Consumer medicine information

1. Why am I taking PRILIGY?

PRILIGY contains the active ingredient dapoxetine hydrochloride. PRILIGY is a treatment for premature ejaculation (PE) in men 18 to 64 years old. For more information, see Section 1. Why am I taking PRILIGY? in the full CMI.

2. What should I know before I take PRILIGY?

Do not use if you have ever had an allergic reaction to dapoxetine hydrochloride or any of the ingredients listed at the end of the CMI. There are a number of circumstances in which a person should not take this medicine or may need to use caution. It is important to understand if these apply to you before taking PRILIGY. Talk to your doctor or pharmacist if you have any concerns about taking this medicine. See Section 2. What should I know before I take PRILIGY? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with PRILIGY and affect how it works. A list of these medicines is included in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take PRILIGY?

• The recommended dose is one tablet (30 mg) taken when you need it, about 1 to 3 hours before sexual activity. Do not take more than one tablet in a 24 hour period. It is not intended for continuous daily use.

• Swallow the tablet whole with at least one full glass of water. PRILIGY can be taken with or without food.

• Avoid alcohol when taking PRILIGY. Do not drink grapefruit juice within 24 hour prior to taking PRILIGY.

5. What should I know while taking PRILIGY?

6. Are there any side effects?

Common side effects include nausea; headache; dizziness; fainting or feeling dizzy upon standing; increased blood pressure; flushing; trembling; tingling or numbness; blurred vision, eye pain; ringing in ears; nasal congestion; dry mouth, vomiting, diarrhoea, constipation, abdominal pain, indigestion, intestinal gas, bloating; excessive sweating; fatigue, sleepiness, yawning; difficulty paying attention, feeling irritable; erectile dysfunction (difficulty getting or keeping an erection); difficulty sleeping; anxiety, nervousness; decreased sexual desire; and abnormal dreams. Serious side effects requiring medical attention include fits (seizures); changes in your mood, thoughts of suicide or harming yourself; an allergic reaction; unusual bruising and bleeding. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Boxed Warnings

Syncope. Patients on Priligy need to be made aware that they could experience syncope at any time with or without prodromal symptoms during their treatment with Priligy. Syncope characterized as loss of consciousness has been reported in clinical trials and is considered medicinal product related. A dose response relationship is suggested. Prodromal symptoms (such as nausea, dizziness or light headedness) often preceded the syncope. Patients should be counselled about the importance of maintaining adequate hydration, and about how to recognise and act upon prodromal signs and symptoms (see Section 4.4 Special Warnings and Precautions for Use) to decrease the likelihood of serious injury associated with falls due to loss of consciousness. Patients must not take more than one tablet once every 24 hours due to increased risk.

1 Name of Medicine

Dapoxetine (as hydrochloride).

2 Qualitative and Quantitative Composition

Priligy is available as 30 mg tablets. Each Priligy 30 mg film-coated tablet contains 30 mg of dapoxetine base (as hydrochloride).
Excipient with known effect. Contains lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Priligy 30 mg: light grey film-coated tablets debossed with "30" inside a triangle on one side.

4 Clinical Particulars

4.9 Overdose

There have been no reports of overdose during clinical trials.
There were no unexpected adverse events in a clinical pharmacology study of Priligy with daily doses up to 240 mg (two 120 mg doses given 3 hours apart). In general, symptoms of overdose with SSRIs include serotonin mediated adverse reactions such as somnolence, gastrointestinal disturbances such as nausea and vomiting, tachycardia, tremor, agitation and dizziness.
In cases of overdose, standard supportive measures should be adopted as required. Due to high protein binding and large volume of distribution of dapoxetine hydrochloride, forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit. No specific antidotes for Priligy are known.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Carcinogenicity. In studies with oral administration, dapoxetine was not carcinogenic to rats when administered daily for approximately two years at doses up to 225 mg/kg/day, yielding approximately three times the exposure to dapoxetine (plasma AUC) seen in human males given the recommended clinical dose of 30 mg. Dapoxetine also did not cause tumours in Tg.rasH2 mice when administered orally at the maximum possible doses of 100 mg/kg/day for 6 months and 200 mg/kg/day for 4 months. Exposure to dapoxetine in the mice at 100 mg/kg/day after 6 months administration was equivalent to that seen in humans at the 30 mg dose.
Daily topical dermal administration for 6 months to transgenic mice at 375, 750, or 1500 mg/kg/day produced some tumour promoter activity (papillomas at the application site) at 750 mg/kg/day or higher. Systemic exposure, to dapoxetine (plasma AUC) was approximately 2 to 3-fold that of males given the recommended clinical dose of 30 mg. The clinical relevance of this finding is unknown.
Genotoxicity. Dapoxetine was not mutagenic in vitro in the bacterial Ames assay or the forward mutation test in mouse lymphoma cells. Dapoxetine was not clastogenic in the in vitro chromosomal aberration test in Chinese hamster ovary cell or the in vivo mouse micronucleus assay. The major human metabolite, dapoxetine N-oxide, was negative in tests for bacterial mutagenicity and in vitro clastogenicity.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Dapoxetine hydrochloride belongs to the pharmacotherapeutic group of selective serotonin reuptake inhibitors (SSRIs).
Dapoxetine hydrochloride is a white to slightly yellow powder. It is freely soluble in methanol, propylene glycol, some organic solvents (e.g. n, n-dimethylformamide) and slightly soluble in ethanol. The solubility of dapoxetine hydrochloride in aqueous media is a function of the pH (soluble at pH 3.9, sparingly soluble at pH 2.1 and insoluble at pH > 7.0).
Chemical structure. Dapoxetine hydrochloride has the following chemical structure:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSDAPHYD.gif Chemical name. The chemical name is (+)-(S)-N,N-dimethyl- (α)-[2-(1-naphthalenyloxy)ethyl]-benzenemethanamine hydrochloride.
Molecular formula. C₂₁H₂₃NO.HCl.
Molecular mass. MW: 341.88.
CAS number. 129938-20-1.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

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