MEGACE 160 MG TABLETS

Active substance: MEGESTROL ACETATE

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(leaflet continued)
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 coordination, 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 the following 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)
If any of these side effects continue or become
troublesome go back to your doctor.
If you notice any other side-effects tell your
doctor or pharmacist.
5. How to store your medicine
Do not store above 25°C. Store in the original
package in order to protect from moisture.
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.

6. Further information
What Megace Tablets contain
Each tablet contains Megestrol acetate 160mg.
The other ingredients are: colloidal anhydrous
silica, lactose monohydrate, magnesium
stearate, povidone, sodium starch glycolate
and microcrystalline cellulose.
What Megace Tablets look like and contents
of the pack
White, oval shaped tablet, one side marked
with a score line and the reverse marked with
160.
Your tablets are available in blister packs of 30
tablets.
Manufactured by: Brecon Pharmaceuticals Ltd,
England. Procured from within the EU.
Product Licence holder: Quadrant
Pharmaceuticals Ltd. Lynstock House,
Lynstock Way, Lostock, Bolton BL6 4SA
Repackaged by Maxearn Ltd, Bolton BL6 4SA.
PL 20774/1342

Megace 160mg Tablets

POM

PP1/1342/V2
Date of preparation 4th July 2013
Megace is a registered trademark of
Bristol-Myers Squibb Company.

Please check the expiry date of the product,
shown on the carton and blister of Megace
Tablets. Do not use after the month stated.
Keep your medicines out of the sight and
reach of children.
If the tablets show any signs of deterioration or
discolouration, consult your pharmacist for
advice. If damaged please tell your doctor or
pharmacist.
If you are told to stop taking this medicine,
return any unused tablets your pharmacist.

(leaflet continued overleaf)
Tell your doctor if you have:
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.
2. Before taking your medicine
Do not take Megace Tablets if you:
are allergic (hypersensitive) to megestrol
acetate or any of the other ingredients of
Megace Tablets.
1. What Megace Tablets are and what they
are used for
The name of your medicine is Megace Tablets.
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.
In this leaflet:
1. What Megace Tablets are and what they
are used for
2. Before taking your medicine
3. How to take your medicine
4. Possible side effects
5. How to store your medicine
6. Further information
Please read this leaflet carefully before you
start taking your medicine.
This leaflet provides a summary of the
information available on your medicine.
This medicine has been prescribed for
you. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours. If you want to know
more or are not sure ask your Doctor or
Pharmacist.
The name of your medicine is Megace 160mg
Tablets, but will be referred to as Megace
Tablets throughout the remainder of the leaflet.

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.
Do not stop taking them, unless advised to do
so by your doctor.
Megace Tablets should be taken for at least
two months to see if they are effective. Some
patients take them for many years.
Tablets should be swallowed with a glass of
water.
This medicine is not recommended for
children.
The usual dosage is 160mg megestrol acetate
per day
3. How to take your medicine
Always take Megace Tablets exactly as your
doctor has told you. You should check with
your doctor if you are not sure.
Important information about some of the
ingredients of Megace
Megace 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.
Driving and using machines
Megace Tablets do not usually affect your
ability to drive
Pregnancy and Breast-feeding
Do not take Megace Tablets if you are
pregnant, think you may be pregnant, or if you
are breast-feeding
Taking Megace Tablets with other
medicines
Always tell your doctor or pharmacist about
other medicines you may be taking or have
recently taken including those obtained without
a prescription.

Megace® 160mg Tablets
megestrol acetate
PACKAGE LEAFLET: INFORMATION FOR THE USER

PP1/1342/V2

(leaflet continued)
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 coordination, 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 the following 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)
If any of these side effects continue or become
troublesome go back to your doctor.
If you notice any other side-effects tell your
doctor or pharmacist.
5. How to store your medicine
Do not store above 25°C. Store in the original
package in order to protect from moisture.
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.
Please check the expiry date of the product,
shown on the carton and blister of Megace
Tablets. Do not use after the month stated.
Keep your medicines out of the sight and
reach of children.
If the tablets show any signs of deterioration or
discolouration, consult your pharmacist for
advice. If damaged please tell your doctor or
pharmacist.
If you are told to stop taking this medicine,
return any unused tablets your pharmacist.

6. Further information
What Megace Tablets contain
Each tablet contains Megestrol acetate 160mg.
The other ingredients are: colloidal anhydrous
silica, lactose monohydrate, magnesium
stearate, povidone, sodium starch glycolate
and microcrystalline cellulose.
What Megace Tablets look like and contents
of the pack
White, oval shaped tablet, one side marked
with a score line and the reverse marked with
160.
Your tablets are available in blister packs of 30
tablets.
Manufactured by: Brecon Pharmaceuticals Ltd,
England. Procured from within the EU.
Product Licence holder: Quadrant
Pharmaceuticals Ltd. Lynstock House,
Lynstock Way, Lostock, Bolton BL6 4SA
Repackaged by Maxearn Ltd, Bolton BL6 4SA.
PL 20774/1342

Megace 160mg Tablets

POM

PP1/1342/V2
Date of preparation 4th July 2013
Megace is a registered trademark of
Bristol-Myers Squibb Company.

(leaflet continued overleaf)
Tell your doctor if you have:
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.
2. Before taking your medicine
Do not take Megace Tablets if you:
are allergic (hypersensitive) to megestrol
acetate or any of the other ingredients of
Megace Tablets.
1. What Megace Tablets are and what they
are used for
The name of your medicine is Megace Tablets.
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.
3.
4.
5.
6.

In this leaflet:
1. What Megace Tablets are and what they
are used for
Before taking your medicine
How to take your medicine
Possible side effects
How to store your medicine
Further information
Please read this leaflet carefully before you
start taking your medicine.
This leaflet provides a summary of the
information available on your medicine.
This medicine has been prescribed for
you. Do not pass it on to others. It may
harm them, even if their symptoms are
the same as yours. If you want to know
more or are not sure ask your Doctor or
Pharmacist.
The name of your medicine is Megace 160mg
Tablets, but will be referred to as Megace
Tablets throughout the remainder of the leaflet.

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.
Do not stop taking them, unless advised to do
so by your doctor.
Megace Tablets should be taken for at least
two months to see if they are effective. Some
patients take them for many years.
Tablets should be swallowed with a glass of
water.
This medicine is not recommended for
children.
The usual dosage is 160mg megestrol acetate
per day
3. How to take your medicine
Always take Megace Tablets exactly as your
doctor has told you. You should check with
your doctor if you are not sure.
Important information about some of the
ingredients of Megace
Megace 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.
Driving and using machines
Megace Tablets do not usually affect your
ability to drive
Pregnancy and Breast-feeding
Do not take Megace Tablets if you are
pregnant, think you may be pregnant, or if you
are breast-feeding
Taking Megace Tablets with other
medicines
Always tell your doctor or pharmacist about
other medicines you may be taking or have
recently taken including those obtained without
a prescription.

Megace® 160mg Tablets
megestrol acetate
PACKAGE LEAFLET: INFORMATION FOR THE USER

PP1/1342/V2

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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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