Continence 40 mg/ml Syrup for Dogs

United Kingdom - English - VMD (Veterinary Medicines Directorate)

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Active ingredient:
Phenylpropanolamine
Available from:
Support Pharma S.L.
ATC code:
QG04BX91
INN (International Name):
Phenylpropanolamine
Pharmaceutical form:
Syrup
Prescription type:
POM-V - Prescription Only Medicine – Veterinarian
Therapeutic group:
Dogs
Therapeutic area:
Neurological Agent
Authorization status:
Authorized
Authorization number:
42120/4006
Authorization date:
2019-08-09

Revised: September 2019

AN: 00957/2019

SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE VETERINARY MEDICINAL PRODUCT

CONTINENCE 40 mg/ml syrup for dogs

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml contains:

Active substance:

Phenylpropanolamine…………………………………………40.28 mg

equivalent to phenylpropanolamine hydrochloride………...50 mg

For the full list of excipients, see section 6.1.

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.

Page 1 of 6

Revised: September 2019

AN: 00957/2019

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 ingested. Adverse

effects may include dizziness, headache, nausea, insomnia or restlessness, and

increased blood pressure. Accidental ingestion by a child may be fatal.

To avoid accidental ingestion, the product must be used and kept out of sight and

reach of children. Always replace the cap securely after use and store the syringe

and bottle inside the cardboard box at all times.

In case of accidental ingestion, seek medical attention immediately and show the

package leaflet or the label to the physician.

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.

4.6.

Adverse reactions (frequency and seriousness)

In the course of field clinical trials, loose stools, liquid diarrhoea, decrease in appetite,

arrhythmia and collapse were reported in some dogs. Treatment was continued

depending on the severity of the undesirable effect observed.

Sympathomimetics may produce a wide range of effects, most of which mimic the

results of excessive stimulation of the sympathetic nervous system (e.g. effects on

heart rate and blood pressure).

Dizziness, aggressiveness and restlessness have been noted in some dogs following

treatment. Hypersensitivity may occur in very rare cases.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- rare (more than 1 but less than 10 animals in 10,000 animals treated)

- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7.

Use during pregnancy, lactation or lay

Do not administer to pregnant or lactating bitches.

4.8.

Interaction with other medicinal products and other forms of interaction

Care should be exercised in administering the product with other sympathomimetic

drugs, anticholinergic drugs, tricyclic antidepressants or specific type B monoamine

oxidase inhibitors.

Page 2 of 6

Revised: September 2019

AN: 00957/2019

4.9.

Amounts to be administered and administration route

For oral use.

The recommended dose of phenylpropanolamine is 1.5 mg/kg bodyweight

(equivalent to 0.15 ml per 5 kg bodyweight) twice daily in the feed. Alternatively, 1

mg/kg bodyweight (equivalent to 0.1 ml per 5 kg bodyweight) may be administered

three times daily in the feed. The absorption rate is increased if the product is

administered to fasted dogs.

Page 3 of 6

3.

Invert

bottle

and,

holding the syringe, pull the

piston

downwards

aspiring

the product slowly into the

dosing syringe, to avoid the

formation

bubbles.

Stop at the mark shown on

the plunger corresponding to

the required volume of the

product.

1.

Remove

child-

proof

security

pressing

firmly

down

rotating

anticlockwise.

2.

Take

dosing

syringe with the piston

all the way down and

insert

into

dosing syringe adaptor.

Firmly push down.

5. Hold the dosing syringe

on top of the dog's food

and push the piston to the

bottom to ensure delivery

of the full dose of the

product.

6. Replace the cap

on the bottle and

screw clockwise to

close.

Keep

bottle

safe

place,

room

temperature, out of

4. Straighten the bottle

and grasp the lower

part

syringe,

close to the neck of the

bottle.

Remove

dosing syringe from the

bottle

turning

carefully.

Revised: September 2019

AN: 00957/2019

4.10. Overdose (symptoms, emergency procedures, antidotes), if necessary

Lethargy and inappetence have been reported following an overdose of 2.5 mg/kg 3

times daily.

An overdose of phenylpropanolamine could produce symptoms of excessive

stimulation of the sympathetic nervous system. Treatment should be symptomatic.

Alpha-adrenergic blockers may be appropriate in the case of severe overdose.

4.11. Withdrawal period(s)

Not applicable.

5.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic

group:

Genito-urinary

system

hormones,

urologicals, phenylpropanolamine

ATC vet code: QG04BX91

5.1.

Pharmacodynamic properties

Phenylpropanolamine is a racemic mixture of D and L enantiomers.

Phenylpropanolamine hydrochloride is a sympathomimetic agent which acts by direct

stimulation of the smooth muscle of the internal urethral sphincter. It is an analogue

of the endogenous sympathomimetic amines.

Phenylpropanolamine hydrochloride has weak sympathomimetic activity and

produces a wide range of pharmacological effects. It appears to act directly on the

smooth muscle of the lower urinary tract. The smooth muscle is thought to be largely

responsible for the maintenance of tone in the resting state.

The clinical effect of phenylpropanolamine in urinary incontinence is based on its

stimulation effect on α-adrenergic receptors. This causes an increase in, and a

stabilisation of, the closure pressure in the urethra, which is innervated mainly by

adrenergic nerves.

5.2.

Pharmacokinetic particulars

In the dog, the mean half-life of phenylpropanolamine is approximately 3 hours with

maximal plasma concentrations being found after approximately 1 hour. No

accumulation of phenylpropanolamine has been observed after a dose of 1 mg/kg 3

times daily over 15 days.

When the product is administered to a fasted dog, bioavailability is increased

significantly.

Page 4 of 6

7. Dry the tip with a clean

cloth or paper. Wash the dosing

syringe by removing the piston

and rinse the items with hot water.

8. Dry carefully, making sure that the

inside of the syringe is dry before

reinserting the piston. Store the syringe

inside the cardboard box to avoid

access by children.

Revised: September 2019

AN: 00957/2019

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of excipients

Liquid sorbitol (non crystallising)

6.2.

Major incompatibilities

None known.

6.3.

Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after the first opening of the immediate packaging: 3 months.

6.4.

Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

Keep the container tightly closed and store the bottle and syringe inside the

cardboard box at all times.

6.5.

Nature and composition of immediate packaging

50 ml high-density polyethylene (HDPE) bottle with a low-density polyethylene

(LDPE) dosing syringe adaptor and a child-resistant screw-cap in polypropylene and

polyethylene.

The cardboard box contains 1.5 ml LDPE/polystyrene dosing syringe.

6.6.

Special precautions for the disposal of unused veterinary medicinal products

or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste material derived from such

veterinary medicinal product should be disposed of in accordance with local

requirements.

7.

MARKETING AUTHORISATION HOLDER

FATRO S.p.A.

Via Emilia, 285

Ozzano Emilia - Bologna

Italy

8.

MARKETING AUTHORISATION NUMBER

Vm 11557/4004

9.

DATE OF FIRST AUTHORISATION

09 August 2019

Page 5 of 6

Revised: September 2019

AN: 00957/2019

10.

DATE OF REVISION OF THE TEXT

September 2019

Approved 17 September 2019

Page 6 of 6

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