DOSAGE AND ADMINISTRATION

tell your doctor if you smoke; if you have ever had an erection that lasted more than 4 hours; and if you have recently had diarrhea, vomiting, not been drinking enough fluids, or sweating a lot which may have caused dehydration (loss of a large amount of body fluids.

Also tell your doctor if you have or have ever had pulmonary veno-occlusive disease (PVOD; blockage of veins in the lungs); any condition that affects the shape of the penis; diabetes; high cholesterol; high or low blood pressure; irregular heartbeat; a heart attack or heart failure; angina (chest pain); a stroke; ulcers in the stomach; a bleeding disorder; blood circulation problems; blood cell problems such as sickle cell anemia (a disease of the red blood cells), multiple myeloma (cancer of the plasma cells), or leukemia (cancer of the white blood cells); or heart, kidney, or liver disease. Also tell your doctor if you or any of your family members have or have ever had an eye disease such as retinitis pigmentosa (an inherited eye condition that causes loss of vision) or if you have ever had sudden severe vision loss, especially if you were told that the vision loss was caused by a blockage of blood flow to the nerves that help you see.

What Does ‘Low-Dose’ Mean?

If you experience chest pain, dizziness, or nausea during sexual activity, call your doctor immediately or get emergency medical treatment, and avoid sexual activity until your doctor tells you otherwise. tell all your health care providers that you are taking tadalafil. If you ever need emergency medical treatment for a heart problem, the health care providers who treat you will need to know when you last took tadalafil. Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine. If you are taking tadalafil for erectile dysfunction on a regular schedule, take the missed dose as soon as you remember it.

Take as directed

However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose or more than one dose per day to make up for a missed one. If you are taking tadalafil for PAH or BPH, take the missed dose as soon as you remember it. Do not take a double dose to make up for a missed one. pain in the stomach, back, muscles, arms, or legs sudden decrease or loss of vision (see below for more information) changes in color vision (seeing a blue tinge on objects or having difficulty telling the difference between blue and green) sudden decrease or loss of hearing (see below for more information) erection that lasts longer than 4 hours swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs Some patients experienced a sudden loss of some or all of their vision after they took tadalafil or other medications that are similar to tadalafil. if you are a woman and you are taking tadalafil to treat PAH, tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking tadalafil, call your doctor. if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking tadalafil.

• Cialis 10mg tablets should be stored in a cool, dry environment.
• Protect the medication from direct sunlight and moisture.
• Proper storage ensures medication stability and safety.
• Keep Cialis out of sight and reach of children and pets.
• Do not use expired Cialis tablets; dispose of them safely.
• Store away from heat sources to prevent degradation.
• Use original packaging to keep track of medication.
• If you experience any storage issues, consult your pharmacist.
• Keep a record of medication expiry dates for safety.
• Avoid storing Cialis in the bathroom due to humidity.
• Use a designated medication container for safe storage.

talk to your doctor about the safe use of alcoholic beverages during your treatment with tadalafil. If you drink a large amount of alcohol (more than five glasses of wine or five shots of whiskey) while you are taking tadalafil you are more likely to experience certain side effects of tadalafil such as dizziness, headache, fast heartbeat, and low blood pressure.

• Cialis tadalafil 10mg tablets are prescribed for watchful monitoring initially.
• Patients should report chest pain or vision changes while on Cialis.
• Cialis is not recommended for use in women or children.
• The drug is contraindicated in patients with severe liver or kidney disease.
• Avoid grapefruit juice, which may increase Cialis blood levels.
• Use caution if you have a history of heart disease.
• Some medications can increase Cialis's side effects; always disclose all drugs.
• Cialis may interact with blood pressure medications, affecting their efficacy.
• Always inform your physician about any new health issues during treatment.
• Do not adjust your Cialis dosage without medical advice.
• Follow-up appointments help optimize treatment and manage side effects.

if you are taking tadalafil to treat erectile dysfunction, tell your doctor if you have ever been advised by a health care professional to avoid sexual activity for medical reasons or if you have ever experienced chest pain during sexual activity.

