INSTRUCTION FOR USE

Posology and method of administration

Method of administration

Oral route. Dissolve tablet in about 200 ml of water, drink it immediately after completely dissolve.

Posology

Adults:  The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician.

Note: Maximum daily dose of codeine should not exceed 240 mg.  Dosage should be adjusted to meet the specific requirements of other active ingredients in combination with codeine in the product.

Children aged 12 years to 18 years:  1 to 2 tablets to be taken every 6 hours, up to a maximum of 8 tablets in any 24-hour period.

Children aged less than 12 years: It is not recommended in children below the age of 12 years for pain-relief therapy because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine.

Contraindications

Hypersensitivity to any of the constituents of the tablets.

Phenylketonuria

Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency

Breastfeeding women

In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers

In all paediatric patients (0-18 years of age) who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome due to an increased risk of developing serious and life-threatening adverse reactions

In people who are taking or have taken a monoamine oxidase inhibitor within 2 weeks.

Obstructive airways disease

Head injuries or conditions where intracranial pressure is raised.

Diarrhea or acute ulcerative colitis.

Warnings and precautions 

EFFER-PARALMAX CODEIN should be used with caution in the following conditions:

Driving and using machines because drug may cause drowsiness.

The elderly, patient with severe liver impairment, severe renal impairment, prostatic hypertrophy, hypothyroidism, or respiratory diseases.

During long-term treatment, abrupt discontinuation may lead to discontinuation syndrome.

This medicinal product contains 282 mg sodium per tablet. This should be particularly taken into account for those on a low salt diet, patients with edema due to kidney disease, cardiovascular disease.

Don’t taken together with alcohol and another Paracetamol containing product. 

The physician should warn patients of serious signs of skin reactions such as Steven-Jonhson syndrome (SJS), toxic epidermal necrolysis (TEN) or Lyell syndrome, acute generalized exanthematous pustulosis (AGEP).

CYP2D6 metabolism:

Codeine is partially metabolised by the liver enzyme CYP2D6 into morphine, its active metabolite. If a patient has a deficiency or is completely lacking this enzyme an adequate analgesic effect will not be obtained. Estimates indicate that up to 7% of the Caucasian population may have this deficiency. However, if the patient is an extensive or ultra-rapid metaboliser, there is an increased risk of developing side effects of opioid toxicity even at commonly prescribed doses. These patients convert codeine into morphine rapidly resulting in higher-than-expected serum morphine levels.

General symptoms of opioid toxicity include confusion, omnolence, shallow breathing, small pupils, nausea, vomiting,

constipation and lack of appetite. In severe cases this may include symptoms of circulatory and respiratory depression, which may be life-threatening and very rarely fatal. Estimates of prevalence of ultra-rapid metabolisers in different populations are summarized below:

Patient with compromised respiratory function

Codeine is not recommended for use in children in whom respiratory function might be compromised including neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures. These factors may worsen symptoms of morphine toxicity.

Post-operative use in children

There have been reports in the published literature that codeine given post- operatively in children after tonsillectomy and/or adenoidectomy for obstructive sleep apnoea, led to rare, but life-threatening adverse events including death. All children received doses of codeine that were within the appropriate dose range; however, there was evidence that these children were either ultra-rapid or extensive metabolisers in their ability to metabolise codeine to morphine.

Aspartame

The tablets contain aspartame and so it should not be taken by patients with phenylketonuria.

Pregnancy and lactation

Pregnancy

Epidemiological studies during pregnancy have shown that the use of paracetamol at recommended doses is safe, but there is no evidence of the safety of codeine. Opioid analgesics reduce respiratory depression and neonatal withdrawal syndrome.

Therefore, it should be used with caution in pregnant women.

Breast-feeding

EFFER-PARALMAX CODEIN is contraindicated in women during breast-feeding.

At normal therapeutic doses codeine and its active metabolites may be present in breast milk at very low doses and is unlikely to adversely affect the breast fed infant.  However, if the patient is an ultra-rapid metaboliser of CYP2D6, higher levels of the active metabolite, morphine, may be present in breast milk and on very rare occasions may result in symptoms of opioid toxicity in the infant, which may be fatal.

Effects of drugs on work (operators of machinery, driving vehicles, people working at height and other cases)

This product can cause drowsiness, caution should be exercised when driving or using machines.

Shelf life

36 months from the manufacturing date. Do not use after the expiry date.

Al/Al strips. Box of 05 strips x 4 effervescent tablets.

Al/Al strips. Box of 10 strips x 4 effervescent tablets.