IBUPROFEN AND CODEINE

For oral administration. 4).

Recommended dosage:

Adults, the elderly and children over 12 years: One or two tablets every four to six hours. Do not take more than 6 tablets in 24 hours. Leave at least four hours between doses. 4).

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 ibuprofen in any 24-hour period.

8mg film-coated Tablets, treatment duration and treatment goals, should be agreed together with the patient, in accordance with pain management guidelines. 8mg film-coated Tablets should not be used longer than necessary. The duration of treatment should be as short as possible and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a healthcare professional.

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.

). 8). There is a risk of renal impairment in dehydrated children and adolescents. g. g. GI haemorrhage). Severe hypokalaemia and renal tubular acidosis have been reported due to prolonged use of ibuprofen at higher than recommended doses.

9). Presenting signs and symptoms included reduced level of consciousness and generalised weakness. Ibuprofen induced renal tubular acidosis should be considered in patients with unexplained hypokalaemia 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.

Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). g. ≤ 1200 mg/day) is associated with an increased risk of myocardial infarction.

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. 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 anytime 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 Interactions). When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn. 8). Most of these reactions occurred within the first month. If signs and symptoms suggestive of these reactions appear this medicine should be withdrawn immediately and an alternative treatment considered (as appropriate).

Masking of symptoms of underlying infections:

Ibuprofen 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 this medicine is 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. Codeine Codeine should be used with caution in patients with hypotension, hypothyroidism or head injury.

As with other opioids, codeine should be used with caution in patients taking benzodiazepines or other central nervous system (CNS) depressants, including alcohol. The effects of CNS depressants (including alcohol) may be potentiated by codeine.

g. peptic ulcer), recent gastrointestinal surgery, gallstones, myasthenia gravis, prostatic hypertrophy, 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. 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 […]

8mg film-coated Tablets concurrently with any other codeine containing compounds. Ibuprofen Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see GI and cardiovascular risks below).

2).

Respiratory:

Bronchospasm may be precipitated in patients suffering from or with a previous history of bronchial asthma or allergic disease. 5). 8 Undesirable effects). 8). There is a risk of renal impairment in dehydrated children and adolescents.

g. g. GI haemorrhage). Severe hypokalaemia and renal tubular acidosis have been reported due to prolonged use of ibuprofen at higher than recommended doses. 9). Presenting signs and symptoms included reduced level of consciousness and generalised weakness.

Ibuprofen induced renal tubular acidosis should be considered in patients with unexplained hypokalaemia 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.

Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). g. ≤ 1200 mg/day) is associated with an increased risk of myocardial infarction.

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. 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 anytime 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.

Caution should be advised in patients receiving concomitant medications which could increase the risk of gastrotoxicity, ulceration or bleeding, such as oral corticosteroids, selective serotonin-reuptake inhibitors, anti-platelet agents such as aspirin or anticoagulants such as warfarin (see section

Hypersensitivity to ibuprofen, codeine or any of the excipients 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, special warnings and precautions for use). 6 Pregnancy and lactation). 6). In patients with respiratory depression, chronic constipation or raised intracranial pressure.

5). 4). In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers.