Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets)

1. Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) © The Swiss Pharmacy

2. Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) Super Tadarise (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) is a combination medication containing Tadalafil 20mg and Dapoxetine 60mg in a single tablet. Super Tadarise is used for the treatment of male erectile dysfunction as well as treatment of premature ejaculation in adult men, when treatment of both indications are required at the same time. © The Swiss Pharmacy

3. Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) Super Tadarise Tablets are manufactured by Sunrise Remedies Private Limited, India in the strength of 80 mg and 100 mg (as Extra Super Tadarise). © The Swiss Pharmacy

4. Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) Chemical Structure - Tadalafil © The Swiss Pharmacy

5. Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) Chemical Structure - Dapoxetine Hydrochloride © The Swiss Pharmacy

6. Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) The active ingredient contained in Super Tadarise tablets as well as Extra Super Tadarise are Tadalafil and Dapoxetine Hydrochloride. Each Super Tadarise tablet contains 20 mg of Tadalafil and 60 mg of Dapoxetine. Each Extra Super Tadarise tablet contains 40 mg of Tadalafil and 60 mg of Dapoxetine. © The Swiss Pharmacy

7. Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) Uses of Super Tadarise 80 mg Tablets: The medical effect produced by Super Tadarise tablets is due to it's two components: Tadalafil and Dapoxetine Hydrochloride. Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor used for the treatment of Erectile Dysfunction (ED). Dapoxetine Hydrochloride is indicated for the treatment of premature ejaculation (PE) in adult men aged 18 to 64 years. Dapoxetine Hydrochloride should only be prescribed to patients who meet all the following criteria: An intravaginal ejaculatory latency time (IELT) of less than two minutes; and persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes; and marked personal distress or interpersonal difficulty as a consequence of PE; and poor control over ejaculation as well as a history of premature ejaculation in the majority of intercourse attempts over the prior 6 months. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html © The Swiss Pharmacy

8. Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) Recommended Adult Dosage The dose of Super Tadarise Tablets Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Tablets) is one tablet once a day, with or without meals. The tablet has to be administered one to three hours before sexual activity. Do not take more than 1 tablet in any 24 hour period. i.e. At least 24 hours should pass before you take the next dose. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html © The Swiss Pharmacy

9. Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) Contraindications ➔Super Tadarise is contraindicated in patients with a known hypersensitivity to Tadalafil , Dapoxetine Hydrochloride or any component of the tablet. ➔Administration of Super Tadarise to patients using any form of organic nitrate is contraindicated. Tadalafil was shown to potentiate the hypotensive effect of nitrates. ➔Administration of this medicine to patients with significant pathological cardiac conditions is contraindicated. ➔A history of mania or severe depression. ➔Concomitant treatment with thioridazine, or within 14 days of discontinuing treatment with Thioridazine. Similarly, Thioridazine should not be administered within 7 days after Super Tadarise has been discontinued. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html © The Swiss Pharmacy

10. Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) Contraindications ➔Concomitant treatment with serotonin reuptake inhibitors [selective serotonin reuptake inhibitors (SSRIs), serotonin- norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs)] or other medicinal/herbal products with serotonergic effects [e.g., L-tryptophan, triptans, tramadol, linezolid, lithium, St. John's Wort (Hypericum perforatum)] 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 Super Tadarise has been discontinued. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html © The Swiss Pharmacy

11. Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) Storage Instructions Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html © The Swiss Pharmacy

12. Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) Warnings Patients must not be administered Super Tadarise if sex is inadvisable due to cardiovascular status. Taking Super Tadarise with alpha blockers, antihypertensives or substantial amounts of alcohol (5 units or greater) may lead to hypotension. Super Tadarise is not recommended in combination with alpha blockers for the treatment of BPH because efficacy of the combination has not been adequately studied and because of the risk of blood pressure lowering. Caution is advised when Super Tadarise is used as a treatment for ED in men taking alpha blockers. Super Tadarise is not suitable and must not be used if taking potent inhibitors of CYP3A4. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html © The Swiss Pharmacy

13. Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) Warnings Patients should seek emergency treatment if an erection lasts for more than 4 hours. Use Super Tadarise with caution in patients predisposed to priapism. Patients must stop taking Super Tadarise and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of Non Arteritic Ischemic Optic Neuropathy (NAION). Discuss increased risk of NAION in patients with history of NAION. Patients must stop Super Tadarise tablets and seek prompt medical attention in the event of sudden decrease or loss of hearing. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html © The Swiss Pharmacy

14. Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) Warnings Dapoxetine, a constituent of Super Tadarise is only indicated in men with Premature Ejaculation who meet all the criteria listed listed earlier. Hence Super Tadarise must not be prescribed to men who have not been diagnosed with Premature Ejaculation. Before starting treatment, a careful medical examination including history of orthostatic events should be performed by the physician. 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 Super Tadarise must be avoided. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html © The Swiss Pharmacy

15. Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) Warnings Antidepressants, including SSRIs, increased the risk compared to placebo of suicidal thinking and suicidality in short-term studies in children and adolescents with Major Depressive Disorder and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24. In clinical trials with Dapoxetine, a constituent of Super Tadarise for the treatment of premature ejaculation, there was no clear indication of treatment-emergent suicidality in evaluation of possibly suicide-related adverse events. Patients should avoid operating hazardous machinery, should syncope or its prodromal symptoms such as dizziness or lightheadedness occur. The risk of adverse cardiovascular outcomes from syncope (cardiac syncope and syncope from other causes) is increased in patients with underlying structural cardiovascular disease. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html © The Swiss Pharmacy

16. Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) Warnings Patients should be advised not to use Super Tadarise in combination with recreational drugs. Patients should be advised not to use Super Tadarise 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 Super Tadarise. Super Tadarise 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html © The Swiss Pharmacy

17. Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) Warnings This medicine is not suitable in patients taking moderate CYP3A4 inhibitors and in patients taking potent CYP2D6 inhibitors since the Dapoxetine dose is restricted to 30 mg. Super Tadarise 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. Due to the potential of SSRIs to lower the seizure threshold, Super Tadarise should be discontinued in any patient who develops seizures and avoided in patients with unstable epilepsy. Patients with controlled epilepsy should be carefully monitored. Super Tadarise should not be used in individuals below 18 years of age. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html © The Swiss Pharmacy

18. Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) Warnings Super Tadarise is not indicated for psychiatric disorders and should not be used in men with these disorders, such as schizophrenia, or in those suffering with co-morbid depression, as worsening of symptoms associated with depression cannot be excluded. There have been reports of bleeding abnormalities with SSRIs. Caution is advised in patients taking Super Tadarise, particularly in concomitant use with medicinal products known to affect platelet function or anticoagulants, as well as in patients with a history of bleeding or coagulation disorders. Super Tadarise is not recommended for use in patients with severe renal impairment and caution is advised in patients with mild or moderate renal impairment. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html © The Swiss Pharmacy

19. Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) Super Tadarise Tablets and Alcohol Avoid alcohol while you are taking this medicine as both Tadalafil and Dapoxetine interact with alcohol. Do not drink excessive amounts of alcohol (eg, 5 or more glasses of wine or 5 or more shots of whiskey) when taking Tadalafil. When taken in excess, alcohol can increase your chances of getting a headache or dizziness, increase your heart rate, or lower your blood pressure. The effects of alcohol, such as dizziness, drowsiness, slow reflexes or impaired judgement, may be increased if taken with Dapoxetine. Make sure you are not dehydrated (don't have enough water in your body). URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html © The Swiss Pharmacy

20. Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) Driving And Using Machines You may feel sleepy, dizzy, faint, have difficulty concentrating and blurred vision while taking this medicine. If you experience any of these or similar effects, you should avoid driving or operating hazardous machinery. The effects of alcohol may be increased if taken with this medicine and you may be more at risk of injury from fainting or from other side effects if you take this medicine with alcohol. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html © The Swiss Pharmacy

21. Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) 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., paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia and hypomania. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html © The Swiss Pharmacy

22. Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) Possible Side Effects Most common side effects of Tadalafil Dapoxetine Combination tablets (Super Tadarise) include increased thirst and a light- headedness following sudden movements - this is natural, as blood moves into the genital areas. The common side effects include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, nausea, dizziness, diarrhoea, insomnia, fatigue and pain in limb. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html © The Swiss Pharmacy

23. Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) Super Tadarise Tablets Overdosage Single doses up to 500 mg of Tadalafil have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients. Adverse events were similar to those seen at lower doses. In cases of overdose, standard supportive measures should be adopted as required. Hemodialysis contributes negligibly to Tadalafil elimination. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html © The Swiss Pharmacy

24. Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) Super Tadarise Tablets Overdosage No case of Dapoxetine overdose has been reported. There were no unexpected adverse events in a clinical pharmacology study of Dapoxetine 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 Dapoxetine are known. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html © The Swiss Pharmacy

25. Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) Super Tadarise Tablets During Pregnancy Super Tadarise is a combination medication containing Tadalafil and Dapoxetine Hydrochloride. Tadalafil has been classified by the US FDA as Pregnancy Category B. Dapoxetine Hydrochloride has been classified by the US FDA as Pregnancy Category C. Super Tadarise tablets are not indicated for use by women. There is no evidence to suggest that Dapoxetine Hydrochloride exposure has an effect on a partner's pregnancy based on limited observational data obtained from the clinical trial database. There are no adequate and well-controlled studies of Tadalafil or Dapoxetine conducted in pregnant women. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html © The Swiss Pharmacy

26. Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) Super Tadarise Tablets During Nursing Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) is not indicated for use by women. Tadalafil and/or its metabolites were secreted into the milk in lactating rats at concentrations approximately 2.4-fold greater than found in the plasma. It is not known if either Dapoxetine or its metabolites are excreted in human breast milk. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html © The Swiss Pharmacy

27. Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) Super Tadarise Tablets Super Tadarise Tablets (Generic Tadalafil and Dapoxetine Hydrochloride Tablets) are manufactured by Sunrise Remedies Private Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9753_Super-Tadarise-Tablets.html © The Swiss Pharmacy