OPTRUMA Film-coated tablet Ref.[49845] Active ingredients: Raloxifene

Source: European Medicines Agency (EU)  Revision Year: 2022  Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherland

Product name and form

Optruma 60 mg film coated tablets.

Pharmaceutical Form

Film coated tablet.

Elliptically shaped, white tablets imprinted with the code ‘4165’.

Qualitative and quantitative composition

Each film coated tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene free base.

Excipient with known effect: Each tablet contains lactose (149.40 mg).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Raloxifene

As a selective oestrogen receptor modulator (SERM), raloxifene has selective agonist or antagonist activities on tissues responsive to oestrogen. It acts as an agonist on bone and partially on cholesterol metabolism (decrease in total and LDL-cholesterol), but not in the hypothalamus or in the uterine or breast tissues.
List of Excipients

Tablet core:

Povidone
Polysorbate 80
Lactose
Lactose monohydrate
Crospovidone
Magnesium stearate

Tablet coating:

Titanium dioxide (E171)
Polysorbate 80
Hypromellose
Macrogol 400
Carnauba wax

Ink:

Shellac
Propylene glycol
Indigo carmine (E132)

Pack sizes and marketing

Optruma tablets are packed either in PVC/PE/PCTFE blisters or in high density polyethylene bottles.

Blister boxes contain 14, 28, or 84 tablets. Bottles contain 100 tablets.

Not all pack sizes may be marketed in all countries.

Marketing authorization holder

Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherland

Marketing authorization dates and numbers

EU/1/98/074/001
EU/1/98/074/002
EU/1/98/074/003
EU/1/98/074/004

Date of first authorisation: 5 August 1998
Date of latest renewal: 11 August 2008

Drugs

Drug Countries
OPTRUMA Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, Tunisia
 
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