MYPRODOL Hard capsule Ref.[115249] Active ingredients: Codeine Ibuprofen Paracetamol

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

Codeine phosphate

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

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

• 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 CAPSULE therapy,
• In view of MYPRODOL CAPSULE’s inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients,
• Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs including MYPRODOL CAPSULES, 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 CAPSULES, in patients with a history of ulcers, and the elderly,
• When gastrointestinal bleeding or ulceration occurs in patients receiving MYPRODOL CAPSULES treatment with MYPRODOL CAPSULES should be stopped,
• MYPRODOL CAPSULES should be given with caution to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohn’s disease, hiatus hernia, gastro-oesophageal 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 necrolysis have been reported. MYPRODOL CAPSULES should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
• Drug Reaction with Eosinophillia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as MYPRODOL. 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 MYPRODOL and evaluate the patient immediately.
• Foetal Toxicity: Limit use of NSAIDs, including MYPRODOL 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.
• Between 20 weeks and 30 weeks gestation, limit MYPRODOL CAPSULES use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if MYPRODOL CAPSULES treatment extends beyond 48 hours. Discontinue MYPRODOL CAPSULES if oligohydramnios occurs and follow up according to clinical practice.
• Severe cutaneous adverse reactions (SCARs): Severe cutaneous adverse reactions (SCARs) such as toxic epidermal necrolysis (TEN), Steven-Johnson syndrome (SJS), acute generalized exanthematous pustulosis (AGEP), eosinophilia and systemic (DRESS)/Drug-induced hypersensitivity syndrome (DIHS) and fixed drug eruptions (FDE) have been reported in patients treated with paracetamol containing medicines. If a patient develops SCAR, treatment with MYPRODOL CAPSULES must immediately be discontinued and appropriate treatment instituted (see Section 4.8).

• 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 CAPSULES may enhance the effects of anti-coagulants such as warfarin.
• Anti-platelet medicines and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding.

MYPRODOL CAPSULES are not recommended for use by pregnant or breastfeeding women.

Use of non-steroidal anti-inflammatory drugs during the third trimester of pregnancy, may result in persistent pulmonary hypertension of the new-born.

Use of NSAIDs, including MYPRODOL CAPSULES, 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 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). The onset of labour may be delayed and its duration increased.

Fertility

No data on male and female fertility are available

Patients should be advised not to drive or operate machinery if affected by dizziness or sedation. This medicine can impair cognitive function and can affect a patient’s ability to drive safely. Patients should be advised that they do not engage in the above activities until they are aware of the measure to which MYPRODOL CAPSULES affects them.

a. Summary of the safety profile

In view of the product’s inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.

The most commonly observed adverse events are gastro-intestinal in nature

b. Tabulated summary of adverse reactions

Ibuprofen:

Paracetamol: |

Codeine phosphate: |

c. Description of selected adverse reactions

Ibuprofen

Acute reversible renal failure has been reported. Ibuprofen should be used with care in patients with impaired renal function.

Codeine phosphate

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 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.

d. Paediatric population

MYPRODOL CAPSULES are not recommended for use for children under twelve years of age (see section 4.2).

e. Other special populations

The dosage should be reduced in elderly and debilitated patients.

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.