Cialis 20 mg ( Tadalafil ) 4 film-coated tablets

What is Cialis?

Cialis (tadalafil) relaxes muscles of the blood vessels and increases blood flow to particular areas of the body.

Cialis is used to treat erectile dysfunction (impotence) and symptoms of benign prostatic hypertrophy (enlarged prostate).

Another brand of tadalafil is Adcirca, which is used to treat pulmonary arterial hypertension and improve exercise capacity in men and women. Do not take Cialis while also taking Adcirca, unless your doctor tells you to.

Important information
Do not take Cialis if you are also using a nitrate drug for chest pain or heart problems, including nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, and some recreational drugs such as "poppers". Taking tadalafil with a nitrate medicine can cause a sudden and serious decrease in blood pressure.

Some medicines can cause unwanted or dangerous effects when used with Cialis. Tell your doctor about all your current medicines, especially riociguat (Adempas).

Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours. A prolonged erection (priapism) can damage the penis.

Get medical help at once if you have nausea, chest pain, or dizziness during sex.

Stop using Cialis and get emergency medical help if you have sudden vision loss.

Before taking this medicine
You should not take Cialis if you are allergic to tadalafil.

Taking Cialis with certain other medicines can cause a sudden and serious decrease in blood pressure. Do not take this medicine if you also use:

riociguat (to treat pulmonary arterial hypertension); or

a nitrate drug (for chest pain or heart problems) such as nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, or recreational drugs such as amyl nitrate or nitrite "poppers".

Some tadalafil can remain in your bloodstream for 2 or more days after each dose you take (longer if you have liver or kidney disease). Avoid nitrate use during this time.

To make sure this Cialis is safe for you, tell your doctor if you have ever had:

heart disease or heart rhythm problems;

a heart attack or stroke;

angina (chest pain), high or low blood pressure;

pulmonary hypertension (unless you are taking tadalafil for this);

a condition called pulmonary veno-occlusive disease (narrowing of the veins that carry blood from the lungs to the heart);

liver or kidney disease (or if you are on dialysis);

vision loss, or retinitis pigmentosa (an inherited condition of the eye);

a bleeding disorder;

a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;

a physical deformity of the penis (such as Peyronie's disease), or an erection lasting longer than 4 hours;

a stomach ulcer; or

health problems that make sexual activity unsafe.

Sudden vision loss has occurred in a small number of people taking medicines like tadalafil (Viagra or others). Most of these people already had certain eye problems or had high cholesterol, diabetes, coronary artery disease, a history of smoking, or were over 50 years old). It is not clear whether the medicine was the actual cause of vision loss.

Cialis is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether tadalafil passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Cialis is not approved for use by anyone younger than 18 years old.

How should I take Cialis?
Cialis is usually taken only once per day. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Cialis can be taken with or without food.

Do not break or split a tablet. Swallow it whole.

For erectile dysfunction, take Cialis just before sexual activity but not more than once per day.

Cialis can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill. Follow your doctor's instructions.

Do not take Cialis for erectile dysfunction if you are taking Adcirca for pulmonary arterial hypertension.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?
As Cialis is used as needed, you are not likely to be on a dosing schedule.

What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Cialis?
Drinking alcohol with this medicine can cause side effects.

Grapefruit and grapefruit juice may interact with tadalafil and lead to unwanted side effects. Avoid the use of grapefruit products while taking this medicine.

Cialis side effects
Get emergency medical help if you have signs of an allergic reaction to Cialis: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop and get medical help at once if you have nausea, chest pain, or dizziness during sex. You could be having a life-threatening side effect.

Stop using this medicine and call your doctor at once if you have:

a light-headed feeling, like you might pass out;

an erection is painful or lasts longer than 4 hours (prolonged erection can damage the penis);

vision changes or sudden vision loss;

ringing in your ears or sudden hearing loss; or

heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

Common Cialis side effects may include:

headache;

flushing (warmth, redness, or tingly feeling);

nausea, upset stomach;

stuffy nose; or

muscle pain, back pain, pain in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also:
Cialis side effects (in more detail)

What other drugs will affect Cialis?
Tell your doctor about all your current medicines and any you start or stop using, especially:

medicines to treat erectile dysfunction or pulmonary arterial hypertension;

an antibiotic or antifungal medicine;

antiviral medicine to treat hepatitis C or HIV/AIDS;

drugs to treat high blood pressure or a prostate disorder; or

seizure medicine.

