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MYPRODOL® CAPSULES

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

MYPRODOL® CAPSULES

COMPOSITION:
Each capsule contains:
Ibuprofen 200 mg
Codeine Phosphate 10 mg
Paracetamol 250 mg
Sugar free

PHARMACOLOGICAL CLASSIFICATION:
A.2.8 Analgesic Combinations

PHARMACOLOGICAL ACTION:
MYPRODOL®CAPSULES have an analgesic, anti-inflammatory and anti-pyretic action.

INDICATIONS:
MYPRODOL®CAPSULES are indicated for the relief of mild to moderate pain of inflammatory origin with or without fever.

CONTRA-INDICATIONS:
Impaired hepatic and renal function, peptic ulceration or a history of such ulceration. Cardiovascular disease.
Hypersensitivity to any of the active ingredients.
Contra-indicated in respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion, after operations on the biliary tract, acute alcoholism, head injuries and conditions in which intracranial pressure is raised. It should not be given during an attack of bronchial asthma or in heart failure secondary to chronic lung disease.
Contra-indicated in patients taking monoamine oxidase inhibitors or within fourteen days of stopping such treatment.
Caution is advised in those patients who are receiving coumarin anticoagulants.
Patients who are sensitive to aspirin should not be given MYPRODOL®CAPSULES.

WARNINGS:
The safety of continuous administration of MYPRODOL®CAPSULES has not been established for a period greater than four weeks.
Codeine:
Exceeding the prescribed dose, together with prolonged and continuous use of this medication may lead to dependency and addiction.
Paracetamol:
Dosages in excess of those recommended may cause severe liver damage.

PREGNANCY AND LACTATION:
MYPRODOL®CAPSULES are not recommended for use by pregnant or breast feeding women.
Regular use of NSAIDs 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.

DOSAGE AND DIRECTIONS FOR USE:
Not recommended for children under twelve years of age.
Adults:
One to two capsules four hourly and not more than twelve capsules per twenty four hours. Consult your doctor if no relief is obtained with the recommended dosage.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
In view of the product’s inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.
Ibuprofen:
Peptic ulceration and gastro-intestinal bleeding have been reported. Other side-effects include dizziness, dyspepsia, nausea, nervousness, skin rash, pruritus, tinnitus, oedema, depression, drowsiness, insomnia, blurred vision and other ocular reactions.
Hypersensitivity reactions, abnormalities of liver function tests, impairment of renal function, agranulocytosis and thrombocytopenia have occasionally been reported. Acute reversible renal failure has been reported. Ibuprofen should be used with care in patients with impaired renal function.
Paracetamol:
Sensitivity reactions resulting in reversible skin rash or blood disorders may occur. Haematological reactions have been reported.
Codeine Phosphate:
Codeine phosphate may cause nausea, vomiting, constipation, drowsiness, confusion, dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, changes of mood and miosis. Micturition m ...

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