くすりのしおり

Internal
Revised: 7/2016

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 :
NAUZELIN Tablets 5
 Active ingredient:
Domperidone
 Dosage form:
white tablet, diameter: 6.1 mm, thickness: 3.2 mm
 Print on wrapping:
KH305, 5mg, ナウゼリン

Effects of this medicine

This medicine suppresses activities of dopamine in the stomach and duodenum to improve gastrointestinal motility, and acts on CTZ (chemoreceptor trigger zone) involved in causing nausea to suppress nausea.
It is usually used to treat nausea, vomiting and loss of appetite in chronic gastritis and gastroptosis in adults, and to improve nausea caused by cold or periodic vomiting in children.

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: gastrointestinal bleeding, mechanical ileus, gastrointestinal perforation, prolactinoma, hepatic disorder, renal disorder or heart disease.
    If the patient is a child with dehydration or fever.
  • If you are pregnant, possible 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))
  • For adults: In general, take 10 mg of the active ingredient at a time, three times daily, before meal. If you also take levodopa product, take 5 to 10 mg of the active ingredient at a time, three times daily, before meal. The dosage may be adjusted according to the age or symptoms.
    For children: In general, take 1 to 2 mg of the active ingredient per kilogram of the body weight daily, in three divided doses, before meal. The dosage may be adjusted according to the age, body weight or symptoms. The maximum daily dose is 30 mg of the active ingredient. For children aged 6 or older, the maximum daily dose is 1 mg of the active ingredient per kilogram of the body weight.
    This preparation contains 5 mg of the active ingredient in a tablet. Strictly follow the instructions.
  • If you miss a 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

  • This medicine may cause sleepiness and dizziness. Take care in driving a car or engaging in dangerous activities.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include diarrhea, constipation, heartburn, nausea, vomiting, lactation and gynecomastia in adults, and diarrhea, extrapyramidal disorder (muscle stiffness, tremor of limbs, etc.), sleepiness and rash in children. 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.
  • dizziness, orthostatic dizziness, cold sweat, facial pallor  [shock]
  • breathing difficulty, hives, swelling around eyes and mouth  [anaphylaxis]
  • tremor of limbs, muscle stiffness, twist or cramp in neck, upward rotation of eyes  [extrapyramidal symptoms]
  • decreased consciousness, sudden muscle contraction  [consciousness disorder, convulsion]
  • general malaise, loss of appetite, yellowing in skin and white of eyes  [hepatic dysfunction, jaundice]
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 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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