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 Daxas (Roflumilast).
Behaviour changes and suicidal thoughts: People taking Daxas (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 Daxas (Roflumilast), contact your doctor immediately. Family members or caregivers of people who are taking Daxas (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 Daxas (Roflumilast) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Daxas (Roflumilast), and whether any special monitoring is needed.
If you have a history of depression with thoughts of self-harm or suicide, Daxas (Roflumilast) should be avoided.
Cancer: If you have cancer, discuss with your doctor how Daxas (Roflumilast) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Daxas (Roflumilast), and whether any special monitoring is needed.
Continue taking bronchodilators: Daxas (Roflumilast) does not replace your bronchodilator medications (e.g., salbutamol), so you should take both Daxas (Roflumilast) and your bronchodilator medication (e.g., salbutamol) daily.
Heart diseases: Daxas (Roflumilast) can cause abnormal heart rhythms. If you have had heart disease, discuss with your doctor how Daxas (Roflumilast) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Daxas (Roflumilast), and whether any special monitoring is needed.
Infections: Stop using Daxas (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 Daxas (Roflumilast) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Daxas (Roflumilast), and whether any special monitoring is needed.
Liver function: If you have mild liver disease, discuss with your doctor how Daxas (Roflumilast) may affect your medical condition, how this medical condition may affect the dosing and effectiveness of Daxas (Roflumilast), and whether any special monitoring is needed. Daxas (Roflumilast) 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 Daxas (Roflumilast). Contact your doctor immediately if you are diagnosed with any of these diseases while taking Daxas (Roflumilast).
Sudden attacks of breathlessness: Daxas (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 Daxas (Roflumilast) have experienced weight loss. While taking Daxas (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: Daxas (Roflumilast) should not be used while you are pregnant unless the benefits clearly outweigh the risks. If you become pregnant while taking Daxas (Roflumilast), contact your doctor immediately.
Breast-feeding: Daxas (Roflumilast) may pass into breast milk. If you are a breast-feeding mother and are taking Daxas (Roflumilast), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using Daxas (Roflumilast) have not been established for children.
