Megace 160 mg Tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Megestrol acetate
Available from:
LTT Pharma Limited
ATC code:
L02AB; L02AB01
INN (International Name):
Megestrol acetate
Dosage:
160 milligram(s)
Pharmaceutical form:
Tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Progestogens; megestrol
Authorization status:
Authorised
Authorization number:
PPA1562/194/001
Authorization date:
2017-01-20

Read the complete document

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 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.

What is in this leaflet:

What Megace tablets are and what they are used for

What you need to know before you take Megace tablets

s How to take Megace tablets

Possible side effects

How to store Megace tablets

Contents of the pack and other information

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.

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).

Warnings and precautions

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.

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.

®

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Ref:194/001/101116/1/F

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6

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(Megestrol acetate)

MEGACE 160 mg Tablets

4

Contents of the pack and other 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,

sodium starch and purified water

What Megace tablets look like and contents of the pack

Megestrol acetate tablets (160 mg) are white oval shaped biconvex tablets

scored on one side and engraved with “160” on the other side and are

available in blister packs of 30 tablets.

The Parallel Product Authorisation Holder is:

LTT Pharma Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,

Worcestershire, B98 0RE, UK.

Repackaged by:

Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,

Worcestershire, B98 0RE, UK.

The manufacturer is:

AndersonBrecon (UK) Ltd, Pharos House, Wye Valley Business Park

Hay-on-Wye, Hereford, HR3 5PG, UK

Megace is a

registered trademark of

VALEANT sp.z o.o sp. j.

Revision date: 10/11/16

PPA:1562/194/001

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone LTT Pharma Limited,

Tel: +44 (0)1527 505414

for help.

POM

PACKAGE LEAFLET: INFORMATION FOR THE USER (

Continued)

*

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 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 HPRA Pharmacovigilance,

Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971

Fax: +353 1 6762517 Website: www.hpra.ie

e-mail: medsafety@hpra.ie

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.

Do not use this medicine after the expiry date which is stated on the carton

and on the blister strip as EXP. The expiry date refers to the last day of that

month.

Keep this medicine out of the sight and reach of children.

Do not throw away any medicines via wastewater or household waste. Ask

your pharmacist how to throw away medicines you no longer use. These

measures will help protect the environment.

5

6

MEGACE 160 mg Tablets

®

Ref:194/001/101116/1/B

(Megestrol acetate)

Read the complete document

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 used medicinal product or waste materials derived from

such medicinal product and other handling of the product

No special requirements.

7 PARALLEL PRODUCT AUTHORISATION HOLDER

LTT Pharma Limited

Unit 18

Oxleasow Road

East Moons Moat

Redditch

Worcestershire

B98 0RE

United Kingdom

8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA1562/194/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 20

January 2017

10 DATE OF REVISION OF THE TEXT

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