MANIDIPINE Tablet Ref.[8265] Active ingredients: Manidipine

Source: European Medicines Agency (EU) 

Product name and form

Manidipine 10 mg tablets.

Manidipine 20 mg tablets.

Pharmaceutical Form

Tablet.

The 10 mg tablets are round convex, yellow coloured, with midline score line.

The 20 mg tablets are oval convex, yellow coloured, with midline score line.

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

Qualitative and quantitative composition

Manidipine dihydrochloride 10 mg

Excipients: lactose monohydrate 66.40 mg

Manidipine dihydrochloride 20 mg

Excipients: lactose monohydrate 132.80 mg

For a full list of excipients, see Section 6.1.

Active Ingredient Description
Manidipine

Manidipine (INN) is a calcium channel blocker (dihydropyridine type) that is used clinically as an antihypertensive. It is selective for vasculature and does not produce effects on the heart at clinically relevant dosages.

List of Excipients

Lactose monohydrate
Maize starch
Low-substituted hydroxypropylcellulose
Hydroxypropylcellulose
Magnesium stearate
Riboflavin

Pack sizes and marketing

PVC/PVDC blister sealed with Al/PVDC.

10 and 20 mg: 14, 28, 30, 56, 84, 90, 98, 112 tablets.

Not all pack sizes may be marketed

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