ADIZEM-XL Prolonged release capsule Ref.[7555] Active ingredients: Diltiazem

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Napp Pharmaceuticals Ltd, Cambridge Science Park, Milton Road, Cambridge CB4 0GW

Product name and form

ADIZEM-XL capsules 120, 180, 200, 240 and 300 mg.

Pharmaceutical Form

Prolonged release capsule.

Adizem-XL capsules 120 mg are approximately 16mm long with a pale pink body and a navy blue cap, marked DCR 120.

Adizem-XL capsules 180 mg are approximately 18mm long with a dark pink body and a royal blue cap, marked DCR 180.

Adizem-XL capsules 200 mg are approximately 19mm long with a light brown body and a light brown cap, marked DCR 200.

Adizem-XL capsules 240 mg are approximately 19mm long with a dark red body and a blue cap, marked DCR 240.

Adizem-XL capsules 300 mg are approximately 22mm long with a dark maroon body and a pale blue cap, marked DCR 300.

Qualitative and quantitative composition

Each capsule contains 120, 180, 200, 240 or 300 mg diltiazem hydrochloride.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Diltiazem

Diltiazem is a calcium antagonist. It restricts the slow channel entry of calcium into the cell and so reduces the liberation of calcium from stores in the sarcoplasmic reticulum. This results in a reduction of the amount of available intracellular calcium reducing myocardial oxygen consumption.

List of Excipients

Capsule Contents:

Microcrystalline cellulose
Ethylcellulose N10
Colloidal anhydrous silica
Polysorbate 80
Dibutyl sebacate
Magnesium stearate

Capsule shells:

Iron oxide (E172)
Titanium dioxide (E171)
Sodium laurilsulfate
Gelatin
Erythrosine (E127) (not present in the 200 mg capsule)
Indigo carmine (E132) (not present in the 200 mg capsule)
Patent blue V (E131) (300 mg capsule only)

Printing ink:

Shellac
Simeticone
Propylene glycol
Titanium dioxide (E171)

Pack sizes and marketing

PVC/PVdC blister packs with aluminium foil (containing 28 capsules).

Marketing authorization holder

Napp Pharmaceuticals Ltd, Cambridge Science Park, Milton Road, Cambridge CB4 0GW

Marketing authorization dates and numbers

PL 16950/0010-0013, 0121

Adizem-XL Capsules 120, 180, 240, 300 mg:

Date of first authorisation: 11 August 1993
Date of latest renewal: 23 September 2003

Adizem-XL Capsules 200 mg:

Date of first authorisation: 10 September 2001
Date of latest renewal: 23 September 2003

Drugs

Drug Countries
ADIZEM Ireland, Israel, United Kingdom

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