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You should not take tadalafil tablets if your healthcare provider has

• Tadalafil 5mg is primarily used to treat erectile dysfunction.
• It works by relaxing blood vessels in the penis.
• Typically taken once daily for ongoing management.

told you not to have sexual activity because of your health problems.

• Do not take tadalafil 5mg with nitrate medications.
• Alcohol may increase side effects or reduce effectiveness.
• Store at room temperature, away from moisture and heat.

have low blood pressure or have high blood pressure that is not controlled have retinitis pigmentosa, a rare genetic (runs in

17.8 Sudden Hearing Loss

Ask your healthcare provider or pharmacist if you are not sure if any of your medicines are nitrates or guanylate cyclase stimulators, such as riociguat. (See “Who Should Not Take Tadalafil Tablets?”) Tell all of your healthcare providers that you take tadalafil tablets. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took tadalafil tablets. After taking a single tablet, some of the active ingredient of tadalafil tablets remains in your body for more than 2 days. The active ingredient can remain longer if you have problems with your kidneys or liver, or you are taking certain other medications (see “Can Other Medicines Affect Tadalafil Tablets?”).

Typical dosages

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. See also “What Are The Possible Side Effects Of Tadalafil Tablets?” Tadalafil tablets are a prescription medicine taken by mouth for the treatment of: men with symptoms of benign prostatic hyperplasia (BPH) Tadalafil Tablets for the Treatment of ED ED is a condition where the penis does not fill with enough blood to harden and expand when a man is sexually excited, or when he cannot keep an erection. Once a man has completed sexual activity, blood flow to his penis decreases, and his erection goes away. Some form of sexual stimulation is needed for an erection to happen with tadalafil tablets. families) eye disease have ever had severe vision loss, including a condition called NAION have a deformed penis shape or Peyronie’s

disease have had an erection that lasted more than 4 hours have blood cell problems such as sickle cell anemia, multiple

Proper Use

If you experience these symptoms, stop taking tadalafil tablets and contact a healthcare provider right away.These are not all the possible side effects of tadalafil tablets. For more information, ask your healthcare provider or pharmacist.How Should I Store Tadalafil Tablets?Store tadalafil tablets at room temperature between 59oF and 86oF (15oC and 30oC).Keep tadalafil tablets and all medicines out of the reach of children.General Information About Tadalafil Tablets:Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use tadalafil tablets for a condition for which it was not prescribed. Do not give tadalafil tablets to other people, even if they have the same symptoms that you have. It may harm them.This is buy tadalafil a summary of the most important information about tadalafil tablets.

Product TENOFOVIR DISOPROXIL / 245 mg Tablet

If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about tadalafil tablets that is written for health providers. For more information you can also call 1-866-257-2597.What Are the Ingredients In Tadalafil Tablets?Active Ingredient: tadalafil, USPInactive Ingredients: croscarmellose sodium, hydroxypropyl cellulose, iron oxide yellow, iron oxide red, ferrosoferric oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, polyvinyl alcohol-partially hydrolyzed, macrogol/PEG 3350 and lecithin (soya).This Patient Information has been approved by the U.S. Food and Drug AdministrationRx only*The brands listed are trademarks of their respective owners and are not trademarks of Solco Healthcare US, LLC. The makers of these brands are not affiliated with and do not endorse Solco Healthcare US, LLC or its products.Distributed by:Solco Healthcare US, LLCSomerset, NJ 08873, USAManufactured by:Zhejiang Huahai Pharmaceutical Co., Ltd.Xunqiao, Linhai, Zhejiang 317024, ChinaRevised: 08/2022Repackaged By: Preferred Pharmaceuticals Inc. myeloma, or leukemia Tell your healthcare provider about all the medicines

you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

4.3 Concomitant Guanylate Cyclase (GC) Stimulators

Men who have both ED and symptoms of BPH may take tadalafil tablets for the treatment of both conditions. Tadalafil tablets are not for women or children. Tadalafil tablets must be used only under a healthcare provider’s care. Do not take tadalafil tablets if you: use recreational drugs called “poppers” like amyl nitrite and butyl nitrite. (See “What Is The Most Important Information I Should Know About Tadalafil Tablets?”) take any medicines called guanylate cyclase stimulators, such as riociguat. Especially tell your healthcare provider if you take any of the following*: medicines called nitrates (see

