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Each tablet contains Paracetamol Ph. Codeine is indicated 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. Codeine should not be used in children below the age of 12 years because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine see sections 4. Solpadeine Max Soluble Tablets are contraindicated in patients with hypersensitivity to paracetamol, caffeine, codeine, opioid analgesics or any of the other constituents.
Solpadeine Max Soluble Tablets contain mg sodium in each tablet. This should be taken into where the patient has been placed on a restricted sodium intake e. Care is advised in the administration of Solpadeine Max Soluble Tablets to patients with severe renal or severe hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Patients with obstructive bowel disorders or acute abdominal conditions should consult a doctor before using this product. Patients with a history of cholecystectomy should consult a doctor before using this product as it may cause acute pancreatitis in some patients. Excessive intake of caffeine e.
Codeine is metabolised by the liver enzyme CYP2D6 into morphine. If a patient has a deficiency or is completely lacking this enzyme an adequate analgesic effect will not be obtained. 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 Long term effects of solpadeine 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. Estimates of prevalence of ultra-rapid metabolisers in different populations are summarized below:. 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.
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.
Wait at least four hours after taking any other painkiller before you take this medicine. If you take this medicine for headaches for more than 3 days it can make them worse. If you need to take it for longer than 3 days you should see your doctor or pharmacist for advice. This can give you withdrawal symptoms from the medicine when you stop taking it. If the pain does not improve after 3 days, talk to your doctor for advice.
When you stop taking it you may get withdrawal symptoms. You should Long term effects of solpadeine to your doctor or pharmacist if you think you are suffering from withdrawal symptoms. If you have any unwanted side-effects you should seek advice from your doctor, pharmacist or other healthcare professional. Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side-effects via the internet at www.
If you take the medicine according to the instructions on the pack it is unlikely that you will become addicted to the medicine. However, if the following apply to you it is important that you talk to your doctor:. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no ificant effect.
Codeine may antagonize the effects of metoclopramide and domperidone on gastrointestinal motility. Codeine potentiates the central depressive effects of central nervous system depressants including alcohol, anaesthetics, hypnotics, sedatives, tricyclic antidepressants and phenothiazines. MAOIs taken with pethidine have been associated with severe CNS excitation or depression including hypertension or hypotension. Although this has not been documented with codeine, it is possible that a similar interaction may occur and therefore the use of codeine should be avoided while the patient is taking MAOIs and for 2 weeks after MAOI discontinuation.
Opiate analgesics may interact with monoamine oxidase inhibitors MAOI and result in serotonin syndrome. Use during pregnancy should be avoided, unless advised by a physician. This includes maternal use during labour because of the potential for respiratory depression in the neonate. The safety of paracetamol-caffeine-codeine during pregnancy has not been established relative to the possible adverse effects of foetal development and should be avoided during pregnancy due to the possible increased risk of lower birth weight and spontaneous abortion associated with caffeine consumption.
At normal therapeutic doses codeine and its active metabolite may be present in breast milk at very low doses and is unlikely to adversely affect the breast fed infant.
However, if the patient is an ultra-rapid metaboliser 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. Although ificant caffeine toxicity has not been observed in breastfed infants, caffeine may have a stimulating effect on the infant. Due to the caffeine content of this product it should not be used if you are pregnant or breastfeeding. Patients should be advised not to drive or operate machinery if affected by dizziness or sedation.
This medicine can impair cognitive function and can affect a patient's ability to drive safely. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act When taking this medicine, patients should be told:. Long term effects of solpadeine events from historical clinical trial data are both infrequent and from small patient exposure. Due to the limited clinical trial data the frequency of these adverse events is not known cannot be estimated from available data but the post-marketing experience indicates that adverse drug reactions to paracetamol are rare and serious reactions are very rare.
Body System. When the recommended paracetamol-caffeine-codeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related adverse effects such as insomnia, restlessness, anxiety, irritability, headaches, gastrointestinal disturbances, and palpitations.
