Medine.co.uk

Out of date information, search another

Exemestane 25mg Film Coated Tablets

Out of date information, search another
Document: document 6 change

PACKAGE LEAFLET: INFORMATION FOR THE USER

Exemestane 25 mg film-coated tablets

Exemestane


Read all of this leaflet carefully before you start taking this medicine.

•    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. Do ■ not pass it on to others. It may harm them, even if theirsymptoms are the same as yours.

: • If any of the side effects gets serious, or if you 1 notice any side effects not listed in this leaflet, please tell yourdoctororpharmacist.

In this leaflet:

1.    What Exemestane is and what it is used for

2.    Before you take Exemestane

3.    How to take Exemestane

4.    Possible side effects

5.    Howto store Exemestane

6.    Further information


1. WHAT EXEMESTANE IS AND WHAT IT IS USED FOR


Your medicine is called Exemestane. Exemestane belongs to a group of medicines known as aromatase inhibitors. These drugs interfere with a substance called aromatase, which is needed to make the female sex hormone, oestrogen, especially in postmenopausal women. Reducing oestrogen levels in the body is a way of treating hormone-dependent breast cancer.

Exemestane 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.

It is also used to treat hormone-dependent advanced breast cancer in postmenopausal women when a different hormonal drug treatment has not worked well enough.


•    If you have a history or are suffering from any condition which affects the strength of your bones. This is because drugs 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. You may have to undergo tests to measure your bone density before and during treatment. Your doctor can give you medicine to prevent or treat the bone loss.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Exemestane should not be given at the same time as hormone replacement therapy (HRT). The following medicines should be used cautiously when taking Exemestane. Let your doctor know if you are taking medicines such as:

•    rifampicin (an antibiotic),

•    carbamazepine or phenytoin (anti-convulsants used to treat epilepsy),

•    the herbal remedy St John's wort (Hypericum perforatum), or preparations containing it.

Pregnancy and breast-feeding

Do not take Exemestane 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 Exemestane, you should not attempt to drive or operate machinery.


3. HOWTOTAKE EXEMESTANE


2. BEFORE YOU TAKE EXEMESTANE


Do not take Exemestane

•    if you are or have previously been allergic (hypersensitive) to exemestane (the active ingredient in Exemestane or any of the other ingredients of Exemestane (Please see section 6).

•    if you have not already been through 'the menopause1, i.e. you are still having your monthly period,

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

Take special care with Exemestane

•    Before treatment with Exemestane, your doctor may want to take blood samples to make sure you have reached the menopause.

•    Before taking Exemestane, tell your doctor if you have problems with your liver or kidneys.


Always take Exemestane exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure. Your doctor will tell you how to take Exemestane and for how long.

Adults and the elderly

The usual dose is one 25 mg film-coated tablet daily. Exemestane film-coated tablets should be taken by; mouth after a meal at approximately the same time: each day.    1

Children and adolescents

Exemestane is not suitable for use in children and adolescents.

If you take more Exemestane 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 Exemestane film-coated tablets.


If you forget to take Exemestane

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

If you forget to take your film-coated 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 Exemestane

Do not stop taking your film-coated tablets even if you are feeling well, unless your doctor tells you.


If any side effects gets serious or if you notice any side effect not listed on this leaflet, please tell your doctor or your pharmacist as soon as possible.


5. HOW TO STORE EXEMESTANE


4. POSSIBLE SIDE EFFECTS


Like all medicines, Exemestane can cause side effects, although not everybody gets them. In general, Exemestane is well tolerated and the following side effects observed in patients treated with Exemestane are mainly mild or moderate in nature. Most of the side effects are associated with a shortage of oestrogen (e.g. hotflushes).

Very common side effects, (ocurring in more than 1 in 10 people):

•    Difficulty sleeping

•    Headache

•    Hotflushes

•    Feeling sick

•    Increased sweating

•    Muscle and joint pain (including osteoarthritis, back pain, arthritis and joint stiffness)

•    Tiredness

Common side effects, (occuring in more than 1 in 100 but less than 1 in 10 people):

•    Loss of appetite

•    Depression

•    Dizziness, carpal tunnel syndrome (a combinations of pins and needles, numbness and pain affecting all of the hand except the little finger)

•    Stomach ache, vomiting (being sick), constipation, indigestion, diarrhoea

•    Skin rash, hair loss

•    Thinning of bones which might decrease their strength (osteoporosis), leading to bone fractures (breaks or cracks) in some cases

•    Pain, swollen hands and feet

Uncommon side effects,(occurring in more than 1 in 1000 but less than 1 in 100 people) :

•    Drowsiness

•    Muscle weakness

Inflammation of the liver (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 if you think you have any of these symptoms.

If you have any blood tests done, it may be noticed that there are changes in your liver function. Changes in the amount of certain blood cells (lymphocytes) and platelets (blood cells which cause clotting) circulating in your blood may occur, especially in patients with a pre-existing lymphopenia (reduced lymphocytes in the blood).


Keep out of the reach and sight of children.

Do not use Exemestane after the expiry date which is stated on the carton after <EXP>.

The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.


6. FURTHER INFORMATION


What Exemestane contains

The active substance is exemestane. Each film coated tablet contains 25 mg exemestane.

The other ingredients are:

Tablet core:

Mannitol, Copovidone, Crospovidone, Silicified Microcrystalline Cellulose, Sodium Starch Glycolate (Type A), Magnesium Stearate

Film coating:

Hypromellose, Macrogol400,Titanium Dioxide.

What Exemestane looks like and contents of the pack

White to off-white, round compound cup tablet, with “25” on one side and plain on the reverse.

Exemestane is available in blister packs of:

10, 14,20, 30, 60, 90 and 100 (Blistersof 10or 14) film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder

Morningside Healthcare Ltd.

115 Narborough Road,

Leicester, LE3 0PA, UK

Manufacturer

EirGen Pharma Ltd.

Westside Business Park, Old Kilmeaden Road, Waterford, Ireland


and

Siegfried Generics (Malta) Ltd

HHF070 Hal Far Industrial Estate, Hal Far

BBG3000, Malta

This leaflet was last approved in 09/2010.