ANTALGEX T Capsule Ref.[115641] Active ingredients: Paracetamol Tramadol

Posology

The use of ANTALGEX T 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 the intensity of the pain and to the sensibility of the patient. In general, the lowest dose producing analgesic effect should be selected.

A total daily dose of 8 capsules (equivalent to 300 mg of tramadol and 2600 mg of paracetamol) should not be exceeded. The dosing interval should not be less than 6 hours.

Adults and adolescents (over 12 years old)

An initial dose of two capsules of ANTALGEX T is recommended. Additional doses can be taken as needed, not exceeding 8 capsules (equivalent to 300 mg of tramadol and 2600 mg of paracetamol) per day.

The dosing interval should not be less than 6 hours.

ANTALGEX T should under no circumstances be administered for longer than it is strictly necessary (see also section 4.4 Special warnings and precautions for use). If repeated use or long term treatment with ANTALGEX T is required as a result of the nature and severity of the illness, then a careful, regular monitoring should take place (with breaks in the treatment, where possible), to assess whether the continuation of the treatment is necessary.

Paediatric population

The effective and safe use of ANTALGEX T has not been established in children below the age of 12 years old. The treatment is therefore not recommended in this population.

Geriatric population

A dosing adjustment is generally not required in patients aged 75 years old or less without clinically manifest hepatic or renal insufficiency. In patients over 75 years old, the elimination may be extended. Then, if required, the dosing interval should be prolonged in terms of the patient’s needs.

Renal failure/dialysis

The elimination of tramadol is delayed in patients with renal insufficiency. In those patients, a prolongation of the dosing intervals should be considered carefully in terms of the patient’s needs.

Hepatic failure

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 patient’s requirements (see section 4.4). Because of the presence of paracetamol, ANTALGEX T should not be used in patients with severe hepatic impairment (see section 4.3).

Method of administration

Oral use.

Capsules should be swallowed whole, with a sufficient amount of beverage.

ANTALGEX T is a fixed combination of active substances. In case of an overdose, the symptoms may include the signs and symptoms of toxicity of tramadol or paracetamol or both of these active ingredients.

Symptoms of overdose from tramadol

In principle, when intoxicated with tramadol, symptoms similar to those of other centrally acting analgesics (opioids) are to be expected. These include mostly, miosis, vomiting, cardiovascular collapse, consciousness disorders that can lead to coma, convulsions and respiratory depression up to respiratory arrest. Serotonin syndrome also has been reported.

Symptoms of overdose from paracetamol

An overdose is of particular concern in young children.

Symptoms of paracetamol overdose in the first 24 hours are the following: 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 encephalopathy, 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) could become irreversibly bounded to liver tissue.

Emergency treatment

• Transfer immediately to a specialised unit.
• Maintain respiratory and circulatory functions.
• Prior to starting treatment, a blood sample should be taken as soon as possible after overdose in order to measure the plasma concentration of paracetamol and tramadol and in order to perform the hepatic function tests.
• Perform hepatic function tests as soon as possible and repeat every 24 hours. Usually, an increase in hepatic enzymes (ASAT, ALAT) is usually observed, which normalizes after one or two weeks.
• Empty the stomach by causing the patient to vomit (when the patient is conscious) or gastric lavage.
• Supportive measures such as maintaining the patency of the airway and maintaining cardiovascular function should be instituted; naloxone should be used to reverse respiratory depression; fits can be controlled with diazepam.
• Tramadol is minimally eliminated from the serum by haemodialysis or haemofiltration. Therefore treatment of acute intoxication with ANTALGEX T with haemodialysis or haemofiltration alone is not suitable for detoxification.

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. Any adult or adolescent who had ingested around 7.5 g or more of paracetamol in the preceding 4 hours or any child who has ingested ≥150 mg/kg of paracetamol in the preceding 4 hours should undergo gastric lavage.

Paracetamol plasmatic concentrations 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 life supportive measures must be put in place.

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.

Store in the original package, protect from heat, light and moisture.

Store below 30°C.

ANTALGEX T is available in boxes of 20 capsules.

ANTALGEX T capsules are packed in PVC/Aluminium blisters.

No special requirements.