部份中文布洛芬钠处方资料（仅供参考）
药品英文名
Ibuprofen 
药理作用
本品为苯丙酸类非甾体抗炎镇痛药。具有较强的抗炎、抗风湿及解热镇痛作用，通过抑制前列腺素的合成，阻断炎症介质的释放而起作用。
特点为对血象及肾功能无明显影响，胃肠道刺激性小，体内无药物蓄积的趋向。用于风湿性关节炎，其消炎、镇痛、解热作用与阿司匹林、保泰松相似，比对乙酰氨基酚好，而对胃肠道的不良反应较轻，易为患者接受。
本品治疗痛风只起消炎、镇痛作用，并不能纠正高尿酸血症。对血小板的黏着和聚集反应有抑制作用，并延长出血时间。其抗炎作用与阿司匹林等效。用于类风湿性关节炎，本品每天0.8～1.6g和阿司匹林每天3～6g一样有效，而胃肠道的不良反应比阿司匹林少。治疗骨关节炎，本品像吲哚美辛一样有效而不良反应较少。
药动学
口服吸收快且完全，与食物同服时吸收减慢，但吸收量不减少。服药后1～2h血药浓度可达峰值，t1/24～5h;血药浓度波动较小，无药物蓄积的倾向。该药可缓慢透过滑膜腔，血药浓度降低后关节腔内仍能保持较高的浓度，并易透过胎盘和进入乳汁中，其血浆蛋白结合率为99%，主要经肝脏代谢，60%～90%经肾随尿排出，其中1%为原形物，少部分随粪便排出，进入乳汁者极少，本品可经直肠或皮肤吸收。无蓄积。
适应证
临床用于风湿性关节炎及类风湿性关节炎、骨关节炎、急性痛风、轻至中等度的疼痛（包括痛经)及各种原因引起的发热。
本品可用于减轻疼痛和炎症，如扭伤、劳损、腰痛、肩周炎、滑囊炎、肌腱炎、腱鞘炎，类风湿性关节炎及非类风湿性关节炎、骨关节炎，痛经、牙痛及术后疼痛。因本品对胃肠道的副不良反应比阿司匹林少，故适用于对阿司匹林不能耐受的患者。
禁忌证
1.阿司匹林或其他非甾体抗炎药过敏者，对本品可有交叉过敏反应。
2.孕妇及哺乳期妇女禁用。
3.哮喘、鼻息肉综合征及血管水肿患者禁用。
4.活动期消化性溃疡或有溃疡合并出血和穿孔者。
注意事项
1.慎用：
(1)支气管哮喘，用药后加重；
(2)心功能不全、高血压(可致水潴留、水肿)；
(3)血友病或其他出血性疾病(包括凝血障碍及血小板功能异常)。用药后出血时间延长，出血倾向加重：
(4)消化道溃疡病史。用药后易出现胃肠道不良反应，包括产生新的溃疡；
(5)肾功能不全。用药后肾功能不良反应增多，甚至导致肾衰竭。
2.药物对妊娠的影响：用于晚期妊娠妇女可使孕期延长，引起难产及产程延长。3.药物对检验值或诊断的影响：
(1)抑制血小板聚集，可使出血时间延长，但停药24h该作用即可消失；
(2)血尿素氮及血清肌酐含量升高，肌酐清除率可下降；
(3)氨基转移酶升高。
4.定期检查血象及肝、肾功能，
5.本药解热镇痛作用仅是对症治疗，应用时还应针对病因治疗。
6.应用阿司匹林或其他非甾体类抗炎药引起胃肠道不良反应的患者，可改用本药，但应密切注意不良反应。
7.有溃疡病史者使用本药，宜在严密观察或加用抗酸药物下服用。
8.治疗类风湿关节炎等多种慢性关节炎时，本药应与其他慢作用抗风湿药同用以控制类风湿关节炎的活动性及病情进展。
9.用药期间如出现胃肠出血、肝、肾功能损害、视力障碍、血象异常以及过敏反应等情况，即应停药。
10.用药过量者血浆浓度可达704mg/L而不出现任何中毒症状。约20%用药过量者在服药后4h出现中毒症状，包括：抽搐、昏迷、视物模糊、复视、眼颤、头痛、耳鸣、心率减慢、血压降低、腹痛、恶心、血尿、肾功能不全。用药过量应作紧急处理，包括催吐或洗胃，口服药用炭、抗酸药或(和)利尿药及其他支持疗法。
不良反应
1.恶心、呕吐、胃烧灼感或消化不良、胃痛或不适感（胃肠道刺激或溃疡形成)、头晕、过敏性皮疹等，发生率可达3%～9%；
2.皮肤瘙痒、下肢水肿或体重骤增、腹胀、便秘、腹泻、食欲减退或消失、头痛、耳鸣、精神紧张等，发生率可达1%～3%；
3.血便或柏油样便（胃肠道出血)、过敏性肾炎、膀胱炎、肾病综合征、肾乳头坏死或肾衰竭、荨麻疹、支气管痉挛、视力模糊、耳聋、肝功能减退、精神恍惚、嗜睡、失眠、心跳等，很少见，发生率小于1%。
4.服药过量可引起头痛、呕吐、嗜睡、低血压等。偶见胃肠道溃疡及出血、转氨酶升高。
用法用量
口服：
1.抗风湿：每次200～400mg，每天3次（类风湿关节炎比骨关节炎用量要大些)；2.轻或中等疼痛（包括痛经)的止痛：每次200～400mg，每4～6小时1次。
3.成人用药最大限量一般为每天2.4g。晚间服药可使疗效保持一夜，亦有有助于防止晨僵。
药物相应作用
1.与其他非甾体类抗炎药同用时增加胃肠道不良反应，并有致溃疡的危险。
2.长期与对乙酰氨基酚同用时可增加对肾脏的毒副作用。
3.与肝素、双香豆素等抗凝药及血小板聚集抑制药同用时，有增加出血的危险。
4.与维拉帕米、硝苯地平同时用，布洛芬的血药浓度增高。
5.可增高地高辛的血药浓度，同用时须注意调整地高辛的剂量。
6.可增强抗糖尿病药（包括口服降糖药)的作用。
7.与抗高血压药同用时可影响后者的降压效果，使各种降压药的降压作用减低。
8.丙磺舒可降低布洛芬的排泄，增高布洛芬血药浓度，从而增加毒性。
9.可降低甲氨蝶呤的排泄，增高甲氨蝶呤血药浓度，甚至可达中毒水平。
10.与阿司匹林或其他水杨酸类药物同用时，药效不增强，而胃肠道不良反应及出血倾向发生率增高。
11.与呋塞米同用时，后者的排钠和降压作用减弱。
12.本品可抑制苯妥英的降解。
13.饮酒或与其他抗炎药同用时，增加对胃肠道不良反应，并有致溃疡的危险。
临床研究
本品治疗痛风只起消炎止痛作用，并不能纠正高尿酸血症。用于风湿性关节炎的治疗，其消炎、镇痛作用与阿司匹林、保泰松相似，比对乙酰氨基酚好，而对胃肠道的不良反应轻，易为患者接受。本品对胃肠道不良反应比阿司匹林少，适用于阿司匹林不能耐受的患者。治疗骨关节炎，本品像吲哚美辛一样有效而不良反应较少。
包装规格
200毫克/片
