Source: Health Products Regulatory Authority (ZA) Revision Year: 2024 Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead 2191
MYBUCOD is contraindicated in:
MYBUCOD should not be administered continuously for longer than 5 days as safety has not been established.
MYBUCOD contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest doctor, hospital or Poison Centre must be contacted immediately.
Dosages in excess of those recommended may cause severe liver damage.
Alcohol should be avoided. Increased risk of liver toxicity, especially in alcoholics using high doses of MYBUCOD for a prolonged period of time.
Severe cutaneous adverse reactions (SCARs) such as toxic epidermal necrolysis (TEN), Steven-Johnson syndrome (SJS), acute generalised exanthematous pustulosis (AGEP), eosinophilia and systemic (DRESS)/Drug induced hypersensitivity syndrome (DIHS) and fixed drug eruptions (FDE) have been reported in patients treated with paracetamol containing medicines. If a patient develops SCAR, treatment with MYBUCOD must immediately be discontinued and appropriate treatment instituted.
EXCEEDING THE PRESCRIBED DOSE, TOGETHER WITH PROLONGED AND CONTINUOUS USE OF THIS MEDICATION MAY LEAD TO DEPENDENCY AND ADDICTION.
Tolerance, physical and psychological dependence, and opioid use disorder (OUD) may develop upon repeated administration of opioids such as codeine, as in MYBUCOD. Abuse or intentional misuse of MYBUCOD may result in overdose and/or death.
Serious clinical outcomes, including fatalities, have been reported in association with abuse and dependence with codeine/ibuprofen combinations, particularly when taken for prolonged periods at higher than recommended doses. These have included reports of gastrointestinal perforations, gastrointestinal haemorrhages, severe anaemia, renal failure, renal tubular acidosis, and severe hypokalaemia associated with the ibuprofen component.
Patients should be informed about the risks and signs of OUD as well as serious clinical outcomes. If these signs occur, patients should be advised to contact their doctor. Withdrawal symptoms, such as restlessness and irritability may occur once the drug is stopped.
MYBUCOD should be used with caution in the following:
Conditions predisposing to and exacerbated by fluid retention such as compromised cardiac function, congestive heart disease, pre-existing oedema, hypertension, and renal function impairment: MYBUCOD may cause fluid retention and oedema (See section 4.3).
Special care has to be taken in the following cases:
The elderly have an increased frequency of adverse reactions to NSAIDs including MYBUCOD, especially gastrointestinal perforation, ulceration, and bleeding (PUBs) which may be fatal.
Elderly patients are more likely to develop adverse hepatic or renal effects and if gastrointestinal ulceration or bleeding occurs is more likely to cause serious consequences.
Gastrointestinal 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 gastrointestinal events.
The risk of gastrointestinal bleeding, perforation or ulceration or is higher with increasing doses of MYBUCOD, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly.
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.
The use of ibuprofen, as in MYBUCOD, with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided due to the increased risk of ulceration or bleeding (see section 4.5).
Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as corticosteroids, selective serotonin- reuptake inhibitors and anti-platelet medicines such as aspirin (see section 4.5).
When gastrointestinal bleeding or ulceration occurs in patients receiving MYBUCOD, the treatment should be withdrawn.
MYBUCOD should be given with caution to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohn’s disease, hiatus hernia, gastro-oesophageal reflux disease, angiodysplasia) as the condition may be exacerbated (see section 4.8).
Caution 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 MYBUCOD therapy.
In view of MYBUCODs inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients
Caution is required in patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking), and should only be treated with MYBUCOD after careful consideration.
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported (see section 4.8).
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. Acute generalised exanthematous pustulosis (AGEP) has been reported.
MYBUCOD should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Exceptionally, varicella can be at the origin of serious cutaneous and soft tissues infectious complications. It is advisable to avoid use of MYBUCOD, in case of varicella.
Drug reaction with eosinophilia and systemic symptoms has been reported in patients taking NSAIDs such as MYBUCOD. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling. Other clinical manifestations may include hepatitis, nephritis, haematological abnormalities, myocarditis, or myositis. Sometimes symptoms of DRESS may resemble an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its presentation, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, discontinue MYBUCOD and evaluate the patient immediately.
MYBUCOD is metabolised in the liver. Increased risk of hepatotoxicity (see section 4.3 and 4.8). Dosage of MYBUCOD in excess of those recommended may cause severe liver damage.
