PATIENT INFORMATION LEAFLET

MEGACE™ TABLETS
Megestrol Acetate BP

Your doctor has prescribed Megace Tablets for you.  This leaflet gives a summary of information about your medicine.  If you want to know more, or are not sure about anything, ask your doctor or pharmacist.

REMEMBER
This medicine is for you.  Only a doctor can prescribe it for you.  NEVER give this medicine to anyone else, even if they have the same symptoms as you, as it may harm them.

Q.	WHAT IS IN MEGACE TABLETS
A.	The active ingredient in Megace is called megestrol acetate.  Megace tablets are available in two strengths – 40 mg and 160 mg.
	Megace 40 mg tablets contain 40 mg megestrol acetate, acacia, calcium hydrogen phosphate; lactose; magnesium stearate; maize starch; silicon dioxide.  These are available in blister packs of 100 tablets.
	Megace 160 mg tablets contain 160 mg megestrol acetate, colloidal silicon dioxide, lactose monohydrate magnesium stearate; microcrystalline cellulose, povidone; sodium starch glycollate.  These are available in blister packs of 30 tablets.
	Megace belongs to group of medicines called "progestogens” and is related to the naturally occurring hormone called progesterone.

Q.	WHO SUPPLIES MEGACE TABLETS?
A	PL HOLDER
Bristol-Myers Squibb Holdings Ltd
Hounslow
Middlesex, TW3 3JA United Kingdom	PA HOLDER
Bristol-Myers Squibb Holdings Ltd
Dublin 
Republic of Ireland	
	PL NUMBERS	40 mg	0125/0144	PA NUMBERS	40 mg	48/27/1	
		160 mg	0125/0173		160 mg	48/27/2	
	MANUFACTURER
Bristol-Myers Squibb GmbH
Regensburg
Germany		

Q.	WHAT IS THIS MEDICINE FOR?
A. 	Megace may be used to treat certain types of cancer known as 'hormone-dependent' cancer, examples of this include cancer of the breast or womb.

BEFORE TAKING YOUR MEDICINE
Q.	SHOULD YOU BE TAKING MEGACE TABLETS?
A.	If you answer 'YES' to any of the following questions, DO NOT take Megace Tablets. Go back to your doctor as soon as possible to discuss your concerns and follow the advice given.
1.	Have you had an allergic reaction to similar tablets or any of the ingredients in MEGACE TABLETS?
2.	Are you pregnant, planning to become pregnancy or breast feeding?
3.	Do you have a medical history of blood clots (thrombophlebitis).

Q	CAN YOU TAKE OTHER MEDICINES?
A.	You can take other medicines whilst taking Megace but you should always discuss all the medicines you are taking with your doctor or pharmacist.  These include medicines bought at a pharmacy or elsewhere, e.g. supermarket.

Q.	IS IT ALL RIGHT TO DRINK ALCOHOL?
A.	There is no interaction between Megace tablets and moderate amounts of alcohol.  However, check with your doctor whether alcohol is advisable for you.

Q.	IS IT ALL RIGHT TO DRIVE?
A.	Megace tablets do not usually affect your ability to drive.

Q.	WILL MEGACE AFFECT MY BLOOD SUGAR IF I AM DIABETIC?
A.	Megace tablets may raise your blood sugar.  If you notice that your blood sugar is higher than normal consult your doctor.

TAKING YOUR MEDICINE
Q.	HOW SHOULD YOU TAKE MEGACE TABLETS?
A.	For treatment of breast cancer the usual dosage is 160 mg megestrol acetate per day.  For treatment of the womb lining (endometrium) the dose usually ranges between 40 and 320 mg per day.
Always follow your doctor's instructions.  The label will tell you how many tablets and how often your doctor wants you to take the medicine.  Tablets should be swallowed with a glass of water

Q.	SHOULD YOU TAKE THE TABLETS BEFORE OR AFTER MEALS?
A.	It does not matter.

Q.	HOW LONG SHOULD YOU TAKE THE TABLETS FOR?
A.	It usually takes two months of continuous treatment to see if Megace is effective. Continue with Megace tablets until your doctor tells you otherwise.  Some patients take Megace for many years.

Q	WHAT IF YOU TAKE TOO MANY TABLETS OR A CHILD SWALLOWS SOME?
A.	Go to your nearest hospital Casualty Department or tell your doctor immediately.  Take the empty container and any remaining medicine with you.

Q.	WHAT IF YOU MISS OR FORGET TO TAKE A DOSE?
A.	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 double doses to make up for the one you missed.

UNDESIRABLE EFFECTS
Q.	ARE THERE ANY UNWANTED EFFECTS OF MEGACE TABLETS
A.	All medicines have side effects.  The following side effects may be caused by blood clots.  These occur rarely, but if you experience any of the following tell your doctor straight away:
Loss of co-ordination (sudden)
slurred speech (sudden)
pains in your arms, groin or leg (especially in calf of leg)
shortness of breath (sudden)
weakness numbness or pain in arm or leg
headache (severe or sudden)
fainting

The following side effects have been seen:
changes in appetite, changes in weight, water retention (swelling of ankles and feet), nausea, vomiting, changes in vaginal bleeding (breakthrough bleeding, spotting).

Less common side effects are shortness of breath, hot flushes, changes in mood, raised blood pressure, raised blood sugar, reddening of the face and neck, increased facial and body hair, urticaria (hives or nettle rash), loss of scalp hair, pain or numbness in fingers.  In some cases, blood clots may be fatal.
There may also be a temporary increase in the signs and symptoms of your disease.  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.

LOOKING AFTER YOUR MEDICINE
You will see an 'EXPIRY DATE' on the outer packaging of Megace Tablets.  Do not use after this date.  Keep all your medicines where children cannot reach them, preferably in a locked cupboard or medicine cabinet.
Keep Megace Tablets below 25°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 doctor decides to stop the tablets, ask you; pharmacist to tell you what to do with any you have left.

DATE OF LAST REVISION
January 1996