Anadin original

Overdose

Salicylate poisoning is usually associated with a plasma concentration of > 350 mg/l (2.5 mmol/L). Most adult deaths occur in patients whose concentration exceeds 700 mg / L (5.1 mmol/L). A single dose of less than 100 mg / kg is unlikely to cause serious poisoning.

Aspirin

Common signs include vomiting, dehydration, tinnitus, dizziness, deafness, sweating, warm limbs with limited pulse, increased respiratory rate, and hyperventilation. In most cases, there is some degree of acid-base disorder.

Mixed respiratory alkalosis and metabolic acidosis with normal or high arterial pH (normal or reduced concentration of hydrogen ions) are usually observed in adults and children over four years of age. In children aged four years and less, dominant metabolic acidosis with a low arterial pH (increased concentration of hydrogen ions) is common. Acidosis may increase the transport of salicylates across the blood-brain barrier.

Unusual signs include hematemesis, hyperpyrexia, hypoglycemia, hypokalemia, thrombocytopenia, increased INR/PTR, intravascular coagulation, renal failure, and non-cardiac pulmonary edema.

Features of the central nervous system, including confusion, disorientation, coma, and seizures, are more common in children than in adults.

Caffeine

Common signs include CNS stimulation, restlessness, nervousness, restlessness, insomnia, agitation, muscle twitching, confusion, convulsions.

Cardiac symptoms include tachycardia, cardiac arrhythmia. Stomach symptoms include abdominal or stomach pain.

Other overdose symptoms associated with the caffeine component include diuresis and redness of the face.

Management

Aspirin

Give activated charcoal if an adult presents within one hour after ingestion of more than 250 mg/kg.. The concentration of salicylate in the blood plasma should be measured, although the severity of poisoning can not be determined only by this indicator and it is necessary to take into account the clinical and biochemical features. Elimination is enhanced by the alkalinization of the urine, which is achieved by the introduction of 1.26% sodium bicarbonate. The pH of the urine should be monitored. Correction of metabolic acidosis by intravenous administration 8.4 % sodium bicarbonate (check the serum potassium first). Forced diuresis should not be used, as it does not increase the excretion of salicylates and can cause pulmonary edema.

Hemodialysis is the method 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 the age of 10 or over the age of 70 have an increased risk of salicylate toxicity and may need 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.

Shelf life

36 Months:

Cardboard boxes containing PVC / aluminum glass paper blister tape 4, 6, 8, 12, 16, 24, 32 pills.

24 Months:

Paper version/Plastic tape 4, 8

Polypropylene drum with lid CRC 24, 32

Aluminum containers with approved plastic lid CRC 16, 32

Paper / polyethylene laminated strips of packages 4, 8

Contraindications

Hypersensitivity to the active ingredients or any other components. Peptic ulcer and persons with a history of peptic ulcer, hemophilia, concomitant anticoagulant therapy, children under 16 years of age and breastfeeding due to the possible risk of developing Reyes syndrome.

Incompatibilities

Out of stock

List of excipients

Quinine Sulfate Ph Eur

Corn starch Ph Eur

Microcrystalline Cellulose Ph Eur

Hydroxypropylmethylcellulose (Metocel E5) Ph Eur

Hydroxypropylmethylcellulose (Metocel E15) PH Euro

Polyethylene Glycol (Carbowax 3350) USNF

Calcium Stearate USNF

Pharmaceutical form

Tablet for oral administration.

Undesirable effects

Side effects are moderate and infrequent, but there is a high frequency of gastrointestinal irritation with a small asymptomatic blood loss. Increased bleeding time. Aspirin can provoke bronchospasm and cause asthma attacks or other hypersensitivity reactions in susceptible people. Aspirin can cause gastrointestinal bleeding, sometimes severe. It can cause gout in susceptible people. Possible risk of developing Rey's syndrome in children under the age of 16.

High doses of caffeine can cause tremors and heart palpitations.

Report of suspected adverse reactions

It is important to report suspicious adverse reactions after obtaining approval for the use of the drug. This allows you to continue monitoring the benefit/risk balance of the drug. Medical professionals are asked to report any suspicious adverse reactions under the Yellow Card scheme to www.mhra.gov.uk/yellowcard.

Preclinical safety data

No one claimed it.

Therapeutic indications

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

For the symptomatic treatment of sprains, sprains, rheumatic pains, sciatica, lumbago, fibrositis, muscle aches and pains, swelling and stiffness of the joints, flu, fever and feverish colds.

