Vardif Tablets (Generic Vardenafil Hydrochloride Trihydrate Tablets)

1. Vardif Tablets (Generic Vardenafil Hydrochloride Trihydrate Tablets) © The Swiss Pharmacy

2. Vardif Tablets (Generic Vardenafil Hydrochloride Trihydrate Tablets) Vardif (Generic Vardenafil Hydrochloride Tablets) is used for the treatment of erectile dysfunction in adult men, a medical condition which implies difficulties in getting or keeping an erection long enough to satisfactorily complete sexual activity. In combination with sexual stimulation, Vardenafil works by increasing blood flow to the penis to help a man get and keep an erection. © The Swiss Pharmacy

3. Vardif Tablets (Generic Vardenafil Hydrochloride Trihydrate Tablets) Vardif Tablets are manufactured by Alpha-Pharma Healthcare Limited, India in the strength of 20mg. © The Swiss Pharmacy

4. Vardif Tablets (Generic Vardenafil Hydrochloride Trihydrate Tablets) Chemical Structure © The Swiss Pharmacy

5. Vardif Tablets (Generic Vardenafil Hydrochloride Trihydrate Tablets) The active ingredient contained in Vardif tablets is Vardenafil Hydrochloride. Each Vardif tablet contains Vardenafil Hydrochloride equivalent to 20 mg of Vardenafil. © The Swiss Pharmacy

6. Vardif Tablets (Generic Vardenafil Hydrochloride Trihydrate Tablets) Uses of Vardif 20 mg Tablets: Vardif Tablets (Generic Vardenafil Hydrochloride Trihydrate Tablets) is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED).These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly. The penis is one of the areas where this enzyme works. 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. When a man is sexually stimulated, his body's normal response is to increase blood flow to his penis to produce an erection. By controlling the enzyme, Vardenafil helps to maintain an erection after the penis is stroked by increasing blood flow to the penis. Without physical action to the penis, such as that occurring during sexual intercourse, Vardenafil will not work to cause an erection. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html © The Swiss Pharmacy

7. Vardif Tablets (Generic Vardenafil Hydrochloride Trihydrate Tablets) Recommended Adult Dosage For most patients, the starting dose of Vardif Tablets (Generic Vardenafil Hydrochloride Tablets) for use as needed is 10 mg as needed 25 minutes to 60 minutes prior to sexual activity. Increase to 20 mg or decrease to 5 mg based upon efficacy/tolerability. Not to be taken more than once per day (i.e. 24 hours must pass before you take your next dose) Vardif Tablets URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html © The Swiss Pharmacy

8. Vardif Tablets (Generic Vardenafil Hydrochloride Trihydrate Tablets) Recommended Adult Dosage Elderly (65 years old and more): Dose adjustments are not required in elderly patients. However, an increase to a maximum 20 mg dose should be carefully considered depending on the individual tolerability. Hepatic impairment: A starting dose of 5 mg should be considered in patients with mild and moderate hepatic impairment (Child-Pugh A-B). Based on tolerability and efficacy, the dose may subsequently be increased. The maximum dose recommended in patients with moderate hepatic impairment (Child-Pugh B) URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html © The Swiss Pharmacy

9. Vardif Tablets (Generic Vardenafil Hydrochloride Trihydrate Tablets) Recommended Adult Dosage Renal impairment: No dose adjustment is required in patients with mild to moderate renal impairment. In patients with severe renal impairment (creatinine clearance less than 30 ml/min), a starting dose of 5 mg should be considered. Based on tolerability and efficacy the dose may be increased to 10 mg and 20 mg URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html © The Swiss Pharmacy

10. Vardif Tablets (Generic Vardenafil Hydrochloride Trihydrate Tablets) Contraindications ➔Vardif is contraindicated in patients with a known hypersensitivity to Vardenafil Hydrochloride or any component of the tablet. ➔Administration of Vardif with with nitrates and nitric oxide donors is contraindicated. ➔Vardif is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION). URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html © The Swiss Pharmacy

11. Vardif Tablets (Generic Vardenafil Hydrochloride Trihydrate Tablets) Storage Instructions Vardif Tablets (Generic Vardenafil Hydrochloride Trihydrate 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=p9565_Vardenafil-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html © The Swiss Pharmacy

12. Vardif Tablets (Generic Vardenafil Hydrochloride Trihydrate Tablets) Warnings Cardiovascular Effects: Patients should not use Vardif tablets if sex is inadvisable due to cardiovascular status. Risk of Priapism: In the event that an erection lasts more than 4 hours, the patient should seek immediate medical assistance. Effects on the Eye: Patients should stop use of Vardif tablets, and seek medical attention in the event of sudden loss of vision in one or both eyes, which could be a sign of nonarteritic anterior ischemic optic neuropathy (NAION). Vardif tablets should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a “crowded” optic disc may also be at an increased risk of NAION. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html © The Swiss Pharmacy

