13 NONCLINICAL TOXICOLOGY

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. If you experience these symptoms, stop taking CIALIS and contact a healthcare provider right away.

• Cialis 5 mg does not cure erectile dysfunction but manages its symptoms.
• The medication is often preferred for its long-lasting effects.
• Dosing may be adjusted based on individual response and tolerance.
• Use Cialis 5 mg exactly as recommended for safety and effectiveness.

These are not all the possible side effects of CIALIS.

• Cialis 5 mg is not intended for use in women.
• No studies have shown benefit in female sexual dysfunction.
• However, tadalafil is used off-label for some female conditions?
• Not recommended; potential harm during pregnancy.
• Do not expose fetuses to the drug.
• Nursing mothers should avoid use as tadalafil may pass into milk.
• Keep out of reach of women and children.
• Only male patients should take this medication.

For more information, ask your healthcare provider or pharmacist. Store CIALIS at room temperature between 59° and 86°F (15° and 30°C).

8.3 Females and Males of Reproductive Potential

CIALIS may be taken with or without meals. If you take too much CIALIS, call your healthcare provider or emergency room right away. How Should I Take CIALIS for Symptoms of BPH? For symptoms of BPH, CIALIS is taken once daily. Do not take CIALIS more than one time each day.

When to take

Take one CIALIS tablet every day at about the same time of day. If you miss a dose, you may take it when you remember but do not take more than one dose per day. How Should I Take CIALIS for ED? For ED, there are two ways to take CIALIS - either for use as needed OR for use once daily. Take one cost cialis everyday CIALIS tablet before you expect to have sexual activity.

Generic version

You may be able to have sexual activity at 30 minutes after taking CIALIS and up to 36 hours after taking it. You and your healthcare provider should consider this in deciding when you should take CIALIS before sexual activity. Your healthcare provider may change your dose of CIALIS depending on how you respond to the medicine, and on your health condition. CIALIS for once daily use is a lower dose you take every day. You may attempt sexual activity at any time between doses. Keep CIALIS and all medicines out of the reach of children.

Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use CIALIS for a condition for which it was not prescribed. Do not give CIALIS to other people, even if they have the same symptoms that you have. This is a summary of the most important information about CIALIS.

5.3 Prolonged Erection

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. CIALIS and other medicines may affect each other. Always check with your healthcare provider before starting or stopping any medicines. 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?”) medicines called guanylate cyclase stimulators, such as riociguat (Adempas®), used to treat pulmonary hypertension These include 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.

Pulmonary arterial hypertension

If CIALIS is taken with certain alpha blockers, your blood pressure could suddenly drop. other medicines to treat high blood pressure (hypertension) medicines called HIV protease inhibitors, such as ritonavir (Norvir®, Kaletra®) some types of oral antifungals such as ketoconazole (Nizoral®), itraconazole (Sporanox®) some types of antibiotics such as clarithromycin (Biaxin®), telithromycin (Ketek®), erythromycin (several brand names exist. Please consult your healthcare provider to determine if you are taking this medicine). CIALIS is also marketed as ADCIRCA for the treatment of pulmonary arterial hypertension. Do not take sildenafil citrate (Revatio®) with CIALIS.

Financial and insurance assistance

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. 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. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about CIALIS that is written for health providers. For more information you can also visit or call 1-877-CIALIS1 (1-877-242-5471).

4.1 Nitrates

How Should I Take CIALIS for Both ED and the Symptoms of BPH? For both ED and the symptoms of BPH, CIALIS is taken once daily. 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).

1. They Look Different

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 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. 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 CIALIS.

Why Should I Pay More For the Same Results?

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. An erection that won't go away (priapism). 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. This Patient Information has been approved by the U.S.

17.4 Concomitant Use with Drugs Which Lower Blood Pressure

CIALIS for the Treatment of Symptoms of BPH BPH is a condition that happens in men, where the prostate gland enlarges which can cause urinary symptoms. CIALIS 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. Men who have both ED and symptoms of BPH may take CIALIS for the treatment of both conditions. CIALIS is not for women or children. CIALIS must be used only under a healthcare provider's care.

