INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo MYBULEN Tablets

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

MYBULEN Tablets

COMPOSITION:
Each tablet contains:

Ibuprofen         200,0 mg
Paracetamol         350,0 mg
Codeine Phosphate         10,0 mg

PHARMACOLOGICAL CLASSIFICATION:
A 2.8 Analgesic Combinations.

PHARMACOLOGICAL ACTION:
MYBULEN has analgesic, anti-inflammatory and anti-pyretic actions.

INDICATIONS:
MYBULEN is used in the management of mild to moderate pain of inflammatory origin.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients.
Safety in pregnancy and lactation has not been established.
Ibuprofen
Should not be given to patients with active peptic ulceration and impaired hepatic and renal function. Care is required in patients receiving coumarin anti-coagulants. Should not be given to patients who are hypersensitive to aspirin or other non-steroidal anti-inflammatory drugs.
Because of the possibility of cross-sensitivity due to structural relationships which exists among non-steroidal anti-inflammatory medicines, acute allergic reactions may be more likely to occur in patients who have exhibited allergic reactions to these compounds.
Paracetamol
Severe liver function impairment.
Codeine Phosphate
Respiratory depression, acute alcoholism, acute asthma, head injuries or raised intracranial pressure, heart disease secondary to chronic lung disease.
Patients taking monoamine oxidase inhibitors, or within 14 days of stopping such treatment.

WARNINGS:
Do not use continuously for more than 10 days without consulting your doctor.
Consult your doctor if pain or fever persists or gets worse, if new symptoms occur or if redness and swelling is present, as these could be signs of a serious condition.
Consult a doctor if no relief is obtained from the recommended dosage. Patients suffering from liver and kidney disease should take MYBULEN under medical supervision.
Store in a safe place out of the reach of children.
Use during Pregnancy:
Regular use of nonsteroidal anti-inflammatory agents (NSAID's) during the third trimester of pregnancy may result in premature closure of the foetal ductus arteriosus in utero and possibly in persistent pulmonary hypertension of the newborn. The onset of labour may be delayed and its duration increased.
Paracetamol
Dosages in excess of those recommended may cause severe liver damage.
In the event of overdosage or suspected overdosage, prompt medical attention is critical for adults as well as children, even if there is no obvious signs or symptoms. The nearest doctor, hospital or poisons control centre must be contacted immediately.
Patients suffering from hepatitis or alcoholism, or recovering from any form of liver disease, should not take paracetamol.
Codeine Phosphate
Potentiates the effect of alcohol and other sedatives.
Risk of severe constipation if used with antidiarrhoeal agents such as diphenoxylate. Increased risk of constipation and urinary retention if used with other anticholinergic agents.
Use with caution in patients with obstructive bowel disorders, liver impairment, myasthenia gravis, prostatic hypertrophy and impaired renal function.

