Ibuprofen Tablets 200mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen Tablets 200mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Ibuprofen B.P 200mg For a full list of excipients see 6.1
3 PHARMACEUTICAL FORM
Pink colour sugar coated tablets.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications POM indication:
Ibuprofen is indicated for its anti-inflammatory and analgesic effect in the treatment of rheumatoid arthritis (including juvenile rheumatoid arthritis or still’s diseases), ankylosing spondylitis, osteoarthritis and other non-rheumatoid (seronegative) arthropathies.
P indications:
Ibuprofen is indicated for rheumatic and muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza. Also, for the relief of the pain of non-serious arthritic conditions.
GSL indications:
Ibuprofen is indicated for rheumatic and muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness, symptoms of colds and influenza.
4.2 Posology and method of administration
For POM product:
For oral administration.
To be taken preferably with or after food.
Adult: The recommended initial dose of Ibuprofen is 1200mg daily in divided doses. Some patients can be maintained on 600-1200mg daily. It can be
advantageous in severe conditions to increase the dosage to 1600mg daily in divided doses until the acute phase is brought under control.
Elderly: The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.
Children: 20mg of Ibuprofen per kg of body weight daily, except that in children weighing less than 30 kg, the total of Ibuprofen given in 24 hours should not exceed 500mg.
For P product:
For oral administration and short term use only.
The minimum effective dose should be used for the shortest time necessary to relieve symptoms. If the product is required for more than 10 days or if the symptoms worsen or do not improve, the patient should consult a doctor. If in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.
1 or 2 tablets to be taken, up to 3 times a day, as required. The tablets should be taken with water. When 2 tablets are taken, pain relief can last for up to 8 hours.
Leave at least 4 hours between doses and do not take more than 6 tablets in any 24 hour period.
Not to be given to children under 12 years of age.
For GSL product:
For oral administration and short term use only.
The minimum effective dose should be used for the shortest time necessary to relieve symptoms. If the product is required for more than 10 days or if the symptoms worsen or do not improve, the patient should consult a doctor. If in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.
1 or 2 tablets to be taken, up to 3 times a day, as required. The tablets should be taken with water. When 2 tablets are taken, pain relief can last for up to 8 hours.
Leave at least 4 hours between doses and do not take more than 6 tablets in any 24 hour period.
Not to be given to children under 12 years of age.
4.3 Contraindications
Hypersensitivity to Ibuprofen or any of the constituents in the product.
Ibuprofen is contraindicated in patients who have previously known hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or Urticaria, allergic disease) in response to aspirin or other non steroidal antiinflammatory Drugs (NSAIDs)
Bronchospasm may be precipitated in patients suffering from bronchial asthma or allergic disease.
Active or previous peptic ulceration (two or more distinct episodes of proven ulceration or bleeding).
History of upper gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
Patients with severe hepatic failure, renal failure or heart failure (see section 4.4).
Use in last trimester of pregnancy (see section 4.6).
4.4 Special warnings and precautions for use
Ibuprofen may be use with caution in patients with gastrointestinal disease and chronic inflammatory intestinal disease as these conditions may be exacerbated, (ulcerative colitis, Crohn’s disease) but may be tolerated by patients with intolerance to other anti-rheumatic drugs (see section 4.8).
In patients with renal, cardiac or hepatic impairment, caution is required since the use of NSAIDs may result in deterioration of renal function (see section 4.3 and 4.8).The dose should be kept as low as possible and renal function should be monitored. Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease.
NSAIDs should be given with care to patients with a history of heart failure or hypertension since oedema has been reported in association with ibuprofen administration (see section 4.5).
Undesirable effect may reduced by using the minimum effective dose for the shortest possible duration.
The elderly are at increased risk of the serious consequences of adverse reactions.
Caution is required in patients with certain conditions:
Systemic lupus erythematosus as well as those with mixed connective tissue disease due to increased risk of aseptic meningitis (see section 4.8).
Use with concomitant NSAIDs including cyclo-oxygenase-2 specific inhibitors should be avoided (see section 4.5).
Cardiovascular and cerebrovascular effects:
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 (eg < 1200mg daily) is associated with an increased risk of myocardial infarction.
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.
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 (including ulcerative colitis, Crohn’s disease)
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 gastro toxicity or bleeding, such as corticosteroids, or anticoagulants such as warfarin, selective serotonin re-uptake inhibitors or antiplatelet agents such as aspirin (see section 4.5).
Where GI bleeding or ulceration occurs in patients receiving Ibuprofen, the treatment should be withdrawn immediately.
