EXALBIC 500MG TABLET

Uses and Benefits of EXALBIC 500MG TABLET (ROFLUMILAST 500MCG)

Roflumilast 500mcg is used mainly for severe COPD associated with chronic bronchitis, to reduce the frequency of flare-ups.

WHAT THIS MEDICINE IS USED FOR

• Reducing the number of COPD exacerbations (flare-ups) in patients with a history of frequent flare-ups
• Long-term maintenance treatment of severe chronic bronchitis-type COPD, add-on to other COPD medicines

HOW IT WORKS

• It blocks an enzyme called PDE4 inside lung and immune cells
• This lowers inflammation in the airways over time
• It helps prevent worsening of symptoms rather than giving immediate relief

WHAT IT IS NOT USED FOR

• Not for sudden breathlessness or acute asthma attacks
• Not a bronchodilator and does not open airways quickly
• Not used for asthma as a primary treatment
• Not suitable for mild COPD without frequent flare-ups

This medicine works slowly and is meant for long-term control, not immediate symptom relief. It should always be used alongside other COPD treatments as advised by your doctor.

Side Effects of EXALBIC 500MG TABLET (ROFLUMILAST 500MCG)

COMMON SIDE EFFECTS

• Diarrhoea
• Nausea
• Headache
• Weight loss
• Reduced appetite

LESS COMMON SIDE EFFECTS

• Difficulty sleeping
• Dizziness
• Stomach pain
• Back pain
• Feeling generally unwell

SERIOUS SIDE EFFECTS — STOP AND SEE A DOCTOR IMMEDIATELY

• Signs of depression, anxiety, or thoughts of self-harm
• Severe or persistent diarrhoea leading to dehydration
• Unexplained significant weight loss
• Signs of allergic reaction such as rash, swelling of face/lips, difficulty breathing
• Severe stomach pain or signs of liver problems like yellowing of eyes/skin

This is not a complete list. Report any unusual or persistent symptom to your doctor or pharmacist.

How to Use EXALBIC 500MG TABLET (ROFLUMILAST 500MCG)

HOW TO TAKE IT

• Take exactly as prescribed by your doctor, usually once daily
• Can be taken with or without food
• Swallow the tablet whole with water; do not crush or chew unless advised
• Take at the same time each day to build a routine
• Continue taking it regularly even if you feel well, as it works to prevent future flare-ups
• Do not stop suddenly without talking to your doctor

IF YOU MISS A DOSE

• Take it as soon as you remember on the same day
• If it is almost time for your next dose, skip the missed one
• Do not take two doses together to make up for a missed one

STORAGE

• Store at room temperature, away from direct heat and sunlight
• Keep in its original packaging until use
• Keep out of reach of children
• Do not use after the expiry date printed on the pack

Safety Information and Precautions for EXALBIC 500MG TABLET (ROFLUMILAST 500MCG)

This medicine is available only with a valid doctor's prescription in India.

DO NOT TAKE THIS MEDICINE IF YOU

• Are allergic to roflumilast or any of its ingredients
• Have moderate to severe liver disease
• Have a history of depression with suicidal thoughts or self-harm
• Are pregnant or breastfeeding, unless specifically advised by your doctor

TELL YOUR DOCTOR BEFORE STARTING IF YOU

• Have any history of mental health problems, especially depression
• Have unexplained weight loss or low body weight
• Have liver problems of any kind
• Are taking other medicines, including over-the-counter drugs and supplements
• Are planning pregnancy or are breastfeeding

MEDICINES THAT CAN INTERACT

• Strong enzyme inducers such as rifampicin, phenobarbital, carbamazepine, phenytoin may reduce its effect
• Strong enzyme inhibitors such as ketoconazole, fluvoxamine, cimetidine, erythromycin may increase side effects
• Oral contraceptives containing certain hormone combinations may need review
• Always share your complete medicine list with your doctor or pharmacist

FREQUENTLY ASKED QUESTIONS

Can this medicine be used during an acute asthma or COPD attack?

No, it is not a rescue medicine and does not give quick relief; use your prescribed inhaler for sudden symptoms.

How long does it take to work?

It may take several weeks to months of regular use before you notice fewer flare-ups, so continue as directed even if you feel no immediate change.

Can I stop this medicine once I feel better?

• Do not stop without consulting your doctor, as stopping suddenly may increase the risk of COPD flare-ups.
• Doctor ya pharmacist se salah lein.