Summary of Product Characteristics (SmPC) - BANIMAX TABLETS
1 NAME OF THE MEDICINAL PRODUCT
Banimax Tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250mg Aspirin and 250mg Paracetamol
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Bilayered tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Banimax Tablets are indicated for the short term treatment of mild to moderate pain, for example that associated with headache, toothache or injury, and the symptomatic relief of febrile illnesses, such as upper respiratory infections and influenza.
4.2 Posology and method of administration
Posology
Adults: 2 tablets three to four times a day every 4 to 6 hours to a maximum of 8 tablets during any 24 hour period.
Elderly: A reduced dosage may be required see precautions and warnings. Do not give to children under 16 years, unless specifically indicated (e.g. for Kawasaki's disease).
Method of administration:
Oral
The tablets should be swallowed whole and not broken or crushed.
4.3 Contraindications
- Hypersensitivity to aspirin, paracetamol or to any of the excipients listed in section 6.1
- Patients with asthma or allergic reactions to other non-steroidal anti-inflammatory drugs.
- Patients with active of chronic or recurrent gastric or duodenal ulcers with/without concomitant bleeding.
- Patients with haemorrhagic disease such as haemophilia.
- Patients with severe renal and liver disorders.
- Aspirin must not be given to children under 16 years of age.
- The last 3 months of pregnancy. (Doses > 100 mg/day during the third trimester of pregnancy)
4.4 Special warnings and precautions for use
Patients suffering from glucose-6-phosphate dehydrogenase deficiency.
Banimax should not be used before or after dental extractions and it should not be taken before or after alcohol consumption.
Care is advised in the administration of Banimax to patients with severe renal disease. The hazards of overdosage are greater in those with alcoholic liver disease.
Do not exceed the stated dose.
Patients should be advised not to take other paracetamol or aspirin-containing products concurrently.
If symptoms persist consult your doctor.
Keep out of the reach of children.
There is a possible association between Aspirin and Reye's Syndrome when administered to children. Reye's Syndrome is a very rare disease which affects the brain and liver, and can be fatal. For this reason it should not be given to children under 16 years unless specifically indicated (e.g. for Kawasaki's disease).
The label should contain the statement "do not give to children under 16 years of age, unless on the advice of a doctor", "immediate medical advice should be sought in the event of an overdose, even if you feel well", and "Do not take with any other paracetamol containing products".
Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported in patients with severe illness such as severe renal impairment and sepsis, or in patients with malnutrition and other sources of glutathione deficiency (e.g. chronic alcoholism), who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin. If HAGMA due to pyroglutamic acidosis is suspected, prompt discontinuation of paracetamol and close monitoring, is recommended. The measurement of urinary 5-oxoproline may be useful to identify pyroglutamic acidosis as underlying cause of HAGMA in patients with multiple risk factors.
Rare cases of acute myocardial ischemia with or without myocardial infarction as part of a hypersensitivity reaction (Kounis syndrome) have been reported in patients treated with acetylsalicylic acid. In the event of confirmed Kounis syndrome due to acetylsalicylic acid, Banimax should be discontinued immediately.
Important information regarding the ingredients in this medicine Sodium: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
4.5 Interaction with other medicinal products and other forms of interaction
Banimax may potentiate: -
- The action of anticoagulants, such as heparin and warfarin, increasing the risk of bleeding.
- The risk of gastrointestinal bleeding during concomitant therapy with corticosteroids.
- The effect of metoclopramide.
- Anti-epileptic drugs such as phenytoin and sodium valproate.
- The effects and side effects of other NSAID's.
- The effects of oral anti-diabetic drugs.
- The toxicity of methotrexate by inhibiting tubular secretion of the drug.
Banimax may reduce the action of: Diuretics
e.g. spironolactone and thiazides.
Uricosuria
Banimax excretion is increased by alkalinisation of urine.
The paracetamol component of this product may cause a marginal increase in blood levels of chloramphenicol.
The speed of absorption of the paracetamol component may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine.
Metamizole may reduce the effect of acetylsalicylic acid on platelet aggregation, when taken concomitantly. Therefore, this combination should be used with caution in patients taking low dose aspirin for cardioprotection.
Caution should be taken when paracetamol is used concomitantly with flucloxacillin as concurrent intake has been associated with high anion gap metabolic acidosis due to pyroglutamic acidosis, especially in patients with risks factors (see section 4.4).
