NORTRILEN Film-coated tablet Ref.[51158] Active ingredients: Nortriptyline

Source: Medicines Authority (MT)  Revision Year: 2022  Publisher: H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark

Product name and form

Nortrilen 10 mg film-coated tablets.

Nortrilen 25 mg film-coated tablets.

Pharmaceutical Form

10 mg: Round, slightly biconvex, white, film-coated tablets with a flat top, on one side marked “NL”.

25 mg: Round, slightly biconvex, white, film-coated tablets with a flat top, on one side marked “NO”.

Qualitative and quantitative composition

Nortrilen 10 mg: Each tablet contains 10 mg nortriptyline (as 11.38 mg nortriptyline hydrochloride).

Nortrilen 25 mg: Each tablet contains 25 mg nortriptyline (as 28.45 mg nortriptyline hydrochloride).

For a 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

Tablet core:

Maize starch
Lactose monohydrate
Copovidone
Glycerol (85%)
Cellulose microcrystalline
Talc
Magnesium stearate

Coating:

Hypromellose 5
Macrogol 6000

Colour:

Titanium dioxide (E171)

Pack sizes and marketing

10 mg: 50 and 100 tablets in High Density Polyethylene (HDPE) container.

25 mg: 50 and 100 tablets in High Density Polyethylene (HDPE) container.

Not all pack sizes may be marketed.

Marketing authorization holder

H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark

Marketing authorization dates and numbers

NORTRILEN Tablets 10 mg MA601/00101
NORTRILEN Tablets 25 mg MA601/00102

18th September 2006 / 11th October 2012

Drugs

Drug Countries
NORTRILEN Hong Kong, Malta, Netherlands

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