There is a risk of renal impairment in dehydrated children and adolescents.
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.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine as this product contains sucrose.
Each tablet contains 76.15 mg of sucrose. This should be taken into account in patients with diabetes mellitus.
The label will include:
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 ingredients 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, consult your doctor.
For the P product the label will state:
Do not use if you have ever had a stomach ulcer or are allergic to ibuprofen or aspirin.
If you are allergic to or taking any other pain killer, pregnant, or suffer from asthma speak to your doctor before taking ibuprofen.
Do not exceed the stated dose.
Keep out of the reach of children. If symptoms persist, consult your doctor.
For the GSL product the label will state:
Do not use if you have ever had a stomach ulcer or are allergic to ibuprofen or aspirin.
If you are allergic to or taking any other pain killer, pregnant, or suffer from asthma speak to your doctor before taking ibuprofen.
Do not exceed the stated dose.
Keep out of the reach of children. If symptoms persist, consult your doctor.
4.5 Interaction with other medicinal products and other forms of interaction
Ibuprofen should not be used in combination with:
Aspirin: Unless low dose aspirin (not above 75 mg daily) has been advised by a doctor as this may increase the incidence 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 as these may increase the incidence of adverse effects (see section 4.4).
Ibuprofen may interfere with the efficacy of antihypertensive drugs. NSAIDs may enhance the effects of anti-coagulants and diminish the effect of anti-hypertensives or thiazide diuretics. If given to patients receiving anticoagulant therapy, prothrombin time should be monitored daily.
Ibuprofen should be used in caution in combination with:
Corticosteroids: may increase the risk of adverse reactions, especially the gastrointestinal tract (see section 4.4).
Antihypertensives: NSAIDs may diminish the effects of these drugs.
Anticoagulants: NSAIDs may enhance the effects of anti-coagulants, 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).
Methotrexate: there is evidence for the potential increase in plasma levels of methotrexate.
Tacrolimus: possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.
Zidovudine: there is evidence for an increased risk of haemathroses and haematoma in HIV (+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.
Diuretics: reduced diuretic effects. Diuretics can increase the risk of nephrotoxicity of NSAIDs.
Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.
Lithium: decrease elimination of lithium.
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.
Other analgesics: avoid concomitant use of two or more NSAIDs
Quinolone antibiotics: animal data indicates that NSAIDs can increase the risk of convulsion associated with quinolone antibiotics.
Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.
4.6 Pregnancy and lactation
Whilst no teratogenic effects have been demonstrated in animal studies, Ibuprofen should be avoided during the first six months of pregnancy. Congenital abnormalities have been reported in association with ibuprofen administration in man; however, these are low in frequency and do not appear to be follow any discernible pattern.
In view of the known effects of NSAIDs on the foetal cardiovascular system (a closure of ductus arteriosus) use in pregnancy should be avoided.
During the third 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 duration of labour increased with an increased bleeding tendency in both mother and child (see section 4.3)
Ibuprofen appears in breast milk in very low concentrations and is unlikely to affect the breast-fed infant adversely.
See section 4.4 regarding female fertility.
4.7 Effect 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 and GSL
None expected at recommended doses and duration of therapy.
4.8 Undesirable effects Hypersen sitivity:
hypersensitivity reactions have been reported following treatment with ibuprofen. 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, pruritis, urticaria, purpura, angiodema and less commonly bullous dermatoses (including epidermal necrolysis and erythema multiform), photosensitivity and rarely exfoliative dermatitis.
The list of the following adverse effects relates to those experienced with Ibuprofen at OTC doses, from short-term use.
In chronic conditions, under long-term treatment, additional adverse effects may occur.
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 (2400 mg daily) and n long-term treatment may be associated with a small increased risk of arterial thrombotic events (eg myocardial infarction of stroke).
Blood and lymphatic disorders
Very rare: Haematopoietic disorder (anaemia, haemolytic anemia, Aplastic anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis, neutropenia).
First signs are: fever, sore throat, superficial mouth ulcers, flu like symptoms, severe exhaustion, nose and skin bleeding.
Immune system disorders
Uncommon: Hypersensitivity reactions with urticaria and pruritus.
Very rare: 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.
Severe hypersensitivity reactions.
Symptoms could be: facial, tongue and larynx swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, Angioedema or severe shock ). Exacerbation of asthma and bronchospasm.
Psychiatric disorders
Very rare: Nervousness.
Nervous system Uncommon: Headache Very rare: Aseptic meningitis.
