Product Description
Wondering about possible side effects?
Safety is important. And it helps to know about possible side effects.
Alfin 100 can cause serious side effects. Rarely reported side effects include:
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 one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). Stop taking Alfin 100 and call your healthcare provider right away if you have sudden vision loss in one 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 Alfin 100 and contact a doctor right away
Other important information:
Alfin 100 can help a man get and keep an erection when he becomes sexually stimulated. It’s not right for everyone. Here are some other things you should know:
Do not take Alfin 100 if you:
take any medicines called nitrates, often prescribed for chest pain, or guanylate cyclase stimulators like Adempas (riociguat) for pulmonary hypertension. Your blood pressure could drop to an unsafe level.
are allergic to sildenafil, as contained in Alfin 100 and REVATIO, or any of the ingredients in Alfin 100.
Discuss your health with your doctor to ensure that you are healthy enough for sex. If you experience chest pain, dizziness, or nausea during sex, seek immediate medical help.
The most common side effects of Alfin 100 are:
headache
flushing
upset stomach
abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision
stuffy or runny nose
back pain
muscle pain
nausea
dizziness
rash
In addition, heart attack, stroke, irregular heartbeat and death have happened rarely in men taking Alfin 100. Most, but not all, of these men had heart problems before taking Alfin 100. It is not known if Alfin 100 caused these problems.
Tell your healthcare provider if you have any side effect that bothers you or does not go away.
These are not all the possible side effects of Alfin 100. For more information, ask your healthcare provider or pharmacist.
Talk to your doctor.
Discuss your general health and ED symptoms with your doctor to see if Alfin 100 is right for you.
Patients should always ask their doctors for medical advice about adverse events.
You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit http://www.fda.gov/MedWatch or call 1-800-FDA-1088.
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for Important Safety Information and Indication
IMPORTANT SAFETY INFORMATION
Do not take Alfin 100 (sildenafil citrate) if you:
take any medicines called nitrates, often prescribed for chest pain, or guanylate cyclase stimulators like Adempas (riociguat) for pulmonary hypertension. Your blood pressure could drop to an unsafe level
are allergic to sildenafil, as contained in Alfin 100 and REVATIO, or any of the ingredients in Alfin 100
Discuss your health with your doctor to ensure that you are healthy enough for sex. If you experience chest pain, dizziness, or
nausea during sex, seek immediate medical help.
Alfin 100 can cause serious side effects. Rarely reported side effects include:
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 one or both eyes can be a sign of a serious eye problem called
non-arteritic anterior ischemic optic neuropathy (NAION). Stop taking Alfin 100 and call your healthcare provider right away if you
have any sudden vision loss
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 Alfin 100 and contact a doctor right away
Before you take Alfin 100, tell your healthcare provider 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 NAION
have bleeding problems
have or have had stomach ulcers
have liver problems
have kidney problems or are having kidney dialysis
have any other medical conditions
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins,
and herbal supplements.
Alfin 100 may affect the way other medicines work, and other medicines may affect the way Alfin 100 works, causing side effects.
Especially tell your healthcare provider if you take any of the following:
medicines called nitrates
medicines called guanylate cyclase stimulators such as Adempas (riociguat)
medicines called alpha-blockers, such as Hytrin (terazosin
HCl), Flomax (tamsulosin HCl), Cardura (doxazosin
mesylate), Minipress (prazosin HCl), Uroxatral (alfuzosin HCl),
Jalyn (dutasteride and tamsulosin HCl), or Rapaflo (silodosin).
Alpha-blockers are sometimes prescribed for prostate
problems or high blood pressure. In some patients, the use
of Alfin 100 with alpha-blockers can lead to a drop in blood pressure or to fainting
medicines called HIV protease inhibitors, such as ritonavir (Norvir), indinavir sulfate (Crixivan), saquinavir (Fortovase or Invirase), or atazanavir sulfate (Reyataz)
some types of oral antifungal medicines, such as
ketoconazole (Nizoral) and itraconazole (Sporanox)
some types of antibiotics, such as clarithromycin (Biaxin),
telithromycin (Ketek), or erythromycin
other medicines that treat high blood pressure
other medicines or treatments for ED
Alfin 100 contains sildenafil, which is the same medicine found
in another drug called REVATIO. REVATIO is used to treat a
rare disease called pulmonary arterial hypertension (PAH).
Alfin 100 should not be used with REVATIO or with other PAH
treatments containing sildenafil or any other PDE5 inhibitors
(such as Adcirca [tadalafil])
Alfin 100 does not protect against sexually transmitted diseases, including HIV.
The most common side effects of Alfin 100: headache; flushing; upset stomach; abnormal vision, such as changes in color vision
(such as having a blue color tinge) and blurred vision; stuffy or runny nose; back pain; muscle pain; nausea; dizziness; rash.
INDICATION
Alfin 100 is prescription medicine used to treat erectile dysfunction (ED).
Alfin 100 is not for women or children.
Please see full Prescribing Information for Alfin 100 (25 mg, 50 mg, 100 mg) tablets.
Alfin 100 is available by prescription only.
Patients should always ask their doctors for medical advice about adverse events.
