Uses of Romilast 0.5: - Chronic obstructive pulmonary disease (COPD) Chronic obstructive pulmonary disease Romilast 0.5 is contraindicated to patients with a history of hypersensitivity to Roflumilast or any of other ingredients of the tablet and if a patient has moderate to severe liver impairment.

Antihistamines anti-allergies & hypo-sensitisation

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.

How to use Roflumilast: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Roflumilast may be taken with or without food, but it is better to take it at a fixed time. Adult Dose: Chronic Obstructive Pulmonary Disease Reduction of frequency of exacerbations or worsening of symptoms 500 mcg PO once daily Child Dose: Safety and efficacy not established

Erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine; rifampicin, phenobarb, carbamazepine, phenytoin, theophylline, OC.

Roflumilast is contraindicated to patients with a history of hypersensitivity to Roflumilast or any of other ingredients of the tablet and if a patient has moderate to severe liver impairment.

Common - Headache - Weight loss - Dizziness - Insomnia (difficulty in sleeping) - Back pain - Nausea - Diarrhea - Decreased appetite - Flu 1-10% Diarrhea (9.5%),Weight loss (7.5%),Nausea (4.7%),Headache (4.4%),Back pain (3.2%),Insomnia (2.4%),Decreased appetite (2.1%),Dizziness (2.1%) 1-10% Abdominal pain (1-2%),Anxiety (1-2%),Depression (1-2%),Dyspepsia (1-2%),Gastritis (1-2%),Muscle spasms (1-2%),Rhinitis (1-2%),Sinusitis (1-2%),Tremor (1-2%),Urinary tract infection (1-2%),Vomiting (1-2%) Frequency Not Defined Suicidality

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Roflumilast should not be used during pregnancy & lactation.

Precaution: Roflumilast is not a bronchodilator and should not be used for the treatment of a sudden attack of breathlessness. Patients treated with this drug should have their weight monitored regularly. If unexplained or clinically significant weight loss occurs, this should be evaluated, and discontinuation of Roflumilast should be considered. Roflumilast should be given with caution in patients with severe immunological diseases (HIV infection, multiple sclerosis, lupus erythematosus, progressive multifocal leukoencephalopathy and others), severe acute infectious diseases (tuberculosis or acute hepatitis), cancer (except basal-cell carcinoma), and severe impairment of the heart function. Lactation: Probable that roflumilast, its metabolites, or both are excreted into milk; avoid use

No case of overdose has been reported in clinical studies with Roflumilast. However, during the Phase I studies of Roflumilast, at an increased rate after a single oral dose of 2500 mcg and a single dose of 5000 mcg, The following symptoms were observed: headache, gastrointestinal disorders, dizziness, palpitations, lightheadedness, clamminess and arterial hypotension.Missed Dose: Patients should be advised that if they forget to take a tablet at the usual time, they should take the tablet as soon as they remember or continue on the next day with the next tablet at the usual time. Patients should not take a double dose to make up for a forgotten dose.

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

Antihistamines anti-allergies & hypo-sensitisation

Selective phosphodiesterase (PDE)-4 inhibitor; PDE-4 inhibition leads to accumulation of intracellular cyclic adenosine monophosphate (cAMP) in lung tissue and is thought to be underlying mechanism of action.

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Roflumilast should not be used during pregnancy & lactation.