くすりのしおり

Internal
Revised: 5/2019

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 :
PARMODIA Tablets 0.1mg
 Active ingredient:
Pemafibrate
 Dosage form:
white tablet with split line, diameter: 7.1 mm, thickness: 2.9 mm
 Print on wrapping:
パルモディア0.1mg, パルモディア, 0.1mg, PARMODIA 0.1mg

Effects of this medicine

This medicine binds to nuclear receptors (PPARα) to regulate expression of targeted gene. It consequently lowers triglyceride levels in the blood and increases HDL cholesterol.
It is usually used to treat hyperlipidemia (including familial hyperlipidemia).

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, hepatic cirrhosis, biliary atresia, renal dysfunction or cholelithiasis.
  • 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 1 tablet (0.1 mg of the active ingredient) at a time, twice a day, in the morning and in the evening. The dosage may be adjusted according to the age or symptoms, however, the maximum dose should not exceed 2 tablets (0.2 mg) at a time, twice a day. Strictly follow the instructions.
  • If you miss a dose, take the missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and follow 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

  • Strictly follow the instructions on dietary/exercise therapy.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include cholelithiasis (upper abdominal pain, fever) and diabetes mellitus (dry mouth, excess intake of fluid, excessive urination, fatigue). 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]
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 out of the reach of children. Store away from direct sunlight, heat and moisture.
  • Discard the remainder. Do not store them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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