Active substance: estriol 1 mg/tablet

For the full list of excipients, see section “Pharmaceutical particulars”.

Round single-scored tablets.

Dogs (bitches).

The treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in ovariohysterectomised bitches.

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.

High doses of oestrogen may have a tumour-promoting effect in target organs with oestrogen receptors (mammary glands).

In case of oestrogenic effects, the dose should be lowered.

Not applicable.

Oestrogenic effects such as swollen vulva, swollen mammary glands and/or attractiveness to males and vomiting have been observed at the highest recommended dose of 2 mg per dog. The incidence is about 5-9 %. These effects are reversible after lowering the dose.

In rare cases vaginal bleeding occurred. In rare cases development of alopecia has also been observed.

Do not use this product during pregnancy or lactation. See also section “Contraindications”.

None known.

For oral administration.

A relationship between final effective dose and body weight has not been established and therefore the dose has to be determined for each dog on an individual basis.

The following dosing schedule is advised: start treatment with 1 tablet (1 mg estriol) 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 to be given in one dose. Some dogs do not need daily treatment; treatment every other day may be tried, once the effective daily dose has been established.

The minimum dose given should not be less than 0.5 mg per dog per day. Ensure the dose used to achieve the therapeutic effect is as low as possible. Do not use more than 2 tablets per dog per day. If no response to treatment is obtained the diagnosis should be reconsidered in order to investigate other causes for the incontinence such as neurological disorders, bladder neoplasia, etc.

Animals should be re-examined every 6 months during treatment.

In case of overdose typical oestrogen effects may occur. These effects are reversible after lowering the dose.

Not applicable.

ATC Vet Code: QG03CA04

Estrogens

Estriol is a short-acting natural oestrogen. In ovarioectomised female dogs it has a beneficial effect on urinary incontinence. In the target animal safety study and the clinical trials, including long-term treatment, no signs of bone marrow suppression were observed. This is probably due to the short-acting oestrogenic character of estriol.

After oral administration Estriol is nearly completely absorbed from gastrointestinal tract. Nearly the whole Estriol is bound to Albumin in Plasma. Estriol is excreted in conjugated from via the urine.

After oral administration of multiple doses no accumulation occurs.

Amylopectin

Potato starch

Magnesium stearate

Lactose

None.

3 years.

Do not store above 30°C.

Blister package of clear PVC film backed by aluminium foil provided with heat seal coating (vinyl copolymer) on the side in contact with the tablets. One blister contains 30 tablets.

Pack size: carton box with 1 blister.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

UK(NI): Intervet International B.V., The Netherlands

UK(GB): Vm 01708/5038

Date of first authorisation: 24/03/2000

Date of last renewal: 15/03/2010

29 August 2014.

For animal treatment only. Keep out of the sight and reach of children.