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

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2024  Publisher: Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom

Product name and form

Tramadol 50 mg capsules, hard.

Pharmaceutical Form

Capsule, hard.

Green/Yellow, size ‘4’ hard gelatin capsules filled with white to off-white powder and imprinted with ‘T’ on green cap and ‘02’ on yellow body with black ink.

Qualitative and quantitative composition

Each hard capsule contains 50 mg tramadol hydrochloride.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Tramadol

Tramadol 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 may contribute to its analgesic effect are inhibition of neuronal reuptake of noradrenaline and enhancement of serotonin release. Tramadol has an antitussive effect. In contrast to morphine, analgesic doses of tramadol over a wide range have no respiratory depressant effect.

List of Excipients

Contents of capsule:

Cellulose, microcrystalline
Silica, colloidal anhydrous
Sodium starch glycolate (Type A)
Magnesium stearate

Capsule shell:

Body

Gelatin
Sodium lauryl sulphate
Iron oxide yellow (E172)
Titanium dioxide (E171)

Cap

Gelatin
Sodium lauryl sulphate
Indigo carmine
Iron oxide yellow (E172)
Titanium dioxide (E171)

Printing ink:

Shellac
Black iron oxide (E172)

Pack sizes and marketing

PVC/PVDC/Aluminium foil blister: 10, 20, 30, 50, 60, 90, 100 and 500 Capsules.

HDPE bottle pack with polypropyle closure: 30, 200 and 500 Capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Milpharm Limited, Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom

Marketing authorization dates and numbers

PL 16363/0335

07/12/2012

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