Loading…
TRAMADOL HYDROCHLORIDE AND PARACETAMOL is a brand name for Tramadol. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Tramadol hydrochloride and Paracetamol tablets are indicated for the symptomatic treatment of moderate to severe pain. The use of Tramadol hydrochloride and Paracetamol tablets should be restricted to patients whose moderate to severe pain is considered to require a combination of paracetamol and tramadol (see section…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology The use of Tramadol hydrochloride and Paracetamol tablets should be restricted to patients whose moderate to severe pain is considered to require a combination of paracetamol and tramadol. The dose should be adjusted according to intensity of pain and the sensitivity of the individual patient.
The lowest effective dose for analgesia should generally be selected. The total dose of 8 tablets (equivalent to 300 mg tramadol hydrochloride and 2600 mg paracetamol) per day should not be exceeded. The dosing interval should not be less than six hours.
Adults and Adolescents (12 years and older) An initial dose of two tablets of Tramadol hydrochloride and Paracetamol tablets is recommended. Additional doses can be taken as needed, not exceeding 8 tablets (equivalent to 2600 mg paracetamol and 300 mg tramadol) per day.
The dosing interval should not be less than six hours. 4 - Special warnings and precautions for use). If repeated use or long term treatment with Tramadol hydrochloride and Paracetamol tablets is required as a result of the nature and severity of the illness, then careful, regular monitoring should take place (with breaks in the treatment, where possible), to assess whether continuation of the treatment is necessary.
Paediatric population The effective and safe use of Tramadol hydrochloride and Paracetamol tablets has not been established in children below the age of 12 years. Treatment is therefore not recommended in this population. Special populations Elderly patients A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest hepatic or renal insufficiency.
In older people over 75 years elimination may be prolonged. Therefore, if necessary the dosage interval is to be extended according to the patient’s requirements. Renal insufficiency/dialysis In patients with renal insufficiency the elimination of tramadol is delayed.
In these patients prolongation of the dosage intervals should be carefully considered according to the patient’s requirements. Hepatic insufficiency In patients with severe hepatic impairment the elimination of tramadol is delayed. 4).
3). Method of administration Oral use. Tablets must be swallowed whole, with a sufficient quantity of liquid. They must not be broken or chewed. Treatment goals and discontinuation Before initiating treatment with Tramadol hydrochloride and Paracetamol tablets, 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.
The most commonly reported undesirable effects during the clinical trials performed with the paracetamol and tramadol combination were nausea, dizziness and somnolence, observed in more than 10 % of the patients. Cardiac disorders: • Uncommon (≥ 1/1000 to < 1/100): palpitations, tachycardia, arrythmia.
Nervous system disorders: • Very common (≥ 1/10): dizziness, somnolence • Common (≥ 1/100 to < 1/10): headache trembling • Uncommon (≥ 1/1000 to < 1/100): involuntary muscular contractions, paraesthesia, amnesia • Rare (≥ 1/10000 to < 1/1000): ataxia, convulsions, syncope.
• Not known (frequency cannot be estimated from the available data): Serotonin syndrome Psychiatric disorders: • Common (≥ 1/100 to < 1/10): confusional state, mood altered, anxiety, nervousness, euphoric mood, sleep disorders • Uncommon (≥ 1/1000 to < 1/100): depression, hallucinations, nightmares • Rare (≥ 1/10000 to < 1/1000): delirium, drug dependence.
Post marketing surveillance: • very rare (< 1/10000): abuse. Eye disorders: • Rare (≥ 1/10000 to < 1/1000): blurred vision, miosis, mydriasis Ear disorders: • Uncommon (≥ 1/1000 to < 1/100): tinnitus Investigations: • Uncommon (≥ 1/1000 to < 1/100): transaminases increased Respiratory, thoracic and mediastinal disorders: • Uncommon (≥ 1/1000 to < 1/100): dyspnoea Gastrointestinal disorders: • Very common (≥ 1/10): nausea • Common (≥ 1/100 to < 1/10): vomiting, constipation, dry mouth, diarrhoea abdominal pain, dyspepsia, flatulence • Uncommon (≥ 1/1000 to < 1/100): dysphagia, melaena.
Liver and biliary system disorders: • Uncommon (≥ 1/1000 to < 1/100): hepatic transaminases increase. g. rash, urticaria). Urinary system disorders: • Uncommon (≥ 1/1000 to < 1/100): albuminuria, micturition disorders (dysuria and urinary retention).
