ATORVASTATIN TABLETS 10mg “DSEP” [Class 1 Drugs]

The most commonly reported adverse reactions include itch, rash, skin eruption, redness, liver disorder, vomiting, diarrhea, gastritis, loose stool, nausea, stomatitis, heartburn, constipation, gastric distress, abdominal pain, epigastric pain, abdominal bloating, cough, dizziness, insomnia, cerebral infarction (sudden paralysis of limbs or face on one side, numbness, speech difficulties, vision disturbance, consciousness disturbance), pneumonia, headache, general malaise and herpes zoster. 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.

• muscle pain, lassitude, reddish brown urine[rhabdomyolysis, myopathy, immune-mediated necrotizing myopathy]
• nausea/vomiting, general malaise, yellowing of the skin and the white of eyes[fulminant hepatitis, hepatitis, liver dysfunction, jaundice]
• fever, sore throat/headache/dull headache, general malaise, nose/gum/subcutaneous bleeding[agranulocytosis, pancytopenia, thrombocytopenia]
• fever, loss of appetite, red rash[toxic epidermal necrolysis, oculomucocutaneous syndrome, erythema multiforme]
• dry mouth, excessive fluid intake/urination, getting tired easily[hyperglycemia, diabetes mellitus]

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.

• Your dosing schedule prescribed by your doctor is ((        to be written by a healthcare professional))
• For hypercholesterolemia: In general, for adults, take 1 tablet (10 mg of atorvastatin) at a time, once a day. The dosage may be adjusted according to the age or symptoms. For severe patients, the dosage may be increased up to 2 tablets (20 mg) per day.
  For familial hypercholesterolemia: In general, for adults, take 1 tablet (10 mg of atorvastatin) at a time, once a day. The dosage may be adjusted according to the age or symptoms. For severe patients, the dosage may be increased up to 4 tablets (40 mg) per day.
  In any case, strictly follow the instructions.
• If you miss a dose, take the missed dose as soon as possible within before bedtime. 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.

• If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines or foods.
  If you have: diabetes mellitus, hypothyroidism, alcohol poisoning, liver dysfunction or renal dysfunction.
  If you or your family member have/has hereditary myopathy such as muscular dystrophy.
  If you have a history of drug-induced muscle disorder.
  If you have or have a history of myasthenia gravis.
• 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.)

• Keep out of the reach of children. Store at room temperature (1 to 30 degrees Celsius) away from direct sunlight and moisture.
• Discard the remainder. Do not store them. If you do not know how to discard, seek advice of your pharmacy or medical institution. Do not give the unused medicines to others.