16 HOW SUPPLIED/STORAGE AND HANDLING
Product: 53002-3719
NDC: 53002-3719-3 30 TABLET, FILM COATED in a BOTTLE
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 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 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. 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. These events may be accompanied by tinnitus and dizziness.
Manufactured for:
Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854
By:
HETERO
TM
Hetero Labs Limited, Unit V, Polepally, Jadcherla,
Mahabubnagar-509 301, India.
Revised: 03/2023
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 or your child 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.
- children 1 to 17 years old to improve their ability to exercise, and in children too young to do certain exercise and lung testing.
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 or your child: - 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 or your child: - 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 or your child take , including prescription and overthe-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 or your child 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 contains 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 or your child take. Keep a list of your or your child’s 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 or your child’s 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 3 times a day.
- If you or your child 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
- headache
- upset stomach
- getting red or hot in the face (flushing)
- arm or leg pain
- muscle aches and pain
- back pain
- diarrhea
The most common side effect of sildenafil tablets in children is an erection that lasts for more than 4 hours (priapism).
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.
|
| What are the ingredients in sildenafil tablets? Active ingredients: sildenafil citrate, USP
Inactive ingredients: croscarmellose sodium, dibasic calcium phosphate anhydrous, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide and triacetin
Manufactured for:
Camber Pharmaceuticals, Inc.
Piscataway, NJ 08854
By:
HETEROTM
Hetero Labs Limited, Unit V, Polepally, Jadcherla,
Mahabubnagar – 509 301, India.
For more information, call 1-866-495-1995.
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Hetero Labs Limited.
|
This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 03/2023
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.
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