Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Pinewood Laboratories Limited, Ballymacarbry, Clonmel, Co. Tipperary, Ireland
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) after taking ibuprofen, aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
History of gastrointestinal bleeding or perforation, related to previous NSAID therapy.
Active or history of recurrent peptic ulcer/gastrointestinal haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
Patients with conditions involving an increased tendency to bleeding.
Severe hepatic failure, renal failure and heart failure (NYHA Class IV) (see section 4.4, Special warnings and precautions for use).
Last trimester of pregnancy (see section 4.6 Pregnancy and lactation).
Undesirable effects may be minimised by using the minimum effective dose for the shortest possible duration necessary to control symptoms (see section 4.2, and GI and cardiovascular risks below).
The use of Fenpaed Ibuprofen 100 mg/5 ml Oral Suspension with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided due to the increased risk of ulceration or bleeding (see section 4.5).
The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of analgesic medication. Patients with medication overuse headache should not be treated by increasing the dose of the analgesic. In such cases the use of analgesics should be discontinued.
The concomitant consumption of excessive alcohol with NSAIDs, including ibuprofen, may increase the risk of adverse effects on the gastrointestinal tract, such as GI haemorrhage or the central nervous system possibly due to an additive effect.
The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation which may be fatal (see section 4.2).
There is a risk of renal impairment in dehydrated children and adolescents.
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.
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.
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 gastrointestinal disease, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal 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, or 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 ulcerative colitis or Crohn’s disease as these conditions may be exacerbated (see section 4.8 Undesirable effects).
Ibuprofen should be used with caution in patients suffering from, or with a previous history of, bronchial asthma, chronic rhinitis or allergic disease, since such patients may have NSAID – sensitive asthma which has been associated with severe bronchospasm, urticaria or angioedema.
Administration of NSAID’S such as Ibuprofen may cause dose dependent in prostaglandin formation and precipitate renal failure. The habitual concomitant intake of various similar painkillers further increases this risk. Patients at greater risk of this reaction include those with impaired renal function, cardiac impairment or liver dysfunction, those taking diuretics and the elderly. For these patients, use the lowest effective dose, for the shortest possible duration and monitor renal function especially in long-term treated patients (see also section 4.3).
Ibuprofen 100mg/5ml Oral Suspension 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.
Appropriate monitoring and caution (discussion with doctor or pharmacist) are required prior to starting treatment in patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention; hypertension and oedema have been reported in association with NSAID therapy.
Clinical studies suggest that use of Ibuprofen, particularly at a high dose (2400 mg/day) 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/day) 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.
Caution should be used when initiating treatment with ibuprofen in patients with considerable dehydration. There is a risk of renal impairment especially in dehydrated children, adolescents and the elderly.
As with other NSAIDs, long-term administration of ibuprofen has resulted in renal papillary necrosis and other renal pathologic changes. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of an NSAID may cause a dose dependant reduction in prostaglandin formation and, secondarily, in renal blood flow, which may cause renal failure.
Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pre-treatment state.
Systemic lupus erythematosus and mixed connective tissue disease – increased risk of aseptic meningitis (see below and section 4.8 Undesirable effects).
Severe skin reactions:
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 100mg/5ml Oral Suspension should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesion, or any other sign of hypersensitivity.
Exceptionally, varicella can be at the origin of serious cutaneous and soft tissues infectious complications. To date, the contributing role of NSAIDs in the worsening of these infections cannot be ruled out. Thus, it is advisable to avoid use of ibuprofen in case of varicella (chickenpox).
Ibuprofen, like other NSAIDs, can interfere with platelet aggregation and prolong bleeding time in normal subjects.
Aseptic meningitis has been observed on rare occasions in patients on ibuprofen therapy. Although it is probably more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has been reported in patients who do not have an underlying chronic disease.
Ibuprofen 100mg/5ml Oral Suspension 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 100mg/5ml Oral Suspension is administered for fever or pain relief in relation to infection, monitoring of infection is advised. In non-hospital settings, the patient should consult a doctor if symptoms persist or worsen.
