PULMIDONE 801 801 mg Tablet

PULMIDONE 801 801 mg tablet by Beximco Pharmaceuticals Ltd. contains Pirfenidone. It is used in Bangladesh mainly for adults with idiopathic pulmonary fibrosis, a long-term lung disease that causes scarring and worsening breathlessness.

Pirfenidone helps slow lung scarring by reducing fibrotic and inflammatory processes in the lungs. A key caution is that it can affect the liver and increase sensitivity to sunlight, so medical monitoring and sun protection are important.

• Treatment of idiopathic pulmonary fibrosis in adults.

Pirfenidone is usually started at a low dose and gradually increased to a maintenance dose as tolerated. It is commonly taken with food to reduce nausea and dizziness. The exact dose, titration schedule, and any dose changes for side effects or liver problems must be decided by the prescribing doctor.

• Common: nausea, indigestion, loss of appetite, abdominal discomfort, vomiting, diarrhoea, tiredness, dizziness, headache, weight loss, rash, itching, and increased sensitivity to sunlight.
• Serious: liver enzyme elevation or liver injury, severe skin reactions, severe photosensitivity reaction, angioedema or serious allergic reaction, and marked gastrointestinal intolerance leading to dehydration or weight loss.

Use caution in people with liver disease, kidney disease, low body weight, poor appetite or significant weight loss, a history of severe skin reactions, or those who are frequently exposed to sunlight. Liver function tests are usually needed before and during treatment. Avoid excessive sun exposure, use protective clothing and sunscreen, and report yellowing of the eyes or skin, dark urine, severe rash, swelling of the face or lips, or breathing difficulty urgently. Use Pirfenidone only under the guidance of a registered doctor or pharmacist.

• Strong CYP1A2 inhibitors such as fluvoxamine can greatly increase pirfenidone exposure and should generally be avoided.
• Ciprofloxacin and other CYP1A2 inhibitors may increase pirfenidone levels; dose adjustment or closer monitoring may be needed.
• Smoking can reduce pirfenidone levels and may reduce effectiveness; patients should inform the doctor if they smoke or stop smoking.
• Avoid unnecessary combination with other medicines that may affect the liver unless advised by a doctor.
• Food can improve tolerability and is generally recommended when taking pirfenidone.

• Known hypersensitivity to pirfenidone or any component of the product.
• Previous angioedema or serious allergic reaction related to pirfenidone.
• Concomitant use with fluvoxamine, unless the prescriber specifically manages an alternative plan.
• Severe hepatic impairment or end-stage liver disease.
• Severe renal impairment or end-stage renal disease requiring dialysis, unless a specialist decides otherwise.

There is limited human information on pirfenidone use during pregnancy and breastfeeding. It should be used in pregnancy only if the potential benefit justifies the potential risk. Breastfeeding patients should discuss whether to stop breastfeeding or avoid the medicine, based on specialist advice.

Store in a cool, dry place away from direct sunlight and moisture. Keep in the original packaging, tightly closed, and out of the reach of children. Do not use after the expiry date.