Roflumilast belongs to the class of medications called phosphodiesterase 4 (PDE4) inhibitors. It is used along with a bronchodilator (e.g., salbutamol) to treat severe chronic obstructive pulmonary disease (COPD) with chronic cough and sputum (mucous) in adults who have frequent flare-ups. Roflumilast works by reducing inflammation in the lungs.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
Each yellow, D-shaped film-coated tablet, embossed with "D" on one side contains 500 µg of roflumilast. Nonmedicinal ingredients: lactose monohydrate, maize starch, povidone, and magnesium stearate; film coating: hypromellose, macrogol 4000, titanium dioxide, and yellow iron oxide.
The recommended dose of roflumilast is 500 µg taken by mouth once daily. Roflumilast may be taken with or without food.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.Store this medication at room temperature and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Do not take roflumilast if you:
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Stop taking the medication and seek immediate medical attention if any of the following occur:
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Before you begin taking a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should take this medication.
Behaviour changes and suicidal thoughts: People taking roflumilast have experienced depression, including thoughts of suicide. If you experience any behaviour changes or symptoms such as sad mood, anxiety, feeling of helplessness, feeling of guilt, loss of pleasure or interest in activities, changes in sleep patterns, or restlessness while taking roflumilast, contact your doctor immediately. Family members or caregivers of people who are taking roflumilast should contact the person’s doctor immediately if they notice unusual behaviour changes.
If you have depression or a history of depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
If you have a history of depression with thoughts of self-harm or suicide, this medication should be avoided.
Cancer: If you have cancer, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Continue taking bronchodilators: Roflumilast does not replace your bronchodilator medications (e.g., salbutamol), so you should take both roflumilast and your bronchodilator medication (e.g., salbutamol) daily.
Heart diseases: Roflumilast can cause abnormal heart rhythms. If you have had heart disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.Infections: Stop using roflumilast and get immediate medical attention if symptoms of severe acute infection occur (e.g., fever, chills, or shaking; fast heartbeat; rapid breathing; confusion; and skin rash).
If you have infections such as tuberculosis, viral hepatitis, herpes viral infection and herpes zoster, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Liver function: If you have mild liver disease, discuss with your doctor how this medication may affect your medical condition, how this medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. This medication is not recommended for people with moderate to severe liver disease.
Severe immune system diseases: If you have a severe immune system disease such as HIV infection, multiple sclerosis, lupus erythematosus, and progressive multifocal leukoencephalopathy, you should not take roflumilast. Contact your doctor immediately if you are diagnosed with any of these diseases while taking roflumilast.
Sudden attacks of breathlessness: Roflumilast does not treat sudden attacks of breathlessness. You should always have a bronchodilator medication (e.g., salbutamol) to treat a sudden attack of breathlessness.
Weight loss: People taking roflumilast have experienced weight loss. While taking roflumilast, you or your caregivers should monitor your weight regularly. You or your caregiver should contact your doctor if an unexpected weight loss has occurred.
Pregnancy: This medication should not be used while you are pregnant unless the benefits clearly outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: This medication may pass into breast milk. If you are a breast-feeding mother and are taking roflumilast, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.
There may be an interaction between roflumilast and any of the following:
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
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