8 USE IN SPECIFIC POPULATIONS

Canada residents can call 1-844-764-7669. Do not share this medication with others. Lab and/or medical tests (such as blood pressure, complete blood count, kidney/liver tests) may be done while you are taking this medication. If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

• Tadalafil 40mg is sometimes used in clinical trials for other conditions.
• Using this high dose increases the risk of side effects; caution is advised.
• Tadalafil 40mg should only be used under medical supervision.
• Be aware of potential vision changes or sudden loss when using this medication.
• The medication is generally well-tolerated when used responsibly.
• Overdose symptoms may include severe hypotension and priapism.

Store in the original container at room temperature away from light and moisture. Keep the drying agent (desiccant) in the bottle. Tightly close the bottle when not in use. Keep all medications away from children and pets. Do not flush medications down the sublingual tadalafil toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you.

This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs. Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider. The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional.

5.1 Hypotension

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: itching/swelling (especially of the face/tongue/throat) This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Serious Tadalafil Side Effects (Occurring in less than 1 in 1,000 people)

You may report side effects to FDA at 1-800-FDA-1088 or at In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. Before taking this medication, tell your doctor or pharmacist if you are allergic to macitentan or tadalafil; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

The Bottom Line

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other lung conditions (such as pulmonary veno-occlusive disease) heart problems (such as angina, previous heart attack, irregular heartbeat, heart failure) penis conditions (such as angulation, fibrosis/scarring, Peyronie's disease) conditions that may increase the risk of priapism (such as sickle cell anemia, leukemia, multiple myeloma) eye problems (such as retinitis pigmentosa, sudden decreased vision, NAION) Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This medication can affect fertility in males. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.

It works by relaxing blood vessels, which improves blood flow to specific areas of the body. Tadalafil is available in various strengths and should always be taken as prescribed by your healthcare provider. It is important to consult your doctor before making any changes to your dosage. Our telemedicine providers are also available to help manage your treatment. The generic name refers to the active ingredient, while the brand name is assigned by the manufacturer. The generic name is listed in parentheses. Tadalafil belongs to a class of medications known as Phosphodiesterase-5 (PDE5) inhibitors.

Tadalafil is used to treat a variety of conditions, and the appropriate dosage depends on the condition being treated.

• Tadalafil 40mg is a higher dose used for severe erectile dysfunction.
• Always consult a doctor before taking Tadalafil 40mg.
• Avoid alcohol when using Tadalafil 40mg to prevent side effects.
• Tadalafil 40mg should not be used more than once in 24 hours.
• Possible side effects include headache, flushing, and nasal congestion.
• Do not take Tadalafil 40mg with nitrates or alpha-blockers.

Always consult your doctor or one of our telemedicine providers before making any changes to your dose. As needed: 10 mg taken at least 30 minutes before sexual activity. The dose may be increased to 20 mg or reduced to 5 mg depending on how well it works and how well it is tolerated.

8.1 Pregnancy

Discuss the use of reliable forms of birth control (such as condoms, birth control pills) before starting treatment, during treatment, and for 1 month after the last dose. It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions.

What is the best time to take tadalafil daily?

Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug are: When used with nitrates, this medication can cause a serious drop in your blood pressure, which can lead to dizziness, fainting, and rarely heart attack or stroke. Do not use any of the following drugs during treatment with this medication or within 48 hours of your last dose of macitentan/tadalafil: certain drugs used to treat chest pain/angina (nitrates such as nitroglycerin, isosorbide) recreational drugs called "poppers" containing amyl or butyl nitrite If you are also taking an alpha blocker medication (such as doxazosin, tamsulosin) to treat an enlarged prostate/BPH or high blood pressure, your blood pressure may get too low which can lead to dizziness or fainting. Your doctor may adjust your medications to minimize your risk of low blood pressure. Do not take more than one dose per day. Daily use: 2.5 mg once daily, taken at the same time each day, regardless of sexual activity. The dose may be increased to 5 mg based on individual response. 5 mg once daily, taken at the same time each day. The duration of treatment depends on the severity of symptoms and how well the medication is working. 40 mg once daily (two 20 mg tablets).

2.3 Dose Adjustment in Hepatic Impairment

Other medications can affect the removal of macitentan/tadalafil from your body, which may affect how this medication works. Do not take this medication with any other product that contains tadalafil or other similar medications for erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, vardenafil). If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Do not split the dose or exceed 40 mg per day. 5 mg once daily, with potential adjustments based on individual response.

4.1 Concomitant Organic Nitrates

Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets. Tell your doctor if your condition does not get better or if it gets worse.

Benign Prostatic Hyperplasia

Runny/stuffy nose, sore throat, cough, chills, dizziness, lightheadedness, headache, muscle pain, flushing, nausea, vomiting, or stomach upset may occur. If any of these effects last or gets worse, tell your doctor or pharmacist promptly. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Canadian Brand Name

Tell your doctor right away if you have any serious side effects, including: signs of low red blood cell count (such as unusual tiredness, rapid breathing, pale skin, shortness of breath, fast heartbeat) increased shortness of breath or trouble breathing new or worsening swelling of the hands/ankles/feet signs of liver disease (such as nausea/vomiting that doesn't stop, dark urine, stomach/abdominal pain, yellowing eyes/skin) Rarely, sudden decreased vision, or even permanent blindness, may occur in one or both eyes (NAION). If this serious problem occurs, stop taking this medication and get medical help right away. You have a slightly greater chance of developing NAION if you have heart disease, diabetes, high cholesterol, certain other eye problems ("crowded disk"), high blood pressure, if you are over 50, or if you smoke. Rarely, a sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness, may occur. Stop taking this medication and get medical help right away if you get any of these side effects. Tadalafil is not a standard treatment for COPD but may be used off-label. Consult your healthcare provider for more information. This is an off-label use and should only be taken under close medical supervision. 40 mg once daily for pulmonary hypertension. For other types of hypertension, consult your healthcare provider for specific dosing recommendations. This is an off-label use and should be discussed with your doctor. 10 mg taken as needed before sexual activity. The dose may be adjusted based on response and tolerability.