DOSAGE AND DIRECTIONS FOR USE:
Adults:
One to two tablets six-hourly if necessary.
Not recommended for children under 12 years of age.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Ibuprofen:
The most common side-effects are generally gastro-intestinal disturbances such as gastrointestinal discomfort, nausea and vomiting; these are usually mild and reversible but in some patients peptic ulcers and severe gastro-intestinal bleeding have been reported. Long-term administration of doses higher than 30 mg daily carries an increased risk of severe gastro-intestinal side-effects.
Central nervous system-related side-effects include headache, vertigo, dizziness, nervousness, tinnitus, depression, drowsiness and insomnia.
Hypersensitivity reactions may occur occasionally and include fever, angioedema, bronchospasm, asthma and rashes.
Hepatotoxicity and aseptic meningitis, which occur rarely, may also be hypersensitivity reactions.
Some patients may experience visual disturbances.
Haematological adverse effects which include anaemias, thrombocytopenia, non-thrombocytopenic purpura (Henoch-Schönlein), neutropenia, aplastic anaemia, leucopenia, eosinophilia, and agranulocytosis have been reported and constitute indications for the immediate withdrawal of NSAIDs.
Nephrotoxicity such as interstitial nephritis, nephrotic syndrome and renal failure have been reported. Haematuria has also occurred. Fluid retention may occur.
Other side-effects which may occur in isolated cases include: photosensitivity, alveolitis, pulmonary eosinophilia, pancreatitis, Stevens-Johnson-syndrome and toxic epidermal necrolysis. The induction or exacerbation of colitis has occurred.
Changes in differential liver function parameters have been observed. Some patients may develop increased serum transaminase levels during treatment with NSAIDs. Blood-urea-nitrogen elevation has been observed in some patients. These elevations are not progressive over the course of treatment with NSAIDs, a plateau being reached, which returns towards baseline levels if treatment is stopped. The rise in blood-urea-nitrogen is not being associated with elevations of serum creatine.
Special Precautions
Because of their adverse gastro-intestinal effects NSAIDs should not be given to patients with peptic ulceration and should be used with caution in patients with a history of such disorders. Non-steroidal anti-inflammatory drugs should be used with caution in patients with infections since symptoms such as fever and inflammation may be masked. Other general precautions to be observed include administration to patients with haemorrhagic disorders, asthma or allergic disorders, a history of hypersensitivity reactions to aspirin or other non-steroidal anti-inflammatory drugs, hypertension, and impaired renal hepatic, or cardiac function.
In view of the product's inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.
It should be given with care to the elderly.
Interactions
Ibuprofen may enhance the effects of oral anti-coagulants. Increased plasma concentrations of lithium, methotrexate and cardiac glycosides may occur. An increased risk of nephrotoxicity may occur if NSAIDs are given with ACE-(Angiotensin-converting enzyme) inhibitors, cyclosporin, tacrolimus or diuretics. Effects on renal function may lead to reduced excretion of some agents. An increased risk of hyperkalaemia may occur if given with ACE-inhibitors or potassium-sparing diuretics. The antihypertensive effects of ACE-inhibitors, betablockers and diuretics may be reduced.
Convulsions due to an interaction with the quinolones may occur. The effects of phenytoin and sulphonylurea may be enhanced. The effects of NSAIDs may be enhanced with moclobemide.
The risk of gastro-intestinal bleeding and ulceration is increased when used with corticosteroids or alcohol, biphosphonates or oxipentifylline. An increased risk of haematoxicity exists during the concomitant use with zidovudine.
Paracetamol
Haematological reactions including thrombocytopenia, neutropenia, pancytopenia, leucopenia and agranulocytosis have been reported. Anaemia, dermatitis, hepatitis, renal colic, renal failure and sterile pyuria have occurred.
Pancreatitis, skin rashes and other allergic reactions may occur. The rash is usually erythematous or urticarial but sometimes more serious and accompanied by fever and mucosal lesions.
Codeine Phosphate
The most common side-effects are nausea, vomiting, constipation, drowsiness and confusion.
Difficulty in micturition and ureteric or biliary spasm may occur. Has an antidiuretic effect. Dry mouth sweating facial flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, changes of mood, euphoria and miosis also occur. Pruritis and urticaria can occur.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Ibuprofen
The most likely symptoms of overdosage are gastro-intestinal such as epigastric pain, nausea and vomiting. A syndrome of coma, hyperkalaemia, with cardiac arrhythmias, metabolic acidosis, pyrexia and respiratory and renal failure has been reported. Institute symptomatic and other supportive treatments which may be necessary. Monitor and support vital functions.
