Bupropion Granules Instructions
Please read the instructions carefully and use as directed or purchase and use under the guidance of a pharmacist
Warning: for other Not recommended for those with hypersensitivity to other NSAIDs. Contraindicated in pregnant and lactating women.
Allergy to aspirin Contraindicated in patients with asthma.
[Drug Name]
Generic Name: Ibuprofen Granules
Trade name: Enzyme
English Name:Ibuprofen Granules
Hanyu Pinyin:Buluofen Keli
[Ingredients]
This product contains the main ingredient ibuprofen0.2g. The excipients are: lactose, microcrystalline cellulose, silicon dioxide, sodium carboxymethyl starch, aspartame, povidoneK30.
[Properties]This product is white or light yellow granules with aromatic smell.
[Category of action] This product is an over-the-counter drug in the category of antipyretic and analgesic.
[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.
[Specifications] Each tablet contains ibuprofen0.2. family:Arial”>g.
[Usage and Dosage] Take with warm water,4. family:Arial”>to8year-old children, once. family:Times New Roman”>0.5packs;88packs “font-family:Arial”>for children and adults over 8 years of age, one1package at intervals if pain or fever persists 4to6hour repeat dose1times,24hours not to exceed4times.
[Adverse Reactions]
Originator Reported17485of the total cases, adverse reactions occurred532cases (3.04%)690 visits, mainly digestive (upset stomach, loss of appetite, abdominal pain, nausea/vomiting, etc:2.99% ), rash (0.20%), pruritus (0.14%), facial edema (0.15%), etc.
1.Important Adverse effects
(1)Shock, allergy-like symptoms
Possible for shock, allergy-like symptoms (both unknown frequency*), therefore, adequate observation should be made, discontinue the drug and take appropriate measures when symptoms such as chest tightness, chills, cold sweats, dyspnea, numbness of extremities, decreased blood pressure, angioedema, and urticaria occur.
(22 span>)Aplastic anemia, hemolytic anemia, granulocytopenia, thrombocytopenia
There is a risk of aplastic anemia, hemolytic anemia, granulocytopenia, and thrombocytopenia (all at unknown frequency*), therefore adequate observation should be made, discontinue the drug if abnormalities are detected, and take appropriate measures.
(3) span>)Peptic ulcer, gastrointestinal bleeding, ulcerative colitis
Peptic ulcer, gastrointestinal bleeding, and ulcerative colitis are possible (both of unknown frequency*), discontinue medication if abnormalities are detected, and take appropriate action.
(4) span>)Toxic Epidermal Necrolysis (Toxic Epidermal Necrolysis:TEN), Cutaneous Mucocutaneous Eye Syndrome (Stevens-JohnsonSyndrome)Syndrome family:Times New Roman”>
There is a risk of toxic epidermolysis bullosa (Toxic Epidermal Necrolysis:TEN), cutaneous mucocutaneous eye syndrome (Stevens-Johnson syndrome) (all frequencies unknown*) and therefore should be adequately observed and acted upon.
(5)Acute renal failure, interstitial nephritis, nephrotic syndrome
There is a risk of acute renal failure, interstitial nephritis, and nephrotic syndrome (all with unknown frequency*) and therefore should be adequately observed for the development of oliguria, hematuria, urinary protein, BUN/elevated blood creatinine, hyperkalemia, hypoproteinemia, etc. Discontinue the drug and take appropriate measures.
(6) span>)Aseptic meningitis
There is a risk of aseptic meningitis (frequency unknown*) and should therefore be adequately observed for the development of neck stiffness, fever, headache, vomiting/ discontinue the medication and take appropriate action if symptoms such as nausea or confusion occur.
[InSLE (systemic lupus erythematosus) orMCTD(mixed connective tissue disease) patients are particularly susceptible to aseptic meningitis. ]
(7)Liver function disease, jaundice
There is a risk of liver function disorders (jaundice,AST(GOT)elevation,ALT(GPT)elevated,gamma-GTPelevated, etc.), and fulminant hepatitis (all of unknown frequency). span>*), so adequate observation should be made, discontinue the drug if abnormalities are detected, and take appropriate measures.
