Source: European Medicines Agency (EU)
Levomethadone 2.5 mg tablets.
Levomethadone 5 mg tablets.
Levomethadone 20 mg tablets.
Levomethadone 30 mg tablets.
| Pharmaceutical Form |
|---|
|
Tablet. Levomethadone 2.5 mg tablets: White to off-white, oblong tablet of 9.0 × 4.0 mm and break scores on both sides. The tablet can be divided into equal doses. Levomethadone 5 mg tablets: White to off-white, round tablet with a diameter of 9 mm and break scores on both sides. The tablet can be divided into equal doses. Levomethadone 20 mg tablets: White to off-white, round tablet with a diameter of 9 mm and cross break scores on one side. The tablet can be divided into four equal doses. Levomethadone 30 mg tablets: White to off-white, round tablet with a a diameter of 10 mm and a break score on one side. The tablet can be divided into equal doses. |
Levomethadone 2.5 mg: Each tablet contains levomethadone as 2.5 mg levomethadone hydrochloride.
Levomethadone 5 mg: Each tablet contains levomethadone as 5 mg levomethadone hydrochloride.
Levomethadone 20 mg: Each tablet contains levomethadone as 20 mg levomethadone hydrochloride.
Levomethadone 30 mg: Each tablet contains levomethadone as 30 mg levomethadone hydrochloride.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Levomethadone |
Levomethadone is a fully synthetic opioid analgesic which, as a basic diphenylmethane derivative, can be structurally derived from morphine. Bradycardia, hypotension, bronchoconstriction and antidiuresis are among the pharmacological effects of levomethadone, in addition to other classical opioid effects such as sedation, euphoria and miosis. |
| List of Excipients |
|---|
|
Microcrystalline cellulose |
Child resistant aluminium//PVC/PE/PVDC unit-dose peel-off or push-through blisters with 10, 14, 20, 28, 30, 50, 56, 60, 98, 100 tablets.
HDPE bottles with child-resistant polypropylene screw cap with 28, 56, 98, 100, 250 tablets.
Not all pack sizes may be marketed.
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