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IBUPROFEN TWELVE PLUS PAIN RELIEF is a brand name for Ibuprofen. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ibuprofen Oral Suspension is used for the short-term relief of: migraine, headaches, backache, dental pain, neuralgia and period pains as well as rheumatic and muscular pains, and pain of non-serious arthritic conditions. Ibuprofen Oral Suspension relieves pain and reduces inflammation and temperature. It also…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology For oral administration and short-term use only. During short-term use, if symptoms persist or worsen the patient should be advised to consult a doctor. 4). If in children and adolescents between 12 and 18 years this medicinal product is required for more than 3 days, or if symptoms worsen, a doctor should be consulted.
Page 2 of 11 If in adults the product is required for more than 10 days, or if the symptoms worsen, the patient should consult a doctor.
Adults, the elderly and children and adolescents aged 12 to 18 years:
Take 200-400mg (5-10ml), up to three times a day as required. Leave at least four hours between doses and do not take more than 1200mg (30ml) in any 24 hour period. Ibuprofen Oral suspension should not be used in children under 12 years of age The package includes an oral syringe for oral administration of Ibuprofen Oral Suspension.
25 ml steps up to 5 ml. 5 ml oral suspension corresponds to 200 mg ibuprofen. The bottle should be shaken vigorously before use.
Special patient groups Elderly population:
No special dose adjustment is required in the elderly. 4), the elderly should be monitored particularly carefully. Method of administration For oral administration. The bottle should be shaken vigorously before use. The oral suspension can be taken with food.
The package includes an oral syringe for oral administration or Ibuprofen oral suspension. 25ml steps up to 5ml. 5ml oral suspension corresponds to 200mg ibuprofen.
Adverse events which have been associated with Ibuprofen are given below, listed by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1000 to <1/100, rare (≥ 1/10,000 to <1/1000), 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. The list of the following adverse events relates to those experienced with ibuprofen at OTC doses for short term use. In the treatment of chronic conditions, under long-term treatment, additional adverse events may occur.
The adverse events observed most often are gastrointestinal in nature. Adverse events Page 7 of 11 are mostly dose-dependent, in particular the risk of occurrence of gastrointestinal bleeding is dependent on the dosage range and duration of treatment.
4). System Organ Class Frequency Adverse Event Blood and Lymphatic System Disorders Very rare Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis)1.
Uncommon Hypersensitivity reactions consisting of:
Urticarial and pruritus2 Immune System Disorders Very rare Severe hypersensitivity reactions. Symptoms could be: facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angiodema or severe shock)2 Respiratory, Thoracic and Mediastinal Disorders Not Known Respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea2.
Uncommon HeadacheNervous System Disorders Very rare Aseptic meningitis3. Cardiac Disorders Not Known Cardiac failure and oedema4 Kounis syndrome Vascular Disorders Not Known Hypertension4 Uncommon Abdominal pain, nausea, dyspepsia5 Rare Diarrhoea, flatulence, constipation and vomiting Gastrointestinal Disorders Very rare Peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haemotemesis6, sometimes fatal, particularly in the elderly.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see gastrointestinal and cardiovascular risks below).
Masking of symptoms of underlying infections:
Ibuprofen 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 is Page 3 of 11 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. 2).
Respiratory:
Bronchospasm may be precipitated in patients suffering from, or with a history of, bronchial asthma or allergic disease. 5). 8). There is a risk of renal impairment in dehydrated children and adolescents. Renal tubular acidosis and hypokalaemia may occur following acute overdose and in patients taking ibuprofen products over long periods it high doses (typically greater than 4 weeks), including doses exceeding the recommended daily dose.
8) 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).
1. g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin (acetylsalicylic acid) or other non-steroidal anti-inflammatory drugs (NSAIDs). 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. 4). 6)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Ulcerative stomatitis, gastritis. 4). Hepatobiliary Disorders Very rare Liver disorders Uncommon Various skin rashes2 Skin and Subcutaneous Tissue Disorders Very rare Severe cutaneous adverse reactions (SCARs) (including Erythema multiforme exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis) Page 8 of 11 Not Known Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome).
Acute generalised exanthematous pustulosis (AGEP). Photosensitivity reactions. Very rare Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema Renal and Urinary Disorders Not Known Ureteric colic, dysuria, renal tubular acidosis9 Investigations Very rare Decreased haemoglobin levels Infections and infestations Not Known Exacerbation of infections related inflammation has been described, in exceptional cases, severe skin infections and soft tissue complications may occur during a varicella infection.
Metabolic and Nutrition Disorders Not Known Decreased Appetite Hypokalaemia9 Description of Selected Adverse Reactions 1First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.
2Hypersensitivity reactions have been reported following treatment with ibuprofen. These may consist of (a) nonspecific allergic reactions and anaphylaxis, (b) respiratory tract activity comprising asthma, aggravated asthma, bronchospasm, dyspnoea or (c) assorted skin disorders, including rashes of various types pruritus, urticaria, purpura, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
3The 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).
Of note, single cases of symptoms of aseptic meningitis (such as stiff neck, headache, nausea, vomiting, fever or disorientation) have been observed during treatment with ibuprofen, in patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease).
g. 4). 5The adverse events observed most often are gastrointestinal in nature. 6Sometimes fatal. 8Especially in long-term use, associated with increased serum urea and oedema. Also includes papillary necrosis. Page 9 of 11 9Renal 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store).
g. ≤1200 mg daily) is associated with an increased risk of myocardial infarction. 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 oral suspension. 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.
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. 8 – undesirable effects).
GI bleeding, ulceration or 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 GI events. 3), 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. 5). When GI bleeding or ulceration occurs in patients receiving Ibuprofen Oral Suspension, the treatment should be withdrawn.
8). Most of these reactions occurred within the first month. If signs and symptoms suggestive of these reactions appear ibuprofen should be withdrawn immediately, and an alternative treatment considered (as appropriate).
Advice for patients with sugar-related disorders:
This medicinal product contains maltitol liquid. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
Advice for patients on a controlled sodium diet:
This medicinal […]