Avana Tablets (Generic Avanafil Tablets)

1. Avana Tablets (Generic Avanafil Tablets) © The Swiss Pharmacy

2. Avana Tablets (Generic Avanafil Tablets) Avana (Generic Avanafil tablets) is a phosphodiesterase 5 (PDE5) inhibitor which is used to treat male sexual function problems (impotence or erectile dysfunction-ED). In combination with sexual stimulation, Avanafil works by increasing blood flow to the penis to help a man get and keep an erection. In order for Avana to be effective, sexual stimulation is necessary. © The Swiss Pharmacy

3. Avana Tablets (Generic Avanafil Tablets) Avana Tablets are manufactured by Sunrise Remedies Private Limited, India in the strengths of 50 mg and 100 mg. © The Swiss Pharmacy

4. Avana Tablets (Generic Avanafil Tablets) Chemical Structure © The Swiss Pharmacy

5. Avana Tablets (Generic Avanafil Tablets) The active ingredient contained in Avana tablets is Avanafil. Each Avana tablet contains 50 mg or 100 mg of Avanafil. © The Swiss Pharmacy

6. Avana Tablets (Generic Avanafil Tablets) Uses of Avana 50 mg and 100 mg Tablets: Avana (Generic Avanafil Tablets) is used to treat men who have erectile dysfunction (also called sexual impotence). Avanafil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. 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, avanafil 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, Avanafil will not work to cause an erection. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9881_Avana-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9881_Avana-Tablets.html © The Swiss Pharmacy

7. Avana Tablets (Generic Avanafil Tablets) Recommended Adult Dosage For most patients, the starting dose of Avana Tablets (Generic Avanafil Tablets) is 100 mg taken approximately 15 minutes before sexual activity, on an as needed basis. Take Avana no more than once a day (i.e. 24 hours must pass before you take the next dose). The dose may be increased to 200 mg taken as early as approximately 15 minutes before sexual activity, or decreased to 50 mg taken approximately 30 minutes before sexual activity, based on efficacy and/or tolerability. Use the lowest dose that provides benefit. Avana Tablets URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9881_Avana-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9881_Avana-Tablets.html © The Swiss Pharmacy

8. Avana Tablets (Generic Avanafil Tablets) Recommended Adult Dosage Avana may be taken with or without food. Do not use Avana with strong CYP3A4 inhibitors. In case taking a moderate CYP3A4 inhibitor, the dose should be no more than 50 mg in a 24-hour period. In patients on stable alpha-blocker therapy, the recommended starting dose of Avana is 50 mg. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9881_Avana-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9881_Avana-Tablets.html © The Swiss Pharmacy

9. Avana Tablets (Generic Avanafil Tablets) Contraindications ➔Avana is contraindicated in patients with a known hypersensitivity to Avanafil or any component of the tablet. Hypersensitivity reactions have been reported, including pruritis and eyelid swelling. ➔Administration of Avana tablets with any form of organic nitrates, either regularly and/or intermittently, is contraindicated. ➔Administration of this medicine with Guanylate Cyclase (GC) stimulators such as Riociguat is contraindicated. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9881_Avana-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9881_Avana-Tablets.html © The Swiss Pharmacy

10. Avana Tablets (Generic Avanafil Tablets) Storage Instructions Avana Tablets (Generic Avanafil 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=p9881_Avana-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9881_Avana-Tablets.html © The Swiss Pharmacy

11. Avana Tablets (Generic Avanafil Tablets) Warnings Patients should not use Avana if sexual activity is inadvisable due to cardiovascular status or any other reason. Use of Avana with alpha-blockers, other antihypertensives, or substantial amounts of alcohol (greater than 3 units) may lead to hypotension. Patients should seek emergency treatment if an erection lasts greater than 4 hours. Patients should stop Avana 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). URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9881_Avana-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9881_Avana-Tablets.html © The Swiss Pharmacy

