SINEPIN Capsule Ref.[7922] Active ingredients: Doxepin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2021  Publisher: Marlborough Pharmaceuticals Ltd, Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR, UK

Product name and form

SINEPIN 25mg Capsules.

Doxepin 25mg Capsules.

Pharmaceutical Form

Capsules.

Dark blue cap and orange body, opaque, size 3 hard gelatin capsules.

Qualitative and quantitative composition

Active Ingredient: Doxepin Hydrochloride BP.

The capsules contain Doxepin Hydrochloride BP equivalent to 25mg doxepin.

Excipient(s) with known effect: Each capsule also contains 130.00 mg of lactose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Doxepin

Doxepin is not a central nervous system stimulant nor a monoamine oxidase inhibitor. The current hypothesis is that the clinical effects are due, at least in part, to influences on the adrenergic activity at the synapses so that deactivation of noradrenaline by reuptake into the nerve terminals is prevented.

List of Excipients

Doxepin 25mg Capsule:

Lactose
Magnesium stearate
Maize starch dried
Sodium lauryl sulphate

Capsule shell constituents:

Amaranth (E123)
Erythrosine (E127)
Gelatin
Patent blue V (E131)
Sunset yellow (E110)
Titanium dioxide (E171)

Doxepin 25mg Capsules are free of gluten and sucrose.

Pack sizes and marketing

Doxepin 25mg Capsules are available as: Packs of 28 capsules. Aluminium/PVC blister strips; 2 rows of 7 capsules per strip, 2 strips in a carton box.

Marketing authorization holder

Marlborough Pharmaceuticals Ltd, Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR, UK

Marketing authorization dates and numbers

PL 23138/0002

September 2006

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.