Aceclofenac Enteric-coated Capsules

This product is a non-steroidal anti-inflammatory drug with anti-inflammatory and analgesic effects. Its mechanism of action may be mainly through inhibiting cyclooxygenase activity, thereby reducing prostaglandin synthesis.

The main ingredient of this product is: Aceclofenac. Chemical name: 2-[(2,6-dichlorophenyl)amino]phenylacetoxyacetic acid

This product is an enteric-coated capsule, and the contents are off-white granules and powder.

Symptomatic treatment of pain and inflammation caused by osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, etc.

This product should be swallowed or taken with food. Adults: The maximum recommended daily dose is 200 mg (4 capsules), swallowed twice, 2 capsules each time, once in the morning and once in the evening.

According to literature reports, the main adverse reactions of this product are gastrointestinal adverse reactions, indigestion (7.5%), abdominal pain (6.2%), nausea and diarrhea. 1. Common adverse reactions (incidence greater than 1%): mainly gastrointestinal system disorders, nausea, diarrhea, abdominal pain, indigestion; liver and gallbladder: increased transaminase. 2. Occasional adverse reactions (incidence 1% to 0.1%): generally: dizziness, gastrointestinal tract flatulence, gastritis, constipation, vomiting, ulcerative oral mucositis; skin itching, rash and dermatitis; metabolism and nutrition: increased urea nitrogen and creatinine. 3. Rare (incidence less than 0.1%): General symptoms include headache, fatigue, facial edema, allergic symptoms, weight gain; blood: anemia, granulocytopenia, thrombocytopenia, neutropenia; cardiovascular: edema, palpitations, gastrocnemius spasm, flushing, purpura; central nervous system: sensory disturbances, tremors; gastrointestinal system disorders: gastrointestinal bleeding and ulcers, bloody diarrhea, hepatitis or pancreatitis, tarry stools, oral mucosal inflammation; skin: eczema; metabolism and nutrition: elevated alkaline phosphatase, hyperkalemia; psychiatric: depression, dreaminess, drowsiness, insomnia; eyes: visual abnormalities; others: taste disturbance, vasculitis. In addition, like other non-steroidal anti-inflammatory analgesics, severe hypersensitivity reactions of the skin and mucous membranes may occur.

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 gastrointestinal ulcers/bleeding, or patients with recurrent ulcers/bleeding in the past. 6. Patients with severe heart failure. 7. Patients with liver and kidney dysfunction. 8. Contraindicated for pregnant women during the last 3 months of pregnancy.

Precautions for children: The safety and effectiveness of the drug for children have not been determined, so it is not recommended for children. Precautions for pregnancy and lactation: 1. Anti-inflammatory drugs may block uterine contractions and delay delivery. They may cause contraction and closure of the intrauterine ductus arteriosus, leading to pulmonary hypertension and respiratory insufficiency in the newborn. Anti-inflammatory drugs may also reduce fetal platelet function and inhibit fetal renal function, thereby causing oligohydramnios and neonatal anuria. Therefore, pregnant women are prohibited from using this product in the last three months of pregnancy. 2. It is not clear whether this product will be secreted into breast milk, so women should not use this product during breastfeeding unless the doctor deems it necessary. Precautions for the elderly: Generally, there is no need to reduce the dose. However, because elderly patients are more likely to have side effects than adults, they should be used with caution. During treatment, some patients had no pre-symptoms or obvious medical history, but as a result, severe gastrointestinal bleeding and/or perforation occurred. Elderly patients are also more likely to cause renal, liver and cardiovascular damage.

1. Avoid using this product in combination with the following drugs: Nonsteroidal anti-inflammatory drugs inhibit the secretion of methotrexate in the renal tubules and may have slight metabolic interactions, resulting in reduced methotrexate clearance. Therefore, during high-dose methotrexate treatment, nonsteroidal anti-inflammatory drugs should always be avoided. Some nonsteroidal anti-inflammatory drugs can inhibit the elimination process of lithium salts in the kidneys, increasing the lithium concentration in the blood. They should be avoided in combination with lithium salts. If they must be used in combination, the lithium level in the serum should be measured frequently. Nonsteroidal anti-inflammatory drugs can inhibit platelet aggregation and damage the gastrointestinal mucosa, increase the activity of anticoagulants, and thus lead to a tendency for gastrointestinal bleeding in users of anticoagulants. Avoid using this product in combination with coumarin oral anticoagulants, ticlopidine, thrombolytic agents, and heparin. 2. This product needs to be used in combination with the following drugs, and the dose should be adjusted or extra attention should be paid. When using this product, even if low-dose methotrexate is used, attention should be paid to the possible drug interactions between them, especially for patients with renal insufficiency. If these two drugs are used at the same time within 24 hours, they should be more vigilant, because the blood concentration of methotrexate may increase and lead to increased toxicity. Non-steroidal anti-inflammatory drugs are used together with cyclosporine or tacli, because the former will reduce the synthesis of renal prostaglandins and increase the risk of renal toxicity, so renal function should be closely monitored during combined treatment. Taking this product and aspirin or other non-steroidal anti-inflammatory drugs at the same time will increase the incidence of side effects, so be vigilant. Non-steroidal anti-inflammatory drugs will weaken the diuretic effect of certain diuretics such as furosemide and bufenac, and will also reduce the antihypertensive effect of thiazide diuretics. Using them together with potassium-sparing diuretics will increase potassium levels, so potassium should be monitored; the simultaneous use of non-steroidal anti-inflammatory drugs and ACE (angiotensin-converting enzyme) inhibitors will increase the risk of acute renal failure in patients with dehydration. The combined use of this product with bendroflumethiazide (diuretic antihypertensive drug) did not find an effect on blood pressure control. However, the interaction between this product and other antihypertensive drugs such as beta-receptor antagonists cannot be ruled out. It has been reported that this product may cause hypoglycemia, and the dose of hypoglycemic drugs should be adjusted when used. 3. This product is mainly metabolized by cytochrome P4502C9, so there may be a risk of drug interaction with phenytoin sodium, digoxin, cimetidine, tolbutamide, phenylbutazone, amiodarone, miconazole and sulfaphenazole. Since this product is almost completely bound to plasma proteins, those drugs with high protein binding rates may be replaced by this product, so attention should be paid and monitoring is required.

Seal and store in a cool place (not exceeding 20℃).

50mg

Tentative 18 months

Guangzhou Baiyunshan Guanghua Pharmaceutical Co., Ltd.

• Founded in:

  1993-01-30

• Address:

  No.1 Nanshi Road, Haizhu District, Guangzhou

• Tax NO.:

  914401011904851166

• Registered Funds:

  55.285 million yuan

• Website:

  Log in to view

• Email:

  Log in to view