YPOZANE 1.875, 3.75, 7.5 mg – patient leaflet, side effects, dosage

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE

Marketing authorisation holder and manufacturer:

VIRBAC S.A. -

1ère avenue

2065 m - LID-

06516 Carros -

France

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

YPOZANE 1.875 mg tablets for dogs

YPOZANE 3.75 mg tablets for dogs

YPOZANE 7.5 mg tablets for dogs

YPOZANE 15 mg tablets for dogs

Osaterone acetate

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

Each tablet contains 1.875 mg, 3.75 mg, 7.5 mg or 15 mg osaterone acetate

4. INDICATION(S)

Treatment of benign prostatic hypertrophy in male dogs.

5. CONTRAINDICATIONS

None.

6. ADVERSE REACTIONS

The most commonly reported adverse reactions are mild and transient modifications of appetite, either increased (very common) or decreased (very rare). Behavioural changes such as modification of dog’s activity or more social behaviour are common. Other adverse reactions such as transient vomiting and/or diarrhoea, increased thirst or lethargy occur less commonly. The enlargement of mammary glands occurs less commonly and can be associated with lactaction in very rare cases.

Transient side-effects of changes in the hair coat such as hair loss or hair modification have been seen very rarely following administration of Ypozane.

All these adverse reactions are reversible without any specific treatment.

The frequency of adverse reactions is defined using the following convention:

• very common (more than 1 in 10 animals treated displaying adverse reaction(s))
• common (more than 1 but less than 10 animals in 100 animals treated )
• uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
• rare (more than 1 but less than 10 animals in 10,000 animals treated)
• very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

7. TARGET SPECIES

Dogs (male)

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

For oral use.

Administer 0.25 - 0.5 mg osaterone acetate per kilogram bodyweight, once a day, for 7 days as follows:

9. ADVICE ON CORRECT ADMINISTRATION

Tablets can be given either directly into the mouth or with food. The onset of clinical response to treatment is usually seen within 2 weeks and persists for at least 5 months after treatment.

Re-evaluation by the veterinarian should take place 5 months after treatment, or earlier if clinical signs recur. A decision to retreat at this or at a later time point should be based on veterinary examination taking into account the risk benefit profile of the medicine.

If clinical response to treatment is considerably shorter than expected, a re-evaluation of the diagnosis is necessary.

The maximum dose should not be exceeded.

10. WITHDRAWAL PERIOD(S)

Not applicable.

11. SPECIAL STORAGE PRECAUTIONS

Keep out of the reach and sight of children.

This veterinary medicinal product does not require any special storage conditions. Do not use after the expiry date stated on the blister after “EXP”

12. SPECIAL WARNING(S)

Use with caution in dogs with a history of liver disease.

Wash hands after administration.

In the case of accidental ingestion by a person, seek medical advice immediately and show the package leaflet or the label to the physician.

A single oral dose of 40 mg osaterone acetate in human males was followed by a sporadic decrease of sexual hormones, reversible after 16 days. There was no clinical effect.

In female laboratory animals, osaterone acetate caused serious adverse effects on reproductive functions. Therefore, women of child bearing age should avoid contact with, or wear disposable gloves, when administering the product.

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 :

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).

15. OTHER INFORMATION

Benign prostatic hypertrophy (BPH) is a natural consequence of ageing. Over 80% of male dogs above 5 years of age are affected. BPH is a development and enlargement of the prostate due to the male hormone testosterone. This might lead to multiple non-specific clinical signs such as abdominal pain, difficulties in defaecation and urination, blood in urine and locomotive disorders.

België/Belgique/Belgien

VIRBAC BELGIUM NV

Esperantolaan 4

BE-3001 Leuven

Tél/Tel : +32-(0)16 387 260

Česká republika

VIRBAC

1^ere avenue 2065 m LID

FR-06516 Carros

Francie

Tel: 33 (0) 4 92 08 73 00

Danmark

VIRBAC Danmark A/S

Profilvej 1

DK-6000 Kolding

Tlf: +45 75521244

Luxembourg/Luxemburg

VIRBAC BELGIUM NV

Esperantolaan 4

BE-3001 Leuven

Belgique / Belgien

Tel/Tel: +32-(0)16 387 260

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VIRBAC HUNGARY KFT

Szent Istvan krt.11.II/21.

HU-1055 Budapest

Tel: +36703387177

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U^re avenue 2065 m LID

FR-06516 Carros

Franza

Tel: 33 (0) 4 92 08 73 00

Tel: +33-(0)4 92 08 73 00

Tel: + 34 (0) 93 470 79 40

EL-14452, MeTa^óppoon

TqX.: +30 2106219520

Box 1027

SE-171 21 Solna

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VIRBAC

1^ére avenue 2065 m LID

FR-06516 Carros

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FR-06516 Carros

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FR-06516 Carros

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United Kingdom (Northern Ireland)

VIRBAC

1ere avenue 2065m LID

FR-06516 Carros

France

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PenySnuKa Efcnrapua

VIRBAC S.A.

1^ere avenue 2065 m LID

FR-06516 Carros

OpaH^ua

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VIRBAC

1^ere avenue 2065 m LID

FR-06516 Carros

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