Effer Paralmax Codein 10

POSOLOGY AND METHOD OF ADMINISTRATION

Administration

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

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 modified to meet the specific requirements of other active ingredients in combination with codeine in the product.

Posology  

● Adults:  1-2 tablets every 4-6 hours, up to a maximum of 8 tablets in any 24-hour period.

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

● Children aged less than 12 years: should not be used in children below the age of 12 because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine.

● Elderly: There is no current report for dose modification in the elderly. Dosage should be reduced in patients with impaired liver function when necessary.

CONTRAINDICATIONS

- Hypersensitivity to any of the constituents of the tablets.

- Children aged less than 12 years.

- Severe liver disease and respiratory failure.

- Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency.

- Breastfeeding women

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

- All pediatric patients (0-18 years of age) who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome due to an increased risk of developing severe and life-threatening adverse reactions.

- The patient with acute diarrhea.

- In people who are taking or have taken an IMAO within two weeks.

WARNINGS AND PRECAUTIONS

- In patients with liver failure, kidney failure. 

- Drinking alcohol too much and using paracetamol for a long time may increase the risk of live toxicity, should avoid using alcohol.

- Paracetamol should be used with caution in patients with pre-existing anemia, as cyanosis may not be evident, despite dangerously high methemoglobin concentrations in the blood.

- Use codeine phosphate with caution in people with respiratory diseases such as asthma, emphysema, or drug addiction history.

- Do not use codeine phosphate to relieve cough in suppurative pulmonary and bronchi diseases when it is necessary to cough up purulent sputum.

- Pregnancy.

- Driving and using machines.

- The physician should warn patients of severe 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 metabolized by the liver enzyme CYP2D6 into morphine, its active metabolite. If a patient has a deficiency or completely lacks 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 metabolizer, 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, somnolence, shallow breathing, small pupils, nausea, vomiting, constipation, and lack of appetite. In severe cases, this may include circulatory and respiratory depression symptoms, which may be life-threatening and very rarely fatal. Estimates of the prevalence of ultra-rapid metabolites in different populations are summarized below:

Patients with compromised respiratory function

Codeine is not recommended for use in children whose 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 metabolizers in their ability to metabolize codeine to morphine.

Each EFFER-PARALMAX CODEINE 10 tablet contains aspartame, a source of phenylalanine, which may be harmful to people with phenylketonuria.

PREGNANCY AND LACTATION

Pregnancy    

The safety of paracetamol-codeine in pregnancy has not been established because of its association with adverse effects on fetal development. The use of paracetamol-codeine during labor can cause respiratory distress in the neonate.

Therefore if possible, EFFER-PARALMAX CODEINE 10 should be avoided during pregnancy.

Breast-feeding

EFFER-PARALMAX CODEINE 10 is contraindicated in women during breastfeeding.

At normal therapeutic doses, codeine and its active metabolites may be present in breast milk at very low doses and are unlikely to adversely affect the breastfed infant.  However, if the patient is an ultra-rapid metabolizer 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)

The drug 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.

Al/Al strips.  Box of 25 strips x 4 effervescent tablets.