Class A
Ibuprofen Extended Release Capsules Instructions
Please read the instructions carefully and use according to the instructions or buy and use under the guidance of a pharmacist.
Drug Name
Generic Name: Ibuprofen Sustained-release Capsules
English name: Ibuprofen Sustained-release Capsules
Hanyu Pinyin：Buluofen Huanshijiaonang
Ingredients
Each capsule contains 0.3g of ibuprofen, the main ingredient. Excipients: sucrose, starch, dextrin, povidone K30, stearic acid.
Properties]
The contents of this product are white spherical pills.
Acting category]
This product is an antipyretic and analgesic class of non-prescription drugs.
Indications
For the relief of mild to moderate pain such as headache, joint pain, migraine, toothache, muscle pain, neuralgia, dysmenorrhea. It is also used for fever caused by common cold or influenza.
Specification
0.3g
Dosage]
Take orally. Adults take 1 capsule once, 2 times a day (once in the morning and once in the evening).
Adverse reactions
1. A few patients may experience nausea, vomiting, abdominal pain, diarrhea, constipation, gastrointestinal gas, heartburn or mild indigestion, gastrointestinal ulcers and bleeding, elevated transaminases, headache, dizziness, tinnitus, blurred vision, nervousness, drowsiness, lower limb edema or sudden weight gain.
2. Rare rash, urticaria, pruritus. Very rare severe allergic skin reactions, exfoliative dermatitis, Stevens Johnson Syndrome or maculopapular dermatoses such as erythema multiforme and epidermolysis bullosa.
3. Rare allergic nephritis, cystitis, nephrotic syndrome, renal papillary necrosis, or renal failure, with particular attention to long-term use, usually accompanied by elevated serum urea levels and edema. Rarely, bronchospasm and exacerbation of asthma.
4. A prior history of intestinal disease, such as ulcerative colitis and Crohn’s disease, may aggravate the condition.
5. Very rare hematopoietic disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, granulocyte deficiency with initial symptoms of fever, sore throat, superficial oral ulcers, flu-like symptoms, severe fatigue, unexplained bruising or bleeding) or liver disease, hepatic failure, hepatitis.
6, Very rare severe allergic reactions, symptoms include: facial, lip, tongue and throat edema, dyspnea, tachycardia, hypotension (allergic reaction, angioedema or shock).
7, Treatment with NSAIDs has been reported with edema, hypertension, fluid retention and heart failure.
8.In patients with autoimmune diseases, (e.g. systemic lupus erythematosus, mixed connective tissue disease) there have been isolated cases of symptoms of aseptic meningitis, such as neck stiffness, headache, nausea, vomiting, fever or confusion during ibuprofen treatment.
9. Discontinue immediately and consult a physician if the following symptoms occur: allergic reactions, such as rash and itching, sometimes accompanied by dyspnea or edema of the lips, tongue, throat or face; rash, peeling and mouth ulcers; aggravation of asthma; gastric ulcers, vomiting of blood or brown residue (like coffee grounds), or passing black tarry stools; aggravation of intestinal disease (ulcerative colitis or Crohn’s disease); unexplained bruising or bleeding fever, sore throat, mouth ulcers, extreme pallor or weakness; meningitis (symptoms may include neck stiffness, headache, nausea, vomiting, fever, or feeling confused; especially if you have an autoimmune disease (e.g., systemic lupus erythematosus, mixed connective tissue disease); less or more urine than usual, cloudy urine, blood in your urine, or pain and/or swelling in your back (especially in your legs) ); feeling breathless or swollen legs and feet, chest pain, sudden unilateral weakness, sudden slurred speech; developing liver problems, such as jaundice, symptoms may include yellowing of the skin and whites of the eyes.
[Contraindications
1. Contraindicated for those who are allergic to ibuprofen, excipients in this product, aspirin or other non-steroidal anti-inflammatory drugs.
2, Pregnant and lactating women are prohibited.
3.It is prohibited for asthma patients who are allergic to aspirin.
4, Contraindicated in patients with liver disease, kidney disease and heart disease.
5. Contraindicated in patients taking other drugs containing ibuprofen or other NSAIDs, including those taking drugs known to be specific cyclooxygenase-2 inhibitors. Unless recommended by a physician.
6, Contraindicated in patients with a history of prior upper gastrointestinal bleeding or perforation associated with treatment with NSAIDs.
7. Contraindicated in patients with active or prior history of peptic ulcer, gastrointestinal bleeding or perforation.
Precautions】
1.This product is a symptomatic treatment drug, self-medication should not be used for a long time or in large quantities, for pain relief should not exceed 5 days, for fever relief should not exceed 3 days, if the symptoms are not relieved, please consult a physician or pharmacist.
2. This product is best taken during or after a meal.
3.It is prohibited for those who are allergic to this product and other antipyretic, analgesic and anti-inflammatory drugs. Use with caution for allergic persons.
4.If rash, mucous membrane damage or allergic symptoms appear when using this product for the first time, stop taking it and consult a physician.
