Aromasin 25 mg coated tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Exemestane
Available from:
IMED Healthcare Ltd.
ATC code:
L02BG; L02BG06
INN (International Name):
Exemestane
Dosage:
25 milligram(s)
Pharmaceutical form:
Coated tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Aromatase inhibitors; exemestane
Authorization status:
Authorised
Authorization number:
PPA1463/069/001
Authorization date:
2012-08-31

Package leaflet: Information for the user

Aromasin 25 mg coated tablets

exemestane

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 or pharmacist.

This includes any possible side effects not listed in this leaflet.

See section 4.

What is in this leaflet

1. What Aromasin is and what it is used for

2. What you need to know before you take Aromasin

3. How to take Aromasin

4. Possible side effects

5. How to store Aromasin

6. Contents of the pack and other information

1.

What Aromasin is and what it is used for

Your medicine is called Aromasin. Aromasin belongs to a group of

medicines known as aromatase inhibitors. These medicines interfere

with a substance called aromatase, which is needed to make the

female sex hormones, oestrogens, especially in postmenopausal

women. Reduction in oestrogen levels in the body is a way of

treating hormone dependent breast cancer.

Aromasin is used to treat hormone dependent early breast cancer in

postmenopausal women after they have completed 2-3 years of

treatment with the medicine tamoxifen.

Aromasin is also used to treat hormone dependent advanced breast

cancer in postmenopausal women when a different hormonal drug

treatment has not worked well enough.

2.

What you need to know before you take Aromasin

Do not take Aromasin:

if you are or have previously been allergic to exemestane (the

active ingredient in Aromasin) or any of the other ingredients of

this medicine (listed in section 6).

if you have not already been through ‘the menopause’, i.e. you

are still having your monthly period.

if you are pregnant, likely to be pregnant or breast-feeding.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Aromasin.

Before treatment with Aromasin, your doctor may want to take

blood samples to make sure you have reached the menopause.

Routine checking of your vitamin D level will also be made

before treatment, as your level may be very low in the early

stages of breast cancer. You will be given vitamin D supplement

if your levels are below normal.

Before taking Aromasin, tell your doctor if you have problems

with your liver or kidneys.

Tell your doctor if you have a history or are suffering from any

condition which affects the strength of your bones. Your doctor

may want to measure your bone density before and during the

treatment of Aromasin. This is because medicines of this class

lower the levels of female hormones and this may lead to a loss

of the mineral content of bones, which might decrease their

strength.

Other medicines and Aromasin

Tell your doctor or pharmacist if you are taking, have recently taken

or might take any other medicines, including medicines obtained

without a prescription.

Aromasin should not be given at the same time as hormone

replacement therapy (HRT).

The following medicines should be used cautiously when taking

Aromasin. Let your doctor know if you are taking medicines such as:

rifampicin (an antibiotic),

carbamazepine or phenytoin (anticonvulsants used to treat

epilepsy),

the herbal remedy St John's Wort (Hypericum perforatum), or

preparations containing it.

Pregnancy and breast-feeding

Do not take Aromasin if you are pregnant or breast- feeding.

If you are pregnant or think you might be, tell your doctor.

Discuss contraception with your doctor if there is any possibility that

you may become pregnant.

Driving and using machines

If you feel drowsy, dizzy or weak whilst taking Aromasin, you should

not attempt to drive or operate machinery.

Aromasin contains sucrose, sodium and methyl

parahydroxybenzoate

If you have been told that you have intolerance to some sugars,

contact your doctor before taking this medicinal product. This

medicine contains less than 1 mmol sodium (23 mg) per tablet,

that is to say essentially ‘sodium-free’.

Aromasin contains a small amount of methyl

parahydroxybenzoate, which may cause allergic reactions

(possibly delayed), if this should happen please contact your

doctor.

3.

How to take Aromasin

Adults and the elderly patients

Always take this medicine exactly as your doctor has told you.

Check with your doctor if you are not sure.

Aromasin tablets should be taken by mouth after a meal at

approximately the same time each day. Your doctor will tell you how

to take Aromasin and for how long. The recommended dose is one

25 mg tablet daily.

If you need to go to the hospital whilst taking Aromasin, let the

medical staff know what medication you are taking.

Use in children

Aromasin is not suitable for use in children.

If you take more Aromasin than you should

If too many tablets are taken by accident, contact your doctor at

once or go straight to the nearest hospital casualty department.

Show them the pack of Aromasin tablets.

If you forget to take Aromasin

Do not take a double dose to make up for a forgotten tablet.

If you forget to take your tablet, take it as soon as you remember. If

it is nearly time for the next dose, take it at the usual time.

If you stop taking Aromasin

Do not stop taking your tablets even if you are feeling well, unless

your doctor tells you.

If you have any further questions on the use of this medicine, ask

your doctor, pharmacist or nurse.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although

not everybody gets them.

Hypersensitivity, inflammation of the liver (hepatitis) and

inflammation of the bile ducts of the liver which cause yellowing of

the skin (cholestatic hepatitis) may occur. Symptoms include feeling

generally unwell, nausea, jaundice (yellowing of the skin and eyes),

itching, right sided abdominal pain and loss of appetite. Contact your

doctor promptly to seek urgent medical advice if you think you have

any of these symptoms.

