EXEMESTANE DOC GENERICI

PACKAGE LEAFLET: INFORMATION FOR THE USER

EXEMESTANE DOC Generici 25 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 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

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

Your medicine is called EXEMESTANE DOC GENERICS. EXEMESTANE DOC GENERICS belongs to
a group of medicines called aromatase inhibitors. These medicines interfere with a
substance called aromatase, which is needed to produce the female hormone estrogen,
particularly in postmenopausal women. Reducing estrogen levels in the body is a
way to treat hormone-dependent breast cancer.
EXEMESTANE DOC GENERICS is used to treat early-stage hormone-dependent breast cancer in
postmenopausal women after they have completed 2–3 years of treatment with tamoxifen.
It is also used to treat advanced hormone-dependent breast cancer in
postmenopausal women when a different hormonal treatment has not been sufficiently effective.

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

Do not take EXEMESTANE DOC Generics

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• if you have not yet reached menopause, i.e. you still have menstrual periods
• if you are pregnant, could become pregnant, or are breastfeeding

Warnings and precautions
Talk to your doctor or pharmacist before taking EXEMESTANE DOC Generics.
Before starting treatment with EXEMESTANE DOC Generics, your doctor may want to perform blood tests to confirm that you have reached menopause.
Before taking EXEMESTANE DOC Generics, tell your doctor if you have liver or kidney problems.
If you have had or currently have any condition related to bone density. This is because medicines of this class reduce levels of female hormones, which may lead to loss of bone mineral content and consequently reduce bone density. You may need to have your bone density measured before and during treatment. Your doctor may prescribe a medication or vitamin D supplements to prevent or treat bone loss.
If you are an athlete: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Other medicines and EXEMESTANE DOC Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
EXEMESTANE DOC Generics must not be taken together with hormone replacement therapy (HRT). The following medicines should be used with caution when taking EXEMESTANE DOC Generics.
Tell your doctor 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, breastfeeding and fertility
Do not take EXEMESTANE DOC Generics if you are pregnant or breastfeeding.
Tell your doctor if you are pregnant or think you might be pregnant.
If there is any possibility you could become pregnant, discuss with your doctor an appropriate contraceptive method.

Driving and using machines
If you experience drowsiness, dizziness or weakness while taking EXEMESTANE DOC Generics, you should avoid driving or operating machinery.

3. How to take EXEMESTANE DOC Generici

Take this medicine exactly as instructed by 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 elderly
The usual dose is one 25 mg film-coated tablet daily.
EXEMESTANE DOC Generici film-coated tablets should be taken orally after a
meal, every 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 your doctor immediately or go to the nearest emergency room.
Show this pack of EXEMESTANE DOC Generici film-coated tablets.
If you forget to take EXEMESTANE DOC Generici
If you forget to take your tablet at the scheduled time, take it as soon as you remember. If it is almost time for your next dose, take the next tablet at your 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.
If you have any questions about how to use 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 of the side effects are related to estrogen deficiency (for example, hot flushes).

Very common side effects (occur in 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 (occur in more than 1 in 100 but less than 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 of nausea), constipation, indigestion, diarrhoea
• skin redness, hair loss
• abnormal liver function tests
• thinning of the bones which may lead to reduced bone density (osteoporosis), resulting in fractures (breaks or cracks)
• pain, swollen hands and feet

Uncommon side effects (occur in more than 1 in 1,000 but less than 1 in 100 people)

• drowsiness
• muscle weakness
• leucopenia (decrease in the number of white blood cells)
• increased liver function parameters
• skin disorders (sudden outbreak of pustules on the skin)
• hypersensitivity
• liver inflammation (hepatitis) may occur. Symptoms include general feeling of malaise, 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 blood tests, you may notice abnormalities in kidney function. Changes in the levels of certain blood cells (lymphocytes) and platelets (blood cells involved in clotting) circulating in the blood may occur, especially in patients with pre-existing lymphopenia (low lymphocyte count in the blood).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 medicinal product does not require any special storage conditions.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information
What EXEMESTANE DOC Generici contains
The active substance is exemestane.
Each film-coated tablet contains 25 mg of exemestane.
The other components 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 film-coated tablet, engraved with "25" on one side and smooth on the other.
EXEMESTANE DOC Generici is available in packs containing 30 or 100 film-coated tablets (blister packs of 10).

Marketing Authorization 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 medicine is authorized in the Member States of the European Economic Area under the
following names:
United Kingdom: Exemestane 25 mg film-coated tablets
Spain: Exemestano Apotex 25 mg comprimidos recubiertos EFG
Italy: EXEMESTANE DOC Generici 25 mg compresse rivestite con film

This leaflet was last updated on