Revisory of the manual!This kind of medicine for children, pregnant women and lactating women

On June 23, the State Drug Administration issued an announcement saying that according to the results of the adverse reaction evaluation, in order to further ensure the safety of the public's medication, it was decided to uniformly revise the content of the instructions of the amino sugar, which involves the amino sugar Mexin enteric tablet, and Aminoganic enteric cytar capsules, amino sipylisycapoly release capsules and other medicines.

The information shows that the amendments to the amino sugar centered preparation manual include adverse reactions, contraindications, precautions, and drug interaction. For example, in terms of "pregnant women and breastfeeding women", it is modified to be disabled: pregnant women and lactating women. In terms of "children's medication", it is modified to: children's disable. In terms of "medication items for the elderly", the frequency of adverse reactions in the use of this product in elderly patients increases, and it should be used with caution.

According to the requirements of the revision, the instructions for amino sugar beauty centered preparations should be included in terms of adverse reactions and are not limited to the following: After the monitoring after listing, it is found that the report of this product has the following adverse reactions (unknown incidence) Measles, erythema, redness, sweaty. Gastrointestinal: nausea, vomiting, dry mouth, reflux of gastric canal, indigestion, abdominal pain, abdominal discomfort, diarrhea, abdominal distension, loss of appetite, gastrointestinal bleeding, constipation, and abnormal liver function. Nervous system and mental reaction: dizziness, headache, drowsiness, insomnia, tremor, numbness, anxiety. Systemic reaction: fatigue, chest discomfort, pain, edema. Immune system: allergic reaction, allergic shock. Cardiovascular system: palpitations, arrhythmia, and elevated blood pressure. Respiratory system: dyspnea, asthma. Others: dizziness, visual damage, hematuria.

The State Drug Administration requires that the listing permit holders of amino sugar Meixin preparations shall be reported to the National Drug Administration's Drug Review Center or the provincial pharmaceutical supervision and management department for the record before September 21, 2022. If the revised content involves drug labels, it should be revised together; the instructions and other contents of the label should be consistent with the original approval content. Drugs produced from the date of filing shall not continue to use the original drug instructions. The holder of the drug listing permit shall be replaced by the drug manual and label of the factory within 9 months after the filing.

Aminoganic drugs are mainly used for symptomatic treatment of anti -inflammatory and analgesic. The State Drug Administration reminds that clinicians and pharmacists should carefully read the amendments to the above -mentioned drug manuals. When selecting the medication, they should conduct a full benefit/risk analysis based on the new revision instructions. Patients should read the drug instructions carefully before taking the medicine. If the prescription medicine is used, the medicine should be strictly used.

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"Announcement of the State Drug Administration on Amending the Merittates of Amino Slympiad (No. 49, 2022)"

(Changjiang Daily Da Wuhan Client Products Source: Edit Integration of the State Drug Administration website, People's Daily, etc.

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