2，3，4，5，6，8，10，12，15，16片/盒
生产厂家：（上市许可持有人）
利洁时保健（英国）有限公司

Nurofen 200mg Tablets
Reckitt Benckiser Healthcare (UK) Ltd
1. Name of the medicinal product
Nurofen 200 mg Tablets
2. Qualitative and quantitative composition
Ibuprofen 200 mg
Excipient(s) with known effect:
Sucrose
Sodium
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Coated Tablet
A white to off-white, biconvex, round, sugar coated tablet printed 'Nurofen' in black on one face.
4. Clinical particulars
4.1 Therapeutic indications
For the relief of migraine-headaches, backache, dental pain, neuralgia and period pains as well as rheumatic and muscular pains.
Nurofen relieves pain and reduces inflammation and temperature as well as relieving headaches and other types of pain. It also relieves cold and flu symptoms.
4.2 Posology and method of administration
For oral administration and short-term use only.
During short-term use, if symptoms persist or worsen the patient should be advised to consult a doctor.
Adults and children and adolescents between 12 and 18 years:
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).
If in children and adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.
If in adults the product is required for more than 10 days, or if the symptoms worsen the patient should consult a doctor.
Children and Adolescents between 12 and 18 years: Take 1 or 2 tablets with water, up to three times a day as required.
Adults: Take 1 or 2 tablets with water, up to three times a day as required.
Leave at least four hours between doses.
Do not take more than 6 tablets in any 24 hour period.
Not for use by children under 12 years of age.
4.3 Contraindications
Hypersensitivity to ibuprofen or any of the excipients in the product.
Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema, or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs.
Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
Severe heart failure (NYHA Class IV), renal failure or hepatic failure (see section 4.4)
Last trimester of pregnancy
4.4 Special warnings and precautions for use
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 and GI and cardiovascular risks below).
The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.
Respiratory:
Bronchospasm may be precipitated in patients suffering from, or with a previous history of, bronchial asthma or allergic disease.
Other NSAIDs:
The use of Ibuprofen with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5).
