What Side Effects Can I Expect From Taking Priligy?

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Priligy is one of the treatments for erectile dysfunction available here at Assured Pharmacy. To help our clients understand their medications and medical conditions, we’ve written a series of articles on our blog that will provide further information about different conditions and medications.
This article is about Priligy. We’ll cover what Priligy is, what it is used for, how to take it, who cannot take it and any side effects you can expect from taking it.

Priligy (Dapoxetine)

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What is Priligy?

Priligy is the brand name for a medication known as Dapoxetine Hydrochloride. Each film−coated tablet of Priligy contains Dapoxetine hydrochloride equivalent to 30 mg or 60 mg Dapoxetine.
The excipient (other substance in the tablet) with known effect is Lactose. Each 30 mg tablet of Priligy contains 45.88 mg of lactose. Each 60 mg tablet of Priligy contains 91.75 mg of lactose.

 

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The other substances (excipients) in each Priligy tablet (that are inactive) include:
Tablet core:

  • Lactose monohydrate
  • Microcrystalline cellulose
  • Croscarmellose sodium
  • Colloidal anhydrous silica
  • Magnesium stearate

Tablet coating:

  • Lactose monohydrate
  • Hypromellose
  • Titanium dioxide (E171)
  • Triacetin
  • Iron Oxide Black (E172)
  • Iron Oxide Yellow (E172)

The legal category for Priligy is POM. This means it is a prescription only medicine and supply can only be made according to the instructions in a prescription issued by a qualified doctor or non-medical prescriber.

 

What is Priligy used for?

Priligy (Dapoxetine) is indicated for the treatment of premature ejaculation in men aged 18 to 64 years of age who meet all the following criteria:

  • Poor control over ejaculation,
  • A history of premature ejaculation over the past 6 months in the majority of intercourse attempts,
  • Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes
  • Marked personal distress or interpersonal difficulty because of premature ejaculation, and
  • An intravaginal ejaculatory latency time of fewer than two minutes

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Priligy

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Finasteride

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How do I take Priligy?

When treatment is initiated, the starting dose of Priligy is one 30mg tablet taken 1 hour to 3 hours before sexual activity. Treatment using Priligy should never be started by taking a 60mg dose.
Priligy is not intended for continuous daily use. Priligy should be taken only when sexual activity is anticipated. Priligy must not be taken more frequently than once every 24 hours.
If your response to the 30mg dose is insufficient and you have not experienced moderate to severe side effects (see below), then you may increase the dose to the maximum recommended dose of 60mg as needed 1 to 3 hours before sexual activity.
Please note that the likelihood of a side effect occurring, and the severity of the side effect is higher with the 60mg dose.
After the first four weeks of treatment starting, or after you have taken at least 6 doses, you need to have another consultation with the prescriber. This appointment gives the prescriber the opportunity to evaluate your individual benefit-risk and to determine whether or not it is appropriate for your treatment with Priligy to continue.
There is limited data about the safety and effectiveness of Priligy after 24 weeks of use. This is why it is recommended that you have a consultation with your prescriber every 6 months. This way, the prescriber can evaluate if there is a clinical need for you to continue taking Priligy and balance the benefit-risk.
Click here now so that you can have your clinical evaluation from the comfort of your home by having a remote consultation with our in-house doctor today.

 

Who should not take Priligy?

Priligy is licensed for use in adult men only aged 18 to 64 years for the treatment of premature ejaculation who meet all the criteria listed above.
Priligy should not be prescribed for men who have not been diagnosed with premature ejaculation or who do not meet all the criteria listed above.
Priligy is not licensed for use by women and children, so it should not be taken by women or children under the age of 18 years.
The effectiveness and safety of Priligy in men aged 65 years and older has not been assessed.
Adult men who are hypersensitive to the active ingredient Dapoxetine or to any of the excipients, should not take Priligy.
Adult men diagnosed with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose−galactose malabsorption should also not take this medicine.
Adult men with some pre-existing medical conditions or those taking certain classes of medications cannot take Priligy. Therefore, it is important for you to see a doctor to discuss your individual circumstances. You can either book a consultation with your regular GP or click here to start a consultation with our in-house doctor.
It is important that during your consultation, you inform the doctor of all previous and existing conditions you have. You should also inform the doctor of all medications you are currently taking including herbal remedies and over the counter medications that you may have bought without needing a prescription. You should mention if you are allergic to any medication too or if there’s any medication you cannot take for any reason.
The list of conditions and the list of medications that may affect the suitability of use of Priligy for your individual circumstances are outside the scope of this article. That is why it is important for you to have an in-depth consultation with a doctor before treatment is initiated. This way, you minimise the risk of any adverse effects occurring.

