Dapoxy (D-force) 10x60mg - Dapoxetine

Administration

To get the best from your D-Force 60 mg treatment, please read the following carefully:

The recommended starting dose for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. Treatment with D-Force 60 mg should not be initiated with the 60 mg dose. Tablets should be swallowed whole to avoid the bitter taste.

This premature ejaculation medicine will become effective within 30 to 60 minutes. Effective treatment time is up to 12 hours. It is recommended that tablets are swallowed whole with a full glass of water. D-Force 60 mg can be taken either with or without food. D-Force 60 mg should not be taken more than once every 24 hours and is not intended for continuous daily use. D-Force 60 mg should be taken only when sexual activity is anticipated.

If the individual response to 30 mg is insufficient and the patient has not experienced moderate or severe adverse reactions or prodromal symptoms suggestive of syncope, the dose may be increased to a maximum recommended dose of 60 mg taken as needed. The incidence and severity of adverse events is higher with the 60 mg dose.

Read the Patient Information Leaflet if available from your pharmacist before you start taking D-Force 60 mg from Zenit Pharmaceutical Industries Pvt. Ltd. and each time you get a refill.

If you have any questions, ask your doctor or pharmacist.

Side effects

Along with its needed effects, D-Force 60 mg may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Commonly reported side effects of D-Force 60 mg include: headache, dizziness, flushing and nausea. See below for a comprehensive list of adverse effects.

Common side effects

• dizziness
• headache
• nausea
• flushing
• anxiety
• agitation
• restlessness
• insomnia
• abnormal dreams
• libido decreased
• vision blurred
• diarrhoea
• vomiting
• blood pressure increased

Uncommon side effects

The following side effects of D-Force 60 mg may occur that usually do not need medical attention. These side effects are not dangerous and may normally diminish as your body adjusts to the medicine. Patients presenting with these side effects generally do not need to stop taking D-Force 60 mg.

Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• depression
• euphoric mood
• nervousness
• apathy
• confusional state
• disorientation
• sleep disorder
• insomnia
• nightmare
• loss of libido
• anorgasmia
• eye pain
• visual disturbance
• vertigo
• tachycardia
• hypotension
• systolic hypertension
• hot flush
• cold sweat
• ejaculation failure
• heart rate increased
• blood pressure diastolic increased

Rare serious side effects

Although serious side effects are rare, if you experience any the following serious side effects, stop taking D-Force 60 mg and seek emergency medical care immediately.

• dizziness exertiona
• sudden onset of sleep
• defecation urgency

D-Force 60 mg has minor or moderate influence on the ability to drive and use machines. Dizziness, disturbance in attention, syncope, blurred vision and somnolence have been reported in subjects receiving dapoxetine in clinical trials. Therefore, patients should be warned to avoid situations where injury could result, including driving or operating hazardous machinery.

Combining alcohol with dapoxetine may increase alcohol-related neurocognitive effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking D-Force 60 mg.

Warning

D-Force 60 mg should not be prescribed to men who have not been diagnosed with Premature Ejaculation.

D-Force 60 mg should not be used in men with erectile dysfunction (ED) who are using PDE5 inhibitors.

An orthostatic test should be performed before initiating therapy (blood pressure and pulse rate, supine and standing). In case of a history of documented or suspected orthostatic reaction, treatment with D-Force 60 mg should be avoided.

Patients should be cautioned to avoid situations where injury could result, including driving or operating hazardous machinery, should syncope or its prodromal symptoms such as dizziness or lightheadedness occur. 

Possibly prodromal symptoms, such as:

• nausea
• dizziness
• lightheadedness
• palpitations
• asthenia
• confusion and diaphoresis

The symptoms generally occurred within the first 3 hours following dosing, and often preceded the syncope. Patients need to be made aware that they could experience syncope at any time with or without prodromal symptoms during their treatment with D-Force 60 mg. It is important to maintaining adequate hydration and how to recognize prodromal signs and symptoms to decrease the likelihood of serious injury associated with falls due to loss of consciousness.

The risk of adverse cardiovascular outcomes from syncope (cardiac syncope and syncope from other causes) is increased in patients with underlying structural cardiovascular disease (e.g., documented outflow obstruction, valvular heart disease, carotid stenosis and coronary artery disease).

Patients should be advised not to use D-Force 60 mg in combination with recreational drugs. Recreational drugs with serotonergic activity such as ketamine, methylenedioxymethamphetamine (MDMA) and lysergic acid diethylamide (LSD) may lead to potentially serious reactions if combined with D-Force 60 mg. These reactions include, but are not limited to, arrhythmia, hyperthermia, and serotonin syndrome. Use of D-Force 60 mg with recreational drugs with sedative properties such as narcotics and benzodiazepines may further increase somnolence and dizziness.

