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Enurace 50, 50 mg Tablets for Dogs

Information leaflet

Generated by Unregistered Batch DOC TO PDF Converter 2011.3.827.1514, please register!
                                                              Revised: October 2011
                                                                     AN: 00059/2011

                    SUMMARY OF PRODUCT CHARACTERISTICS


1.    NAME OF THE VETERINARY MEDICINAL PRODUCT

UK, NL, IT, BE, DE, ES:       ENURACE 50, 50 mg tablets for dogs
FR:                           ENURACE grand chien


2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

Active substance:
40.7 mg Ephedrine equivalent to 50 mg Ephedrine Hydrochloride.

Excipients:
For a full list of excipients, see section 6.1.


3.    PHARMACEUTICAL FORM

Tablets.
Round, white tablet with break line on one side and inscription ENURACE 50 on the
other side.


4.    CLINICAL PARTICULARS

4.1 Target species
Ovariohysterectomised female dogs.

4.2 Indications for use, specifying the target species
Treatment of urinary incontinence caused by urethral sphincter mechanism
incompetence in ovariohysterectomised female dogs.

4.3 Contraindications
Do not use in dogs with glaucoma.
Do not use in case of hypersensitivity to Ephedrine or to any of the excipients.

4.4 Special warnings for each target species
This product is not suitable for treatment of inappropriate urination resulting of behaviour
problems.

4.5   Special precautions for use

i. Special precautions for use in animals
Do not use the product in dogs under 20 kilogram of bodyweight.

As ephedrine is an alpha and beta adrenergic receptor agonist, the product should be
used with caution in dogs with cardiovascular disease and only after a comprehensive
risk/benefit analysis by the attending veterinarian.


                                          Page 1 of 5
Generated by Unregistered Batch DOC TO PDF Converter 2011.3.827.1514, please register!
                                                              Revised: October 2011
                                                                     AN: 00059/2011

The dog’s cardiovascular functionality should be carefully assessed before the start of
the treatment with the product and it should be periodically monitored during the
treatment.

In addition, a similar approach should be adopted in animals suffering from partial
urethral obstruction, hypertension, diabetes mellitus, hyperadrenocorticism,
hyperthyroidism or other metabolic disorders. It should be mentioned that the
Polyuria/Polydipsia (PU/PD) frequently accompanying the aforementioned conditions
may be falsely diagnosed as urinary incontinence.

ii. Special precautions to be taken by the person administering the veterinary
medicinal product to animals
Ephedrine hydrochloride could be toxic if ingested. Adverse effects may include
insomnia and nervousness, dizziness, headache, increased blood pressure, increased
sweating and nausea.

Ingestion may be fatal, especially in children. To avoid accidental ingestion, the product
must be used and kept out of the reach of children. Always replace the cap securely
after use.

In the event of accidental ingestion, most importantly by children, seek immediate
medical attention showing the physician the package insert.

It is strongly recommended that pregnant women should wear gloves for administration.

Wash hands after administration.

4.6 Adverse reactions (frequency and seriousness)
• Cardiovascular effects like tachycardia, atrial fibrillation, stimulation of the heart
   activity; and vasoconstriction.
• Stimulation of the central nervous system leading to sleeplessness, excitation,
   anxiety and muscle tremors.
• Panting
• Mydriasis
• Cystitis
• Bronchodilatation and decrease of mucus release in the respiratory mucosal
   membranes.
• Reduction of the motility and tone of the intestinal wall.

Due to the nature of Ephedrine the mentioned effects can occur at the recommended
therapeutic dose, with anxiety and cardiovascular effects being the most prevalent. In
10% of the treatments, side effects have been observed in efficacy studies.

4.7 Use during pregnancy, lactation or lay
Not applicable.

4.8 Interaction with other medicinal products and other forms of interaction
• Ephedrine may interact with other sympathicomimetics.
• Ephedrine may enhance glucocorticoid metabolism.
• Concomitant use with MAO-inhibitors may cause hypertension.
• Ephedrine can enhance the activity of products of the same class as theophylline.
• Volatile anaesthetics may enhance the sensitivity of the myocardium to the
   cardiovascular effects of Ephedrine.
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