CO-DYDRAMOL Tablet (2020)
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Περιεχόμενα
1. Name of the medicinal product
Co-dydramol 10mg/500mg Tablets.
2. Qualitative and quantitative composition
Each tablet contains 500 mg paracetamol and 10 mg dihydrocodeine tartrate. For the full list of excipients see section 6.1.
3. Pharmaceutical form
Tablet. Flat bevelled edge white tablets marked S/8 on one side.
4.1. Therapeutic indications
For the relief of mild to moderate pain.
4.2. Posology and method of administration
Posology <u>Adults and children over 16 years:</u> One to two tablets every four to six hours when necessary up to a maximum of eight tablets in 24 hours. <u>Elderly:</u> As for adults, however a reduced ...
4.3. Contraindications
Co-dydramol Tablets must not be given to patients with respiratory depression, chronic obstructive airways disease or liver disease. Hypersensitivity to the active substances or any of the excipients listed ...
4.4. Special warnings and precautions for use
Dihydrocodeine may bring about histamine release, therefore it should not be given during an asthma attack and it should be administered with due care to persons liable to such attack. The dosage should ...
4.5. Interaction with other medicinal products and other forms of interaction
Dihydrocodeine should be used with caution in patients taking monoamine oxidase inhibitors, CNS depressants or metoclopramide. The speed of absorption of paracetamol may be increased by metoclopramide ...
4.6. Pregnancy and lactation
Pregnancy Paracetamol: A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol ...
4.7. Effects on ability to drive and use machines
Dihydrocodeine may cause vertigo which may affect the ability to drive or use machines. This medicine can impair cognitive function and can affect a patients ability to drive safely. This class of medicine ...
4.8. Undesirable effects
Regular prolonged use of dihydrocodeine is known to lead to addiction and tolerance. Symptoms of restlessness and irritability may result when treatment is then stopped. Prolonged use of a painkiller for ...
4.9. Overdose
Paracetamol 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). Risk ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Anilides <b>ATC code:</b> N02BE71 Paracetamol has analgesic and antipyretic effects. It is only a weak inhibitor of prostaglandin biosynthesis, although there is some ...
5.2. Pharmacokinetic properties
Paracetamol is well absorbed from the gastrointestinal tract, peak plasma concentrations occurring 0.5-2 hours after ingestion. It is metabolised in the liver and excreted in the urine mainly as glucuronide ...
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
Pregelatinised starch Maize starch Povidone Potassium sorbate Purified talc Stearic acid Magnesium stearate Microcrystalline cellulose
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
2 years in polypropylene bottles. 3 years in PVC blisters.
6.4. Special precautions for storage
No special precautions for storage.
6.5. Nature and contents of container
White polypropylene bottles with a cotton wool plug and a white wadless polypropylene screw cap. Pack size: 100, 500 tablets. PVC blister strips contained in cardboard cartons. Pack size: 30, 60, 100 tablets. ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom
8. Marketing authorization number(s)
PL 17780/0070
9. Date of first authorization / renewal of the authorization
1 October 2001/16 March 2009
10. Date of revision of the text
20 November 2020
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