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ALYQ- tadalafil tablet, film coated


  1. Never Take Alyq With Any Nitrate Or Guanylate Cyclase Stimulator Medicines:
  2. Nitrates Include:
  3. Guanylate Cyclase Stimulators Include:
  4. What Is Alyq ?
  5. Who Should Not Take Alyq ?
  6. Before Taking Alyq , Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You:
  7. How Should I Take Alyq ?
  8. What Should I Avoid While Taking Alyq ?
  9. The Following Side Effects Were Reported Rarely In Patients Taking Tadalafil:
  10. The Most Common Side Effects With Alyq Include:
  11. How Should I Store Alyq ?
  12. What Are The Ingredients In Alyq ?
  13. Patient Information

Never Take Alyq With Any Nitrate Or Guanylate Cyclase Stimulator Medicines: 

  • Your blood pressure could drop quickly to an unsafe level
  • You could get dizzy, faint and even have a heart attack or stroke.

Nitrates Include: 

  • Medicines that treat chest pain (angina)
  • Nitroglycerin in any form including tablets, patches, sprays, and ointments
  • Other nitrate medicines (isosorbide mononitrate or dinitrate)
  • Street drugs that are inhaled, called poppers (amyl nitrate, butyl nitrate or nitrite)

Guanylate Cyclase Stimulators Include: 

  • Riociguat (Adempas) a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension

Ask your healthcare provider or pharmacist if you are not sure if you take a nitrate or guanylate cyclase stimulator medicine.

What Is Alyq ? 

ALYQ is a prescription medicine used to treat pulmonary arterial hypertension (PAH, high blood pressure in your lungs) to improve your ability to exercise.

It is not known if ALYQ is safe or effective in children.

Who Should Not Take Alyq ? 

Do not take ALYQ if you

  • take any medicines called nitrates.
  • use recreational drugs called poppers like amyl nitrate, butyl nitrate or nitrite.
  • take any medicines called guanylate cyclase stimulators
  • are allergic to tadalafil or any other ingredient in ALYQ . at the end of this leaflet.

Before Taking Alyq , Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You: 

  • are allergic to ALYQ or CIALISor any of its ingredients. )
  • anti-hypertensives, used to treat high blood pressure. Your blood pressure could suddenly drop. You could get dizzy or faint.
  • alpha blockers, used to treat prostate disease and high blood pressure. Your blood pressure could suddenly drop. You could get dizzy or faint.
  • protease inhibitors, used to treat HIV infection, such as ritonavir (Norvir, Kaletra)
  • ketoconazole (Extina, Xolegel, Ketozole, Nizoral A-D, Nizoral) itraconazole (Sporanox)
  • erythromycin (several brand names exist. Please consult your healthcare provider to determine if you are taking this medicine)
  • rifampin (Rifadin, Rifamate, Rifater, Rimactane)
  • bosentan (Tracleer)
  • phenobarbital, phenytoin (Dilantin), carbamazepine (Tegretol)
  • CIALISor other medicines or treatments for erectile dysfunction (impotence).
  • Tadalafil is also marketed as CIALISfor the treatment of male erectile dysfunction (ED, impotence) and for the signs and symptoms of benign prostatic hyperplasia (BPH, enlarged prostate). Do not take both ALYQ and CIALIS. Do not take ALYQ and other medicines or treatments for erectile dysfunction.

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How Should I Take Alyq ? 

  • Take ALYQ exactly as your healthcare provider tells you.
  • Take ALYQ tablets at the same time every day. You should take both tablets at the same time, one after the other, every day. Do not split your dose.
  • ALYQ can be taken with or without food.
  • Do not change your dose or stop taking ALYQ without speaking to your healthcare provider.
  • If you take too much ALYQ , call your healthcare provider or go to an emergency department right away.

What Should I Avoid While Taking Alyq ? 

Do not have more than 4 alcohol-containing drinks in a short period of time while you take ALYQ . Drinking too much alcohol can lower your blood pressure. You could get dizzy or faint.

The Following Side Effects Were Reported Rarely In Patients Taking Tadalafil: 

  • Decreased eyesight or loss of vision in one or both eyes (NAION). 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).Talk to your healthcare provider or go to the emergency department right away.An erection that lasts more than 4 hoursmust be treated as soon as possible or you can have lasting damage to your penis, including the inability to have erections.

The Most Common Side Effects With Alyq Include: 

  • headache
  • muscle pain
  • getting red or hot in the face (flushing)
  • nausea
  • pain in the arms, legs, or back
  • upset stomach
  • stuffy or congested nose

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 ALYQ . For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How Should I Store Alyq ? 

Store ALYQ tablets at room temperature between 68 to 77 F (20 to 25 C).

Keep ALYQ and all medicines out of the reach of children.

General Information about the safe and effective use of ALYQ

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use ALYQ for a condition for which it was not prescribed. Do not give ALYQ to other people, even if they have the same symptoms you have. It may harm them.

This patient information leaflet summarizes the most important information about ALYQ . If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ALYQ that is written for healthcare professionals. For more information, call Teva Pharmaceuticals USA, Inc. at 1-888-838-2872.

What Are The Ingredients In Alyq ? 

Active Ingredient: tadalafil, USP

Inactive Ingredients: croscarmellose sodium, iron oxide red, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part hydrolyzed, povidone, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate, talc, and titanium dioxide.

Brands listed are the trademarks of their respective owners.

Manufactured In Israel By:
Teva Pharmaceutical Ind. Ltd.
Jerusalem, 9777402, Israel

Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454

Iss. 01/2019

Patient Information 

See FDA-Approved Patient Labeling (Patient Information)

  • Inform patients of contraindication of ALYQ with any use of organic nitrates or GC stimulators.
  • Inform patients that tadalafil is also marketed as CIALISfor erectile dysfunction (ED) and for the signs and symptoms of benign prostatic hyperplasia (BPH). Advise patients taking ALYQ not to take CIALISor other PDE5 inhibitors.
  • Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking ALYQ . Such an event may be a sign of NAION.
  • Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking ALYQ . These events may be accompanied by tinnitus and dizziness.

Brands listed are the trademarks of their respective owners.

Manufactured In Israel By:
Teva Pharmaceutical Ind. Ltd.
Jerusalem, 9777402, Israel

Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454

Iss. 01/2019



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