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Contra-indications, warnings, etc
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.
Adverse reactions (frequency & seriousness)
Sympathomimetics may produce very rarely a wide range of effects, most of which mimic the results of excessive stimulation of the sympathetic nervous system such as effects on heart rate (tachycardia) or effects on blood pressure (increased blood pressure), which can induce proteinuria.
Dizziness, decrease in appetite, arrhythmia, collapse, aggression, hyperactivity (including restlessness), polydipsia, polyuria, ataxia, seizure and hypersensitivity may occur in very rare cases. Liquid diarrhoea/loose stool, emesis and lethargy have been reported rarely.
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 treated)
- uncommon (more than 1 but less than 10 animals in 1,000 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).
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.
Use during pregnancy, lactation or lay
Do not administer to pregnant or lactating bitches.
Interaction with other medicinal products and other forms of interaction
Care should be exercised in administering Propalin Syrup with other sympathomimetic drugs, anticholinergic drugs, tricyclic antidepressants or specific type B monoamine oxidase inhibitors. It should not be used in patients treated with non-selective monoamine oxidase inhibitors.
Overdose (symptoms, emergency procedures, antidotes), if necessary
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.
Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Withdrawal periods
Not applicable
Operator warning
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 product must be used and kept out of reach of children. Always replace the cap securely after use. In the event of accidental ingestion, seek immediate medical attention showing the physician the package insert.
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.