LERCANIDIPINE HYDROCHLORIDE Film-coated tablet Ref.[6938] Active ingredients:

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220 Hafnarfjörõur, Iceland

Product name and form

Lercanidipine hydrochloride 10 mg film-coated tablet.

Pharmaceutical Form

Film-coated tablet.

Lercanidipine hydrochloride 10 mg film-coated tablet: Yellow, round, biconvex 6.5 mm film-coated tablets, scored on one side, marked ‘L’ on the other side.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Qualitative and quantitative composition

One film-coated tablet contains 10 mg lercanidipine hydrochloride, equivalent to 9.4mg lercanidipine.

Excipient with known effect: Lercanidipine hydrochloride 10 mg film-coated tablet: Lactose monohydrate 30 mg

For the full list of excipients, see section 6.1.

List of Excipients

Tablet core:

Magnesium stearate
Povidone
Sodium starch glycolate Type A
Lactose monohydrate
Cellulose, microcrystalline

Film-coating:

Lercanidipine 10 mg film-coated tablets:

Macrogol
Polyvinyl alcohol, partly hydrolysed
Talc
Titanium dioxide (E171)
Yellow iron oxide (E172)

Pack sizes and marketing

Blister pack (Aluminium/PVC/PVDC) with push-through foil.

Tablet container (HDPE), closed with a sealed LDPE-cap.

Pack sizes

Blister (AL/PVC/PVDC):

Lercanidipine hydrochloride 10 mg film-coated tablets: 14, 20, 28, 30, 50, 56, 60, 90, 98, 100 film-coated tablets.

Tablet containers:

Lercanidipine hydrochloride 10 mg film-coated tablets: 100 film-coated tablets.

Marketing authorization holder

Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220 Hafnarfjörõur, Iceland

Marketing authorization dates and numbers

PL30306/0136

19.06.2009/24.09.2014

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