4.6 Fertility, pregnancy and lactation
As Banimax contains aspirin and paracetamol it should not be taken by pregnant women in the first and second trimester unless under medical supervision and only if the expected benefit to the mother is considered to be greater than the risk to the baby.
Banimax should not be taken in the last trimester of pregnancy and when breast feeding as the aspirin component impairs platelet function and increases the risk of haemorrhage to the baby e.g. intracranial haemorrhage.
A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.
The aspirin component of Banimax may also cause delayed onset, and increased duration of labour, closure of foetal ductus arteriosus in utero and possibly persistent pulmonary hypertension of new born; kernicterus in jaundiced neonates.
Low doses (up to and including 100 mg/day):
Clinical studies indicate that doses up to 100 mg/day for restricted obstetrical use, which require specialised monitoring, appear safe.
Doses of above 100 mg/day and up to 500 mg/day:
There is insufficient clinical experience regarding the use of doses above 100 mg/day up to 500 mg/day. Therefore, the recommendations below for doses of 500 mg/day and above apply also for this dose range.
Doses of 500 mg/day and above:
From the 20th week of pregnancy onward, Banimax use may cause oligohydramnios resulting from foetal renal dysfunction. This may occur shortly after treatment initiation and is usually reversible upon discontinuation. In addition, there have been reports of ductus arteriosus constriction following treatment in the second trimester, most of which resolved after treatment cessation. Therefore, during the first and second trimester of pregnancy, Banimax should not be given unless clearly necessary. If Banimax is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible. Antenatal monitoring for oligohydramnios and ductus arteriosus constriction should be considered after exposure to Banimax for several days from gestational week 20 onward. Banimax should be discontinued if oligohydramnios or ductus arteriosus constriction are found.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:
- cardiopulmonary toxicity (premature constriction/closure of the ductus arteriosus and pulmonary hypertension);
- renal dysfunction (see above);
the mother and the neonate, at the end of pregnancy, to:
- possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses;
- inhibition of uterine contractions resulting in delayed or prolonged labour.
Consequently, acetylsalicylic acid at doses higher than 100 mg/day is contraindicated during the third trimester of pregnancy (see sections 4.3). Doses up to and including 100 mg/day may only be used under strict obstetric monitoring.
4.7 Effects on ability to drive and use machines
Banimax has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
Banimax may cause gastric irritation and dyspepsia. In some cases of intensive use gastric bleeding may occur. Nausea and vomiting, diarrhoea, tinnitus, vertigo, mental confusion. There have been reports of blood disorder, in particular thrombocytopenia and more rarely, agranulocytosis and of acute pancreatitis. Hypersensitivity reactions such as skin reactions, dyspnoea and bronchospasms. Rhinitis, angioedema, severe cutaneous skin eruptions have been reported and pre-orbital oedema may occur. Very rare cases of serious skin reactions have been reported.
Kounis syndrome (acute myocardial ischemia with or without myocardial infarction as part of a hypersensitivity reaction), with frequency not known (see section 4.4).
Metabolism and nutrition disorders:
Not known - High anion gap metabolic acidosis with frequency.
Description of selected adverse reactions
High anion gap metabolic acidosis
Cases of high anion gap metabolic acidosis due to pyroglutamic acidosis have been observed in patients with risk factors using paracetamol (see section 4.4). Pyroglutamic acidosis may occur as a consequence of low glutathione levels in these patients.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
Aspirin
Salicylate poisoning is usually associated with plasma concentrations >350 mg/L (2.5 mmol/L). Most adult deaths occur in patients whose concentrations exceed 700 mg/L (5.1 mmol/L). Single doses less than 100 mg/kg are unlikely to cause serious poisoning.
Symptoms:
Common features include vomiting, dehydration, tinnitus, vertigo, deafness, sweating, warm extremities with bounding pulses, increased respiratory rate and hyperventilation. Some degree of acid-base disturbance is present in most cases.
A mixed respiratory alkalosis and metabolic acidosis with normal or high arterial pH (normal or reduced hydrogen ion concentration) is usual in adults and children over the age of four years. In children aged four years or less, a dominant metabolic acidosis with low arterial pH (raised hydrogen ion concentration) is common. Acidosis may increase salicylate transfer across the blood brain barrier.
