Chlorphenamine yellow sensitive tablets

[Drug name]

Generic name: Compound Diclofenac Sodium and Chlorphenamine Maleate Tablets

Chinese Pinyin: Lüfenhuangmin Pian

[Ingredients]

This product is a compound preparation, and its components are: each tablet contains 15mg of diclofenac sodium, 15mg of artificial bezoar, and 2.5mg of chlorphenamine maleate.

[Properties] This product is a film-coated tablet, which is light yellow after removing the coating.

[Indications] It is used for headache, fever, nasal congestion, runny nose, sore throat, sputum and other symptoms caused by colds.

[Usage and Dosage] Oral. 1 to 2 tablets at a time, 3 times a day or as prescribed by a doctor.

[Adverse Reactions] There are many reports of children with hematuria after taking the drug; followed by stomach discomfort and burning sensation; in addition, there are headaches, dizziness, drowsiness, as well as rash, palpitations, chest tightness, sore throat and other adverse reactions.

【Contraindications】1. Patients with known allergies to this product.

2. Patients who have asthma, urticaria or allergic reactions after taking aspirin or other non-steroidal anti-inflammatory drugs.

3. Contraindicated for the treatment of perioperative pain in coronary artery bypass grafting (CABG).

4. Patients with a history of gastrointestinal bleeding or perforation after the use of non-steroidal anti-inflammatory drugs.

5. Patients with active peptic ulcers/bleeding, or patients with recurrent ulcers/bleeding in the past.

6. Patients with severe heart failure.

7. Contraindicated for newborns or premature infants.

8. Contraindicated for patients with hepatic and renal insufficiency.

【Precautions】1. Avoid combined use with other non-steroidal anti-inflammatory drugs, including selective COX-2 inhibitors.

2. According to the need to control symptoms, use the lowest effective dose in the shortest treatment time to minimize adverse reactions.

3. Adverse reactions such as gastrointestinal bleeding, ulcers, and perforations may occur at any time during treatment with all NSAIDs, and the risk may be fatal. These adverse reactions may be accompanied by or without warning symptoms, regardless of whether the patient has a history of gastrointestinal adverse reactions or a history of serious gastrointestinal events. Patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease) should use NSAIDs with caution to avoid worsening their condition. When patients develop gastrointestinal bleeding or ulcers while taking this drug, they should stop taking it. Elderly patients experience an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal.

4. Clinical trials of multiple COX-2 selective or non-selective NSAIDs for up to 3 years have shown that this product may cause an increased risk of serious cardiovascular thrombotic adverse events, myocardial infarction, and stroke, which may be fatal. All NSAIDs, including COX-2 selective or non-selective drugs, may have similar risks. Patients with cardiovascular disease or risk factors for cardiovascular disease are at greater risk. Even if there are no previous cardiovascular symptoms, doctors and patients should remain vigilant about the occurrence of such events. Patients should be informed of the symptoms and/or signs of serious cardiovascular safety and the steps to be taken if they occur.

Patients should be alert to symptoms and signs such as chest pain, shortness of breath, weakness, slurred speech, and should seek medical help immediately if any of the above symptoms or signs occur.

5. Like all nonsteroidal anti-inflammatory drugs (NSAIDs), this product can cause new hypertension or aggravate existing hypertension symptoms, any of which can lead to an increased incidence of cardiovascular events. When patients taking thiazide or loop diuretics take nonsteroidal anti-inflammatory drugs (NSAIDs), the efficacy of these drugs may be affected. Nonsteroidal anti-inflammatory drugs (NSAIDs), including this product, should be used with caution in patients with hypertension. Blood pressure should be closely monitored when starting treatment with this product and throughout treatment.

6. Patients with a history of hypertension and/or heart failure (such as fluid retention and edema) should use it with caution.

7. NSAIDs, including this product, may cause fatal and serious skin adverse reactions, such as exfoliative dermatitis, Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). These serious events may occur without warning. Patients should be informed of the symptoms and signs of severe skin reactions, and this product should be discontinued at the first appearance of skin rash or other signs of allergic reaction.

8. This product can cross the placenta and should be avoided during pregnancy.

9. Small amounts of chlorpheniramine can be excreted from breast milk and inhibit lactation.

10. Use with caution in patients with liver or kidney damage or a history of ulcers, especially the elderly.

11. Use with caution in the following situations: bladder neck obstruction, pyloric duodenal obstruction, cardiovascular disease, glaucoma, hypertension, etc.

12. It should not be taken by those who drive motor vehicles, operate machinery, or work at heights.

[Pregnant and lactating women] It should not be taken.

[Children's use] Children should use with caution.

【Use in the elderly】Not clear yet.

【Drug interactions】1. When used with aspirin or other salicylic acid drugs, the efficacy does not increase, but the incidence of gastrointestinal adverse reactions and bleeding tendency increases. 2. This product can reduce the effects of insulin and other hypoglycemic drugs, causing blood sugar to rise. 3. Aspirin can reduce the bioavailability of this product. 4. This product can enhance the effects of adamantane, anticholinergics, phenothiazines, and antisympathomimetics. 5. When this product is taken at the same time as tricyclic antidepressants, it can enhance the efficacy of the latter.

【Overdose】Not clear yet.

【Pharmacology and toxicology】Diclofenac sodium in this product is a non-steroidal anti-inflammatory analgesic derived from phenylacetic acid. Its mechanism of action is to inhibit the activity of cyclooxygenase, thereby blocking the conversion of arachidonic acid to prostaglandins. At the same time, it can also promote the binding of arachidonic acid with triglycerides, reduce the concentration of free arachidonic acid in cells, and indirectly inhibit the synthesis of leukotrienes. Diclofenac sodium is a stronger non-steroidal anti-inflammatory drug. Its inhibitory effect on prostaglandin synthesis is stronger than that of aspirin and indomethacin.

Chlorpheniramine maleate antagonizes H1 receptors to counteract histamine allergic reactions. It does not affect histamine metabolism or prevent histamine release in the body. It also has M cholinergic receptor blocking and central inhibition effects. Artificial bezoar has antipyretic, analgesic, sedative, and anti-inflammatory effects.

[Pharmacokinetics] This product is quickly and completely absorbed orally. The blood drug concentration reaches its peak in about 6 hours. It must be metabolized by the liver, and the metabolites are mainly excreted through the kidneys. Artificial bezoar can pass through the placental barrier.

[Storage] Store in sealed containers (10℃~30℃).

[Packaging] ① Aluminum-plastic, 24 tablets per plate, 1 plate per box.

② Aluminum-plastic, 24 tablets per plate, 2 plates per box.

③ White plastic bottle, 50 tablets per bottle.

[Validity period] 36 months

[Approval number] National Medicine Approval No. H44024196