Adverse reactions identified during post-marketing use are listed below by MedDRA system organ class. The frequency of these reactions is not known. Constipation, nausea, vomiting, dyspepsia, dry mouth, acute pancreatitis in patients with a history of cholecystectomy. Overuse of this product, defined as consumption of quantities in excess of the recommended dose, or consumption for a prolonged period of time may lead to physical or psychological dependency.
Symptons of restlessness and irritability may result when treatment is stopped. The effects in overdosage will be potentiated by simultaneous ingestion of alcohol and psychotropic drugs. Central nervous system depression, including respiratory depression, may develop but is unlikely to be severe unless other sedative agents have been co-ingested, including alcohol, or the overdose is very large. The pupils may be pin-point in size; nausea and vomiting are common.
Hypotension and tachycardia are possible but unlikely. This should include general symptomatic and supportive measures including a clear airway and monitoring of vital s until stable. Give naloxone if coma or respiratory depression is present. Naloxone is a competitive antagonist and has a short half-life, so large and repeated doses may be required in a seriously poisoned patient. Observe for at least four hours after ingestion, or eight hours if a sustained release preparation has been taken. Liver damage is possible in adults who have taken 10 g or more of paracetamol.
Ingestion of 5 g or more of paracetamol may lead to liver damage if the patient has risk factors see below. Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes. Is likely to be glutathione deplete e.
Symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic Long term effects of solpadeine may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema and death.
Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage.
Cardiac arrhythmias and pancreatitis have been reported. Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of ificant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose Long term effects of solpadeine.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion earlier concentrations are unreliable. Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule.
If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit. Overdose of caffeine may result in epigastric pain, vomiting, diuresis, tachycardia or cardiac arrhythmia, CNS stimulation insomnia, restlessness, excitement, agitation, jitteriness, tremors and convulsions.
It must be noted that for clinically ificant symptoms of caffeine overdose to occur with this product, the amount ingested would be associated with serious paracetamol-related liver toxicity. Patients should receive general supportive care e. The administration of activated charcoal may be beneficial when performed within one hour of the overdose. The CNS effects of overdose may be treated with intravenous sedatives. Treatment of overdose with Solpadeine Max Soluble Tablets requires assessment of plasma paracetamol levels for antidote treatment, with s and symptoms of codeine and caffeine toxicity being managed symptomatically.
Caffeine has a stimulatory effect on the central nervous system and possesses a weak diuretic action.
Codeine is a centrally acting weak analgesic. Codeine, particularly in combination with other analgesics such as paracetamol, has been shown to be effective in acute nociceptive pain. Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Concentration of the drug in plasma reaches a peak in 30 — 60 minutes and the plasma half- life is 1- 4 hours. Paracetamol is relatively uniformly distributed throughout most body fluids and exhibits variable protein binding.
Excretion is almost exclusively renal, in the form of conjugated metabolites. Codeine phosphate is well absorbed after administration and distributes widely throughout the body. Caffeine is rapidly but irregularly absorbed after oral administration, absorption is pH-related. After an oral dose of mg, peak plasma concentration of 1. Plasma half-life is between hours. There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC. Laminate strips packed into cardboard cartons containing 8, 16, 20, 24 or 32 tablets.
Not all pack sizes may be marketed. Help us improve emc by letting us know which of the following best describes you. Toggle. Search emc: Enter medicine name or company Start typing to retrieve search suggestions. Continue typing to refine. Solpadeine Max Soluble Tablets. Back to top Omega Pharma Ltd contact details. Active ingredient paracetamol caffeine codeine phosphate hemihydrate.
Legal Category P: Pharmacy. SmPC Patient Leaflet. Last updated on emc: 19 Dec View changes Print. Show table of contents Hide table of contents 1. Name of the medicinal product 2. Qualitative and quantitative composition 3. Pharmaceutical form 4. Clinical particulars 4.Long term effects of solpadeine
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