Summary of Product Characteristics (SmPC) - Ibuprofen 200 mg film-coated tablets
1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen 200 mg film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 200 mg Ibuprofen
Also contains 13.33 mg lactose (in the form of lactose monohydrate). For full list of excipients, refer to section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, capsule-shaped, film-coated tablet, plain on both sides.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the relief of mild to moderate pain including rheumatic or muscular pain, backache, headache, dental pain, migraine, neuralgia, dysmenorrhoea, feverishness and for the relief of symptoms of colds and influenza.
4.2 Posology and method of administration
For oral administration and short-term use only.
Not to be used for children under 12 years of age.
Adults, the elderly and children over 12 years:
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4). The patient should consult a doctor if symptoms persist or worsen, or if the product is required for more than 10 days.
200-400 mg to be taken up to three times a day as required. Leave at least four hours between doses and do not take more than 1200 mg in any 24 hour period.
Method of administration
For oral administration. To be taken preferably with or after food, with a glass of water. Ibuprofen tablets should be swallowed whole and not chewed, broken, crushed or sucked on to avoid oral discomfort and throat irritation.
4.3 Contraindications
- Hypersensitivity to Ibuprofen or any of the excipients listed in section 6.1.
Patients who have previously shown hypersensitivity reactions (e.g.
asthma, rhinitis, angioedema or urticaria) in response to aspirin or other non-steroidal anti-inflammatory 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 hepatic failure, renal failure or heart 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 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.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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:
Caution is required in certain conditions like systemic lupus erythematosus and mixed connective tissue disease due to increased risk of aseptic meningitis (see section 4.8).
Renal:
Renal tubular acidosis and hypokalaemia may occur following acute overdose and in patients taking ibuprofen products over long periods at high doses (typically greater than 4 weeks), including doses exceeding the recommended daily dose. Renal impairment as renal function may further deteriorate (see section 4.3 and 4.8)
Hepatic:
Hepatic dysfunction (see section 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, oedema and/or cardiac impairment have been reported in association with NSAID therapy (see Section 4.8).
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 myocardial infarction.
Patients with uncontrolled hypertension, congestive heart failure (NYHA IIIII), 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.
Cases of Kounis syndrome have been reported in patients treated with Ibuprofen 200mg film-coated tablets. Kounis syndrome has been defined as cardiovascular symptoms secondary to an allergic or hypersensitive reaction associated with constriction of coronary arteries and potentially leading to myocardial infarction.
Impaired female fertility:
There is limited evidence that drugs which inhibit cyclo- oxygenase/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 and chronic inflammatory intestinal 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 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 gastro-toxicity or bleeding, such as oral corticosteroids, or anticoagulants such as warfarin or selective serotonin re- uptake 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 immediately.
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. Acute generalised exanthematous pustulosis (AGEP) has been reported in relation to ibuprofen-containing products. Ibuprofen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Paediatric population
There is a risk of renal impairment in dehydrated children and adolescents.
Masking of symptoms of underlying infections
Ibuprofen 200mg tablets can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection. This has been observed in bacterial community acquired pneumonia and bacterial complications to varicella. When Ibuprofen 200mg tablets is administered for fever or pain relief in relation to infection, monitoring of infection is advised. In nonhospital settings, the patient should consult a doctor if symptoms persist or worsen.
Severe cutaneous adverse reactions (SCARs)
Severe cutaneous adverse reactions (SCARs), including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and Toxic Epidermal Necrolysis (TEN), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), which can be life-threatening or fatal, have been reported in association with the use of ibuprofen (see section 4.8). Most of these reactions occurred within the first month. If signs and symptoms suggestive of these reactions appear Ibuprofen should be withdrawn immediately, and an alternative treatment considered (as appropriate).
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 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. 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 (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 anti-coagulants, such as warfarin (See section 4.4).
Antihypertensives and diuretics: since NSAIDs may diminish the effect of these drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the co-administration of an ACE inhibitor or Angiotensin II antagonist and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking a coxib concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter.
Corticosteroids: Increase the 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 cardiac 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 Fertility, 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 used unless clearly necessary. If 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 synthetase 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 breast milk in a very low concentration and is unlikely to affect the breast-fed infant adversely.
Fertility
See section 4.4 regarding female fertility.
4.7 Effects on ability to drive and use machines
Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.
4.8 Undesirable effects
Adverse events which have been associated with Ibuprofen are given below, listed by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare(≥1/10,000 to <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
The adverse events observed most often are gastrointestinal in nature. Adverse events are mostly dose-dependent, in particular the risk of occurrence of gastrointestinal bleeding is dependent on the dosage range and duration of treatment.
