TRIPARC Granular powder Ref.[115300] Active ingredients: Acetylsalicylic acid Caffeine Paracetamol

Posology

Do not exceed the stated dose.

Use the lowest effective dose for the shortest possible duration of treatment.

Adults

One powder to be taken with water every three hours.

Do not use more than one powder every 3 to 4 hours if necessary and not more than 6 powders during a 24-hour period.

Maximum daily dose: 6 powder sachets.

Minimum dosing interval: 3 hours.

Should not be taken with other paracetamol or aspirin containing medicines (see section 4.5).

Paediatric population

No data are available (see sections 4.3 and 4.4).

Method of administration

For oral administration.

Powder to be taken with water.

Immediate medical management is required in the event of overdose, even if symptoms of overdose are not present. If overdose is confirmed or suspected, seek immediate advice from your Poison Control Centre and refer patient to nearest Emergency Medical Centre for management and expert treatment. This should happen even in patients without symptoms or signs of overdose due to the risk of delayed liver damage.

Aspirin

Symptoms

Mild chronic salicylate intoxication, or salicylism, usually occurs only after repeated use of large doses. Salicylism can also occur following excessive topical application of salicylates. Symptoms include dizziness, tinnitus, deafness, sweating, nausea and vomiting, headache and confusion, vertigo, deafness, sweating, mental confusion, dehydration, increased respiratory rate, hyperventilation, warm extremities with bounding pulses, respiratory alkalosis, metabolic acidosis, ketosis and depression of the central nervous system and may be controlled by reducing the dosage. Tinnitus can occur at the plasma concentrations of 150 to 300 micrograms/ml required for optimal anti-inflammatory activity; more serious adverse effects occur at concentrations above 300 micrograms/ml.

Depression of the CNS may lead to coma; cardiovascular collapse and respiratory failure may also occur. In children drowsiness and metabolic acidosis commonly occur; hypoglycaemia may be severe.

In children serious signs of overdosage may develop rapidly. Uncommon features include haematemesis, hyperpyrexia, hypoglycaemia, hypokalaemia, thrombocytopaenia, increased INR/ PTR, intravascular coagulation, renal failure and noncardiac pulmonary oedema. Central nervous system features including confusion, disorientation, coma and convulsions are less common in adults than in children.

Treatment

Treatment with activated charcoal should be considered if plasma salicylate concentration is greater than 250 mg/kg.

Plasma salicylate concentrations should be measured although the severity of poisoning cannot be determined from this alone and the clinical and biochemical features must be taken into account.

Elimination of aspirin is increased by urinary alkalinisation, which is achieved by the administration of 1,26% sodium bicarbonate. The urine pH should be monitored. Metabolic acidosis should be corrected with intravenous 8,4% sodium bicarbonate (first check serum potassium). Forced diuresis should not be used since it does not enhance salicylate excretion and may cause pulmonary oedema.

Haemodialysis is the treatment of choice for severe poisoning and should be considered in patients with plasma salicylate concentrations >700 mg/l (5,1 mmol/l), or lower concentrations associated with severe clinical or metabolic features.

Patients under 10 years or over 70 years of age may be at an increased risk of salicylate toxicity and may require dialysis at an earlier stage.

Paracetamol

Prompt treatment is essential even when there are no obvious symptoms. In the event of an overdosage, consult a doctor immediately, or take the person directly to hospital. A delay in starting treatment may mean that antidote is given too late to be effective. Evidence of liver damage is often delayed until after the time for effective treatment has lapsed.

Susceptibility to paracetamol toxicity is increased in patients who have taken repeated high doses (greater than 5 to10 g/day) of paracetamol for several days, in chronic alcoholism, chronic liver disease, AIDS, malnutrition, fasting and with the use of medicines that induce liver microsomal oxidation such as barbiturates, isoniazid, rifampicin, phenytoin and carbamazepine.

Symptoms

Symptoms of paracetamol overdosage in the first 24 hours include pallor, nausea, vomiting, anorexia and abdominal pain may persist for a week or more. Cerebral oedema and nonspecific myocardial depression have also occurred. Mild symptoms during the first two days of acute poisoning, do not reflect the seriousness of the overdosage.

Liver damage may become apparent 12 to 48 hours or later after ingestion, initially by elevation of the serum transaminase and lactic dehydrogenase activity, metabolic acidosis, increased serum bilirubin concentration and prolongation of the prothrombin time/INR failure. Liver damage may lead to encephalopathy, coma and death.