Ibuprofen, as in MYBUCOD, may cause the retention of sodium, potassium and fluid in patients who have not previously suffered from renal disorders because of its effect on renal perfusion. This may cause oedema or even lead to cardiac insufficiency or hypertension in predisposed patients.
MYBUCOD is contraindicated in renal function impairment as renal failure may be provoked, especially in patients with pre-existing renal impairment (see section 4.3).
There have been reports of acute interstitial nephritis with haematuria, proteinuria and occasionally nephrotic syndrome. Cases of renal toxicity have also been observed in patients in whom prostaglandins play a compensatory role in the maintenance of renal perfusion. In these patients, administration of MYBUCOD may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of suffering this reaction are those with renal dysfunction, heart failure, hepatic dysfunction, those taking diuretics and ACE inhibitors and the elderly. Discontinuation of MYBUCOD is generally followed by recovery to the pre-treatment state.
There is a risk of renal impairment in dehydrated children and adolescents.
Asthma may be exacerbated in patients suffering from or with a previous history of bronchial asthma or allergic disease. MYBUCOD may decrease respiratory drive and increase airway resistance in these patients (see section 4.3).
Systemic lupus erythematosus and mixed connective tissue disease -increased risk of aseptic meningitis (see section 4.8).
In patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen as contained in MYBUCOD, single cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever, or disorientation have been observed.
Hypersensitivity reactions have been reported.
MYBUCOD should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other sign of hypersensitivity. If taking for pain, including arthritic pain, and the pain persists for longer than 5 days, or if taking for fever and the fever persists for longer than 3 days, or if the condition deteriorates or new symptoms develop, a healthcare provider needs to be contacted as additional treatment may be necessary.
The antipyretic, analgesic, and anti-inflammatory action of ibuprofen as contained in MYBUCOD may mask symptoms of the occurrence of worsening 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 MYBUCOD 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.
Diabetic patients may experience a false result with blood glucose test.
Possibility of cross sensitivity.
Dosage should be reduced.
May be exacerbated.
Increased risk of bleeding.
Limit use of NSAIDs, including MYBUCOD, between 20 and 30 weeks of pregnancy due to the risk of oligohydramnios/foetal renal dysfunction. Avoid use of NSAIDs in women around 30 weeks gestation and later in pregnancy due to the risks of oligohydramnios/foetal renal dysfunction and premature closure of the foetal ductus arteriosus (see section 4.3 and 4.6). If NSAID treatment is necessary between 20 weeks and 30 weeks gestation, limit MYBUCOD use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if MYBUCOD treatment extends beyond 48 hours. Discontinue MYBUCOD if oligohydramnios occurs and follow up according to clinical practice.
Possible enhanced bleeding if surgery is required.
MYBUCOD is not recommended for use for children under twelve years of age (see section 4.2).
Unless low-dose aspirin (not above 75mg daily) has been advised by a doctor, concomitant administration of ibuprofen, as in MYBUCOD, and acetylsalicylic acid is not generally recommended because of the potential of increased adverse effects.
Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose acetylsalicylic acid on platelet aggregation when they are dosed concomitantly. Although there are uncertainties regarding extrapolation of data to the clinical situation, the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded.
Use of two or more NSAIDs concomitantly could result in an increase in side effects.
Enhancement of anticoagulant effect and the possibility of gastrointestinal ulceration or bleeding (see section 4.3 and 4.4).
Increased and prolonged methotrexate plasma concentration and an increased risk of methotrexate toxicity.
NSAIDs, such as ibuprofen, as in MYBUCOD, inhibit the tubular secretion of methotrexate and certain metabolic interactions can occur resulting in decreased clearance of methotrexate. The administration of Ibuprofen within 24 hours before or after the administration of methotrexate can lead to an elevated concentration of methotrexate and an increase in its toxic effects. Therefore, concomitant use of MYBUCOD and high doses of methotrexate should be avoided. Also, the potential risk of interactions in low dose treatment with methotrexate should be considered, especially in patients with impaired renal function. In combined treatment, renal function should be monitored.
Corticosteroids:
Increased risk of gastrointestinal perforation, ulceration, or bleeding (PUBs) (see section 4.4).
