Product information

Nuromol 200mg/500mg tablets

Active ingredients: Each tablet contains ibuprofen (200mg) and paracetamol (500mg). Indications: 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 requires stronger analgesia than ibuprofen or paracetamol alone. Dosage instructions: Adults over 18 yrs: One tablet to be taken up to three times per day with water. If needed, dose may be increased to two tablets three times a day. Leave at least six hours between doses. Maximum of 6 tablets per 24 hours. To minimise side effects, it is recommended that patients take Nuromol with food. If symptoms persist, worsen or if the product is required for more than 3 days, the patient should consult a doctor. Elderly: The lowest effective dose should be used for the lowest possible duration. The patient should be monitored regularly for gastrointestinal bleeding when using a NSAID. Contra-indications: Known hypersensitivity to ibuprofen, paracetamol or any other excipients. History of hypersensitivity reactions associated with acetylsalicylic acid/NSAIDs. History of, or an existing gastrointestinal ulceration/perforation or bleeding, defects in coagulation, severe hepatic failure, severe renal failure or severe heart failure. During the last trimester of pregnancy. Do not give: in concomitant use with other paracetamol-containing products or with other NSAID containing products, including cyclo-oxygenase-2 (COX-2) specific inhibitors and doses of acetylsalicylic acid above 75 mg daily. Side effects, precautions: The risk of paracetamol overdose is 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. Caution is required in elderly patients and in patients with certain conditions: respiratory disorders, cardiovascular, cerebrovascular, renal and hepatic impairment, gastrointestinal bleeding, ulceration and perforation, SLE and mixed connective tissue disease. Serious skin conditions and impaired female fertility may occur. Severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells). Warnings for use: do not give to patients who have taken ibuprofen or paracetamol in the last 6 hours; do not give in combination with paracetamol or NSAID containing medicine. Common side effects: abdominal pain, diarrhoea, dyspepsia, nausea, stomach discomfort and vomiting. Increase in amino-transferase, gammaglutamyltransferase, blood creatine, blood urea, liver disfunction. Recommended retail price: (ex. VAT): £3.99 (12 tablets), £6.99 (24 tablets). Supply classification: P Marketing authorisation holder: Reckitt Benckiser Healthcare (UK) Ltd, Slough, SL1 3UH MA number: PL 00063/0649 Date last revised: February 2018 For full information refer to SPC (http://www.medicines.org.uk/emc/)

Ibuprofen 200mg Liquicaps or Nurofen Express 200mg Liquid Capsules or Nurofen 200mg Liquid Capsules: Each capsule, soft contains Ibuprofen 200 mg.

Indications: for the symptomatic relief of rheumatic or muscular pain, backache, neuralgia, migraine, headache, dental pain, dysmenorrhoea, feverishness colds and influenza symptoms. Dosage and Administration: Adults, the elderly and children and adolescents between 12 and 18 years: Take one or two capsules, up to three times a day as required. Leave at least 4 hours between doses. Do not take more than 6 capsules in any 24 hour period. Not for use by children under 12 years of age. Children and adolescents between 12 and 18 years: Do not use for more than 10 days, or if symptoms worsen, without medical advice. Adults: Do not use for more than 10 days, or if symptoms worsen, without medical advice. Contraindications: Known hypersensitivity to ibuprofen or other ingredients. History of bronchospasm, asthma, rhinitis, or urticaria, associated with aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs). History of, or existing gastrointestinal ulceration/perforation or bleeding, including that associated with NSAIDs. Severe hepatic failure, severe renal failure or severe heart failure. Concomitant NSAIDs, including COX-2 inhibitors. Last trimester of pregnancy. Special warnings and precautions for use: SLE and mixed connective tissue disease. Gastrointestinal disorders and chronic inflammatory intestinal disease. Hypertension and/or cardiac impairment. Renal impairment can occur, particularly in dehydrated children and adolescents. Hepatic dysfunction. Bronchial asthma or allergic disease. 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 GI events. Caution with concomitant medications which could increase the risk of gastrotoxicity or bleeding, such as corticosteroids, or anticoagulants such as warfarin or anti-platelet agents such as aspirin. Withdraw treatment if GI bleeding or ulceration occurs. Possible reversible effects on fertility. Avoid use during the first 6 months of pregnancy if possible. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Side effects: Hypersensitivity reactions including: (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract reactivity e.g. asthma, aggravated asthma, bronchospasm, dyspnoea, (c) various skin reactions e.g. pruritus, urticaria, angiodema and more rarely exfoliative, bullous dermatoses (including epidermal necrolysis and erythema multiforme) and DRESS syndrome (drug reaction with eosinophilia and systemic symptoms). Gastrointestinal disturbance including: peptic ulcer, perforation or GI haemorrhage, headache, acute renal failure, liver disorders, haematopoietic disorders including anaemia. Product Licence Number: PL 00063/0648. Licence Holder: Reckitt Benckiser Healthcare (UK) Ltd, SL1 4AQ. Legal category: GSL MRRP: £3.29 (10 capsules), £4.29 (16 capsules) Date: June 2018 – For full information refer to SPC (http://www.medicines.org.uk/emc/)

