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TYLEX 30 MG/500 MG EFFERVESCENT TABLETS

Information leaflet

                                                   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

 Effervescent tablet.
 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.

 4.3 Contraindications

 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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Date Printed 07/04/2011                               CRN 2096709                                         page number: 1
                                                    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
 use.

 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
 deafness.

 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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Date Printed 07/04/2011                               CRN 2096709                                         page number: 2
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