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TYLEX is a brand name for Acetaminophen (also known as Paracetamol). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Tylex Capsules is indicated for use in patients older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol or ibuprofen (alone).
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults:
Tylex Capsules are given orally. The usual dose is one or two capsules every 4 to 6 hours when necessary to a maximum daily dose of 240 mg codeine and 4 g paracetamol (up to 8 capsules per day).
Duration of treatment:
Codeine should be used at the lowest effective dose for the shortest period of time. 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.
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.
Elderly:
As for adults, however a reduced dose may be required. See warnings. 4).
Children aged 12 to 15 years:
One capsule every 6 hours when necessary to a maximum of 4 capsules in 24 hours.
Children aged 16 to 18 years:
One to two capsules every 6 hours when necessary up to a maximum of 8 capsules in 24 hours. Method of administration For oral administration. Treatment goals and discontinuation Before initiating treatment with Tylex, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines.
During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with codeine, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
4).
Reported adverse reactions seem more prominent in ambulatory than non-ambulatory patients and some of these effects may be alleviated if the patient lies down.
A tabulated list of adverse reactions are outlined below:
System Organ Class Frequency Adverse Effects Blood and lymphatic system disorders Not Known Thrombocytopenia, agranulocytosis, neutropenia, leucopenia Metabolism and nutrition disorders Not known High anion gap metabolic acidosis Immune system disorders Not Known Anaphylactic shock, hypersensitivity including skin rash may occur.
) Nervous system disorders Not Known Dizziness, sedation, headache Ear and labyrinth disorders Not Known Deafness1 Respiratory thoracic and mediastinal disorders Not Known Bronchospasm, dyspnoea Gastro-intestinal disorders Not Known Nausea, vomiting, constipation, abdominal pain, pancreatitis2 Hepatobiliary disorders Not Known Sphincter of Oddi dysfunction Skin and subcutaneous tissue disorders Not Known Pruritus, rash, urticaria Very rare cases of serious skin reactions have been reported.
General disorders and administration site conditions Uncommon Drug withdrawal syndrome 1 Deafness has been reported in patients after long term use of high doses of codeine – paracetamol. 2 Drug-induced pancreatitis associated with paracetamol has been reported in literature to be a rare reaction only occurring in patients taking in excess of the recommended doses.
Literature reports have also associated cases of pancreatitis with codeine. 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.
In clinical use of paracetamol containing products, there have been a few reports of blood dyscrasias including thrombocytopenia and agranulocytosis but these were not necessarily causally related to paracetamol. Anaphylaxis, angioedema and toxic epidermal necrolysis have also been associated with the use of paracetamol.
Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs: Concomitant use of Tylex and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.
Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia.
Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage. If a decision is made to prescribe Tylex concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin.
If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.
The risk-benefit of continued use should be assessed regularly by the prescriber. Tylex capsules contain sodium metabisulfite, a sulfite that may cause allergic reactions including anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible people.
The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than non-asthmatic people. g. the elderly (who may be sensitive to their central and gastro-intestinal effects) and debilitated patients, patients with CNS depression, hypothyroidism, Addison's disease, prostatic hypertrophy or urethral stricture, myasthenia gravis, inflammatory or obstructive bowel disorders.
1. In children under the age of 12 years. 4). In patients for whom it is known they are CYP2D6 ultra-rapid metabolisers. 4. 6) Monoamine oxidase inhibitor therapy, concurrent or within 14 days.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Prolonged use of a painkiller for headaches can make them worse. Codeine can produce typical opioid effects including constipation, nausea, vomiting, dizziness, light-headedness, confusion, drowsiness and urinary retention. The frequency and severity are determined by dosage, duration of treatment and individual sensitivity.
Regular prolonged use of codeine is known to lead to addiction and tolerance. Symptoms of restlessness and irritability may result when treatment is stopped. Drug dependence Repeated use of Tylex can lead to drug dependence, even at therapeutic doses.
4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Care should also be observed if prolonged therapy is contemplated. Hepatobiliary disorders Codeine may cause dysfunction and spasm of the sphincter of Oddi, thus increasing the risk of biliary tract symptoms and pancreatitis. Therefore, codeine/paracetamol has to be administered with caution in patients with pancreatitis and diseases of the biliary tract.
Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with alcoholic liver disease. 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.
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.
Administration of pethidine and possibly other opioid analgesics to patients taking a monoamine oxidase inhibitor (MAOI) has been associated with very severe and sometimes fatal reactions. 5). Patients positively identified with aspirin induced asthma, or who have ever experienced an asthmatic reaction to aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) or are at high risk of aspirin induced asthma should avoid all products that contain aspirin or NSAIDs indefinitely.
In these patients paracetamol should be recommended in low or moderate dose (< 1000 mg in a single dose) unless contraindicated. Although paracetamol might logically be presumed to be the best alternative analgesic in patients with aspirin sensitivity, cross reactions have been reported.
5). Codeine is 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, 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.
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