SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Incurin 1 mg tablet

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

Active substance: Estriol 1 mg

Excipients:

Qualitative composition of excipients and other constituents

Amylopectin

Potato starch

Magnesium stearate

Lactose

White, round, single-scored tablets.

3. CLINICAL INFORMATION

3.1 Target species

Dog (bitch).

3.2 Indications for use for each target species

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

3.3 Contraindications

Do not use in intact bitches as the efficacy has only been established in ovariohysterectomised bitches.

Do not use in animals with symptoms of polyuria-polydipsia. Do not use in animals younger than 1 year.

3.4 Special warnings

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

3.5 Special precautions for use

Special precautions for safe use in the target species:

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

Special precautions to be taken by the person administering the veterinary medicinal product to animals Not applicable.

Special precautions for the protection of the environment: Not applicable.

3.6 Adverse events

Dog (bitch):

Very common (> 1 animal / 10 animals treated):	Swollen vulva1,2, mammary gland oedema1,2, attractiveness to males1,2. Vomiting1,2.
Rare (1 to 10 animals / 10 000 animals treated):	Vaginal haemorrhage. Alopecia.

¹ Observed at the highest recommended dose of 2 mg per dog. ² These effects are reversible after lowering the dose.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

3.7 Use during pregnancy, lactation or lay

Pregnancy and lactation:

The use is not recommended during pregnancy or lactation.

3.8 Interaction with other medicinal products and other forms of interaction

None known.

3.9 Administration routes and dosage

Oral use.

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

Recommended dosing schedule:

Start treatment with 1 tablet (1 mg estriol) every day.

If treatment is successful, lower the dose to half a tablet per day.

If treatment is not successful, increase the dose to 2 tablets per day to be administered as a single dose.

Do not use more than 2 tablets per dog per day.

The minimum dose should not be less than half a tablet (0.5 mg estriol) per dog per day.

Ensure the dose used to achieve the therapeutic effect is as low as possible. Some dogs do not need daily treatment. Once an effective daily dose has been established, treatment every other day may be tried.

If no response to treatment is achieved, the diagnosis should be reconsidered and other causes for the incontinence such as neurological disorders, bladder neoplasia, etc. investigated.

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

3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)

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

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

3.12 Withdrawal periods

Not applicable.

4. PHARMACOLOGICAL INFORMATION

4.1 ATCvet code: QG03CA04

4.2 Pharmacodynamics

Estriol is a short-acting natural oestrogen. In ovariohysterectomised 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.

4.3 Pharmacokinetics

After oral administration, estriol is nearly completely absorbed from gastrointestinal tract. Almost all of the absorbed estriol is bound to plasma albumin.

Estriol is excreted in conjugated form via the urine.

After oral administration of multiple doses, no accumulation occurs.

5. PHARMACEUTICAL PARTICULARS

5.1 Major incompatibilities

Not applicable.

5.2 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

5.3 Special precautions for storage

Do not store above 30 °C.

5.4 Nature and composition of immediate packaging

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 of 30 tablets.

5.5 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Medicines should not be disposed of via wastewater.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

6. NAME OF THE MARKETING AUTHORISATION HOLDER

MSD Animal Health UK Limited

7. MARKETING AUTHORISATION NUMBER

Vm 01708/5038

8. DATE OF FIRST AUTHORISATION

24 March 2000

9. DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

September 2025

10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Approved 29 December 2025