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IBUPROFEN/PARACETAMOL INTERDOS is a brand name for Acetaminophen (also known as Paracetamol). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For the temporary relief of mild to moderate pain which has not been relieved by ibuprofen or paracetamol individually such as migraine, headache, backache, period pain, dental pain, rheumatic and muscular pain, cold and flu symptoms, sore throat and fever.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology For short term-use only. Before Ibuprofen/Paracetamol is taken, the patient should first try ibuprofen or paracetamol for pain relief in accordance with the product instructions, for the first day of treatment. If the pain has not been relieved by ibuprofen or paracetamol during the first day of treatment, then the next day Ibuprofen/Paracetamol can be taken.
4). The patient should consult a doctor if the symptoms persist or worsen or if the product is required for more than 3 days.
Adults:
One capsule 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 capsules may be taken up to three times a day. Leave at least six hours between doses.
Do not take more than six capsules of this medicine (3000 mg Paracetamol, 1200 mg Ibuprofen) in any 24 hour- period. To minimize side effects, it is recommended that patients take this medicine with food. 4). The elderly are at increased risk of the serious consequences of adverse reactions.
If an 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. Not for use by children under 18 years.
Method of administration For oral use.
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.
Adverse events which have been associated with Ibuprofen alone or Paracetamol alone are given below, tabulated by system organ class and frequency. 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 Haematopoietic disorders1 Uncommon Hypersensitivity with urticaria and pruritus2 Immune system disorders Very rare Severe hypersensitivity reactions.
Symptoms can include facial, tongue and throat swelling, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock)2 Psychiatric disorders Very rare Confusion, depression and hallucinations. Nervous system disorders Very rare Aseptic meningitis4, paraesthesia, optic neuritis and somnolence.
Eye disorders Very rare Visual disturbance. Ear and labyrinth disorders Very rare Tinnitus and vertigo. Cardiac Disorders Very rare Cardiac failure and oedema5 Not known Kounis syndrome Vascular Disorders Very rare Hypertension5 Respiratory and thoracic and mediastinal disorders Very rare Respiratory reactivity including: asthma, exacerbation of asthma, bronchospasm and dyspnoea 2 Common Abdominal pain, vomiting, diarrhoea, dyspepsia, nausea andabdominal discomfort6 Gastrointestinal Disorders Uncommon Peptic ulcer, gastrointestinal perforation or gastrointestinal haemorrhage, melaena haematemesis7, mouth ulceration, exacerbation of ulcerative colitis and Crohn’s disease8, gastritis, pancreatitis, flatulence and constipation.
Do not exceed the recommended dose. 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.
Keep out of the sight and reach of children.
Paracetamol:
The hazards of paracetamol overdose are greater in patients with non-cirrhotic alcoholic liver disease. Immediate medical advice should be sought in the event of an overdose, even if the patient feels well, because of the risk of delayed, serious liver damage.
Do not take with any other paracetamol containing products. 9). 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). 2).
Caution is required in patients with certain conditions: • Respiratory disorders:
In patients suffering from, or with a history of, bronchial asthma or allergic disease NSAIDs have been reported to precipitate bronchospasm. 8). • Cardiovascular and cerebrovascular effects Cases of Kounis syndrome have been reported in patients treated with this medicine.
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. Appropriate monitoring and medical advice are required for 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.
This product is contraindicated: • In patients with a known hypersensitivity to ibuprofen, paracetamol or any other excipients in the product. 5). g. bronchospasm, angioedema, asthma, rhinitis, or urticaria) associated with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
4). • Patients with defects in coagulation. 4). 5). 6)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Hepatobiliary disorders Very rare Abnormal liver function, hepatitis and jaundice9 Common Hyperhidrosis Uncommon Various skin rashes2 Very rare Cases of serious skin reactions have been reported. Severe cutaneous adverse reactions (SCARs) (including Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis) Skin and subcutaneous tissue disorders Not known Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) Acute generalised exanthematous pustulosis (AGEP).
Photosensitivity reactions Metabolism and Nutrition Disorders Not known Decreased Appetite Hypokalaemia* Very rare Nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome, and acute and chronic renal failure 10 Renal and urinary disorders Not known Ureteric colic, dysuria Renal tubular acidosis* General disorders and administration site conditions Very rare Fatigue and malaise.
Common Alanine aminotransferase increased, gamma- glutamyltransferase increased and liver function tests abnormal with paracetamol. Blood creatinine increased and blood urea increased. Investigations Uncommon Aspartate aminotransferase increased, blood alkaline phosphatase increased, blood creatine phosphokinease increased, blood creatinine increased, haemoglobin decreased and platelet count increased.
Description of Selected Adverse Reactions 1Examples include agranulocytosis, anaemia, aplastic anaemia, haemolytic anaemia leucopenia, neutropenia, pancytopenia and thrombocytopenia. First signs are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising and nose bleeding.
2Hypersensitivity reactions have been reported. g. g, pruritus, urticaria, angioedema and, more rarely, exfoliative and bullous dermatoses (including epidermal necrolysis, and erythema multiforme). 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.
4The 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).
4). 4) 6The adverse events observed most often are gastrointestinal in nature. 7Sometimes fatal, particularly in the elderly. 4. 9). 10 Especially in long-term use, associated with increased serum urea and oedema. Also, includes papillary necrosis.
*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 reactions Reporting suspected […]
g. myocardial infarction or stroke). 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.
g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) particularly if high doses of ibuprofen (2400 mg/day) are required. • Cardiovascular, renal and hepatic impairment: The administration of NSAIDs may cause a dose dependent reduction in prostaglandin formation and precipitate 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). 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.
8). Gastrointestinal (GI) bleeding, ulceration and 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. 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 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 ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin selective serotonin-reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see […]