LïPïR2. ï3mA
Prompt treatment is essential. In the event of an overdosage consult a doctor immediately, or take the person to a hospital directly. A delay in starting treatment may mean that the antidote is given too late to be effective. Evidence of liver damage is often delayed until after the time for effective treatment has lapsed.
Susceptibility to paracetamol toxicity is increased in patients who have taken repeated high doses (greater than 5-10 g/day) of paracetamol for several days, in chronic alcoholism, chronic liver disease, AIDS, malnutrition, and with the use of drugs that induce liver microsomal oxidation such as barbiturates, isoniazid, rifampicin, phenytoin and carbamazepine.
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and possibly abdominal pain. Mild symptoms during the first two days of acute poisoning do not reflect the potential seriousness of the overdosage.
Liver damage may become apparent 12 to 48 hours or later, after ingestion, initially by elevation of the serum transaminase and lactic dehydrogenase activity, increased serum bilirubin concentration and prolongation of the prothrombin time. Liver damage may lead to encephalopathy, coma and death.
Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Abnormalities of glucose metabolism and metabolic acidosis may occur. Cardiac arrhythmias have been reported.
Treatment for Paracetamol Overdosage
Prompt treatment is essential in the management of paracetamol overdosage. Any adult person who has ingested about 7,5 g or more of paracetamol (or a child who has had more than 140 mg/kg) within the preceding 4 hours should have the stomach emptied by lavage (emesis may be adequate for children) and a single dose of 50 g activated charcoal given via the lavage tube.
N-acetylcysteine should be ad ministered in all cases of suspected overdose as soon as possible, preferably within 8 hours of overdosage, although treatment up to 36 hours after ingestion may still be of benefit, especially if more than 150 mg/kg of paracetamol was taken.
IV: An initial dose of 150 mg/kg N-acetylcysteine in 200 mL glucose injection given intravenously over 15 minutes, followed by an intravenous infusion of 50 mg/kg in 500 mL of glucose injection over the next 4 hours, and then 100 mg/kg in 1000 mL glucose injection over the next 16 hours. The volume of intravenous fluids should be modified for children.
Orally (not the treatment of choice): 140 mg/kg as a 5% solution initially, followed by a 70 mg/kg solution every 4 hours for 17 doses. N-acetylcysteine is more likely to be effective if administered within 8 hours of overdosage.
A plasma paracetamol level should be determined four hours after ingestion in all cases of suspected overdosage. Levels done before four hours, unless high, may be misleading.
Patients at risk of liver damage, and hence requiring continued treatment of N-acetylcysteine can be identified according to their plasma paracetamol level. The plasma paracetamol level can be plotted against the time since ingestion in the nomogram below.
Those whose plasma paracetamol levels are above the “normal treatment line”, should continue N-acetylcysteine treatment with 100 mg/kg over 16 hours repeatedly until recovery.
Patients with increased susceptibility to liver damage as identified above, should continue treatment if concentrations are above the “high-risk treatment line”. Prothrombin index correlates best with survival.
If N-acetylcysteine is not available, methionine 2,5 g may be given immediately, followed by 2,5 g every 4 hours for 3 doses. Patients should, however, preferably be transferred to a facility where N-acetylcysteine can be given.
Monitor all patients with significant ingestions for at least ninety six hours.
Codeine Phosphate
Respiratory depression is the most important feature of overdosage and occurs with circulatory failure and deepening coma. Pin-point pupils, hypotension and hypothermia, excitement and convulsions, especially in children, and non-cardiogenic pulmonary oedema occur.
Immediate attention should be given to maintaining adequate respiration. Naloxone should be given intravenously in a dose of 0,4 mg every 2-3 minutes until improvement occurs or to a maximum of 10 mg. Children may be given 0,01 mg/kg initially followed by a dose of 0,1 mg/kg.

IDENTIFICATION:
Blue, capsule-shaped, film-coated tablet with a break score on one side.

PRESENTATION:
Securitainers of 30, 60 and 100 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C, in well closed containers.
Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
30/2.8/0138

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Pharmacare Limited
7 Fairclough Road
Korsten
Port Elizabeth
6020

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
30 June 1999

{please see original package insert for omitted nomogram}

        D654
        PINETOWN PRINTERS

Updated on this site: October 2004
Source: Community Pharmacy

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