MYPRODOL Suspension Ref.[115246] Active ingredients: Codeine Ibuprofen Paracetamol

MYPRODOL SUSPENSION is not recommended for use by pregnant or breastfeeding women (see section 4.6).

The safety of continuous administration of MYPRODOL SUSPENSION has not been established for a period greater than four weeks.

Paracetamol

This product 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.

Ibuprofen

• Ibuprofen should be used with care in patients with impaired renal function.
• 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 MYPRODOL SUSPENSION therapy. In view of ibuprofen’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 diclofenac after careful consideration.
• Elderly: The elderly has an increased frequency of adverse reactions to NSAIDs including ibuprofen in MYPRODOL SUSPENSION, especially gastrointestinal perforation, ulceration and bleeding (PUBs) which may be fatal.
• The risk of gastrointestinal perforation, ulceration or bleeding (PUBs) is higher with increasing doses of MYPRODOL SUSPENSION, in patients with a history of ulcers, and the elderly.
• When gastrointestinal bleeding or ulceration occurs in patients receiving MYPRODOL SUSPENSION, treatment with MYPRODOL SUSPENSION should be stopped.
• MYPRODOL SUSPENSION should be given with caution to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohn’s disease, hiatus hernia, gastroesophageal reflux disease, angiodysplasia) as the condition may be exacerbated.
• Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolyis have been reported. MYPRODOL SUSPENSION should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
• Regular use of NSAIDs such as ibuprofen in MYPRODOL SUSPENSION during the third trimester of pregnancy, may result in persistent pulmonary hypertension of the new-born. The onset of labour may be delayed and its duration increased (see section 4.6).
• Foetal Toxicity: Limit use of NSAIDs, including MYPRODOL SUSPENSION, between 20 to 30 weeks of pregnancy due to the risk of oligohydramnios/foetal renal dysfunction. Avoid use of NSAIDs in women around 20 weeks gestation and later in pregnancy due to the risks of oligohydramnios/foetal renal dysfunction and premature closure of the foetal ductus arteriosus (see sections 4.3 and 4.6).
• If NSAID treatment is necessary between 20 weeks and 30 weeks gestation, limit MYPRODOL SUSPENSION use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if MYPRODOL SUSPENSION treatment extends beyond 48 hours. Discontinue MYPRODOL SUSPENSION if oligohydramnios occurs and follow up according to clinical practice (see sections 4.3 and 4.6).

Codeine phosphate

Exceeding the prescribed dose, together with prolonged and continuous use of this medication, may lead to dependency and addiction.

• Codeine phosphate 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 dosage should be reduced in elderly and debilitated patients.
• 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.

MYPRODOL SUSPENSION contains sodium benzoate (excipient)

This medicine contains 10 mg sodium benzoate in each 10 mL which is equivalent 0,1% m/v.

Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in new-born babies (up to 4 weeks old) (see section 4.3).

MYPRODOL SUSPENSION contains sodium

This medicinal product contains 26,88 mg sodium per 10 mL, equivalent to 1,344 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.

• NSAIDs: use of two or more NSAIDs concomitantly could result in an increase in side effects.
• Corticosteroids: increased risk of gastrointestinal perforation, ulceration or bleeding (PUBs).
• Anti-coagulants: MYPRODOL SUSPENSION may enhance the effects of anti-coagulants such as warfarin.
• Anti-platelet medicines and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding.

Pregnancy

MYPRODOL SUSPENSION is not recommended for use by pregnant women (see section 4.4). Regular use of non-steroidal anti-inflammatory medicines (such as ibuprofen) during the third trimester of pregnancy, may result in persistent pulmonary hypertension of the new-born. The onset of labour may be delayed and its duration increased.

Use of NSAIDs, including MYPRODOL SUSPENSION, can cause premature closure of the foetal ductus arteriosus and foetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, the use of MYPRODOL SUSPENSION 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.

Breastfeeding

MYPRODOL SUSPENSION is not recommended for use by breastfeeding women (see section 4.4).

Fertility

No data on male and female fertility is available.

MYPRODOL SUSPENSION has moderate influence on the ability to drive and use machines, as it may cause dizziness, drowsiness and blurred vision.

It is not always possible to predict to what extent MYPRODOL SUSPENSION may interfere with the daily activities of a patient.

Patients should ensure that they do not engage in the above activities until they are aware of the measure to which MYPRODOL SUSPENSION affects them.

a. Summary of the safety profile

The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal.

b. Tabulated summary of adverse reactions

Ibuprofen:

Paracetamol: |

Codeine phosphate: |

c. Description of selected adverse reactions

No information available.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8

Not applicable.