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roflumilast

Pronunciation: roe FLOO mi last

Brand: Daliresp

What is the most important information I should know about roflumilast?

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You should not use roflumilast if you are allergic to it, or if you have moderate or severe liver disease.

There are many other drugs that can make roflumilast less effective and should not be used at the same time. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Before you take roflumilast, tell your doctor if you have liver disease or a history of depression, mental illness, or suicidal thoughts or actions.

You may have unusual thoughts or behavior, or thoughts about suicide, while taking this medicine. Tell your doctor if you have new or worsening depression, or suicidal thoughts. Your family or other caregivers should also be alert to changes in your mood or symptoms.

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Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, depression, trouble sleeping, or if you feel impulsive, or you have thoughts about suicide or hurting yourself.

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Call your doctor at once if you have rapid and unintended weight loss.

What is roflumilast?

Roflumilast reduces inflammation in the lungs that leads to COPD (chronic obstructive pulmonary disease).

Roflumilast is used to prevent worsening of chronic obstructive pulmonary disease (COPD) in people with severe COPD and chronic bronchitis.

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Roflumilast is not a bronchodilator. It will not treat a bronchospasm attack that has already begun.

Roflumilast may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking roflumilast?

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You should not use roflumilast if you are allergic to it, or if you have moderate or severe liver disease.

There are many other drugs that can make roflumilast less effective and should not be used at the same time. This includes:

  • bosentan (Tracleer);
  • dexamethasone (Cortastat, Dexasone, Solurex, DexPak);
  • St. John's wort;
  • rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), or rifapentine (Priftin);
  • a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton);
  • HIV medication such as efavirenz (Sustiva, Atripla), etravirine (Intelence), nevirapine (Viramune), or ritonavir (Norvir, Kaletra);
  • medicines to treat narcolepsy, such as armodafinil (Nuvigil) or modafinil (Progivil); or
  • seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline).

To make sure you can safely take roflumilast, tell your doctor if you have any of these other conditions:

  • liver disease;
  • a history of depression, mental illness, or suicidal thoughts or actions.

You may have unusual thoughts or behavior, or thoughts about suicide, while taking this medicine. Tell your doctor if you have new or worsening depression, or suicidal thoughts. Your family or other caregivers should also be alert to changes in your mood or symptoms.

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FDA pregnancy category C. It is not known whether roflumilast will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

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Roflumilast can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using roflumilast.

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Do not give this medication to anyone under 18 years old without medical advice. Do not share this medication with other people, even if they have the same symptoms you have.

How should I take roflumilast?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Roflumilast is usually taken once per day, with or without food. Follow your doctor's instructions.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include fast or pounding heartbeats, cold or clammy skin, or feeling like you might pass out.

What should I avoid while taking roflumilast?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of roflumilast?

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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

You may have unusual thoughts or behavior, or thoughts about suicide, while taking this medicine. Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, depression, trouble sleeping, or if you feel impulsive, or you have thoughts about suicide or hurting yourself.

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Call your doctor at once if you have a serious side effect such as:

  • rapid and unintended weight loss;
  • tremors;
  • pain or burning when you urinate;

Less serious side effects may include:

  • nausea, diarrhea, stomach pain;
  • loss of appetite, minor weight loss;
  • dizziness;
  • runny or stuffy nose;
  • back pain; or
  • flu symptoms.

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.

What other drugs will affect roflumilast?

Tell your doctor about all other medicines you use, especially:

  • birth control pills;
  • cimetidine (Tagamet);
  • conivaptan (Vaprisol);
  • imatinib (Gleevec);
  • isoniazid (for treating tuberculosis);
  • lidocaine (Xylocaine);
  • methoxsalen (Oxsoralen, Uvadex, 8-Mop);
  • primaquine (anti-malaria medication);
  • an antidepressant such as fluvoxamine (Luvox) or nefazodone;
  • an antibiotic such as ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), norfloxacin (Noroxin), ofloxacin (Floxin), or telithromycin (Ketex);
  • antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or thiabendazole (Mintezol);
  • heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), mexiletine (Mexitil), nicardipine (Cardene) or quinidine (Quin-G);
  • HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir, Kaletra);

This list is not complete and other drugs may interact with roflumilast. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about roflumilast.


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

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