Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: PHARMACARE LIMITED, Healthcare Park, Woodlands Drive, Woodmead, 2191
MYBULEN CAPSULES are contraindicated in:
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2).
Caution is required in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with MYBULEN CAPSULES therapy (see section 4.3).
MYBULEN CAPSULES should only be administered under strict consideration of the benefitrisk ratio in the following conditions: Systemic Lupus Erythematosus (SLE) or mixed connective tissue diseases; congenital disturbance of porphyrin metabolism (e.g. acute intermittent porphyria).
Special care has to be taken in the following cases:
The elderly have an increased frequency of adverse reactions to NSAIDs, including MYBULEN CAPSULES, especially gastrointestinal ulceration, bleeding and perforation (PUBs) which may be fatal.
Elderly patients are more likely to develop adverse hepatic or renal effects, and if gastrointestinal ulceration or bleeding occurs, it is more likely to cause serious consequences.
Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs, such as ibuprofen as in MYBULEN CAPSULES, at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events.
The risk of gastrointestinal bleeding, ulceration or perforation (PUBs) is higher with increasing doses of MYBULEN CAPSULES, in patients with a history of ulcers, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly.
Patients with a history of gastrointestinal toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.
Caution should be advised in patients receiving concomitant medicines which could increase the risk of ulceration or bleeding, such as oral corticosteroids, selective serotonin reuptake inhibitors or anti-platelet medicines such as acetylsalicylic acid (see section 4.5).
The use of ibuprofen, as in MYBULEN CAPSULES, with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided due to the increased risk of ulceration or bleeding (see section 4.5).
When gastrointestinal bleeding or ulceration occurs in patients receiving MYBULEN CAPSULES, treatment with MYBULEN CAPSULES should be stopped. MYBULEN CAPSULES should be given with caution to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohn’s disease, hiatus hernia, gastrooesophageal reflux disease, angiodysplasia) as these conditions may be exacerbated (see section 4.8).
Appropriate caution, monitoring and advice are required for patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with MYBULEN CAPSULES therapy.
In view of MYBULEN CAPSULES’s inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.
Caution is required in patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) and should only be treated with MYBULEN CAPSULES 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.
MYBULEN CAPSULES 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 MYBULEN CAPSULES, in case of varicella.
Drug reaction with eosinophillia and systemic symptoms (DRESS) has been reported in patients taking NSAIDs such as MYBULEN CAPSULES. 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. Eosinophillia 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 MYBULEN CAPSULES and evaluate the patient immediately.
Hepatic function impairment may increase the risk of hepatotoxicity (see sections 4.3 and 4.8).
Ibuprofen, as in MYBULEN CAPSULES, 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.
MYBULEN CAPSULES are contraindicated in renal function impairment as renal failure may be provoked (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 MYBULEN CAPSULES 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 MYBULEN CAPSULES 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 (see section 4.3).
The antipyretic, analgesic and anti-inflammatory action of MYBULEN CAPSULES may mask the signs and symptoms of the occurrence 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 MYBULEN CAPSULES are administered for fever or pain relief in relation to infection, monitoring of infection is advised. In nonhospital settings, the patient should consult a doctor if symptoms persist or worsen.
In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis (see section 4.8).
Symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed.
Aseptic meningitis has been observed on occasions in patients on ibuprofen, as in MYBULEN CAPSULES therapy. Although it is probably more likely to occur in patients with systemic lupus erythematosus (SLE) and related connective tissue diseases, it has been reported in patients who do not have an underlying chronic disease.
Severe acute hypersensitivity reactions (for example anaphylactic shock) are observed rarely. At the first signs of hypersensitivity reaction after taking MYBULEN CAPSULES therapy must be stopped. Medically required measures, in line with the symptoms, must be initiated by specialist personnel.
Bronchospasm, urticaria or angioedema may be precipitated in patients suffering from or with a previous history of bronchial asthma, chronic rhinitis, sinusitis, nasal polyps, adenoids or allergic diseases. Ibuprofen, as in MYBULEN CAPSULES, may mask the signs or symptoms of an infection (fever, pain and swelling).
