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DELTAEXTANE 25 MG COATED TABLETS

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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.
2.
3.
4.
5.
6.

1.

What DELTAEXTANE is and what it is used for
Before you take DELTAEXTANE
How to take DELTAEXTANE
Possible side effects
How to store DELTAEXTANE
Further information

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.

Deltaextane - PIL EN

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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).

Deltaextane - PIL EN

Duration of treatment
Your doctor will tell you how long you should take DELTAEXTANE tablets.
If you take more DELTAEXTANE than you should
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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:
Very common:
Common:
Uncommon:
Rare:
Very rare:
Not known:

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

Deltaextane - PIL EN

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

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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

Deltaextane - PIL EN

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Helm Pharmaceuticals GmbH
Nordkanalstrasse 28
20097
Hamburg
Germany
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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

Deltaextane - PIL EN

This leaflet was last approved in 01/2011.

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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