral sphincter incompetence in the bitch, particularly that associated with ovariohysterectomy. 4.3 CONTRAINDICATIONS The use of Propalin is not appropriate for the treatment of behavioural causes of inappropriate urination. Do not administer to patients treated with non-selective monoamine oxidase inhibitors. Do not use in case of known hypersensitivity to active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Propalin syrup should be avoided in hypertensive individuals. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Due to the very low doses to be administered, and to avoid any risk of overdose, the animal must be weighed, and the recommended doses must be respected. Phenylpropanolamine, a sympathomimetic drug, may affect the cardiovascular system, especially blood pressure and heart rate, and 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, hyperthyroidism or other metabolic disorders. In bitches less than 1 year old the possibility of anatomical disorders contributing to incontinence should be considered prior to treatment. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON Read the complete document