Ukraine Product

Wonder Tablets

Wonder Tablets

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:
Treatment of premature ejaculation (PE) in men 18 to 64 years of age.

When you should consult your doctor?

You should consult your doctor if you experience any of the following:

    • Psychiatric adverse reactions: depression, change of mood, depressed mood, euphoria, nervousness, disturbance, agitation, anxiety, indifference, apathy, confusional state, disorientation, abnormal thinking, somatosensory amplification, sleep disturbances, initial insomnia (sleep disturbance),  middle insomnia sleep disturbances, nightmares, unusual dreams, insomnia, bruxism (gnashing of teeth during sleep), decreased libido, anorgasmia, increased alertness (vigilance), anxiety.
    • Nervous system adverse reactions: dizziness, headache, somnolence, disturbance in attention, tremor, paraesthesia, syncope condition, vasovagal syncope, postural dizziness, akathisia, dysgeusia, hypersomnia, lethargy, atony, sedation, depressed level of consciousness, exertional dizziness, sudden onset of sleep
    • Eye adverse reactions: blurred vision, mydriasis, eye pain, visual disturbance.
    • Ear and equilibration adverse reactions: tinnitus, vertigo.
    • Cardiovascular system adverse reactions: dermahemia, “flushes”, hypotension, orthostatic hypotension, orthostatic hypertension, increased BP, systolic hypertension, diastolic hypertension, refusal of sinoatrial node (sinus arrest), sinus bradycardia, tachycardia.
    • Respiratory system adverse reactions: sinus congestion, yawning.
    • Gastrointestinal adverse reactions: dry mouth, nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, flatulence, abdominal discomfort, defecation urgency.
    • Skin and subcutaneous tissue adverse reactions: skin rashes, hyperhidrosis, pruritus, cold sweat.
    • Reproductive system and breast adverse reactions: erectile dysfunction, abnormal ejaculation, male orgasmic disorders, paresthesia of male genital area.
    • Immune system adverse reactions: allergic reactions.
    • General adverse reactions: weakness, fatigue, asthenia, irritability, hot flashes, anxiety, cacesthesia, abnormal sensation, feeling of intoxication, withdrawal syndrome.

WHAT TO DO IF YOU MISS A DOSE?

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise take it as soon as you remember and then go back to taking it as you would normally.

Things you MUST NOT DO while on this medicine?

