Source: European Medicines Agency (EU) Revision Year: 2013
Metamizole sodium 500 mg/ml oral drops, solution.
| Pharmaceutical Form |
|---|
|
Oral drops, solution. Clear, yellow solution with raspberry flavour. |
1 ml (20 drops) contains 500 mg metamizole sodium monohydrate.
1 drop contains 25 mg metamizole sodium monohydrate.
Excipient with known effect: Metamizole sodium contains 1.5 mmol (or 35 mg) sodium per ml (20 drops).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Metamizole sodium |
Metamizole sodium is a pyrazolone derivative with analgesic, antipyretic and slight antiinflammatory and spasmolytic properties. It has the most potent analgesic effect of all the pyrazolone derivatives. As with other analgesics, its mechanism of action has not been elucidated in detail. It includes inhibition of prostaglandin synthesis (PGE1 and PGE2) and reversible inhibition of platelet aggregation. It inhibits cyclo-oxygenase and influences the effect of arachidonic acid. |
| List of Excipients |
|---|
|
Disodium phosphate anhydrous |
Dropper container, consisting of amber glass bottle (type III), fitted with a LDPE dropper applicator and closed with a child-resistant, tamper-evident screw cap, consisting of HDPE/polypropylene.
Dropper container containing 10 ml, 20 ml, 50 ml or 100 ml oral drops, solution
Not all pack sizes may be marketed.
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