Finasteride & Sildenafil - Important Safety Information
Finasteride is for use by MEN ONLY and should NOT be used by women or children.
Read this Patient Information before you start taking Finasteride and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
What is Finasteride?
Finasteride is a prescription medicine used for the treatment of male pattern hair loss (androgenetic alopecia).
It is not known if Finasteride works for a receding hairline on either side of and above your forehead (temporal area).
Finasteride is not for use by women and children.
Who should not take Finasteride?
Do not take Finasteride if you:
are pregnant or may become pregnant. Finasteride may harm your unborn baby.
Finasteride tablets are coated and will prevent contact with the medicine during handling, as long as the tablets are not broken or crushed. Females who are pregnant or who may become pregnant should not come in contact with broken or crushed Finasteride tablets.
If a pregnant woman comes in contact with crushed or broken Finasteride tablets, wash the contact area right away with soap and water. If a woman who is pregnant comes into contact with the active ingredient in Finasteride, a healthcare provider should be consulted. See the end of this leaflet for a complete list of ingredients in Finasteride.
What should I tell my healthcare provider before taking Finasteride? Before taking Finasteride, tell your healthcare provider if you:
have any other medical conditions, including problems with your prostate or liver
Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take Finasteride?
Take Finasteride exactly as your healthcare provider tells you to take it.
You may take Finasteride with or without food.
If you forget to take Finasteride, do not take an extra tablet. Just take the next tablet as usual.
Finasteride will not work faster or better if you take it more than once a day.
What are the possible side effects of Finasteride?
decrease in your blood Prostate Specific Antigen (PSA) levels. Finasteride can affect a blood test called PSA (Prostate-Specific Antigen) for the screening of prostate cancer. If you have a PSA test done you should tell your healthcare provider that you are taking Finasteride because Finasteride decreases PSA levels. Changes in PSA levels will need to be evaluated by your healthcare provider. Any increase in follow-up PSA levels from their lowest point may signal the presence of prostate cancer and should be evaluated, even if the test results are still within the normal range for men not taking Finasteride. You should also tell your healthcare provider if you have not been taking Finasteride as prescribed because this may affect the PSA test results. For more information, talk to your healthcare provider.
The most common side effects of Finasteride include:
decrease in sex drive
trouble getting or keeping an erection
a decrease in the amount of semen
The following have been reported in general use with Finasteride:
breast tenderness and enlargement. Tell your healthcare provider about any changes in your breasts such as lumps, pain or nipple discharge.
decrease in sex drive that continued after stopping the medication;
allergic reactions including rash, itching, hives and swelling of the lips, tongue, throat, and face;
problems with ejaculation that continued after stopping medication;
difficulty in achieving an erection that continued after stopping the medication;
male infertility and/or poor quality of semen.
in rare cases, male breast cancer.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Finasteride. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You can find instructions on how to report side effects here: https://www.gov.uk/report-problem-medicine-medical-device
How should I store Finasteride?
Store Finasteride at room temperature between 59˚F to 86˚F (15˚C to 30˚C).
Keep Finasteride in a closed container and keep Finasteride tablets dry (protect from moisture).
Keep Finasteride and all medicines out of the reach of children.
General information about the safe and effective use of Finasteride.
Medicines are sometimes prescribed for purposes other than those listed in this Patient Information. Do not use Finasteride for a condition for which it was not prescribed. Do not give Finasteride to other people, even if they have the same symptoms you have. It may harm them.
Do not take Sildenafil (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 Sildenafil and REVATIO, or any of the ingredients in Sildenafil
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
Sildenafil 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 Sildenafil 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 Sildenafil and contact a doctor right away
Before you take Sildenafil, 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.
Sildenafil may affect the way other medicines work, and other medicines may affect the way Sildenafil 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 Sildenafil 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
Sildenafil 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). Sildenafil should not be used with REVATIO or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca tadalafil)
Sildenafil does not protect against sexually transmitted diseases, including HIV.
The most common side effects of Sildenafil: 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.
Sildenafil is not for women or children.