Wonder is only indicated in men with known premature ejaculation. Safety has not been established and there are no data on the ejaculation-delaying effects in men without known premature ejaculation.
Other forms of sexual dysfunction.
Subjects with other forms of sexual dysfunction, including erectile dysfunction (ED) should be carefully examined by a doctor before starting the treatment. Wonder should not be administered to men with ED who use PDE5 inhibitors.
Orthostatic hypotension.
To identify the susceptibility to orthostatic hypotension, careful medicinal observation of patient, including orthostatic test (measurement of blood pressure and heart-rate variation while resting supine and standing) should be performed before initiating therapy. In case of a history of documented or suspected orthostatic reaction, treatment with Wonder should be avoided.
The prescriber should counsel the patient in advance about the necessary measures required in case of prodromal symptoms of orthostatic hypotension (e.g. dizziness when standing). Particularly, in case of orthostatic hypotension the patient should immediately lie down so his head is lower than the rest of his body or sit down with his head between his knees until the symptoms pass. The prescriber should also inform the patient not to rise quickly after prolonged lying or sitting.
Suicide/suicidal thoughts.
There are no adequate data on a possible risk of suicidal behavior among adults treated with dapoxetine.
Syncope.
Prior to initiating treatment, patient should be cautioned about the syncope that may occur at any moment during the treatment with Wonder® with or without prodromal symptoms (nausea, dizziness, diaphoresis, palpitations, asthenia, confusion). Prodromal symptoms generally occur within the first 3 hours following dosing, and often precede the syncope. Prior to initiating therapy with Wonder®, prescriber should counsel patient about the importance of maintaining adequate hydration and about how to recognize prodromal signs and symptoms to decrease the possibility of serious injury associated with falls due to loss of consciousness.
The prescriber should counsel the patient in advance about the necessary measures required in case of prodromal symptoms of syncope. Particularly, if the patient experiences possibly prodromal symptoms, the patient should immediately lie down so his head is lower than the rest of his body or sit down with his head between his knees until the symptoms pass. Also, prescriber should warn patient to avoid situations where injury may occur, including driving or operating hazardous machinery, in case of syncope or other CNS effects.
Patients with cardiovascular risk factors.
The risk of adverse cardiovascular outcomes from syncope is increased in patients with organic diseases of cardiovascular system (coronary heart disease, heart disease, valvular heart disease, carotid artery stenosis).
Concomitant use with recreational drugs. 
Patients should be advised not to use Wonder in combination with recreational drugs. Recreational drugs with serotonergic activity (ketamine, methylene dioxymethamphetamine (MDMA) and lysergic acid diethylamide (LSD)), may lead to potentially serious reactions (arrhythmia, hyperthermia, serotonin syndrome and etc.) if combined with Wonder. Simultaneous use of Wonder and recreational drugs with sedative properties (hypnotics and benzodiazepines) may further increase clinical signs of somnolence and dizziness.
Ethanol.
Combining alcohol with Wonder may increase alcohol−related effects of CNS, and may also lead to occurrence of neurocardiogenic adverse events (syncope), thereby increasing the risk of accidental injury. Therefore, patients should be advised to avoid alcohol while taking Wonder.
Medicinal products with vasodilatation properties.
Wonder should be prescribed with caution in patients taking medicinal products with vasodilatation properties (alpha-adrenergic receptor antagonists, nitrates) due to possible reduced orthostatic tolerance.
Moderate CYP3A4 inhibitors.
The dose should be restricted to 30 mg in patients concomitantly treated with Wonder and moderate CYP3A4 inhibitors.
Potent CYP2D6 inhibitors.
Caution is advised if increasing the dose of Wonder 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 genotype, as this may increase exposure levels, which may result in a higher incidence and severity of dose dependent adverse events.
Mania.
Wonder 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.
Seizures.
Due to the potential of SSRIs to lower the seizure threshold, Wonder should be discontinued in patients with unstable epilepsy. If seizures occur, the drug administration should be discontinued. Patients with controlled epilepsy should be carefully monitored.
Depression and/or psychiatric disorders.
Patient with underlying signs and symptoms of depression should be evaluated prior to treatment with Wonder to exclude undiagnosed depressive disorders. Concomitant treatment of Wonder with antidepressants, including SSRIs and SNRIs, is contraindicated. Discontinuation of treatment for depression or anxiety in order to initiate Wonder is not recommended.
Wonder is not indicated for psychiatric disorders (such as schizophrenia or depression) as worsening of symptoms associated with depression cannot be excluded. Patient should immediately inform the physician about any distressing thoughts or feelings occurring during treatment with Wonder. If signs and symptoms of depression develop during treatment, Wonder should be discontinued.
Hemorrhages.
Bleeding abnormalities (hemorrhages) may occur in case of SSRIs administration. Caution is advised in patients taking Wonder, particularly in concomitant use with medicinal products known to affect platelet function (atypical antipsychotics and phenothiazines, acetylsalicylic acid, NSAIDs, antiplatelet agents) or anticoagulants (warfarin). Also, the drug should be administered with caution in patients with a history of bleeding or coagulation disorders.
Renal impairment.
Wonder is contraindicated for use in patients with severe renal impairment and caution is advised in patients with mild or moderate renal impairment.
Withdrawal effects.
The 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 (paresthesias), anxiety, confusion, headache, atony, emotional lability, insomnia and hypomania.
Eye disorders.
The use of Wonder may be associated with symptoms such as mydriasis and eye pain. Wonder should be used with caution in patients with raised intraocular pressure or those at risk of angle closure glaucoma.
Excipients.
The drug contains lactose. If you have known intolerance to some sugars, consult your doctor before using this medicinal product.

What to do if you accidentally take too much (overdose) of the medicine?

Currently, no case of overdose with dapoxetine has been reported.
Symptoms: somnolence, gastrointestinal disturbances (nausea and vomiting), tachycardia, tremor, agitation and dizziness.
Treatment: standard supportive measures should be adopted as required. Due to high protein binding and large volume of distribution of dapoxetine, forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit. No specific antidote for drug is known.

