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IBUPROFEN CAPLETS 200 MG

Active substance(s): IBUPROFEN / IBUPROFEN / IBUPROFEN

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SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen Caplets 200mg

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient Ibuprofen mg/tablet 200mg

3

PHARMACEUTICAL FORM
Film-coated Tablets (Tablets) A white, pillow-shaped, film-coated, tablet

4. 4.1.

CLINICAL PARTICULARS Therapeutic Indications POM: For its analgesic anti-inflammatory effects in the treatment of rheumatoid arthritis (including juvenile rheumatoid arthritis or Stills disease), ankylosing spondylitis, osteoarthritis, other non-rheumatoid (seronegative) arthropathies. In the treatment of non-articular rheumatic conditions, ibuprofen is indicated in periarticular conditions such as frozen shoulder (capsulitis), bursitis, tendonitis, tenosynovitis, low back pain and soft tissue injuries such as sprains and strains. Ibuprofen is also indicated for its analgesic effect in the relief of mild to moderate pain such as dysmenorrhoea, dental and post-operative pain and for the symptomatic relief of headache, including migraine headache. P: For the relief of pain of non-serious arthritic conditions and for the relief of rheumatic or muscular pain, backache, neuralgia, headache including migraine headache, dental pain, dysmenorrhoea, feverishness and the symptoms of colds and influenza. GSL: For the relief of rheumatic or muscular pain, backache, neuralgia, headache including migraine headache, dental pain, dysmenorrhoea, feverishness and the symptoms of colds and influenza.

4.2

Posology and method of administration
POM: For oral administration. To be taken preferably with or after food.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).
Adults and Children over 12 years: The recommended dosage is 1200 - 1800mg daily in divided doses. Some patients can be maintained on 600 - 1200mg daily. In severe or acute conditions it can be advantageous to increase the dosage until the acute phase is brought under control, provided that the daily dose does not exceed 2400mg in divided doses. Children under 12 years: The daily dosage is 20mg/kg of body weight in divided doses. In juvenile rheumatoid arthritis up to 40mg/kg of body weight daily in divided doses may be taken. Not recommended for children weighing less than 7kg. Elderly: No special dosage modifications are required, unless renal or hepatic function is impaired, in which case dosage should be assessed individually. The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy. P and GSL: For oral administration and short-term use only. Adults, the elderly and children over 12 years:

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.
One to two (200-400 mg) tablets to be taken up to three times a day, as required. Leave at least four hours between doses and do not take more than 6 tablets (1200mg) in any 24 hour period. Children under 12 years: Not suitable for children under 12 years.

4.3

Contraindications POM, P/GSL
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 ibuprofen, 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, related to previous NSAIDs therapy. Severe heart failure, renal failure or hepatic failure (see section 4.4). Last trimester of pregnancy (see section 4.6).

P/GSL only
Children under 12 years.

4.4

Special warnings and precautions for use
POM 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 use of ibuprofen with concomitant NSAIDs including cyclo-oxygenase-2 selective inhibitors should be avoided (see section 4.5). Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation, which may be fatal (see section 4.2). Respiratory disorders: Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma, since NSAIDs have been reported to precipitate bronchospasm in such patients. Cardiovascular, Renal and Hepatic impairment: The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly. Renal function should be monitored in these patients (See also section 4.3). Cardiovascular and cerebrovascular effects:

Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy. Clinical trial 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.
Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).

Gastrointestinal bleeding, ulceration and perforation: 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. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk (see below and section 4.5). 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.
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). SLE and mixed connective tissue disease: In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis (See section 4.8).

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. Impaired female fertility: The use of ibuprofen may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of ibuprofen should be considered. P/GSL

Undesirable effects may be minimised by using the lowest effective dose for the shortest 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 cyclo-oxygenase-2 selective inhibitors should be avoided (see section 4.5). SLE and mixed connective tissue disease: Systemic lupus erythematosus and 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). 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 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). 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 cyclooxygense/prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment. Gastrointestinal: NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohns 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 anytime 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 NSAIDSs (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.
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 or any other ingredient of the product, aspirin or other related painkillers are taking other NSAID painkillers, or aspirin with a daily dose above 75 mg 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, consult your doctor. 4.5 Interaction with other medicinal products and other forms of interaction
POM Other analgesics including cyclo-oxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDs (including aspirin) as this may increase the risk of adverse effects (see section 4.4). Anti-hypertensives: Reduced anti-hypertensive effect. Diuretics: Reduced diuretic effect. Diuretics can increase the risk of nephrotoxicity of NSAIDs. Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma cardiac glycoside levels. Lithium: Decreased elimination of lithium. Methotrexate: Decreased elimination 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 effects of mifepristone. Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see section 4.4). Anticoagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin (see section 4.4). 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. Anti-platelet agents and selective serotonin-reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding (see section 4.4). 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.

Low Dose Aspirin: 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).

