Source: Marketing Authorisation Holder Revision Year: 2022
JURNISTA 4 mg prolonged-release tablets.
JURNISTA 8 mg prolonged-release tablets.
JURNISTA 16 mg prolonged-release tablets.
JURNISTA 32 mg prolonged-release tablets.
JURNISTA 64 mg prolonged-release tablets.
| Pharmaceutical Form |
|---|
|
Prolonged-release tablet. JURNISTA 4 mg tablet: pale beige, round, biconvex tablet, with ‘HM 4’ printed in black ink on one side JURNISTA 8 mg tablet: red, round, biconvex tablet, with ‘HM 8’ printed in black ink on one side. JURNISTA 16 mg tablet: yellow, round, biconvex tablet, with ‘HM 16’ printed in black ink on one side. JURNISTA 32 mg tablet: white, round, biconvex tablet, with ‘HM 32’ printed in black ink on one side. JURNISTA 64 mg tablet: blue, round, biconvex tablet, with ‘HM 64’ printed in black ink on one side. |
Each JURNISTA 4 mg prolonged-release tablet contains 4.36 mg and delivers 4 mg hydromorphone hydrochloride, equivalent to 3.56 mg hydromorphone.
Each JURNISTA 8 mg prolonged-release tablet contains 8.72 mg and delivers 8 mg hydromorphone hydrochloride, equivalent to 7.12 mg hydromorphone.
Each JURNISTA 16 mg prolonged-release tablet contains 16.35 mg and delivers 16 mg hydromorphone hydrochloride, equivalent to 14.24 mg of hydromorphone.
Each JURNISTA 32 mg prolonged-release tablet contains and delivers 32.00 mg hydromorphone hydrochloride, equivalent to 28.48 mg of hydromorphone.
Each JURNISTA 64 mg prolonged-release tablet contains and delivers 64.00 mg hydromorphone hydrochloride, equivalent to 56.96 mg of hydromorphone.
Excipient with known effect:
Each 4 mg tablet contains 0.01 mg lactose.
Each 8 mg tablet contains 4.37 mg lactose.
Each 16 mg tablet contains 6.81 mg lactose.
Each 32 mg tablet contains 10.02 mg lactose.
Each 64 mg tablet contains 8.03 mg lactose.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Hydromorphone |
Hydromorphone is an agonist of mu receptors. The pharmacological actions of hydromorphone and morphine do not differ significantly. Hydromorphone and related opioids produce their major effects on the central nervous system and bowel. Hydromorphone is indicated for the relief of severe pain in cancer. |
| List of Excipients |
|---|
|
Coated tablet core: Polyethylene oxide 200K Colour overcoat: 8 mg, 16 mg, 32 mg & 64 mg: Lactose monohydrate, hypromellose, titanium dioxide E171, glycerol triacetate, ferric oxide red E172 (8 mg)/ferric oxide yellow E172 (16 mg)/indigo carmine lake E132 (64 mg). 4 mg only: Hypromellose; titanium dioxide E171, Macrogol 400, ferric oxide yellow E172, ferric oxide red E172 and iron oxide black E172. Clear overcoat: Hypromellose Printing ink: Iron oxide black E172 |
PVC/Aclar aluminium blisters.
Pack sizes of 7, 10, 14, 20, 28, 30, 35, 40, 50, 56, 60, 100 tablets.
Not all pack sizes may be marketed.
| Drug | Countries | |
|---|---|---|
| JURNISTA | Australia, Germany, Estonia, Spain, Singapore, South Africa |
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