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SOLPADEINE MIGRAINE IBUPROFEN & CODEINE is a brand name for Ibuprofen. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Codeine is indicated in patients older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen alone. For such conditions as soft tissue injuries, including sprains, strains and musculo-tendonitis, backache, non-serious…
Verbatim from this product's MHRA label. Tap a section to expand.
4). 1-2 tablets, up to three times a day as required, preferably with or after food. Leave at least four hours between doses and do not take more than 6 tablets in any 24 hour period.
Paediatric population:
Children and adolescents aged 12 – 18 years: 1 – 2 tablets, up to three times a day as required, preferably with or after food. Leave at least six hours between doses and do not take more than 6 tablets in any 24 hour period. 4).
Elderly:
Non-steroidal anti-inflammatory drugs (NSAIDs) should be used with particular caution in elderly patients who are prone to adverse events.
Route of Administration:
For oral administration and short-term use only. Treatment goals and discontinuation Before initiating treatment with Solpadeine Migraine Ibuprofen & Codeine Tablets, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines.
During treatment in case of prescription, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with codeine, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
4). 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. 8 mg codeine (6 tablets) in any 24-hour period.
Adverse reactions reported from extensive post-marketing experience are listed below by System Organ Class and frequency. The following convention has been utilized for the classification of undesirable effects: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000), not known (cannot be estimated by available data).
Ibuprofen The following list of adverse effects relates to those experienced with ibuprofen at OTC doses, for short term use. In treatment of chronic conditions, under long-term treatment, additional adverse effects may occur. System Organ Class Frequency Adverse Events Gastrointestinal disorders Uncommon Abdominal pain, heartburn nausea and dyspepsia.
Rare Diarrhoea, flatulence, constipation and vomiting. Very rare Peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis, gastritis. 4). Oesophagitis, pancreatitis.
Nervous system disorders Very rare Aseptic meningitis Very Rare Acute renal failure, papillary necrosis, especially in long- term use, associated with increased serum urea and oedema. Not known Ureteric colic, dysuria Renal and urinary disorders Not known Renal tubular acidosis* Hepatobiliary disorders Very rare Liver function disorders, especially in long- term treatment.
Hepatitis, including jaundice Blood and lymphatic system disorders Very rare Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs are: fever, sore throat, superficial mouth ulcers, flu- like symptoms, severe exhaustion, unexplained bleeding and bruising.
Skin and subcutaneous tissue disorders Not known Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), Acute generalized exanthematous pustulosis(AGEP) and photosensitivity reactions. Uncommon Hypersensitivity reactions with urticaria and pruritus.
Patients should be advised to consult their doctor if their headaches become persistent. 5). This medicine contains less than 1 mmol sodium (23 mg) per 2 tablets, that is to say essentially ‘sodium- free’. Solpadeine Migraine Ibuprofen & Codeine Tablets contain lactose.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactosemal absorption should not take this medicine. Ibuprofen Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see GI and cardiovascular risks below).
The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal. Patients should be advised not to take other ibuprofen containing products.
Respiratory:
Bronchospasm may be precipitated in patients suffering from, or with a history of, bronchial asthma or allergic disease. 5). 8). 8). There is a risk of renal impairment in dehydrated children and adolescents. Severe hypokalemia and renal tubular acidosis have been reported due to prolonged use of ibuprofen at higher than recommended doses.
This risk is increased with the use of codeine/ibuprofen as patients may become dependent on the codeine component (see warning on Opioid use disorder. 9). Presenting signs and symptoms included reduced level of consciousness and generalized weakness.
Ibuprofen induced renal tubular acidosis should be considered in patients with unexplained hypokalemia and metabolic acidosis. 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.
Solpadeine Migraine Ibuprofen & Codeine Tablets are contraindicated in individuals with hypersensitivity to ibuprofen, codeine, opioid analgesics or any of the constituents in the product. g. asthma, rhinitis, angioedema or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs.
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). 6) Respiratory depression, chronic constipation.
In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Immune system disorders Very rare Severe hypersensitivity reactions. Symptoms could be: facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension (anaphylaxis, angioedema or severe shock). Cardiac disorders Not known Oedema, hypertension,cardiac failure and Kounis syndrome.
4). 4). Respiratory, thoracic and mediastinal disorders Very rare Exacerbation of asthma and bronchospasm. Codeine Undesirable effects depend on dose and individual patient metabolism. 4). 4). Nervous system disorders Not known Dizziness, worsening of headache with prolonged use, drowsiness.
Hepatobiliary disorders Not known Sphincter of Oddi dysfunction Skin and subcutaneous tissue disorder Not known Pruritus, sweating. General disorders and administration site conditions Uncommon Drug withdrawal syndrome Renal and urinary disorders Not known Difficulty with micturition Description of Selected Adverse Reactions: *Renal tubular acidosis and hypokalemia have been reported in the post- marketing setting typically following prolonged use of the ibuprofen component at higher than recommended doses due to dependence on the codeine component.
**Drug dependence Repeated use of this medicine can lead to drug dependence, even at therapeutic doses. 4).
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 via the Yellow Card Scheme.
uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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).
g. 1200 mg daily) is associated with an increased risk of myocardial infarction and/or 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 (2400mg/day) should be avoided.
, hypertension, hyperlipidaemia, diabetes mellitus, smoking). 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.
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. 6). 8). 5). 8). 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 serious 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, the treatment should be withdrawn.
Dermatological:
Severe cutaneous adverse reactions (SCARs) Severe cutaneous adverse reactions (SCARs), including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome) and acute […]