PACIMOL Uncoated tablet (2021)
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Περιεχόμενα
1. Name of the medicinal product
Pacimol, paracetamol 500 mg, uncoated tablets.
2. Qualitative and quantitative composition
<u>Active ingredient:</u> Paracetamol (BP) 500 mg/tablet. <u>Excipient(s) with known effect:</u> For the full list of excipients, see section 6.1.
3. Pharmaceutical form
White, capsule shaped, biconvex uncoated tablet with break line on one side.
4.1. Therapeutic indications
For the temporary relief of pain & discomfort, in headaches, colds and flu symptoms, rheumatic. muscular and neuralgic conditions and dental pain. Assist in reducing fever.
4.2. Posology and method of administration
<u>Adults and children aged 12 years and over:</u> 1 to 2 tablets every four to six hours as required. Maximum of 8 tablets in 24 hours. Maximum daily dose: 4000 mg. <u>Children 7 to 11 years:</u> ½ to ...
4.3. Contraindications
These products are contraindicated in patients with a previous history of hypersensitivity to paracetamol or any of the excipients.
4.4. Special warnings and precautions for use
Contains paracetamol. Do not use with any other paracetamol‐containing products. The concomitant use with other products containing paracetamol may lead to an overdose. Paracetamol overdose may cause liver ...
4.5. Interaction with other medicinal products and other forms of interaction
The following interactions with paracetamol have been noted: The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of ...
4.6. Pregnancy and lactation
Use in pregnancy As with the use of any medicine during pregnancy, pregnant women should seek medical advice before taking paracetamol. Pregnancy Category A. Paracetamol has been taken by a large number ...
4.7. Effects on ability to drive and use machines
Paracetamol is unlikely to cause an effect on the ability to drive or use machinery.
4.8. Undesirable effects
Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post‐marketing experience at therapeutic/labelled dose ...
4.9. Overdose
Experience following overdose with paracetamol indicates that the clinical signs of liver injury occur usually after 24 to 48 hours and have peaked after 4 to 6 days. Paracetamol overdose may cause liver ...
5.1. Pharmacodynamic properties
CAS: 103‐90‐2 (paracetamol) Paracetamol MW 151.17 ATC code Paracetamol, N02BE01 Paracetamol is a para‐aminophenol derivative that exhibits analgesic and anti—pyretic activity. Its mechanism of action ...
5.2. Pharmacokinetic properties
Absorption Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Food intake delays paracetamol absorption. Distribution Paracetamol is distributed into most body tissues. ...
5.3. Preclinical safety data
N/A.
6.1. List of excipients
Pregelatinised starch Sodium metabisulpite Magnesium stearate Purified water
6.2. Incompatibilities
No known incompatibilities.
6.3. Shelf life
60 months from date of manufacture.
6.4. Special precautions for storage
Store below 25°C.
6.5. Nature and contents of container
Blister pack of 1000 tablets.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Ipca Pharma (NZ) Pty Limited, PO Box 74509, Auckland 1546 +64 2136 0880 in New Zealand or +61 3 98856172 in Australia
9. Date of first authorization / renewal of the authorization
Date of first approval: October 2020
10. Date of revision of the text
July 2019
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