General disorders and administration site conditions: • Uncommon (≥ 1/1000 to < 1/100): chills, chest pain Metabolism and nutrition disorders: • Unknown (≥ 1/1000 to < 1/100): hypoglycaemia, high anion gap metabolic acidosis Renal and urinary disorders: • Uncommon (≥ 1/1000 to < 1/100): albuminuria, micturition disorders (dysuria and urinary retention) Vascular disorders: • Uncommon (≥ 1/1000 to < 1/100): hypertension, hot flush Drugs dependence Repeated use of Tramadol hydrochloride and Paracetamol tablets can lead to drug dependence, even at therapeutic doses.
Warnings In adults and adolescents 12 years and older: the maximum dose of 8 tablets of Tramadol hydrochloride and Paracetamol tablets should not be exceeded. 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.
In severe renal insufficiency (creatinine clearance <10 ml/mm), Tramadol hydrochloride and Paracetamol tablets is not recommended. 3). 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. In severe respiratory insufficiency, Tramadol hydrochloride and Paracetamol tablets are not recommended. Tramadol is not suitable as a substitute in opioid-dependent patients.
Although it is an opioid agonist, tramadol cannot suppress morphine withdrawal symptoms. Convulsions have been reported in tramadol-treated patients susceptible to seizures or taking other medications that lower the seizure threshold, especially selective serotonin re-uptake inhibitors, tricyclic antidepressants, antipsychotics, centrally acting analgesics or local anaesthesia.
Epileptic patients controlled by a treatment or patients susceptible to seizures should be treated with Tramadol hydrochloride and Paracetamol tablets only if there are compelling circumstances. 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. 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.
4)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Tramadol in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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 tramadol, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.
4).
4). 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: Tramadol • Postural hypotension, bradycardia, collapse (tramadol).
• Post-marketing surveillance of tramadol has revealed rare alterations of warfarin effect, including elevation of prothrombin times. g. dyspnoea, bronchospasm, wheezing, angioneurotic oedema) and anaphylaxis. • Rare cases (≥1/10000 to <1/1000): changes in appetite, motor weakness, and respiratory depression.
• Psychic side-effects may occur following administration of tramadol which vary individually in intensity and nature (depending on personality and duration of medication). g. decision behaviour perception disorders). • Worsening of asthma has been reported though a causal relationship has not been established.
• Symptoms of withdrawal reactions, similar to those occurring during opiate withdrawal may occur as follows: agitation, anxiety, nervousness, insomnia, hyperkinesia, tremor and gastrointestinal symptoms. 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.
• Respiratory, thoracic and mediastinal disorders - Not known (frequency cannot be estimated from the available data): hiccups Paracetamol • Adverse effects of paracetamol are rare but hypersensitivity including skin rash may occur.
Very rare cases of serious skin reactions may occur. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but these were not necessarily causally related to paracetamol. • There have been several reports that suggest that paracetamol may produce hypoprothrombinaemia when administered with warfarin-like compounds.
In other studies, prothrombin time did not change. • Very rare cases of serious skin reactions have been reported. 5). 4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients. 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.
Sleep-related breathing disorders 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.
CYP2D6 metabolism Tramadol is metabolised by the liver enzyme CYP2D6. If a patient has a deficiency or is completely lacking this enzyme an adequate analgesic effect may not be obtained. 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 a risk of developing side effects of opioid toxicity even at commonly prescribed doses. 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. 9% Northern European 1% to 2% Post-operative use in children There have been reports in the published literature that tramadol given post- operatively in children after tonsillectomy and/or adenoidectomy for obstructive sleep apnoea, led to rare, but life threatening adverse events.
Extreme caution should be exercised when tramadol is administered to children for post-operative pain relief and should be accompanied by close monitoring for symptoms of opioid toxicity including respiratory depression. Children with compromised respiratory function Tramadol 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 opioid toxicity. Precautions for use Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs Concomitant use of Tramadol hydrochloride and Paracetamol tablets with 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 drugs should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Tramadol hydrochloride and Paracetamol tablets concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of the concomitant treatment should be as short as possible.
Tolerance, psychic and physical dependence may develop, even at therapeutic doses and especially after long-term use. 2). Tramadol hydrochloride and Paracetamol tablets should be used with caution in opioid dependent patients, or in patients with cranial trauma, in patients prone to convulsive disorder, biliary tract disorders, in a state of shock, in an altered state of consciousness for unknown reasons, with problems affecting the respiratory center or the […]