Target species
Dogs.
Indications for use for each target species
Treatment of urinary incontinence associated with urethral sphincter incompetence in the bitch.
Efficacy has only been demonstrated in ovariohysterectomised bitches.
Contraindications
Do not use in patients treated with non-selective monoamine oxidase inhibitors. Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings
The use of the veterinary medicinal product is not appropriate for the treatment of behavioural causes of inappropriate urination.
Special precautions for use
Special precautions for safe use in the target species:
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 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. High overdose may be fatal, especially in children.
To avoid accidental ingestion, the veterinary medicinal product must be used and kept out of reach of children. Always replace the cap secure after use.
In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
In case of accidental skin contact, wash the contaminated area with soap and water.
Wash hands after use of the veterinary medicinal product.
In case of accidental eye contact, rinse the eye with clean water for about 15 minutes and seek medical advice.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
Dogs:
Rare (1 to 10 animals / 10,000 animals treated): | Diarrhoea1, loose stool, emesis Lethargy |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Tachycardia2, high blood pressure2, arrhythmia Proteinuria3 Wobbliness, ataxia, seizure Decreased appetite Collapse, polydipsia Aggression, hyperactivity (agitation) Hypersensitivity |
| Polyuria |
1 Liquid
2 Effects of sympathomimetics producing excessive stimulation of the sympathetic nervous system.
3 Due to increased blood pressure.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Do not use during pregnancy or lactation..
Interaction with other medicinal products and other forms of interaction
Care should be exercised in administering the veterinary medicinal product with other sympathomimetic drugs, anticholinergic drugs, tricyclic antidepressants or specific type B monoamine oxidase inhibitors.
Administration routes and dosage
Oral use.
To ensure a correct dosage, body weight should be determined as accurately as possible.
The recommended dose for the veterinary medicinal product is 1mg of phenylpropanolamine hydrochloride for 1kg bodyweight 3 times daily in the feed, corresponding to 0.1 ml of the veterinary medicinal product / 5 kg bodyweight (i.e., a graduation of the provided syringe for 5 kg), 3 times daily.
The absorption rate is increased if the veterinary medicinal product is administered to fasted dogs.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
In healthy dogs, no side effects were observed at up to 5 times the recommended dosage. However, 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. However, no specific recommendation on drugs or dosages can be given.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Not applicable.