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IBUPROFEN & PARACETAMOL is a brand name for Ibuprofen. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: The medicinal product is used for temporary relief of mild to moderate pain which has not been relieved by ibuprofen or paracetamol individually, such as migraine, headache, period pain, dental pain, rheumatic and muscular pain, cold and flu symptoms, sore throat and fever. Ibuprofen/Paracetamol is intended for adults…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology For short term-use only. The patient should try ibuprofen or paracetamol alone first. 4). The patient should consult a doctor if the symptoms persist or worsen or if it is necessary to use this medicine for more than 3 days.
Adults:
One tablet to be taken up to three times per day with water. Leave at least six hours between doses. If the one tablet dose does not control symptoms, a maximum of two tablets may be taken up to three times a day. Leave at least six hours between doses.
Do not take more than six tablets (3000 mg Paracetamol, 1200 mg Ibuprofen) within 24 hours period. 4). To minimise side effects, it is recommended that patients take Ibuprofen/Paracetamol with food. 4). The elderly are at increased risk of the serious consequences of adverse reactions.
If NSAID is considered necessary, the lowest effective dose should be used for the shortest possible duration. The patient should be monitored regularly for gastrointestinal bleeding during NSAID therapy. Paediatric population Not for use by children under 18 years.
Method of administration For oral administration
Clinical trials with this product have not indicated any other undesirable effects other than those for ibuprofen or paracetamol alone. The following table lists adverse effects from pharmacovigilance data experienced by patients taking ibuprofen alone or paracetamol alone in short-term and long-term use.
Frequencies are defined as: 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). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
System Organ Class Frequency Adverse Events Blood and Lymphatic System Disorders Very rare Hematopoietic system disorders (agranulocytosis, anaemia, aplastic anaemia, haemolytic anaemia, leucopenia, neutropenia, pancytopenia and thrombocytopenia).
The first symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising and nose bleeding. Immune System Disorders Very rare Hypersensitivity reactions such as non-specific hypersensitivity reactions and anaphylactic reactions.
Severe hypersensitivity reactions. Symptoms may include: swelling of the face, tongue and larynx, shortness of breath, tachycardia, hypotension, (anaphylactic reaction, angioedema or vascular or life-threatening shock). Psychiatric Disorders Very rare Confusion, depression and hallucinations.
4). Eye Disorders Very rare Visual disturbance. Ear and Labyrinth Disorders Very rare Tinnitus and vertigo. Cardiac and Vascular disorders Very rare Oedema, hypertension, cardiac failure and Kounis syndrome1. Respiratory, thoracic and mediastinal disorders Very rare Respiratory tract activity including asthma, aggravated asthma, bronchospasm and shortness of breath.
Do not use until first trying ibuprofen or paracetamol individually to relieve your pain according to the pack instructions. Consult a doctor if the symptoms persist or worsen or if the product is required for more than 3 days. The risk associated with overdose of paracetamol is higher in patients with alcohol- induced liver failure without symptoms of cirrhosis.
In the event of overdose, immediately contact a doctor even if the patient feels well because there is a risk of delayed, serious liver damage. g. chronic alcoholism who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin.
If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.
2). 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.
Masking of symptoms of underlying infections:
Ibuprofen/Paracetamol 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/Paracetamol 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. 2).
Caution is required in patients with certain conditions: • Respiratory disorders:
1. g. bronchospasm, angioedema, asthma, rhinitis, or urticaria) associated with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs). • History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
• Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). • In patients with coagulation disorders. 4). 5). 5). 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Common Abdominal pain, diarrhoea, dyspepsia, nausea, abdominal discomfort, vomiting. 4). 4). Gastritis and pancreatitis have been reported less frequently. Hepatobiliary disorders Very rare Hepatic impairment, hepatitis or jaundice. 9).
Skin and Uncommon Various types of rashes, including pruritus and urticaria. Angioedema and swelling of the face. Very rare Hyperhydrosis, purpura and photosensitivity. Severe cutaneous adverse reactions (SCARs) (including Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis).
subcutaneous tissue disorders Not known Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), acute generalised exanthematous pustulosis (AGEP). Very rare Various forms of nephrotoxicity including interstitial nephritis, nephrotic syndrome and acute or chronic renal failure.
Not known Ureteric colic, dysuria Renal and urinary disorders Not known Renal tubular acidosis2 General disorders and administration site conditions Very rare Fatigue and malaise. Common Increased alanine aminotransferase, increased gamma-glutamyltransferase activity and altered parameters of liver function after paracetamol administration.
Blood creatinine increased and blood urea increased. Investigations Uncommon Increased aspartate aminotransferase, increased alkaline phosphatase in the blood, increased creatinine phosphokinase in the blood, decreased haemoglobin, and increased platelet count.
4). 2Renal 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. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.
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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
In patients suffering from, or with a history of, bronchial asthma, cases of sudden bronchoconstriction after treatment with NSAIDs have been reported. • Cardiovascular, renal and hepatic impairment: The administration of NSAIDs may cause a dose dependent suppression of prostaglandin synthesis and accelerate the occurrence of renal failure.
Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly. 3). • Cardiovascular and cerebrovascular effects: Appropriate monitoring and medical advice are required for patients with a history of hypertension or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.
g. myocardial infarction or stroke). ≤1200mg/day) is associated with an increased risk of arterial thromboembolic 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.
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. 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.
• Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal (GI) bleeding, ulceration or perforation, which can be fatal, have been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.
3) and in the elderly. These patients should commence treatment on the lowest dose available. g. 5). 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.
5). When GI bleeding or ulceration occurs […]