Ibuprofen Film Coated Tablets 200 Mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen Film Coated Tablets 200 mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 200 mg.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Film coated tablets.
Pink biconvex tablets marked with ‘LPC’ on one side and ‘I 200’ on the other.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Rheumatic and muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza.
4.2 Posology and method of administration
Posology:
The minimum 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.
Adults, the elderly and children over 12 years:
Two tablets with water up to three times a day, as required. Take with or after food.
Leave at least 4 hours between doses and do not take more than six tablets in any 24 hour period.
If in children and in adolescents this medical product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.
Children under 12 years of age:
Not recommended.
Method of administration:
For oral administration and short term use only.
4.3 Contraindications
Hypersensitivity to Ibuprofen or to any of the excipients listed in section 6.1. Previous hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs.
Active or previous peptic ulcer/ haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
History of upper gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
Use with concomitant NSAIDs including cyclo-oxydenase-2 specific inhibitors (See section 4.5 Interactions).
Severe hepatic failure, renal failure or heart failure (See section 4.4 Special warnings and precautions for use).
Last trimester of pregnancy (see section 4.6 Pregnancy and lactation).
Bleeding disorders, Severe heart failure.
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 are at increased risk of the serious consequences 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. The possibility of cross-sensitivity with aspirin and other NSAIDs should be borne in mind.
SLE and mixed connective tissue disease :
Systemic lupus erythematous and mixed connective tissue disease - increased risk of aseptic meningitis (see section 4.8 Undesirable effects).
Renal:
Hypertension and/or cardiac impairment as renal function may deteriorate and/or fluid retention occur. The dose should be kept as low as possible and renal function should be monitored.
Renal impairment as renal function may further deteriorate (see sections 4.3 Contraindications and section 4.8 Undesirable effects).
There is a risk of renal impairment in dehydrated children and adolescents. Hepatic:
Hepatic dysfunction (see section 4.3 Contraindications and section 4.8 Undesirable effects).
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 (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). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. <1200 mg daily) 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 impair cyclo-oxygenase/ prostoglandin 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 Undesirable effects).
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.
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 gastrotoxicity, ulceration or bleeding, such as corticosteroids, or anticoagulants such as warfarin (prothrombin time should be monitored daily for the first few days of combined treatment ), selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (see section
4.5 Interactions).
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.
Treatment should be discontinued in patients reporting blurred or diminished vision, scotomata and /or changes in colour vision.
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.
The label will include:
Read the enclosed leaflet before taking this product.
Do not take if you:
• Have or have ever had a stomach ulcer, perforation or bleeding
• Are allergic to ibuprofen or any other ingredient of the product, aspirin or other related painkillers
• Are taking NSAID painkillers, or aspirin with a daily dose above 75 mg
• Are in the last 3 months of pregnancy
Speak to your pharmacist or doctor before taking this product if you:
• Have asthma, liver, heart, kidney, diabetes, high cholesterol, high blood pressure, a stroke or bowel problems
• Are in the first 6 months of pregnancy
• Are a smoker
Do not exceed the stated dose. If symptoms persist or worsen, consult your doctor.
4.5 Interaction with other medicinal products and other forms of interaction
Ibuprofen should not be used in combination with:
Aspirin (Acetylsalicylic Acid): Unless low-dose aspirin (not above 75 mg) has been advised by a doctor, as this may increase the risk of adverse effects (see section 4.3 Contraindications).
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: As these may increase the risk of adverse effects (see section 4.3 Contraindications).
Ibuprofen should be used with caution in combination with:
Aminoglycosides: Increased renal toxicity has been reported in patients receiving concomitant ibuprofen and aminoglycoside therapy.
Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin (See section 4.4 Special warnings and precautions).
Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4).
Antihypertensives'. NSAIDs may diminish the effect of these drugs.
Cardiac Glycosides: NSAIDs may exacerbate heart failure, reduce GFR and increase plasma cardiac glycoside concentration.
Cyclosporin: Increased risk of nephrotoxicity.
Corticosteroids: May increase the risk of adverse reactions in the gastrointestinal tract (see section 4.4 Special warnings)
Diuretics: NSAIDs may diminish the effect of these drugs. They may increase the risk of hyperkalaemia with potassium-sparing diuretics and may also antagonise thiazides. The risk of nephrotoxicity of NSAIDs is increased.
Lithium: There is evidence for potential increases in plasma levels of lithium
Methotrexate: There is potential for an increase in plasma methotrexate.
Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone administration, as NSAIDs can reduce the effects of mifepristone.
Phenytoin Sodium: Phenytoin concentration and toxicity have been increased by 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.
Sulphonylureas: Ibuprofen may interfere with the efficacy of sulphonylureas.
Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.
Zidovudine: There is evidence of an increased risk of haemarthroses and haematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen. Increased risk of haematological toxicity when NSAIDs are given with zidovudine.
4.6 Fertility, pregnancy and lactation
Pregnancy:
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 Contraindications).
NSAIDs should not be used in the first two trimesters of pregnancy or labour unless the potential benefit to the patient outweighs the potential risk to the foetus.
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, ibuprofen is contraindicated during the third trimester of
pregnancy.
Breast-feeding:
In limited studies, Ibuprofen appears in the breast milk in very low
concentration and is unlikely to affect the breast-fed infant.
Fertility:
See section 4.4 regarding female fertility.
4.7 Effects on ability to drive and use machines
None at the recommended doses and duration of therapy.
4.8 Undesirable effects
|
System Organ Class |
Frequency |
Adverse Events |
|
Gastrointestinal Disorders |
Uncommon: |
Abdominal pain, nausea and 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. | |
|
Not Known |
Exacerbation of ulcerative colitis and Crohn’s disease (see section 4.4). | |
|
Nervous System Disorders |
Uncommon: |
Headache, dizziness, nervousness, depression, drowsiness and insomnia. |
|
Very rare |
Symptoms of aseptic meningitis such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed with NSAIDs. | |
|
Cardiac Disorders |
Not Known |
Cardiac failure and oedema. |
|
Vascular Disorders |
Not Known |
Hypertension. |
|
Renal and Urinary Disorders |
Very rare: |
Acute renal failure, interstitial nephritis, nephrotic syndrome, papillary necrosis, especially in long term use, associated with |
|
increased serum urea and oedema. Haematuria. Fluid retention may rarely precipitate congestive heart failure in elderly patients. | ||
|
Not Known |
Renal insufficiency. | |
|
Hepatobiliary Disorders |
Very rare: |
Liver disorders, abnormalities of liver function tests. |
|
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. |
|
Skin and Subcutaneous Tissue Disorders |
Uncommon: |
Various skin rashes (see Immune system). |
|
Very rare: |
Severe forms of skin reaction such as bullous reactions including Stevens- Johnson syndrome, erythema multiforme and epidermal necrolysis can occur. | |
|
Immune system Disorders |
Hypersensitivity reactions consisting of1: | |
|
Uncommon: |
Urticaria and pruritus | |
|
Very Rare: |
Severe hypersensitivity reactions. Symptoms could be facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). Patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) may be especially susceptible (see section 4.4Special warnings and precautions for use). | |
|
Not known |
Respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm, dyspnoea. | |
|
Investigations |
Very rare |
Decreased haemoglobin levels. |
|
Other Disorders |
Rare: |
Vertigo, tinnitus. |
|
Very rare: |
Toxic amblyopia, reversible on cessation of treatment. | |
1 Hypersensitivity reactions have been reported and these may consist of:
a) Non-specific allergic reactions and anaphylaxis
b) Respiratory tract reactivity, e.g. asthma, aggravated asthma, bronchospasm,
dyspnoea
c) Various skin reactions, e.g. pruritus, urticarial, purpura, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis, erythema multiform).
In the treatment of chronic conditions, under long term use, additional adverse effects may occur.
Clinical trial and epidemiological data suggest that 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 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 clearly 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
Pharmacodynamic group: anti-inflammatory and anti-rheumatic products, nonsteroids, propionic acid derivatives (ATC code: MO1 AE01).
Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostoglandin synthesis. In humans ibuprofen reduces pain, swelling 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 hours before or within 30 minutes after immediate release aspirin dosing (81 mg), a decreased effect of aspirin 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.
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 1-2 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
Ibuprofen has been used in general medicine over a long period exceeding 20 years. No relevant information additional to that already included elsewhere in the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Cores:
Pregelatinised starch Maize starch
Colloidal anhydrous silica Magnesium stearate
Coating:
Hypromellose Macrogol 6000
Erythrosine lake FD&C Red no. 3 (E127) Titanium dioxide (E171)
Dioctyl sodium sulphosuccinate
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
2 years for container.
3 years for blisters.
6.4 Special precautions for storage
Do not store above 25°C. Store in the original package.
6.5 Nature and contents of container
Polypropylene tablet containers with a low density polyethylene tamper evident lid, containing either 8, 12 or 16 tablets.
Blister packs of 8, 12 or 16 consisting of rigid white PVC and aluminium foil. Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Special Concept Development (UK) Limited
Unit 1-7 Colonial Way
Watford
Hertfordshire
WD24 4YR
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 36722/0026
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
24/06/2014
10 DATE OF REVISION OF THE TEXT
02/06/2016