Diclofenac Sodium Sustained Release Capsules

Pharmacological action: Diclofenac sodium 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 combination of arachidonic acid and 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. Non-clinical toxicology study: Oral administration of diclofenac sodium to rats at 2 mg/kg per day, long-term observation, no increase in tumor incidence was found. In a two-year study on mice, 2 mg/kg was used daily, and no tumor-prone tendency was found. Various mutation studies have not found that diclofenac sodium induces gene mutations. Rats were given 4 mg/kg per day, and no infertility occurred in both males and females.

The main ingredient of this product is diclofenac. Its chemical name is [o-(2,6-dichloroaniline)]phenylacetic acid.

This product is a capsule, and the contents are white or off-white micro-pellets.

1. Relieve acute attacks or persistent joint swelling and pain in rheumatoid arthritis, osteoarthritis, spondyloarthritis, gouty arthritis, rheumatoid arthritis and other chronic arthritis; 2. Various soft tissue rheumatic pains, such as shoulder pain, tenosynovitis, bursitis, myalgia and pain after sports injuries; 3. Acute mild and moderate pains such as pain after surgery, trauma, strain, primary dysmenorrhea, toothache, headache, etc.

This product should be swallowed whole, do not chew. 50mg (1 tablet) at a time, twice a day, or as directed by your doctor

1. Gastrointestinal reactions: The most common adverse reactions include stomach discomfort, abdominal pain, burning sensation, acid reflux, poor appetite, nausea and constipation, etc. A small number of patients may experience ulcers, bleeding, and perforation. 2. Nervous system manifestations include headache, dizziness, drowsiness, excitement, etc. 3. It may cause edema, oliguria, electrolyte imbalance and other serious adverse reactions. 4. Other rare adverse reactions include transient increase in serum transaminase, and very few patients may experience jaundice, rash, arrhythmia, granulocytopenia, thrombocytopenia, etc.

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 during 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.

Precautions for children: This product is not recommended for children under 14 years old. Precautions for pregnancy and lactation: This product can cross the placenta. Animal experiments showed toxicity to fetal mice, but it was not teratogenic. It is forbidden for pregnant and lactating women. Precautions for the elderly: This product can cause or aggravate gastrointestinal bleeding, gastric ulcers and perforations in the elderly, so use with caution.

1. When drinking alcohol and other non-steroidal anti-inflammatory drugs are used together, gastrointestinal adverse reactions will increase, and there is a risk of ulcers. Long-term use with acetaminophen may increase the toxic side effects on the kidneys. 2. When used together with anticoagulants such as heparin and dicoumarol and platelet aggregation inhibitors, there is an increased risk of bleeding. 3. When used together with furosemide, the latter's sodium excretion and antihypertensive effects are weakened. 4. When used together with verapamil and nifedipine, the blood concentration of this product increases. 5. This product can increase the blood concentration of digoxin, and the dose of digoxin should be adjusted when used together. 6. When this product is used together with antidiabetic drugs, it can affect the efficacy of the latter, so it needs to be considered carefully. 7. When this product is used together with antihypertensive drugs, it can affect the antihypertensive effect of the latter. 8. Probenecid can reduce the excretion of this product, increase the blood concentration, and thus increase the toxicity, so it is advisable to reduce the dose of this product when used together. 9. This product can reduce the excretion of methotrexate and increase its blood concentration, even to toxic levels, so this product should not be used with medium or large doses of methotrexate. 10. It can cause hyperkalemia when used with potassium-sparing diuretics.

Keep away from light, tightly closed and in a dry place.

50 mg

24 months

China Pharmaceutical University Pharmaceutical Co., Ltd.

• Founded in:

  1994-12-05

• Address:

  No. 50, Majia Street, Gulou District, Nanjing

• Tax NO.:

  91320000134755425F

• Registered Funds:

  98 million yuan

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