1 INDICATIONS AND USAGE

When a man is sexually stimulated, his body's normal response is to increase blood flow to his penis to produce an erection.

By controlling the enzyme, tadalafil helps to maintain an erection after the penis is stroked by increasing blood flow to the penis. Without physical action to the penis, such as that occurring during sexual intercourse, tadalafil will not work to cause an erection.

• The mechanism for treating BPH is separate from its effect on blood vessels.
• For BPH, it works by inhibiting PDE5 in the prostate, bladder, and urethra.
• This leads to smooth muscle relaxation in the lower urinary tract.
• Patients may experience improved urinary frequency, urgency, and flow.
• It is not a treatment for prostate cancer, though symptoms can overlap.
• A prostate-specific antigen (PSA) test is often done before and during treatment.
• Tadalafil can cause a slight decrease in measured PSA levels.
• Your doctor needs to be aware you are taking it when interpreting PSA results.
• It represents a non-surgical option for managing moderate BPH symptoms.
• Surgical options remain for cases where medication is not effective enough.

Tadalafil is also used to treat men who have signs and symptoms of benign prostatic hyperplasia (BPH).

13.2 Animal Toxicology and/or Pharmacology

See also “What Are The Possible Side Effects Of CIALIS?” CIALIS is a prescription medicine taken by mouth for the treatment of erectile dysfunction (ED) in men. 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 CIALIS. protect a man or his partner from sexually transmitted diseases, including HIV.

Does Cialis increase the size of a man’s penis?

Speak to your healthcare provider about ways to guard against sexually transmitted diseases. serve as a male form of birth control CIALIS is only for men over the age of 18 who have ED, including men with diabetes or who have undergone prostatectomy CIALIS is not for women or children. CIALIS must be used only under a healthcare provider's care. use recreational drugs called “poppers” like amyl nitrite and butyl nitrite. (See “What Is The Most Important Information I Should Know About CIALIS?”) What Should I Tell My Healthcare Provider Before Taking CIALIS? BPH is caused by an enlarged prostate.

• Cialis 10 mg is available by prescription only.
• It may help men with occasional or chronic ED.
• Cialis is also used for benign prostatic hyperplasia.
• Effects of 10 mg Cialis can vary between users.
• Take Cialis on an empty stomach for faster action.
• Alcohol can increase side effects of Cialis.
• Cialis flexibility allows use as needed or daily.
• Store Cialis at room temperature away from moisture.
• Possible drug interactions include blood pressure meds.
• Regular medical checkups are recommended during use.
• Discontinue use and seek medical advice if adverse reactions occur.

Men with BPH usually have difficulty urinating, a decreased flow of urination, hesitation at the beginning of urination, and a need to get up at night to urinate. Tadalafil will make these symptoms less severe and reduce the chance that prostate surgery will be needed. This medicine is also used to treat erectile dysfunction and signs and symptoms of BPH. Tadalafil is also used in both men and women to treat the symptoms of pulmonary arterial hypertension to improve your ability to exercise. This is high blood pressure that occurs in the main artery that carries blood from the right side of the heart (the ventricle) to the lungs.

When the smaller blood vessels in the lungs become more resistant to blood flow, the right ventricle must work harder to pump enough blood through the lungs. Tadalafil works on the PDE5 enzyme in the lungs to relax the blood vessels. This will increase the supply of blood to the lungs and reduce the workload of the heart.

Cost of Different Doses

Do not change your dose or the way you take CIALIS without talking to your healthcare provider. Your healthcare provider may lower or raise your dose, depending on how your body reacts to CIALIS and your health condition. CIALIS may be taken with or without meals. If you take too much CIALIS, call your healthcare provider or emergency room right away. There are two ways to take CIALIS: Do not take CIALIS more than one time each day.

3.2 Primary efficacy endpoints

Take one CIALIS tablet before you expect to have sexual activity. Your healthcare provider may change your dose of CIALIS depending on how you respond to the medicine, and on your health condition. Do not take CIALIS more than one time each day. Take one CIALIS tablet every day at about the same time of day. You may attempt sexual activity at any time between doses. This medicine is available only with your doctor's prescription. This product is available in the following dosage forms: In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do.

This is a decision you and your doctor will make. For this medicine, the following should be considered: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines.