Anti-platelet medicines (e.g clopidogrel and ticlopidine) and selective serotonin reuptake inhibitors (SSRIs):
Increased risk of gastrointestinal bleeding (see section 4.4).
Antihypertensives, beta blockers and diuretics:
NSAIDs, such as ibuprofen, as in MYBUCOD, may reduce the effect of antihypertensives, such as ACE inhibitors, beta blockers, angiotensin-II antagonists and diuretics.
In patients with reduced kidney function (e.g. dehydrated patients or elderly patients with reduced kidney function), the concomitant use of an ACE inhibitor, beta blocker or angiotensin II antagonist with a cyclooxygenase-inhibiting medicines can lead to further impairment of kidney function and through to acute renal failure. This is usually reversible. Such combination should therefore only be used with caution, especially in elderly patients.
The patients have to be instructed to drink sufficient liquid and periodic monitoring of the kidney values should be considered for the time immediately after the start of the combination therapy.
The concomitant administration of MYBUCOD and potassium-sparing diuretics or ACE-inhibitors can result in hyperkalaemia. Careful monitoring of potassium levels is necessary. Diuretics can also increase the risk of nephrotoxicity of MYBUCOD.
Captopril:
Studies indicate that ibuprofen, as in MYBUCOD, counteracts the effect of captopril of ncreased sodium excretion.
Aminoglycosides:
MYBUCOD may decrease the excretion of aminoglycosides and increase their toxicity.
Antidiabetic medicines (e.g sulphonylureas):
Hypoglycaemic effects of these medicines may be increased.
In the case of simultaneous treatment, monitoring of blood glucose levels is recommended.
Digoxin, phenytoin and lithium:
MYBUCOD may exacerbate cardiac failure, reduce glomerular filtration rate. Co-administration of MYBUCOD with digoxin, phenytoin or lithium preparations can increase the serum level of these medicines. Checking the serum lithium level, serum digoxin and serum phenytoin levels is generally not required on correct use (over 3 or 4 days maximum).
Ciclosporin:
The risk of nephrotoxicity and kidney damage by ciclosporin is increased by the concomitant administration of certain NSAIDs. This effect cannot be ruled out for the combination of ciclosporin and ibuprofen, as in MYBUCOD, either.
Tacrolimus:
Possible increased risk of nephrotoxicity when NSAIDs, as in MYBUCOD are given with tacrolimus.
Colestyramine:
Concomitant treatment with colestyramine and ibuprofen, as in MYBUCOD, results in prolonged and reduced (25%) absorption of ibuprofen. The medicines should be administered with at least one hour interval.
Mifepristone:
NSAIDs, such as ibuprofen as contained in MYBUCOD, should not be used for 8-12 days after mifepristone administration as it can reduce the effect of mifepristone. A decrease in the efficacy of mifepristone can theoretically occur due to the antiprostaglandin properties of MYBUCOD.
Probenecid or sulfinpyrazone:
May cause a delay in the elimination of ibuprofen, as in MYBUCOD. The uricosuric action of these substances is decreased.
Quinolone antibiotics:
MYBUCOD can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs, as in MYBUCOD and quinolones may have an increased risk of developing convulsions.
Zidovudine:
Increased risk of haematological toxicity when NSAIDs, such as ibuprofen as contained in MYBUCOD, are given with zidovudine. There is evidence of an increased risk of haemarthrosis and haematoma in HIV haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen, as in MYBUCOD. Blood counts 1 to 2 weeks after starting use are recommended.
Ritonavir:
May increase the plasma concentrations of NSAIDs, such as ibuprofen, as in MYBUCOD.
Alcohol, bisphosphonates and oxpentifylline:
The risk of gastrointestinal bleeding and ulceration is increased when MYBUCOD is used with alcohol, bisphosphonates or oxpentifylline.
Baclofen:
Elevated baclofen toxicity.
CYP2C9 Inhibitors:
Concomitant administration of MYBUCOD with CYP2C9 inhibitors may increase the exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9 inhibitors) an increased S (+) ibuprofen, as in MYBUCOD, exposure by approximately 80% to 100% has been shown. Reduction of the MYBUCOD dose should be considered when potent CYP2C9 inhibitors are administered concomitantly, particularly when high doses of MYBUCOD are administered with either voriconazole or fluconazole.
Herbal extracts:
Ginkgo biloba may potentiate the risk of bleeding with NSAIDs, such as ibuprofen as in MYBUCOD.
