LYNLOR Capsule, hard Ref.[8076] Active ingredients: Oxycodone

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Product name and form

Lynlor 10mg Capsules, hard.

Oxycodone hydrochloride 10mg Capsules, hard.

Pharmaceutical Form

Capsule, hard (capsule)

Hard capsules, 14.4 mm in length, with a white body marked with ‘10’ and a brown cap marked with ‘OXY’.

Qualitative and quantitative composition

Each capsule contains 10.0 mg oxycodone hydrochloride corresponding to 8.96 mg oxycodone.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Oxycodone

Oxycodone is a full opioid agonist with no antagonist properties. It has an affinity for kappa, mu and delta opioid receptors in the brain and spinal cord. Oxycodone is similar to morphine in its action. The therapeutic effect is mainly analgesic, anxiolytic, antitussive and sedative.

List of Excipients

Capsule content:

Microcrystalline cellulose
Magnesium stearate

Capsule shell:

Gelatine
Sodium laurilsulfate
Titanium dioxide (E171)
Iron oxide yellow (E172)
Iron oxide red (E172)
Indigotine (E132)

Printing ink: Shellac, Iron oxide black (E172), Potassium hydroxide (for pH-adjustment)

Pack sizes and marketing

Blister packs (PVC/PVdC/Al).

Pack sizes: 10, 14, 20, 28, 30, 50, 56, 90, 98 and 100 capsules

Child resistant blister packs (PVC/PVdC/Al/PET/paper).

Pack sizes: 10, 14, 20, 28, 30, 50, 56, 90, 98 and 100 capsules

Child resistant HDPE containers with threaded neck with PP Cap (Twist off Cap).

Pack sizes: 56, 98, 100 and 250 capsules

Not all pack sizes may be marketed.

Marketing authorization holder

Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Marketing authorization dates and numbers

PL 0142/1080

01/02/2013

18/04/2018

Drugs

Drug Countries
LYNLOR United Kingdom

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