5.5 Sudden Hearing Loss

Before taking CIALIS, tell your healthcare provider about all your medical problems, including if you: are allergic to CIALIS or ADCIRCA any of its ingredients. See the end of this leaflet for a complete list of ingredients in CIALIS. have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack. You should not take CIALIS if your healthcare provider has told you not to have sexual activity because of your health problems. have low blood pressure or have high blood pressure that is not controlled have retinitis pigmentosa, a rare genetic (runs in 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 myeloma, or leukemia Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

What if I miss a dose?

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 CIALIS?”) These include Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl) or Uroxatral® (alfuzosin HCl). other medicines to treat high blood pressure (hypertension) medicines called HIV protease inhibitors, such as ritonavir (Norvir®, Kaletra®) CIALIS is also marketed as ADCIRCA for the treatment of pulmonary arterial hypertension. Take CIALIS exactly as your healthcare provider prescribes it. Your healthcare provider will prescribe the dose that is right for you. Some men can only take a low dose of CIALIS or may have to take it less often, because of medical conditions or medicines they take. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals.

• Cialis 10 mg dosage may be adjusted by doctors.
• It is effective in males with reduced libido.
• Cialis begins working within 30 minutes in most cases.
• It boosts confidence during intimate moments.
• The medication isn’t suitable for women.
• Keep track of your response to the medication.
• Cialis can be part of ED management strategies.
• Avoid taking multiple doses in a 24-hour period.
• The medication is approved by multiple health agencies.
• Consult a doctor if you experience dizziness.
• Cialis should be used responsibly with medical guidance.

For non-prescription products, read the label or package ingredients carefully. Use of Cialis® and Chewtadzy® tablet is not indicated for use in the pediatric population. Safety and efficacy have not been established.

5.12 Effects on Bleeding

Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. This is a summary of the most important information about CIALIS. For more information you can also visit or call 1-877-CIALIS1 (1-877-242-5471). CIALIS® (tadalafil) is a registered trademark of Eli Lilly and Company. The makers of these brands are not affiliated with and do not endorse Eli Lilly and Company or its products.

When to take

Tadalafil is used to treat men who have erectile dysfunction (also called sexual impotence). Tadalafil belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors. These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly. The penis is one of the areas where this enzyme works. Erectile dysfunction is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. Appropriate studies have not been performed on the relationship of age to the effects of Adcirca® and Alyq™ tablet in the pediatric population.

Single (On-Demand) Dosage

If you miss a dose, you may take it when you remember but do not take more than one dose per day. What Should I Avoid While Taking CIALIS? Do not use other ED medicines or ED treatments while taking CIALIS. Do not drink too much alcohol when taking CIALIS (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 serious side effects of tadalafil?

What Are The Possible Side Effects Of CIALIS? See “What Is The Most Important Information I Should Know About CIALIS?” The most common side effects with CIALIS are: headache, indigestion, back pain, muscle aches, flushing, and stuffy or runny nose. Back pain and muscle aches usually go away within 2 days. Call soft tab cialis your healthcare provider if you get any side effect that bothers you or one that does not go away. An erection that won't go away (priapism). Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tadalafil in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

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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 CIALIS) reported a sudden decrease or loss of vision in one or both eyes. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including CIALIS, 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 CIALIS.

Higher dosages of Cialis

If you experience these symptoms, stop taking CIALIS and contact a healthcare provider right away. These are not all the possible side effects of CIALIS. For more information, ask your healthcare provider or pharmacist. Store CIALIS at room temperature between 59° and 86°F (15° and 30°C). Keep CIALIS and all medicines out of the reach of children. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur.

• Cialis 10 mg helps increase blood flow to the penis.
• It is not an aphrodisiac; arousal is needed.
• Take Cialis about 30 minutes before sexual activity.
• The medication is effective regardless of food intake.
• A dose adjustment may be necessary for liver issues.
• Men should not plan to take Cialis more than once daily.
• Cialis has been approved by health authorities worldwide.
• Some users report improved erectile quality.
• Cialis may cause muscle pain or nasal congestion.
• Consult your doctor to confirm if Cialis is safe for you.
• Keep out of reach of children and stored properly.

In these cases, your doctor may want to change the dose, or other precautions may be necessary.

When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below.