The habitual intake of analgesics, such as MYBULEN CAPSULES, particularly the combination use of different analgesic medicines, may cause permanent renal damage and a risk of renal failure (analgesics nephropathy). MYBULEN CAPSULES may temporarily inhibit platelet aggregation and has been shown to prolong the bleeding time. MYBULEN CAPSULES should be used with caution in patients with anaemia, as anaemia may be exacerbated.
Consumption of alcohol should be avoided since it may intensify side effects of MYBULEN CAPSULES, especially if affecting the gastrointestinal tract or the central nervous system. Patients on MYBULEN CAPSULES should report to their doctor signs or symptoms of gastrointestinal ulceration or bleeding, blurred vision or other eye symptoms, skin rash, weight gain or oedema.
Limit use of NSAIDs, including MYBULEN CAPSULES, 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).
These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation. Oligohydramnios is often, but not always, reversible with treatment discontinuation.
Complications of prolonged oligohydramnios may include limb contractures and delayed lung maturation. In some post marketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.
If MYBULEN CAPSULES is necessary between 20 weeks and 30 weeks gestation, limit MYBULEN CAPSULES use to the lowest effective dose and shortest duration possible. Healthcare professionals should consider ultrasound monitoring of amniotic fluid if MYBULEN CAPSULES treatment extends beyond 48 hours. Discontinue MYBULEN CAPSULES if oligohydramnios occurs and follow up according to clinical practice.
MYBULEN CAPSULES 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 of MYBULEN CAPSULES 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 MYBULEN CAPSULES for a prolonged period of time.
If taken for pain, including arthritic pain, and the pain persists for longer than 5 days, or if taken for fever and the fever persists for longer than 3 days or if the condition deteriorates or new symptoms develop, patients should contact their doctor as additional treatment may be necessary.
Exceeding the prescribed dose, together with prolonged and continuous use of MYBULEN CAPSULES, may lead to dependency and addiction.
MYBULEN CAPSULES should be used with caution in patients with:
In elderly or debilitated patients the dosage should be reduced.
MYBULEN CAPSULES are not recommended for children under twelve years of age (see section 4.2).
Concomitant use of ibuprofen and the following medicines should be avoided.
Concomitant administration of ibuprofen, as in MYBULEN CAPSULES, and acetylsalicylic acid is not generally recommended because of the potential of increased adverse effects. Data suggest that ibuprofen, as in MYBULEN CAPSULES, 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 these data to the clinical situation, the possibility that regular, long-term use of MYBULEN CAPSULES may reduce the cardio protective effect of low-dose acetylsalicylic acid cannot be excluded.
As a result of synergistic effects, the concurrent use of several NSAIDs can increase the risk of gastrointestinal ulcers and haemorrhage. Co-administration of ibuprofen, as in MYBULEN CAPSULES, with other NSAIDs should therefore be avoided (see section 4.4).
Use of two or more NSAIDs concomitantly may result in an increase in side effects.
MYBULEN CAPSULES may enhance the effects of anti-coagulants such as warfarin or heparin (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 MYBULEN CAPSULES, inhibits 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 MYBULEN CAPSULES 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. Ibuprofen should be taken only with caution in combination with the following medicines
Increased risk of gastrointestinal ulceration, bleeding or perforations (PUBs) (see section 4.4).
Increased risk of gastrointestinal bleeding and ulceration (see section 4.4).
NSAIDs, such as ibuprofen, as in MYBULEN CAPSULES, 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 MYBULEN CAPSULES 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 MYBULEN CAPSULES.
Studies indicate that ibuprofen, as in MYBULEN CAPSULES, counteracts the effect of captopril of increased sodium excretion.
MYBULEN CAPSULES may decrease the excretion of aminoglycosides and increase their toxicity.
The hypoglycaemic effects of these medicines may be increased. In the case of simultaneous treatment, monitoring of blood glucose levels is recommended.
MYBULEN CAPSULES may exacerbate cardiac failure and reduce glomerular filtration rate.
Co-administration of MYBULEN CAPSULES 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).
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 MYBULEN CAPSULES, either.
Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.
Concomitant treatment with colestyramine and ibuprofen, as in MYBULEN CAPSULES, results in prolonged and reduced (25 %) absorption of ibuprofen. The medicines should be administered with at least one hour interval.