Bone marrow depressants:
The leucopenic and/or thrombocytopenic effects of these medicines may be increased.
Increased risk of hepatotoxicity. Possible decrease in therapeutic effects of paracetamol, as in MYBUCOD.
Absorption of paracetamol, as in MYBUCOD, may be accelerated.
Excretion of paracetamol, as in MYBUCOD, may be affected, and plasma concentrations altered.
Absorption of paracetamol, as in MYBUCOD, is reduced if given within one hour of colestyramine.
Possible severe and sometimes fatal reactions may occur (see section 4.3).
Depressant effects are enhanced.
Increased risk of severe constipation.
Increased risk of severe constipation and central nervous system depression.
Hypotensive effects may be potentiated.
MYBUCOD is not recommended for use by pregnant or breastfeeding women (see section 4.3 and 4.4).
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period.
Second and third trimester:
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors, such as MYBUCOD may expose the foetus to:
At the end of pregnancy the mother and the neonate may be exposed to:
Because of these risks, the use of MYBUCOD dose and duration between 20 and 30 weeks of gestation should be limited and avoided at around 30 weeks of gestation and later in pregnancy (see section 4.3 and 4.4).
MYBUCOD contains codeine phosphate, a narcotic analgesic. Use of narcotic analgesics during pregnancy is associated with foetal adverse effects, which include physical dependence and withdrawal, retardation of growth, and neonatal respiratory depression with high doses.
At normal therapeutic doses codeine, as in MYBUCOD, and its active metabolite may be present in breast milk at very low doses and is unlikely to adversely affect the breastfed infant. However, if the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of the active metabolite, morphine, may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant, which may be fatal.
In limited studies, ibuprofen as contained in MYBUCOD, appears in the breast milk in very low concentration and is unlikely to affect the breastfed infant adversely. With therapeutic doses during short term treatment the risk for influence on infant seems unlikely. If, however, longer treatment is prescribed, early weaning should be considered.
There is some evidence that medicines which inhibit cyclo- oxygenase/prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment.
MYBUCOD has minor influence on the ability to drive or operate machinery. Since adverse events such as drowsiness have been reported in patients receiving MYBUCOD, patients should not drive, use machinery, or perform any tasks that require concentration, until they are certain that MYBUCOD does not adversely affect their ability to do so (see section 4.8).
In view of MYBUCOD’s inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.
The most commonly observed adverse events are gastro-intestinal in nature.
Ibuprofen:
| System organ class | Frequent | Less frequent | Frequency unknown (cannot be estimated from the available data) |
|---|---|---|---|
| Infections and Infestations | Rhinitis, aseptic meningitis (especially in patients with existing autoimmune disorders, such as systemic lupus erythematosus and mixed connective tissue disease) with symptoms of stiff neck, nausea, vomiting, fever or disorientation. | ||
| Blood and the lymphatic system disorders | Haematopoietic disorders (leucopoenia, pancytopenia, agranulocytosis, thrombocytopenia with or without purpura, aplastic anaemia, haemolytic anaemia, anaemia, neutropenia). First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising. | ||
| Immune system disorders | Hypersensitivity reactions with urticaria and pruritus, symptoms could be facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or severe shock). Exacerbation of asthma and bronchospasm. | Respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea. | |
| Psychiatric disorders | Confusional state, nervousness, insomnia, depression, anxiety, hallucination. | ||
| Nervous system disorders | Dizziness. | Drowsiness, headache, somnolence, fatigue, agitation, irritability. | |
| Eye disorders | Blurred vision and other ocular reactions. | ||
| Ear and labyrinth disorders | Tinnitus. | ||
| Cardiac disorders | Angina pectoris, cardiac dysrhythmias, oedema, hypertension, and cardiac failure. | ||
| Respiratory, thoracic and mediastinal disorders | Bronchospasm. | Alveolitis, pulmonary eosinophilia. | |
| Metabolism and nutrition disorders | Hypokalaemia. | ||
| Gastrointestinal disorders | Heartburn, dyspepsia, abdominal cramps and pain, nausea, vomiting, flatulence, diarrhoea, constipation. | Peptic ulceration, perforation or gastrointestinal bleeding, sometimes fatal; gastrointestinal ulcers, sometimes with bleeding and perforation, occult blood loss which may lead to anaemia, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease, inflammatory bowel disease, complications of colonic diverticula (perforation, fistula), gastritis, oesophagitis, pancreatitis, intestinal strictures, bloating, decreased appetite. | |
