ANADIN Paracetamol Tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Anadin Paracetamol Tablets.
Qualitative and quantitative composition
<u>Active Ingredients:</u> Paracetamol Ph Eur 500 mg/tablet. For excipients see section 6.1.
Pharmaceutical form
Tablet for oral administration.
Therapeutic indications
For the treatment of mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains, symptomatic relief of rheumatic aches and pains and of influenza, ...
Posology and method of administration
<u>Adults, the elderly and young persons 16 years and over:</u> 2 tablets every 4 hours to a maximum of 8 tablets in 24 hours. <u>Children 6–9 years:</u> ½ tablet every 4 hours to a maximum of 4 doses ...
Contraindications
Hypersensitivity to paracetamol or any of the constituents.
Special warnings and precautions for use
Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease. ...
Interaction with other medicinal products and other forms of interaction
Cholestyramine The speed of absorption of paracetamol is reduced by cholestyramine. Therefore, the cholestyramine should not be taken within one hour if maximal analgesia is required. Metoclopramide and ...
Pregnancy and lactation
A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. <u>Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive ...
Effects on ability to drive and use machines
None known.
Undesirable effects
Adverse effects of paracetamol are rare. Very rare cases of serious skin reactions have been reported. There have been reports of blood dyscrasias including thrombocytopenia purpura, methaemoglobenaemia ...
Overdose
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). <u>Risk Factors: ...
Pharmacodynamic properties
Mechanisms of Action/Effect Analgesic The mechanism of analgesic action has not been fully determined. Paracetamol may act predominantly by inhibiting prostaglandin synthesis in the central nervous system ...
Pharmacokinetic properties
Absorption and Fate Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma concentrations occurring about 30 minutes to 2 hours after ingestion. It is metabolised in the liver ...
Preclinical safety data
Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available.
List of excipients
Croscarmellose sodium Povidone Pregelatinised maize starch Hydroxypropyl methylcellulose Polyethylene glycol
Incompatibilities
None known.
Shelf life
All packs 5 years except paper/polythene/laminate and paper/polythene strips: 3 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
PVC/Pvdc hard tempered aluminium foil with glassine paper blister packs of: 8, 12, 16, 32 tablets.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, TW8 9GS, U.K.
Marketing authorization number(s)
PL 44673/0204
Date of first authorization / renewal of the authorization
30 July 1987 / 11 February 1997
Date of revision of the text
July 2020
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