Megace 160 mg Tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Megestrol acetate

Dostępny od:

LTT Pharma Limited

Kod ATC:

L02AB; L02AB01

INN (International Nazwa):

Megestrol acetate

Dawkowanie:

160 milligram(s)

Forma farmaceutyczna:

Tablet

Typ recepty:

Product subject to prescription which may not be renewed (A)

Dziedzina terapeutyczna:

Progestogens; megestrol

Status autoryzacji:

Authorised

Data autoryzacji:

2017-01-20

Ulotka dla pacjenta

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.
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 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.
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
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Megace 160 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Megestrol Acetate 160 mg.
Excipient with known effect:
Each tablet contains Lactose Monohydrate.
_For the full list of excipients, see section 6.1_.
3 PHARMACEUTICAL FORM
Tablet
White, oval, biconvex tablets with a breakline scored on one side and
engraved ‘160’ on the other side.
_Product imported from Greece_
The break line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
As per PA1696/002/001
5 PHARMACOLOGICAL PROPERTIES
As per PA1696/002/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
microcrystalline cellulose,
lactose monohydrate,
magnesium stearate,
povidone,
colloidal anhydrous silica,
sodium starch glycolate.
Purified water.
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the blister and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
Store in the original package in order to protect from moisture.
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6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 30 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USE