PAINAMOL PLUS Tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
PAINAMOL PLUS.
2. Qualitative and quantitative composition
<u>Each tablet contains:</u> Paracetamol 500 mg. Codeine Phosphate 8 mg. <u>Preservative:</u> Sodium metabisulphite 0,081% m/m Contains TARTRAZINE. Contains sugar: sucrose 20,0 mg per tablet. For full ...
3. Pharmaceutical form
Tablet. Flat yellow and red mottled tablet, scored on the one side and a b embossed on the other side.
4.1. Therapeutic indications
PAINAMOL PLUS tablets are indicated for the relief of mild to moderate pain and for the reduction of temperature in febrile conditions.
4.2. Posology and method of administration
Posology <u>Adults:</u> One or two tablets every four to six hours. <u>Children over 12 years:</u> One tablet every four to six hours. <u>Children 6 to 12 years:</u> Half to one tablet every six hours. ...
4.3. Contraindications
Hypersensitivity to PAINAMOL PLUS or to any of the excipients listed in section 6.1. Codeine is contra-indicated in respiratory depression, especially in the presence of cyanosis and excessive bronchial ...
4.4. Special warnings and precautions for use
Do not use continuously for more than 10 days without consulting your doctor. Dosages in excess of those recommended may cause severe liver damage. Codeine should be given with extreme caution in patients ...
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
Pregnancy Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dose. A large amount of data on pregnant women indicate neither malformative, nor ...
4.7. Effects on ability to drive and use machines
Codeine may cause drowsiness, if affected patients should be advised not to drive or operate machinery. This medicine can impair cognitive function and can affect a patients ability to drive safely.
4.8. Undesirable effects
System Organ<br />Class Frequency Adverse Reaction <b>Blood and the<br />lymphatic system<br />disorders</b> Frequency<br />Unknown agranulocytosis, thrombocytopenia,<br />circulatory failure <b>Immune ...
4.9. Overdose
Paracetamol: Symptoms include nausea and vomiting. Liver damage which may be fatal may only appear after a few days. Kidney failure has been described following acute intoxication. In the event of overdosage, ...
5.1. Pharmacodynamic properties
Category A.2.8 analgesic combination Paracetamol has analgesic and antipyretic actions. Codeine Phosphate is an analgesic of the opioid class. Opioid analgesic bind with stereospecific receptors at many ...
5.2. Pharmacokinetic properties
Paracetamol is readily absorbed from the gastro-intestinal tract with peak plasma levels occurring about 30 minutes to 2 hours after ingestion. It is metabolised in the liver and excreted in the urine ...
6.1. List of excipients
Alcohol 90% v/v Be-Tabs Red C344/TF Gelatin Magnesium Stearate Modified Starch Povidone Powdered Sucrose Purified Water Sodium Metabisulphite Starch maize Yellow Saffron LS2002/22
6.2. Incompatibilities
None known.
6.3. Shelf life
<u>24 Months:</u> 20, 100, 500, 1000 and 5000 tablets. <u>15 Months:</u> Patient ready packs of different pack sizes.
6.4. Special precautions for storage
Store at or below 25°C. Protect from strong light in a well-closed container. Protect from moisture. Exposure to air should be minimum.
6.5. Nature and contents of container
Cartons with 2 X 10 tablets in push through blister packs. Containers with 100, 500 and 1000 tablets. Blue/green plastic buckets containing 5000 tablets. Patient ready packs of different pack sizes.
6.6. Special precautions for disposal and other handling
Not applicable.
7. Marketing authorization holder
Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill Ext.1, Roodepoort, 1724, South Africa
8. Marketing authorization number(s)
P/2.8/311 (S.A.)
9. Date of first authorization / renewal of the authorization
27 February 1996
10. Date of revision of the text
04 November 2022
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