Is it safe in pregnancy and breast-feeding?

 Wonder is not indicated for use by women.

Storage Conditions:

Store below 25 °С.  Keep out of reach of children.

Drug Description

Qualitative and quantitative composition
1 tablet contains: dapoxetine hydrochloride equivalent to dapoxetine 30 mg or 60 mg;
For a full list of excipients, see section 6.1.

Pharmaceutical form:  Film coated tablets.
Main physicochemical properties:round, biconvex, gray film-coated tablets, smooth on both sides.


Indications and dosage.

Indications
Treatment of premature ejaculation (PE) in men 18 to 64 years of age.

Dosage:
Wonder should be administered orally to adult males 18 to 64 years of age. The whole tablet should be swallowed and washed down with one full glass of water. Take it regardless of meal.
Dosage for adult men aged 18 to 64 years.
The recommended starting dose for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. Treatment should not be initiated with the 60 mg dose.
If 30 mg dose is ineffective and high tolerable, the dose of Wonder tablets may be increased to a dose of 60 mg.
The maximum recommended dose frequency of Wonder tablets is once every 24 hours.
Wonder tablets are not intended for continuous daily use. Wonder should be taken only when sexual activity is anticipated.
Clinical necessity of continuing the treatment with Wonder should be evaluated by the physician after the first four weeks of treatment (or at least after intake of 6 doses) and at least every six months in the future.
Dosage for patients over 65 years.
The drug is contraindicated for patients over 65 years.
Dosage for patients with renal impairment.
The dose adjustment for patients with mild and moderate renal impairment is not required; however, the drug should be administered with caution. The drug is contraindicated for use in patients with severe renal impairment.
Dosage for patients with hepatic impairment.
The dose adjustment for patients with mild hepatic impairment is not required; however, the drug should be administered with caution. The drug is contraindicated in patients with moderate and severe hepatic impairment (Child−Pugh Class B and C).
Dosage for patients with known genotype of CYP2D6 poor metabolizers or patients treated with potent CYP2D6 inhibitors.
Caution is advised if increasing the dose to 60 mg in patients known to be of CYP2D6 poor metabolizer genotype or in patients concomitantly treated with potent CYP2D6 inhibitors.
Dosage for patients treated with moderate or potent inhibitors of CYP3A4.
Concomitant use of potent CYP3A4 inhibitors is contraindicated. The dose should be restricted to 30 mg in patients concomitantly treated with moderate CYP3A4 inhibitors and caution is advised.
Children.
The drug is not indicated for use in treatment of children under the age of 18 years.

Side effects and drug interactions.

Side effect
Psychiatric adverse reactions: depression, change of mood, depressed mood, euphoria, nervousness, disturbance, agitation, anxiety, indifference, apathy, confusional state, disorientation, abnormal thinking, somatosensory amplification, sleep disturbances, initial insomnia (sleep disturbance),  middle insomnia sleep disturbances, nightmares, unusual dreams, insomnia, bruxism (gnashing of teeth during sleep), decreased libido, anorgasmia, increased alertness (vigilance), anxiety.
Nervous system adverse reactions: dizziness, headache, somnolence, disturbance in attention, tremor, paraesthesia, syncope condition, vasovagal syncope, postural dizziness, akathisia, dysgeusia, hypersomnia, lethargy, atony, sedation, depressed level of consciousness, exertional dizziness, sudden onset of sleep
Eye adverse reactions: blurred vision, mydriasis, eye pain, visual disturbance.
Ear and equilibration adverse reactions: tinnitus, vertigo.
Cardiovascular system adverse reactions: dermahemia, “flushes”, hypotension, orthostatic hypotension, orthostatic hypertension, increased BP, systolic hypertension, diastolic hypertension, refusal of sinoatrial node (sinus arrest), sinus bradycardia, tachycardia.
Respiratory system adverse reactions: sinus congestion, yawning.
Gastrointestinal adverse reactions: dry mouth, nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, flatulence, abdominal discomfort, defecation urgency.
Skin and subcutaneous tissue adverse reactions: skin rashes, hyperhidrosis, pruritus, cold sweat.
Reproductive system and breast adverse reactions: erectile dysfunction, abnormal ejaculation, male orgasmic disorders, paresthesia of male genital area.
Immune system adverse reactions: allergic reactions.
General adverse reactions: weakness, fatigue, asthenia, irritability, hot flashes, anxiety, cacesthesia, abnormal sensation, feeling of intoxication, withdrawal syndrome.

