COGESIC Tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
COGESIC (Tablets).
2. Qualitative and quantitative composition
Each tablet contains: Codeine phosphate 8 mg Paracetamol 500 mg <u>Preservative:</u> Sodium metabisulphite 0,081% m/m Contains sugar (sucrose) 20 mg
3. Pharmaceutical form
Flat blue tablet, scored on the one side.
4.1. Therapeutic indications
COGESIC 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
DO NOT EXCEED THE RECOMMENDED DOSE. Adults One or two tablets every four to six hours. Do not exceed an adult dose of 8 tablets per day. Children over 12 years One tablet every four to Or hours. Children ...
4.3. Contraindications
Hypersensitivity to any of the ingredients. Codeine is contraindicated in respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion and after operations on the biliary ...
4.4. Special warnings and precautions for use
Paracetamol <b>COGESIC contains paracetamol which may be fatal in overdose. In the event of overdosage or suspected overdose and notwithstanding the fact that the person may be asymptomatic, the nearest ...
4.5. Interaction with other medicinal products and other forms of interaction
Codeine should be given with extreme caution in patients taking monoamine oxidase inhibitors or within 14 days of stopping such treatment (see WARNINGS AND SPECIAL PRECAUTIONS). The depressant effects ...
4.6. Pregnancy and lactation
The administration of codeine during labour may cause respiratory depression in the newborn infant (see WARNINGS AND SPECIAL PRECAUTIONS).
4.7. Effects on ability to drive and use machines
COGESIC may causes drowsiness. Patients should be advised, particularly at the initiation of therapy, against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss ...
4.8. Undesirable effects
Paracetamol Sensitivity reactions resulting in reversible rash or blood disorders may occur. Codeine Codeine may cause nausea, vomiting, constipation, drowsiness, confusion, dry mouth, sweating, facial ...
4.9. Overdose
Paracetamol <b>Prompt treatment Is essential.</b> In the event of an overdosage, consult a doctor immediately, or take the person to a hospital directly. A delay in starting treatment may mean that the ...
5.1. Pharmacodynamic properties
<b>Pharmacological classification:</b> A 2.8 Analgesic Combinations Pharmacological action COGESIC tablets have analgesic and antipyretic action.
6.1. List of excipients
Gelatin Indigo carmine lake E132 IH (CI 73015:1) Povidone Magnesium stearate Maize starch Modified starch Powdered sucrose
6.4. Special precautions for storage
Store at or below 25°C and protect from strong light in a well-closed container. Protect from moisture. Exposure to air should be minimal. KEEP OUT OF REACH OF CHILDREN.
6.5. Nature and contents of container
Cartons containing 2 10 tablets in push through blister packs. White plastic (LOPE) Ziploc bag (Patient Ready Pack) containing 56 tablets. Amber plastic (PVC) bottles containing 100, 500, and 1000 tablets. ...
7. Marketing authorization holder
Oethmaan Biosims (PTY) Ltd, Office 207A, Sherwood House, Greenacres Office Park, c/o Victory and Rustenburg Roads, Victory Park, Johannesburg 2195
8. Marketing authorization number(s)
0/2.8/109
9. Date of first authorization / renewal of the authorization
Date of registration: 23 August 1989
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