ANADIN Original Tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Anadin Original.
2. Qualitative and quantitative composition
Active Ingredients: Aspirin BP 325mg/tablet Caffeine PhEur 15mg/tablet For excipients see section 6.1.
3. Pharmaceutical form
Tablet for oral administration.
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 ...
4.2. Posology and method of administration
<u>Adults, the elderly and young persons aged 16 and over:</u> 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, ...
4.3. Contraindications
Hypersensitivity to the active ingredients or any of the other constituents. Peptic ulceration and those with a history of peptic ulceration; haemophilia, concurrent anti-coagulant therapy; children under ...
4.4. Special warnings and precautions for use
Caution should be exercised in patients with asthma, allergic disease, impairment of hepatic or renal function (avoid if severe) and dehydration. Do not take if you have a stomach ulcer. Do not exceed ...
4.5. Interaction with other medicinal products and other forms of interaction
Other NSAIDs and corticosteroids: Concurrent use of other NSAIDs or corticosteroids may increase the likelihood of GI side effects. <u>Diuretics:</u> Antagonism of the diuretic effect. <u>Anticoagulants: ...
4.6. Pregnancy and lactation
There is clinical and epidemiological evidence of safety of aspirin in pregnancy, but it may prolong labour and contribute to maternal and neonatal bleeding, and so should not be used in late pregnancy. ...
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
Side effects are mild and infrequent, but there is a high incidence of gastro-intestinal irritation with slight asymptomatic blood loss. Increased bleeding time. Aspirin may precipitate bronchospasm and ...
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 ...
5.1. Pharmacodynamic properties
ASPIRIN Mechanisms of action/effect Salicylates inhibit the activity of the enzyme cyclo-oxygenase to decrease the formation of precursors of prostaglandins and thromboxanes from arachidonic acid. Although ...
5.2. Pharmacokinetic properties
ASPIRIN Absorption and fate Absorption is generally rapid and complete following oral administration. It is largely hydrolysed in the gastrointestinal tract, liver and blood to salicylate which is further ...
5.3. Preclinical safety data
None stated.
6.1. List of excipients
Quinine Sulfate Ph Eur Maize Starch Ph Eur Microcrystalline Cellulose Ph Eur Hydroxypropyl Methylcellulose (Methocel E5) Ph Eur Hydroxypropyl Methylcellulose (Methocel E15) Ph Eur Polyethylene Glycol (Carbowax ...
6.2. Incompatibilities
None known.
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 ...
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 ...
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, U.K.
8. Marketing authorization number(s)
PL 44673/0203
9. Date of first authorization / renewal of the authorization
31 August 1993
10. Date of revision of the text
July 2020
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