160 mg tablets
megestrol acetate

What Megace is and what it is used for

Megace is a hormonal drug that inhibits the growth of certain types of cancer cells.

Megace is used to treat advanced breast cancer.

What you need to know before taking Megace

Do not take Megace:

  • if you are allergic to megestrol acetate or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before taking Megace:

  • if you have a history of blood clots
  • if you have liver disease
  • if you do not tolerate certain sugars
  • if you are pregnant or breastfeeding

Children and young people

Safety and efficacy in children have not been established.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is a risk that the fetus is affected. Children who are breastfed may be affected. Therefore, do not use Megace while breastfeeding other than on a doctor’s prescription.

Driving and using machines

Megace has not been shown to affect its ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Megace contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Megace.

How to take Megace

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Dose one is determined by the doctor, who adjusts it individually for you. The recommended dose is 1 tablet daily.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following may be signs of serious side effects:

The following symptoms may be signs of a blood clot:

Contact your doctor immediately and stop the treatment if you notice any of the above.

Common (affects more than 1 user in 100)

  • Indigestion
  • Skin, hair, eyes, general
    • weight gain
    • fluid swelling
    • disorders of the menstrual pattern
    • pain
    • abnormal mental fatigue, feeling dormant ( lethargy )
    • impotence

Uncommon (affects less than 1 user in 100)

  • Heart and lungs
    • heart failure
    • high blood pressure
    • hot flashes
    • respiratory distress
  • Indigestion
  • Skin, hair, eyes, general
    • rash
    • hair loss
    • diabetes
    • frequent urination
    • mood swings
    • temporary worsening of the disease at the beginning of treatment
  • Tests can show
    • elevated blood sugar
    • elevated levels of cortisone in the body, can cause facial swelling, obesity on the torso, brittle skin, etc.
    • insufficient adrenal cortex function (lack of production of certain hormones )

Rare (affects less than 1 user in 1,000)

  • Heart and lungs
  • Skin, hair, eyes, general
    • increased hair growth on the body
    • tremors
    • nerve impact in the hand, can manifest itself as numbness, pain, etc.

Other reported side effects (no known frequency) include flatulence, weakness, and pain.

How to store Megace

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

  • The active substance is megestrol acetate, 160 mg per tablet
  • The other ingredients are lactose monohydrate 224.5 mg per tablet, microcrystalline cellulose, sodium starch glycolate, povidone, colloidal anhydrous silica, magnesium stearate. (See section 2 “Megace contains lactose”.)

What the medicine looks like and contents of the pack

28 pcs (print packaging)

56 pcs (print packaging)

112 pcs (print packaging)

30 pcs (glass jar)

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

BAUSCH HEALTH IRELAND LIMITED

3013 Lake Drive

Citywest Business Campus

Dublin 24 – D24PPT3 – Ireland

Manufacturer

Haupt Pharma Amareg GmbH

Donaustaufer Strasse 378

93055 Regensburg,

Germany

Local representative

Bausch & Lomb Nordic AB

Söder Mälarstrand 45

118 25 Stockholm

Muhammad Nadeem

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