In general, Aromasin is well tolerated and the following side effects

observed in patients treated with Aromasin are mainly mild or

moderate in nature. Most of the side effects are associated with a

shortage of oestrogen (e.g. hot flushes)

Very common: may affect more than 1 in 10 people

Depression

Difficulty sleeping

Headache

Hot flushes

Dizziness

Feeling sick

Increased sweating

Muscle and joint pain (including osteoarthritis, back pain, arthritis

and joint stiffness)

Tiredness

A reduction in the number of white blood cells

Abdominal pain

Elevated level of liver enzymes

Elevated level of a haemoglobin breakdown in the blood

Elevated level of a blood enzyme in the blood due to liver

damage

Pain

Common: may affect up to 1 in 10 people

Loss of appetite

Carpal tunnel syndrome (a combination of pins and needles,

numbness and pain affecting all of the hand except the little

finger) or tingling/prickling of the skin

Vomiting (being sick), constipation, indigestion, diarrhoea

Hair loss

Skin rash, hives and itchiness

Thinning of bones which might decrease their strength

(osteoporosis), leading to bone fractures (breaks or cracks) in

some cases

Swollen hands and feet

A reduction in the number of platelets in the blood

Feeling of weakness

Uncommon: may affect up to 1 in 100 people

Hypersensitivity

Rare: may affect up to 1 in 1,000 people

A breakout of small blisters on an area of the skin in a rash

Drowsiness

Inflammation of the liver

Inflammation of the bile ducts of the liver which cause yellowing

of the skin

Not known: frequency cannot be estimated from the available

data

Low level of certain white blood cells in the blood

Changes in the amount of certain blood cells (lymphocytes) and

platelets circulating in your blood, especially in patients with a pre-

existing lymphopenia (reduced lymphocytes in the blood) may also

be seen.

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

By reporting side effects you can help provide more information on

the safety of this medicine.

5.

How to store Aromasin

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

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

the outer carton and the blister after ‘EXP’ or ‘SCAD’. The expiry

date refers to the last day of that month.

This medicine does not require any special storage conditions. Store

in the original package.

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.

6.

Contents of the pack and other information

What Aromasin contains

The active substance is exemestane. Each coated tablet contains

25 mg exemestane.

The other ingredients are silica colloidal hydrated, crospovidone,

hypromellose, magnesium stearate, mannitol, microcrystalline

cellulose, sodium starch glycolate (Type A), polysorbate, polyvinyl

alcohol, simeticone, macrogol, sucrose, magnesium carbonate light,

methyl parahydroxybenzoate (E218), cetyl esters wax, talc,

carnauba wax, ethyl alcohol, shellac, titanium oxide (E171) and iron

oxides (E172).

What Aromasin looks like and contents of the pack

Aromasin is a round, biconvex, off-white, coated tablet marked 7663

on one side.

Aromasin are in over-labelled cartons containing 30 tablets.

Parallel Product Authorisation Holder and Manufacturer

Parallel Product Authorisation Holder:

IMED Healthcare Ltd

Unit 625 Kilshane Avenue

Northwest Business Park

Ballycoolin

Dublin 15

Ireland

Manufacturer:

Pfizer Italia S.r.l

Località Marino del Tronto

63100 Ascoli Piceno (AP)

Italy.

Repackaged by:

Cast Healthcare Ltd

Unit E The Business Centre

5-7 Tobermore Road

Draperstown

Northern Ireland

BT45 7AG

IMED Healthcare Ltd

Unit 625 Kilshane Avenue

Northwest Business Park

Ballycoolin

Dublin 15

Ireland

This medicinal product is authorised in the Member States of the

EEA under the following names: Austria, Belgium, Denmark,

Finland, Germany, Greece, Iceland, Ireland, Italy, Luxemburg,

Netherlands, Portugal, Sweden, United Kingdom: Aromasin France:

Aromasine Spain: Aromasil

This leaflet was last revised in June 2019

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Aromasin 25 mg coated tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Substance: exemestane

Each coated tablet contains 25 mg exemestane.

Each tablet also contains sucrose and methyl parahydroxybenzoate (E218).

For a full list of Excipients, see section 6.1

3 PHARMACEUTICAL FORM

Coated tablet.

Product imported from Italy

Round, biconvex, off-white coated tablet marked 7663 on one side.

4 CLINICAL PARTICULARS

As per PA0822/111/001

5 PHARMACOLOGICAL PROPERTIES

As per PA0822/111/001

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Silica, colloidal hydrated

Crospovidone

Magnesium stearate

Mannitol

Microcrystalline cellulose

Sodium starch glycolate (type A)

Polysorbate

Hypromellose

Polyvinyl alcohol

Simeticone

Macrogol

Sucrose

Magnesium carbonate, light

Titanium dioxide (E171)

Methyl Parahydroxybenzoate (E218)

Cetyl esters wax

Talc

Carnauba wax

Ethyl alcohol

Shellac

Iron oxides (E172)

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6.2 Incompatibilities

Not applicable.

6.3 Shelf life

The shelf-life expiry date of this product is the date shown on the container and outer carton of the product on the

market in the country of origin.

6.4 Special precautions for storage

This medicinal product does not require any special temperature storage conditions.

Store in the original package.

6.5 Nature and contents of container

Blister strips of 15 tablets in an over-labelled outer carton.

Pack size: 30 tablets.

6.6 Special precautions for disposal and other handling

No special requirements.

7 PARALLEL PRODUCT AUTHORISATION HOLDER

IMED Healthcare Ltd.

New Road

Buncrana

Co. Donegal

Ireland

8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA1463/069/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 31st August 2012

10 DATE OF REVISION OF THE TEXT

August 2015

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