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 Daxas (Roflumilast). If you are concerned about side effects, discuss the risks and benefits of Daxas (Roflumilast) with your doctor.

The following side effects have been reported by at least 1% of people taking Daxas (Roflumilast). 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.

• back pain
• decreased appetite
• Diarrhea
• dizziness
• fatigue
• headache
• Insomnia (trouble falling asleep or staying asleep)
• muscle spasms
• nausea
• stomach pain
• tremor or shakiness
• trouble sleeping
• vomiting

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:

• anxiety
• decreased appetite
• diarrhea
• dizziness
• irregular heartbeat
• joint or muscle pain
• nausea
• nosebleed
• sense of burning, pricking, or tingling on skin
• severe fatigue, weakness or lack of energy
• signs of Depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• unexplained weight loss

Stop taking the medication and seek immediate medical attention if any of the following occur:

• suicidal thoughts
• symptoms of an allergic reaction (e.g., swelling of the face, tongue, mouth, or throat; Hives; difficulty breathing or swallowing)

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 Daxas (Roflumilast).

Each yellow, D-shaped film-coated tablet, embossed with "D" on one side contains 500 µg of Daxas (Roflumilast). Nonmedicinal ingredients: lactose monohydrate, maize starch, povidone, and magnesium stearate; film coating: hypromellose, macrogol 4000, titanium dioxide, and yellow iron oxide.

Do not take Daxas (Roflumilast) if you:

• are allergic to Daxas (Roflumilast) or any ingredients of Daxas (Roflumilast)
• have moderate or severe liver disease

There may be an interaction between Daxas (Roflumilast) and any of the following:

• anti-cancer medications  (e.g., Carboplatin, Cyclophosphamide, Doxorubicin, Ifosfamide, Vincristine)
• Anakinra
• Azathioprine
• Belimumab
• Bosentan
• Carbamazepine
• Cimetidine
• ciprofloxacin
• corticosteroids (e.g. Dexamethasone, Prednisone)
• Cyclosporine
• Dabrafenib
• Deferasirox
• dexamethasone
• efavirenz
• Enzalutamide
• erythromycin
• Eslicarbazepine
• etravirine
• Fingolimod
• Fluvoxamine
• Infliximab
• ketoconazole
• Loxapine
• Leflunomide
• Lenalidomide
• medications that suppress the immune system (e.g., medications for cancer or organ transplants)
• Modafinil
• mycophenolate
• nevirapine
• Phenobarbital
• Phenytoin
• primidone
• rifabutin
• rifampin
• Riociguat
• St. John’s wort
• Tacrolimus
• Teriflunomide
• Theophylline
• tretinoin

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:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

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 Daxas (Roflumilast). 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.

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.

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.