SEVREDOL Film-coated tablet Ref.[27729] Active ingredients: Morphine

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

Sevredol tablets 10mg, 20 mg, 50 mg.

Pharmaceutical Form

Film-coated tablet.

10 mg: Blue, film coated, capsule shaped, biconvex tablet, with a score line on one side. “IR” is marked on the left side and “10” on the right.

20 mg: Pink film coated capsule shaped, biconvex tablet, with a score line on one side. “IR” is marked on the left side and “20” on the right.

50 mg: Pale green film coated, capsule shaped, biconvex tablet with a score line on one side. “IR” is marked on the left side and “50” on the right.

Qualitative and quantitative composition

Each tablet contains Morphine Sulfate 10mg, 20 mg, 50 mg.

Excipient with known effect:

Lactose, anhydrous.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Morphine

Morphine is a narcotic analgesic obtained from opium. Morphine acts as an agonist at opiate receptors in the CNS particularly Mu and to a lesser extent Kappa receptors. Mu receptors are thought to mediate supraspinal analgesia, respiratory depression and euphoria, and Kappa receptors, spinal analgesia, miosis and sedation.

List of Excipients

Table core

Lactose (anhydrous)
Pregelatinised maize starch
Povidone
Magnesium stearate
Talc

Film coat

10 mg tablet: Opadry (blue) 06B20843 containing Macrogol 400, E464, E133, E171

20mg tablet: Opadry 85F240092 (pink) containing polyvinyl alcohol (E1203), Macrogol 3350, talc, E171, E127, E110

50mg tablet: Opadry OY-21037 Green. (containing hypromellose E464, titanium dioxide E171, macrogol 400, quinoline yellow E104, indigo carmine E132, iron oxide yellow E172).

Pack sizes and marketing

PVdC coated PVC blister packs and polypropylene containers with polyethylene lids containing 56 and 112 tablets.

Medical sample packs containing up to 24 tablets are also available.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 16950/0063 – 0065

01/05/1999

Drugs

Drug Countries
SEVREDOL Australia, Cyprus, Estonia, Spain, France, Croatia, Ireland, New Zealand, Poland, Romania, United Kingdom

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