ANADIN Original Tablet Ref.[50613] Active ingredients: Acetylsalicylic acid Caffeine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, U.K.

4.1. Therapeutic indications

For the treatment of mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains and aches and pains.

For the symptomatic treatment of sprains, strains, rheumatic pain, sciatica, lumbago, fibrositis, muscular aches and pains, joint swelling and stiffness, influenza, feverishness and feverish colds.

4.2. Posology and method of administration

Adults, the elderly and young persons aged 16 and over: 2 tablets every 4 hours to a maximum of 12 tablets in 24 hours.

Do not exceed 12 tablets in 24 hours.

Do not give to children aged under 16, unless specifically indicted (e.g. Kawasaki’s disease).

4.9. Overdose

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 dose less than 100mg/kg are unlikely to cause serious poisoning.

Aspirin

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 old. 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 more common in children than adults.

Caffeine

Common features include CNS stimulation; anxiety, nervousness, restlessness, insomnia, excitement, muscle twitching, confusion, convulsions.

Cardiac Symptoms include tachycardia, cardiac arrhythmia. Gastric symptoms include abdominal or stomach pains.

Other symptoms of overdosage, associated with the caffeine component, include diuresis and facial flushing.

Management

Aspirin

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 intraveneous 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 have increased risk of salicylate toxicity and may require dialysis at an earlier stage.

Caffeine

Treatment of caffeine overdose is primarily symptomatic and supportive. Diuresis should be treated by maintaining fluid and electrolyte balance and CNS symptoms can be controlled by intravenous administration of diazepam.

6.3. Shelf life

36 Months:

Cartons containing PVC/ aluminium glassine paper blister strip 4, 6, 8, 12, 16, 24, 32 tablets.

24 Months:

Paper/Polyethylene strip 4, 8.
Polypropylene drum with CRC cap 24, 32.
Aluminium containers with approved polyethylene CRC Cap 16, 32.
Paper/Polyethylene laminated strip packs 4, 8.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

Cartons containing PVC/aluminium glassine paper blister strip 4, 6, 8, 12, 16, 24, 32 tablets.

Paper/Polyethylene strip 4, 8.

Polypropylene drum with CRC cap 24, 32.

Aluminium containers with approved polyethylene CRC Cap 16, 32.

Paper/Polyethylene laminated strip packs 4, 8.

6.6. Special precautions for disposal and other handling

Not applicable.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.