Nurofen Plus Tablets

Nurofen Plus: Each tablet contains 200mg ibuprofen and 12.8mg of Codeine phosphate. Indications: is indicated in patients older than 12 years of age for the short term treatment of acute, moderate pain (such as rheumatic and muscular pain, backache, migraine, headache, neuralgia, period pain and dental pain) which is not considered to be relieved by other analgesics such as paracetamol, ibuprofen or aspirin alone. Posology and method of administration: Adults, the elderly and children over 12 years of age: One or two tablets every four to six hours. Children aged 12-18 years: One or two tablets every four to six hours. Children under 12 years: Nurofen plus (which contains Codeine) should not be used in children below the age of 12 years because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine. Elderly: No special dosage modifications are required for elderly patients, unless renal or hepatic function is impaired, in which case dosage should be assessed individually. Do not take more than 6 tablets in 24 hours. Leave at least four hours between doses and do not take more than 1200mg in any 24 hour period. The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician. For short term use only. Codeine should be used at the lowest effective dose for the shortest period of time necessary to relieve symptoms. The patient should consult a doctor if symptoms persist or worsen or if the product is required for more than 3 days. Method of administration: for oral administration. Contraindications: Hypersensitivity to Ibuprofen, Codeine or to any of the constituents listed in the product. Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to Acetylsalicylic Acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDSs). 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. Last trimester of pregnancy. In women during breastfeeding. Respiratory depression, chronic constipation. Concomitant treatment with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of stopping treatment. In all paediatric patients (0-18 years of age) who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome due to an increased risk of developing serious and life threatening adverse reactions. In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers. 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. The elderly are at increased frequency of adverse reactions to NSAIDS, especially gastrointestinal bleeding and perforation which may be fatal. 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 Nurofen Plus with concomitant NSAIDS including cyclooxygenase-2-selective inhibitors should be avoided. SLE and mixed connective tissue disease: Systemic lupus erythematosus and mixed connective tissue disease due to increased risk of aseptic meningitis. Renal: Renal impairment as renal function may further deteriorate. There is a risk of renal impairment in dehydrated children and adolescents. Hepatic: Hepatic dysfunction. 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 and oedema have been reported in association with NSAID therapy. 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. Nurofen Plus tablets should be used with caution in those with hypotension and/ or hypothyroidism. The tablets should be used with caution in patients with raised intracranial pressure or head injury. 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 effects: NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) as these conditions may be exacerbated. Gastrointestinal 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, 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 gastrotoxicity, ulceration or bleeding, such as oral corticosteroids, or anticoagulants such as warfarin, selective serotonin reuptake inhibitors or anti-platelet agents such as Acetylsalicylic Acid (aspirin). When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn. Dermatological effects: 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. Patients appear to be at highest risk of 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. Nurofen PLUS should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Do not take concurrently with any other Codeine containing compounds. Care is advised in the administration of Codeine to patients with hypotension, hypothyroidism, adrenocortical insufficiency, shock, obstructive bowel