TRAMADOL Capsule, hard Ref.[7126] Active ingredients: Tramadol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Accord Healthcare Limited, Sage House, 319 Pinner road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Product name and form

Tramadol Hydrochloride Capsules 50mg.

Pharmaceutical Form

Capsule, hard.

Olive/Yellow capsule shell, imprinted ‘TRM’ on the cap and ‘50’ on the body containing white powder.

Qualitative and quantitative composition

Each capsule contains Tramadol hydrochloride 50mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Tramadol

Tramadol, a cyclohexanol derivative, 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 contribute to its analgesic effect are inhibition of neuronal reuptake of noradrenaline and enhancement of serotonin release.

List of Excipients

Lactose monohydrate
Microcrystalline cellulose (E460(i))
Croscarmellose sodium (E466)
Magnesium stearate (E572)

Capsule shell excipients:

Body:

Erythrosine (E127)
Titanium dioxide, (E171)
Yellow iron oxide (E172)
Gelatin

Cap:

Indigo carmine (E132)
Titanium dioxide (E171)
Black iron oxide (E172)
Yellow iron oxide (E172)
Gelatin

Printing ink (Opacode black S-1- 17823 black):

Shellac Glaze
Black iron oxide (E172)
Propylene glycol (E1520)
Ammonium hydroxide (E527)

Pack sizes and marketing

Blister strips formed from 25μm aluminium foil and 250μm thick opaque PVC/PVdC foil.

Blister packs of 10, 30, 60 and 100 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Limited, Sage House, 319 Pinner road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Marketing authorization dates and numbers

PL 20075/0290

10th November 2000

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