Drug details

use recreational drugs called “poppers” like amyl nitrite and butyl nitrite. (See “What Is The Most Important Information I Should Know About CIALIS?”) take any medicines called guanylate cyclase stimulators, such as riociguat. are allergic to CIALIS or ADCIRCA®, or any of its ingredients. See the end of this leaflet for a complete list of ingredients in CIALIS. Symptoms of an allergic reaction may include:rashhivesswelling of the lips, tongue, or throatdifficulty breathing or swallowing 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.

Off-label use for Cialis

What Should I Tell My Healthcare Provider Before Taking CIALIS? Only your healthcare provider and you can decide if CIALIS is right for you. Before taking CIALIS, 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. Ask your healthcare provider if it is safe for you to have sexual activity. You should not take CIALIS if your healthcare provider has told you not to have sexual activity because of your health problems. Food and Drug Administration CIALIS® (tadalafil) is a registered trademark of Eli Lilly and Company.

*The brands listed are trademarks of their respective owners and are not trademarks of Eli Lilly and Company.

• Common side effects include muscle aches and indigestion.
• Cialis 5 mg offers the convenience of a once-daily dose.
• Patients should avoid sudden standing movements due to possible dizziness.
• The medication is not a cure but helps achieve and maintain an erection.

The makers of these brands are not affiliated with and do not endorse Eli Lilly and Company or its products.

Drug Label Information

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. 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 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. INGREDIENTS AND APPEARANCE Inactive IngredientsHydroxypropyl cellulose, Unspecified (UNII: 9XZ8H6N6OH)Hypromellose, Unspecified (UNII: 3NXW29V3WO)Ferric Oxide Yellow (UNII: EX438O2MRT)Lactose monohydrate (UNII: EWQ57Q8I5X)Magnesium stearate (UNII: 70097M6I30)Microcrystalline cellulose (UNII: OP1R32D61U)Sodium lauryl sulfate (UNII: 368GB5141J)Talc (UNII: 7SEV7J4R1U)Titanium dioxide (UNII: 15FIX9V2JP)Croscarmellose sodium (UNII: M28OL1HH48)Triacetin (UNII: XHX3C3X673)Product CharacteristicsColoryellowScoreno scoreShapeOVAL (almond)Size11mmFlavorImprint CodeC;10ContainsPackagingNDC:0002-4463-3030 in 1 BOTTLE; Type 0: Not a Combination Product11/26/2003Marketing InformationNDANDA02136811/26/2003CIALIStadalafil tablet, film coatedProduct InformationProduct TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0002-4464Route of AdministrationORALActive Ingredient/Active MoietyTadalafil (UNII: 742SXX0ICT) (Tadalafil - UNII:742SXX0ICT)Tadalafil20 mgInactive IngredientsHydroxypropyl cellulose, Unspecified (UNII: 9XZ8H6N6OH)Hypromellose, Unspecified (UNII: 3NXW29V3WO)Ferric Oxide Yellow (UNII: EX438O2MRT)Lactose monohydrate (UNII: EWQ57Q8I5X)Magnesium stearate (UNII: 70097M6I30)Microcrystalline cellulose (UNII: OP1R32D61U)Sodium lauryl sulfate (UNII: 368GB5141J)Talc (UNII: 7SEV7J4R1U)Titanium dioxide (UNII: 15FIX9V2JP)Croscarmellose sodium (UNII: M28OL1HH48)Triacetin (UNII: XHX3C3X673)Product CharacteristicsColoryellowScoreno scoreShapeOVAL (almond)Size12mmFlavorImprint CodeC;20ContainsPackagingNDC:0002-4464-3030 in 1 BOTTLE; Type 0: Not a Combination Product11/26/2003Marketing InformationNDANDA02136811/26/2003Labeler - Eli Lilly and Company (006421325)