P/GSL 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). Other NSAIDS including cyclo-oxygenase-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 anti-coagulants, such as warfarin (see section 4.4). Antihypertensives 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.
Low Dose Aspirin: 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).

4.6

Pregnancy and lactation
Pregnancy

POM
Congenital abnormalities have been reported in association with NSAID administration in man; however, these are low in frequency and do not appear to follow any discernible pattern. In view of the known effects of NSAIDs on the foetal cardiovascular system (risk of closure of the ductus arteriosus) use in the last trimester of pregnancy is contraindicated. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child (see section 4.3). NSAIDs should not be used during the first two trimesters of pregnancy or labour unless the potential benefit to the patient outweighs the potential risk to the foetus. P/GSL

Whilst no teratogenic effects have been demonstrated in animal experiments, the use of ibuprofen should, if possible, be avoided during the first 6 months of pregnancy. During the 3rd trimester, ibuprofen is contraindicated as there is a risk of premature closure of the foetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and the

duration increased with an increased bleeding tendency in both mother and child. (see section 4.3).
Lactation

POM
In limited studies so far available, NSAIDs can appear in breast milk in very low concentrations. NSAIDs should, if possible, be avoided when breastfeeding.

P/GSL In limited studies, ibuprofen appears in the breast milk in very low concentration and is unlikely to affect the breast-fed infant adversely. POM/P/GSL See section 4.4 regarding female fertility.

4.7.

Effects on ability to drive and use machines POM

Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery. P
None expected at recommended doses and duration of therapy.

4.8

Undesirable effects
POM Gastrointestinal: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (see section 4.4) have been reported following administration. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely. Hypersensitivity: Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or 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). 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 dose (2400 mg 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) Other adverse reactions reported less commonly include:

Renal: Nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome and renal failure. Hepatic: Abnormal liver function, hepatitis and jaundice. Neurological and special senses: Visual disturbances, optic neuritis, headaches, paraesthesia, reports of aseptic meningitis (especially in patients with existing auto-immune disorders, such as systemic lupus erythematosus, mixed connective tissue disease), with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation (see section 4.4), depression, confusion, hallucinations, tinnitus, vertigo, dizziness, malaise, fatigue and drowsiness. Haematological: Thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia. Dermatological: Bullous reactions including Stevens Johnson syndrome and Toxic Epidermal Necrolysis (very rare). Photosensitivity.

P/GSL Hypersensitivity reactions have been reported and these may consist of: (a) non-specific 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 long-term 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, dyspepsia. Rare: Diarrhoea, flatulence, constipation and vomiting Very rare: Peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis, gastritis. Exacerbation of colitis and Crohns disease (see section 4.4). Nervous System: Uncommon: Headache. Very 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

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties 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 inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400 mg was taken within 8 h before or within 30 min after immediate release aspirin dosing (81 mg), 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. The half-life of ibuprofen is about 2 hours.
In limited studies, ibuprofen appears in the breast milk in very low concentrations.

5.3.

Preclinical safety data There are no preclinical data of relevance to the prescriber which are additional to that already included.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients Microcrystalline cellulose, croscarmellose sodium, lactose , colloidal silicon dioxide, sodium laurilsulfate, magnesium stearate, hypromellose, french chalk, titanium dioxide (E171)

6.2.

Incompatibilities Not applicable.

6.3.

Shelf Life 36 months - Amber glass bottle 36 months - Aluminium blister (Cold Form) 36 months - Aluminium blister (PVC/PVDC) 24 months - HDPE Bottle

6.4

Special precautions for storage

Bottle packs: None Blister pack: (cold form aluminium): Store in a cool, dry place; below 25C Blister pack: (PVC/PVDC and aluminium): Do not store above 30C 6.5. Nature and Contents of Container The following containers will be used. 1. 25, 30, 32, 36, 50, 84 or 100 tablets in an amber glass bottle with a polypropylene child resistant cap with a waxed aluminium-faced pulpboard liner or an induction heat seal liner. 25, 30, 32, 36, 50, 84 or 100 tablets in a white HDPE (high-density polyethylene) bottle with a polyethylene/polypropylene child resistant cap with a waxed aluminium faced liner or an induction heat sealed liner including aluminium/surlyn or aluminium/polyethylene. 6, 8, 10, 12, 16, 18, 20, 24, 25, 30, 32, 36, 48 or 96 tablets in an aluminium cold form blister pack, formed from an aluminium/ nylon laminate and aluminium foil. 6, 8, 10, 12, 16, 18, 20, 24, 25, 30, 32, 36, 48, 80, 84, 88, 96, 100 or 104 tablets in an aluminium blister pack , formed from opaque PVC/PVDC and aluminium foil.

2.

3.

4.

6.6.

Instruction for Use/Handling Not applicable.

7

MARKETING AUTHORISATION HOLDER The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA

8.

MARKETING AUTHORISATION NUMBER PL 00014/0497

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
26/10/2008

10

DATE OF REVISION OF THE TEXT
26/09/2012

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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.

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