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TRAMADOL HYDROCHLORIDE/PARACETAMOL 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: Tramadol hydrochloride/Paracetamol tablets are indicated for symptomatic treatment of moderate to severe pain. The use of Tramadol hydrochloride/Paracetamol tablets should be restricted to patients whose moderate to severe pain is considered to require a combination of Tramadol and Paracetamol (see section 5.1)
Verbatim from this product's MHRA label. Tap a section to expand.
4). Posology The use of Tramadol hydrochloride/Paracetamol tablets should be restricted to patients whose moderate to severe pain is considered to require a combination of Tramadol and Paracetamol. The dose should be individually adjusted according to intensity of pain and 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/Paracetamol tablets is recommended. Additional doses can be taken as needed, not exceeding 8 tablets (equivalent to 300 mg of Tramadol and 2600 mg Paracetamol) 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/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/Paracetamol tablets has not been established in children below the age of 12 years. Treatment is therefore not recommended in this population. Elderly 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 impairment / 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 impairment In patients with hepatic impairment the elimination of tramadol is delayed. 4). 3).
Method of administration:
For oral use only. 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/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/tramadol hydrochloride combination were nausea, dizziness and somnolence, observed in more than 10 % of the patients.
The frequencies are defined as follows:
Very common: ≥1/10 Common: ≥1/100 to <1/10 Uncommon: ≥1/1000 to <1/100 Rare: ≥1/10 000 to <1/1000 Very rare: <1/10 000 Not known: Frequency cannot be estimated from the available data Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Cardiac disorders: • Uncommon: palpitations, tachycardia, arrhythmia. Eye disorders: • Rare: vision blurred, miosis, mydriasis Ear and labyrinth disorders: • Uncommon: tinnitus Gastro-intestinal disorders: • Very common: nausea • Common: vomiting, constipation, dry mouth, diarrhoea, abdominal pain, dyspepsia, flatulence • Uncommon: dysphagia, melaena General disorders and administration site conditions: • Uncommon: chills, chest pain, drug withdrawal syndrome Investigations: • Uncommon: transaminases increased Metabolism and nutrition disorders: • Unknown: hypoglycaemia Nervous system disorders: • Very common: dizziness, somnolence • Common: headache trembling • Uncommon: involuntary muscular contractions, paraesthesia, amnesia • Rare: ataxia, convulsions, syncope, speech disorders.
4). Post marketing surveillance •Very rare: abuse. g. rash, urticaria). Vascular disorders: • Uncommon: hypertension, hot flush 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).
Warnings: • In adults and adolescents 12 years and older, the maximum dose of 8 tablets of Tramadol hydrochloride/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/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/ Paracetamol tablet is 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 this medicine 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 – Interactions with other medicinal products and other forms of interactions). Sleep-related breathing disorders Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia.
4. Special warnings).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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).
g. decision behaviour perception disorders). • Worsening of asthma has been reported though a causal relationship has not been established. • Nervous system disorders: Not known: Serotonin Syndrome • Symptoms of drug withdrawal syndrome, 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: frequency not known: hiccups.
Paracetamol • Adverse effects of paracetamol are rare but hypersensitivity including skin rash 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 hypoprothrombinemia 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. Drug dependence Repeated use of Tramadol hydrochloride/Paracetamol tablets 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.
Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage. Precautions for use Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs Concomitant use of Tramadol hydrochloride/Paracetamol 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. If a decision is made to prescribe Tramadol hydrochloride/Paracetamol concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
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 patients should be followed closely for signs and symptoms of respiratory depression and sedation.
5). Tolerance, psychic and physical dependence may develop, even at therapeutic doses and especially after long-term use. 2). 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.
Tramadol hydrochloride/Paracetamol should be used with caution 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 respiratory function, or with an increased intracranial pressure.
Paracetamol in overdosage may cause hepatic toxicity in some patients. 8). When a patient no longer requires therapy with Tramadol hydrochloride/Paracetamol, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal, especially after long treatment periods.
8). - 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 of anaesthesia should be avoided.
Tolerance and opioid use disorder (abuse and dependence) Tolerance, physical and psychological dependence, and opioid use disorder (OUD) may develop upon repeated administration of opioids such as Tramadol hydrochloride/Paracetamol tablets.
Repeated use of Tramadol hydrochloride/Paracetamol tablets can lead to opioid use disorder (OUD). A higher dose and longer duration of opioid treatment can increase the risk of developing OUD. Abuse or intentional misuse of Tramadol hydrochloride/Paracetamol tablets may result in overdose and/or death.
The risk of developing OUD is increased in patients with a personal or a family […]