Irish Medicines Board
Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Tylex 30 mg / 500 mg Effervescent Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each effervescent tablet contains 500 mg of paracetamol and 30 mg of codeine phosphate hemihydrate.
Excipients: Sodium 326.6 mg/tablet
Apsartame (E951) 25.0 mg/tablet
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Round, white to off-white, bevelled edged tablets.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
For the relief of moderate to severe pain.
4.2 Posology and method of administration
Adults: Tylex Effervescent Tablets are given orally and should be dissolved in at least half a tumblerful of water before
taking. The usual dose is one or two effervescent tablets every four hours as required. The total daily dose should not
exceed 240 mg of codeine phosphate hemihydrate (i.e. not more than four doses per 24 hours should be taken).
Elderly: A reduced dose may be required.
Children: Use in children under 12 years of age is not recommended.
Dosage should be adjusted according to the severity of the pain and the response of the patient. However, it should be
kept in mind that tolerance to codeine can develop with continued use and that the incidence of untoward effects is dose
related. Doses of codeine higher than 60 mg fail to give commensurate relief of pain but merely prolong analgesia and
are associated with an appreciably increased incidence of undesirable side effects.
Tylex Effervescent Tablets should not be administered to patients who have previously exhibited hypersensitivity to
either paracetamol or codeine, or to any of its excipients.
Tylex Effervescent Tablets are not recommended for children under the age of 12 years.
4.4 Special warnings and precautions for use
Because safety and effectiveness in the administration of paracetamol with codeine in children under 12 years of age
have not been established, such use is not recommended.
These tablets should be used with caution in patients with head injuries, increased intracranial pressure, acute
abdominal conditions, the elderly and debilitated, and those with severe impairment of hepatic or renal function,
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Irish Medicines Board
hypothyroidism, Addison's disease and prostatic hypertrophy or urethral stricture, myasthenia gravis, biliary tract
disorders (including recent biliary tract surgery), pre-existing respiratory depression or those with the potential to
develop respiratory depression e.g. pulmonary emphysema, known ultra-rapid metabolisers of codeine, reduced blood
volume, seizures, shock, ulcerative colitis..
The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Tylex Effervescent Tablets contain 326.6 mg sodium/tablet and this should be taken into account when prescribing for
patients for whom sodium restriction is indicated. Tylex Effervescent Tablets also contain 25 mg aspartame/tablet and
therefore care should be taken in phenylketonuria.
At high doses codeine has most of the disadvantages of morphine, including respiratory depression. Codeine can
produce drug dependence of the morphine type, and therefore has the potential for being abused. Prolonged regular
use, except under medical supervision, may lead to physical and psychological dependence (addiction) and result in
withdrawal symptoms, such as restlessness and irritability once the drug is stopped. Codeine may impair the mental/or
physical abilities required for the performance of potentially hazardous tasks.
Severe liver damage may occur if the maximal daily dose is exceeded, if Tylex is taken together with another
paracetamol-containing product, or if Tylex is taken while consuming large amounts of alcohol.
Although paracetamol might logically be presumed to be the best alternative analgesic in patients with aspirin
sensitivity, cross reactions have been reported.
Codeine is partially metabolised by CYP2D6. If a patient has a deficiency or is completely lacking this enzyme they
will not obtain adequate analgesic effects. Estimates indicate that up to 7% of the caucasian population may have this
deficiency. However, if the patient is an ultra-rapid metaboliser there is an increased risk of developing side effects of
opioid toxicity even at low doses. General symptoms of opioid toxicity include nausea, vomiting, constipation, lack of
appetite and somnolence. In severe cases this may include symptoms of circulatory and respiratory depression.
Estimates indicate that up to 1 to 2% of the caucasian population may be ultra-rapid metabolisers.
Abrupt withdrawal of opioids from persons physically dependent on them precipitates a withdrawal syndrome, the
severity of which depends on the individual, the drug used, the size and frequency of the dose, and the duration of drug
Patients should be advised that immediate medical advice should be sought in the event of an overdose, because of the
risk of delayed, serious liver damage. They should be advised not to exceed the recommended dose, not to take other
paracetamol-containing products concurrently, to consult their doctor if symptoms persist and to keep the product out
of the reach of children.
The long term use of high doses of combined codeine – paracetamol has been associated with the occurrence of
4.5 Interaction with other medicinal products and other forms of interaction
Patients receiving other central nervous system depressants (including other opioid analgesics, tranquillisers, sedative
hypnotics and alcohol) concomitantly with Tylex may exhibit an additive depressant effect. When such therapy is
contemplated, the dose of one or both agents should be reduced.
Concurrent use of MAO inhibitors or tricyclic antidepressants with codeine may increase the effect of either the
antidepressant or codeine. Concurrent use of anticholinergics and codeine may produce paralytic ileus.
Quinidine may reduce the concentration of morphine, the active metabolite of codeine, by >90% in patients who are
known to have extensive metabolism via the cytochrome P452D6 pathway.
Concurrent use with centrally acting muscle relaxants may increase the risk of respiratory depression.
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