Excipients: Maltitol, Sodium methylhydroxybenzoate, sodium propylhydroxybenzoate, Propylene glycol and Sodium.
This medicinal product contains Maltitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Maltitol may have a mild laxative effect.
may cause allergic reactions (possibly delayed).
This medicine product contains 5.2 mg propylene glycol in each 5 ml.
This medicine contains less than 1 mmol sodium (23 mg) per 5 ml dose, that is to say essentially ‘sodium-free’.
Ibuprofen should be avoided in combination with:
Acetylsalicylic acid (Aspirin): As with other products containing NSAIDs, concomitant administration of ibuprofen and acetylsalicylic acid is not generally recommended because of the potential of increased adverse effects (see section 4.4).
Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose acetylsalicylic acid 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)
Methotrexate: NSAIDs may inhibit the tubular secretion of methotrexate and reduce clearance of methotrexate.
Ibuprofen should be used with caution in combination with:
Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin (see section 4.4).
Antihypertensives, beta-blockers and diuretics: NSAIDs may reduce the effect of anti-hypertensives, such as ACE inhibitors, angiotensin-II receptor antagonists, beta-blockers and diuretics.
Diuretic can also increase the risk of nephrotoxicity of NSAIDs.
Corticosteroids: increased risk of gastrointestinal ulceration or bleeding with NSAIDs (see section 4.4 Special warnings).
Anti-platelets agents and selective serotonin reuptake inhibitors (SSRIs): Increased risk of gastrointestinal bleeding with NSAIDs (see section 4.4).
Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increased plasma cardiac glycoside levels.
Ciclosporin: Increased risk of nephrotoxicity.
Mifepristone: A decrease in the efficacy of the medicinal product can theoretically occur due to the antiprostaglandin properties of NSAIDs. Limited evidence suggests that coadministration of NSAIDs on the day of prostaglandin administration does not adversely influence the effects of mifepristone or the prostaglandin on cervical ripening or uterine contractility and does not reduce the clinical efficacy of medicinal termination of pregnancy.
Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.
Lithium: Decreased elimination of lithium.
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 quinolone may have increased risk of developing convulsions.
Aminoglycosides: NSAIDs may decrease the excretion of aminoglycosides.
Cholestyramine: The concomitant administration of ibuprofen and cholestyramine may reduce the absorption of ibuprofen in the gastrointestinal tract. However, the clinical significance is unknown.
Sulphonylureas: NSAIDs may potentiate the effects of sulfonylurea medications. There have been rare reports of hypoglycaemia in patients on sulfonylurea medications receiving ibuprofen.
Herbal extracts: Ginkgo biloba may potentiate the risk of bleeding with NSAIDs.
CYP2C9 Inhibitors: Concomitant administration of ibuprofen with CYP2C9 inhibitors may increase the exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increased S(+)-ibuprofen exposure by approximately 80 to 100% has been shown. Reduction of the ibuprofen dose should be considered when potent CYP2C9 inhibitors are administered concomitantly, particularly when high-dose ibuprofen is administered with either voriconazole or fluconazole.
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after the use of a prostaglandin synthesis inhibitor in early pregnancy. The risk is believed to increase with dose and duration of therapy. In animals, the administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation losses 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 given unless clearly necessary. If ibuprofen is used by a woman attempting to conceive, or during the first or 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 synthesis inhibitors may expose the foetus to the following:
At the end of pregnancy, prostaglandin synthesis inhibitors may expose the mother and the neonate to the following:
Consequently, Ibuprofen is contraindicated during the third trimester of pregnancy.
In limited studies, NSAIDs can appear in the breast milk in very low concentrations. NSAIDs should, if possible, be avoided when breastfeeding.
See section 4.4 Special warnings and precautions for use, regarding female fertility.
Undesirable effects such as dizziness, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. If affected, patients should not drive or operate machinery.
The most commonly-observed adverse events are gastrointestinal in nature.
