Sildenafil (Page 5 of 6)

16 HOW SUPPLIED/STORAGE AND HANDLING

Sildenafil Tablets, USP are supplied as white to off white, round shaped, film-coated tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows:

Sildenafil Tablets, USP
Package Configuration Strength NDC Debossing on Tablet
Bottle of 90 Tablets 20 mg 33342-536-10 “N7”
10’s Blister Pack 20 mg 33342-536-66 “N7”
6500’s TLP bulk pack 20 mg 33342-536-58 “N7”

Recommended Storage for Sildenafil Tablets, USP: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight containers (USP).

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
• Inform patients of contraindication of sildenafil tablets with regular and/or intermittent use of organic nitrates.
• Inform patients that sildenafil is also marketed as VIAGRA for erectile dysfunction. Advise patients taking sildenafil tablets not to take VIAGRA or other PDE-5 inhibitors.
• Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking sildenafil tablets. Such an event may be a sign of NAION.
• Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil tablets. These events may be accompanied by tinnitus and dizziness.
VIAGRA® is registered trademark of Pfizer Inc. All other trademarks herein are the property of their respective owners.
Manufactured for:
Macleods Pharma USA, Inc.
Princeton, NJ 08540
Manufactured by:
Macleods Pharmaceuticals Ltd.
Baddi, Himachal Pradesh, INDIA Revised: February 2024

PATIENT INFORMATION

Sildenafil (sil-DEN-a-fil) Tablets

What is the most important information I should know about sildenafil tablets?
Never take sildenafil tablets with any nitrate or guanylate cyclase stimulator medicines.
• Your blood pressure could drop quickly to an unsafe level.
Nitrates include:
• Medicines that treat chest pain (angina)
• Nitroglycerin in any form including tablets, patches, sprays, and ointments
• Isosorbide mononitrate or dinitrate
• Street drugs called “poppers” (amyl nitrate, butyl nitrate or nitrite)
Guanylate cyclase stimulators include:
• Riociguat, a medicine that treats pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.
Ask your healthcare provider or pharmacist if you are not sure if you are taking a nitrate or a guanylate cyclase stimulator medicine.
See “What are the possible side effects of sildenafil tablets?” for more information about side effects.
What are sildenafil tablets?
Sildenafil tablets are a prescription medicine used to treat pulmonary arterial hypertension (PAH). PAH is a type of high blood pressure in the arteries of your lungs. sildenafil tablets may be used in:
• adults to improve your ability to exercise and help slow down the worsening of your physical condition.

It is not known if sildenafil tablets are safe and effective in children younger than 1 year of age.
Do not take sildenafil tablets if you:
• take medicines called nitrates.
• take riociguat, a guanylate cyclase stimulator medicine.
• are allergic to sildenafil or any of the ingredients in sildenafil tablets. See the end of this leaflet for a complete list of ingredients in sildenafil tablets.
Before taking sildenafil tablets, tell your healthcare provider about all of your medical conditions, including if you:
• have low blood pressure
• have heart problems
• have pulmonary veno-occlusive disease (PVOD)
• have bleeding problems or a stomach (peptic) ulcer. It is not known if sildenafil tablets are safe in people with bleeding problems or who have a stomach ulcer.
• have an eye problem called retinitis pigmentosa
• have ever had sudden loss of vision in one or both eyes, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION)
• have ever had hearing problems such as ringing in the ears, dizziness, or loss of hearing
• have a deformed penis shape or Peyronie’s disease
• have any blood cell problems such as sickle cell anemia
• are pregnant or plan to become pregnant. It is not known if sildenafil tablets will harm your unborn baby.
• are breastfeeding or plan to breastfeed. Sildenafil passes into your breast milk. It is not known if it can harm your baby. Talk with your healthcare provider about the best way to feed your baby during treatment with sildenafil tablets.
Tell your healthcare provider about all of the medicines you take, including prescription and over- the-counter medicines, vitamins, and herbal supplements. Sildenafil tablets and certain other medicines may affect each other and can cause side effects.
Especially tell your healthcare provider if you take:
• nitrates or guanylate cyclase stimulators. See “What is the most important information I should know about sildenafil tablets?”

medicines to treat high blood pressure
medicines for erectile dysfunction (impotence). Sildenafil tablets contain sildenafil, which is the same medicine found in another medicine called VIAGRA®. VIAGRA is used for the treatment of erectile dysfunction. Do not take VIAGRA or other PDE-5 inhibitors during treatment with sildenafil tablets.
Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.
Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I take sildenafil tablets?
· Take or give sildenafil tablets exactly as your healthcare provider tells you.
· Your healthcare provider may change your dose of sildenafil tablets as needed. Do not change your dose or stop taking sildenafil tablets without talking to your healthcare provider.
· Sildenafil tablets may be prescribed to you as sildenafil tablets.
· Take your prescribed dose of sildenafil tablets
· If you take too much sildenafil tablets, call your healthcare provider or go to the nearest hospital emergency room right away.
What are the possible side effects of sildenafil tablets?
Sildenafil tablets may cause serious side effects, including:
See “What is the most important information I should know about Sildenafil tablets?”
Decreased blood pressure. Sildenafil tablets may cause low blood pressure that last for a short time. If you take medicines to treat high blood pressure, your healthcare provider should monitor your blood pressure during treatment with sildenafil tablets.
Decreased eyesight or permanent loss of vision in one or both eyes can be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). Most people who develop NAION have certain risk factors. You can ask your healthcare provider if you have questions about risk factors for NAION. If you notice a sudden decrease or loss of vision in one or both eyes during treatment with sildenafil tablets, contact your healthcare provider right away.
Sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness. If you notice a sudden decrease or loss of hearing during treatment with sildenafil tablets, contact your healthcare provider right away.
In men, an erection that lasts for more than 4 hours (priapism). If you have an erection, with or without pain, that lasts more than 4 hours, contact your healthcare provider or get emergency medical help right away. A painful erection that lasts more than 6 hours must be treated right away or you can have lasting damage to your penis, including the inability to have erections.
The most common side effects of sildenafil tablets in adults include:

  • nosebleeds
  • muscle aches and pain
  • headache
  • back pain
  • upset stomach
  • diarrhea
  • getting red or hot in the face (flushing)
  • arm or leg pain

These are not all the possible side effects of sildenafil tablets.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store sildenafil tablets?
• Store sildenafil tablets at room temperature between 68°F to 77°F (20°C to 25°C).
Keep sildenafil tablets and all medicines out of the reach of children.
General information about the safe and effective use of sildenafil tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use sildenafil tablets for a condition for which it was not prescribed. Do not give sildenafil tablets to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about sildenafil tablets that is written for health professionals.
For more information call 1-888-943-3210 or 1-855-926-3384.
What are the ingredients in sildenafil tablets?
Active ingredients: sildenafil citrate
Inactive ingredients:
Sildenafil tablets: microcrystalline cellulose, dibasic calcium phosphate dihydrate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide and triacetin.

Pediatric use information is approved for Viatris Specialty LLC’s, REVATIO (sildenafil) tablets. However, due to Viatris Specialty LLC’s marketing exclusivity rights, this drug product is not labeled with that information.

This Patient Information has been approved by the U.S. Food and Drug Administration.
VIAGRA® is registered trademark of Pfizer Inc. All other trademarks herein are the property of their respective owners.
Manufactured for:
Macleods Pharma USA, Inc.
Princeton, NJ 08540
Manufactured by:
Macleods Pharmaceuticals Ltd.
Baddi, Himachal Pradesh, INDIA
Revised: February 2024

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