(8) span>)Asthma attack
There is a risk of triggering an asthma attack (frequency unknown*), so discontinue the medication and take appropriate measures when symptoms such as shortness of breath and dyspnea occur.
2.Other adverse reactions
Frequency
Category0.1~5%≤0.1%Frequency unknown*Blood Decreased platelet function (prolonged bleeding time)Digestive SystemLack of appetite, nausea/vomiting, upset stomach, abdominal pain, indigestion, diarrheaThirst, stomatitis, bloating, constipation Liver AST(GOT)elevated,ALT(GPT) Elevation,Al-P Elevation, etc.Jaundice**Allergies**Rash, itchingHives, eczemapurpleSensory organs Blurred vision and other visual abnormalities**Deafness, tinnitus, abnormal tastePsychoneurologyHeadache, drowsiness, vertigo, insomnia depressionCardiovascular System Increased blood pressure, palpitationsLower blood pressureotherOedemaFatigue, feverNose bleeds*: The frequency of adverse reactions spontaneously reported by the originator product or occurring abroad is unknown.
**: Occurrence of Discontinue medication in case of adverse reactions.
A few patients may experience nervousness; rare bronchospasm, etc.
[Contraindication]
1.Patients with peptic ulcer (refer to [ Precautions]) [Potential to exacerbate peptic ulcer due to reduced gastric mucosal defenses from prostaglandin synthesis inhibition];
2.Severe blood Patients with blood abnormalities [may develop adverse reactions such as blood disorders and therefore have the potential to further worsen blood abnormalities];
3.Severe Patients with liver dysfunction [may experience adverse reactions such as liver disease and therefore risk further deterioration of liver disease];
4.Severe renal Patients with severe renal impairment [with the potential to further worsen renal disease due to prostaglandin synthesis inhibition resulting in decreased renal blood flow, etc.]
5.Severe Patients with cardiac insufficiency [which may be further worsened by water and sodium retention due to prostaglandin synthesis inhibition];
6.Severe Patients with hypertension [water and sodium retention due to prostaglandin synthesis inhibition, thus risking further increase in blood pressure];
7.Patients with a prior history of hypersensitivity to the Patients with a prior history of hypersensitivity to the components of this product;
8.Patients with hypersensitivity to other Allergic to other NSAIDs;
9.Have aspirin patients with aspirin asthma (triggering asthma attacks caused by non-steroidal anti-inflammatory analgesics, etc.) or their past medical history [which may trigger asthma attacks], and patients with asthma who are allergic to aspirin;
10.Patients using zidovudine [cf. Patients on zidovudine [refer to [Drug Interactions]];
11.Pregnant and Pregnant and lactating women are prohibited. .
[Caution]
1.Use with caution ( Use with caution in the following patients)
(11)Among patients with peptic ulcer due to long-term use of NSAIDs that require long-term use of this product and who are receiving misoprostol[The indication for misoprostol is peptic ulcers caused by NSAIDs, but there are also treatment-resistant peptic ulcers to misoprostol, so the process should be fully observed and used with caution when using this product long-term. span>];
(2)Patients with a prior history of peptic ulcer[have the potential to relapse peptic ulcers];;
(3)Patients with blood abnormalities or their past history[have the potential to worsen or relapse hematologic abnormalities];
(4)Patients with bleeding tendency[ May cause decreased platelet function and therefore may exacerbate bleeding tendencies];
(5)Patients with liver disease or its past history[have the potential to worsen or relapse liver disease];;
(6)Patients with renal disease or its past history or reduced renal blood flow[have the potential to worsen or relapse kidney disease];; =”font-family:Times New Roman”>
(7)Patients with cardiac abnormalities[have May worsen abnormal heart function];
(8)[People with hypertensionhave the potential to raise blood pressure];;
(9)Patients with a prior history of allergy;
(10)Bronchial asthma patients[ Bronchial asthma patients also include aspirin asthma patients, potentially leading to asthma attacks in these patients];
(11)Systemic lupus erythematosus (SLE) patients[have the potential to makeSLEsymptoms (renal disease, etc.) may worsen. Moreover, there is a risk of aseptic meningitis];;
(12)Patients with mixed connective tissue disease[have the potential to cause aseptic meningitis];
(13)Patients with ulcerative colitis[ worsened by the use of other NSAIDs for analgesia has been reported];
(14)Crohn’s disease patients[have reports of worsening of symptoms with other NSAIDs];
2. Important Basic Notes
(1)Please note that treatment with anti-inflammatory analgesics is not allopathic; it is an allopathic medicine and should not be used for prolonged or large amounts for pain relief for more than5days and for relieving fever not more than3day, if symptoms are not relieved, consult your physician or pharmacist.
