Proin 15 mg chewable tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Phenylpropanolamine hydrochloride

Available from:

Cyton Biosciences Ltd

ATC code:

QG04BX91

INN (International Name):

Phenylpropanolamine hydrochloride

Dosage:

15 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

phenylpropanolamin

Therapeutic indications:

Hormone

Authorization status:

Authorised

Authorization date:

2018-03-23

Summary of Product characteristics

Health Products Regulatory Authority
12 April 2018
CRN000TRT
Page 1 of 6
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Proin 15 mg chewable tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Phenylpropanolamine Hydrochloride 15 mg
(as phenylpropanolamine) 12.1 mg
EXCIPIENTS:
Dark Brown lake LB506
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet
Liver-flavoured,
brown
coloured,
round,
biconvex,
un-coated
tablets,
with
a
break-line on one side and embossed with PROIN 15 on the other side.
The tablets can be divided into halves.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the management of urinary incontinence associated with urethral
sphincter
incompetence in the bitch, particularly that associated with
ovariohysterectomy.
4.3 CONTRAINDICATIONS
Do not use in hypertensive animals or in animals that become
hypertensive after
initiating therapy.
Do not administer to patients treated with non-selective monoamine
oxidase
inhibitors.
Health Products Regulatory Authority
12 April 2018
CRN000TRT
Page 2 of 6
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
In bitches less than 1 year old the possibility of anatomical
disorders contributing to
incontinence should be considered prior to treatment.
Do not use the product for the treatment of behavioural causes of
inappropriate
urination.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
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.
Phenylpropanolamine has been shown to increase mean arterial blood
pressure
resulting in hypertension over time. Animals administered the product
should
therefore be monitored for signs of hypertension, particularly with
prolonged use of
the produ