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For more information call Ajanta Pharma USA Inc. at 1-855-664-7744. What Are The Ingredients In tadalafil tablets? Before viewing content on J&J Medical Connect you must identify your role A Medical Information Specialist will assist you shortly. When your Specialist has joined, a button to join the video call will appear here. Click or tap the button below to join the video call with your Medical Information Specialist: Would you like to clear and leave your conversation? This medication must not be used during pregnancy. Your doctor should order a pregnancy test before you start this medication. Ask about the use of reliable forms of birth control before starting treatment, during treatment, and for 1 month after the last dose. If you become pregnant or think you may be pregnant, tell your doctor right away. This combination medication contains 2 drugs: macitentan and tadalafil. It is used by people who are currently taking stable doses of these 2 drugs to treat high blood pressure in the lungs (pulmonary hypertension). Macitentan blocks the effects of a certain natural substance (endothelin-1). Blocking this substance helps decrease blood pressure in the lungs. Tadalafil works by relaxing and widening the blood vessels in your lungs which allows the blood to flow more easily. Decreasing high blood pressure in the lungs allows your heart and lungs to work better and improves your ability to exercise. Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking macitentan/tadalafil and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually once daily. Do not break, crush, or chew the tablets. The dosage is based on your medical condition, response to treatment, and other medications you may be taking. 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. Runny/stuffy nose, sore throat, cough, chills, dizziness, lightheadedness, headache, muscle pain, flushing, nausea, vomiting, or stomach upset may occur.

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Tadalafil tablets and other medicines may affect each other. nitrates or guanylate cyclase stimulators (see “What is the most important information I should know about tadalafil tablets?”) alpha blockers, used to treat prostate disease and high blood pressure. protease inhibitors, used to treat HIV infection, such as ritonavir (Norvir®, Kaletra®) ketoconazole (Extina®, Xolegel®, Ketozole®, Nizoral A-D®, Nizoral®) itraconazole (Sporanox®) Please consult your healthcare provider to determine if you are taking this medicine) CIALIS® or other medicines or treatments for erectile dysfunction (impotence). Tadalafil tablets are also marketed as CIALIS for the treatment of male erectile dysfunction (ED, impotence) and for the signs and symptoms of benign prostatic hyperplasia (BPH, enlarged prostate). Do not take tadalafil tablets and other medicines or treatments for erectile dysfunction. 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. 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.

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Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. Take tadalafil tablets exactly as your healthcare provider tells you. Take tadalafil tablets at the same time every day. Tadalafil tablets can be taken with or without food. 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.

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Do not change your dose or stop taking tadalafil tablets without speaking to your healthcare provider. If you take too much tadalafil tablets, call your healthcare provider or go to an emergency department right away. What should I avoid while taking tadalafil tablets? What are the possible side effects of tadalafil tablets? Decreased eyesight or loss of vision in one or both eyes (NAION). 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. 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. 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.

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See “What is the most important information I should know about tadalafil tablets?” The most common side effects with tadalafil tablets include: getting red or hot in the face (flushing) pain in the arms, legs, or back Tell your healthcare provider about any side effect that bothers you or does not go away. These are not all the possible side effects of tadalafil tablets. You may report side effects to FDA at 1-800-FDA-1088. Keep tadalafil tablets and all medicines out of the reach of children. General Information about the safe and effective use of tadalafil tablets This patient information leaflet summarizes the most important information about tadalafil tablets. 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. 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. 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.

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If you notice a sudden decrease or loss of vision in one or both eyes, contact a healthcare provider right away. Sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness. If you notice a sudden decrease or loss of hearing, contact a healthcare provider right away. In men, an erection that lasts more than 4 hours (with or without pain). An erection that lasts more than 4 hours must be treated as soon as possible or you can have lasting damage to your penis, including the inability to have erections. 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.