Sexual activity may be a strain on your heart, especially if you have heart disease. If you experience chest pain, dizziness, or nausea during sexual activity, call your doctor immediately or get emergency medical treatment, and avoid sexual activity until your doctor tells you otherwise. tell all your health care providers that you are taking tadalafil. If you ever need emergency medical treatment for a heart problem, the health care providers who treat you will need to know when you last took tadalafil. Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine. If you are taking tadalafil for erectile dysfunction on a regular schedule, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose or more than one dose per day to make up for a missed one. If you are taking tadalafil for PAH or BPH, take the missed dose as soon as you remember it. Do not take a double dose to make up for a missed one. pain in the stomach, back, muscles, arms, or legs sudden decrease or loss of vision (see below for more information) changes in color vision (seeing a blue tinge on objects or having difficulty telling the difference between blue and green) sudden decrease or loss of hearing (see below for more information) erection that lasts longer than 4 hours swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs Some patients experienced a sudden loss of some or all of their vision after they took tadalafil or other medications that are similar to tadalafil. The vision loss was permanent in some cases. It is not known if the vision loss was caused by the medication.

14.2 CIALIS for Once Daily Use

Ask your pharmacist any questions you have about refilling your prescription. Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies. Entadfi® (as a combination product containing Finasteride, Tadalafil) Indicated for treatment of erectile dysfunction (ED) Cialis (or generic equivalent) or Chewtadzy only PRN use: 10 mg PO initially before sexual activity, with or without food; may be increased to 20 mg or reduced to 5 mg on basis of efficacy and tolerability; in most patients, maximum dosing frequency is once daily Once-daily use (Cialis): 2.5 mg/day PO in single daily dose, without regard to timing of sexual activity, with or without food; may be increased to 5 mg/day on basis of efficacy and tolerability Indicated for treatment of signs and symptoms of benign prostatic hyperplasia (BPH); daily use also indicated for treatment of patients with both BPH and erectile dysfunction Cialis (or generic equivalent) or Chewtadzy only BPH with ED: 5 mg PO once daily, taken at approximately same time each day without regard to timing of sexual activity Coadministration with finasteride for BPH: Tadalafil 5 mg plus finasteride 5 mg PO once daily for ≤26 weeks; incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and the benefit beyond 26 weeks is unknown Indicated for pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability; studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%) Adcirca, Alyq, Tadliq, or generic equivalent only 40 mg PO once daily; dividing dose for more frequent dosing is not recommended Patients also taking ritonavir: 20 mg PO once daily initially for ≥1 week; may be increased to 40 mg/day on basis of tolerability Cialis, Chewtadzy (PRN use)Mild (CrCl >50 mL/min): No dosage adjustment neededModerate (CrCl 30-50 mL/min): Not to exceed 5 mg PO once daily initially; maximum dosage, 10 mg PO q48hrSevere (CrCl <30 mL/min and on hemodialysis): Not to exceed 5 mg PO q72hr Mild (CrCl >50 mL/min): No dosage adjustment needed Moderate (CrCl 30-50 mL/min): Not to exceed 5 mg PO once daily initially; maximum dosage, 10 mg PO q48hr Severe (CrCl <30 mL/min and on hemodialysis): Not to exceed 5 mg PO q72hr Cialis (once daily use)ED (CrCl >50 mL/min): No dosage adjustment neededBPH or BPH/ED (CrCl 30-50 mL/min): 2.5 mg/day starting dose recommended; may increase to 5 mg according to individual responseED or BPH (CrCl <30 mL/min or hemodialysis): Not recommended ED (CrCl >50 mL/min): No dosage adjustment needed BPH or BPH/ED (CrCl 30-50 mL/min): 2.5 mg/day starting dose recommended; may increase to 5 mg according to individual response ED or BPH (CrCl <30 mL/min or hemodialysis): Not recommended Chewtadzy (once daily use)BPH, ED/BPHCrCl >50 mL/min: No dosage adjustment neededCrCl ≤50 mL/min or hemodialysis: Not recommended CrCl >50 mL/min: No dosage adjustment needed CrCl ≤50 mL/min or hemodialysis: Not recommended Adcirca, Alyq, TadliqMild-to-moderate (CrCl 31-80 mL/min): 20 mg PO once daily initially; may be increased to 40 mg once daily on basis of tolerabilitySevere (CrCl <30 mL/min and on hemodialysis): Avoid use Mild-to-moderate (CrCl 31-80 mL/min): 20 mg PO once daily initially; may be increased to 40 mg once daily on basis of tolerability Severe (CrCl <30 mL/min and on hemodialysis): Avoid use Cialis, Chewtadzy (PRN use)Mild-to-moderate (Child-Pugh class A or B): Not to exceed 10 mg PO once dailySevere (Child-Pugh class C): Not recommended Mild-to-moderate (Child-Pugh class A or B): Not to exceed 10 mg PO once daily Severe (Child-Pugh class C): Not recommended Cialis, Chewtadzy (once daily use)Mild-to-moderate (Child-Pugh class A or B): Data limited; caution advisedSevere (Child-Pugh class C): Not recommended Mild-to-moderate (Child-Pugh class A or B): Data limited; caution advised Severe (Child-Pugh class C): Not recommended Adcirca, Alyq, TadliqMild-to-moderate (Child-Pugh class A or B): Consider starting dosage of 20 mg PO once dailySevere (Child-Pugh class C): Avoid use Mild-to-moderate (Child-Pugh class A or B): Consider starting dosage of 20 mg PO once daily Severe (Child-Pugh class C): Avoid use ED PRN use: Not to exceed 10 mg/72 hr ED or ED/BPH once-daily use: Not to exceed 2.5 mg/day Adcirca, Alyq, TadliqOn ritonavir for at least 1 week: Start tadalafil at 20 mg PO qDay; may increase to 40 qDay based on individual tolerabilityAvoid tadalafil during ritonavir initiationStop tadalafil at least 24 hr before to starting ritonavirAfter at least 1 week following ritonavir initiation, resume tadalafil 20 mg PO qDay; may increase to 40 qDay based on individual tolerability On ritonavir for at least 1 week: Start tadalafil at 20 mg PO qDay; may increase to 40 qDay based on individual tolerability Stop tadalafil at least 24 hr before to starting ritonavir After at least 1 week following ritonavir initiation, resume tadalafil 20 mg PO qDay; may increase to 40 qDay based on individual tolerability Chewtadzy: Not indicated for once daily use for ED because dosing is not possible (recommended dosage for this indication cannot be achieved with lowest available strength) Orphan designation for Duchenne muscular dystrophy (DMD) Eli Lilly and Company; Lilly Corporate Center; Indianapolis, IN 46285 Indicated for treatment of erectile dysfunction (ED) Cialis or generic equivalent only: No dosage adjustment is warranted solely on basis of age; however, greater sensitivity to medications in some older individuals should be considered Indicated for pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability; studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%) Adcirca, Alyq, or generic equivalent only: Lower dose or reduced dosing frequency may be required in elderly because of decreased renal or hepatic clearance Allow 48h after last tadalafil dose before nitrate administration.