SLE and mixed connective tissue disease:
Systemic lupus erythematosus as well as those with mixed connective tissue disease – increased risk of aseptic meningitis (see section 4.8)
Renal:
Renal impairment as renal function may further deteriorate (see sections 4.3 and 4.8).
There is a risk of renal impairment in dehydrated children and adolescents
Hepatic:
Hepatic dysfunction (see sections 4.3 and 4.8)
Cardiovascular and cerebrovascular effects:
Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with NSAID therapy.
Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤1200mg/day) is associated with an increased risk of arterial thrombotic events.
Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided.
Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen (2400 mg/day) are required.
Impaired female fertility:
There is limited evidence that drugs which inhibit cyclo-oxygenase/ prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible upon withdrawal of treatment.
Gastrointestinal:
NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8).
GI bleeding, ulceration or perforation, which can be fatal has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of GI events.
The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available.
Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.
Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (see section 4.5).
When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn.
Dermatological:
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Ibuprofen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Advice for patients with sugar-related disorders:
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Advice for patients on a controlled sodium diet:
This medicinal product contains 1.1 mmol (or 25.3 mg) of sodium per 2 doses (2 tablets). To be taken into consideration by patients on a controlled sodium diet.
The leaflet will include:
The quantity of sodium contained in 2 tablets is approximately 1.1mmol, i.e. about 25.3 mg. This quantity is to be taken into consideration by patients on a controlled sodium diet.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
The label will include:
Read the enclosed leaflet before taking this product
Do not take if you:
• have (or have had two or more episodes of ) a stomach ulcer, perforation or bleeding
• are allergic to ibuprofen, to any of the ingredients, or to aspirin or other related painkillers
• are taking other NSAID pain killers or aspirin with a daily dose above 75mg
Speak to a pharmacist or your doctor before taking if you:
• have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney or bowel problems
• Are a smoker
• Are pregnant
If symptoms persist or worsen, or if new symptoms occur, consult your doctor or pharmacist.
4.5 Interaction with other medicinal products and other forms of interaction
Ibuprofen (like other NSAIDs) should be avoided in combination with:
Aspirin (Acetylsalicylic Acid): Concomitant administration of ibuprofen and acetylsalicylic acid is not generally recommended because of the potential of increased adverse effects unless low-dose aspirin (not above 75mg daily) has been advised by a doctor (see Section 4.4).
Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose aspirin (acetylsalicylic acid) on platelet aggregation when they are dosed concomitantly. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded. No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).
Other NSAIDs including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs as this may increase the risk of adverse effects (see section 4.4)
Ibuprofen should be used with caution in combination with:
Corticosteroids: as these may increase the risk of gastrointestinal ulceration or bleeding (see Section 4.4)
Antihypertensives and diuretics: since NSAIDs may diminish the effects of these drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor or Angiotensin II antagonist and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking a coxib concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter. Diuretics can increase the risk of nephrotoxicity of NSAIDs.
Anticoagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin (See section 4.4).
Ant-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4).
Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.
Lithium: There is evidence for potential increase in plasma levels of lithium.
Methotrexate: There is evidence for the potential increase in plasma levels of methotrexate.
Ciclosporin: Increased risk of nephrotoxicity.
Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.
Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.
Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk haemarthroses and haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.
Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.
4.6 Pregnancy and lactation
Pregnancy:
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryfoetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. During the first and second trimester of pregnancy, Nurofen should not be given unless clearly necessary. If Nurofen is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:
- cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
- renal dysfunction, which may progress to renal failure with oligohydroamniosis;
the mother and the neonate, at the end of the pregnancy, to:
- possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses;
- inhibition of uterine contractions resulting in delayed or prolonged labour.
Consequently, Nurofen is contraindicated during the third trimester of pregnancy.
Lactation/Breastfeeding:
In limited studies, ibuprofen appears in the breast milk in very low concentration and is unlikely to affect the breast-fed infant adversely.
See section 4.4 regarding female fertility.
4.7 Effects on ability to drive and use machines
None expected at recommended dose and duration of therapy.
4.8 Undesirable effects
Adverse events which have been associated with Ibuprofen are given below, listed by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
The list of the following adverse events relates to those experienced with ibuprofen at OTC doses for short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse events may occur.
The adverse events observed most often are gastrointestinal in nature. Adverse events are mostly dose-dependent, in particular the risk of occurrence of gastrointestinal bleeding is dependent on the dosage range and duration of treatment.
Clinical studies suggest that use of ibuprofen, particularly at a high dose 2400mg/day may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke), (see section 4.4).

System Organ Class	Frequency	Adverse Event
Blood and Lymphatic System Disorders	Very rare:	Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.
Immune System Disorders	Uncommon Very rare Not Known	Hypersensitivity reactions consisting of1: Urticaria and pruritus Severe hypersensitivity reactions. Symptoms could be facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). Respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea.
