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According to the results of adverse drug reaction assessment, in order to further protect the safety of public drug use, the State Medical Products Administration decided to uniformly revise
the instructions of domperidone preparations (including domperidone tablets, domperidone dispersible tablets, domperidone oral disintegration tablets, domperidone capsules, domperidone suspension, domperidone maleate tablets).
The relevant matters are hereby announced as follows:
the instructions of domperidone preparations (including domperidone tablets, domperidone dispersible tablets, domperidone oral disintegration tablets, domperidone capsules, domperidone suspension, domperidone maleate tablets).
The relevant matters are hereby announced as follows:
1.
The MAHs of the above-mentioned drugs shall, in accordance with the Measures for the Administration of Drug Registration and other relevant provisions, report to the Drug Evaluation Center of the State Medical Products Administration or the provincial drug regulatory department for the record
before January 24, 2023 in accordance with the revised requirements of domperidone preparations (see Annexes 1 and 2).
The MAHs of the above-mentioned drugs shall, in accordance with the Measures for the Administration of Drug Registration and other relevant provisions, report to the Drug Evaluation Center of the State Medical Products Administration or the provincial drug regulatory department for the record
before January 24, 2023 in accordance with the revised requirements of domperidone preparations (see Annexes 1 and 2).
Where the revised content involves drug labels, they shall be revised together, and the instructions and other contents of the label shall be consistent
with the original approved content.
Drugs produced on the date of filing shall not continue to use the original drug instructions
.
The MAH shall replace
the instructions and labels of the drugs that have left the factory within 9 months after filing.
with the original approved content.
Drugs produced on the date of filing shall not continue to use the original drug instructions
.
The MAH shall replace
the instructions and labels of the drugs that have left the factory within 9 months after filing.
2.
Drug marketing authorization holders shall conduct in-depth research on the mechanism of occurrence of new adverse reactions, take effective measures to publicize and train on drug use and safety issues, and guide physicians and pharmacists in rational drug use
.
Drug marketing authorization holders shall conduct in-depth research on the mechanism of occurrence of new adverse reactions, take effective measures to publicize and train on drug use and safety issues, and guide physicians and pharmacists in rational drug use
.
3.
Clinicians and pharmacists should carefully read the revised content of the above drug instructions, and when selecting drugs, they should conduct a full benefit/risk analysis
according to the newly revised instructions.
Clinicians and pharmacists should carefully read the revised content of the above drug instructions, and when selecting drugs, they should conduct a full benefit/risk analysis
according to the newly revised instructions.
4.
Patients should carefully read the drug instructions before taking medication, and should strictly follow the doctor's advice when using prescription drugs
.
Patients should carefully read the drug instructions before taking medication, and should strictly follow the doctor's advice when using prescription drugs
.
5.
The provincial-level drug regulatory departments shall urge the drug marketing authorization holders of the above-mentioned drugs within the administrative region to do a good job in revising the corresponding instructions and replacing labels and instructions as required, and strictly investigate and deal with violations of laws and
regulations in accordance with law.
The provincial-level drug regulatory departments shall urge the drug marketing authorization holders of the above-mentioned drugs within the administrative region to do a good job in revising the corresponding instructions and replacing labels and instructions as required, and strictly investigate and deal with violations of laws and
regulations in accordance with law.
This is hereby announced
.
.
Attachments: 1.
Requirements for revision of prescription drug inserts for domperidone preparations
Requirements for revision of prescription drug inserts for domperidone preparations
2.
Requirements for revision of over-the-counter instructions for domperidone preparations
Requirements for revision of over-the-counter instructions for domperidone preparations
NMPA
October 24, 2022
Annex 1
Requirements for revision of prescription drug inserts for domperidone preparations
Note: This revision includes domperidone tablets, domperidone dispersible tablets, domperidone oral disintegration tablets, domperidone capsules, domperidone suspension, domperidone maleate tablets
.
.
1.