Acute renal failure with acute tubular necrosis may develop even in the absence of severe liver damage. Abnormalities of glucose metabolism and metabolic acidosis may occur. Cardiac dysrhythmias have been reported.

In the event of overdosage consult a doctor or take the patient to the nearest hospital immediately. Specialised treatment is essential as soon as possible. Any patient who has ingested about 7,5 g of paracetamol in the preceding 4 hours should undergo gastric lavage. Specialised therapy with an antidote such as N-acetylcysteine or methionine may be necessary. If decided upon, N-acetylcysteine should be administered IV as soon as possible.

Treatment of paracetamol overdosage

Immediate hospitalisation is crucial. A single dose of 50 g activated charcoal given via the lavage tube. Ingestion of amounts of paracetamol smaller than this may require treatment in patients susceptible to paracetamol poisoning (see above).

N-acetylcysteine should be administered to all cases of suspected overdose as soon as possible preferably within eight hours of overdosage, although treatment up to 36 hours after ingestion may still be of benefit, especially if more than 150 mg/kg of paracetamol was taken.

IV: An initial dose of 150 mg/kg N-acetylcysteine in 200 ml glucose (5% w/v) intravenous injection, given intravenously over 15 minutes, followed by an infusion of 50 mg/kg in 500 ml glucose (5% w/v) injection over the next four hours, and then 100 mg/kg in 1 000 ml over the next sixteen hours. Sodium chloride 0,9% w/v may be used where glucose 5% w/v is not suitable. The volume of intravenous fluid should be modified for children.

Orally: Although the oral formulation is not treatment of choice, 140 mg/kg may be administered as a 5% solution, may be administered initially, followed by 70 mg/kg every four hours for seventeen doses. N-acetylcysteine is effective if administered within 8 hours of overdosage.

A plasma paracetamol level should be determined four hours after ingestion in all cases of suspected overdosage. Levels done before four hours may be misleading. Patients at risk of liver damage, and hence requiring continued treatment with N-acetylcysteine, can be identified according to their 4-hour plasma paracetamol level. The plasma paracetamol level can be plotted against time since ingestion in the nomogram below. The nomogram should be used only in relation to a single acute ingestion.

Those, whose plasma paracetamol levels are above the “Normal treatment line”, should continue N-acetylcysteine treatment with 100 mg/kg IV over sixteen hours repeatedly until recovery. Patients with increased susceptibility to liver damage as identified above, should continue treatment if concentrations are above the “High-risk treatment line”. Prothrombin index/INR correlates best with survival.

Monitor all patients with significant ingestions for at least ninety-six hours.

Caffeine

Symptoms

Large doses may cause restlessness, CNS stimulation, nervousness, insomnia, confusion, excitement, muscle tremor, tinnitus, scintillating scotoma, tachycardia, extrasystoles, epigastric pain, vomiting, diuresis, cardiac dysrhythmia, agitation, anxiety and convulsions.

Treatment

Treatment is symptomatic and supportive. In the event of overdosage consult a doctor or take the patient to the nearest hospital immediately. Specialised treatment is essential as soon as possible.

24 months.

Store in a cool, dry place at or below 30°C. Keep well closed. Use the sachet immediately after opening. Do not remove the product from the carton until required for use.

TRIPARC is packed in a sachet consisting of a white to off-white paper triple laminated with low-density polyethylene and aluminium foil or a white paper double laminated with low-density polyethylene. 12 or 38 sachets are packed into a unit cardboard carton together with a leaflet. Single doses are packed into a dispenser.

TRIPARC BLACKCURRANT and TRIPARC ORANGE are packed in a sachet consisting of a white paper triple laminated with low-density polyethylene and aluminium foil or a white paper triple laminated with low-density polyethylene and polyester. 10 or 24 sachets are packed into a unit cardboard carton together with a leaflet, and single sachets are packed into a dispenser.

TRIPARC LEMON is packed in a sachet consisting of a white to off-white paper triple laminated with low-density polyethylene and aluminium foil or a white paper triple laminated with low-density polyethylene and polyester. 12 sachets are packed into a unit cardboard carton together with a leaflet.

Not all packs and pack sizes are necessarily marketed.

No special requirements.