Eye disorder
Very rare: Visual disturbance
Ear and labyrinth disorder Very rare: Tinnitus and vertigo.
Cardiac Disorders
Very rare: cardiac failure, angina pectoris.
Vascular disorders
Very rare: hypertension.
Respiratory, thoracic and mediastinal disorders
Very rare: asthma, bronchospasm, dyspnoea and wheezing
Gastrointestinal disorders
The most commonly-observed adverse events are gastrointestinal in nature.
Uncommon: abdominal pain, dyspepsia and nausea.
Rare: Diarrhoea, flatulence, constipation and vomiting.
Very rare: peptic ulcer, perforation or gastrointestinal haemorrhage, malaena, haematemesis sometimes fatal, particularly in the elderly (see section 4.4). Exacerbation of ulcerative colitis and Crohn’s disease (see section 4.3), mouth ulceration.
Skin and subcutaneous tissue disorders
Uncommon: various skin rashes.
Very rare: Severe forms of skin reactions such as bullous reactions, including Stevens-Johnson-syndrome, erythema multiforme and epidermal necrolysis can occur.
Renal and urinary disorders
Very rare: oedema, peripheral oedema Investigations Very rare: decreased haematocrit and haemoglobin levels.
Heapatobiliary disorders
Very rare: Liver disorders, especially in long term treatment, hepatitis and jaundice.
4.9 Overdose
In children ingestion of more than 400mg/kg may cause symptoms. In adults the dose response effects 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 lhour 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
Pharmacotherapeutic group: Propionic acid derivatives.
Ibuprofen is a phenylpropionic acid derivative NSAID tht has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans, Ibuprofen reduces inflammatory pain, swelling and fever. Furthermore, Ibuprofen reversibly inhibits platelet aggregation.
Clinical evidence demonstrates that when 400mg of Ibuprofen are taken, the effects start withing 30-40 minutes of dosing, and 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 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. 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 like for occasional ibuprofen use.
5.2 Pharmacokinetic properties
Ibuprofen is rapidly absorbed following administration and is rapidly distributed Throughout the whole body
Maximum plasma concentrations are reached 45 minutes after indigestion if taken on an empty stomach. When taken with food peak levels are observed 1 to 12 hours.
These times may vary with different dosage forms.
Ibuprofen is absorbed from the gastro-intestinal tract and peak plasma concentration occurs about 1-2 hours after ingestion. Ibuprofen is extensively bound to plasma protein and has a half-life of about 2 hours. It is rapidly excreted in the urine mainly metabolites and their conjugates. About 1% is excreted in urine as unchanged Ibuprofen and 14% as conjugated Ibuprofen.
In limited studies, ibuprofen appears in the breast milk in very low concentration.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescribe^ which are additional to that already included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Pregelatinised Starch 56.00mg
Maize Starch 50.00mg
Povidone 15.00mg
Sodium Luaryl Sulphate 1.60mg
Silicon Dioxide 0.80mg
Magnesium Stearate 1.60mg
Coating:
Povidone 2.25mg
Sucrose 76.15mg
Erythrosine Aluminium Lake (E127) 8.40mg
Purified Talc 42.00mg
Titanium Dioxide 1.20mg
Bees Wax (white) qs
Carnauba Wax qs
6.2 Incompatibilities
None known
6.3 Shelf life
5 years
6.4 Special precautions for storage
Do not store above 30C
Do not freeze
6.5 Nature and contents of container
Dispensing pack 500: A plastic securitainer with a double security closure containing Ibuprofen tablets. (POM)
OTC packs- A plastic securitainers with a double security closure. (P)
Pack size includes 100, 50, and 25.
Or
PVC/foil blister pack in carton. (P)
Pack size includes 96, 84, 48, and 24.
20 micron hard-temper aluminium foil printed (bright side) and coated (dull side) with a heat seal lacquer.250 micron PVC-pharmaceutical grade.
GSL packs-
Pack sizes of 12 and 16.
20 micron hard temper aluminium foil printed (bright side) and coated (dull side) with a heat seal lacquer. 250 micron PVC-pharmaceutical grade.
6.6 Special precautions for disposal
None
7 MARKETING AUTHORISATION HOLDER
Pharmvit Limited 177 Bilton Road Perivale Greenford
Middlesex UB6 7HQ
8 MARKETING AUTHORISATION NUMBER(S)
PL 04556/0022
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
20/05/2009
10 DATE OF REVISION OF THE TEXT
19/08/2016