EXEMESTANE 25 mg Film-Coated Tablets

Зміст інструкції

1. EXEMESTANE DOC Generici 25 mg film-coated tablets
   1. What is EXEMESTANE DOC GENERICI and what it is used for
   2. What you need to know before taking EXEMESTANE DOC Generici
   3. How to take EXEMESTANE DOC Generici
   4. Possible side effects
   5. How to store EXEMESTANE DOC Generici
   6. Contents of the pack and other information

EXEMESTANE DOC Generici 25 mg film-coated tablets

Generic medicine

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, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What EXEMESTANE DOC Generici is and what it is used for
• 2. What you need to know before you take EXEMESTANE DOC Generici
• 3. How to take EXEMESTANE DOC Generici
• 4. Possible side effects
• 5. How to store EXEMESTANE DOC Generici
• 6. Contents of the pack and other information

1. What is EXEMESTANE DOC GENERICI and what it is used for

Your medicine is called EXEMESTANE DOC Generici. EXEMESTANE DOC Generici belongs to
a group of medicines called aromatase inhibitors. These medicines interfere with a
substance called aromatase, which is necessary to produce the female hormone estrogen,
especially in postmenopausal women. Reducing estrogen levels in the body is a
way to treat hormone-dependent breast cancer.
EXEMESTANE DOC Generici is used to treat hormone-dependent breast cancer at an
early stage in postmenopausal women after they have completed 2-3 years of treatment with
tamoxifen.
It is also used to treat hormone-dependent breast cancer at an advanced stage in
postmenopausal women when a different hormonal treatment has not worked well enough.

2. What you need to know before taking EXEMESTANE DOC Generici

Do not take EXEMESTANEDOC Generici

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6)
• if youare not yet postmenopausal, i.e. you still have your menstrual periods
• if you are pregnant, may become pregnant or are breastfeeding

Warnings and precautions
Talk to your doctor or pharmacist before taking EXEMESTANE DOC Generici
before treatment with EXEMESTANE DOC Generici your doctor may want to
perform blood tests to make sure you have reached menopause
before taking EXEMESTANE DOC Generici tell your doctor if you have problems with the
liver or kidneys
if you have suffered or are suffering from any condition concerning the density of your bones. This
is because medicines of this class reduce the levels of female hormones and this can lead to
loss of bone mineral content, which can reduce their density. You may need to
undergo bone density measurement before and during treatment. Your doctor may give you
a medicine or vitamin D supplements to prevent or treat bone loss.

If you play sports: the use of the medicine without therapeutic need constitutes doping and

may still result in a positive doping test.

Other medicines and EXEMESTANE DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
EXEMESTANE DOC Generici should not be given at the same time as hormone replacement therapy (HRT). The following medicines should be used with caution when taking
EXEMESTANE DOC Generici.
Tell your doctor 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, breastfeeding and fertility
Do not take EXEMESTANE DOC Generici if you are pregnant or if you are breastfeeding.
Tell your doctor if you are pregnant or think you might be.
If there is a possibility that you might become pregnant, decide with your doctor on a method of contraception.

Driving and operating machinery
If you feel sleepy, dizzy or weak while taking EXEMESTANE DOC Generici
you should avoid driving or operating machinery.

3. How to take EXEMESTANE DOC Generici

Take this medicine following exactly the instructions of your doctor. If you have any doubts,
consult your doctor or pharmacist. Your doctor will tell you how to take EXEMESTANE DOC Generici and for
how long.

Adults and the elderly
The usual dose is one film-coated tablet of 25 mg daily.
EXEMESTANE DOC Generici film-coated tablets should be taken by mouth after a
meal each day at approximately the same time.

Use in children and adolescents
EXEMESTANE DOC Generici is not recommended for use in children and adolescents.

If you take more EXEMESTANE DOC Generici than you should
If you accidentally take too many tablets, contact immediately or go to the nearest emergency room.
Show this box of EXEMESTANE DOC Generici film-coated tablets.

If you forget to take EXEMESTANE DOC Generici
If you forget to take the tablet at the scheduled time, take it as soon as you remember. If it is close
to the time of taking the next dose, take the next tablet at the usual time.
Do not take a double dose to make up for the forgotten dose.

If you stop taking EXEMESTANE DOC Generici
Do not stop taking the tablets even if you feel well, unless your doctor tells you to do so.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. In general, EXEMESTANE DOC Generici is well tolerated and the following side effects observed in patients treated with EXEMESTANE DOC Generici are mainly mild or moderate in nature. Most side effects are associated with estrogen deficiency (for example hot flushes).

Very common side effects (may affect more than 1 in 10 people)

• difficulty sleeping
• migraine
• hot flushes
• feeling unwell
• increased sweating
• muscle and joint pain (including osteoarthritis, back pain, arthritis and joint stiffness)

Common side effects (may affect up to 1 in 10 people)

• loss of appetite
• depression
• dizziness, carpal tunnel syndrome (a combination of pins and needles, numbness and pain affecting all fingers except the little finger)
• stomach pain, vomiting (feeling sick), constipation, indigestion, diarrhoea
• skin rash, hair loss
• abnormal liver tests
• thinning of the bones which can lead to reduced density (osteoporosis), which leads to fractures (breaks or cracks)
• pain, swollen hands and feet

Uncommon side effects (may affect up to 1 in 1,000 people)

• drowsiness
• muscle weakness
• leukopenia (decrease in the number of white blood cells)
• increased liver function parameters
• skin disorders (sudden eruption of pustules on the skin)
• hypersensitivity
• inflammation of the liver (hepatitis) can occur. Symptoms include a general feeling of being unwell, nausea, jaundice (yellowing of the skin and eyes), itching, pain in the right side of the abdomen and loss of appetite. Contact your doctor immediately if you think you have any of these symptoms.

If you have had some blood tests, you may notice that there are changes in kidney function. Changes in the amount of certain blood cells (lymphocytes) and platelets (blood cells that cause coagulation) circulating in the blood may occur, especially in patients with pre-existing lymphopenia (reduced lymphocytes in the blood).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store EXEMESTANE DOC Generici

This medicine does not require any particular storage conditions.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date indicated on the pack after “EXP”. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What EXEMESTANE DOC Generici contains
The active ingredient is exemestane.
Each film-coated tablet contains 25 mg of exemestane.
The other ingredients are:
Tablet core
Mannitol, copovidone, crospovidone, silicified microcrystalline cellulose, sodium starch glycolate
(Type A), magnesium stearate
Tablet coating:
Hypromellose, macrogol 400, titanium dioxide

Description of the appearance of EXEMESTANE DOC Generici and contents of the pack
White to off-white, round, biconvex tablet with “25” imprinted on one side and smooth on the other.
EXEMESTANE DOC Generici is available in packs of 30 or 100 film-coated tablets
(blisters of 10).

Marketing Authorisation Holder
DOC Generici S.r.l
Via Turati 40
20121 Milano
Italy

Manufacturers responsible for batch release
EirGen Pharma Ltd.
Westside Business Park, Old Kilmeaden Road, Waterford
Ireland
or
Siegfried Generics Ltd
HHF070 Hal Far Industrial Estate
BBG3000 Hal Far
Malta

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
United Kingdom: Exemestane 25 mg film-coated tablets
Spain: Exemestano Apotex 25 mg coated tablets EFG
Italy: EXEMESTANE DOC Generici 25 mg film-coated tablets

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