PARCOTEN Tablet (2022)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
1. Name of the medicinal product
Parcoten 500 mg/10 mg Tablets.
2. Qualitative and quantitative composition
Each tablet contains Paracetamol 500.00 mg and Codeine phosphate 10.00 mg. For the full list of excipients, see section 6.1
3. Pharmaceutical form
Tablets. White, round, flat tablets, 12mm diameter in size and scored on one side.
4.1. Therapeutic indications
Codeine is indicated in patients older than 12 years of age for the treatment of acute moderate pain which is not considered to be relieved by other analgesics such as paracetamol, ibuprofen or aspirin ...
4.2. Posology and method of administration
The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician. Adults aged 18 years and over (including ...
4.3. Contraindications
Hypersensitivity to paracetamol, codeine, opioid analgesics or any of the other constituents. In all paediatric patients (0-18 years of age) who undergo tonsillectomy and/or adenoidectomy for obstructive ...
4.4. Special warnings and precautions for use
Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Do not exceed the ...
4.5. Interaction with other medicinal products and other forms of interaction
Paracetamol The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by cholestyramine. The anticoagulant effect of warfarin and other coumarins may ...
4.6. Pregnancy and lactation
Pregnancy Use during pregnancy should be avoided, unless advised by a physician. This includes maternal use during labour because of the potential for respiratory depression in the neonate. The safety ...
4.7. Effects on ability to drive and use machines
Patients should be advised not to drive or operate machinery if affected by dizziness or sedation. This medicine can impair cognitive function and can affect a patients ability to drive safely. When taking ...
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
Overuse of this product, defined as consumption of quantities in excess of the recommended dose, or consumption for a prolonged period of time may lead to physical or psychological dependency. Symptoms ...
5.1. Pharmacodynamic properties
Paracetamol is an analgesic and antipyretic. Codeine phosphate is a centrally acting weak analgesic and has weak cough suppressant activity. Codeine exerts its effect through μ opioid receptors, although ...
5.2. Pharmacokinetic properties
Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Concentration in plasma reaches a peak in 30-60 minutes. Plasma half-life is 1-4 hours. Paracetamol is relatively ...
5.3. Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
6.1. List of excipients
Magnesium stearate Talc Microcrystalline cellulose Maize starch Povidone
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
Three years.
6.4. Special precautions for storage
Store below 25°C. Protect from light and humidity.
6.5. Nature and contents of container
Blisters of Aluminum/PVC foil. <u>Pack sizes:</u> 2 blisters x 10 tablets 4 blisters x 10 tablets Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
Delorbis Pharmaceuticals Ltd, 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union
8. Marketing authorization number(s)
16100
9. Date of first authorization / renewal of the authorization
19/04/2005
10. Date of revision of the text
10/05/2022
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