What is tadalafil (generic Cialis®)

If you experience a sudden loss of vision while you are white cialis pill taking tadalafil, call your doctor immediately or get emergency medical treatment.

Do not take any more doses of tadalafil or similar medications such as sildenafil (Revatio, Viagra) or vardenafil (Levitra) until you talk to your doctor. Some patients experienced a sudden decrease or loss of hearing after they took tadalafil or other medications that are similar to tadalafil.

• [Clinical studies demonstrated improved erectile function in men with ED.]
• [Shown to significantly improve symptoms of BPH, such as urinary frequency.]
• [Well-tolerated in most patients, with side effects often mild to moderate.]
• [Effectiveness can be influenced by psychological factors and relationship issues.]
• [Consultation with a urologist or primary care physician is recommended for diagnosis.]

The hearing loss usually involved only one ear and did not always improve when the medication was stopped. It is not known if the hearing loss was caused by the medication. If you experience a sudden loss of hearing, sometimes with ringing in the ears or dizziness, while you are taking tadalafil, call your doctor immediately. Call your doctor if you have any unusual problems while taking this medication If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( or by phone (1-800-332-1088). Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Talk to your pharmacist about take-back programs in your community.

16.1 How Supplied

Store it at room temperature and away from excess heat and moisture (not in the bathroom). Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website for more information.

Heavy meals

Keep all medication out of sight and reach of children as many containers are not child-resistant. Place the medication in a safe location – one that is up and away and out of their sight and reach. In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911. Do not let anyone else take your medication. Visit the FDA's Safe Disposal of Medicines website for more information.

5.11 Combination With Other PDE5 Inhibitors or Erectile Dysfunction Therapies

The vision loss was permanent in some cases. It is not known if the vision loss was caused by the medication. If you experience a sudden loss of vision while you are white cialis pill taking tadalafil, call your doctor immediately or get emergency medical treatment. Do not take any more doses of tadalafil or similar medications such as sildenafil (Revatio, Viagra) or vardenafil (Levitra) until you talk to your doctor. Some patients experienced a sudden decrease or loss of hearing after they took tadalafil or other medications that are similar to tadalafil.

