Special Warning : אזהרת שימוש

       4.4 Special warnings and precautions for use


Sensitivity to any food or medicine.
Naturally and rarely, in some people’s bodies, codeine undergoes metabolism (breakdown) more rapidly than in most of the population. In these rare cases, high amounts of metabolites may accumulate and can cause severe side effects, such as: excessive drowsiness, confusing our shallow breathing. In such cases, the patient should be referred immediately for medical treatment.
In most cases, it is impossible to know in advance whether a patient belongs to this group of people at risk for this effect.
Current or past impaired function of: the respiratory system (e.g., asthma), the heart and/or blood vessels, the liver, the kidney/urinary tract, the digestive system (in retinal diseases, diarrhoea, reflux esophagitis, the thyroid, the roostate, from spasms, from severe muscle weakness.
Paracetamol may cause liver damage in the following cases: if given for a prolonged period, drinking alcoholic beverages during the treatment period and if other medicines that effect the liver are used.
Paracetamol may interfere with blood sugar test results.
Prolonged use may cause dependence!
Not to be used frequently or for prolonged period without consultation.
Other fever- and pain -reducing medicines, or cold medicines, should not be taken- to prevent paracetamol poisoning/overdose.
Medicines containing codeine are only used to treat sharp pain (of short duration) of moderate intensity among children above the age of 12 years, and only if the pain cannot be treated by pain relievers such as paracetamol or ibuprofen, since use of codeine may increase the risk of breathing suppressing.
Do not give codeine to children and adolescents above the age of 12 and under the age of 18 after a tonsillectomy or adenoidectomy for treatment of obstructive sleep apnoea, since these patients are more likely than others to suffer from breathing problems.
This medicine is not recommended for children suffering from breathing problems.
Atropine may distrust the results of a gastric acid secretion test- do not take this medicine for 24 hours before the test.
Paracetamol & Codeine:
Codeine is metablised 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.
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, somnolence, 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.


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.
Children 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.


Caution is advised if paracetamol is administered concomitantly with flucloxacillin due to increased risk of high anion gap metabolic acidosis (HAGMA), particularly in patients with severe renal impairment, sepsis, malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), as well as those using maximum daily doses of paracetamol. Close monitoring, including measurement of urinary 5- oxoproline, is recommended.
Atropine:
Use with caution in patients with: urinary retention, acute myocardial infarction, hypertension, conditions associated with tachycardia (including hyperthyroidism, cardiac insufficiency, cardiac surgery), pyrexia and diarrhoea.
Use of atropine in patients with ulcerative colitis may lead to toxic megacolon and ileus.
Increased side effects may be seen in children and the elderly, and in patients with Dow ’s sy dro e.
Atropine may aggravate gastro-oesophageal reflux.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Papaverine:

Sensitivity Reactions
Hepatic Hypersensitivity
Hepatic hypersensitivity with GI symptoms, jaundice, eosinophilia, and altered hepatic function tests results reported.

If such hypersensitivity occurs, the drug should be discontinued.

Glaucoma
Use with caution in patients with glaucoma.
Abuse and Dependence
Potential abuse and dependence to papaverine reported.
       

Effects on Driving

4.7 Effects on ability to drive and use machines
Do not drive or operate dangerous machines while using the medicine since use of this medicine may impair alertness.
Children should be cautioned against bicycle riding or laying near road, etc.