Source: Υπουργείο Υγείας (CY) Revision Year: 2023 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos Street, 3011 Limassol, Cyprus
Medotramol tablets are indicated for the symptomatic treatment of moderate to severe pain.
The use of Medotramol should be restricted to patients whose moderate to severe pain is considered to require a combination of tramadol and paracetamol (see also section 5.1).
The use of Medotramol tablet should be restricted to patients whose moderate to severe pain is considered to require a combination of tramadol and paracetamol.
The dose should be adjusted 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.
An initial dose of two tablets of Medotramol is recommended. Additional doses can be taken as needed, not exceeding 8 tablets (equivalent to 300 mg tramadol and 2600mg paracetamol) per day. The dosing interval should not be less than six hours.
Medotramol should under no circumstances be administered for longer than is strictly necessary (see also section 4.4). If repeated use or long term treatment with Medotramol 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.
The effective and safe use of Medotramol has not been established in children below the age of 12 years.
Treatment is therefore not recommended in this population.
A dose adjustment is not usually necessary in patients up to 75 years without clinically manifest hepatic or renal insufficiency.
In elderly patients over 75 years elimination may be prolonged. Therefore, if necessary the dosage interval is to be extended according to the patient’s requirements.
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.
In patients with hepatic impairment the elimination of tramadol is delayed. In these patients prolongation of the dosage intervals should be carefully considered according to the patient’s requirements (see section 4.4). Because of the presence of paracetamol, Medotramol should not be used in patients with severe hepatic impairment (see section 4.3).
Oral use.
Tablets must be swallowed whole, with a sufficient quantity of liquid.
They must not be broken or chewed.
Medotramol is a fixed combination of active ingredients. In case of overdose, the symptoms may include the signs 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. Serotonin syndrome has also been reported.
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 renal 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 7.5-10 g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified by glutathione when normal doses of paracetamol are ingested), become irreversibly bound to liver tissue.
Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention and any adult or adolescent who had ingested around 7.5g or more of paracetamol in the preceding 4 hours or any child who has ingested ≥150mg/kg of paracetamol in the preceding 4 hours should undergo gastric lavage. 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.
3 years.
This medicinal product does not require any special storage conditions.
Medotramol is packed in PVC/PVDC Alu blisters.
Boxes of 10, 20, 30, 50 and 100 tablets.
Not all pack sizes may be marketed.
No special requirements.
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