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Megace 160 Mg Tablets

Document: leaflet MAH BRAND_PLPI 20774-1342 change

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 the remainder of the 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

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 progestagens 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).

Warning 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

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. Howto 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.

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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 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 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.qov.uk/vellowcard.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Megace tablets

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. Contents of the pack and other 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: ANDERSONBRECON (UK) LIMITED, HEREFORD, U.K. 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


Date of preparation 6th August 2015

Megace is a registered trademark of Bristol-Myers Squibb Company.

PP4/1342/V2