Drug interactions
Monoamine oxidase inhibitors.
In patients receiving the selective serotonin reuptake inhibitors SSRIs in combination with a monoamine oxidase inhibitor (MAOI), there have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental functions changes that include extreme agitation progressing to delirium and coma. These reactions may also appear in patients who have recently discontinued an SSRI and have been started on the MAOIs. Some cases presented with features resembling neuroleptic malignant syndrome. Data on the effects of combined use of an SSRI and MAOIs suggest that these medicinal products may act synergistically to elevate blood pressure and evoke nervous irritation. Therefore, Wonder should not be used in combination with MAOIs, or within 14 days of discontinuing treatment with the MAOIs. Similarly, the MAOIs should not be administered within 7 days after Wonder has been discontinued (see section «Contraindications»).
Thioridazine.
Thioridazine administration alone produces prolongation of the QT interval, which is associated with development of serious ventricular arrhythmias. Since Wonder® inhibits the CYP2D6 isoenzyme activity and the metabolism of thioridazine, than elevated levels of thioridazine are expected to augment the prolongation of the QT interval, respectively. Therefore, Wonder should not be used in combination with thioridazine or within 14 days of discontinuing treatment with thioridazine. Similarly, thioridazine should not be administered within 7 days after Wonder® has been discontinued (see section «Contraindications»).
Medicinal and herbal products with serotonergic effects.
Dapoxetine co-administration with serotonergic medicinal/herbal products (such as MAOIs, L-tryptophan, triptans, tramadol, linezolid, SSRIs, SNRIs, lithium and St. John's Wort), as with other SSRIs, may lead to serotonin associated effects. Wonder should not be used concomitantly with other SSRIs, MAOIs, and other serotonergic medicinal/herbal products or within 14 days of discontinuing treatment with these medicinal/herbal products. Similarly, these medicinal/herbal products should not be administered within 7 days after Wonder has been discontinued (see section «Contraindications»).
Medicinal products with effects on CNS.
The concomitant administration of Wonder with CNS active medicinal products (antiepileptics, antidepressants, neuroleptics, depressant drugs, sedative hypnotics) has not been evaluated, so caution is advised if the concomitant administration of Wonder and such medicinal products is required for patients with premature ejaculation.
Effects of co-administered medicinal products on the pharmacokinetics of dapoxetine.
Dapoxetine is metabolized primarily by CYP2D6, CYP3A4 and flavin-containing monooxygenase 1 (FMO1), therefore, inhibitors of these enzymes may reduce dapoxetine clearance.
Potent CYP3A4 inhibitors.
Concomitant administration of Wonder with potent CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nelfinavir and atazanavir) is contraindicated.
Moderate CYP3A4 inhibitors.
Concomitant treatment with moderate CYP3A4 inhibitors (such as erythromycin, clarithromycin, fluconazole, amprenavir, fosamprenavir, aprepitant, verapamil, diltiazem) may also lead to significantly increased exposure of dapoxetine and desmethyldapoxetine, especially in CYP2D6 poor metabolizers. The maximum dose of dapoxetine should be 30 mg if dapoxetine is combined with any of these drugs.
Concerning metabolizers of CYP2D6, the recommended dose is 30 mg if dapoxetine is administered with potent CYP3A4 inhibitor. Caution is advised if administering 60 mg dose of dapoxetine concomitantly with moderate CYP3A4 inhibitor to such patients.
Potent CYP2D6 inhibitors.
Concomitant administration of Wonder with CYP2D6 potent inhibitors may result in a higher incidence and severity of dose dependent adverse events of dapoxetine, especially in patients known to be CYP2D6 poor metabolizers and may result in a higher incidence and severity of dose dependent adverse events (see section «Administration details»).
PDE5 inhibitors.
Concomitant administration of Wonder with PDE5 inhibitors may lead to orthostatic hypotension (see section «Administration details»).
Effects of dapoxetine on pharmacokinetics of co-administered medicinal products.
Tamsulosin.
Concomitant administration of tamsulosin with dapoxetine did not result in changes in the pharmacokinetics of tamsulosin, however, Wonder should be prescribed with caution in patients who use alpha adrenergic receptor antagonists due to possible reduced orthostatic tolerance (see section «Administration details»).
Medicinal products metabolized by CYP2D6.
Dapoxetine may lead to increase in the plasma concentrations of desipramine and other drugs metabolized by CYP2D6, although the clinical relevance of these changes is likely to be negligible.
Medicinal products metabolized by CYP3A4.
Dapoxetine may lead to decrease in the plasma concentrations of midazolam, although the clinical relevance of these changes is likely to be negligible in most patients.
Medicinal products metabolized by CYP2C19.
There are no data on dapoxetine effects on pharmacokinetics of omeprazole and other CYP2C19 substrates.
Medicinal products metabolized by CYP2C9.
There are no data on dapoxetine effects on pharmacokinetics of glyburide and other CYP2C9 substrates.
Warfarin and other drugs that affect coagulation and/or thrombogenesis.
There are no data evaluating the use safety of warfarin with dapoxetine, therefore, caution is advised for patients taking warfarin chronically. There is evidence of dyscrasia associated with administration of SSRI drugs.
Ethanol.
It has been reported that coadministration of dapoxetine with ethanol does not affect the pharmacokinetics of dapoxetine. However, dapoxetine in combination with ethanol may increase somnolence and significantly decrease activity. Moreover, concomitant use of alcohol and dapoxetine increases the possibility or severity of some adverse reactions (dizziness, loss of consciousness, drowsiness, slow reflexes, impaired judgment), thereby increasing the risk of accidental injury. Therefore, patients should be advised to avoid alcohol while taking Wonder.