5. Must be swallowed whole, not opened or dissolved.
6.Do not chew or suck the extended-release capsule, because this will destroy its extended-release effect.
7, can not be taken at the same time other drugs containing antipyretic and analgesic (such as some compound anti-cold drugs).
8. Do not drink alcohol or beverages containing alcohol while taking this product.
9.Patients with gastrointestinal disease should consult a physician or pharmacist before use.
10, patients with the following conditions should be used with caution and under the guidance of a physician: over 60 years of age, patients with bronchial asthma (may cause bronchospasm) and allergic diseases, coagulation or platelet dysfunction (such as hemophilia or other bleeding disorders), gastrointestinal discomfort, recent gastric surgery, ulcerative colitis or Crohn’s disease, cardiac insufficiency 11, hypertension, have been notified of arterial stenosis (symptoms include calf pain during exercise or mini-stroke), have systemic lupus erythematosus or mixed connective tissue disease, immune system disorders resulting in joint pain, skin changes and other organ conditions in patients (due to increased risk of aseptic meningitis).
11. If gastrointestinal bleeding or ulcers, liver or kidney impairment, cloudy urine or blood in urine, back pain, visual or hearing impairment, abnormal blood picture, chest pain, shortness of breath, weakness, or slurred speech occur, discontinue the drug and consult a physician.
12.In patients with a history of ulcers, especially with bleeding or perforation, and in elderly patients, increasing the dose of NSAIDs can increase the risk of gastrointestinal bleeding, ulcers or perforation.
13. As with other NSAIDs, long-term administration of ibuprofen can lead to renal papillary necrosis and other renal pathological changes. Nephrotoxicity has been observed in patients in whom renal prostaglandins play a compensatory role in maintaining renal perfusion. In these patients, administration of NSAIDs may lead to a dose-dependent decrease in prostaglandin synthesis and result in decreased renal blood flow, which exacerbates renal compensatory dysregulation. The risk of this reaction is highest in patients with renal impairment, in patients with heart failure, in patients with hepatic dysfunction, in patients taking diuretics and angiotensin-converting enzyme inhibitors, and in elderly patients. It usually returns to pre-treatment status after discontinuation of NSAID therapy.
14. Use the lowest possible dose of this product and the shortest possible duration of treatment to relieve symptoms. Ibuprofen may slightly increase the risk of heart attack or stroke. The possibility of such risk increases when high doses and long-term treatment are used.
15. This ibuprofen capsule preparation is for adults only. do not take in children under 12 years of age.
16.Women preparing for pregnancy should use with caution or under the guidance of a physician because ibuprofen is a non-steroidal anti-inflammatory drug that has the potential to impair female fertility but is reversible after discontinuation.
17.Do not overdose, if overdose or serious adverse reactions occur, you should seek medical attention immediately.
18.Prohibit the use of this product when its properties change.
19.Please keep this product out of the reach of children.
20.If you are using other drugs, please consult your doctor or pharmacist before using this product.
Drug Interactions
1. This product can increase gastrointestinal adverse reactions when used with other antipyretic, analgesic and anti-inflammatory drugs, and may lead to ulcers.
2. When used with heparin, bicoumarins (such as warfarin) and other anticoagulants, it may lead to prolongation of prothrombin time and increase bleeding tendency.
3.When this product is used with digoxin, methotrexate and oral hypoglycemic drugs, it can increase the blood concentration of these drugs and should not be used together.
4.When this product is used with furosemide (furanilic acid), the sodium excretion and antihypertensive effect of the latter will be weakened; when used with anti-hypertensive drugs, the antihypertensive effect of the latter will also be reduced.
5.Interaction between ibuprofen and aminoglycosides, glucocorticoids, anti-platelet drugs such as aspirin, cyclosporine, CYP2C9 inhibitors (such as voriconazole and fluconazole), diuretics, lithium, quinolones, zidovudine and selective 5-hydroxytryptamine reuptake inhibitors has been reported, and should be used with caution or under the guidance of physicians.
6. Drug interactions may occur if used in combination with other drugs, please consult your physician or pharmacist for details.
Pharmacological effects]
This product can inhibit the synthesis of prostaglandins, with analgesic, antipyretic and anti-inflammatory effects. It is an extended release dosage form, which allows the drug to be released gradually in the body. Each dose can last 12 hours for pain relief.
Storage】 Keep in sealed.
Package】 Aluminum foil and polyvinyl chloride/polyvinylidene chloride solid pharmaceutical compound blister, 12 capsules per plate, 2 plates per box.
Expiration date】 24 months
Execution Standard
Approval Number】
Date of revision of instruction
[Drug Marketing Licensee
Name: Nanjing Yiheng Pharmaceutical Co.
Registered Address: No. 22, Tianpu Road, Jiangbei New District, Nanjing
Manufacturer
Company Name: Nanjing Yiheng Pharmaceutical Co.
Address: No. 22, Tianpu Road, Jiangbei New District, Nanjing
Postcode：211800
Telephone number: 025-58286666
Fax number: 025-58288000
Website: http://www.easeheal.com
If you have any questions, please contact with the manufacturer