Peptic ulcers, perforation or gastrointestinal bleeding sometimes fatal, particularly in the elderly may occour (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, gastrointestinal haemorrhage and exacerbation of colitis and Crohn’s disease (see section 4.4) have been reported following ibuprofen administration. Less frequently, gastritis, duodenal ulcer, gastric ulcer and gastrointestinal perforation have been observed.
A transient sensation of burning in the mouth or throat may occur with Ibuprofen 100mg/5ml Oral Suspension.
Immune system disorders: 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, dyspnoea.
© Assorted skin disorders, including rashes of various types, pruritis, urticaria, purpurea, angioedema and, very rarely, erythema multiforme, bullous dermatoses (including Stevens- Johnson syndrome and toxic epidermal necrolysis.
Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment. Clinical studies suggest that use of Ibuprofen, particularly at high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).
Rhinitis and aseptic meningitis (especially in patients with existing autoimmune disorders, such as systemic lupus erythematosus and mixed connective tissue disease) with symptoms of stiff neck, headache, nausea, vomiting, fever or disorientation (see section 4.4).
Exacerbation of infection-related inflammations coinciding with the use of NSAIDs has been described. If signs of an infection occur or get worse during use of Ibuprofen the patient is therefore recommended to go to a doctor without delay.
In exceptional cases, severe forms of skin infections and soft-tissue complications may occur during a varicella infection (see also “Infections and infestations”).
The following adverse reactions possibly related to ibuprofen and displayed by MedDRA frequency convention and system organ classification. Frequency groupings are classified according to the subsequent conventions: 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) and Not known (cannot be estimated from the available data).
| System organ class | Frequency | Adverse reaction |
|---|---|---|
| Infections and infestations | Uncommon | Rhinitis |
| Rare | Meningitis aseptic (see section 4.4) | |
| Blood and lymphatic system disorders | Rare | Leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia, haemolytic anaemia |
| Immune system disorders | Uncommon | Hypersensitivity |
| Rare | Anaphylactic reaction | |
| Psychiatric disorders | Uncommon | Insomnia, anxiety |
| Rare | Depression, confusional state | |
| Nervous system disorders | Common | Headache, dizziness |
| Uncommon | Paraesthesia, somnolence | |
| Rare | Optic neuritis | |
| Eye disorders | Uncommon | Visual impairment |
| Rare | Toxic optic neuropathy | |
| Ear and labyrinth disorders | Uncommon | Hearing impaired, tinnitus, vertigo |
| Respiratory, thoracic and mediastinal disorders | Uncommon | Asthma, bronchospasm, dyspnoea |
| Gastrointestinal disorders | Common | Dyspepsia, diarrhoea, nausea, vomiting, abdominal pain, flatulence, constipation, melaena, haematemesis, gastrointestinal haemorrhage |
| Uncommon | Gastritis, duodenal ulcer, gastric ulcer, mouth ulceration, gastrointestinal perforation | |
| Very rare | Pancreatitis | |
| Not known | Exacerbation of Colitis and Crohn´s disease | |
| Hepatobiliary disorders | Uncommon | Hepatitis, jaundice, hepatic function abnormal |
| Very rare | Hepatic failure | |
| Skin and subcutaneous tissue disorders | Common | Rash |
| Uncommon | Urticaria, pruritus, purpura, angioedema, photosensitivity reaction | |
| Very rare | Severe forms of skin reactions (e.g. Erythema multiforme, bullous reactions, including Stevens-Johnson syndrome, and toxic epidermal necrolysis) | |
| Not known | Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), Acute generalised exanthematous pustulosis (AGEP), Photosensitivity reactions | |
| Renal and urinary disorders | Uncommon | Nephrotoxity in various forms e.g.Tubulointerstitial nephritis, nephrotic syndrome and renal failure |
| General disorders and administration site conditions | Common | Fatigue |
| Rare | Oedema | |
| Cardiac disorders | Very rare | Cardiac failure, myocardial infarction (also see section 4.4) |
| Vascular disorders | Very rare | Hypertension |
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.
None stated except as in ‘Interaction with other medicinal products and other forms of interaction’.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
