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MEGESTROL ACETATE160MG TABLETS

Active substance(s): MEGESTROL ACETATE

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Package leaflet: Information for the user

Megace® 160mg tablets
(megestrol acetate)
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.
The name of your medicine is Megace 160mg tablets but will be referred to as Megace tablets throughout this leaflet.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Megace tablets are and what they are used for
What you need to know before you take Megace tablets
How to take Megace tablets
Possible side effects
How to store Megace tablets
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 you 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
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 160mg 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 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 can cause side effects although not everybody gets them.
If you notice any of the following, stop taking Megace 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more information on the safety of this medicine.
5.

How to store Megace tablets

Keep out of the sight and reach of children.
Do not take your tablets after the expiry date which is stated on the carton and blister label after ‘Exp’. The expiry date refers to the last day
of that month.
Do not store above 25°C. Store in the original pack in order to protect from moisture. To be protected from temperatures above 40°C.
They should not get too hot or damp; so do not leave your tablets near a radiator, on a window sill or in the bathroom.
If your tablets become discoloured or show any signs of deterioration, seek the advice of your pharmacist.
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.

6. Contents of the pack and other information
What Megace tablets contain
The active ingredient is megestrol acetate.
Each tablet contains 160mg megestrol acetate.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium starch glycollate, povidone, colloidal anhydrous silica
and magnesium stearate.
What Megace tablets look like and contents of the pack
Off-white, oval, biconvex tablets with a break line on one face and engraved '160' on the other face and are available in blister pack of 30
tablets.
Manufactured by: AndersonBrecon (UK) Limited, Hereford, UK.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
®

Megace 160mg tablets, PL No: 18799/2458
Leaflet date: 03.07.2015

POM

Package leaflet: Information for the user

Megestrol acetate 160mg tablets
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.
The name of your medicine is Megestrol acetate 160mg tablets, but will be referred to as Megestrol tablets throughout this leaflet.

What is in this leaflet:
1.
2.
3.
4.
5.
6.

What Megestrol tablets are and what they are used for
What you need to know before you take Megestrol tablets
How to take Megestrol tablets
Possible side effects
How to store Megestrol tablets
Contents of the pack and other information

1. What Megestrol tablets are and what they are used for
Megestrol 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 tablets
Do not take Megestrol 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 you doctor if you:
have severe liver problems
currently suffer from, or have a history of suffering from blood clots (thrombophlebitis)
have diabetes, as Megestrol 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 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 tablets if you are pregnant, think you may be pregnant, or if you are breast-feeding.
Driving and using machines
Megestrol tablets do not usually affect your ability to drive.
Megestrol tablets contains lactose
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 tablets
Always take Megestrol tablets exactly as your doctor has told you. You should check with your doctor if you are not sure.
The usual dosage is 160mg megestrol acetate per day.
Tablets should be swallowed with a glass of water.
This medicine is not recommended for children.
Megestrol 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 tablets than you should
If you take more Megestrol 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 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 can cause side effects although not everybody gets them.
If you notice any of the following, stop taking Megestrol 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 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more information on the safety of this medicine.
5.

How to store Megestrol tablets

Keep out of the sight and reach of children.
Do not take your tablets after the expiry date which is stated on the carton and blister label after ‘Exp’. The expiry date refers to the last day
of that month.
Do not store above 25°C. Store in the original package in order to protect from moisture. To be protected from temperatures above 40°C.
They should not get too hot or damp; so do not leave your tablets near a radiator, on a window sill or in the bathroom.
If your tablets become discoloured or show any signs of deterioration, seek the advice of your pharmacist.
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.

6. Contents of the pack and other information
What Megestrol tablets contain
Each tablet contains 160mg of the active ingredient megestrol acetate.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium starch glycollate, povidone, colloidal anhydrous silica
and magnesium stearate.
What Megestrol tablets look like and contents of the pack
Off-white, oval, biconvex tablets with a break line on one face and engraved '160' on the other face and are available in blister pack of 30
tablets.
Manufactured by: AndersonBrecon (UK) Limited, Hereford, UK.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Megestrol 160mg tablets, PL No: 18799/2458
Leaflet date: 03.07.2015

POM

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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.

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