Warnings and precautions

Wonder is only indicated in men with known premature ejaculation. Safety has not been established and there are no data on the ejaculation-delaying effects in men without known premature ejaculation.
Other forms of sexual dysfunction.
Subjects with other forms of sexual dysfunction, including erectile dysfunction (ED) should be carefully examined by a doctor before starting the treatment. Wonder should not be administered to men with ED who use PDE5 inhibitors.
Orthostatic hypotension.
To identify the susceptibility to orthostatic hypotension, careful medicinal observation of patient, including orthostatic test (measurement of blood pressure and heart-rate variation while resting supine and standing) should be performed before initiating therapy. In case of a history of documented or suspected orthostatic reaction, treatment with Wonder should be avoided.
The prescriber should counsel the patient in advance about the necessary measures required in case of prodromal symptoms of orthostatic hypotension (e.g. dizziness when standing). Particularly, in case of orthostatic hypotension the patient should immediately lie down so his head is lower than the rest of his body or sit down with his head between his knees until the symptoms pass. The prescriber should also inform the patient not to rise quickly after prolonged lying or sitting.
Suicide/suicidal thoughts.
There are no adequate data on a possible risk of suicidal behavior among adults treated with dapoxetine.
Syncope.
Prior to initiating treatment, patient should be cautioned about the syncope that may occur at any moment during the treatment with Wonder® with or without prodromal symptoms (nausea, dizziness, diaphoresis, palpitations, asthenia, confusion). Prodromal symptoms generally occur within the first 3 hours following dosing, and often precede the syncope. Prior to initiating therapy with Wonder®, prescriber should counsel patient about the importance of maintaining adequate hydration and about how to recognize prodromal signs and symptoms to decrease the possibility of serious injury associated with falls due to loss of consciousness.
The prescriber should counsel the patient in advance about the necessary measures required in case of prodromal symptoms of syncope. Particularly, if the patient experiences possibly prodromal symptoms, the patient should immediately lie down so his head is lower than the rest of his body or sit down with his head between his knees until the symptoms pass. Also, prescriber should warn patient to avoid situations where injury may occur, including driving or operating hazardous machinery, in case of syncope or other CNS effects.
Patients with cardiovascular risk factors.
The risk of adverse cardiovascular outcomes from syncope is increased in patients with organic diseases of cardiovascular system (coronary heart disease, heart disease, valvular heart disease, carotid artery stenosis).
Concomitant use with recreational drugs. 
Patients should be advised not to use Wonder in combination with recreational drugs. Recreational drugs with serotonergic activity (ketamine, methylene dioxymethamphetamine (MDMA) and lysergic acid diethylamide (LSD)), may lead to potentially serious reactions (arrhythmia, hyperthermia, serotonin syndrome and etc.) if combined with Wonder. Simultaneous use of Wonder and recreational drugs with sedative properties (hypnotics and benzodiazepines) may further increase clinical signs of somnolence and dizziness.
Ethanol.
Combining alcohol with Wonder may increase alcohol−related effects of CNS, and may also lead to occurrence of neurocardiogenic adverse events (syncope), thereby increasing the risk of accidental injury. Therefore, patients should be advised to avoid alcohol while taking Wonder.
Medicinal products with vasodilatation properties.
Wonder should be prescribed with caution in patients taking medicinal products with vasodilatation properties (alpha-adrenergic receptor antagonists, nitrates) due to possible reduced orthostatic tolerance.
Moderate CYP3A4 inhibitors.
The dose should be restricted to 30 mg in patients concomitantly treated with Wonder and moderate CYP3A4 inhibitors.
Potent CYP2D6 inhibitors.
Caution is advised if increasing the dose of Wonder 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 genotype, as this may increase exposure levels, which may result in a higher incidence and severity of dose dependent adverse events.
Mania.
Wonder 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.
Seizures.
Due to the potential of SSRIs to lower the seizure threshold, Wonder should be discontinued in patients with unstable epilepsy. If seizures occur, the drug administration should be discontinued. Patients with controlled epilepsy should be carefully monitored.