1. They Look Different

The hearing loss usually involved only one ear and did not always improve when the medication was stopped. It is not known if the hearing loss was caused by the medication. If you experience a sudden loss of hearing, sometimes with ringing in the ears or dizziness, while you are taking tadalafil, call your doctor immediately. Call your doctor if you have any unusual problems while taking this medication If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( or by phone (1-800-332-1088). Keep this medication in the container it came in, tightly closed, and out of reach of children. Keep all medication out of sight and reach of children as many containers are not child-resistant. Place the medication in a safe location – one that is up and away and out of their sight and reach. In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911. Do not let anyone else take your medication.

Medical uses

Daily dosing

Ask your pharmacist any questions you have about refilling your prescription. Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking.

Special Cases

tell your doctor if you smoke; if you have ever had an erection that lasted more than 4 hours; and if you have recently had diarrhea, vomiting, not been drinking enough fluids, or sweating a lot which may have caused dehydration (loss of a large amount of body fluids. Also tell your doctor if you have or have ever had pulmonary veno-occlusive disease (PVOD; blockage of veins in the lungs); any condition that affects the shape of the penis; diabetes; high cholesterol; high or low blood pressure; irregular heartbeat; a heart attack or heart failure; angina (chest pain); a stroke; ulcers in the stomach; a bleeding disorder; blood circulation problems; blood cell problems such as sickle cell anemia (a disease of the red blood cells), multiple myeloma (cancer of the plasma cells), or leukemia (cancer of the white blood cells); or heart, kidney, or liver disease. Also tell your doctor if you or any of your family members have or have ever had an eye disease such as retinitis pigmentosa (an inherited eye condition that causes loss of vision) or if you have ever had sudden severe vision loss, especially if you were told that the vision loss was caused by a blockage of blood flow to the nerves that help you see. if you are a woman and you are taking tadalafil to treat PAH, tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking tadalafil, call your doctor.

How is tadalafil supplied (dosage forms)?

