NORTRIPTYLINE Film-coated tablets Ref.[8081] Active ingredients: Nortriptyline

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Glenmark Pharmaceuticals Europe Limited, Laxmi House, 2B Draycott Avenue, Kenton, Middlesex, HA3 0BU, United Kingdom

Product name and form

Nortriptyline 10 mg Film-coated Tablets.

Pharmaceutical Form

Film-coated Tablet 10mg: White to off white, round shaped, film coated, biconvex tablets, debossed with ‘Y’ on one side and ‘72’ on other side.

Qualitative and quantitative composition

Each 10mg tablet contains nortriptyline hydrochloride equivalent to 10 mg nortriptyline base.

Excipients with known effect: Each 10 mg tablet contains 12 mg Lactose Monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Nortriptyline

Nortriptyline is a tricyclic antidepressant with actions and uses similar to these of amitriptyline. It is the principal active metabolite of amitriptyline.

List of Excipients

Core tablets:

Lactose monohydrate
Calcium hydrogen phosphate dihydrate
Pregelatinised starch
Magnesium stearate

Film-coating (Opadry 21M580023 White):

Hypromellose (E464)
Titanium dioxide (E171)
Ethylcellulose 7cP
Glycerol (E422)
Ethanol anhydrous

Pack sizes and marketing

PVC/PVDC – Aluminium blisters

Pack sizes: 20, 24, 25, 30, 50, 56, 100, 500 tablets.

HDPE bottles with polypropylene cap and heat seal liner

Pack sizes: 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Glenmark Pharmaceuticals Europe Limited, Laxmi House, 2B Draycott Avenue, Kenton, Middlesex, HA3 0BU, United Kingdom

Marketing authorization dates and numbers

PL 25258/0263

06/03/2018

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