MORPHGESIC Controlled release tablet Ref.[7716] Active ingredients: Morphine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Amdipharm UK Limited, Capital House, 85 King William Street, London EC4N 7BL, UK

Product name and form

Rhotard Morphine SR 30 mg Tablets.

Morphgesic SR 30mg Tablets.

Pharmaceutical Form

Controlled release tablets.

Each 30 mg tablet is a violet coloured biconvex round film coated tablet.

Qualitative and quantitative composition

Rhotard Morphine SR 30 mg Tablets/Morphgesic SR 30 mg Tablets.

Each tablet contains 30 mg of morphine sulphate.

Excipients with known effect:

Lactose (63.000 mg per tablet).

FD&C Yellow #6/Sunset Yellow FCF Lake (E110).

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

Lactose
Hydroxyethylcellulose
Hypromellose (E464)
Povidone
Talc
Magnesium Stearate
Macrogol
Industrial Methylated Spirits 99%

Rhotard Morphine SR/Morphgesic SR 30 mg tablets contain the colourants listed below:

Erythrosine lake (E127)
Titanium dioxide (E171)
FD&C Blue #2/Indigo Carmine lake (E132)
FD&C Yellow #6/Sunset Yellow FCF lake (E110)

Pack sizes and marketing

Each pack contains either 10 or 60 tablets in PVC blister packs with aluminium foil lidding.

Marketing authorization holder

Amdipharm UK Limited, Capital House, 85 King William Street, London EC4N 7BL, UK

Marketing authorization dates and numbers

PL 20075/0232

Date of first authorisation: 28 June 2002

Drugs

Drug Countries
MORPHGESIC Cyprus, United Kingdom

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