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                    <p style="text-align: center;"><img src="http://www.dinglu.com/uploads/uploads/image/2021/11/30/569344/%E6%96%B0%E7%99%80%E7%89%87.png" title="/uploads/image/2021/11/30/569344/新癀片.png" alt="新癀片.png"/></p><p><span style="color: rgb(192, 0, 0);">XINHUANG tablet instruction</span></p><p>Do please read the instruction carefully and use it with physician’s suggestion.</p><p>[<span style="color: rgb(192, 0, 0);">Medicine name</span>]</p><p>Proprietary name: XINHUANG Tablet</p><p>Chinese Pinyin: Xinhuang Pian</p><p>[<span style="color: rgb(192, 0, 0);">Main ingredients</span>] Herba Sarcandrae,Radix Et Rhizoma Notoginseng,Galculus Bovis,Pulvis Fellis Suis,Urena lobata Linn,Pearl Toffee,Pulvis Cornus Bubali Concentratus,Red Kojic,Indomethacin.</p><p>[<span style="color: rgb(192, 0, 0);">Description</span>] This product is light brownish gray to brown tablets. It smells fragrant and slightly fishy and tastes bitter.</p><p>[<span style="color: rgb(192, 0, 0);">Main functions and actions</span>] Relieving internal heat and deleting toxin, promoting blood circulation to dispel blood stasis, relieving swelling and stopping pain. It is applicable to noxious-heat-and-blood-stasis-induced swelling and sore throat, toothache, rheumatism, hypochondriac pain, jaundice and innominate toxic swelling.</p><p>[<span style="color: rgb(192, 0, 0);">Specification</span>] 0.32 gram per tablet (indomethacin 6.8mg per tablet)</p><p>[<span style="color: rgb(192, 0, 0);">Usage and Dosage</span>] Orally,To be taken 2~4 tablets at a time ,3 times a day, extenuation for children .For external use,mixed it unfiformity with cooled boiled water,daub on the affected part. </p><p>[<span style="color: rgb(192, 0, 0);">Adverse Reactions</span>]</p><p>1. Digestive system : pharyngeal dryness, oral mucosal erosion, dyspepsia, stomach discomfort, burning sensation, acid reflux, anorexia, nausea, vomiting, abdominal pain, diarrhea, abnormal liver function, gastrointestinal ulcer, bleeding, perforation, etc.</p><p>2. Skin and its appendages : various types of rash, pruritus, subcutaneous hemorrhage, etc. the most serious of which is bullous erythema multiforme.</p><p>3. Respiratory system : dyspnea, laryngeal edema, asthma, etc.</p><p>4. Allergic reactions : anaphylactic shock, vascular edema, etc.</p><p>5. Urinary system : hematuria, edema, urinary pain, renal insufficiency, etc.</p><p>6. Cardiovascular system : elevated blood pressure, chest tightness, etc.</p><p>7. Mental nervous system : dizziness, headache, anxiety, insomnia, etc., Serious people may have mental disorders or seizures, etc.</p><p>8. Blood system : aplastic anemia, leukopenia or thrombocytopenia resulting from suppression of the hematopoietic system, etc.  </p><p>9. Systemic: syncope, fatigue,pallor.</p><p>[<span style="color: rgb(192, 0, 0);">Contraindications</span>]</p><p>The patients who Active ulcers, gastrointestinal bleeding and medical history, ulcerative colitis and medical history, epilepsy, Parkinson 's disease and psychiatric patients, bronchial asthma,angioedema, liver and kidney dysfunction, the product, aspirin or other non-steroidal anti-inflammatory drug allergy banned ; pregnant women and lactating women are forbidden.</p><p>[<span style="color: rgb(192, 0, 0);">Points for attention</span>]</p><p>1. In order to reduce the irritation of drugs to the gastrointestinal tract, this product should be taken after meals or with food or antacid .</p><p>2. This product is a compound preparation of Chinese and Western medicine. When oral administration of this product, it should be avoided to be used simultaneously with non-steroidal anti-inflammatory drugs such as indomethacin.</p><p>3. This product is used for arthralgia, swollen sore throat, toothache, hypochondriac pain, jaundice, undefined swelling, etc. The daily dose should not exceed 12 tablets.</p><p>4. The antipyretic effect of the product is strong, and the dosage should not exceed 2 tablets at a time, not more than 3 times a day. During the antipyretic period, sweating and vacuity should be prevented, and sufficient liquid should be supplemented.</p><p>5.This product external attention : with cold water into a paste, evenly coated in the affected area, about 1mm thick, avoid ulceration, 2-3 times a day, Such as local skin allergies and other reactions should be discontinued.</p><p>6.The oral dosage of this product for children should be calculated according to body weight, 0.07 ~ 0.1g/kg per day, divided into 3 ~ 4 times, and reduced to the minimum dosage after effective.</p><p>7. Indomethacin is cross-allergenic with aspirin. Patients with wheezing caused by aspirin allergy can cause bronchospasm when using this product, and those allergic to other non-steroidal anti-inflammatory and analgesic drugs may also be allergic to this product.</p><p>8. Indomethacin could inhibit platelet aggregation and prolong the bleeding time. The effect lasted for one day after drug withdrawal,Blood urea nitrogen and serum creatinine levels often increased during medication.</p><p>9. The following situations should be used cautiously : 1. Indomethacin can cause sodium and water retention, so patients with cardiac insufficiency and hypertension should be used cautiously ; 2. Since indomethacin can prolong the bleeding time and aggravate the bleeding tendency, patients with hemophilia and other hemorrhagic diseases should be treated with caution. In addition, indomethacin can inhibit the hematopoietic system, and patients with aplastic anemia and neutropenia should also be treated with caution.