DILAROF

It Is a selectIve phosphodIesterase 4 InhIbItor IndIcated as a treatment to reduce the rIsk of COPD exacerbatIons In patIents wIth severe COPD assocIated wIth chronIc bronchItIs and a hIstory of exacerbatIons. LImItatIons of Use: It Is not a bronchodIlator and Is not IndIcated for the relIef of acute bronchospasm

phosphodiesterase inhibitor

Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor which, due to its selective inhibition of the PDE4 isoenzyme, has potential antiinflammatory and antimodulatory effects in the pulmonary system. It is thought that the increased levels of intracellular cyclic AMP are responsible for the therapeutic actions of Roflumilast.

The recommended dosage for patients with COPD is one 500 mcg tablet per day, with or without food.

There are no proven cases of hazardous interactions. There is a case report of an interaction with ethanol and a compound containing pyrimethamine with dapsone and another of potentiation of betahistine with salbutamol. Betahistine is a histamine analogue, concurrent administration of H1 antagonists may cause a mutual attenuation of effect of the active agents.

Acute bronchospasm: Do not use for the relief of acute bronchospasm. ? Psychiatric Events including Suicidality: Advise patients , their caregivers, and families to be alert for the emergence or worsening of insomnia, anxiety, depression, suicidal thoughts or other mood changes, and if such changes occur to contact their healthcare provider. Carefully weigh the risks and benefits of treatment with It in patients with a history of depression and/or suicidal thoughts or behavior. ? Weight Decrease: Monitor weight regularly. If unexplained or clinically significant weight loss occurs, evaluate weight loss and consider discontinuation of It. ? Drug Interactions: Use with strong cytochrome P450 enzyme inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin) is not recommended.

diarrhea, weight decrease, nausea, headache, back pain, influenza, insomnia, dizziness and decreased appetite.

Nursing Mothers: It should not be used by women who are nursing as excretion of roflumilast and/or its metabolites into human milk is probable and there are no human studies that have investigated effects of It on breast-fed infants

In Phase I studies, the following symptoms were observed at an increased rate after single oral doses of 2,500 micrograms and one single dose of 5,000 micrograms (ten times the recommended dose): headache, gastrointestinal disorders, dizziness, palpitations, light-headedness, clamminess and arterial hypotension. In case of overdose, it is recommended that the appropriate supportive medical care is provided. Since Roflumilast is highly protein bound, haemodialysis is not likely to be an efficient method of its removal. It is not known whether Roflumilast is dialysable by peritoneal dialysis.

Store below 30° C, keep away from light, moisture. Keep out of the reach of children.

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