This list is not complete. Other drugs may interact with tadalafil, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

See also:
Cialis drug interactions (in more detail)

Further information
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Cialis only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2020 Cerner Multum, Inc. Version: 11.01.

Side Effects:

In Summary
Common side effects of Cialis include: dyspepsia and headache. Other side effects include: upper respiratory tract infection, back pain, myalgia, cough, and nasal congestion. See below for a comprehensive list of adverse effects.

For the Consumer
Applies to tadalafil: oral tablet

Along with its needed effects, tadalafil (the active ingredient contained in Cialis) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking tadalafil:

Less common

Arm, back, or jaw pain
blurred vision
chest pain or discomfort
chest tightness or heaviness
chills
cold sweats
confusion
dizziness
fainting
faintness or lightheadedness when getting up suddenly from a lying or sitting position
fast or irregular heartbeat
headache
hearing loss
increased erection
nausea
nervousness
pain or discomfort in the arms, jaw, back, or neck
pounding in the ears
slow or fast heartbeat
spontaneous penile erection
sweating
unusual tiredness or weakness
vomiting

Rare

Painful or prolonged erection of the penis
Incidence not known

Blindness
blistering, peeling, or loosening of the skin
cough
cracks in the skin
decrease or change in vision
diarrhea
difficulty with speaking
double vision
fast, irregular, pounding, or racing heartbeat or pulse
headache, severe and throbbing
hives or welts, itching, skin rash
inability to move the arms, legs, or facial muscles
inability to speak
joint or muscle pain
loss of heat from the body
numbness or tingling of the face, hands, or feet
red skin lesions, often with a purple center
red, irritated eyes
red, swollen skin
redness of the skin
redness or soreness of the eyes
scaly skin
slow speech
sores, ulcers, or white spots in the mouth or on the lips
stomach pain
sudden cardiac death
swelling of the feet or lower legs
Some side effects of tadalafil may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Belching
heartburn
indigestion
stomach discomfort, upset, or pain
Less common

Bloody nose
body aches or pain
burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
burning, dry, or itching eyes
burning feeling in the chest or stomach
congestion
difficulty with moving
difficulty with swallowing
dry mouth
dryness or soreness of the throat
excessive eye discharge
eye pain
feeling of constant movement of self or surroundings
feeling of warmth, redness of the face, neck, arms and occasionally, upper chest
fever
hoarseness
lack or loss of strength
loose stools
muscle aching or cramping
muscle stiffness
nasal congestion
neck pain
pain
pain in the arms or legs
pain or burning in the throat
redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
reduced sensitivity to touch
runny nose
sensation of spinning
sleepiness or unusual drowsiness
stomach upset
swelling of the eyelids
swelling or puffiness of the eyes or face
swollen joints
tearing
tender, swollen glands in the neck
tenderness in the stomach area
trouble with sleeping
upper abdominal or stomach pain
voice changes
watering of the eyes

Dosage:

Do not split CIALIS tablets; entire dose should be taken.

CIALIS for Use as Needed for Erectile Dysfunction
The recommended starting dose of CIALIS for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity.
The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. The maximum recommended dosing frequency is once per day in most patients.
CIALIS for use as needed was shown to improve erectile function compared to placebo up to 36 hours following dosing. Therefore, when advising patients on optimal use of CIALIS, this should be taken into consideration.
CIALIS for Once Daily Use for Erectile Dysfunction
The recommended starting dose of CIALIS for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.
The CIALIS dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability.
CIALIS for Once Daily Use for Benign Prostatic Hyperplasia
The recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day.
When therapy for BPH is initiated with CIALIS and finasteride, the recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day for up to 26 weeks.
CIALIS for Once Daily Use for Erectile Dysfunction and Benign Prostatic Hyperplasia
The recommended dose of CIALIS for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.

Use with Food
CIALIS may be taken without regard to food.

