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The dose should be individually adjusted according to intensity of pain and response of the patient. Additional doses can be taken as needed, not exceeding 8 tablets equivalent to mg tramadol and mg paracetamol per day. Treatment is therefore not recommended in this population. In patients over 75 years old, it is recommended that the minimum interval between doses should be not less than 6 hours, due to the presence of tramadol.
As tramadol is removed only very slowly by haemodialysis or by haemofiltration, post dialysis administration to maintain analgesia is not usually required. In moderate cases prolongation of the dosage interval should be carefully considered see Section 4. Tablets must be swallowed whole, with a sufficient quantity of liquid.
They Tramadol hydrochloride what is it used for not be broken or chewed. List of excipients of the medicinal product. Interactions with other medicinal products and other forms of interaction. In order to avoid inadvertent overdose, patients should be advised not to exceed the recommended dose and not to use any other paracetamol including over the counter or tramadol hydrochloride containing products concurrently without the advice of a physician.
The hazards of paracetamol overdose are greater in patients with non-cirrhotic alcoholic liver disease. In moderate cases prolongation of dosage interval should be carefully considered. Although it is an opioid agonist, tramadol cannot suppress morphine withdrawal symptoms. Convulsions have been reported in patients receiving tramadol at the recommended dose levels. The risk may be increased when doses of tramadol exceed the recommended upper dose limit. The clinical need for analgesic treatment should be reviewed regularly see section 4.
In opioid-dependent patients and patients with a history of drug abuse or dependence, treatment should only be for short period and under medical supervision. Symptoms of withdrawal reaction, similar to those occurring during opiate withdrawal, may occur even at therapeutic doses and for short term treatment see section 4. Withdrawal symptoms may be avoided by tapering it at the time of discontinuation especially after long treatment periods.
Rarely, cases of dependence and abuse have been reported see section 4. Symptoms of withdrawal reactions, similar to those occurring during opiate withdrawal may occur see section 4. In one study, use of tramadol during general anaesthesia with enflurane and nitrous oxide was reported to enhance intra-operative recall. Until further information is available, use of tramadol during light planes Tramadol hydrochloride what is it used for anaesthesia should be avoided. Risk of serotoninergic syndrome: diarrhoea, tachycardia, sweating, trembling, confusion, even coma.
Central excitation symptoms evocative of a serotoninergic syndrome: diarrhoea, tachycardia, sweating, trembling, confusion, even coma. In case of recent treatment with MAO inhibitors, a delay of two weeks should occur before treatment with tramadol. The effect on alertness can make driving of vehicles and the use of machines dangerous. Avoid intake of alcoholic drinks and of medicinal products containing alcohol.
Risk of reduced efficacy and shorter duration due to decreased plasma concentrations of tramadol. Decrease of the analgesic effect by competitive blocking effect at the receptors, with the risk of occurrence of withdrawal syndrome. s of Serotonin Syndrome may be for example, confusion, agitation, fever, sweating, ataxia, hyperreflexia, myoclonus and diarrhoea. These drugs can cause increased central depression. The clinical importance of such an interaction has not been studied.
Concomitant use of tramadol with these drugs can increase the risk of convulsions. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine. Paracetamol can be used during pregnancy if clinically needed however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.
Tramadol should not be used during pregnancy as there is inadequate evidence available to assess the safety of tramadol in pregnant women. Tramadol administered before or during birth does not affect uterine contractility. In neonates it may induce changes in the respiratory rate which are usually not clinically relevant. Long-term treatment during pregnancy may lead to withdrawal symptoms in the newborn after birth, as a consequence of habituation.
Approximately 0. For this reason tramadol should not be used during lactation or alternatively, breast-feeding should be discontinued during treatment with tramadol. Discontinuation of breast-feeding is generally not necessary following a single dose of tramadol. Paracetamol is excreted in breast milk but not in a clinically ificant amount. Available published data do not contraindicate breast feeding by women using single ingredient medicinal products containing only paracetamol.
Tramadol and its metabolites are found in small amounts in human breast milk. An infant could ingest about 0. Tramadol should not be ingested during breast feeding. Animal studies do not show an effect of tramadol or of paracetamol on fertility see Section 5. No study on fertility has been performed with the combination of tramadol and paracetamol. There are no data for effects of the combination on human fertility.
If affected, the patient should not drive or operate machinery. This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act When prescribing this medicine, patients should be told:. Although not observed during clinical trials, the occurrence of the following undesirable effects known to be related to the administration of tramadol or paracetamol cannot be excluded:.
These include changes in mood, usually elation occasionally dysphoriachanges in activity usually suppression occasionally increase and changes in Tramadol hydrochloride what is it used for and sensorial capacity. Other symptoms that have very rarely been seen if tramadol hydrochloride is discontinued abruptly include: panic attacks, severe anxiety, hallucinations, paraesthesia, tinnitus and unusual CNS symptoms.
In other studies, prothrombin time did not change. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Healthcare professionals are asked to report any suspected adverse reactions via the yellow card scheme at www. In case of overdose, the symptoms may include the s and symptoms of toxicity of tramadol or paracetamol or of both these active ingredients. In principle, on intoxication with tramadol, symptoms similar to those of other centrally acting analgesics opioids are to be expected.
These include in particular, miosis, vomiting, cardiovascular collapse, consciousness disorders up to coma, convulsions and respiratory depression up to respiratory arrest. An overdose is of particular concern in young children. Symptoms of paracetamol overdosage 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 failure may progress to encephalophathy, coma and death. Acute Tramadol hydrochloride what is it used for failure with acute tubular necrosis may develop even in the absence of severe liver damage.
Cardiac arrhythmias and pancreatitis have been reported. Liver damage is possible in adults who have taken 7.
It is considered that excess quantities of a toxic metabolite usually adequately detoxified by glutathione when normal doses of paracetamol are ingestedbecome irreversibly bound to liver tissue. 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 and any adult or adolescent who had ingested around 7. Paracetamol concentrations in blood should be measured later than 4 hours after overdose in order to be able to assess the risk of developing liver damage via the paracetamol overdose nomogram.
Administration of oral methionine or intravenous N-acetylcysteine NAC which may have a beneficial effect up to at least 48 hours after the overdose may be required. Administration of intravenous NAC is most beneficial when initiated within 8 hours of overdose ingestion.
However, NAC should still be given if the time to presentation is greater than 8 hours after overdose and continued for a full course of therapy. NAC treatment should be started immediately when massive overdose is suspected. General supportive measures must be available. Irrespective of the reported quantity of paracetamol ingested, the antidote for paracetamol, NAC, should be administered orally or intravenously, as quickly as possible, if possible, within 8 hours following the overdose.
Tramadol is an opioid analgesic that acts on the central nervous system. Other mechanisms which contribute to its analgesic effect are inhibition of neuronal Tramadol hydrochloride what is it used for of noradrenaline and enhancement of serotonin release. Tramadol has an antitussive effect. Unlike morphine, a broad range of analgesic doses of tramadol has no respiratory depressant effect. Similarly, the gastro-intestinal motility is not modified.Tramadol hydrochloride what is it used for
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Tramadol Hydrochloride/Paracetamol mg/mg Film-Coated Tablets