Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2023 Publisher: KRKA, d.d., Novo mesto, Š marješ ka cesta 6, 8501 Novo mesto, Slovenia
Tramadol hydrochloride Krka 100 mg prolonged-release tablets.
| Pharmaceutical Form |
|---|
|
Prolonged-release tablet. White, round, biconvex, film coated tablets with embossed mark T1 on one side of the tablet. Tablet diameter: approximately 10 mm. |
Each prolonged-release tablet contains 100 mg tramadol hydrochloride.
Excipient with known effect:
Lactose: 2.38 mg.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Tramadol |
Tramadol is a centrally acting opioid analgesic. It is a non selective pure agonist at μ-, δ- and κ-opioid receptors with a higher affinity for the μ-receptor. Other mechanisms which may contribute to its analgesic effect are inhibition of neuronal reuptake of noradrenaline and enhancement of serotonin release. Tramadol has an antitussive effect. In contrast to morphine, analgesic doses of tramadol over a wide range have no respiratory depressant effect. |
| List of Excipients |
|---|
|
Tablet core: Hypromellose Film coating: Hypromellose |
Child-resistant blister (PVC/PVDC white film//heat sealing paper/Alu foil): 10, 20, 28, 30, 50, 60, 90, 100 prolongedrelease tablets, in a box.
Perforated unit dose child-resistant blister (PVC/PVDC white film//heat sealing paper/Alu foil): 10 × 1, 20 × 1, 28 × 1, 30 × 1, 50 × 1, 60 × 1, 90 × 1, 100 × 1 prolonged-release tablet, in a box.
Not all pack sizes may be marketed.
KRKA, d.d., Novo mesto, Š marješ ka cesta 6, 8501 Novo mesto, Slovenia
PL 01656/0264
31/03/2023
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