Pharmacodynamic properties

ASPIRIN

Mechanisms of action/effect

Salicylates inhibit the activity of the cyclooxygenase enzyme, reducing the formation of prostaglandin and thromboxane precursors from arachidonic acid. Although many therapeutic effects may result from inhibition of prostaglandin synthesis (and subsequent reduction of prostaglandin activity) in various tissues, other actions may also contribute significantly to therapeutic effects.

Painkillers

Produces analgesia through a peripheral action, blocking the generation of a pain impulse, and through a central action, possibly in the hypothalamus.

Anti-inflammatory (Non-periodic)

The exact mechanisms have not yet been determined. Salicylates may act peripherally in inflamed tissue, probably by inhibiting prostaglandin synthesis and possibly by inhibiting the synthesis and / or action of other inflammatory response mediators.

Antipyretic

It can cause an antipyretic effect, acting centrally on the hypothalamic thermoregulatory center, causing peripheral vasodilation, leading to increased cutaneous blood flow, sweating and heat loss.

CAFFEINE

Mechanisms of action/effect

Central Nervous System Stimulant-Caffeine stimulates all levels of the CNS, although its cortical effects are milder and shorter than those of amphetamines.

Auxiliary means for analgesia

Caffeine narrows the blood vessels of the brain with a concomitant decrease in cerebral blood flow and oxygen tension of the brain. Caffeine is thought to help relieve headaches by providing a faster onset of action and / or enhancing pain relief at lower doses of the analgesic. Recent studies with ergotamine suggest that the increased effect of caffeine supplementation may also be associated with improved gastrointestinal absorption of ergotamine when administered with caffeine.

Pharmacokinetic properties

ASPIRIN

Takeover and Fate

Absorption usually occurs quickly and completely after oral administration. It is largely hydrolyzed in the gastrointestinal tract, liver, and blood to salicylate, which is further metabolized mainly in the liver.

CAFFEINE

Takeover and Fate

Caffeine is completely and rapidly absorbed after oral administration, with peak concentrations occurring between 5 and 90 minutes after the dose in subjects on an empty stomach. There are no signs of presystemic metabolism. Elimination is almost entirely carried out by hepatic metabolism in adults.

In adults, there is a pronounced individual variability in the elimination rate. The average plasma half-life is 4.9 hours with a range of 1.9-12.2 hours. Caffeine is distributed in all body fluids. The average binding of caffeine to plasma proteins is 35%.

Caffeine is almost completely metabolized by oxidation, demethylation, and acetylation, and is excreted in the urine. The main metabolites are 1-methylxanthine, 7-methylxanthine, 1,7-dimethylxanthine (paraxanthine). Minor metabolites include 1-methyluric acid and 5-acetylamino-6-formylamino-3-methyluracil (AMPU).

Date of revision of the text

December 2015

Name of the medicinal product

Original Anadin

Marketing authorisation holder

Pfizer of Consumers of Medical Services, LLC

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

Special precautions for storage

Do not store at temperatures above 25°C.

Nature and contents of container

Cardboard boxes containing PVC / aluminum glass paper blister tape 4, 6, 8, 12, 16, 24, 32 pills.

Paper version/Plastic tape 4, 8

Polypropylene drum with lid CRC 24, 32

Aluminum containers with approved plastic lid CRC 16, 32

Paper / polyethylene laminated strips of packages 4, 8

Marketing authorisation number(s)

PL 00165/0060

Qualitative and quantitative composition

Active ingredients:

Aspirin AD 325 mg / tablet
Caffeine PhEur 15 mg / tablet

Special warnings and precautions for use

Caution should be exercised in patients with asthma, allergic diseases, impaired liver or kidney function (avoid in severe form) and dehydration.

Do not take it if you have a stomach ulcer.

Do not exceed the stated dose.

If symptoms persist for more than 3 days, consult your doctor.

There is a possible link between aspirin and Rey's syndrome when taken in children. Rey's syndrome is a very rare disease that affects the brain and liver and can be fatal. For this reason, aspirin should not be given to children under the age of 16 unless specifically indicated (for example, Kawasaki disease).

Effects on ability to drive and use machines

Out of stock

Dosage (Posology) and method of administration

Adults, seniors, and young adults aged 16 and over:

2 tablets every 4 hours, a maximum of 12 tablets for 24 hours.

Do not take more than 12 tablets within 24 hours.

Do not give to children under the age of 16, unless there is a special indication (for example, Kawasaki disease).

Special precautions for disposal and other handling

The

Date of first authorisation/renewal of the authorisation

August 31, 1993