GEN-PAYNE Capsule, hard Ref.[50521] Active ingredients: Codeine Ibuprofen Paracetamol

The safety of continuous administration of GEN-PAYNE 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.
• Codeine phosphate should be given with caution to patients with hypothyroidism, adrenocortical insufficiency, asthma, impaired liver or kidney function, prostatic hyperplasia, shock, hypotension, inflammatory or obstructive bowel disorders or myasthenia gravis.
• The dosage should be reduced in elderly and debilitated patients.

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 GEN-PAYNE CAPSULES therapy. In view of GEN-PAYNE CAPSULES' 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 GEN-PAYNE 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 GEN-PAYNE CAPSULES, in patients with a history of ulcers, and the elderly. When gastrointestinal bleeding or ulceration occurs in patients receiving GEN-PAYNE CAPSULES, treatment with GEN-PAYNE CAPSULES should be stopped.
• GEN-PAYNE CAPSULES should be given with caution to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohn’s disease, hiatus hernia, gastrooesophageal 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. GEN-PAYNE CAPSULES should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
• Regular use of NSAIDs including GEN-PAYNE CAPSULES during the third trimester of pregnancy, may result in persistent pulmonary hypertension of the newborn. The onset of labour may be delayed and its duration increased (see section 4.6).
• GEN-PAYNE CAPSULES should be used with caution in patients with infection since symptoms such as fever and inflammation may be masked.
• Other precautions to be observed include administration to patients with haemorrhagic disorders, asthma, a history of hypersensitivity reactions to aspirin or other nonsteroidal antiinflammatory medications and impaired renal, hepatic or cardiac function. Should be used with caution in the elderly.
• Caution is advised in those patients who are receiving coumarin anticoagulants (see section 4.5).
• Foetal Toxicity: Limit use of NSAIDs, including GEN-PAYNE CAPSULES, between 20 to 30 weeks of pregnancy due to the risk of oligohydramnios/foetal renal dysfunction. Avoid use of NSAIDs in women at 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.

If NSAID treatment is necessary between about 20 weeks and 30 weeks gestation, limit GENPAYNE use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if GEN-PAYNE treatment extends beyond 48 hours. Discontinue GEN-PAYNE if oligohydramnios occurs and follow up according to clinical practice (see section 4.3 and 4.6).

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.

Codeine phosphate

• The depressant effects of codeine are enhanced by depressants of the central nervous system such as alcohol, anaesthetics, hypnotics and sedatives, and phenothiazines.

Ibuprofen

• Lithium, methotrexate and cardiac glycosides: increased plasma concentrations may result.
• ACE inhibitors, cyclosporin, tacrolimus, or diuretics: concurrent administration may increase the risk of nephrotoxicity.
• Effects on renal function may lead to reduced excretion of some medicines.
• Antihypertensives: the antihypertensive effects of some antihypertensives, including ACE inhibitors, beta blockers, and diuretics may be reduced. There may also be an increased risk of hyperkalaemia with ACE inhibitors and potassium-sparing diuretics.
• Quinolones: convulsions may occur.
• Moclobemide: the effects of NSAID’s might be enhanced.
• Phenytoin and sulphonylurea antidiabetics: effects may be enhanced.
• Mifepristone: it is advised that NSAID’s should be avoided 8 to 12 hours after mifepristone use, because of a theoretical risk that these prostaglandin synthetase inhibitors may alter the efficacy of mifepristone.
• Zidovudine: may increase the risk of haemotoxicity.
• NSAIDs: use of two or more NSAIDs concomitantly could result in an increase in side effects.
• Alcohol, bisphosphonates or oxpentifylline: possible increased risk of NSAID associated gastrointestinal bleeding and ulceration.
• Corticosteroids: increased risk of gastrointestinal perforation, ulceration or bleeding (PUBs).
• Anti-coagulants: GEN-PAYNE 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.

GEN-PAYNE CAPSULES are not recommended for use by pregnant or breastfeeding women (see section 4.3).

Regular 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 GEN-PAYNE 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, Because of these risks, the use of GENPAYNE 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.

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 GEN-PAYNE CAPSULES affects them.

a. Summary of the safety profile

The most commonly observed adverse events are gastrointestinal in nature.

b. Tabulated summary of adverse reactions

Codeine phosphate

Ibuprofen

Paracetamol

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.