Active ingredients
Paracetamol ...................................................... 500 mg
Caffeine ................................................................65 mg
Excipients q.s ……………………………………………… 1 tablet
Tablet.
Product description: A capsule-shaped, pink, fragrant tablet, scored on one side, plain on the other side, undamaged edges.
Box of 10 blisters x 10 tablets.
ATC code: N02B E51
The combination of paracetamol and caffeine is a well established analgesic combination.
Paracetamol is rapidly and almost completely absorbed from the gastro-intestinal tract. It is relatively uniformly distributed throughout most body fluids and exhibits variable protein binding. Excretion is almost exclusively renal, in the form of conjugated metabolites.
Caffeine is absorbed readily after oral administration. Maximal plasma concentrations are achieved within one hour and the plasma half-life is about 3.5 hours. 65 - 80% of administered caffeine is excreted in the urine as 1-methyluric acid and 1-methylxanthine.
This medicine has no effects on ability to drive and use machines.
Paracetamol-caffeine is not recommended for use during pregnancy due to the possible increased risk of lower birth weight and spontaneous abortion associated with caffeine consumption.
Caffeine in breast milk may potentially have a stimulating effect on breast fed infants.
Due to the caffeine content of this product it should not be used if you are pregnant or breast feeding.
Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by System Organ Class. Adverse reactions identified during post-marketing use are reported voluntarily from a population of uncertain size, the frequency of these reactions is unknown but likely to be very rare (<1/10,000).
Post-marketing data
Paracetamol
Blood and lymphatic system disorders: Thrombocytopenia, agranulocytosis
Immune system disorders: Very rare cases of serious skin reactions have been reported. Anaphylaxis, cutaneous hypersensitivity reactions including (amongst others) skin rashes and angioedema.
Respiratory, thoracic and mediastinal disorders: Bronchospasm - more likely in patients sensitive to aspirin and other NSAIDs
Hepatobiliary disorders: Hepatic dysfunction
Caffeine
When the recommended paracetamol-caffeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related adverse effects.
Central nervous system: Dizziness, headache
Cardiac disorders: Palpitation
Psychiatric disorders: Insomnia, restlessness, anxiety and irritability
Gastrointestinal disorders: Gastrointestinal disturbances
Please inform your doctor of all undesirable effects upon drug administration.
Paracetamol
Liver damage is possible in adults who have taken 10 g or more of paracetamol. Ingestion of 5 g or more of paracetamol may lead to liver damage if the patient has risk factors as follows
- If the patient is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes. Or
- If the patient regularly consumes ethanol in excess of recommended amounts. Or
- If the patient is likely to be glutathione depleted e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.
Symptoms
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 encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management
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. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.
Caffeine
Symptoms
Overdose of caffeine may result in epigastric pain, vomiting, diuresis, tachycardia or cardia arrhythmia, CNS stimulation (insomnia, restlessness, excitement, agitation, jitteriness, tremors and convulsions).
It must be noted that for clinically significant symptoms of caffeine overdose to occur with this product, the amount ingested would be associated with serious paracetamol-related toxicity.
Management
Patients should receive general supportive care (e.g. hydration and maintenance of vital signs). The administration of activated charcoal may be beneficial when performed within one hour of the overdose, but can be considered for up to four hours after the overdose. The CNS effects of overdose may be treated with intravenous sedatives.
Summary
Treatment of overdose requires assessment of plasma paracetamol levels for antidote treatment, with signs and symptoms of caffeine toxicity being managed symptomatically.
Store in dry places, not exceeding 30oC, protect from light.
Do not exceed stated dose.
Contains paracetamol. Do not use with any other paracetamol containing products. The concomitant use with other products containing paracetamol may lead to an overdose.
Paracetamol overdose may cause liver failure, which may require liver transplant or lead to death.
Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.
Caution should be exercised in patients with glutathione depleted states, as the use of paracetamol may increase the risk of metabolic acidosis.
Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should be avoided while taking this product.
If symptoms persist, medical advice must be sought.
Keep out of the sight and reach of children.
Related to paracetamol: Physicians should warn patients of signs of severe skin reactions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) or Lyell’s syndrome, acute generalized exanthematous pustulosis (AGEP).
Excipients
Wheat starch in this medicine contains only very low levels of gluten and is very unlikely to cause problems if you have coeliac disease. If you have wheat allergy (different from coeliac disease) you should not take this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
Erythrosine lake may cause allergic reactions.
A mild analgesic and antipyretic formulated to give extra pain relief. The tablets are recommended for the treatment of most painful and febrile conditions, for example, headache, including migraine, backache, toothache, rheumatic pain and dysmenorrhoea, and the relief of the symptoms of colds, influenza and sore throat.
Hypersensitivity to paracetamol, caffeine or any of the other constituents.
Oral use.
Adults (including the elderly), and children aged 16 years and over: 1 - 2 tablets up to four times daily. The dose should not be repeated more frequently than every 4 hours. Do not exceed 8 tablets in one day.
Children aged 12 - 15 years: One tablet up to four times daily. The dose should not be repeated more frequently than every 4 hours. Do not exceed 4 tablets in one day.
Not recommended for children under 12 years.
Or as directed by the physician.
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