RISEDRONATE SODIUM 35 mg Film-coated tablet Ref.[7852] Active ingredients: Risedronic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Pharmathen S.A., 6, Dervenakion str., 153 51 Pallini, Attiki, Greece

Product name and form

Risedronate sodium 35 mg film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

White round biconvex film-coated tablet with diameter of 11.2 mm, 5.0 mm in thickness and embossed with “35” on one side.

Qualitative and quantitative composition

Each film-coated tablet contains 35 mg risedronate sodium which is equivalent to 32.5 mg risedronic acid.

Excipients with known effect:

Each film-coated tablet contains 1.9 mg lactose.

Each film-coated tablet contains 0.115 mmol (2.64 mg) of sodium.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Risedronic acid

Risedronic acid is a pyridinyl bisphosphonate that binds to bone hydroxyapatite and inhibits osteoclast-mediated bone resorption. The bone turnover is reduced while the osteoblast activity and bone mineralisation is preserved.

List of Excipients

Tablet core:

Starch, pregelatinised (maize)
Cellulose, microcrystalline
Crospovidone
Magnesium stearate

Film coating:

Hypromellose
Lactose monohydrate
Titanium dioxide (E171)
Macrogol 4000

Pack sizes and marketing

Nature of container: Opaque PVC/PE/PVDC/Aluminium blister in a carton box.

Pack sizes: 1, 2, 4, 10, 12, 16, 24 film-coated tablets

Not all pack sizes may be marketed.

Marketing authorization holder

Pharmathen S.A., 6, Dervenakion str., 153 51 Pallini, Attiki, Greece

Marketing authorization dates and numbers

PL 17277/0239

11/06/2014

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