Use in Specific Populations
Renal Impairment

CIALIS for Use as Needed

Creatinine clearance 30 to 50 mL/min: A starting dose of 5 mg not more than once per day is recommended, and the maximum dose is 10 mg not more than once in every 48 hours.
Creatinine clearance less than 30 mL/min or on hemodialysis: The maximum dose is 5 mg not more than once in every 72 hours [see Warnings and Precautions (5.7) and Use in Specific Populations (8.7)].
CIALIS for Once Daily Use

Erectile Dysfunction

Creatinine clearance less than 30 mL/min or on hemodialysis: CIALIS for once daily use is not recommended [see Warnings and Precautions (5.7) and Use in Specific Populations (8.7)].

Benign Prostatic Hyperplasia and Erectile Dysfunction/Benign Prostatic Hyperplasia

Creatinine clearance 30 to 50 mL/min: A starting dose of 2.5 mg is recommended. An increase to 5 mg may be considered based on individual response.
Creatinine clearance less than 30 mL/min or on hemodialysis: CIALIS for once daily use is not recommended [see Warnings and Precautions (5.7) and Use in Specific Populations (8.7)].
Hepatic Impairment

CIALIS for Use as Needed

Mild or moderate (Child Pugh Class A or B): The dose should not exceed 10 mg once per day. The use of CIALIS once per day has not been extensively evaluated in patients with hepatic impairment and therefore, caution is advised.
Severe (Child Pugh Class C): The use of CIALIS is not recommended [see Warnings and Precautions (5.8) and Use in Specific Populations (8.6)].
CIALIS for Once Daily Use

Mild or moderate (Child Pugh Class A or B): CIALIS for once daily use has not been extensively evaluated in patients with hepatic impairment. Therefore, caution is advised if CIALIS for once daily use is prescribed to these patients.
Severe (Child Pugh Class C): The use of CIALIS is not recommended [see Warnings and Precautions (5.8) and Use in Specific Populations (8.6)].
Concomitant Medications
Nitrates

Concomitant use of nitrates in any form is contraindicated [see Contraindications (4.1)].

Alpha-Blockers

ED — When CIALIS is coadministered with an alpha-blocker in patients being treated for ED, patients should be stable on alpha-blocker therapy prior to initiating treatment, and CIALIS should be initiated at the lowest recommended dose [see Warnings and Precautions (5.6), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].

BPH — CIALIS is not recommended for use in combination with alpha-blockers for the treatment of BPH [see Warnings and Precautions (5.6), Drug Interactions (7.1), and Clinical Pharmacology (12.2)].

CYP3A4 Inhibitors

CIALIS for Use as Needed — For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose of CIALIS is 10 mg, not to exceed once every 72 hours.

Interactions:

A total of 248 drugs are known to interact with Cialis (tadalafil).

9 major drug interactions
141 moderate drug interactions
98 minor drug interactions
Show all medications in the database that may interact with Cialis (tadalafil).

Drug name
Enter a drug name
Most frequently checked interactions
View interaction reports for Cialis (tadalafil) and the medicines listed below.

Adderall (amphetamine / dextroamphetamine)
alfuzosin
amlodipine
amlodipine
amoxicillin
aspirin
Aspirin Low Strength (aspirin)
atorvastatin
atorvastatin
caffeine
Crestor (rosuvastatin)
Eliquis (apixaban)
finasteride
Fish Oil (omega-3 polyunsaturated fatty acids)
Flomax (tamsulosin)
gabapentin
grapefruit
L-Arginine (arginine)
Lipitor (atorvastatin)
lisinopril
lisinopril
losartan
losartan
metformin
omeprazole
oxycodone
prednisone
simvastatin
tamsulosin
testosterone
tramadol
trazodone
Viagra (sildenafil)
Vitamin B12 (cyanocobalamin)
Vitamin D3 (cholecalciferol)
Xarelto (rivaroxaban)
Zoloft (sertraline)

Cialis (tadalafil) alcohol/food interactions
There is 1 alcohol/food interaction with Cialis (tadalafil)

Cialis (tadalafil) disease interactions
There are 9 disease interactions with Cialis (tadalafil) which include:

cardiovascular disease
renal dysfunction
pulmonary disease
priapism
alcoholism
hearing loss
liver disease
retinitis pigmentosa
seizure disorders

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