Patient leaflet - Incurin
B. PACKAGE LEAFLET
PACKAGE LEAFLET
INCURIN 1 mg tablet
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer responsible for batch release :
Intervet International B.V.
Wim de Korverstraat 35
5831 AN Boxmeer
The Netherlands
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
INCURIN 1 mg tablet
Estriol
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS
Active substance: estriol 1 mg/tablet
Round single-scored tablets.
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4. INDICATION
Incurin is indicated for the treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in female dogs.
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5. CONTRAINDICATIONS
Do not use in intact bitches, as the efficacy has only been established in ovariohysterectomised bitches.
Animals showing a polyuria-polydipsia should not be treated with Incurin.
The use of Incurin is contraindicated during pregnancy, lactation and in animals younger than 1 year.
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6. ADVERSE REACTIONS
Mild, oestrogenic effects such as swollen vulva, swollen teats and/or attractiveness for males have been observed at the high dose of 2 mg. These effects are reversible after lowering the dose. Further, in some dogs, symptoms of nausea were observed. Because of its short-acting oestrogenic properties, Incurin does not induce bone marrow suppression in the dog.
In rare cases vaginal bleeding occurred. In rare cases development of alopecia has also been observed.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
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7. TARGET SPECIES
Dog.
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Incurin is intended for once daily oral administration.
Since there exists no relation between the final effective dose and the body weight, a fixed dose per kg body weight is not feasible. The dose has to be fixed for each dog on an individual basis. The following dosing schedule is advised: start treatment with 1 tablet every day. If treatment is successful lower the dose to half a tablet a day. If treatment is not successful increase the dose to 2 tablets a day. Some dogs do not need daily treatment; treatment every other day may be tried once the effective daily dose has been established.
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9. ADVICE ON CORRECT ADMINISTRATION
Not applicable.
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10. WITHDRAWAL PERIOD
Not applicable.
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11. SPECIAL STORAGE CONDITIONS
Keep out of the reach and sight of children.
Do not store above 30°C.
Do not use after the expiry date which is stated on the label after Exp.
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12. SPECIAL WARNINGS
High doses of oestrogen may have a tumour-promoting effect in target organs with oestrogen receptors (mammary glands).
In case of overdose typical oestrogen effects may occur. These effects are reversible after lowering the dose.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
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15. OTHER INFORMATION