 

What side effects can I expect from taking Priligy?

Below is further information about the undesirable effects that may be seen from taking Priligy as provided by the marketing authorisation holder of Priligy.

Priligy (Dapoxetine)

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Summary of the safety profile

Syncope and orthostatic hypotension have been reported in clinical trials.
The following adverse drug reactions were reported during Phase 3 clinical trials most commonly and were dose-related: nausea (11.0% and 22.2% in 30 mg and 60 mg when required Dapoxetine groups, respectively), dizziness (5.8% and 10.9%), headache (5.6% and 8.8%), diarrhoea (3.5% and 6.9%), insomnia (2.1% and 3.9%) and fatigue (2.0% and 4.1%). The most common adverse events leading to discontinuation were nausea (2.2% of Priligy−treated subjects) and dizziness (1.2% of Priligy−treated subjects).

Tabulated list of adverse reactions

The safety of Priligy was evaluated in 4224 subjects with premature ejaculation who participated in five double−blind, placebo−controlled clinical trials. Of the 4224 subjects, 1616 received Priligy 30 mg as needed and 2608 received 60 mg, either as needed or once daily.

Table 1 presents the adverse reactions that have been reported.

Adverse reaction (MedDRA Preferred Term)

System Organ ClassVery common
(>1/10)
Common
(≥1/100 to <1/10)
Uncommon
(≥1/1000 to <1/100)
Rare
(≥1/10000 to <1/1000)
Psychiatric disordersAnxiety, Agitation, Restlessness, Insomnia, Abnormal dreams, Libido decreasedDepression, Depressed mood, Euphoric mood, Mood altered, Nervousness, Indifference, Apathy, Confusional state, Disorientation, Thinking abnormal, Hypervigilance, Sleep disorder, Initial insomnia, Middle insomnia, Nightmare, Bruxism, Loss of libido, Anorgasmia
Nervous system disordersDizziness, HeadacheSomnolence, Disturbance in attention, Tremor, ParaethesiaSyncope, Syncope vasovagal, Dizziness postural, Akathisia, Dysgeusia, Hypersomnia, Lethargy, Sedation, Depressed level of consciousnessDizziness exertional, Sudden onset of sleep
Eye disordersVision blurredMydriasis, Eye pain, Visual disturbanc
Ear and labyrinth disordersTinnitusVertigo
Cardiac disordersSinus arrest, Sinus bradycardia, Tachycardia
Vascular disordersFlushingHypotension, Systolic hypertension, Hot flush
Respiratory, thoracic and mediastinal disordersSinus congestion, YawningDyspnoea, Epistaxis
Gastrointestinal disordersNauseaDiarrhoea, Vomiting, Constipation, Abdominal pain, Abdominal pain upper, Dyspepsia, Flatulence, Stomach discomfort, Abdominal distension, Dry mouthAbdominal discomfort, Gastric discomfortDefecation urgency
Skin and subcutaneous tissue disordersHyperhidrosisPruritis, Cold sweat
Reproductive system and breast disordersErectile dysfunctionEjaculation failure, Male orgasmic disorder, Paraethesia of genital male
General disorders and administration site conditionsFatigue, IrritabilityAsthenia, Feeling hot, Feeling jittery, Feeling abnormal, Feeling drunk
InvestigationsBlood pressure increasedHeart rate increased, Blood pressure diastolic increased, Blood pressure orthostatic increased

Adverse drug reactions reported in the 9-month long−term open−label extension trial were consistent with those reported in the double−blind studies and no additional adverse drug reactions were reported.

