Skip to Content

MEGESTROL ACETATE 160 MG TABLETS

Active substance(s): MEGESTROL ACETATE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Package leaflet: Information for the user

MEGACE® 160 mg Tablets
(megestrol acetate)
This product is available as the above name but will be referred to as Megace tablets throughout the following
leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet:
1. What Megace tablets are and what they are used for
2. What you need to know before you take Megace tablets
3. How to take Megace tablets
4. Possible side effects
5. How to store Megace tablets
6. Contents of the pack and other information
1. What Megace tablets are and what they are used for
Megace tablets contain the active ingredient megestrol acetate. Megestrol acetate belongs to a group of
medicines called progestogens and is used to treat certain types of cancer known as hormone-dependent
cancer, which include cancer of the breast.
2. What you need to know before you take Megace tablets
Do not take Megace tablets if you:
- are allergic to megestrol acetate or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Tell your doctor if you:
- have severe liver problems
- currently suffer from, or have a history of suffering from blood clots (thrombophlebitis)
- have diabetes, as Megace tablets can increase your blood sugar levels
If you are over 65 years of age your doctor may want to monitor your kidney function from time to time, as this
can sometimes decrease with age.
Other medicines and Megace tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and breast-feeding
Do not take Megace tablets if you are pregnant, think you may be pregnant, or if you are breast-feeding.
Driving and using machines
Megace tablets do not usually affect your ability to drive.
Megace tablets contains lactose monohydrate
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicine.
3. How to take Megace tablets
Always take Megace tablets exactly as your doctor has told you. You should check with your doctor if you are
not sure.
The usual dosage is 160 mg megestrol acetate per day.
Tablets should be swallowed with a glass of water.
This medicine is not recommended for children.
Megace tablets should be taken for at least two months to see if they are effective. Some patients take them for
many years.
Do not stop taking them, unless advised to do so by your doctor.
If you take more Megace tablets than you should
If you take more Megace tablets than you should, go to your nearest hospital emergency department or contact
your doctor immediately.
Take the empty container and any remaining medicine with you.
If you forget to take Megace tablets
If you miss a dose, do not worry. If you remember within a few hours of the missed dose take it as soon as
possible, but if it is almost time for your next dose then skip the forgotten one and continue as before. Do not
take a double dose to make up for the one you missed.
4. Possible side effects
As with all medicines, Megace tablets can cause side effects although not everybody gets them.
If you notice any of the following, stop taking Megace tablets and contact your doctor immediately:
- swelling of the face, lips, or tongue
- skin rash
- difficulty breathing
As these may be signs of an allergic reaction.

Other side effects which may occur with Megace tablets are:
Very Common (affects more than 1 in 10 people)
- increase in appetite and weight gain (not associated with water retention)
- shortness of breath
- hot flushes, reddening of the face and neck
- high blood pressure
- increased blood sugar levels
- rounded face, sometimes called ‘moon’ face
- constipation
- swelling of a vein due to a blood clot
- blood clot in the lungs
Signs of a blood clot can include loss of co-ordination, slurred speech, pains in your groin, pains or numbness in
your arm or leg (especially in calf of leg), shortness of breath, weakness, headache, and fainting. If you
experience any of these signs tell your doctor immediately.
Common (affects between 1 in 10 to 1 in 100 people)
- temporary increase in the signs and symptoms of your disease
- changes in mood
- numbness, pain or tingling in fingers or thumb
- heart attack
- hair loss
- diarrhoea
- tiredness
- feeling weak
- impotence
- passing wind
- needing to urinate more often
- feeling sick and being sick
- changes in vaginal bleeding (breakthrough bleeding, spotting)
- build up of fluid which causes swelling (mainly in the ankles)
- pain
- rash, including hives or nettle rash (urticaria)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly (see contact details below). By reporting side effects
you can help provide more information on the safety of this medicine.
United Kingdom:
Website: www.mhra.gov.uk/yellowcard
5. How to store Megace tablets
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original package in order to protect from moisture. Protect from
temperatures above 40°C.
Megace tablets should not get too hot or damp; so do not leave your tablets near a radiator, on a window sill or
in the bathroom.
Please check the expiry date of the product, shown on the carton and blister of Megace tablets. The expiry date
refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help protect the environment.
If your medicine becomes discoloured, or shows any signs of deterioration, consult your pharmacist who will tell
you what to do.
6. Contents of the pack and other information
What Megace tablets contain
Each tablet contains 160 mg of megestrol acetate.
The other ingredients are: magnesium stearate, colloidal silicon dioxide, lactose monohydrate, microcrystalline
cellulose, sodium starch glycolate, povidone and purified water.
What Megace tablets look like and contents of the pack
Megace tablets are white, oval shaped biconvex tablets scored on one side and engraved with “160” on the
other side.
Megace tablets are available in blister packs of 30 tablets.
PL: 15814/1311

POM

Manufactured by AndersonBrecon (UK) Limited, Hereford, U.K.
Procured from within the EU and repackaged by the Product Licence holder: O.P.D. Laboratories Ltd., Unit 6
Colonial Way, Watford, Herts WD24 4PR.
Megace is a registered trademark of Bristol-Myers Squibb Company.
Leaflet revision and issue date (Ref.): 25.01.2017.

To request a copy of this in Braille, large print or audio
please call 01923 332 796.

