MEGACE Tablet Ref.[9741] Active ingredients: Megestrol

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: PharmaSwiss Česká republika s.r.o., Jankovcova 1569/2c, 170 00, Prague 7, Czech Republic

Product name and form

Megace 160 mg Tablets.

Pharmaceutical Form

Tablets.

Off-white, oval, biconvex tablets with a break line, engraved ‘160’ on one face.

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

Qualitative and quantitative composition

Each tablet contains Megestrol Acetate 160 mg.

Excipient with known effect: Each tablet contains 224.5 mg Lactose Monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Megestrol

Megestrol possesses pharmacological properties similar to those of natural progesterone. Megestrol acetate is a potent progestogen that exerts significant anti-oestrogenic effects. It has no androgenic or oestrogenic properties.

List of Excipients

Colloidal anhydrous silica
Lactose monohydrate
Magnesium stearate
Microcrystalline cellulose
Povidone
Sodium starch glycollate

Pack sizes and marketing

Amber glass bottles of 30, 60 or 100.

Blister packs of 30 tablets.

Marketing authorization holder

PharmaSwiss Česká republika s.r.o., Jankovcova 1569/2c, 170 00, Prague 7, Czech Republic

Marketing authorization dates and numbers

PL 33616/0001

20 November 1985 / 25 April 2002

Drugs

Drug Countries
MEGACE Cyprus, France, Croatia, Ireland, Italy, Lithuania, Poland, Singapore, Tunisia, Turkey, United Kingdom

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