I.1 Package Leaflet (PL)

PACKAGE LEAFLET: INFORMATION FOR THE USER Deltaextane 25 mg 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 their symptoms are the same as yours.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What DELTAEXTANE is and what it is used for

2.    Before you take DELTAEXTANE

3.    How to take DELTAEXTANE

4.    Possible side effects

5.    How to store DELTAEXTANE

6.    Further information

1.    WHAT DELTAEXTANE IS AND WHAT IT IS USED FOR

DELTAEXTANE belongs to a group of medicines known as aromatase inhibitors. Aromatase Inhibitors interfere with a substance called aromatase, which is needed to produce the female sex hormones, called oestrogens, especially in postmenopausal women. Reduction in oestrogen levels in the body is a way of treating hormone dependent breast cancer.

DELTAEXTANE 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

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

2.    BEFORE YOU TAKE DELTAEXTANE Do not take DELTAEXTANE

-    if you are allergic (hypersensitive) to exemestane or any of the other ingredients of Deltaextane (for further information, see section 6).

-    if you have not already been through ‘the menopause’, i.e. you are still having your monthly period,

-    if you are pregnant, or are likely to be pregnant

-    if you are breast-feeding.

Take special care with DELTAEXTANE

Before treatment with DELTAEXTANE, your doctor may want to take blood samples to make

sure you have reached the menopause.

if you have problems with your liver or kidneys.

if you have a history or are suffering from any condition which affects the strength of your bones (e.g. osteoprosis). Your doctor may want to measure your bone density before and during the treatment with DELTAEXTANE. 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. Your doctor may give you medicine to prevent or treat bone loss.

Please tell your doctor if one of these conditions applies to you.

Children and adolescents

DELTAEXTANE is not suitable for use in children and adolescents.

Anti-doping test

The active substance exemestane contained in this medication can produce a positive analytic result in an anti-doping test.

Taking other medicines

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

DELTAEXTANE should not be given at the same time as oestrogen-containing medicines, for example hormone replacement therapy (HRT).

The following medicines should be used cautiously when taking DELTAEXTANE:

-    rifampicin (an antibiotic),

-    carbamazepine or phenytoin (medicines used to treat epilepsy),

-    the herbal remedy St Johns Wort (Hypericum perforatum), or preparations containing it.

Taking DELTAEXTANE with food and drink

You should take DELTAEXTANE tablets after a meal.

Pregnancy and breast-feeding

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

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

You should discuss contraception with your doctor if there is any possibility that you may become pregnant.

Driving and using machines

If you feel tired, drowsy, dizzy or weak whilst taking DELTAEXTANE, you should not drive or operate machinery.

Important information about some of the ingredients of DELTAEXTANE

DELTAEXTANE tablets contain sucrose (sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE DELTAEXTANE

Always take DELTAEXTANE exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults and the elderlyThe usual dose is one tablet daily after a meal, at approximately the same time each day.

You should take DELTAEXTANE tablets by mouth. Do not chew the tablets. You can swallow the tablets with some liquid (e.g. a glass of water, 200ml).

Duration of treatment

Your doctor will tell you how long you should take DELTAEXTANE tablets.

If you take more DELTAEXTANE than you should

If you have taken too many tablets by accident, contact your doctor at once or go straight to the nearest hospital casualty department. Show them the pack of DELTAEXTANE tablets.

If you forget to take DELTAEXTANE

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 DELTAEXTANE

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 product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

The following side effects have been reported at the approximate frequencies shown:

more than 1 patient in 10 1 to 10 patients in 100 1 to 10 patients in 1.000 1 to 10 patients in 10.000 less than 1 patients in 10.000

frequency cannot be estimated from the available data

Very common

•    Decreased number of certain blood cells (lymphocytes) especially in patients with a pre-existing lymphopenia (reduced lymphocytes in the blood).

•    Headache

•    Nausea

•    Increased sweating

•    Muscle and joint pain (including inflammation of bones and joints, back pain, pain in limbs and joint stiffness)

•    Hot flushes

•    Tiredness

•    Difficulty sleeping

Common

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

•    Belly ache, vomiting, constipation, indigestion, diarrhoea

•    Skin rash, hair loss

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

•    Loss of appetite

•    Pain, swollen hands and feet

•    Depression

Uncommon

• Drowsiness • Weakness

Rare

• Decreased number of certain white blood cells (leucocytes) and platelets (especially in patients with advanced breast cancer)

Not known

•    Altered liver function tests (including increase of liver enzymes)

If any of the side effects gets serious, or if you notice any side effects not listed on this leaflet, please tell your doctor or your pharmacist.

5.    HOW TO STORE DELTAEXTANE

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

Store in the original container in order to protect from light

Keep out of the reach and sight of children.

Do not use DELTAEXTANE after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month.

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

- The active substance is exemestane. Each tablet contains 25 mg exemestane.

The other ingredients are microcrystalline cellulose, Crospovidone , polysorbate 80, mannitol (E421), colloidal anhydrous silica, magnesium stearate , sucrose, spray-dried acacia, purified talc, titanium dioxide (E171), Opaglos (Dehydrated ethanol, Shellac, Beeswax White, Carnauba Wax Yellow).

What DELTAEXTANE looks like and contents of the pack

DELTAEXTANE is a round, biconvex, white to off-white, coated tablet.

Pack sizes:

UK/H/2394/01/DC:

10, 15, 30, 90, 105, 100, 20, 120

UK/H/2395/01/DC:

10, 15, 30, 90, 105, 100, 20, 120

UK/H/2396/01/DC:

10, 15, 30, 90, 105, 100, 20, 120

UK/H/3947/01/DC:

10, 15, 30, 90, 105, 100, 20, 120, 60

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097

Hamburg

Germany

This medicinal product is authorised in the member states of the EEA under the following names:

UK/H/2394/01/DC

Austria, Finland, France, Germany, Greece, Italy, United Kingdom, The Netherlands, Portugal, Spain:

Deltaextane 25 mg

Ireland: Exemestane Helm 25 mg

UK/H/2395/01/DC

Germany, United Kingdom: Betaextane 25 mg UK/H/2396/01/DC

Italy, Spain, United Kingdom: Pienspeme 25 mg

Portugal: Piex 25 mg

UK/H/3947/01/DC

Belgium, Luxembourg, United Kingdom: Epextane 25 mg This leaflet was last approved in 01/2011.

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