سعر اندوميلاست 0.5 مجم 20 قرص 2026

Tablets containing roflumilast 500 micrograms (0.5 mg) (Al Andalous Pharmaceutical Industries), an oral PDE4 inhibitor for severe COPD; 20 tablets per pack.

• Maintenance treatment of severe COPD with chronic bronchitis and frequent exacerbations, add-on to bronchodilator treatmentPopulation: AdultsEuropean Medicines Agency (EMA)
• Severe COPD associated with chronic bronchitis and a history of frequent exacerbations, as add-on to bronchodilator treatmentPopulation: AdultsAl Andalous Pharmaceutical Industries (manufacturer website)

• Most commonly reported: diarrhoea (5.9%), weight decreased (3.4%), nausea (2.9%), abdominal pain (1.9%) and headache (1.7%); mostly in the first weeks and resolving with continued treatment.International label, same formulation · European Medicines Agency (EMA)

• Hypersensitivity to roflumilast or any excipient.International label, same formulation · European Medicines Agency (EMA)
• Moderate or severe hepatic impairment (Child-Pugh B or C).International label, same formulation · European Medicines Agency (EMA)

• Not a rescue medicine for acute bronchospasm.International label, same formulation · European Medicines Agency (EMA)
• Weight decrease: monitor body weight regularly; stop if unexplained, clinically concerning weight loss occurs.International label, same formulation · European Medicines Agency (EMA)
• Psychiatric disorders (insomnia, anxiety, nervousness, depression; rare suicidal ideation/behaviour): assess benefit-risk; not recommended in patients with a history of depression with suicidal ideation or behaviour.International label, same formulation · European Medicines Agency (EMA)

• CYP1A2/CYP3A4 inhibitors (e.g., fluvoxamine, enoxacin, cimetidine) and combined inhibitorsIncrease total PDE4 inhibitory activity; may increase intolerability.European Medicines Agency (EMA)
• Strong CYP inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin)Reduce total PDE4 inhibitory activity (about 60% with rifampicin) and may reduce efficacy; not recommended.European Medicines Agency (EMA)
• TheophyllineCo-administration increases PDE4 inhibitory activity; maintenance use with theophylline not recommended.European Medicines Agency (EMA)

• Not recommended during pregnancy; women of childbearing potential should use effective contraception during treatment.International label, same formulation · European Medicines Agency (EMA)
• Should not be used during breast-feeding.International label, same formulation · European Medicines Agency (EMA)

• Roflumilast: Non-steroid anti-inflammatory PDE4 inhibitor: inhibition of PDE4, a major cAMP-metabolising enzyme in inflammatory and structural cells, raises intracellular cAMP and targets systemic and pulmonary inflammation in COPD (EU SmPC).