Side Effects

protect a man or his partner from sexually transmitted diseases, including HIV. Speak to your healthcare provider about ways to guard against sexually transmitted diseases. serve as a male form of birth control Tadalafil tablets are only for men over the age of 18, including men with diabetes or who have undergone prostatectomy. Tadalafil Tablets for the Treatment of Symptoms of BPH BPH is a condition that happens in men, where the prostate tadalafil in women gland enlarges which can cause urinary symptoms. Tadalafil Tablets for the Treatment of ED and Symptoms of BPH ED and symptoms of BPH may happen in the same person and at the same time. “What Is The Most Important Information I Should

• Use caution when operating vehicles after taking tadalafil.
• Report any persistent side effects to your healthcare provider.
• Tadalafil 5mg is not intended for use in women.

Know About Tadalafil Tablets?”) medicines called guanylate cyclase stimulators,

• Tadalafil 5mg can be part of a comprehensive ED treatment plan.
• Lifestyle changes like exercise and quitting smoking may enhance results.
• Regular medical check-ups are recommended during use.

such as riociguat (Adempas®), used to treat pulmonary

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are allergic to tadalafil tablets or ADCIRCA®, or any of its ingredients. Symptoms of an allergic reaction may include: swelling of the lips, tongue, or throat Call your healthcare provider or get help right away if you have any of the symptoms of an allergic reaction listed above. What Should I Tell My Healthcare Provider Before Taking Tadalafil Tablets? Tadalafil tablets are not right for everyone. Before taking tadalafil tablets, tell your healthcare provider about all your medical problems, including if you: have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack. hypertension These include Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl),

Cardura® (doxazosin mesylate), Minipress® (prazosin HCl), Uroxatral® (alfuzosin

2.7 Concomitant Medications

Read this important information before you start taking tadalafil tablets and each time you get a refill. If you do not understand the information, or have questions, talk with your healthcare provider or pharmacist. What Is The Most Important Information I Should Know About Tadalafil Tablets? Tadalafil tablets can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. Never take tadalafil tablets with any nitrate or guanylate cyclase stimulator medicines.

Additional file 3: (download PDF )

Do not take tadalafil tablets if you take any medicines called “nitrates.” Nitrates are commonly used to treat angina. Angina is a symptom of heart disease and can cause pain in your chest, jaw, or down your arm. Medicines called nitrates include nitroglycerin that is found in tablets, sprays, ointments, pastes, or patches. Some recreational drugs called “poppers” also contain nitrates, such as amyl nitrite and butyl nitrite. Do not take tadalafil tablets if you take medicines called guanylate cyclase stimulators which include: Riociguat (Adempas®) a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension. HCl), Jalyn® (dutasteride and tamsulosin HCl) or Rapaflo® (silodosin).

Medical uses

You may attempt sexual activity at any time between doses.•If you miss a dose, you may take it when you remember but do not take more than one dose per day.•Some form of sexual stimulation is needed for an erection to happen with tadalafil tablets.What Should I Avoid While Taking Tadalafil Tablets?•Do not use other ED medicines or ED treatments while taking tadalafil tablets.•Do not drink too much alcohol when taking tadalafil tablets (for example, 5 glasses of wine or 5 shots of whiskey). Drinking too much alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate, or lowering your blood pressure.What Are The Possible Side Effects Of Tadalafil Tablets?See “What Is The Most Important Information I Should Know About Tadalafil Tablets?”The most common side effects with tadalafil tablets are: headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose. These side effects usually go away after a few hours. Men who get back pain and muscle aches usually get it 12 to 24 hours after taking tadalafil tablets. Back pain and muscle aches usually go away within 2 days.Call your healthcare provider if you get any side effect that bothers you or one that does not go away.Uncommon side effects include:An erection that won’t go away (priapism).

Patients and study design

If you get an erection that lasts more than 4 hours, get medical help right away. Priapism must be treated as soon as possible or lasting damage can happen to your penis, including the inability to have erections.Color vision changes, such as seeing a blue tinge (shade) to objects or having difficulty telling the difference between the colors blue and green.In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including tadalafil tablets) reported a sudden decrease or loss of vision in one or both eyes. It is uncertain whether PDE5 inhibitors directly cause the vision loss. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including tadalafil tablets, and call a healthcare provider right away.Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been rarely reported in people taking PDE5 inhibitors, including tadalafil tablets. It is not possible to determine whether these events are related directly to the PDE5 inhibitors, to other diseases or medications, to other factors, or to a combination of factors.