</p><p>10. Regular follow-up examination should be conducted during medication : 1.emogram, liver and kidney functions ; 2. Individual  case report mentioned that indomethacin could lead to corneal sedimentation and retinal changes ( including macular disease ). Ophthalmic examination should be performed immediately if the vision was blurred.</p><p>[<span style="color: rgb(192, 0, 0);">Medication for pregnant and lactating women</span>] It is forbidden for pregnant and lactating women.</p><p>[<span style="color: rgb(192, 0, 0);">Children’s medication</span>] Children under 14 years old are generally not suitable for the application of this drug. If it must be taken, it should be reduced and closely observed to prevent the occurrence of serious adverse reactions.</p><p>[<span style="color: rgb(192, 0, 0);">Elderly medication</span>] Elderly patients are prone to renal toxicity, should be cautious.</p><p>[<span style="color: rgb(192, 0, 0);">Drug interaction</span>] The product contains indomethacin, and the possible drug interaction between the drug and the components of the product should be noted when combined with medication.</p><p>1.Long-term combined use with paracetamol can increase renal toxicity, and the incidence of peptic ulcer increases when combined with other non-steroidal anti-inflammatory drugs.</p><p>2. Aspirin can reduce the plasma concentration of indomethacin. This product cannot enhance the efficacy when used with aspirin or other salicylic acid salts, while the gastrointestinal side effects are significantly increased. Due to the enhanced inhibitory effect on platelet aggregation, it can increase the bleeding tendency.</p><p>3.Drinking alcohol or combined with cortical hormone and adrenocorticotropic hormone can increase the risk of gastrointestinal ulcer or bleeding.</p><p>4.When used in combination with digitalis drugs, indomethacin can increase the toxicity of digitalis by increasing its blood concentration ( inhibiting clearance from the kidney ), and therefore the dose of digitalis needs to be adjusted.</p><p>5.When combined with heparin, oral anticoagulants and thrombolytic drugs, indomethacin has a potential risk of increasing bleeding due to its competitive binding protein, which strengthens the anticoagulant effect and inhibits platelet aggregation.</p><p>6.Combined with insulin or oral hypoglycemic agents, indomethacin can strengthen the hypoglycemic effect, and the dose of hypoglycemic agents should be adjusted.</p><p>7.When used with loop diuretics, such as furosemide, indomethacin can weaken the latter's sodium excretion and antihypertensive effects.</p><p>8.Combined with Triamterene can cause renal dysfunction ( creatinine clearance rate decreased, azotemia ).</p><p>9.When combined with nifedipine or verapamil, the plasma concentrations of the latter two increased, and thus the toxicity increased.</p><p>10. Probenecid can reduce the clearance of indomethacin from kidney and bile, increase the blood concentration, increase the toxicity, and reduce the dosage when combined.</p><p>11. Combined use of colchicine and sulfinpyrazone can increase the risk of gastrointestinal ulcer and bleeding.</p><p>12. When used together with lithium salt, the excretion of lithium in urine can be reduced, the blood concentration can be increased and the toxicity can be increased.</p><p>13.Indomethacin can increase the plasma concentration of methotrexate and prolong the time of high blood concentration. If a patient who is using this product needs to do medium or high dose methotrexate treatment, this product should be stopped 24 to 48 hours before to avoid increasing its toxicity.</p><p>14. When used together with the antiviral drug zidovudine, indomethacin can reduce the clearance rate of the latter and increase the toxicity. At the same time, the toxicity of indomethacin also increases,Therefore, the combination of indomethacin should be avoided.</p><p>[<span style="color: rgb(192, 0, 0);">Storage</span>] Preserve in tightly closed containers.</p><p>[<span style="color: rgb(192, 0, 0);">Packing</span>] Pharmaceutical aluminum and plastic blister packaging, 12 tablets per sheet, 36 tablets per box or 48 tablets per box.</p><p>[<span style="color: rgb(192, 0, 0);">Period of Validity</span>] 36 months</p><p>[<span style="color: rgb(192, 0, 0);">Administer standard</span>] Chinese Pharmacopoeia 2015 edition Volume 1</p><p>[<span style="color: rgb(192, 0, 0);">Approval number</span>] GYZZ Z10940006</p><p>[<span style="color: rgb(192, 0, 0);">Marketing Authorization Holder</span>] Xiamen Traditional Chinese Medicine Co., Ltd.</p><p>Registered address: NO.97 BaiYun Road,Tong’an District,Xiamen City,Fujian Province</p><p>[<span style="color: rgb(192, 0, 0);">Manufacturing enterprise</span>]</p><p>Enterprise name: Xiamen Traditional Chinese Medicine Co., Ltd.</p><p>Production address: NO.97 BaiYun Road,Tong’an District,Xiamen City,Fujian Province</p><p>Postcode: 361100</p><p>Tel: 0592-7266588</p><p>Fax: 0592-7266567</p><p>Registered address: NO.97 BaiYun Road,Tong’an District,Xiamen City,Fujian Province</p><p><br/></p>
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