PANADOL ORIGINAL Tablet (2023)
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Περιεχόμενα
1. Name of the medicinal product
Panadol Original Tablets.
2. Qualitative and quantitative composition
Each tablet contains Paracetamol Ph Eur 500.0 mg.
3. Pharmaceutical form
Tablet. White, film-coated capsule shaped tablet with a triangular logo debossed on one side and a break line on the other.
4.1. Therapeutic indications
Panadol Original Tablets is a mild analgesic and antipyretic, and is recommended for the treatment of most painful and febrile conditions, for example, headache including migraine and tension headaches, ...
4.2. Posology and method of administration
<u>Adults, the elderly, and children aged 16 years and over:</u> One or two tablets up to four times daily as required. <u>Children:</u> Aged 10-15 years: One tablet up to four times daily as required. ...
4.3. Contraindications
Hypersensitivity to paracetamol or any of the other constituents.
4.4. Special warnings and precautions for use
Contains paracetamol. Do not use with any other paracetamol-containing products. Underlying liver disease increases the risk or paracetamol related liver damage. Patients who have been diagnosed with liver ...
4.5. Interaction with other medicinal products and other forms of interaction
The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. The anticoagulant effect of warfarin and other coumarins may be enhanced ...
4.6. Pregnancy and lactation
Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results. If clinically needed, paracetamol can be used during pregnancy if clinically needed, however, ...
4.7. Effects on ability to drive and use machines
None.
4.8. Undesirable effects
Adverse events of paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled ...
4.9. Overdose
Paracetamol overdose may cause liver failure which may require liver transplant or lead to death. Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of ...
5.1. Pharmacodynamic properties
Paracetamol is an antipyretic analgesic. The mechanism of action is probably similar to that of aspirin and dependant on the inhibition of prostaglandin synthesis. This inhibition appears, however to be ...
5.2. Pharmacokinetic properties
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. The concentration in plasma reaches a peak in 30 to 60 minutes and the plasma half-life is 1-4 hours after therapeutic ...
5.3. Preclinical safety data
Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available.
6.1. List of excipients
Maize starch Potassium sorbate Purified talc Stearic acid Polyvidone Starch pregelatinised Hypromellose Triacetin Carnauba wax
6.2. Incompatibilities
None.
6.3. Shelf life
48 months.
6.4. Special precautions for storage
None.
6.5. Nature and contents of container
The tablets are packed into either: PVC (250μm or 300μm)/aluminium foil 30μm blister strips or PVC (250μm or 300μm)/aluminium foil 20μm/8μm PET blister strips in an outer cardboard cartons, containing ...
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
Haleon UK Trading Limited, The Heights, Weybridge, Surrey, KT13 0NY, United Kingdom
8. Marketing authorization number(s)
PL 44673/0081
9. Date of first authorization / renewal of the authorization
29.05.84
10. Date of revision of the text
21<sup>st</sup> April 2023
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