Shionogi Pharma "Pirespa" 200mg x 100 tablet

The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.

Brand name:PIRESPA Tablets 200mg

Active ingredient:Pirfenidone

Dosage form:light yellow to light yellow-brown tablet, major axis: 12.2 mm, minor axis: 6.4 mm, thickness: 4.5 mm

Print on wrapping:(Face) ピレスパ 200mg, (Back) ピレスパ 200mg 521 200

Effects of this medicine

This medicine inhibits fibrosis in lung, thereby suppressing aggravation of pulmonary function.

It is usually used for the treatment of idiopathic pulmonary fibrosis.

Before using this medicine, be sure to tell your doctor and pharmacist

・If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.

・If you are pregnant or breastfeeding.

・If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

Dosing schedule (How to take this medicine)

・Your dosing schedule prescribed by your doctor is<<           to be written by a healthcare professional>>

・In general, for adults, start taking 1 tablet (200 mg as the active ingredient) at a time, 3 times a day after meals. After the dose is gradually increased by increments of 1 tablet (200 mg) at a time while observing your condition, it can be increased up to 3 tablets (600 mg) at a time, 3 times a day. The dosage may be adjusted according to your symptoms. Strictly follow the instructions.

・The dose is increased at intervals of 2 weeks generally.

・Since the adverse effects of this medicine tend to be induced when you take it on an empty stomach, take it after a meal.

・If you miss a dose, take it after a light meal as needed when you remember. If it is close to your next dose, skip the missed dose. You should never take two doses at one time.

・If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.

・Do not stop taking this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

・Photosensitivity may occur and skin carcinogenesis may be caused by ultraviolet irradiation. Therefore, avoid ultraviolet irradiation by wearing long-sleeved cloths, a hat, etc. and/or using a parasol and a sunscreen with high sunburn-protective effects (SPF50+, PA+++) when you go out.

・Since this medicine may cause drowsiness, dizziness and light-headed feeling, avoid driving a car and operating dangerous machinery.

・Since cigarette smoking affects the effect of this medicine, refrain from smoking.

・If you are breastfeeding, avoid breastfeeding while taking this medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include photosensitivity (exaggerated sunburn caused by sunlight, itch, pigmentation), loss of appetite, stomach discomfort and nausea. If any of these symptoms occur, consult with your doctor or pharmacist.

The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.

・malaise, loss of appetite, yellowness in skin or in the white of eyes [hepatic function disorder, jaundice]

・fever, sore throat, chill [agranulocytosis, leukopenia, neutropenia]

The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.

Storage conditions and other information

・Keep the medicine out of the reach of infants and children. Store it at room temperature (1 to 30 degrees Celsius) away from direct sunlight and moisture.

・Discard the remainder. Do not store them. For disposal methods, consult the pharmacy or the medical institution from which you have received the medicine.