CARDENE Hard capsule Ref.[8183] Active ingredients: Nicardipine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Astellas Pharma Ltd., SPACE, 68 Chertsey Road, Woking, Surrey, GU21 5BJ, United Kingdom

Product name and form

Cardene 20 mg.

Cardene 30 mg.

Pharmaceutical Form

Cardene 20 mg: Hard capsule with an opaque blue cap and opaque white body, marked in red ink with the strength and company logo.

Cardene 30 mg: Hard capsule with an opaque blue cap and opaque pale blue body, marked in red ink with the strength and company logo.

Qualitative and quantitative composition

Each Cardene 20 mg hard capsule contains nicardipine hydrochloride 20 mg.

Each Cardene 30 mg hard capsule contains nicardipine hydrochloride 30 mg.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Nicardipine

Nicardipine is a second generation slow calcium channel inhibitor, and belongs to the phenyl-dihydropyridine group. Nicardipine has a greater selectivity for L-type calcium channels in vascular smooth muscle than cardiac myocytes. Nicardipine produces smooth muscle relaxation and marked peripheral vasodilatation.

List of Excipients

Starch, pregelatinised
Magnesium stearate

Cardene 20mg:

Capsule shell body:

Titanium Dioxide E171
Gelatin

Cardene 30mg:

Capsule shell body:

Indigotine E132
Titanium Dioxide E171
Gelatin

Cardene 20mg and 30mg:

Capsule shell cap:

Indigotine E132
Titanium Dioxide E171
Gelatin

Pack sizes and marketing

Cardene 20mg: Securitainer packs of 50 and 100. PVC/aluminium foil blister strips of 21, 56, 84, 100 and 200 capsules.

Cardene 30mg: Securitainer packs of 50 and 100. PVC/aluminium foil blister strips of 21, 56, 60, 84, 100 and 200 capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Astellas Pharma Ltd., SPACE, 68 Chertsey Road, Woking, Surrey, GU21 5BJ, United Kingdom

Marketing authorization dates and numbers

Cardene 20mg – PL 00166/0181
Cardene 30mg – PL 00166/0182

Date of first authorisation: 15 May 1998
Date of latest renewal: 15 July 2002

Drugs

Drug Countries
CARDENE Netherlands, United Kingdom, United States

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