Rofaday Tablet (Roflumilast)

This medicine is usually prescribed for long-term respiratory management in selected COPD patients. It may be recommended for:

• Severe chronic obstructive pulmonary disease (COPD)
• COPD with chronic bronchitis
• Patients with repeated COPD exacerbations or flare-ups
• Maintenance treatment to help reduce worsening of symptoms

It is not used for immediate relief of acute bronchospasm or sudden breathlessness.

This medicine works by blocking the PDE4 enzyme, which plays a role in inflammation inside the lungs. By reducing airway inflammation, it helps lower the risk of COPD flare-ups and supports better long-term breathing control. It is considered an anti-inflammatory maintenance medicine and not a fast-acting bronchodilator.

• Take this medicine exactly as prescribed by your doctor.
• Swallow the tablet whole with water.
• It may be taken with or without food.
• Try to take it at the same time every day for better routine.
• Do not stop treatment suddenly without medical advice.
• Continue using your other prescribed inhalers or COPD medicines unless your doctor changes them.
• This medicine should not be used in place of a rescue inhaler for sudden breathing attacks.

Usual Dose:
The usual adult maintenance dose of Roflumilast is 500 mcg once daily. In some prescribing references, treatment may be started with 250 mcg once daily for 4 weeks to improve tolerability, followed by 500 mcg once daily as the maintenance dose, where that lower starting strength is available.

Missed Dose:
If you miss a dose, take it as soon as you remember. If it is close to the time of your next dose, skip the missed dose and continue your regular schedule. Do not take a double dose.

Overdose:
Taking too much may increase the risk of side effects such as nausea, diarrhoea, headache, dizziness, palpitations, sweating, or low blood pressure. Seek medical attention promptly if overdose is suspected.

Common / Minor Side Effects:

• Diarrhoea
• Nausea
• Headache
• Weight loss
• Loss of appetite
• Insomnia
• Dizziness
• Back pain
• Stomach discomfort

Serious / Major Side Effects:

• Severe or persistent weight loss
• Mood changes, anxiety, depression, or suicidal thoughts
• Severe allergic reaction
• Severe diarrhoea or dehydration
• Worsening general weakness or poor nutrition due to appetite loss

Tell your doctor if side effects persist, worsen, or become difficult to tolerate.

• This medicine is not for sudden breathing attacks or acute bronchospasm.
• Inform your doctor if you have depression, anxiety, insomnia, or a history of suicidal thoughts.
• Regular monitoring of body weight may be advised because weight loss can occur during treatment.
• Tell your doctor if you have liver disease. This medicine is not recommended in moderate to severe liver impairment.
• Use with caution if you are underweight or have poor appetite.
• Tell your doctor about all medicines you take, especially strong CYP3A4 inducers or interacting medicines.
• Use during pregnancy or breastfeeding only if your doctor decides it is necessary.
• Do not stop your other COPD inhalers unless your doctor tells you to do so.

Commonly listed brands containing Roflumilast include:

• Roflair Tablet
• Rofmil Tablet
• Rofum Tablet
• Rofluren Tablet
• Rufus Tablet
• Rofurest Tablet
• Exalbic Tablet
• Roflutab Tablet
• Spirolast Tablet

Total commonly listed substitutes/alternatives: 9

Availability may vary by pharmacy, manufacturer, and strength. Any substitute should be used only after confirming the same strength and suitability with your doctor.

1. What is this medicine used for?
This medicine is used as maintenance treatment in severe COPD, especially in patients with chronic bronchitis and frequent exacerbations.

2. Can this medicine relieve sudden breathlessness?
No. This medicine is not a rescue medicine and should not be used for sudden breathing attacks.

3. Can this medicine cause weight loss?
Yes. Weight loss is a known side effect, so body weight should be monitored during treatment.

4. Can this medicine affect mood or sleep?
Yes. Some patients may experience insomnia, anxiety, depression, or mood changes. Report these symptoms to your doctor immediately.

5. Can this medicine be taken with inhalers?
Yes. It is often used along with other prescribed COPD inhalers and maintenance medicines, as advised by your doctor.

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