disorders, acute abdominal conditions (e.g. peptic ulcer), recent astrointestinal surgery, gallstones, myasthenia gravis, a history of peptic ulcer or convulsions and also in patients with a history of drug abuse. Elderly patients may metabolise or eliminate opioid analgesics more slowly than younger adults. Codeine should be used with caution in the elderly and debilitated patients as they may be more susceptible to the respiratory depressant effects. Prolonged regular use of Codeine, except under medical supervision, may lead to physical and psychological dependence (addiction) and result in withdrawal symptoms, such as restlessness and irritability once the drug is stopped. If you are pregnant or are being prescribed medicines by your doctor, seek this advice before taking this product. Care is advised in the administration of this product in patients with severe renal or severe hepatic impairment (hepatic disease). CYP2D6 metabolism: Codeine is metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite. If a patient has a deficiency or is completely lacking this enzyme an adequate analgesic effect will not be obtained. Estimates indicate that up to 7% of the Caucasian population may have this deficiency. However, if the patient is an extensive or ultra-rapid metaboliser there is an increased risk of developing side effects of opioid toxicity even at commonly prescribed doses. These patients convert codeine into morphine rapidly resulting in higher than expected serum morphine levels. General symptoms of opioid toxicity include confusion, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation and lack of appetite. In severe cases this may include symptoms of circulatory and respiratory depression which may be life-threatening and very rarely fatal. Side effects: Blood and Lymphatic System Disorders, very rare: haematopoietic disorders. Immune System Disorders, uncommon: hypersensitivity reactions with urticaria and Pruritus; very rare: severe hypersensitivity reactions. Symptoms could be: facial, tongue and throat swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or severe shock). Metabolism and Nutrition Disorders, not known: decreased appetite. Psychiatric Disorders, not known: depression, hallucination, confusional state, dependence, mood altered, restlessness, nightmares. Nervous System Disorders, uncommon: headache; very rare: aseptic meningitis; not known: dizziness, drowsiness, convulsion, Intracranial, pressure increased, headache, dyskinesia. Eye Disorders, not known: vision blurred, diplopia. Ear and Labyrinth disorders, not known: vertigo. Cardiac Disorders, not known: cardiac failure, oedema, bradycardia, palpitations. Vascular Disorders, not known: hypertension, orthostatic hypotension. Respiratory, Thoracic and Mediastinal Disorders, not known: respiratory tract reactivity comprising asthma, bronchospasm or dyspnea. Respiratory depression, cough suppression. Gastrointestinal Disorders, uncommon: abdominal pain, nausea and dyspepsia; rare: diarrhoea, flatulence, constipation and vomiting; very rare: peptic ulcer, gastrointestinal perforation or gastrointestinal haemorrhage, melaena, and haematemesis. Mouth ulceration and gastritis. Exacerbation of ulcerative colitis and Crohn’s disease. Not known: dry mouth. Hepatobiliary Disorders, very rare: liver disorder; not known: biliary colic. Skin and Subcutaneous Tissue Disorders, uncommon: various skin rashes; very rare: Severe forms of skin reactions such as bullous reactions, including Stevens-Johnsons Syndrome, erythema multiforme and toxic epidermal necrolysis can occur. Not known: flushing. Not known: Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). Musculoskeletal and Connective Tissue Disorders, not known: muscle rigidity. Renal and Urinary Disorders, very rare: acute renal failure; not known: ureteric colic, dysuria. General and Administration Site Conditions, not known: hypothermia, hyperhidrosis, irritability, fatigue, malaise. Investigations, very rare: haemoglobin decreased. Product Licence Number: PL 00063/0376. Licence Holder: Reckitt Benckiser Healthcare (UK) Ltd, SL1 4AQ. Legal category: Pharmacy Only MRRP: £6.99 (24 tablets), £7.99 (32 tablets). Date: May 2018 – For full information refer to SPC (http://www.medicines.org.uk/emc/)

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.