| Hepatobiliary disorders | Abnormalities of liver function tests, hepatitis, jaundice, liver dysfunction, liver damage, especially in long-term use, hepatic failure. | Hepatotoxicity. | |
| Skin and subcutaneous tissue disorders | Skin rash, pruritus. | Severe forms of skin reactions such as bullous reactions, including Stevens-Johnson Syndrome, erythema multiforme and toxic epidermal necrolysis. | Severe cutaneous adverse reactions (SCARs) such as Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), Acute generalised exanthematous pustulosis (AGEP), Photosensitivity reactions. |
| Renal and urinary disorders | Impairment of renal function, acute reversible renal failure, oedema, papillary necrosis, nephritic syndrome, interstitial nephritis which can be associated with renal failure. | Renal tubular acidosis (reported in the post- marketing setting typically following prolonged use at higher than recommended doses due to dependence on the codeine component). | |
| Investigations | Increase of blood urea nitrogen, serum transaminases and alkaline phosphatase, decrease in haemoglobin and haematocrit values, inhibition of platelet aggregation, prolonged bleeding time, decrease of serum calcium, increase in serum uric acid. |
Paracetamol:
| System organ class | Frequent | Less frequent | Frequency unknown (Cannot be estimated from the available data) |
|---|---|---|---|
| Blood and the lymphatic system disorders | Haematological reaction (including thrombocytopenia, leukopenia, pancytopenia, neutropenia and agranulocytosis). | ||
| Hepatobiliary disorders | Hepatitis. | ||
| Renal and urinary disorders | Renal colic, renal failure, sterile pyuria. | ||
| General disorders | Sensitivity reactions resulting in reversible skin rash (which may be accompanied by fever and mucosal lesions) or blood disorders. | Fixed Drug Eruptions (FDE), Drug Induced Hypersensitivity Syndrome (DIHS). |
Codeine Phosphate:
| System organ class | Frequent | Less frequent | Frequency unknown (Cannot be estimated from the available data) |
|---|---|---|---|
| Psychiatric disorders | Euphoria. | ||
| Nervous system disorders | Confusion, vertigo, restlessness, changes in mood, hypothermia, raised intracranial pressure, drowsiness. | ||
| Eye disorders | Changes in miosis, blurred or double vision. | ||
| Cardiac disorders | Bradycardia, palpitations, orthostatic hypotension. | ||
| Vascular disorders | Facial flushing. | ||
| Respiratory, thoracic and mediastinal disorders | Respiratory depression, cough suppression. | ||
| Gastrointestinal disorders | Nausea, vomiting, constipation, dry mouth. Pancreatitis. | ||
| Hepatobiliary disorders | Biliary spasm. | ||
| Skin and subcutaneous tissue disorders | Urticaria, pruritus. | ||
| Renal and urinary disorders | Micturition difficulties, ureteric spasm. | ||
| General disorders and administrative site conditions | Sweating. |
Acute reversible renal failure has been reported. Ibuprofen, as in MYBUCOD, should be used with care in patients with impaired renal function.
Hypersensitivity reactions have been reported following treatment with ibuprofen, as in MYBUCOD.
These may consist of (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract activity comprising asthma, aggravated asthma, bronchospasm, dyspnoea or © assorted skin disorders, including rashes of various types of pruritus, urticaria, purpura, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
The pathogenic mechanism of medicine-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 medicine intake, and disappearance of symptoms after medicine 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).
Codeine phosphate, as in MYBUCOD, should be given with caution to patients with hypothyroidism, adrenocortical insufficiency, impaired liver function, prostatic hypertrophy or shock. It should be used with caution in patients with inflammatory or obstructive bowel disorders.
The depressant effects of codeine are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics, and sedatives, and phenothiazines. The prolonged use of high doses of codeine has produced dependence of the morphine type.
MYBUCOD is not recommended for use for children under twelve years of age (see section 4.2).
The dosage should be reduced in elderly and debilitated patients.
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to: SAHPRA: via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8
Aspen Pharmacare:
E-mail: Drugsafety@aspenpharma.com
Tel: 0800 118 088/<+27 (0)11 239-6200
Not applicable.
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