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Roflair® is indicated as a treatment to reduce the risk of Chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD who have a history of chronic bronchitis with exacerbations. The medication prevents worsening of symptoms in patients with COPD and long-term inflammation of airways (chronic bronchitis). Roflair® is recommended for use in patients over 18 years of age.  Show full description

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Other names for this medication

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Roflair®, manufactured by Cipla and is used in patients with severe COPD to decrease the number of flare-ups or the worsening of its symptoms (exacerbation). The medication contains the active substance Roflumilast, which is an anti-inflammatory drug called phosphodiesterase-4 inhibitor. The medication controls and prevent symptoms (wheezing and shortness of breath) caused by an ongoing lung disease (chronic obstructive pulmonary disease - COPD which includes bronchitis). Roflair® tablets should be used regularly to be effective. The medication serves as an add-on therapy in patients with moderate-to-severe COPD and frequent exacerbations who are already receiving a long-acting bronchodilator. It does not work right away and should not be used for a relief of sudden shortness of breath or wheezing. If such problems occur, you should use a quick-relief inhaler.



- chronic bronchitis;

MOA (mechanism of action):

Roflumilast is a phosphodiesterase 4 (PDE4) inhibitor and a non-steroid, anti-inflammatory agent designed to target both the systemic and pulmonary inflammation associated with chronic obstructive pulmonary disease (COPD). Due to its selective inhibition of the PDE4 isoenzyme in lung cells, Roflumilast has potential anti-inflammatory and anti-modulatory effects in the pulmonary system. Roflumilast acts directly in the airways by inactivating transcription factors involved in the inflammation of the lungs, which helps stop narrowing of airways occurring in COPD, thus easing breathing problems. The medication cannot be used to treat a bronchospasm attack that has already begun.


The recommended dosage of Roflair® is 500 mcg per day taken with or without food.

Missing a dose

If you miss a dose of Roflair® you should take it as soon as you remember. If it is the time for the next dose you should continue your regular dosing schedule. Do not take a double dose to make up for a missed dose. Do not exceed the doctor’s recommended dose.


If an overdose occurs and you are feeling unwell, you should seek emergency medical attention or contact your healthcare provider immediately.


Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F) and away from excess moisture and heat. Throw away any unused medicine after the expiration date. Keep out of the sight and reach of children.

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Side effects

The most common side effects associated with Roflair® are:

  • - diarrhea
  • - nausea
  • - abdominal pain
  • - headache
  • - dizziness
  • - sleeplessness
  • - anxiety
  • - nervousness
  • - depressive mood
  • - weight loss
  • - decreased appetite
  • Less common side effects include:
  • - swelling of the eyelids, face, lips, and tongue
  • - difficulties in breathing
  • - accelerated heartbeat
  • - trembling
  • - gastritis
  • - vomiting
  • - indigestion
  • - rash
  • - muscle pain
  • - back pain
  • - runny or stuffy nose

Side effects occurrence does not only depend on the medication you are taking, but also on your overall health and other factors.


Do not take the medicine if you are allergic to Roflumilast or any other components contained in the medication.

Do not use Roflair® for the relief of acute bronchospasm.

Do not combine the use of with such drugs as bosentan, carbamazepine, dexamethasone, eslicarbazepine acetate, etravirine, fosphenytoin, nafcillin, nevirapine, oxcarbazepine, pentobarbital, phenobarbital, phenytoin, primidone, rifabutin, rifampin, rifapentine.

Do not take the medication if you have moderate or severe liver problems.

Do not use the drug if you have severe immunological diseases such as HIV infection, multiple sclerosis (MS), lupus erythematosus (LE) or progressive multifocal leukoencephalopathy (PML).

Do not take Roflair® if you have severe acute infectious diseases such as tuberculosis, or acute hepatitis.

Do not use the tablets if you have cancer or serious impairment of the heart function.

Do not give Roflair® to children and adolescents under 18 years of age.

The medicine is not recommended in patients with a history of depression associated with suicidal thinking or behavior.

Do not take the medication during pregnancy and breastfeeding.

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Frequently asked questions

Q: What is Roflair® used for?

A: This medicine is used in people with a severe chronic obstructive pulmonary disease (COPD) to reduce the number of episodes or worsening of COPD symptoms. Roflair® belongs to a class of medications called phosphodiesterase inhibitors and works by decreasing swelling in the lungs.

Q: How to take Roflair®?

A: Always take this medicine exactly as your doctor has told you. The recommended dose is 500 mcg once daily. You should swallow the tablet with some water. This medication can be taken with or without food. Take the medication at the same time every day. Do not use it to treat sudden attacks of breathing problems. Talk to your doctor about the use of other medications to treat symptoms of a sudden breathing problem.

Q: Can Roflair® be used during pregnancy or breastfeeding?

A: The tablets can be used during pregnancy or breastfeeding only if the potential benefit justifies the potential risk to the fetus. Do not take the medication without consulting your doctor.

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