[Adverse reactions] should contain the following content
[Adverse reactions] should contain the following content
The following adverse reactions/events of domperidone preparations (containing domperidone maleate) were detected postmarketing (these adverse reactions/events were reported from spontaneous reports where sample size could not be determined and it was difficult to accurately estimate their frequency of occurrence):
Gastrointestinal system: dry mouth, nausea, vomiting, belching, heartburn, indigestion, gastroesophageal reflux, abdominal pain, bloating, abdominal discomfort, diarrhea, constipation
.
.
From the nervous system: dizziness, headache, vertigo, drowsiness, tremor, extrapyramidal reactions
.
.
Skin and subcutaneous tissue: rash, itching, erythematous rash, maculopapular rash, urticaria, sweating
.
.
Mental illness: insomnia, burnout, nervous nervousness
.
.
Systemic diseases: fatigue, thirst, fever, pain, edema
.
.
Immune system: hypersensitivity, anaphylactic shock
.
.
Organs of the heart: palpitations, arrhythmias, tachycardia
.
.
Reproductive system and mammary glands: galactorrhea, breast pain, breast swelling, menstrual irregularities, male breast development
.
.
Respiratory, thoracic and mediastinum: chest tightness, dyspnea
.
.
Urinary system: frequent urination, difficulty
urinating.
urinating.
Muscles, bones: muscle spasm
.
.
Metabolic and nutritional diseases: loss
of appetite.
of appetite.
2.
[Precautions] should include the following content
[Precautions] should include the following content
Children under 12 years of age (especially infants), adolescents and adults weighing less than 35 kg should be used with caution and closely monitored for adverse effects
.
.
(Note: If the safety content of the original approval specification is more comprehensive or stricter than the content required by this amendment, the original approval content
shall be retained.
) If other contents of the specification are inconsistent with the above revision requirements, they shall be revised
together.
）
shall be retained.
) If other contents of the specification are inconsistent with the above revision requirements, they shall be revised
together.
）
Annex 2
Over-the-counter label revision requirements for domperidone preparations
Note: This revision includes domperidone tablets, domperidone dispersible tablets, domperidone oral disintegration tablets, and domperidone suspension
.
.
1.
[Adverse reactions] should include the following content:
[Adverse reactions] should include the following content:
The following adverse reactions/events of domperidone preparations (containing domperidone maleate) were detected postmarketing (these adverse reactions/events were reported from spontaneous reports where sample size could not be determined and it was difficult to accurately estimate their frequency of occurrence):
Gastrointestinal system: dry mouth, nausea, vomiting, belching, heartburn, indigestion, gastroesophageal reflux, abdominal pain, bloating, abdominal discomfort, diarrhea, constipation
.
.
From the nervous system: dizziness, headache, vertigo, drowsiness, tremor, extrapyramidal reactions
.
.
Skin and subcutaneous tissue: rash, itching, erythematous rash, maculopapular rash, urticaria, sweating
.
.
Mental illness: insomnia, burnout, nervous nervousness
.
.
Systemic diseases: fatigue, thirst, fever, pain, edema
.
.
Immune system: hypersensitivity, anaphylactic shock
.
.
Organs of the heart: palpitations, arrhythmias, tachycardia
.
.
Reproductive system and mammary glands: galactorrhea, breast pain, breast swelling, menstrual irregularities, male breast development
.
.
Respiratory, thoracic and mediastinum: chest tightness, dyspnea
.
.
Urinary system: frequent urination, difficulty
urinating.
urinating.
Muscles, bones: muscle spasm
.
.
Metabolic and nutritional diseases: loss
of appetite.
of appetite.
II.
[Precautions] shall include the following content:
[Precautions] shall include the following content:
This product is not intended for children under 12 years of age (especially infants), adolescents weighing less than 35 kg and adults
.
.
(Note: If the safety content of the original approval specification is more comprehensive or stricter than the content required by this amendment, the original approval content
shall be retained.
) If other contents of the specification are inconsistent with the above revision requirements, they shall be revised
together.
）
shall be retained.
) If other contents of the specification are inconsistent with the above revision requirements, they shall be revised
together.
）