 

Description of selected adverse reactions

Syncope characterized as loss of consciousness, with bradycardia or sinus arrest observed in patients wearing Holter monitors, has been reported in clinical trials and is considered medicinal product-related. The majority of cases occurred during the first 3 hours after dosing, after the first dose or associated with study-related procedures in the clinical setting (such as blood draw and orthostatic manoeuvres and blood pressure measurements). Prodromal symptoms often preceded the syncope
The occurrence of syncope and possibly prodromal symptoms appears dose dependent as demonstrated by higher incidence among patients treated with higher than recommended doses in Phase 3 clinical trials.
Orthostatic hypotension has been reported in clinical trials. The frequency of syncope characterized as loss of consciousness in the Priligy clinical development program varied depending on the population studied and ranged from 0.06% (30 mg) to 0.23% (60 mg) for subjects enrolled in the Phase 3 placebo-controlled clinical trials to 0.64% (all doses combined) for Phase 1 non-PE healthy volunteer studies.

 

Other special populations

Caution is advised if increasing the dose to 60 mg in patients taking potent CYP2D6 inhibitors or if increasing the dose to 60 mg in patients known to be of CYP2D6 poor metabolizer.

 

Withdrawal effects

Abrupt discontinuation of chronically administered SSRIs used to treat chronic depressive disorders has been reported to result in the following symptoms: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g. paraesthesia such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia and hypomania.
Results of a safety study showed a slightly higher incidence of withdrawal symptoms of mild or moderate insomnia and dizziness in subjects switched to placebo after 62 days of daily dosing.

 

Reporting of suspected adverse reactions

Reporting of all suspected adverse reactions is important. It allows for continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals and patients are asked to report any suspected adverse reactions via the Yellow Card Scheme.
You can find out more information about the Yellow Card Scheme by clicking here.

Order treatment

Orlistat

From: £53.00

Priligy

From: £24.00

Propecia

From: £64.99

Finasteride

From: £17.99

Is there anything else I need to know about Priligy?

This medicine may make you sleepy. If this happens, do not drive or use tools or machines. Do not drink alcohol.
You should also swallow this medicine whole with at least a full glass of water. Do not crush or chew the tablet.
A physical examination may be needed before treatment with Priligy can be initiated.
Whilst on Priligy, if you experience symptoms like light-headedness soon after standing, you should immediately lie down flat but ensure that your head is lower than the rest of your body or sit down with your head between his knees until the symptoms pass. Also, you should not get up quickly after prolonged lying or sitting.
Due to risks of symptoms like dizziness and light-headedness occurring, it is advisable to avoid situations that could lead to an injury like driving or operating hazardous machinery.
You should not take any alcohol whilst on Priligy. This is because the Priligy-alcohol combination increases the risks of alcohol-related neurocognitive effects and may also enhance neurocardiogenic effects like syncope, thereby increasing the risk of injury occurring. Syncope is a temporary loss of consciousness due to a sudden drop in blood pressure. Self-rated alertness has been reported as being significantly decreased when alcohol is taken with Priligy.

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If you would like more information about Priligy, please click here to fill out our contact form. Alternatively, you can call us on 01625 460 621.
Should you need urgent medical assistance, please dial 999.

 

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References

  1. https://www.medicines.org.uk/emc/search?q=%22Priligy%22
  2. https://www.medicines.org.uk/emc/product/1269/smpc#EXCIPIENTS
  3. https://bnf.nice.org.uk/medicinal-forms/dapoxetine.html
  4. https://www.assuredpharmacy.co.uk/shop/priligy-dapoxetine
  5. https://www.medicines.org.uk/emc/product/1269/smpc#INDICATIONS
  6. https://www.medicines.org.uk/emc/product/1269/smpc#POSOLOGY
  7. https://www.medicines.org.uk/emc/product/1269/smpc#CLINICAL_PRECAUTIONS

Assured Pharmacy is not liable for the currency or accuracy of the information contained in this blog post. For specific information about your personal medical condition, please contact our doctors or pharmacists for advice on [email protected]