Ibuprofen 200mg Soft Capsules
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen 200mg Soft Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Ibuprofen 200 mg.
Excipient(s): sorbitol (E420), ponceau 4R red (E124)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, soft.
Wine red colour oval shaped soft gelatin capsules containing colourless to pale yellow coloured, transparent, viscous liquid, printed ‘142’ in white colour on capsule shell.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Ibuprofen 200mg Soft Capsules are indicated adults and children over 12 years for the symptomatic relief of:
• rheumatic or muscular pain
• backache
• neuralgia
• migraine
• headache
• dental pain
• dysmenorrhoea
• feverishness
• colds and influenza symptoms
4.2 Posology and method of administration
For oral administration and short-term use only.
Adults, the elderly and children over 12 years:
Take one or two capsules, up to three times a day as required.
Leave at least 4 hours between doses.
Do not take more than 6 capsules in any 24 hour period.
Not for use by children under 12 years of age without medical advice.
The lowest effective dose should be used for the shortest time 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.
4.3 Contraindications
Hypersensitivity to ibuprofen or to any of the excipients.
Patients with a history of bronchospasm, asthma, rhinitis, or urticaria associated with aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
Patients with a history of, or existing gastrointestinal ulceration/perforation or bleeding, including that associated with NSAIDs. (See Section 4.4)
Patients with severe hepatic failure, severe renal failure or severe heart failure. See also Section 4.4
Use with concomitant NSAIDs, including cyclo-oxygenase-2 specific inhibitors - increased risk of adverse reactions (see section 4.5)
During the last trimester of pregnancy as there is a risk of premature closure of the fetal 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 4.6).
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 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 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 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 the use of ibuprofen, particularly at high doses (2400 mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g.<1200mg daily) is associated in an increased risk of myocardial infarction.
Impaired female fertility:
There is some evidence that drugs which inhibit cyclo-oxygenase/ prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment.
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 anytime 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 complaicated 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.
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 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
This medicine contains 17.4 mg of potassium per dose.
To be taken into consideration by patients on a controlled potassium diet.
Contains 58.6 mg of sorbitol per dose, a source of 14.6 mg of fructose per dose.
Patients with rare hereditary problems of fructose intolerance should not take this medicine.
If symptoms persist or worsen, or if new symptoms occur, consult your doctor or pharmacist.
This medicine contains Ponceau 4R. May cause allergic reactions
4.5 Interaction with other medicinal products and other forms of interaction
Ibuprofen (like other NSAIDs) should not be used 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 4.3).
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:
• 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. Diuretics can increase the risk of nephrotoxicity of NSAIDs.
• Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin (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 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 Fertility, pregnancy and lactation
Whilst no teratogenic effects have been demonstrated in animal experiments, the use of Ibuprofen 200mg Soft Capsules 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 Contraindications).
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
Hypersensitivity reactions have been reported and these may consist of
• non-specific allergic reactions and anaphylaxis
• respiratory tract reactivity e.g. asthma, aggravated asthma, bronchospasm, dyspnoea
• various skin reactions e.g. pruritus, urticaria, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erthema multiforme).
The list of the following 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.
MedDRA frequency convention
Very common (>1/10)
Common (>1/100 to <1/10) Uncommon (>1/1,000 to <1/100) Rare (>1/10,000 to <1/1,000) Very rare (<1/10,000)
|
Medra organ class |
Freque ncy |
Undesirable Effect(s) |
|
Gastrointestinal Disorders |
Uncomm on: |
Abdominal pain, dyspepsia and nausea |
|
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 ulcerative colitis and Crohn’s disease (See section 4.4) (see section 4.4) |
|
Nervous System |
Uncomm on: |
Headache |
|
Very rare |
Aseptic meningitis - single cases have been reported very rarely. | |
|
Kidney |
Very rare: |
Decrease of urea excretion and oedema can occur. Also, acute renal failure. Papillary necrosis, especially in longterm use, and increased serum urea concentrations have been reported. |
|
Liver |
Very rare: |
Liver disorders, especially in long-term treatment. |
|
Blood |
Very rare: |
Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs are: fever, sore throat, superficial mouth ulcers, flulike symptoms, severe exhaustion, unexplained bleeding and bruising. |
|
Skin |
Uncomm on |
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 |
Very rare: |
In patients with existing autoimmune 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) |
|
Hypersensitivity Reactions |
Uncomm on: |
Hypersensitivity reactions with urticaria and pruritus. |
|
Very rare |
Severe hypersensitivity reactions. Symptoms could be: facial, tongue and larynx swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or severe shock). Exacerbation of asthma and bronchospasm. |
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).
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 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
ATC Code: M01A E01 Propionic acid derivative
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.
Clinical evidence demonstrates that when 400mg 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 before 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 relevant effect is considered to be likely for occasional ibuprofen use.
5.2 Pharmacokinetic properties
Ibuprofen is well absorbed from the gastrointestinal tract. Ibuprofen is extensively bound to plasma proteins.
Ibuprofen 200mg Soft Capsules consist of ibuprofen 200 mg dissolved in a hydrophilic solvent inside a gelatin shell. On ingestion, the gelatin shell disintegrates in the gastric juice releasing the solubilised ibuprofen immediately for absorption. The median peak plasma concentration is achieved approximately 30 minutes after administration.
The median peak plasma concentration for Ibuprofen tablets is achieved approximately 1-2 hours after administration.
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.
Elimination half-life is approximately 2 hours.
No significant differences in pharmacokinetic profile are observed in the elderly.
5.3 Preclinical safety data
No relevant information, additional to that contained elsewhere in the SPC.
6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Capsule contents:
Macrogol 400 Sorbitan mono-oleate Sorbitol
Potassium hydroxide (E525)
Water, purified.
Capsule shell:
Gelatin (E441)
Macrogol 400 Sorbitol (E420)
Ponceau 4 R red (E124) Water, purified.
Triglycerides - medium chain
Capsule printing:
Shellac, glaze Titanium dioxide (E171) Propylene glycol
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Store below 25 °C Store in the original pack.
6.5 Nature and contents of container
Blisters PVC / Aluminium and PVdC / Aluminium packed into cartons. Each carton may contain 10, 12 or 16 capsules in blister strips Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7
MARKETING AUTHORISATION HOLDER
Bell, Sons & Co (Druggists) Ltd Gifford House Slaidburn Crescent Southport
Merseyside, PR9 9AL
8 MARKETING AUTHORISATION NUMBER(S)
PL 01305/0105
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
17/04/2014
10 DATE OF REVISION OF THE TEXT
17/04/2014