Roflumilast

Dosage Forms Available

• Roflumilast is available for oral administration (tablet).

Age and Dose Restrictions

• Roflumilast is for adults and is not recommended for children under 18 years of age.

Contraindications

• Roflumilast is contraindicated if you are allergic to roflumilast and if you have moderate or severe liver problems.

Other Medications to Avoid

• Roflumilast may interact with CYP3A4 or dual CYP3A4/CYP1A2 inhibitors (e.g., erythromycin, ketoconazole) and CYP3A4 inducers (e.g., rifampicin, phenobarbital).

Overdose and Missed Dose

• Overdose of Roflumilast may cause severe nausea, vomiting, diarrhoea, abdominal pain, dizziness, headache, and fatigue. If you observe these symptoms, consult your doctor and follow their advice.

• If a dose is missed, it should be taken as soon as remembered. However, if it is close to the time for the next dose, the missed dose should be skipped.

Management of Side Effects

Most side effects are temporary and generally harmless and resolve when discontinuing Roflumilast. However, if you experience any severe side effects or worsening of any symptoms, please consult your doctor.

• Drinking plenty of water may help manage common side effects such as diarrhoea.

• Regular rest can help manage symptoms of fatigue or dizziness.

Use in Driving and Operating Machinery

• Roflumilast may cause dizziness or sleepiness. If affected, avoid driving or operating machinery after taking this medicine.

Use in Pregnancy and Lactation

• Roflumilast should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Consult your doctor before using this medicine during pregnancy and breastfeeding.

Caution in Other Conditions

• Caution is advised in patients with mild liver impairment, HIV infection, multiple sclerosis (MS), lupus erythematosus (LE) or progressive multifocal leukoencephalopathy (PML), severe acute infectious diseases such as acute hepatitis and cancer.

Special Dietary and Lifestyle Recommendations

• Avoid excessive caffeine to reduce the risk of exacerbating side effects like insomnia.

• Monitor weight regularly as roflumilast can affect appetite.

• Regularly monitor liver function through prescribed tests, as roflumilast can affect the liver.