State Food and Drug Administration: 3 non transfer of proprietary Chinese medicine, revision of the manual, children, pregnant women pay attention!

On March 4, the State Drug Administration issued a notice to transfer Weitongning tablets, HuaZhiShuan and Xiaoshuan Tongluo preparations (tablets, capsules, granules) out of the over-the-counter drug list, manage them according to the prescription drugs, and revise the above drug instructions It is pointed out in the announcement that the three pharmaceutical manufacturers involved shall, in accordance with the measures for the administration of drug registration and other relevant regulations, put forward the supplementary application for the revision of the drug specification in accordance with the revision requirements of the relevant drug specification (see Annex 1-3), and report it to the provincial drug regulatory department for the record before April 30, 2019 If the revised contents involve drug labels, they shall be revised together; the instructions and other contents of the labels shall be consistent with the original approved contents Within 6 months after the supplementary application is filed, the ex factory drug instructions and labels shall be replaced It is pointed out that drug manufacturers should carry out in-depth research on the mechanism of new adverse reactions, take effective measures to do well in the publicity and training of related drug use and safety issues, and guide doctors to use drugs reasonably Weitongning tablet is used for clearing away heat and drying dampness, regulating qi and stomach, making acid and relieving pain It is used for stomach ache caused by combination of dampness and heat, too much stomach acid, stomach depression and belching, acid and noise, loss of appetite, secret constipation of stool, short and red urination The drug has been included in the national medical insurance category B according to the database of home-made drugs of pharmaceutical intelligence, 10 domestic enterprises currently hold production approval documents, as shown in the figure below The taboo items in the revised manual mainly proposed that children, pregnant women and lactating women should not be allowed Requirements for revision of the instructions of Weitongning tablet 1 It should be noted that "please read the instructions carefully and use them under the guidance of the doctor" 2、 Warning words should include: This product contains fairies 3、 [adverse reactions] should include: 1 Digestive system: nausea, vomiting, diarrhea, constipation, dry mouth, abdominal pain, etc 2 Skin and its accessories: rash, pruritus, etc 3 Mental nervous system: dizziness, headache, mental disorder, drowsiness, insomnia, etc 4 Systemic reaction: anaphylactic reaction, etc 5 Others: palpitation, etc 6 Patients with renal insufficiency may have aluminum accumulation poisoning and mental symptoms after long-term application 4、 [contraindications] should include: 1 Forbidden for children, pregnant women and lactating women 2 It is forbidden for patients with hypertension, heart disease, tachycardia and glaucoma 3 It is forbidden to take if the liver and kidney function is not complete 4 In case of appendicitis or acute abdomen, this product can aggravate the condition and increase the risk of appendix perforation It should be forbidden 5、 [precautions] items should include: 1 Diet should be light, avoid spicy, cold and greasy food 2 This product contains aluminum hydroxide It is not suitable for fracture patients to take it because of the formation of insoluble aluminum phosphate complex, which leads to the decrease of serum phosphate concentration and the removal of phosphorus from bone; it can hinder the absorption of phosphorus, and long-term use can cause hypophosphatemia; patients with hypophosphatemia (such as malabsorption syndrome) should use it with caution; this product has the effect of constipation, so people with long-term constipation should use it with caution 3 The elderly patients should use it with caution 4 This product contains fairies, should be taken strictly according to the usage and dosage, not excessive or long-term use In case of adverse reactions or other untimely drug discontinuation as described in the instruction manual, patients with serious symptoms should go to the hospital in time 5 It is forbidden to use this product in case of allergy, and it should be used with caution in case of allergic constitution 6、 [drug interaction] items should include: avoid taking other drugs within 1 hour after taking the medicine, because aluminum hydroxide can combine with other drugs to reduce absorption and affect the efficacy HuaZhiShuan can clear away heat and dry dampness, stop astringency and stop bleeding It is used for internal and external hemorrhoids and mixed hemorrhoids caused by dampness and heat of large intestine According to the domestic drug database of pharmaceutical intelligence, at present, only Guangzhou Baiyunshan jingxiutang Pharmaceutical Co., Ltd holds the production approval of the drug It is worth noting that the revised manual also indicates that children, pregnant women and lactating women are prohibited Requirements for revision of the hemorrhoid suppository Manual 1 It should be noted that "please read the manual carefully and use it under the guidance of the doctor" 2、 Warning words should include: This product contains goldenrod 3、 [adverse reactions] should include: 1 Skin and its accessories: pruritus, rash, etc 2 Digestive system: diarrhea, abdominal pain, etc 3 Systemic reaction: anaphylactic reaction, etc 4 Mental nervous system: dizziness, etc 5 Others: palpitation, etc 4、 [contraindications] should include: 1 Forbidden for children, pregnant women and lactating women 2 It is forbidden for patients with hypertension, heart disease, tachycardia and glaucoma 5、 [precautions] items should include: 1 This product is administered by rectum It is forbidden to take it internally 2 Avoid smoking, alcohol and spicy, greasy and irritant food 3 Keep the stool unobstructed 4 The elderly patients should use it with caution 5 Patients with serious liver and kidney diseases, diabetes or blood diseases should be careful 6 It is not suitable for patients with anal fissure 7 This product contains Flos chrysanthus, should be used strictly according to the usage and dosage, not excessive or long-term use In case of adverse reactions or other untimely drug discontinuation as described in the instruction manual, patients with serious symptoms should go to the hospital in time 8 The medicine should be stored in a cool and dry place to prevent deformation due to heat 9 It is forbidden to use this product in case of allergy, and it should be used with caution in case of allergic constitution Xiaoshuan Tongluo Xiaoshuan Tongluo, as a blood regulating agent, has the effect of promoting blood circulation and removing blood stasis, warming channels and dredging collaterals Indications: increased blood lipid, mental retardation caused by cerebral thrombosis, stiff tongue, late and astringent speech, unclear pronunciation, cold hands and feet, and pain in activities At present, the drug is included in the national medical insurance class B According to the pharmaceutical intelligence data, at present, Wenjingtongluo mainly has tablets, with 97 enterprises holding production approval documents In addition, for granules, 1 enterprise holds production approval; for capsules, 3 enterprise holds production approval (attached with production enterprise form) In this manual, it is worth noting that the taboo item indicates: forbidden for pregnant women Requirements for revision of Xiaoshuan Tongluo preparation manual 1 It should be noted that "please read the manual carefully and use it under the guidance of doctors"; the items of [function indications] should be modified according to the prescription drug manual 2、 [adverse reactions] items shall include: reports of adverse reactions such as nausea, vomiting, abdominal pain, diarrhea, dizziness, headache, rash, pruritus, etc 3、 [contraindications] should include: 1 Forbidden for pregnant women 2 No hemorrhagic stroke 3 It is forbidden to use this product or its ingredients if they are allergic 4、 [precautions] items should include: avoid raw cold, spicy, animal fat food; use with caution in case of yin deficiency, internal heat, wind fire and phlegm heat Attachment: Xiaoshuan Tongluo preparation manufacturer's statement: this point of view only represents the author, not the position of yaozhi.com, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.