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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
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