If NSAIDs, such ibuprofen as in MYBULEN CAPSULES, are used within 8 to 12 days after mifepristone administration they can reduce the effect of mifepristone. A decrease in the efficacy of mifepristone may occur due to the antiprostaglandin properties of MYBULEN CAPSULES.
May cause a delay in the elimination of ibuprofen, as in MYBULEN CAPSULES. The uricosuric action of these substances is decreased.
MYBULEN CAPSULES can increase the risk of convulsions associated with quinolone antibiotics. Patients taking MYBULEN CAPSULES and quinolones may have an increased risk of developing convulsions.
Increased risk of haematological toxicity when MYBULEN CAPSULES are given with zidovudine. There is evidence of an increased risk of haemarthrosis and haematoma in HIV positive haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen, as in MYBULEN CAPSULES. Blood counts 1 to 2 weeks after starting use together are recommended.
May increase the plasma concentrations of NSAIDs, such as ibuprofen as in MYBULEN CAPSULES.
The side effects of MYBULEN CAPSULES may be enhanced with moclobemide.
The leukopenic and/or thrombocytopenic effects of these medicines may be increased.
The risk of gastrointestinal bleeding and ulceration is increased when MYBULEN CAPSULES are used with alcohol, bisphosphonates or oxypentifylline.
Elevated baclofen toxicity.
Concomitant administration of MYBULEN CAPSULES 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 MYBULEN CAPSULES, exposure by approximately 80% to 100% has been shown. Reduction of the MYBULEN CAPSULES dose should be considered when potent CYP2C9 inhibitors are administered concomitantly, particularly when high-dose MYBULEN CAPSULES are administered with either voriconazole or fluconazole.
Ginkgo biloba may potentiate the risk of bleeding with NSAIDs, such as ibuprofen as in MYBULEN CAPSULES.
Increased risk of hepatotoxicity. Possible decrease in therapeutic effects of paracetamol, as in MYBULEN CAPSULES.
Absorption of paracetamol, as in MYBULEN CAPSULES, may be accelerated.
Absorption of paracetamol, as in MYBULEN CAPSULES, is reduced if given within one hour of colestyramine.
Excretion of paracetamol, as in MYBULEN CAPSULES, may be affected and plasma concentrations altered.
Sometimes fatal reactions may occur in patients taking MAOIs concomitantly and also within 14 days of stopping such treatment (see section 4.3).
The depressant effects of MYBULEN CAPSULES is enhanced.
Increased risk of severe constipation.
Increased risk of severe constipation and central nervous system depression.
Hypotensive effects may be potentiated.
MYBULEN CAPSULES are not recommended for use by pregnant or breastfeeding women (see section 4.3 and 4.4).
First trimester:
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies raise concern about 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, prostaglandin synthesis inhibitors, such as MYBULEN CAPSULES ,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 MYBULEN CAPSULES, 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 sections 4.3 and 4.4).
MYBULEN CAPSULES 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.
Paracetamol as part of a combination medicine, as contained in MYBULEN CAPSULES, should not be taken. Frequent use of paracetamol in late pregnancy may be associated with an increased risk of persistent wheezing in the infant which may persist into childhood.
Ibuprofen, as in MYBULEN CAPSULES is excreted in the breast milk in very low concentrations.
With therapeutic doses during short term treatment the risk for influence on the infant seems unlikely. If, however, longer treatment is prescribed, early weaning should be considered. MYBULEN CAPSULES should not be used during breastfeeding.
MYBULEN CAPSULES contains codeine phosphate. Breastfed infants of mothers taking codeine may be at an increased risk of toxicity from its metabolite morphine.
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.
MYBULEN CAPSULES has a minor influence on the ability to drive or use machines. Since adverse reactions such as dizziness, drowsiness and visual disturbances have been reported in patients receiving MYBULEN CAPSULES, patients should not drive, use machinery or perform any tasks that require concentration, until they are certain that MYBULEN CAPSULES does not adversely affect their ability to do so (see section 4.8).
The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease (see section 4.4) have been reported following administration. Less frequently, gastritis has been observed.
Clinical studies suggest that use of ibuprofen, as in MYBULEN CAPSULES, particularly at a high dose (2 400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).
Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment, such as ibuprofen, as in MYBULEN CAPSULES. In view of MYBULEN CAPSULES’s inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients (see section 4.4).
| 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 (leukopenia, pancytopenia, agranulocytosis, thrombocytopenia with or without purpura, aplastic anaemia, haemolytic anaemia, anaemia, neutropenia). The first symptoms or signs may include: fever, sore throat, surface mouth ulcers, flu-like symptoms, severe fatigue, nasal and skin bleeding, unexplained bleeding and bruising | ||
| Immune system disorders | Hypersensitivity reactions such as urticaria, pruritus, purpura and exanthema as well as asthma attacks (sometimes with hypotension); severe hypersensitivity reactions. The symptoms may include: facial oedema, swelling of the tongue, internal laryngeal swelling with constriction of the airways, dyspnoea, tachycardia, fall of blood pressure to the point of life-threatening shock | 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 | Paraesthesia |
| Eye disorders | Blurred vision, other ocular reactions, toxic amblyopia | Visual impairment, toxic optic neuropathy | |
| Ear and labyrinth disorders | Tinnitus | Impaired hearing, vertigo | |
| Cardiac disorders | Heart failure may be precipitated in compromised patients, angina pectoris, cardiac dysrhythmias palpitations, myocardial infarction, acute pulmonary oedema. | Oedema, hypertension | |
| Respiratory, thoracic and mediastinal disorders | Bronchospasm | ||
| Gastrointestinal disorders | Heartburn, dyspepsia, abdominal cramps and pain, nausea, vomiting, flatulence, diarrhoea, constipation, gastric irritation | 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, Crohn’s disease and inflammatory bowel disease, complications of colonic diverticula (perforation, fistula), gastritis, bloating, decreased appetite, oesophagitis, pancreatitis, intestinal strictures | |
| Hepatobiliary disorders | Abnormalities of liver function tests, hepatitis, jaundice, liver dysfunction, liver damage, especially in long-term use, hepatic failure | ||
| Skin and subcutaneous tissue disorders | Skin rash, pruritus | Photosensitivity reaction, severe forms of skin reactions (erythema multiforme, exfoliative dermatitis, bullous reactions including StevensJohnson syndrome and toxic epidermal necrolysis, alopecia, necrotising fasciitis | Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), Acute generalised exanthematous pustulosis (AGEP) |
| Renal and urinary disorders | Impairment of renal function, acute renal failure, renal papillary necrosis in long-term use; development of oedema especially in patients with arterial hypertension or renal insufficiency, nephrotic syndrome, interstitial nephritis which can be associated with renal failure | ||
| General disorders and administrative site conditions | Malaise | ||
| 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 |
| System organ class | Frequent | Less frequent | Frequency unknown (cannot be estimated from the available data) |
|---|---|---|---|
| Blood and the lymphatic system disorders | Haematological reaction (including agranulocytosis, thrombocytopenia, neutropenia, pancytopenia, leukopenia) | ||
| Hepatobiliary disorders | Hepatitis | ||
| Skin and subcutaneous tissue disorders | Hypersensitivity reactions resulting in reversible skin rash (which may be accompanied by fever and mucosal lesions) or blood disorders | ||
| Renal and urinary disorders | Renal colic, renal failure |
| System organ class | Frequent | Less frequent | Frequency unknown (cannot be estimated from the available data) |
|---|---|---|---|
| Nervous system disorders | Confusion, drowsiness, restlessness, changes in mood, vertigo, raised intracranial pressure | ||
| Eye disorders | Miosis | ||
| Cardiac disorders | Bradycardia, palpitations, orthostatic hypotension | ||
| Respiratory, thoracic and mediastinal disorders | Respiratory depression | ||
| Gastrointestinal disorders | Nausea, vomiting, constipation, dry mouth | ||
| Hepatobiliary disorders | Biliary spasm | ||
| Skin and subcutaneous tissue disorders | Sweating, facial flushing, urticaria, pruritus | ||
| Renal and urinary disorders | Micturition difficulties, ureteric spasm | ||
| General disorders and administrative site conditions | Hypothermia |
Acute reversible renal failure has been reported.
Hypersensitivity reactions have been reported following treatment with ibuprofen, as in MYBULEN CAPSULES. 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 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 MYBULEN CAPSULES, should be given with caution to patients with hypothyroidism, adrenocortical insufficiency, 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.
MYBULEN CAPSULES are 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: 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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