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NUROMOL PAIN RELIEF is a brand name for Ibuprofen. 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 associated with migraine, headache, backache, period pain, dental pain, rheumatic and muscular pain, pain of non-serious arthritis, cold and flu symptoms, sore throat and fever. This product is especially suitable for pain which has not been relieved by ibuprofen or…
Verbatim from this product's MHRA label. Tap a section to expand.
For oral administration and short term-use only (not more than 3 days). 4). The patient should consult a doctor if the symptoms persist or worsen or if the product is required for more than 3 days. This medicine is for short-term use and it is not recommended for use beyond 3 days.
Adults:
One tablet to be taken up to three times per day with water. The interval between single doses should be at least six hours. 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 (1200mg Ibuprofen, 3000mg Paracetamol) in any 24 hours period. To minimise 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. Paediatric population Not for use by children and adolescents under 18 years.
Method of administration 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.
System Organ Class Frequency Adverse Events Blood and lymphatic system disorders Very rare (≤1/10,000) Haematopoietic disorders1 Uncommon Hypersensitivity with urticaria and pruritus2 Immune system disorders Very rare (≤1/10,000) Severe hypersensitivity reactions.
Symptoms can include facial, tongue and throat swelling, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock)2 Metabolism and Nutrition Disorders Not known High anion gap metabolic acidosis3 Psychiatric disorders Very rare (≤1/10,000) Confusion, depression and hallucinations.
Uncommon (≥1/1,000 to ≤1/100):
Headache and dizziness. Rare Paraesthesia Nervous system disorders Very rare (≤1/10,000) Aseptic meningitis4, optic neuritis and somnolence. Eye disorders Very rare (≤1/10,000) Visual disturbance. Ear and labyrinth Very rare Tinnitus and vertigo.
disorders (≤1/10,000) Common Oedema Very rare (≤1/10,000) Cardiac failure Cardiac disorders Not known Kounis syndrome Vascular Disorders Very Rare Hypertension5 Respiratory and thoracic and mediastinal disorders Very rare (≤1/10,000) Respiratory tract reactivity including: asthma, exacerbation of asthma, bronchospasm and dyspnoea 2 Common (≥1/100 to ≤1/10) Abdominal pain, vomiting, diarrhoea, dyspepsia, nausea and abdominal discomfort6 Gastrointestinal Disorders Uncommon (≥1/1,000 to ≤1/100): Peptic ulcer, gastrointestinal perforation or gastrointestinal haemorrhage, melaena haematemesis 7, mouth ulceration, exacerbation of ulcerative colitis and Crohn’s disease8, gastritis, pancreatitis, flatulence and constipation.
This medicine is for short-term use and is not recommended for use beyond 3 days.
Paracetamol:
Care is advised in the administration of Paracetamol to patients with severe renal or severe hepatic impairment. The hazard of paracetamol overdose is greater in patients with non- cirrhotic alcoholic liver disease. 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. • 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. Renal function should be monitored in these patients. 3). Dose reduction is recommended in patients showing signs of worsening hepatic function.
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.
1. 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). 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 (≤1/10,000) 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 Not known Decreased Appetite Hypokalaemia* Renal and urinary disorders Very rare (≤1/10,000) Not known Nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome, and acute and chronic renal failure 10.
Ureteric colic, dysuria Renal tubular acidosis* Not known General disorders and administration site conditions Very rare (≤1/10,000) Fatigue and malaise. Common (≥1/100 to ≤1/10) Alanine aminotransferase increased, gamma- glutamyltransferase increased and liver function tests abnormal with paracetamol.
Blood creatinine increased and blood urea increased. Investigations Uncommon (≥1/1,000 to ≤1/100) Aspartate aminotransferase increased, blood alkaline phosphatase increased, blood creatine phosphokinease increased, blood creatinine increased, haemoglobin decreased and platelet count increased.
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 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 […]
• Cardiovascular and cerebrovascular effects Cases of Kounis syndrome have been reported in patients treated with Nuromol Pain Relief 200mg/500mg 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.
Appropriate monitoring and advice are required for patients with a history of hypertension and/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).
g. ≤1200 mg daily) 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. • Gastrointestinal bleeding, ulceration and perforation: 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.
5). When GI bleeding or ulceration occurs in patients receiving ibuprofen containing products, the treatment should be withdrawn. 8). • SLE and mixed connective tissue disease: In […]