Tadali Superb Tablets (Tadalafil and Dapoxetine Hydrochloride Tablets)

1. Tadali Superb Tablets (Tadalafil and Dapoxetine Hydrochloride Tablets) © The Swiss Pharmacy

2. Tadali Superb Tablets (Tadalafil and Dapoxetine Hydrochloride Tablets) Tadali Superb (Tadalafil and Dapoxetine Tablets) is a combination medication containing Tadalafil 20mg and Dapoxetine 60mg in a single tablet. Tadali Superb is used for the treatment of male erectile dysfunction as well as treatment of premature ejaculation in men at the same time. © The Swiss Pharmacy

3. Tadali Superb Tablets (Tadalafil and Dapoxetine Hydrochloride Tablets) Tadali Superb Tablets are manufactured by Alpha-Pharma Healthcare Limited, India in the strength of 80 mg (Tadalafil 20 mg and Dapoxetine 60 mg). © The Swiss Pharmacy

4. Tadali Superb Tablets (Tadalafil and Dapoxetine Hydrochloride Tablets) Chemical Structure - Tadalafil © The Swiss Pharmacy

5. Tadali Superb Tablets (Tadalafil and Dapoxetine Hydrochloride Tablets) Chemical Structure - Dapoxetine Hydrochloride © The Swiss Pharmacy

6. Tadali Superb Tablets (Tadalafil and Dapoxetine Hydrochloride Tablets) The active ingredients contained in Tadali Superb tablets are Tadalafil and Dapoxetine Hydrochloride. Each Tadali Superb tablet contains 20 mg of Tadalafil and 60 mg of Dapoxetine. © The Swiss Pharmacy

7. Tadali Superb Tablets (Tadalafil and Dapoxetine Hydrochloride Tablets) Uses of Tadali Superb 80 mg tablets: The medical effect produced by Tadali Superb tablets is due to it's two components: Tadalafil and Dapoxetine Hydrochloride. Tadalafil is a phosphodiesterase 5 (PDE5) inhibitor used to treat men who have erectile dysfunction (also called sexual impotence). Erectile dysfunction is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. 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=p9959_Tadali-Superb.html https://www.theswisspharmacy.com/product_info.php?info=p9959_Tadali-Superb.html © The Swiss Pharmacy

8. Tadali Superb Tablets (Tadalafil and Dapoxetine Hydrochloride Tablets) Recommended Adult Dosage The dose of Tadali Superb Tablets Tadali Superb Tablets (Tadalafil and Dapoxetine Tablets) is orally 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=p9959_Tadali-Superb.html https://www.theswisspharmacy.com/product_info.php?info=p9959_Tadali-Superb.html © The Swiss Pharmacy

9. Tadali Superb Tablets (Tadalafil and Dapoxetine Hydrochloride Tablets) Contraindications ➔Tadali Superb is contraindicated in patients with a known hypersensitivity to Tadalafil , Dapoxetine Hydrochloride or any component of the tablet. ➔Administration of Tadali Superb 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 Tadali Superb has been discontinued. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9959_Tadali-Superb.html https://www.theswisspharmacy.com/product_info.php?info=p9959_Tadali-Superb.html © The Swiss Pharmacy

10. Tadali Superb Tablets (Tadalafil and Dapoxetine Hydrochloride Tablets) Contraindications ➔Concomitant treatment of potent CYP3A4 inhibitors such as Ketoconazole, Itraconazole, Ritonavir, Saquinavir, Telithromycin, Nefazadone, Nelfinavir, Atazanavir, etc.. ➔Moderate and severe hepatic impairment. ➔Do not use Tadali Superb in patients who are using a GC stimulator, such as Riociguat. Tadalafil may potentiate the hypotensive effects of GC stimulators. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9959_Tadali-Superb.html https://www.theswisspharmacy.com/product_info.php?info=p9959_Tadali-Superb.html © The Swiss Pharmacy

11. Tadali Superb Tablets (Tadalafil and Dapoxetine Hydrochloride Tablets) Storage Instructions Tadali Superb Tablets (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=p9959_Tadali-Superb.html https://www.theswisspharmacy.com/product_info.php?info=p9959_Tadali-Superb.html © The Swiss Pharmacy

12. Tadali Superb Tablets (Tadalafil and Dapoxetine Hydrochloride Tablets) Warnings Patients should not use Tadali Superb if sex is inadvisable due to cardiovascular status Use of Tadali Superb with alpha blockers, antihypertensives or substantial amounts of alcohol (5 units or greater) may lead to hypotension Tadali Superb 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 Tadali Superb is used as a treatment for ED in men taking alpha blockers. Tadali Superb is not suitable and should not be used if taking potent inhibitors of CYP3A4. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9959_Tadali-Superb.html https://www.theswisspharmacy.com/product_info.php?info=p9959_Tadali-Superb.html © The Swiss Pharmacy

