Urilin Syrup 45ml

4.1 Target species Dogs (bitches). 4.2 Indications for use, specifying the target species For the treatment of urinary incontinence associated with acquired urethral sphincter incompetence in the bitch only. The efficacy of phenylpropanolamine has only been demonstrated in ovariohysterectomised bitches. 4.3 Contraindications Please see section 4.7. Do not use in animals 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. 4.4 Special warnings for each target species It is not appropriate to use the product for the behavioural cause of inappropriate urination. 4.5 Special precautions for use Special precautions for use in animals Because phenylpropanolamine is a sympathomimetic agent, it may affect the cardiovascular system, especially blood pressure and heart rate, and therefore 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 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 for the person administering the veterinary medicinal product to animals • People with known hypersensitivity to phenylpropanolamine should avoid contact with the veterinary medicinal product. • 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 the sight and reach of children. • Always replace the cap firmly after use to ensure that the child resistant closure operates correctly. • In the event of accidental ingestion, seek immediate medical attention showing the doctor the package leaflet. • Contact with eyes and skin should be avoided. • In the event of accidental skin contact, wash the contaminated area with soap and water. Wash hands after use of the product. • Redness and irritation may develop after eye or skin contact with 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 some dogs, loose stools, liquid diarrhoea, a decrease in appetite, arrhythmia and collapse have been reported following treatment with phenylpropanolamine. Occasional nausea and vomiting have also been reported. Treatment was continued depending on the severity of the undesirable effect observed. As phenylpropanolamine is a sympathomimetic agent it is possible to produce a wide range of effects most of which mimic the results of excess stimulation of the sympathetic nervous system (e.g. effects on the heart rate and blood pressure). Dizziness and restlessness were also occasionally reported. Hypersensitivity may occur in very rare cases. 4.7 Use during pregnancy, lactation or lay Do not use in 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.