Package leaflet: Information for the user (r)

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.    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 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

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.    What Megestrol tablets are and what they are used for

2.    What you need to know before you take Megestrol tablets

3.    How to take Megestrol tablets

4.    Possible side effects

5.    How to store Megestrol tablets

6.    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