(2) span>)When using this product to relieve pain from chronic diseases, the following should be noted;
1) Long-term use Regular laboratory tests (urinalysis, hematology and liver function tests, etc.) are required when this product is used. If abnormalities are found, take immediate measures such as dose reduction or discontinuation;
2) should consider drug therapy other than drug therapy.
(33 span>)When using this product to relieve pain from acute illness, the following should be noted;
1) First analyze the acute inflammation, pain, and fever before administering medication;
2) In principle, avoid long-term use of the same drug;
3) If there is a cause-specific treatment method should be used.
(44 span>) Adequately observe the patient’s status and watch for adverse reactions. There is a risk of hypothermia, deficiency, and cold hands and feet, especially in children and elderly patients with hyperthermia or wasting disease, and the patient’s status needs to be adequately observed after administration;
(5) span>) may cause occult infections and should therefore be used in combination with appropriate antibacterial agents for the treatment of infectious inflammation, with adequate observation and caution;
(6) span>) should be avoided in combination with other anti-inflammatory and analgesic drugs;
(7)Do not consume alcohol or beverages containing alcohol while taking this product;
(8) span>)If overdose or serious adverse reactions occur, seek immediate medical attention;
(9) span>)) is contraindicated in cases of hypersensitivity to this product;
(10) span>)The use of this product is prohibited when its properties are changed;
(11)Keep this product out of the reach of children;
(12) span>) must be used by children under adult supervision;
(13) Children must be supervised by an adult. span>)If you are using other drugs, please consult your physician or pharmacist before using this product;
(14) span>)If gastrointestinal bleeding or ulcers, chest pain, shortness of breath, weakness, or slurred speech occur, discontinue the drug and consult your physician.
3.Other notes
Transient infertility has been reported in women who use NSAIDs for long periods of time for analgesia.
[Drug Interactions]
This product is mainly metabolized by hepatic enzymes CYP2C9for metabolism.
1.Contraindications to co-administration (Prohibited co-administration)
Drug names, etc.Clinical symptoms and managementMechanisms and risk factorsZidovudin(Rituxan)has been reported to enhance the bleeding tendency in patients with hemophilia. The mechanism is unknown. 2.Caution on collocation (note collocation)
Drug names, etc.Clinical symptoms and managementMechanisms and risk factorsCoumarin-based anticoagulants such as warfarinHas the potential to potentiate the effects of coumarin-based anticoagulants (warfarin). The dosage should therefore be adjusted with care. This product binds competitively with plasma proteins of warfarin and free warfarin is increased. Aspirin preparations (when used as an antiplatelet agent)Aspirin has been reported to weaken platelet aggregation inhibition. This product is thought to inhibit platelet cyclooxygenase-1(COX-1) in combination with aspirin. Anticoagulants such as warfarin
Antiplatelet agents such as clopidogrel
Selective5-hydroxytryptamine reuptake inhibitors (SSRI) fluvoxamine, paroxetine, and othersThere is a risk of increased gastrointestinal bleeding. Has the potential to enhance interactions. Lithium formulations such as lithium carbonateThere have been reports of elevated blood lithium concentrations and lithium toxicity, so the combination should be observed adequately, such as monitoring blood lithium concentrations, and administered with caution. Due to the inhibitory effect of this product on prostaglandin synthesis, resulting in decreased renal sodium excretion, decreased lithium clearance, and increased lithium concentrations in blood. Thiazide diuretics such as hydrochlorothiazide
Tab diuretics such as tachyphylaxisThe report noted that weakening the effects of these diuretics. Water and sodium retention in vivo due to the inhibitory effect of this product on prostaglandin synthesis. ACEInhibitors such as Enalapril
βreceptor blockers such as propranololHas the potential to weaken the antihypertensive effect. Vasodilation and water and sodium excretion are inhibited due to the inhibitory effect of this product on prostaglandin synthesis. Tacrolimus hydrateAcute renal failure has been reported. Nephritic damage of tamoxifen hydrate is exacerbated by the prostaglandin synthesis-inhibiting effect of this product. New quinolone antibacterial agents such as enrofloxacin hydrateThere have been reports of spasticity caused by the combination of other NSAIDs for analgesia. Co-administration enhances neoquinolone antimicrobialGABAinhibition. MethotrexateIt may enhance the effect of methotrexate, so care should be taken to adjust the dosage, etc. The inhibition of prostaglandin synthesis by this product results in decreased renal blood flow, inhibition of renal excretion of methotrexate, and increased blood concentrations of methotrexate. DeglutethimideIt is possible to reduce the blood concentration of this product. Decholamine is an anion-exchange resin that binds to this product in the digestive tract and retards/inhibits the absorption of this product. Sulfonylurea hypoglycemic agents such as chlorosulfonylurea and glibenclamideHas the potential to enhance the hypoglycemic effect (hypoglycemia), so care should be taken to adjust the dosage. The product binds competitively to the plasma proteins of these drugs, and free form drug is increased. forCYP2C9inhibiting drugs such as voriconazole, fluconazoleIt is possible to elevate blood concentrations of this product. These drugs inhibit the metabolic enzymes of this product (CYP2C9). 1)This product can increase gastrointestinal side effects and may cause ulcers when used with other antipyretic, analgesic, and anti-inflammatory drugs.
2) This product is used in combination with When used with furosemide (furanilic acid), the sodium excretion and antihypertensive effect of the latter is reduced; when used with antihypertensives, the antihypertensive effect of the latter is also reduced.
3) This product, when used with The concomitant use of digoxin can increase the blood concentration of these drugs and should not be used together.
4) If used with other (4)If used in conjunction with other drugs, drug interactions may occur.
[Pharmacological action] This product inhibits the synthesis of prostaglandins and has analgesic, antipyretic and anti-inflammatory effects. This product is rapidly absorbed orally.
1. Anti-inflammatory effects
Acute inflammatory effects of this product on ultraviolet erythema (guinea pigs) and keratocystis edema (rats)ID50(administered orally) respectively4.4 mg/kg, 22 mg/kg, with aspirin (ID50are115 mg/Kg, 200 mg/Kg) showed stronger anti-inflammatory effects compared to At 10-30mg/kg/day doses it inhibited chronic inflammation in adjuvant arthritis with an effect that was greater than that of aspirin. span>5 to 10fold.
2. Analgesic effect
Rats given transoral2 to 30 mg/kgof this product on inflammatory pain in the footpad (Randall- Selitto method) with analgesic effect of aspirin30fold. The ID50 (administered orally) for acetylcholine-induced elevation (in mice) was1.9mg/kg, which is 1.9mg/kg, the effect of aspirin New Roman”>28 times more effective than aspirin.
3. Antipyretic effect
Given orally to rats5-10mg/kgof this product significantly inhibited the fever induced by the injectable yeast suspension, and the effect was 2020 of that of aspirin. Roman”>20fold.
[Storage]at room temperature. [Packaging][Packaging span>Laminated film for pharmaceutical packaging, per box10pack; each box12pack; each box15packs or 20packs per boxpacks. [Expiration date]18months[Executive Standard]
[Approval number]State Drug CertificateH10950286
[Instruction revision date]
[Manufacturer]
Company Name: Ha Pharmaceutical Group Shiyang Pharmaceutical Factory
Production Address: Airport Road, Daoli District, Harbin838No.
Postal Code:150078
Tel:0451-86386877
Fax Number:0451-84667676
Website:http:// www.shiyitang.com
Contact the manufacturer if you have any questions