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PRILIGY® - New approved medication for Premature Ejaculation available for New Zealand

Fri, 03/12/2010 - 7:23am
Johnson & Johnson

PRILIGY® - New approved medication for Premature Ejaculation available for New Zealand

New Zealand Press Association

Media Release 12 March 2010

Janssen-Cilag announced today that PRILIGY® (dapoxetine) is now approved and available for use in New Zealand for the treatment of premature ejaculation (PE) in men 18-64 years of age.

PE is a common men's medical condition, but it is rarely talked about. However, it is widespread and could affect the quality of life of an estimated 250,000 New Zealand men and their partners .

Dr. Warrick White, an Auckland GP who specialises in men's sexual health explains, "Despite up to 20-24% of men over 24 years of age experiencing PE at some point in their lives , the social stigma attached to the condition may cause men to be embarrassed and reluctant to talk to a doctor about ways to improve their condition".

PE can be a distressing condition that can be present from the first sexual encounter or can develop later in life for a variety of reasons. Nearly 1 out of 4 men with PE (24.4%) reports significant levels of anxiety .

The symptoms of PE are: a short time to ejaculation, not being able to control when ejaculation happens and distress relating to either of these situations.

PRILIGY® is a medicine specifically developed for the treatment of PE. It is an oral tablet that can be taken approximately 1-3 hours before sex is anticipated. PRILIGY® is an unfunded medicine (men will need to pay for it) and available only with a prescription.

For further information on PRILIGY® visit www.priligy.co.nz

For media enquiries or to arrange further medical comment from Dr Warrick White please contact: Lwindi Ellis T: 09 356 6242 / E: lwindi.ellis@draftfcb.com

Notes for editors: Dr. Warrick White is on the New Zealand and Australasian advisory board for Janssen-Cilag. Unapproved imitations (counterfeit) of dapoxetine have been sold. Government officials from around the world have warned of potential risks associated with counterfeit drugs. As for any prescription medication, patients should purchase PRILIGY® (dapoxetine) only from a NZ registered pharmacy. Patients should be especially cautious of internet pharmacies, as many of these are unlicensed.

Availability of PRILIGY®
PRILIGY® will be available in New Zealand from mid February 2010. PRILIGY® is available by prescription only. Patients will need to pay for PRILIGY® as it is not government funded. People who think they may be experiencing PE should speak to their GP for advice.

About Janssen-Cilag
Janssen-Cilag has a long track record in developing and marketing treatments for central nervous system disorders, pain management, oncology, infectious diseases, reproductive health and gastrointestinal disorders. More information about Janssen-Cilag can be found at www.janssen-cilag.com

PRILIGY DTC MANDATORIES 091215

This media release does not contain all of the available information. It does not take the place of talking to your doctor.

PRILIGY® (dapoxetine hydrochloride) is a prescription medicine used to treat men, 18 to 64 years old, with frequent premature ejaculation (PE), which troubles the man and affects the relationship with his sexual partner. PE is a common sexual disorder in which ejaculation happens with minimal sexual stimulation before, on, or shortly after penetration, and before the man wishes it. It is available as 30mg and 60mg tablets.

When not to take PRILIGY:

Do not take PRILIGY if you have an allergy to it or to any of the ingredients in it. Please refer to the Consumer Medicine Information for a list of ingredients. You must not take this medicine if you have heart problems, moderate to severe liver problems, if you are under 18 years or over 65 years of age, if you are taking MAOIs (monoamine oxidase inhibitors) used to treat depression or have taken a MAOI within the last 14 days or if you are taking thioridazine used to treat schizophrenia or have taken it within the last 14 days.

Side Effects:

Side effects associated with the use of PRILIGY include nausea, headache, dizziness, diarrhoea, abdominal pain, difficulty in sleeping, unusual tiredness and nasal congestion. Serious side effects include fainting and allergy such as rash, itching or hives on the skin; shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body.

Precautions:

Before you start to take PRILIGY, you must tell your doctor if you have not been diagnosed with premature ejaculation or if you use recreational drugs such as ecstasy, LSD, narcotics or benzodiazepines. In particular, tell your doctor if you have or have had any medical conditions such as a history of dizziness from low blood pressure, heart and blood vessel problems, bleeding tendencies, depression, psychiatric disease such as schizophrenia, a history of mania or bipolar disorder, seizures, or severe liver or kidney problems. Avoid consuming alcohol when taking this medicine. You should also tell your doctor if you are taking any other medicines, including medicines you can buy without a prescription from a pharmacy, supermarket or health food store. Do not drive or operate machinery while taking PRILIGY until you know how it affects you.

Always follow your doctor's instructions carefully. If symptoms continue or you experience side effects, see your doctor, pharmacist or healthcare professional. For further information, please refer to the Consumer Medicine Information, which can be found on the Ministry of Health website: http://www.medsafe.govt.nz. Alternatively contact your pharmacist or Janssen-Cilag on 0800 800 806.

PRILIGY is an unfunded prescription medicine for which charges will apply. Use strictly as directed. Consult your doctor if PRILIGY is right for you.

PRILIGY is included in the Intensive Medicines Monitoring Programme. PRILIGY® is a registered trademark of ORTHO-MCNEIL PHARMACEUTICAL for dapoxetine tablets.

Date of preparation: 15 December 2009. Janssen-Cilag (NZ) Ltd, 105 Carlton Gore Rd, Newmarket, Auckland, New Zealand. TAPS Approval No: CH2520

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