13. Vardif Tablets (Generic Vardenafil Hydrochloride Trihydrate Tablets) Warnings Sudden Hearing Loss: Patients should stop Vardif tablets and seek medical attention in the event of sudden decrease or loss in hearing. Alpha-Blockers: Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. In some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting). QT Prolongation: Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using Vardif tablets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html © The Swiss Pharmacy

14. Vardif Tablets (Generic Vardenafil Hydrochloride Trihydrate Tablets) Effects On Ability To Drive And Use Machines Patients should be aware of how they react to Vardenafil (Vardif tablets) before driving or operating machinery. Due to the vasodilatory properties of PDE5 inhibitors, concomitant use with alpha-blockers may contribute to dizziness. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html © The Swiss Pharmacy

15. Vardif Tablets (Generic Vardenafil Hydrochloride Trihydrate Tablets) Possible Side Effects Most common Vardenafil (Vardif tablets) side effects with an incidence rate of greater than or equal to 2% are headache, flushing, nasal congestion, dyspepsia, sinusitis, flu syndrome, dizziness, increased creatine kinase, nausea, back pain. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html © The Swiss Pharmacy

16. Vardif Tablets (Generic Vardenafil Hydrochloride Trihydrate Tablets) Possible Side Effects The following side effects occurred in less than 2% of the patients during Vardenafil clinical trials: Body as a whole: allergic edema and angioedema, feeling unwell, allergic reactions, chest pain Auditory: tinnitus, vertigo Cardiovascular: palpitation, tachycardia, angina pectoris, myocardial infarction, ventricular tachyarrhythmias, hypotension Digestive: nausea, gastrointestinal and abdominal pain, dry mouth, diarrhea, gastroesophageal reflux disease, gastritis, vomiting, increase in transaminases Musculoskeletal: increase in creatine phosphokinase (CPK), increased muscle tone and cramping, myalgia URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html © The Swiss Pharmacy

17. Vardif Tablets (Generic Vardenafil Hydrochloride Trihydrate Tablets) Possible Side Effects Nervous: paresthesia and dysesthesia, somnolence, sleep disorder, syncope, amnesia, seizure Respiratory: dyspnea, sinus congestion Skin and appendages: erythema, rash Ophthalmologic: visual disturbance, ocular hyperemia, visual color distortions, eye pain and eye discomfort, photophobia, increase in intraocular pressure, conjunctivitis Urogenital: increase in erection, priapism URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html © The Swiss Pharmacy

18. Vardif Tablets (Generic Vardenafil Hydrochloride Trihydrate Tablets) Vardif Tablets Overdosage The maximum dose of Vardif (Generic Vardenafil Hydrochloride Tablets) for which human data are available is a single 120 mg dose administered to eight healthy male volunteers. The majority of these subjects experienced reversible back pain/myalgia and/or “abnormal vision.” When Vardenafil was administered in higher doses and more frequently than the recommended dose regimen (40 mg tablets twice daily) cases of severe back pain have been reported. This was not associated with any muscle or neurological toxicity. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html © The Swiss Pharmacy

19. Vardif Tablets (Generic Vardenafil Hydrochloride Trihydrate Tablets) Treatment of Vardif Tablets Overdosage In cases of Vardif overdose, standard supportive measures should be taken as required. Renal dialysis is not expected to accelerate clearance since Vardenafil is highly bound to plasma proteins and is not significantly eliminated in the urine. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html © The Swiss Pharmacy

20. Vardif Tablets (Generic Vardenafil Hydrochloride Trihydrate Tablets) Vardif Tablets During Pregnancy Vardenafil Hydrochloride (Vardif Tablets) is classified by the US FDA as Pregnancy Category B. Vardif is not indicated for use in women. No evidence of specific potential for teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits that received Vardenafil at up to 18 mg/kg/day during organogenesis. This dose is approximately 100 fold (rat) and 29 fold (rabbit) greater than the AUC values for unbound Vardenafil and its major metabolite in humans given the maximum recommended human dose (MRHD) of 20mg. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html © The Swiss Pharmacy

21. Vardif Tablets (Generic Vardenafil Hydrochloride Trihydrate Tablets) Vardif Tablets Vardif Tablets (Generic Vardenafil Hydrochloride Trihydrate Tablets) are manufactured by Alpha- Pharma Healthcare Private Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9565_Vardenafil-Tablets.html © The Swiss Pharmacy