PALLADONE Prolonged release capsule Ref.[8904] Active ingredients: Hydromorphone

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0GW

Product name and form

PALLADONE SR capsules 2 mg, 4 mg, 8 mg, 16 mg, 24 mg.

Pharmaceutical Form
Prolonged release capsule. Hard gelatin capsule containing spherical prolonged release pellets. The 2 mg capsules are yellow/white capsules marked HCR2. The 4 mg capsules are pale blue/clear capsules marked HCR4. The 8 mg capsules are pink/clear capsules marked HCR8. The 16 mg capsules are brown/clear capsules marked HCR16. The 24 mg capsules are dark blue/clear capsules marked HCR24.

Qualitative and quantitative composition

Each capsule contains hydromorphone hydrochloride 2 mg, 4 mg, 8 mg, 16 mg, 24 mg.

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
Microcrystalline cellulose Hypromellose Ethylcellulose (N10) Colloidal anhydrous silica Dibutyl sebacate Capsule shells: Gelatin Sodium laurilsulfate Titanium dioxide (E171) Black Printing ink: Shellac Propylene glycol Iron oxide (E172) The capsule shells contain the following colours: 2 mg capsule – Quinoline yellow (E104) 4 mg capsule – Erythrosine (E127), Indigo carmine (E132) 8 mg capsule – Erythrosine (E127) 16 mg capsule – Iron oxide (E172) 24 mg capsule – Indigo carmine (E132)

Pack sizes and marketing

a) PVdC/PVC blister packs with aluminium backing foil.

b) Polypropylene containers with polyethylene lids.

Pack sizes: 30, 56, 60 capsules.

Marketing authorization holder

Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0GW

Marketing authorization dates and numbers

PL 16950/0051
PL 16950/0052
PL 16950/0053
PL 16950/0054
PL 16950/0055

17/01/2006

Drugs

Drug	Countries
PALLADONE	Germany, Ireland, United Kingdom

Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.