D-Force 60 mg should not be used in patients with a history of mania/hypomania or bipolar disorder and should be discontinued in any patient who develops symptoms of these disorders.

Patients should be advised not to use D-Force 60 mg in combination with alcohol. Combining alcohol with dapoxetine may increase alcohol-related neurocognitive effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking D-Force 60 mg.

D-Force 60 mg should be prescribed with caution in patients taking medicinal products with vasodilatation properties (such as alpha adrenergic receptor antagonists and nitrates) due to possible reduced orthostatic tolerance.

D-Force 60 mg should not be used below 18 years of age.

Contraindications

Patients taking this medicine types should NOT take D-Force 60 mg:

• SSRI in combination with a monoamine oxidase inhibitor (MAOI)
• recreational drugs (ketamine, methylenedioxymethamphetamine (MDMA) and lysergic acid diethylamide (LSD))
• thioridazine
• serotonergic medicinal/herbal products (including MAOIs, L-tryptophan, triptans, tramadol, linezolid, SSRIs, SNRIs, lithium and St. John's Wort)
• CNS active medicinal products (e.g., antiepileptics, antidepressants, antipsychotics, anxiolytics, sedative hypnotics)
• potent CYP3A4 inhibitors
• potent CYP2D6 inhibitors
• PDE5 inhibitors due to possible reduced orthostatic tolerance
• tamsulosin
• medicinal products metabolized by CYP2D6
• medicinal products metabolized by CYP3A4
• medicinal products metabolized by CYP2C19
• medicinal products metabolized by CYP2C9
• warfarin
• dapoxetine in combination with alcohol increased somnolence and significantly decreased self-rated alertness

Patients taking any of the above medicines should wait 14 days after discontinuing treatment before taking D-Force 60 mg. Patients should stop taking D-Force 60 mg at least 7 days prior to starting treatment on any of the above medicines.

How it works

Dapoxetine is a short-acting selective serotonin reuptake inhibitor (SSRI) marketed for the treatment of premature ejaculation in men. Human ejaculation is primarily mediated by the sympathetic nervous system. The ejaculatory pathway originates from a spinal reflex centre, mediated by the brain stem, which is influenced initially by a number of nuclei in the brain (medial preoptic and paraventricular nuclei).

The mechanism of action of dapoxetine in premature ejaculation is presumed to be linked to the inhibition of neuronal reuptake of serotonin and the subsequent potentiation of the neurotransmitter's action at pre– and postsynaptic receptors.

Dapoxetine inhibits the ejaculatory expulsion reflex by acting at a supraspinal level within the lateral paragigantocellular nucleus (LPGi). Postganglionic sympathetic fibers that innervate the seminal vesicles, vas deferens, prostate, bulbourethral muscles and bladder neck cause them to contract in a coordinated fashion to achieve ejaculation. Dapoxetine has the ability to lengthen the time between sexual arousal and climax.

Ingestion of a high fat meal modestly reduced the Cmax and modestly increased the AUC of dapoxetine and slightly delayed the time for dapoxetine to reach peak concentrations. These changes are not clinically significant. D-Force 60 mg can be taken with or without food.

Tips

Do not take more than one dose of D-Force 60 mg per day.

It is recommended that tablets be taken with at least one full glass of water.

D-Force 60 mg is only indicated in men with premature ejaculation. D-Force 60 mg should not be prescribed to men who have not been diagnosed with premature ejaculation. There are no data on the ejaculation-delaying effects in men without premature ejaculation.

Always talk to your doctor before taking ANY medication for premature ejaculation.

D-Force 60 mg should not be used in men with erectile dysfunction (ED) who are using PDE5 inhibitors.

Do not take D-Force 60 mg if you are also taking:

• antiepileptics
• antidepressants
• antipsychotics
• anxiolytics
• sedative hypnotics

Do not take D-Force 60 mg with recreational drugs such as:

• ketamine
• methylenedioxymethamphetamine (MDMA)
• lysergic acid diethylamide (LSD)

Always buy your medications from a reputable supplier as there are a lot of counterfeit products on the market.

Certain lifestyle and psychological factors, such as smoking, drinking, and stress, can impact on premature ejaculation.

Eliminating these may also help improve the ejaculation, for example:

• staying more active
• losing weight if you are overweight
• reducing alcohol intake
• stopping smoking and reducing stress

Combining alcohol with dapoxetine may increase alcohol-related neurocognitive effects and may also enhance neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking D-Force 60 mg.