13. Tadali Superb Tablets (Tadalafil and Dapoxetine Hydrochloride Tablets) Warnings Patients should seek emergency treatment if an erection lasts for more than 4 hours. Use Tadali Superb with caution in patients predisposed to priapism. Patients should stop Tadali Superb 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 should stop Tadali Superb 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=p9959_Tadali-Superb.html https://www.theswisspharmacy.com/product_info.php?info=p9959_Tadali-Superb.html © The Swiss Pharmacy

14. Tadali Superb Tablets (Tadalafil and Dapoxetine Hydrochloride Tablets) Warnings Dapoxetine, a constituent of Tadali Superb is only indicated in men with Premature Ejaculation who meet all the criteria listed listed earlier. Dapoxetine should not be prescribed to men who have not been diagnosed with Premature Ejaculation. Before treatment initiation, 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 Tadali Superb should be avoided. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9959_Tadali-Superb.html https://www.theswisspharmacy.com/product_info.php?info=p9959_Tadali-Superb.html © The Swiss Pharmacy

15. Tadali Superb Tablets (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 Tadali Superb 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=p9959_Tadali-Superb.html https://www.theswisspharmacy.com/product_info.php?info=p9959_Tadali-Superb.html © The Swiss Pharmacy

16. Tadali Superb Tablets (Tadalafil and Dapoxetine Hydrochloride Tablets) Warnings Patients should be advised not to use Tadali Superb in combination with recreational drugs. Patients should be advised not to use Tadali Superb 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 Tadali Superb. Tadali Superb 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=p9959_Tadali-Superb.html https://www.theswisspharmacy.com/product_info.php?info=p9959_Tadali-Superb.html © The Swiss Pharmacy

17. Tadali Superb Tablets (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. Tadali Superb 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, Tadali Superb should be discontinued in any patient who develops seizures and avoided in patients with unstable epilepsy. Patients with controlled epilepsy should be carefully monitored. Tadali Superb should not be used in individuals below 18 years of age. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9959_Tadali-Superb.html https://www.theswisspharmacy.com/product_info.php?info=p9959_Tadali-Superb.html © The Swiss Pharmacy

18. Tadali Superb Tablets (Tadalafil and Dapoxetine Hydrochloride Tablets) Warnings Tadali Superb 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 Tadali Superb, 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. Tadali Superb 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=p9959_Tadali-Superb.html https://www.theswisspharmacy.com/product_info.php?info=p9959_Tadali-Superb.html © The Swiss Pharmacy

19. Tadali Superb Tablets (Tadalafil and Dapoxetine Hydrochloride Tablets) Warnings Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. The use of Dapoxetine, a constituent of Tadali Superb has been associated with ocular effects such as mydriasis and eye pain. Dapoxetine should be used with caution in patients with raised intraocular pressure or those at risk of angle closure glaucoma. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9959_Tadali-Superb.html https://www.theswisspharmacy.com/product_info.php?info=p9959_Tadali-Superb.html © The Swiss Pharmacy

20. Tadali Superb Tablets (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=p9959_Tadali-Superb.html https://www.theswisspharmacy.com/product_info.php?info=p9959_Tadali-Superb.html © The Swiss Pharmacy

21. Tadali Superb Tablets (Tadalafil and Dapoxetine Hydrochloride Tablets) Possible Side Effects Most common side effects Tadalafil Dapoxetine Combination tablets (Tadali Superb) are relatively common, such as 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=p9959_Tadali-Superb.html https://www.theswisspharmacy.com/product_info.php?info=p9959_Tadali-Superb.html © The Swiss Pharmacy

22. Tadali Superb Tablets (Tadalafil and Dapoxetine Hydrochloride Tablets) Tadali Superb 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=p9959_Tadali-Superb.html https://www.theswisspharmacy.com/product_info.php?info=p9959_Tadali-Superb.html © The Swiss Pharmacy

23. Tadali Superb Tablets (Tadalafil and Dapoxetine Hydrochloride Tablets) Tadali Superb 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=p9959_Tadali-Superb.html https://www.theswisspharmacy.com/product_info.php?info=p9959_Tadali-Superb.html © The Swiss Pharmacy

24. Tadali Superb Tablets (Tadalafil and Dapoxetine Hydrochloride Tablets) Tadali Superb Tablets During Pregnancy Tadali Superb 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. Tadali Superb 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=p9959_Tadali-Superb.html https://www.theswisspharmacy.com/product_info.php?info=p9959_Tadali-Superb.html © The Swiss Pharmacy

25. Tadali Superb Tablets (Tadalafil and Dapoxetine Hydrochloride Tablets) Tadali Superb Tablets Tadali Superb Tablets (Tadalafil and Dapoxetine Hydrochloride Tablets) are manufactured by Alpha- Pharma Healthcare Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9959_Tadali-Superb.html https://www.theswisspharmacy.com/product_info.php?info=p9959_Tadali-Superb.html © The Swiss Pharmacy