BACAGIN Tablet Ref.[115684] Active ingredients: Ibuprofen Paracetamol

For oral administration and short term-use only (not more than 3 days).

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4). The patient should consult a doctor if the symptoms persist or worsen or if the product is required for more than 3 days.

This medicine is for short-term use and it is not recommended for use beyond 3 days.

Adults

One tablet to be taken up to three times per day with water. The interval between single doses should be at least six hours.

If the one tablet dose does not control symptoms, a maximum of two tablets may be taken up to three times a day. Leave at least six hours between doses.

Do not take more than six tablets in any 24 hours period.

To minimise side effects, it is recommended that patients take this medicine with food.

Elderly

No special dosage modifications are required (see section 4.4). The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used for the shortest possible duration. The patient should be monitored regularly for gastrointestinal bleeding during NSAID therapy.

Paediatric population

In Children between 6-12 years, 1 tablet three times daily. The maximum daily dose for children is 3 tablets and tablets should be taken at an interval of not less than 8 hours. The tablets should be taken with or after meals. Bacagin tablet is not recommended for long-term therapy. If symptoms persist after two days of treatment, consult your doctor.

Not for use by children and adolescents under 6 years.

Method of administration

Oral use.

Paracetamol

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has one or more of the risk factors below:

a) Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

b) Regularly consumes alcohol in excess of recommended amounts.

c) Is likely to be glutathione depleted e.g., eating disorders, cystic fibrosis, HIV infection, starvation, cachexia

Symptoms

Symptoms of paracetamol overdose in the first 24 hours include pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion as liver function tests become abnormal. 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.

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.

Patients who present with serious hepatic dysfunction beyond 24 hours from ingestion should seek medical advice from a poisoning specialist and be managed in accordance with established guidelines.

Ibuprofen

In children ingestion of more than 400 mg/kg of Ibuprofen may cause symptoms. In adults the dose response effect is less clear cut.

The half-life in overdose is 1.5-3 hours.

Symptoms

Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning metabolic acidosis may occur and the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur if there is a co-incident of dehydration. Exacerbation of asthma is possible in asthmatics.

Management

Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.

36 months.

Store below 30°C. Keep out the reach of children.

PVC heat-sealed to aluminum foil, blister pack containing: 10 tablets per blister and 10 blisters per cardboard box.

No special requirements.