Dear patients and physician friends:
In order to implement the requirements of the Drug Administration Law of the People's Republic of China on establishing a drug surveillance system and fulfill the main responsibility of drug surveillance for drug marketing authorization holders, the National Medical Products Administration officially issued the "Quality Management Standards for Drug Surveillance" on May 13, 2021, and implemented it from December 1, 2021.
Our company has established a pharmacovigilance management system in accordance with the "Quality Management Standards for Pharmacovigilance". In accordance with regulatory requirements, we have established the Drug Safety Committee of Nanjing Daoqun Pharmaceutical R&D Co., Ltd. and set up a Pharmacovigilance Department to undertake the reporting and monitoring of adverse reactions of our company's 0.3g aspirin enteric coated tablets.
The contact information for work is as follows:
Before using this product (0.3g aspirin enteric coated tablets), please read this safety notice carefully and strictly follow the instructions and dosage requirements in the product manual. At the same time, pay attention to relevant precautions and medication instructions for special populations to avoid drug interactions and minimize the probability of adverse reactions. The scope of adverse drug reaction reports includes adverse reactions of qualified drugs that are unrelated to the intended use of the drug under normal usage and dosage, as well as other adverse events caused by drug quality issues or that may be related to over indications, over dosage, contraindications, medication errors, etc.
The known adverse reactions of this product are as follows:
| System organ classes | Adverse reaction disease name |
| Diseases of the blood and lymphatic system | Hypoprothrombin (high dose), anemia, bleeding, hemolysis |
| Immune system diseases | Allergic reactions in the skin, respiratory tract, gastrointestinal tract, and cardiovascular system (asthma, hypotension, respiratory distress attacks, rhinitis, nasal congestion, anaphylactic shock, and angioedema) |
| Metabolic and nutritional diseases | Hypoglycemia and gout |
| Nervous system disease | Headache, dizziness, hearing loss, tinnitus, and mental disorder |
| Respiratory, thoracic, and mediastinal diseases | Rhinitis, paroxysmal bronchospasm, severe dyspnea, non cardiogenic pulmonary edema |
| Gastrointestinal system diseases | Gastrointestinal discomfort (heartburn, nausea, vomiting, abdominal pain, and diarrhea), slight gastrointestinal bleeding, gastrointestinal ulcers (perforation), gastrointestinal bleeding, gastrointestinal inflammation, upper gastrointestinal abnormalities (esophagitis, erosive duodenitis, erosive gastritis, esophageal ulcers, perforation), lower gastrointestinal abnormalities (small and large intestine ulcers, colitis, and intestinal perforation), black stool, vomiting blood |
| Hepatobiliary disease | Elevated liver function test values |
| Skin and subcutaneous tissue diseases | Rash, urticaria, angioedema, Steven Johnson syndrome, Lyell syndrome, purpura, nodular erythema, polymorphic erythema |
| Kidney and urinary system diseases | Acute renal failure, acute interstitial nephritis |
| Systemic diseases and various reactions at the site of administration | Reye syndrome |
If you experience any (including the above) clinical adverse reactions/events while using our 0.3g aspirin enteric coated tablets, please contact our pharmacovigilance department (hotline 400-860-8006) as soon as possible, or send your feedback information to our work email（ pv@daoqun.cn ）.
In order to report to the higher authorities on time within the regulatory deadline, please cooperate with us to verify and investigate the key information of relevant cases (drug information, patient information, adverse reaction related information, reporter information, etc.), work together to promote drug safety work, and ensure the safety of drug use for the general public.
Nanjing Daoqun Pharmaceutical R&D Co., Ltd
June 14th, 2024