CONTINENCE 40 mg/ml syrup for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Phenylpropanolamine hydrochloride

Available from:

FATRO S.p.A.

ATC code:

QG04BX91

INN (International Name):

Phenylpropanolamine hydrochloride

Dosage:

40 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:

2019-10-11

Summary of Product characteristics

Health Products Regulatory Authority
02 January 2020
CRN009FZT
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
CONTINENCE 40 mg/ml syrup for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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1 ml contains:
​
​
​
​
​
​
ACTIVE SUBSTANCE:
​
​
​
Phenylpropanolamine
​
40.28
mg​
​
equivalent to phenylpropanolamine hydrochloride
​
50
mg​
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​
​
​
For the full list of excipients, see section 6.1.
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​
3 PHARMACEUTICAL FORM
Syrup.
Clear colourless to pale yellow solution.
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 administer to patients treated with non-selective monoamine
oxidase inhibitors.
Do not use in cases of known hypersensitivity to the active substance
or to any of the excipients.
Do not administer to pregnant or lactating bitches.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The product should be avoided in hypertensive individuals.
In bitches less than 1 year old the possibility of anatomical
disorders contributing to incontinence should be considered prior
to treatment.
The use of the product is not appropriate 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.
Care should be exercised in treating animals with severe renal or
hepatic insufficiency, diabetes mellitus, hyperadrenocorticism,
glaucoma, hyperthyroidism or other metabolic disorders.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Phenylpropanolamine hydrochloride is toxic when overdoses are