if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking tadalafil. talk to your doctor about the safe use of alcoholic beverages during your treatment with tadalafil. If you drink a large amount of alcohol (more than five glasses of wine or five shots of whiskey) while you are taking tadalafil you are more likely to experience certain side effects of tadalafil such as dizziness, headache, fast heartbeat, and low blood pressure. if you are taking tadalafil to treat erectile dysfunction, tell your doctor if you have ever been advised by a health care professional to avoid sexual activity for medical reasons or if you have ever experienced chest pain during sexual activity. Sexual activity may be a strain on your heart, especially if you have heart disease. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies. Entadfi® (as a combination product containing Finasteride, Tadalafil) Indicated for treatment of erectile dysfunction (ED) Cialis (or generic equivalent) or Chewtadzy only PRN use: 10 mg PO initially before sexual activity, with or without food; may be increased to 20 mg or reduced to 5 mg on basis of efficacy and tolerability; in most patients, maximum dosing frequency is once daily Once-daily use (Cialis): 2.5 mg/day PO in single daily dose, without regard to timing of sexual activity, with or without food; may be increased to 5 mg/day on basis of efficacy and tolerability Indicated for treatment of signs and symptoms of benign prostatic hyperplasia (BPH); daily use also indicated for treatment of patients with both BPH and erectile dysfunction Cialis (or generic equivalent) or Chewtadzy only BPH with ED: 5 mg PO once daily, taken at approximately same time each day without regard to timing of sexual activity Coadministration with finasteride for BPH: Tadalafil 5 mg plus finasteride 5 mg PO once daily for ≤26 weeks; incremental benefit of tadalafil decreases from 4 weeks until 26 weeks, and the benefit beyond 26 weeks is unknown Indicated for pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability; studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%) Adcirca, Alyq, Tadliq, or generic equivalent only 40 mg PO once daily; dividing dose for more frequent dosing is not recommended Patients also taking ritonavir: 20 mg PO once daily initially for ≥1 week; may be increased to 40 mg/day on basis of tolerability Cialis, Chewtadzy (PRN use)Mild (CrCl >50 mL/min): No dosage adjustment neededModerate (CrCl 30-50 mL/min): Not to exceed 5 mg PO once daily initially; maximum dosage, 10 mg PO q48hrSevere (CrCl <30 mL/min and on hemodialysis): Not to exceed 5 mg PO q72hr Mild (CrCl >50 mL/min): No dosage adjustment needed Moderate (CrCl 30-50 mL/min): Not to exceed 5 mg PO once daily initially; maximum dosage, 10 mg PO q48hr Severe (CrCl <30 mL/min and on hemodialysis): Not to exceed 5 mg PO q72hr Cialis (once daily use)ED (CrCl >50 mL/min): No dosage adjustment neededBPH or BPH/ED (CrCl 30-50 mL/min): 2.5 mg/day starting dose recommended; may increase to 5 mg according to individual responseED or BPH (CrCl <30 mL/min or hemodialysis): Not recommended ED (CrCl >50 mL/min): No dosage adjustment needed BPH or BPH/ED (CrCl 30-50 mL/min): 2.5 mg/day starting dose recommended; may increase to 5 mg according to individual response ED or BPH (CrCl <30 mL/min or hemodialysis): Not recommended Chewtadzy (once daily use)BPH, ED/BPHCrCl >50 mL/min: No dosage adjustment neededCrCl ≤50 mL/min or hemodialysis: Not recommended CrCl >50 mL/min: No dosage adjustment needed CrCl ≤50 mL/min or hemodialysis: Not recommended Adcirca, Alyq, TadliqMild-to-moderate (CrCl 31-80 mL/min): 20 mg PO once daily initially; may be increased to 40 mg once daily on basis of tolerabilitySevere (CrCl <30 mL/min and on hemodialysis): Avoid use Mild-to-moderate (CrCl 31-80 mL/min): 20 mg PO once daily initially; may be increased to 40 mg once daily on basis of tolerability Severe (CrCl <30 mL/min and on hemodialysis): Avoid use Cialis, Chewtadzy (PRN use)Mild-to-moderate (Child-Pugh class A or B): Not to exceed 10 mg PO once dailySevere (Child-Pugh class C): Not recommended Mild-to-moderate (Child-Pugh class A or B): Not to exceed 10 mg PO once daily Severe (Child-Pugh class C): Not recommended Cialis, Chewtadzy (once daily use)Mild-to-moderate (Child-Pugh class A or B): Data limited; caution advisedSevere (Child-Pugh class C): Not recommended Mild-to-moderate (Child-Pugh class A or B): Data limited; caution advised Severe (Child-Pugh class C): Not recommended Adcirca, Alyq, TadliqMild-to-moderate (Child-Pugh class A or B): Consider starting dosage of 20 mg PO once dailySevere (Child-Pugh class C): Avoid use Mild-to-moderate (Child-Pugh class A or B): Consider starting dosage of 20 mg PO once daily Severe (Child-Pugh class C): Avoid use ED PRN use: Not to exceed 10 mg/72 hr ED or ED/BPH once-daily use: Not to exceed 2.5 mg/day Adcirca, Alyq, TadliqOn ritonavir for at least 1 week: Start tadalafil at 20 mg PO qDay; may increase to 40 qDay based on individual tolerabilityAvoid tadalafil during ritonavir initiationStop tadalafil at least 24 hr before to starting ritonavirAfter at least 1 week following ritonavir initiation, resume tadalafil 20 mg PO qDay; may increase to 40 qDay based on individual tolerability On ritonavir for at least 1 week: Start tadalafil at 20 mg PO qDay; may increase to 40 qDay based on individual tolerability Stop tadalafil at least 24 hr before to starting ritonavir After at least 1 week following ritonavir initiation, resume tadalafil 20 mg PO qDay; may increase to 40 qDay based on individual tolerability Chewtadzy: Not indicated for once daily use for ED because dosing is not possible (recommended dosage for this indication cannot be achieved with lowest available strength) Orphan designation for Duchenne muscular dystrophy (DMD) Eli Lilly and Company; Lilly Corporate Center; Indianapolis, IN 46285 Indicated for treatment of erectile dysfunction (ED) Cialis or generic equivalent only: No dosage adjustment is warranted solely on basis of age; however, greater sensitivity to medications in some older individuals should be considered Indicated for pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability; studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%) Adcirca, Alyq, or generic equivalent only: Lower dose or reduced dosing frequency may be required in elderly because of decreased renal or hepatic clearance Allow 48h after last tadalafil dose before nitrate administration.