Uncommon features include haematemesis, hyperpyrexia, hypoglycaemia, hypokalaemia, thrombocytopaenia, increased INR/PTR, intravascular coagulation, renal failure and non-cardiac pulmonary oedema.
Central nervous system features including confusion, disorientation, coma and convulsions are less common in adults than in children.
Management:
Give activated charcoal if an adult presents within one hour of ingestion of more than 250 mg/kg. The plasma salicylate concentration 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 is increased by urinary alkalinisation, which is achieved by the administration of 1.26% sodium bicarbonate. The urine pH should be monitored. Correct metabolic acidosis 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 ten years or over 70 have increased risk of salicylate toxicity and may require dialysis at an earlier stage.
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 risk factors (see below).
Risk Factors:
If the patient
a, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes.
Or
b, Regularly consumes ethanol in excess of recommended amounts. Or
c, Is likely to be glutathione deplete 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) but results should not delay initiation of treatment beyond 8 hours after ingestion, as 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.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Analgesics and Antipyretics
ATC code: N02AA79.
Banimax is indicated for the short term treatment of mild to moderate pain, for example that associated with headache, toothache or injury and in the symptomatic relief of febrile illnesses, such as upper respiratory infection and influenza. This is a paracetamol/aspirin combination product. The paracetamol is in immediate release form while the aspirin is delayed release in order to reduce gastric irritation.
5.2 Pharmacokinetic properties
It has been demonstrated that micro-encapsulation of aspirin delays dissolution, thus minimising exposure of the gastric mucosa to acetyl salicylic acid and encouraging release in the small bowel; hence gastric irritation may be reduced. Although this increases the time for peak plasma concentration of acetyl salicylic acid to occur compared with that observed after administration of immediate release aspirin, it may result in more sustained analgesia if the total bioavailability of the drug is not reduced. In order to counter any delay in the onset of analgesia which may result from micro-encapsulation of the aspirin, immediate release paracetamol is included in the formulation.
5.3 Preclinical safety data
Acute Toxicity
Paracetamol hepatoxicity is directly dependent on the plasma concentration related to time. Plasma concentrations above 1.2 mmol/I at 4 honrs. 0.6 mmol/I at 8 hours and 0.3 mmol/l at 12 hours are criteria for treatment with acety1cysteine to prevent irreversible liver damage.
Chronic Toxicity
In animal experiments the subchronic and chronic toxicity of paracetamol occurred in rats and mice as lesions in the gastro-intestinal tract, blood-count changes, degeneration and even necrosis of the hepatic and renal parenchyma. The metabolites that are assumed to have the toxic effects and the organic changes associated with them have been proven in humans as well.
Therefore, paracetamol should not be taken for a long period of time and in excessive doses. Oral daily doses with clearly hepatotoxic effects are around 5.8g for non-alcoholics, symptoms of intoxication can occur as soon as 3 weeks after administration.
Mutagenic and tumorigenic potential
In mammalian cell cultures paracetamol induces chromosome mutations depending on its concentration. In vivo tests show negative as well as slightly positive results. Due to the insufficient relevance of the most part of the in vivo tests no final evaluation is possible at this time.
Long-term studies in rats and mice have yielded no indications of a carcinogenic effect.
Reproductive toxicity
Paracetamol passes the placental barrier. Animal studies and experience to date in humans reveal no evidence of embryotoxicity.
Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Microcrystalline cellulose BP
Sodium starch glycollate BP
Sugar stearate E473
Quinoline yellow lake E104
Patent V blue lake E131
Polyethylene CIO
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Store in a dry place a temperature not exceeding 25°C, and protect from light.
6.5 Nature and contents of container
Blister packs in packs of 10.
6.6 Special precautions for disposal
The tablets should be swallowed whole and not broken or crushed.
7 MARKETING AUTHORISATION HOLDER
BRISTOL LABORATORIES LIMITED
Unit 3, Canalside
Northbridge Road,
Berkhamsted
Herts HP4 1EG
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 17907/0292
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
06/03/2009
10 DATE OF REVISION OF THE TEXT
28/08/2026
11 DOSIMETRY (IF APPLICABLE)
12 INSTRUCTIONS FOR PREPARATION OF
RADIOPHARMACEUTICALS (IF APPLICABLE)