Package leaflet: Information for the user

MEGESTROL ACETATE 160 mg Tablets
This product is available as the above name but will be referred to as Megestrol Acetate tablets throughout the
following leaflet.
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their
signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet:
1. What Megestrol Acetate tablets are and what they are used for
2. What you need to know before you take Megestrol Acetate tablets
3. How to take Megestrol Acetate tablets
4. Possible side effects
5. How to store Megestrol Acetate tablets
6. Contents of the pack and other information
1. What Megestrol Acetate tablets are and what they are used for
Megestrol Acetate tablets contain the active ingredient megestrol acetate. Megestrol acetate belongs to a group
of medicines called progestogens and is used to treat certain types of cancer known as hormone-dependent
cancer, which include cancer of the breast.
2. What you need to know before you take Megestrol Acetate tablets
Do not take Megestrol Acetate tablets if you:
- are allergic to megestrol acetate or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Tell your doctor if you:
- have severe liver problems
- currently suffer from, or have a history of suffering from blood clots (thrombophlebitis)
- have diabetes, as Megestrol Acetate tablets can increase your blood sugar levels
If you are over 65 years of age your doctor may want to monitor your kidney function from time to time, as this
can sometimes decrease with age.
Other medicines and Megestrol Acetate tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pregnancy and breast-feeding
Do not take Megestrol Acetate tablets if you are pregnant, think you may be pregnant, or if you are breastfeeding.
Driving and using machines
Megestrol Acetate tablets do not usually affect your ability to drive.
Megestrol Acetate tablets contains lactose monohydrate
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicine.
3. How to take Megestrol Acetate tablets
Always take Megestrol Acetate tablets exactly as your doctor has told you. You should check with your doctor if
you are not sure.
The usual dosage is 160 mg Megestrol Acetate tablet per day.
Tablets should be swallowed with a glass of water.
This medicine is not recommended for children.
Megestrol Acetate tablets should be taken for at least two months to see if they are effective. Some patients
take them for many years.
Do not stop taking them, unless advised to do so by your doctor.
If you take more Megestrol Acetate tablets than you should
If you take more Megestrol Acetate tablets than you should, go to your nearest hospital emergency department
or contact your doctor immediately.
Take the empty container and any remaining medicine with you.
If you forget to take Megestrol Acetate tablets
If you miss a dose, do not worry. If you remember within a few hours of the missed dose take it as soon as
possible, but if it is almost time for your next dose then skip the forgotten one and continue as before. Do not
take a double dose to make up for the one you missed.
4. Possible side effects
As with all medicines, Megestrol Acetate tablets can cause side effects although not everybody gets them.
If you notice any of the following, stop taking Megestrol Acetate tablets and contact your doctor immediately:
- swelling of the face, lips, or tongue
- skin rash
- difficulty breathing
As these may be signs of an allergic reaction.

Other side effects which may occur with Megestrol Acetate tablets are:
Very Common (affects more than 1 in 10 people)
- increase in appetite and weight gain (not associated with water retention)
- shortness of breath
- hot flushes, reddening of the face and neck
- high blood pressure
- increased blood sugar levels
- rounded face, sometimes called ‘moon’ face
- constipation
- swelling of a vein due to a blood clot
- blood clot in the lungs
Signs of a blood clot can include loss of co-ordination, slurred speech, pains in your groin, pains or numbness in
your arm or leg (especially in calf of leg), shortness of breath, weakness, headache, and fainting. If you
experience any of these signs tell your doctor immediately.
Common (affects between 1 in 10 to 1 in 100 people)
- temporary increase in the signs and symptoms of your disease
- changes in mood
- numbness, pain or tingling in fingers or thumb
- heart attack
- hair loss
- diarrhoea
- tiredness
- feeling weak
- impotence
- passing wind
- needing to urinate more often
- feeling sick and being sick
- changes in vaginal bleeding (breakthrough bleeding, spotting)
- build up of fluid which causes swelling (mainly in the ankles)
- pain
- rash, including hives or nettle rash (urticaria)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly (see contact details below). By reporting side effects
you can help provide more information on the safety of this medicine.
United Kingdom:
Website: www.mhra.gov.uk/yellowcard
5. How to store Megestrol Acetate tablets
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original package in order to protect from moisture. Protect from
temperatures above 40°C.
Megestrol Acetate tablets should not get too hot or damp; so do not leave your tablets near a radiator, on a
window sill or in the bathroom.
Please check the expiry date of the product, shown on the carton and blister of Megestrol Acetate tablets. The
expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help protect the environment.
If your medicine becomes discoloured, or shows any signs of deterioration, consult your pharmacist who will tell
you what to do.
6. Contents of the pack and other information
What Megestrol Acetate tablets contain
Each tablet contains 160 mg of megestrol acetate.
The other ingredients are: magnesium stearate, colloidal silicon dioxide, lactose monohydrate, microcrystalline
cellulose, sodium starch glycolate, povidone and purified water.
What Megestrol Acetate tablets look like and contents of the pack
Megestrol Acetate tablets are white, oval shaped biconvex tablets scored on one side and engraved with “160”
on the other side.
Megestrol Acetate tablets are available in blister packs of 30 tablets.
PL: 15814/1311

POM

Manufactured by AndersonBrecon (UK) Limited, Hereford, U.K.
Procured from within the EU and repackaged by the Product Licence holder: O.P.D. Laboratories Ltd., Unit 6
Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 25.01.2017.

To request a copy of this in Braille, large print or audio
please call 01923 332 796.

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide