Skip to Content

UK Edition. Click here for US version.

BOOTS IBUPROFEN TABLETS 200MG

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Ibuprofen 200mg tablets Boots Ibuprofen Tablets 200mg

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200mg Ibuprofen. Excipients: Each tablet contains: 100.28 mg sucrose For a full list of excipients, see section 6.1

3

PHARMACEUTICAL FORM
Coated tablet Round white sugar coated tablet

4.
4.1.

CLINICAL PARTICULARS
Therapeutic indications
For the relief of rheumatic or muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness. Ibuprofen 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. The tablets should be swallowed whole with a drink of water. Adults, the elderly and children over 12years: The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days.

200mg-400mg (1-2 tablets) to be taken up to 3 times a day as required. Leave at least four hours between doses and do not take more than 1200mg (6 tablets) in any 24 hour period. Children under 12 years of age: Not recommended.

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 antiinflammatory 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, relating to previous NSAIDs therapy. Severe heart failure, renal failure or hepatic failure (see section 4.4) Last trimester of pregnancy (see section 4.6)

4.4.

Special warnings and precautions for use
Undesirable effects may be minimised by using the lowest effective dose for the shortest possible duration necessary to control symptoms (see 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 due to the increased risk of ulceration or bleeding and other side effects. (see section 4.5). SLE and mixed connective tissue disease: Systemic lupus erythematosus (SLE) and mixed connective tissue disorders- increased risk of aseptic meningitis (see section 4.8) Renal: Renal impairment as renal function may further deteriorate (see section 4.3 and 4.8). 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 mild heart failure as fluid retention; hypertension and oedema have been reported in association with NSAID therapy. Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at a high dose (2400mg daily) and in long term treatment 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 daily) is associated with an increased risk of myocardial infarction.

Impaired female fertility: There is limited evidence that drugs which inhibit cyclooxygenase/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, Crohns disease) as these 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 serious 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 when 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 of other sign of hypersensitivity. This medicine contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine. The label will include: Read the enclosed leaflet before taking this product.



Do not use if you: have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding are allergic to Ibuprofen or any other ingredient of the product, aspirin or other related painkillers are taking other NSAID painkillers, 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 should be avoided in combination with: Aspirin: Unless low-dose aspirin (not above 75mg daily) has been advised by a doctor, as this may increase the risk of adverse reactions (see section 4.4). Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and 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: Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin (see section 4.4) Anti-hypertensives and diuretics: NSAIDs may diminish the effect of these drugs. Diuretics can increase the risk of nephrotoxicity of NSAIDs. Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see section 4.4). Anti-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 increases in plasma levels of lithium. Methotrexate: There is a potential for an increase in plasma 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 of 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 embryo-foetal 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, Ibuprofen should not be given unless clearly necessary. If Ibuprofen 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 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, Ibuprofen is contraindicated during the third trimester of pregnancy. In limited studies, Ibuprofen appears in 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 doses and duration of therapy.

4.8.

Undesirable effects
Hypersensitivity reactions have been reported and these may consist of (a) nonspecific allergic reactions and anaphylaxis, (b) respiratory tract reactivity, eg asthma, aggravated asthma, bronchospasm, dyspnoea, (c) various skin reactions, e.g. pruritus, urticaria, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme)

The following list of adverse effects relates to those experienced with ibuprofen at OTC doses, for short-term use. In the treatment of chronic conditions, under longterm treatment, additional adverse effects may occur. Hypersensitivity reactions: Uncommon: hypersensitivity reactions with urticaria and pruritus Very rare: severe hypersensitivity reactions. Symptoms could be: facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock) Exacerbation of asthma and bronchospasm Gastrointestinal: The most commonly observed adverse events are gastrointestinal in nature. Uncommon: abdominal pain, nausea and dyspepsia Rare: diarrhoea, flatulence, constipation and vomiting Very rare: peptic ulcer, perforation or gastrointestinal haemorrhage, malaena, haematemesis, sometimes fatal, particularly in the elderly, ulcerative stomatitis, gastritis Exacerbation of ulcerative colitis and Crohns disease (see section 4.4) Nervous system: Uncommon: headache Vary rare: aseptic meningitis single cases have been reported very rarely Renal: Very rare: acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema Hepatic: Very rare: liver disorders Haematological: 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. Dermatological: Uncommon: various skin rashes Very rare: severe forms of skin reactions such as bullous reactions, including Stevens Johnson syndrome, erythema multiforme and toxic epidermal necrolysis can occur. Immune system: In patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed (see section 4.4).

Cardiovascular and cerebrovascular: Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. Clinical trial and epidemiological data suggest that use of ibuprofen (particularly at high doses 2400mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

4.9

Overdose In children ingestion of more than 400 mg/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.
5.1.

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
ATC code: M01A E01, Anti-inflammatory and anti-rheumatic products, non-steroids, Propionic acid derivatives. Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy be inhibition of prostaglandin synthesis. In humans ibuprofen reduces inflammatory

pain, swellings and fever. Furthermore, ibuprofen reversibly inhibits platelet aggregation. Clinical evidence demonstrates that when 400 mg of ibuprofen is taken the pain relieving effects can last for up to 8 hours. Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400mg was taken within 8 h or within 30 min after immediate release aspirin dosing (81mg), a decreased effect of ASA on the formation of thromboxane or platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use.

5.2. Pharmacokinetic properties
Ibuprofen is rapidly 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. Ibuprofen is metabolised in the liver to two major metabolites with primary excretion via the kidneys, either as such or as major conjugates, together with a negligible amount of unchanged ibuprofen. Excretion by the kidney is both rapid and complete. The elimination half life of ibuprofen is approximately 2 hours. No significant differences in pharmacokinetic profile are observed in the elderly. In limited studies ibuprofen appears in the breast milk in very low concentrations.

5.3

Preclinical safety data There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.

6
6.1

PHARMACEUTICAL PARTICULARS
List of excipients Tablet Core Colloidal anhydrous silica Potato Starch Povidone Microcrystalline cellulose

Alginic acid Magnesium stearate Sodium lauryl sulphate Sodium starch glycollate Croscarmellose sodium Coating Materials PVAP sealcote (contains polyvinyl acetate phthalate & stearic acid) Purified talc Sucrose Calcium carbonate Acacia Titanium dioxide (E171) Carnauba wax

6.2

Incompatibilities Not applicable

6.3

Shelf life 3 years

6.4

Special precautions for storage Do not store above 25C. Keep the blister tightly closed and in the outer carton to protect from moisture and light.

6.5

Nature and contents of container Blister Packs. Tablets are packed individually in pre-moulded PVC film and sealed with aluminium foil.

Pack sizes: 8, 12, 16 tablets

6.6

Special precautions for disposal Not applicable

7

MARKETING AUTHORISATION HOLDER
Bristol Laboratories Limited Unit 3, Canalside, Northbridge Road, Berkhamsted, HP4 1EG

8

MARKETING AUTHORISATION NUMBER(S)
PL 17907/0159

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
23/05/2006

10

DATE OF REVISION OF THE TEXT
30/11/2011

11

DOSIMETRY (IF APPLICABLE)

12

INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide