Patient information: uses, side effects, how to take - Sildenafil

What is the most important information I should know about SILDENAFIL ORAL FILM ?

SILDENAFIL ORAL FILM can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines.Do not take SILDENAFIL ORAL FILM if you take any other medicines called nitrates. Nitrates are used to treat chest pain (angina). A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.

Do not take SILDENAFIL ORAL FILM if you take medicines called guanylate cyclase stimulators which include:

Riociguat a medicine that treats pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension.

Tell all your healthcare providers that you take SILDENAFIL ORAL FILM . If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took SILDENAFIL ORAL FILM.

Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. SILDENAFIL ORAL FILM does not protect you or your partner from getting sexually transmitted diseases, including Human Immunodeficiency Virus (HIV).

What is SILDENAFIL ORAL FILM ?

SILDENAFIL ORAL FILM is a prescription medicine used to treat erectile dysfunction (ED).

SILDENAFIL ORAL FILM is not for use in women or children.

It is not known if SILDENAFIL ORAL FILM is safe and effective in women or children under 18 years of age.

Do not take SILDENAFIL ORAL FILM if you:

take medicines called nitrates.
take any medicines called guanylate cyclase stimulators.
are allergic to sildenafil or any of the ingredients in SILDENAFIL ORAL FILM. See the end of this Patient information leaflet for a complete list of ingredients in SILDENAFIL ORAL FILM.

Before taking SILDENAFIL ORAL FILM , tell your healthcare provider about all of your medical conditions, including if you:

have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve or heart failure.
have had heart surgery within the last 6 months.
have pulmonary hypertension.
have had a stroke.
have low blood pressure, or high blood pressure that is not controlled.
have a deformed penis shape.
have had an erection that lasted for more than 4 hours.
have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia.
have retinitis pigmentosa, a rare genetic (runs in families) eye disease.
have ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION).
have bleeding problems.
have or have had stomach ulcers.
have liver problems.
have kidney problems or are having kidney dialysis.

Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements.

SILDENAFIL ORAL FILM may affect the way other medicines work, and other medicines may affect the way SILDENAFIL ORAL FILM works causing side effects. Especially tell your healthcare provider if you take any of the following:

medicines called nitrates (see “What is the most important information I should know about SILDENAFIL ORAL FILM ?”)
medicines called guanylate cyclase stimulators, such as riociguat (see “ What is the most important information I should know about SILDENAFIL ORAL FILM ?”)
medicines called alpha blockers such as doxazosin. Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of SILDENAFIL ORAL FILM with alpha-blockers can lead to a drop-in blood pressure or to fainting.
medicines called HIV protease inhibitors, such as ritonavir and saquinavir.
some types of oral antifungal medicines, such as ketoconazole and itraconazole.
some types of antibiotics, such as erythromycin.
other medicines that treat high blood pressure.
other medicines or treatments for ED.

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 them to show to your healthcare provider and pharmacist when you get a new medicine.

How should I take SILDENAFIL ORAL FILM?

Take SILDENAFIL ORAL FILM exactly as your healthcare provider tells you to take it.
Your healthcare provider will tell you how much SILDENAFIL ORAL FILM to take and when to take it.
Your healthcare provider may change your dose if needed.
Take SILDENAFIL ORAL FILM by mouth about 1 hour before sexual activity. You may take SILDENAFIL ORAL FILM between 30 minutes to 4 hours before sexual activity if needed.
SILDENAFIL ORAL FILM can be taken with or without food.
Do not cut or chew SILDENAFIL ORAL FILM.
Do nottake SILDENAFIL ORAL FILM more than 1 time a day.
If you take too much SILDENAFIL ORAL FILM, call your healthcare provider or go to the nearest hospital emergency room right away.

Instructions for Use

Important information you need to know before using SILDENAFIL ORAL FILM

Do not remove the film from the pouch unless ready for immediate use.
Do not handle the oral film with wet hands.

a) Take the pouch and locate the notch on the side of the pouch.

b) Gently tear along the dotted line to open the pouch.

c) Gently peel both parts of the pouch. Now you can hold each side of the pouch between your thumb and your index finger.

d) Take the oral film with dry fingers out of the pouch and put it onto your tongue. It will dissolve in your mouth and can be swallowed with saliva.

What are the possible side effects of SILDENAFIL ORAL FILM ?

SILDENAFIL ORAL FILM can cause serious side effects including:

See “What is the most important information I should know about SILDENAFIL ORAL FILM ?”
an erection that will not go away (priapism).If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, priapism can permanently damage your penis.
sudden vision loss in one or both eyes.Sudden vision loss in 1 or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). It is uncertain whether PDE5 inhibitors directly cause the vision loss. Stop taking SILDENAFIL ORAL FILM and call your healthcare provider right away if you have sudden vision loss in 1 or both eyes.
sudden hearing decrease or hearing loss.Some people may also have ringing in their ears (tinnitus) or dizziness. If you have these symptoms, stop taking SILDENAFIL ORAL FILM and contact a healthcare provider right away.

The most common side effects of SILDENAFIL ORAL FILM are:

headache
flushing
upset stomach
stuffy or runny nose
dizziness

Other side effects include:

abnormal vision, such as changes in color and blurred vision
back pain
muscle pain
nausea
rash

Tell your healthcare provider if you have any side effect that bothers you or does not go away.

These are not all of the possible side effects of SILDENAFIL ORAL FILM. 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 ORAL FILM ?

Store SILDENAFIL ORAL FILM at room temperature between 68°F to 77°F (20°C to 25°C).

Keep SILDENAFIL ORAL FILM and all medicines out of the reach of children.

General information about the safe and effective use of SILDENAFIL ORAL FILM .

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use SILDENAFIL ORAL FILM for a condition for which it was not prescribed. Do not give SILDENAFIL ORAL FILM 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 ORAL FILM that is written for health professionals.

What are the ingredients in SILDENAFIL ORAL FILM ?

Active ingredient:sildenafil

Inactive ingredients: Blue Videojet ink, FD&C Blue No.2, glycerin, grapefruit flavor, lemon flavor, maltodextrin, polysorbate 20, polyvinyl acetate dispersion, propylene glycol monocaprylate, sucralose, titanium dioxide.

Contains no ingredient made from a gluten-containing grain (wheat, barley or rye).

Manufactured by: ALTERGON Italia Srl, via Zona Industriale, Morra de Sanctis, Avellino 83040, Italy

Manufactured for: IBSA Institut Biochimique SA, CH-6912 Pazzallo, Switzerland

Distributed by: YARAL Pharma Inc., Parsippany, NJ 07054 USA

This Patient Information has been approved by the U.S. Food and Drug Administration Approved: 12/2025

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