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Other brands with the same active ingredient
These brands contain the same active ingredient (Roflumilast). Strength and form may differ — confirm substitution with your doctor or pharmacist before switching.
Indications & Uses
Rofumil is indicated for:
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Adult dose: The recommended dose is one tablet of 500 micrograms Roflumilast, taken once daily. It may need to be taken for several weeks before its full effect is felt, and clinical trials have followed its use for up to one year. For elderly patients aged 65 years and older, no dose adjustment is necessary. Patients with renal impairment likewise need no dose adjustment. Patients with mild hepatic impairment, classified as Child Pugh A, have limited clinical data available, so Roflumilast should be used with caution in these cases and a dose adjustment cannot currently be recommended. Patients with moderate or severe hepatic impairment, classified as Child Pugh B or C, must not take Roflumilast. Roflumilast has no relevant use in the pediatric population under 18 years of age. The tablet should be swallowed with water at the same time every day, and it can be taken with or without food.
Side Effects
Rofusis is usually well tolerated. Some people notice side effects such as reduced appetite and weight loss, trouble sleeping, headache, diarrhoea, nausea, or stomach discomfort.
Cautions & Contraindications
Warnings & Precautions
Rofusis contains an active ingredient that some patients need to be counselled about before starting therapy. Not a rescue medicine: Rofusis works as an anti-inflammatory agent, so it should not be used to relieve a sudden asthma or bronchospasm attack. Weight loss: In year-long studies, patients taking Rofusis lost weight more often than those on placebo. Most who stopped the medicine had regained the lost weight within three months. Underweight patients should have their weight checked at every visit, and all patients should weigh themselves regularly. If weight loss is unexplained and becomes a concern, Rofusis should be stopped and the patient's weight monitored further. Special health conditions: Because there is not enough experience to guide safe use, Rofusis should not be started, or should be stopped if already in use, in patients with serious immune-related diseases (such as HIV infection, multiple sclerosis, lupus, or progressive multifocal leukoencephalopathy), severe acute infections, cancers other than basal cell carcinoma, or in those taking immune-suppressing medicines such as methotrexate, azathioprine, infliximab, etanercept, or long-term oral corticosteroids (short courses of systemic corticosteroids are not included). There is limited experience in patients with dormant infections such as tuberculosis, viral hepatitis, herpes, or shingles. Rofusis has not been studied in patients with congestive heart failure of NYHA class 3 or 4, so its use is not recommended in this group. Mental health effects: Rofusis can raise the risk of mental health problems such as insomnia, anxiety, nervousness, and depression. Rare cases of suicidal thoughts and behaviour, including completed suicide, have occurred in patients with or without a prior history of depression, usually within the first few weeks of treatment. If a patient reports past or current psychiatric symptoms, or is also taking other medicines that can cause such effects, the doctor should carefully weigh the benefits and risks before starting or continuing Rofusis. It is not recommended for patients with a history of depression linked to suicidal thoughts or behaviour. Patients and caregivers should be told to report any change in mood or behaviour, or any suicidal thoughts, to the prescriber right away. Treatment should be stopped if new or worsening psychiatric symptoms, suicidal thoughts, or a suicide attempt occur. Persistent side effects: Side effects such as diarrhoea, nausea, stomach pain, and headache usually appear in the first few weeks of treatment and tend to ease with continued use. If they persist and remain hard to tolerate, treatment with Rofusis should be reviewed. This is more likely in groups with higher drug exposure, such as black, nonsmoking women, or patients also taking the CYP1A2 inhibitor fluvoxamine, or dual CYP3A4/1A2 inhibitors such as enoxacin and cimetidine. Theophylline: There is no clinical evidence supporting the use of Rofusis together with theophylline as maintenance therapy, so this combination is not recommended. Lactose: Rofusis tablets contain lactose. Patients with rare hereditary conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Contraindications
Do not use Roflumilast if you are allergic to it or to any of its other ingredients. It should also be avoided if you have moderate to severe liver problems.