Effects of this medicine

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 have liver disorder or hypervitaminosis A.
  If you have a history of pancreatitis.
  If you have a risk factor of pancreatitis.

• If you are pregnant, possibly 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, take this medicine once a day after meals. The dosage will be determined based on body surface area (BSA) as follows: 4 capsules (300 mg of the active ingredient) per dose for patients with 0.88 to 1.12 m² of BSA, 5 capsules (375 mg) per dose for patients with 1.13 to 1.37 m² of BSA, 6 capsules (450 mg) per dose for patients with 1.38 to 1.62 m² of BSA, 7 capsules (525 mg) per dose for patients with 1.63 to 1.87 m² of BSA, 8 capsules (600 mg) per dose for patients with 1.88 to 2.12 m² of BSA, 9 capsules (675 mg) per dose for patients with 2.13 to 2.37 m² of BSA, 10 capsules (750 mg) per dose for patients with 2.38 to 2.62 m² of BSA. The dosage will be adjusted according to your symptoms. Strictly follow the instructions.

• If you miss a dose, take the missed dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. 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

• Teratogenic action (possibility to cause fetal malformation) has been reported in animal experiments. If you have a possibility of pregnancy, be sure to avoid pregnancy at least for 1 month before you start this medicine, while you are taking it, and for 1 month after you discontinue it. Since this medicine may diminish the medicinal effect of oral contraceptive agents, avoid using oral contraceptive agents as monotherapy. Use 2 or more birth control methods in combination. Have a pregnancy test periodically in order to confirm that you do not become pregnant.
• If your partner has a possibility of pregnancy, be sure to avoid pregnancy while you are taking it and for at least 3 month after you discontinue it.
• Photosensitivity may occur while you are taking this medicine. Avoid exposure to sunlight by wearing hats or clothing, etc., or by using highly effective sunscreens when you are outside.

Possible adverse reactions to this medicine

• high lipid level detected with a blood test [hyperlipidemia (hypertriglyceridemia, hypercholesteremia)]
• nausea, vomiting, severe gastric/abdominal pain, back pain [pancreatitis]
• dullness, edema, intolerance to the cold, slowness in motion or in conversation, light headedness, lassitude, cold sweat, dizziness, headache, palpitation, a sense of hunger, shaking limbs [pituitary hypothyroidism, hypoglycemia]
• fever, sore throat, dullness, dizziness, headache, ear ringing, palpitation, shortness of breath [leukopenia, neutropenia, anemia]
• nausea, vomiting, loss of appetite, flapping tremor, dullness, yellowing of the whites of eyes, nausea, vomiting, loss of appetite, itch, yellowing of the skin, dark urine [liver failure, liver dysfunction]
• cold-like symptom, dullness, fever, vomiting [infection]
• fever, dry cough, breathing difficulty, shortness of breath [interstitial pulmonary disease]
• vomiting of blood, nausea, vomiting, chest pain, chest tightness, pressure in chest, severe abdominal pain, abdominal bloating, severe pain in legs, bleeding, anesthesia [thromboembolism]
• lassitude, numbness of hands, stiffness in limbs, numbness of legs, muscle pain, reddish-brown urine [rhabdomyolysis]

Storage conditions and other information

• Keep out of the reach of children. Store away from light, heat and moisture.
•  Discard the remainder. Do not store them. Ask the pharmacist and the medical institution how to discard them.