Nervous System Disorders	Uncommon Very rare	Headache Aseptic meningitis2
Cardiac Disorders	Not Known	Cardiac failure and oedema
Vascular Disorders	Not Known	Hypertension
Gastrointestinal Disorders	Uncommon Rare Very rare Not Known	Abdominal pain, nausea, dyspepsia Diarrhoea, flatulence, constipation and vomiting Peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis, gastritis Exacerbation of colitis and Crohn's disease (section 4.4).
Hepatobiliary Disorders	Very rare	Liver disorders
Skin and Subcutaneous Tissue Disorders	Uncommon Very rare	Various skin rashes Severe forms of skin reactions such as bullous reactions including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis can occur.
Renal and Urinary Disorders	Very rare Not Known	Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema. Renal insufficiency
Investigations	Very rare	Decreased haemoglobin levels

Description of Selected Adverse Reactions
1 Hypersensitivity reactions have been reported following treatment with ibuprofen. These may consist of (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract activity comprising asthma, aggravated asthma, bronchospasm, dyspnoea or (c) assorted skin disorders, including rashes of various types pruritus, urticaria, purpura, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
2The pathogenic mechanism of drug-Induced aseptic meningitis is not fully understood. However, the available data on NSAID-related aseptic meningitis points to a hypersensitivity reaction (due to a temporal relationship with drug intake, and disappearance of symptoms after drug discontinuation). Of note, single cases of symptoms of aseptic meningitis (such as stiff neck, headache, nausea, vomiting, fever or disorientation) have been observed during treatment with ibuprofen, in patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
4.9 Overdose
In children ingestion of more than 400mg/kg may cause symptoms. In adults the dose response effect is less clear cut. The half-life in overdose is 1.5-3 hours.
Symptoms:
Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning metabolic acidosis may occur and the prothrombin time/ INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.
Management:
Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.
5. Pharmacological properties
5.1 Pharmacodynamic properties
ATC Code: M01AE01
Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans, ibuprofen reduces inflammatory pain, swellings and fever. Furthermore, ibuprofen reversibly inhibits platelet aggregation.
Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose aspirin (acetylsalicylic acid) on platelet aggregation when they are dosed concomitantly. Some pharmacodynamics studies show that when single doses of ibuprofen 400mg was taken within 8 h before or within 30 min after immediate release aspirin (acetylsalicylic acid) dosing (81mg), a decreased effect of (acetylsalicylic acid) on the formation of thromboxane or platelet aggregation occurred. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded. No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 4.5).
5.2 Pharmacokinetic properties
Ibuprofen is rabidly absorbed following administration and is rapidly distributed throughout the whole body. The excretion is rapid and complete via the kidneys.
Maximum plasma concentrations are reached 45 minutes after ingestion if taken on an empty stomach. When taken with food, peak levels are observed after 1 to 2 hours. These times may vary with different dosage forms.
Elimination half-life is approximately 2 hours.
In limited studies, ibuprofen appears in the breast milk in very low concentrations.
5.3 Preclinical safety data
No relevant information, additional to that contained elsewhere in the SPC.
6. Pharmaceutical particulars
6.1 List of excipients
Tablet Core
Croscarmellose Sodium
Sodium Laurilsulfate
Sodium Citrate
Stearic Acid
Colloidal Anhydrous Silica
Sugar coat ingredients
Carmellose Sodium
French Chalk for Tablets (Talc)
Acacia Spray Dried
Sucrose
Titanium Dioxide
Macrogol 6000
Tablet printing
Black Printing Ink (solids)1
1Black Printing Ink contains shellac, Iron oxide black (E172) and propylene glycol
6.2 Incompatibilities
Not applicable
6.3 Shelf life
24 months
6.4 Special precautions for storage
Do not store above 25°C
Store in the original pack
6.5 Nature and contents of container
The tablets will be packed in blisters consisting of:
Push through laminate consisting of opaque, white 250 micron PVC heat-sealed to 20 micron aluminium foil
or
Push through laminate consisting of opaque, white 250 micron PVC with 40 gsm PVdC, heat-sealed to 20 micron aluminium foil.
The blisters are contained in a cardboard or plastic carton
2, 3, 4, 5, 6, 8, 10, 12, 15, 16 tablets
Not all packs will be marketed.
6.6 Special precautions for disposal and other handling
Not applicable
7. Marketing authorisation holder
Reckitt Benckiser Healthcare (UK) Ltd
Slough
SL1 4AQ
8. Marketing authorisation number(s)
PL 00063/0385
9. Date of first authorisation/renewal of the authorisation
15/07/2003
10. Date of revision of the text
09/11/2015