Medical network, June 2, according to the adverse drug reactions assessment results, in order to further ensure public security, the state food and drug supervision and administration bureau decided to compound glycyrrhiza oral solution manual 【 ingredients 】, 【 side effect 】, 【 taboo 】 and 【 notes 】 to revise. The relevant issues are hereby announced as follows: 

 

A pharmaceutical production enterprise, all compound liquorice oral solution shall be in accordance with the relevant provisions of the "drug registration management measures" and so on, in accordance with requirements of the manual revision compound glycyrrhiza oral solution (see attachment), put forward to revise the description of the supplement, on July 31, 2017 shall be reported to the provincial food and drug regulatory authorities for the record. 

 

If the amendment involves the label of drugs, it shall be amended together. The specification and the other contents of the label should be consistent with the original approval. The leaflet and label shall be replaced within 6 months after the application for filing. 

 

Pharmaceutical producing enterprises shall each compound glycyrrhiza oral solution on new adverse reaction mechanism to carry out in-depth study, to take effective measures to make use and safety propaganda and training, to guide physicians rational drug use. 

 

Second, clinicians should carefully read compound glycyrrhiza oral solution manual revision content, when choosing drugs, shall be amended according to the new instruction to fully benefit/risk analysis. 

 

The patient should follow the doctor's instructions strictly and should read the instructions carefully before taking the medicine. 

 

I hereby announce that. 

 

Attachment: revised instructions for the oral solution of the compound licorice 

 

The general administration of food and drug administration 

 

On May 27, 2017 

 

Revision requirements for compound licorice oral solution specification 

 

One, the [ingredient] term 

 

The concrete signs of "camphor tincture" (camphor, tincture * * * * * * * * * * * * * * *), and the "* * mg" of "camphor tincture" were added. The specific content shall be revised according to the respective products. 

 

Second, the revision of [adverse reactions] is: 

 

Gastrointestinal system: dry mouth, nausea, vomiting, bloating, abdominal pain, diarrhea, etc. 

 

Skin and its accessories: sweat, itching, rash, etc. 

 

Cardiovascular system: hot flashes, heart palpitations, elevated blood pressure, etc. 

 

Respiratory system: chest, gas, breathing difficulties, etc. 

 

The central and peripheral nervous system: dizziness, headache, lethargy, convulsion, tremor, insomnia, mental abnormalities, etc. 

 

Urinary system: urinary retention, facial edema, etc. 

 

Systemic damage: allergic reaction, allergic shock, hot water, etc. 

 

3, the term "taboo" should include: 

 

Pregnant women and breastfeeding women are banned. 

 

Disable this product and its constituents. 

 

Disables of ethanol (alcohol) allergy. 

 

Items of caution should include the following: 

 

Bronchial asthma, chronic obstructive pulmonary disease (COPD), respiratory suppressor. 

 

Careful use of gastritis and peptic ulcers. 

 

Seek medical attention immediately if you take an overdose or have a serious adverse reaction. 

 

The athlete is careful. 

 

It is not allowed to operate machinery and vehicles after taking this product because it contains ethanol (alcohol). It should also avoid the use of cefuses or the drugs that are susceptible to dithion reactions. 

 

Blood pressure should be monitored during the use of this product. 

 

5, the term "pregnant and lactating women's medicine" is revised: 

 

Disabled. 

 

6, the term "aged medicine" is revised: 

 

The elderly organ is metabolized slowly, it is not good for such drug, it must be strictly followed by the doctor's orders. 

 

7, the [drug interactions] are revised: 

 

Be careful not to take a strong cough medicine at the same time. 

 

If you are taking other medicines, please consult a physician or pharmacist before using this product. 

 

3. This product includes ethanol, and the higher reaction caused by cephalosporin drugs or double sulfur medicines can make the blood of acet aldehyde concentration increase, a double sulfur shimron reaction (facial blushing, headache, dizziness, abdominal pain, stomach pain, nausea, vomiting, shortness of breath, heart rate, blood pressure lowering, and drowsiness, illusion, etc.). 

 

(note: if the other contents of the specification are inconsistent with the above amendment, the amendment shall be made.)