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MEGACE 160 MG TABLETS

Active substance: MEGESTROL ACETATE

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MEGACE® 160 mg Tablets
(megestrol acetate)

T04441

The name of your medicine is Megace 160 mg tablets, but will be referred to as
Megace tablets throughout the leaflet.
Patient Information Leaflet
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.
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
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. 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.
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.
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.
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.
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.
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.
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 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:

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- 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 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.
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 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 out of the sight and reach of children.
If you are told to stop taking this medicine, return any unused tablets to your
pharmacist.
6. Further Information
What Megace tablets contain
Each Megace tablet contains 160 mg of the active ingredient megestrol acetate.
The other ingredients are: microcrystalline cellulose, lactose monohydrate,
magnesium stearate, povidone, colloidal anhydrous silica, and sodium starch
glycolate.
What Megace tablets look like and contents of the pack
Megace 160 mg tablets are white, oval shaped, biconvex tablets, scored on one
side and engraved with “160” on the other side. They available in blister packs of 30
tablets.
Manufacturer and Product Licence Holder:
This product is manufactured by Brecon Pharmaceuticals Ltd, England.
It is procured from within the EU by the Product Licence Holder: Swinghope Ltd,
Brandon House, Marlowe Way, Croydon CR0 4XS and repackaged by Interport Ltd,
Brandon House, Marlowe Way, Croydon CR0 4XS.
POM
PL No: 10380/1549

Megace 160 mg tablets.

Leaflet revision date: 07/11/2013
MEGACE® is a registered trademark of Bristol-Myers Squibb Company, USA.

T04441

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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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