Depression and/or psychiatric disorders.
Patient with underlying signs and symptoms of depression should be evaluated prior to treatment with Wonder to exclude undiagnosed depressive disorders. Concomitant treatment of Wonder with antidepressants, including SSRIs and SNRIs, is contraindicated. Discontinuation of treatment for depression or anxiety in order to initiate Wonder is not recommended.
Wonder is not indicated for psychiatric disorders (such as schizophrenia or depression) as worsening of symptoms associated with depression cannot be excluded. Patient should immediately inform the physician about any distressing thoughts or feelings occurring during treatment with Wonder. If signs and symptoms of depression develop during treatment, Wonder should be discontinued.
Hemorrhages.
Bleeding abnormalities (hemorrhages) may occur in case of SSRIs administration. Caution is advised in patients taking Wonder, particularly in concomitant use with medicinal products known to affect platelet function (atypical antipsychotics and phenothiazines, acetylsalicylic acid, NSAIDs, antiplatelet agents) or anticoagulants (warfarin). Also, the drug should be administered with caution in patients with a history of bleeding or coagulation disorders.
Renal impairment.
Wonder is contraindicated for use in patients with severe renal impairment and caution is advised in patients with mild or moderate renal impairment.
Withdrawal effects.
The 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 (paresthesias), anxiety, confusion, headache, atony, emotional lability, insomnia and hypomania.
Eye disorders.
The use of Wonder may be associated with symptoms such as mydriasis and eye pain. Wonder should be used with caution in patients with raised intraocular pressure or those at risk of angle closure glaucoma.
Excipients.
The drug contains lactose. If you have known intolerance to some sugars, consult your doctor before using this medicinal product.


Overdosage and Contraindications

Overdose
Currently, no case of overdose with dapoxetine has been reported.
Symptoms: somnolence, gastrointestinal disturbances (nausea and vomiting), tachycardia, tremor, agitation and dizziness.
Treatment: standard supportive measures should be adopted as required. Due to high protein binding and large volume of distribution of dapoxetine, forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit. No specific antidote for drug is known.

Contraindication
Hypersensitivity to active substance or to any of the excipients.
Cardiovascular diseases:

  • heart failure (NYHA class II-IV);
  • conduction abnormalities (AV-block, sick sinus syndrome);
  • ischemic heart disease;
  • valvular heart disease.

Moderate and severe hepatic impairment.
History of syncope conditions.
History of psychiatric disorders (mania, severe depression).
Moderate and severe hepatic failure.
Severe renal dysfunction.
Concomitant treatment with the following drugs:

    • potent CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nelfinavir, atazanavir, etc).
    • monoamine oxidase inhibitors (MAOIs);
    • thioridazine;
    • serotonin reuptake inhibitors (selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, tricyclic antidepressants) or other medicinal or herbal products with serotonergic effects (e.g., L-tryptophan, triptans, tramadol, linezolid, lithium, St. John’s Wort).

Clinical pharmacology.

PHARMACOLOGICAL PROPERTIES.  
Pharmacotherapeutic group: Agents used in urology. Other remedies used in urology.
АТC code G04B X14.
Pharmacodynamics
Mechanism of action.
Dapoxetine and its major metabolites, desmethyldapoxetine (DED) and didesmethyldapoxetine are potent selective serotonin reuptake inhibitors (SSRIs).
The mechanism of action of dapoxetine in premature ejaculation (PE) is presumed to be linked to the inhibition of neuronal reuptake of serotonin and the subsequent potentiation of the neurotransmitter actions on presynaptic and postsynaptic receptors.

Pharmacokinetics
Absorption
Dapoxetine is rapidly absorbed with maximum plasma concentrations (Cmax) occurring approximately 1-2 hours after ingestion. The absolute bioavailability of dapoxetine is 42% (15 to 76%).  The effect of food on dapoxetine absorption is negligible. Dose-dependent increases in both Cmax and “area under the curve” (AUC) indicants have been observed after single doses of dapoxetine 30 mg and 60 mg. Following multiple doses of dapoxetine 30 mg and 60 mg, AUC values increase by approximately 50% (for both dapoxetine and desmethyldapoxetine). 

Distribution
More than 99% of dapoxetine and 98.5% of desmethyldapoxetine are bound in vitro to human serum proteins. Dapoxetine has a mean steady state volume of distribution of 162 L.
Metabolism
Enzyme systems of the liver and kidneys participate in dapoxetine metabolism. Unchanged dapoxetine and its metabolites: dapoxetine−N−oxide, desmethyldapoxetine and didesmethyldapoxetine circulate in plasma.
Elimination
The metabolites of dapoxetine are primarily eliminated in the urine as conjugates. Following oral administration, dapoxetine has an initial plasma half-life of approximately 1.5 hours and a terminal half-life of approximately 19 hours. Plasma concentration of the drug was approximately 5% of peak concentration by 24 hours post-dose.
Pharmacokinetics in special populations
Elderly patients (65 years and over)
There are no significant differences in pharmacokinetic parameters of dapoxetine between elderly and young patients.
Patients with renal impairment
No significant changes in dapoxetine pharmacokinetics have been reported in patients with mild to moderate chronic renal failure. Data on changes in pharmacokinetic parameters in patients with acute renal failure and those who receiving hemodialysis are limited.
Patients with hepatic impairment
There are data that in patients with mild and severe hepatic impairment, pharmacokinetics of dapoxetine and its active metabolites are changed significantly. Thus, use of dapoxetine is contraindicated in this population.

Patients with polymorphism of CYP2D6 enzyme
The pharmacokinetics of dapoxetine and desmethyldapoxetine in poor metabolizers of CYP2D6 differs significantly from similar parameters, observed in extensive metabolizers of CYP2D6. Particularly, poor metabolizers of CYP2D6 show increased Cmax and AUC pharmacokinetic parameters. This increase may induce more frequent and severe adverse reactions. Moreover, simultaneous administration of Wonder with CYP2D6 inhibitors may also lead to serious adverse reactions in poor metabolizers of CYP2D6.
PHARMACEUTICAL PARTICULARS
List of excipients
lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, magnesium stearate, coating Opadry 03K575000 gray: hypromellose, titanium dioxide (E 171), triacetin, iron oxide black (E 172), iron oxide yellow (E 172).
 Incompatibilities
Not applicable
Shelf life
2 years.
Special precautions for storage
Store below 25 °С.  Keep out of reach of children.
Nature and contents of container
1 or 4 tablets are in blister; 1 blister is in a carton pack.
Special precautions for disposal and other handling
Not applicable
MARKETING AUTHORISATION HOLDER
KUSUM HEALTHCARE PVT LTD.

CERTIFICATES

KEEP IN TOUCH

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INDIA
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