Propalin Syrup

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Phenylpropanolamine hydrochloride

Available from:

Vetoquinol Ireland Limited

ATC code:

QG04BX91

INN (International Name):

Phenylpropanolamine hydrochloride

Dosage:

50 milligram(s)/millilitre

Pharmaceutical form:

Syrup

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

phenylpropanolamin

Authorization status:

Authorised

Authorization date:

1993-07-14

Summary of Product characteristics

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