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Incurin - Patient leaflet, side effects, dosage

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Sources: Original PDF (ema.europa.eu)

Patient leaflet - Incurin

B. PACKAGE LEAFLET

PACKAGE LEAFLET

INCURIN 1 mg tablet

  • 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

  • 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

INCURIN 1 mg tablet

Estriol

  • 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS

Active substance: estriol 1 mg/tablet

Round single-scored tablets.

  • 4. INDICATION

Incurin is indicated for the treatment of hormone-dependent urinary incontinence due to sphincter mechanism incompetence in female dogs.

  • 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.

  • 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.

  • 7. TARGET SPECIES

Dog.

  • 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.

  • 9. ADVICE ON CORRECT ADMINISTRATION

Not applicable.

  • 10. WITHDRAWAL PERIOD

Not applicable.

  • 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.

  • 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.

  • 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.

  • 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

  • 15. OTHER INFORMATION

Sources: Original PDF (ema.europa.eu)

Frequently Asked Questions

What is Incurin used for in pets?

Incurin is primarily used to treat hormone-responsive urinary incontinence in female dogs. It helps to manage symptoms and improve their quality of life.

Can Incurin be given to male dogs?

No, Incurin is specifically formulated for female dogs. Male dogs typically do not experience the same type of urinary incontinence that Incurin addresses.

How does Incurin work to prevent urinary leaks?

Incurin contains the active ingredient estriol, which is a natural estrogen. This hormone helps to strengthen the bladder sphincter muscle, reducing involuntary leaks.

What are the common side effects of Incurin?

Some common side effects may include increased thirst, increased urination, or minor changes in appetite. If you notice severe side effects, contact your veterinarian immediately.

Is Incurin safe for long-term use?

In most cases, Incurin can be used safely for an extended period. However, regular veterinary check-ups are recommended to monitor your dog's health.

How long does it take for Incurin to start working?

Many pet owners notice improvements within a few weeks of starting treatment with Incurin. However, responses can vary based on individual circumstances.

Can I stop giving my dog Incurin suddenly?

It's important not to stop or alter your dog's medication without consulting your veterinarian first. They can advise you on the best way to discontinue use if needed.

Are there alternatives to Incurin for treating urinary incontinence?

Yes, there are other options available such as medications like phenylpropanolamine (PPA) or surgical interventions depending on the specific case and underlying causes.

Should I adjust my dog's dosage of Incurin if they gain weight?

Weight gain can affect medication effectiveness. If you notice weight changes, consult with your veterinarian for possible dosage adjustments.

Can Incurin interact with other medications my dog is taking?

Yes, it's possible for Incurin to interact with certain medications. Always inform your vet about all medications and supplements your dog is currently taking.

Is there a specific diet that should be followed while my dog is on Incurin?

While there isn't a specific diet required when using Incurin, maintaining a balanced and healthy diet can support overall health and successful treatment outcomes.

Can I give my dog supplements while they are on Incurin?

Some supplements may be safe, but always consult with your veterinarian before introducing any new products while your dog is on medication like Incurin.

Will my dog's behavior change while taking Incurin?

Most dogs should not experience significant behavioral changes; however, if you notice anything unusual, consult your vet as it may indicate a reaction.

Is there an age restriction for using Incurin in dogs?

Incurin is generally recommended for adult female dogs who have been spayed. Its safety in very young or elderly dogs should be discussed with your veterinarian.

How should I store my dog's medication like Incurin?

Incurin should be stored at room temperature in a dry place away from direct sunlight and out of reach of children and pets.

Can my dog continue exercising while taking Incurin?

Yes, regular exercise is encouraged unless otherwise advised by your vet. It can actually help improve overall health and well-being.

What should I do if I miss a dose of Incurin?

If you miss a dose of Incurin, give it as soon as you remember. If it's almost time for the next dose, skip the missed one—do not double up!

Are there any signs that indicate that my dog's dosage may need adjustment?

Signs such as worsening symptoms of incontinence, excessive thirst or urination may indicate that a dosage adjustment is needed—consult your vet promptly.

Does spaying affect the need for medications like Incurin?

Spaying removes estrogen production from ovaries which can lead to urinary incontinence; thus some spayed females may require medications like Incurin post-surgery.