•
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.
| System Organ Class | Frequency | Adverse Event |
| Blood and Lymphatic System Disorders | Very rare: | Haematopoietic disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising. |
| Immune System Disorders | Uncommon Very rare | Hypersensitivity reactions consisting of1: Urticaria and pruritus Severe hypersensitivity reactions. Symptoms could be facial, tongue and |
| Not Known | laryngeal swelling, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). Respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea. | |
| Nervous System Disorders | Uncommon Very rare | Headache Aseptic meningitis2 |
| Cardiac Disorders | Not Known | Cardiac failure and oedema |
| Vascular Disorders | Not Known | Hypertension |
| Gastrointestinal Disorders | Uncommon Rare Very rare Not known | Abdominal pain, nausea, dyspepsia Diarrhoea, flatulence, constipation and vomiting Peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis, gastritis Exacerbation of colitis and Crohn's disease (section4.4). |
| Hepatobiliary Disorders | Very rare | Liver disorders |
| Skin and Subcutaneous Tissue Disorders | Uncommon Very rare Not known | Various skin rashes Severe cutaneous adverse reactions (SCARs) (including Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis) Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) Acute generalised exanthematous pustulosis (AGEP) Photosensitivity reactions |
| Metabolism and Nutrition Disorders | Not known Not known | Decreased Appetite Hypokalaemia* |
| Renal and Urinary Disorders | Very rare Not known Not known | Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema. Renal insufficiency Ureteric colic, dysuria |
| Not known | Renal tubular acidosis* | |
| Investigations | Very rare | Decreased haemoglobin levels |
Description of Selected Adverse Reactions
1 Hypersensitivity reactions have been reported and these may consist of: -
- Non-specific allergic reaction and anaphylaxis
- Respiratory tract reactivity, e.g. asthma, aggravated asthma, bronchospasm or dyspnoea
- Assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, more rarely, exfoliative and bullous dermatoses (including toxic epidermal necrolysis and erythema multiforme).
2The pathogenic mechanism of drug-Induced aseptic meningitis is not fully understood. However, the available data on NSAID-related aseptic meningitis points to a hypersensitivity reaction (due to a temporal relationship with drug intake, and disappearance of symptoms after drug discontinuation). Of note, single cases of symptoms of aseptic meningitis (such as stiff neck, headache, nausea, vomiting, fever or disorientation) have been observed during treatment with ibuprofen, inpatients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease).
*Renal tubular acidosis and hypokalaemia have been reported in the post-marketing setting typically following prolonged use of the ibuprofen component at higher than recommended doses.
Reporting of suspected adverse events
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Toxicity
Signs and symptoms of toxicity have generally not been observed at doses below 100 mg/kg in children or adults. However, supportive care may be needed in some cases. Children have been observed to manifest signs and symptoms of toxicity after ingestion of 400 mg/kg or greater. 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 significant amounts of ibuprofen will manifest symptoms within 4 to 6 hours.
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, dizziness, occasionally excitation, nystagmus and disorientation or coma. Occasionally patients develop convulsions, fainting, hypothermia, apnoea and respiratory or CNS depression, cardiovascular toxicity resulting in hypotension, bradycardia or tachycardia. 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.
Prolonged use at higher than recommended doses may result in severe hypokalaemia and renal tubular acidosis. Symptoms may include reduced level of consciousness and generalised weakness (see section 4.4 and section 4.8).
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: M01AE01
Group – Anti-inflammatory and anti-rheumatic products, non-steroids
Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In human 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 hours before or 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 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 breast milk in very low concentrations.
5.3 Preclinical safety data
No relevant information additional to that already contained is elsewhere in the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Tablet core
Sodium lauryl sulphate
Croscarmellose sodium
Lactose monohydrate
Microcrystalline cellulose
Povidone
Colloidal Anhydrous silica
Stearic acid
Tablet coating
Hypromellose
Macrogol 6000
Purified Talc
Titanium dioxide (E-171)
6.2 Incompatibilities
None.
6.3 Shelf life
48 months.
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions
6.5 Nature and contents of container
Each Alu-PVC blister contains 24, 48, 84 & 96 tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7 MARKETING AUTHORISATION HOLDER
NOUMED LIFE SCIENCES LIMITED
NOUMED HOUSE
SHOPPENHANGERS ROAD
MAIDENHEAD, BERKSHIRE
SL6 2RB
UNITED KINGDOM
8 MARKETING AUTHORISATION NUMBER(S)
PL 44041/0058
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
07/02/2025
10 DATE OF REVISION OF THE TEXT
07/02/2025