Aceclofenac Tablets

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

The main ingredient of this product is aceclofenac.

This product is a film-coated tablet.

It is used to treat the symptoms of pain and inflammation caused by osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, and can promote the regeneration and repair of joint cartilage. It can also be used to treat chronic polyarthritis, postoperative pain, post-traumatic pain, neck and shoulder pain, waist and leg pain, headache, migraine, sprain, strain, muscle pain, toothache, dysmenorrhea, etc.

Aceclofenac tablets are taken orally with at least half a cup of water and can be taken with food. 1. Adults: The maximum recommended daily dose is 2 tablets, taken twice a day, 1 tablet each time, once in the morning and once in the evening. 2. Elderly: Generally, there is no need to reduce the dose, but it must be used with caution and close observation of possible adverse reactions. 3. Children's medication: The safety and effectiveness of children's medication have not been confirmed. 4. Patients with hepatic insufficiency: Patients with mild to moderate hepatic insufficiency should reduce the dose of aceclofenac. The recommended initial dose is 1 tablet per day. 5. Patients with renal insufficiency: Patients with mild to moderate renal insufficiency do not need to adjust the dose, but should be cautious.

The main adverse reactions are gastrointestinal (dyspepsia, abdominal pain, nausea and diarrhea). The most common are dyspepsia (7.5%) and abdominal pain (6.2%). Common (>1/100) gastrointestinal disorders: dyspepsia, abdominal pain, nausea and diarrhea. Liver and gallbladder: elevated liver enzymes. Occasionally (1/100-1/1000) General: dizziness. Gastrointestinal system: flatulence, gastritis, constipation, vomiting, ulcerative oral mucositis. Skin: itching, rash and dermatitis. Metabolism and nutrition: elevated urea nitrogen and creatinine. Rare (<1/1000) General: headache, fatigue, facial edema, allergic reactions, weight gain. Blood: anemia, granulocytopenia, thrombocytopenia, neutropenia. Cardiovascular: edema, palpitations, gastrocnemius spasm, flushing, purpura. Central and peripheral nervous system: sensory disturbances, tremor. Gastrointestinal disorders: gastrointestinal bleeding and ulcers, bloody diarrhea, hepatitis or pancreatitis, tarry stools, oral mucosal inflammation. Urinary disorders: interstitial nephritis. Skin: eczema. Metabolism and nutrition: elevated alkaline phosphatase, hyperkalemia. Psychiatric: depression, dreaminess, drowsiness, insomnia. Eyes: abnormal vision. Other: taste perversion, vasculitis. As with other NSAIDs, severe hypersensitivity reactions of the skin and mucous membranes may occur.

1. Patients with known allergies to this product. 2. Patients who have experienced 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. 6. Patients with severe heart failure.

Precautions for children: The safety and effectiveness of the drug for children have not been established, so it is not recommended for children. Precautions for pregnancy and lactation: There have been several reports of anti-inflammatory drugs affecting the fetus, which may be caused by inhibiting prostaglandin synthesis. Anti-inflammatory drugs can block uterine contractions and delay delivery. They can cause constriction and atresia of the intrauterine ductus arteriosus, leading to pulmonary hypertension and respiratory insufficiency in the newborn. Anti-inflammatory drugs can reduce fetal platelet function and inhibit fetal renal function, resulting in oligohydramnios and anuria in the newborn. Anti-inflammatory drugs are contraindicated in the last three months of pregnancy. It is not clear whether aceclofenac can be secreted into human milk. Therefore, aceclofenac should not be used during breastfeeding unless the doctor deems it necessary. Precautions for the elderly: Generally, there is no need to reduce the dose, but the following situations should be noted: Elderly patients are generally more likely to experience side effects and should be used with caution. During treatment, many patients have no previous symptoms or obvious medical history, but severe gastrointestinal bleeding and/or perforation occurs. Elderly patients are more likely to suffer from renal, cardiovascular and liver damage.

1. Avoid using the following drugs together: NSAIDs inhibit the secretion of methotrexate in the renal tubules and may have slight metabolic interactions, resulting in reduced methotrexate clearance. Therefore, NSAIDs should always be avoided during high-dose methotrexate treatment. Some NSAIDs can inhibit the elimination of lithium salts in the kidneys, resulting in increased serum lithium concentrations. Unless serum lithium levels can be measured frequently, lithium salts should be avoided in combination. NSAIDs inhibit platelet aggregation and damage the gastrointestinal mucosa, which can increase the activity of anticoagulants and increase the risk of gastrointestinal bleeding in patients using anticoagulants. Unless close monitoring can be performed, aceclofenac should be avoided in combination with coumarin oral anticoagulants, ticlopidine, thrombolytic agents and heparin. 2. The following combined medications require dose adjustment or attention: When using low-dose methotrexate, attention should also be paid to the possibility of drug interactions between NSAIDs and methotrexate, especially in patients with renal insufficiency. If NSAIDs are used with methotrexate within 24 hours, caution should be exercised because methotrexate blood concentrations may increase, leading to increased toxicity. The use of NSAIDs with cyclosporine or tacrolimus increases the risk of nephrotoxicity due to decreased renal prostaglandin synthesis, so renal function should be closely monitored during combined therapy. Concomitant use of aspirin and other NSAIDs increases the incidence of side effects and should be used with caution. NSAIDs can reduce the diuretic effect of furosemide (diuretics) and bumetanide (diuretics), possibly by inhibiting prostaglandin synthesis. They can also reduce the antihypertensive effect of thiazides (diuretics). Concomitant use with potassium-sparing diuretics can increase potassium levels, so serum potassium should be monitored. Concomitant use of NSAIDs and ACE (angiotensin-converting enzyme) inhibitors increases the risk of acute renal failure in patients with dehydration. Although interactions with other antihypertensive drugs, such as β-receptor antagonists, cannot be ruled out, the combined use of aceclofenac and bendroflumethiazide (diuretic antihypertensive drug) has not been found to affect its blood pressure control. Other possible interactions: There are reports on hypoglycemic and hyperglycemic effects, respectively. Aceclofenac may cause hypoglycemia, and the dose of hypoglycemic drugs should be adjusted when used. No clinically significant differences in pharmacokinetics were observed after a single dose in patients with mild and moderate renal insufficiency. 3. Aceclofenac is mainly metabolized by cytochrome P4502C9, so there may be a risk of drug interactions with phenytoin, digoxin, cimetidine, tolbutamide, phenylbutazone, amiodarone, miconazole and sulfaphenazole. Like other NSAIDs, there is also a risk of drug interactions with drugs eliminated by renal excretion, such as methotrexate and lithium salts. Aceclofenac is actually completely bound to plasma proteins, and will then undergo a displacement effect with other highly protein-bound drugs, so attention must be paid.

Keep tightly closed in a cool place.

0.1 g

24 months.

XI'AN HAIXIN Pharmaceutical Co., Ltd.

• Founded in:

  1995-09-22

• Address:

  No. 20, Tuanjie South Road, Xi'an High-tech Development Zone

• Tax NO.:

  916101312944622939

• Registered Funds:

  $15 million

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