Healthcare Professionals educational material :
Prescriber guide for Dapo (Dapoxetine)

Important Safety Information
Prevalence of PE:
PE is one of the most prevalent male sexual complaints

1

Dapoxetine is highly potent serotonin-transporter inhibitor
The only approved pharmacological therapy indicated for treatment of PE
A new ‘designed-for-purpose’ agent, for the treatment of PE

When taken on demand Dapoxetine (30 and 60 mg) significantly increase the mean IELT* by three to four times

4 times increase in the mean IELT* at endpoint

Ref. Jon L Pryor, Stanley E Althof, Christopher Steidle, Raymond C Rosen, Wayne J G Hellstrom, Ridwan Shabsigh, Maja Miloslavsky, Sherron Kell, for the Dapoxetine Study Group Lancet 2006; 368: 929–37 Vol 368 September 9, 2006 * (IELT) intravaginal ejaculatory latency times

80% reported Satisfaction with sexual intercourse:

Ref. Jon L Pryor, Stanley E Althof, Christopher Steidle, Raymond C Rosen, Wayne J G Hellstrom, Ridwan Shabsigh, Maja Miloslavsky, Sherron Kell,for the Dapoxetine Study Group Lancet 2006; 368: 929–37 Vol 368 September 9, 2006

Why

The First and the Only approved treatment for (PE) with unique pharmacokinetic properties

With Dapo On Demand treatment of PE because of its physicochemical and pharmacokinetic properties and its clinical efficacy

Department of Clinical and Experimental Pharmacology, Lund University, Hospital, Lund, Sweden,
*Department of Urology, Weill Medical College of Cornell University, New York Presbyterian
Hospital, New York, NY, USA, †Urodoc Ltd, Herne, UK
Accepted for publication 26 August 2005

Is the first and the only specific treatment for premature ejaculation
Significantly improves all parameters including ¹:
- Control
- Satisfaction
- Distress
- Interpersonal difficulty.

4 times increase in the mean IELT at endpoint ²
Associated with patient-reported improvements in their condition ²
Is effective and generally well tolerated for the treatment of premature ejaculation3
On demand Dapoxetine has no significant adverse effects on ⁴:
- libido (1%) or
- Erection (4%)

References:

Kaufman et al. Treatment benefit of dapoxetine for premature ejaculation: results from a placebo-controlled phase III trial. BJU International (2009) 103: pages 651-658.
Buvat et al. Dapoxetine for the Treatment of Premature Ejaculation: Results from a Randomised, Double-Blind, Placebo-Controlled Phase 3 Trial in 22 Countries. Eu ropean Urology Volume (2009)55: Pages 957-968.
Pryor et al. Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised controlled trials. The Lancet (368)2006: Pages 929-937.
KARL-ERIK ANDERSSON, JOHN P. MULHALL* and MICHAEL G. WYLLIE† Depart ment of clinical and Experimental Pharmacology, Lund University,

Important Safety Information

PREVALENCE
OF PE

Premature ejaculation (PE) is one of the most prevalent male sexual complaints

ssris

Of patients on chronic SSRIs , 30–50% experience sexual side-effects
Chronic treatment with these SSRIs:
• Reduces libido
• Compromises erectile function,

Ref: KARL-ERIK ANDERSSON, JOHN P. MULHALL* and MICHAEL G. WYLLIE†Department of Clinical and Experimental Pharmacology, Lund University, Hospital, Lund, Sweden, Department of Urology, Weill Medical College of Cornell University, New York Presbyterian Hospital, New York, NY, USA, † Urodoc Ltd, Herne, UK Accepted for publication 26 August 2005

The main differences between PE and ED

The main differences between PE and ED:

Premature ejaculation (PE)

No problem getting an erection suitable for sexual intercourse

Penis remains erect until ejaculation

Ejaculation occurs before the man wishes it, with low feelings of control over ejaculation, causing distress

Common in men of all ages
Erectile dysfunction (ED)

Difficulty in getting an erection suitable for sexual intercourse or in keeping the penis erect until the end of intercourse

Penis softens before ejaculation or before the end of sexual intercourse

Man may try to ejaculate quickly before he loses his erection

More common in older men

Ref. Food and Drug Administration, 2005.

DOSAGE &
ADMINISTRATION

The recommended starting dose for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity.
The maximum recommended dosing frequency is once every 24 hours.

TOLERABILITY/
SAFETY

By contrast, sexual side effects are infrequent with Dapoxetine.
On demand Dapoxetine has no significant adverse effects on:
o libido (<1%) or
o Erection (<4%)

Ref. KARL-ERIK ANDERSSON, JOHN P. MULHALL* and MICHAEL G. WYLLIE† Department of Clinical and Experimental Pharmacology, Lund University, Hospital, Lund, Sweden, *Department of Urology, Weill Medical College of Cornell University, New York Presbyterian Hospital, New York, NY, USA, †Urodoc Ltd, Herne, UK Accepted for publication 26 August 2005

how to report side effects?

We believe our first responsibility is to the patients, doctors, pharmacists and other health care professionals. In meeting their needs, everything we do must be of high quality. By reporting side effects, you provide National Pharmacovigilance and Drug Safety Center(NPC) & Marketing Authorisation Holder with important feedback about our products.

To report any side effect: The National Pharmacovigilance and Drug Safety Center

Fax: +966-11-2057662
Email: Npc.drug@sfda.gov.sa
Online: http://ade.sfda.gov.sa
Toll free phone: 8002490000

Pharmacovigilance Department in Riyadh Pharma

Fax: +966-11-4065260
Email: khaleda@riyadhpharma.com
Tel: +966-11-4026150 ext. 242
Mobile: +966 501792530

Why