12. Avana Tablets (Generic Avanafil Tablets) Warnings Discuss with patients the increased risk of NAION in patients with a history of NAION. Patients should stop taking Avana and seek prompt medical attention in the event of sudden decrease or loss of hearing. The safety of Avana is unknown in patients with bleeding disorders and patients with active peptic ulceration. In vitro studies with human platelets indicate that STENDRA potentiates the anti-aggregatory effect of sodium nitroprusside (a nitric oxide [NO] donor). URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9881_Avana-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9881_Avana-Tablets.html © The Swiss Pharmacy

13. Avana Tablets (Generic Avanafil Tablets) Avana Tablets and Alcohol Patients should be made aware that both alcohol and PDE5 inhibitors including Avana act as vasodilators. When vasodilators are taken in combination, blood-pressure-lowering effects of each individual compound may be increased. Therefore, physicians should inform patients that substantial consumption of alcohol (e.g., greater than 3 units) in combination with Avana may increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9881_Avana-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9881_Avana-Tablets.html © The Swiss Pharmacy

14. Avana Tablets (Generic Avanafil Tablets) Effects On Ability To Drive And Use Machines Avanafil tablets (Avana tablets) has minor influence on the ability to drive and use machines. As dizziness and altered vision were reported in clinical trials with Avanafil, patients should be aware of how they react to Avana tablets before driving or using machines. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9881_Avana-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9881_Avana-Tablets.html © The Swiss Pharmacy

15. Avana Tablets (Generic Avanafil Tablets) Possible Side Effects Most common Avanafil tablets (Avana tablets) side effects with an incidence rate of greater than or equal to 2% include headache, flushing, nasal congestion, nasopharyngitis, and back pain. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9881_Avana-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9881_Avana-Tablets.html © The Swiss Pharmacy

16. Avana Tablets (Generic Avanafil Tablets) Possible Side Effects The following side effects occurred in less than 1% of patients in the three placebo- controlled 3-month clinical trials and/or the open-label, long-term extension study lasting 12 months. Body as a whole — edema peripheral, fatigue Cardiovascular — angina, unstable angina, deep vein thrombosis, palpitations Digestive — gastritis, gastroesophageal reflux disease, hypoglycemia, blood glucose increased, alanine aminotransferase increased, oropharyngeal pain, stomach discomfort, vomiting Musculoskeletal — muscle spasms, musculoskeletal pain, myalgia, pain in extremity Nervous — depression, insomnia, somnolence, vertigo Respiratory — cough, dyspnea exertional, epistaxis, wheezing Skin and Appendages – pruritus Urogenital – balanitis, erection increased, hematuria, nephrolithiasis, pollakiuria, urinary tract infection. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9881_Avana-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9881_Avana-Tablets.html © The Swiss Pharmacy

17. Avana Tablets (Generic Avanafil Tablets) Avana Tablets Overdosage Single doses of Avanafil tablets up to 800 mg have been given to healthy subjects, and multiple doses up to 300 mg have been given to patients. In cases of Avanafil overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance because avanafil is highly bound to plasma proteins and is not significantly eliminated in the urine URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9881_Avana-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9881_Avana-Tablets.html © The Swiss Pharmacy

18. Avana Tablets (Generic Avanafil Tablets) Avana Tablets During Pregnancy Avanafil (Avana Tablets) has been classified by the US FDA as Pregnancy Category C. Avanafil is not indicated for use in women. There are no adequate and well-controlled studies of Avanafil in pregnant women. Animal studies have revealed reduced offspring growth and maturation at exposures greater than or equal to 17 times the human exposure at the maximum recommended human dose (MRHD). Based on data from animal studies, Avanafil is predicted to have a low risk for major developmental abnormalities in humans. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9881_Avana-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9881_Avana-Tablets.html © The Swiss Pharmacy

19. Avana Tablets (Generic Avanafil Tablets) Avana Tablets Avana Tablets (Generic Avanafil Tablets) are manufactured by Sunrise Remedies Private Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9881_Avana-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9881_Avana-Tablets.html © The Swiss Pharmacy