Package Leaflet: Information for the User

Exemestane Teva 25 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. See section 4.

1. What Exemestane Teva is and what it is used for

2. What you need to know before you take Exemestane Teva

3. How to take Exemestane Teva

4. Possible side effects

5. Storage of Exemestane Teva

6. Contents of the pack and additional information

This medicine is called Exemestano Teva. Exemestano Teva belongs to a group of medicines called aromatase inhibitors. These medicines interfere with a substance called aromatase, necessary for producing female sex hormones, estrogens, especially in postmenopausal women. The reduction of estrogen levels in the body is a form of treatment for hormone-dependent breast cancer.

Exemestano Teva is used to treat hormone-dependent breast cancer in early stages in postmenopausal women after they have completed 2-3 years of treatment with the tamoxifen medicine.

In addition, Exemestano Teva is used to treat advanced hormone-dependent breast cancer in postmenopausal women when another hormonal treatment has not been sufficiently effective.

Do not take Exemestano Teva

• if you are allergic to exemestano or to any of the other ingredients of this medicine (listed in section 6).
• if you have not yet reached menopause, that is, if you still have your period,
• if you are pregnant, think you may be pregnant, or are breastfeeding.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take Exemestano Teva

• Before starting treatment with Exemestano Teva, your doctor may do a blood test to make sure you have reached menopause.
• Before starting treatment with Exemestano Teva, your doctor may do a test to measure your Vitamin D levels. This is because severe Vitamin D deficiency is common in women with early breast cancer. If you have low Vitamin D levels, your doctor will give you a supplement treatment.
• Before taking Exemestano Teva, tell your doctor if you have any liver or kidney problems.
• Inform your doctor if you have a history or are suffering from any disease that affects your bone resistance. Your doctor may measure your bone density before and during treatment with Exemestano Teva. This is because medicines in this group reduce female hormone levels, which can lead to a loss of bone mineral content, and may reduce your resistance.

Children and adolescents

This medicine is not recommended for use in children and adolescents.

Other medicines and Exemestano Teva

Inform your doctor or pharmacist if you are taking/using, have taken/used recently or may have to take/use any other medicine.

Exemestano Teva should not be administered at the same time as hormone replacement therapy (HRT). The following medicines should be used with caution if you are being treated with Exemestano Teva. Inform your doctor if you are taking any of these medicines:

• rifampicin (an antibiotic),
• carbamazepine or phenytoin (antiepileptic medicines used to treat epilepsy),
• St. John's Wort (Hypericum perforatum), or preparations containing it.

Pregnancy and breastfeeding

Do not take Exemestano Teva if you are pregnant or breastfeeding.

If you are pregnant or think you may be pregnant, consult your doctor.

Discuss contraceptive measures with your doctor if there is any possibility of becoming pregnant.

Driving and operating machinery

If you experience dizziness, drowsiness or fatigue while taking Exemestano Teva, do not drive or operate machinery.

Exemestano Teva contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet; this is, essentially “sodium-free”.

Follow exactly the administration instructions for this medication contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Adults and elderly people

Exemestane Teva film-coated tablets should be taken by mouth after a meal, approximately at the same time each day.

Your doctor will tell you how to take Exemestane Teva and the duration of treatment.

The recommended dose is one 25 mg tablet per day.

If you need to go to the hospital while taking Exemestane Teva, inform the medical staff about the medication you are taking.

If you take more Exemestane Teva than you should

If you accidentally take too many tablets, contact your doctor quickly or go directly to the nearest hospital emergency department or call the Toxicology Information Service, phone: 91 562 04 20 indicating the medication and the amount taken. Show them the Exemestane Teva packaging.

If you forget to take Exemestane Teva

Do not take a double dose to compensate for the missed tablet.

If you forget to take a tablet, take it as soon as you remember. If it is close to the time of the next dose, take it at the usual time.

If you interrupt treatment with Exemestane Teva

Do not interrupt treatment even if you do not feel well, unless your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Hypersensitivity, inflammation of the liver (hepatitis) and inflammation of the bile ducts of the liver that cause yellow discoloration of the skin (cholestasis) can occur. Symptoms include general feeling of discomfort, nausea, jaundice (yellow discoloration of the skin and eyes), itching, right-sided abdominal pain, and loss of appetite. Contact your doctor immediately to seek urgent medical help if you think you have any of these symptoms.

Generally, Exemestano Teva is well tolerated, and the following side effects observed in patients treated with Exemestano Teva are mainly mild or moderate in nature. Most side effects are associated with estrogen reduction (such as hot flashes).

Very common (affects more than 1 in 10 people):

• Depression
• Difficulty sleeping
• Headache
• Hot flashes
• Dizziness
• General feeling of discomfort
• Increased sweating
• Muscle and joint pain (including osteoarthritis, back pain, arthritis, and joint stiffness)
• Fatigue
• Reduced number of white blood cells
• Abdominal pain
• Elevated liver enzymes
• Elevated level of hemoglobin breakdown in blood
• Elevated level of blood enzymes due to liver damage
• Pain

Common(may affect up to 1 in 10 people):

• Loss of appetite
• Carpal tunnel syndrome (a combination of tingling, numbness, and pain affecting the entire hand except the little finger), or skin prickling.
• Vomiting (feeling of discomfort), constipation, indigestion, diarrhea
• Skin rash, urticaria, and itching
• Decreased bone density that may decrease bone resistance (osteoporosis) and cause fractures in some cases (breaks or cracking)
• Swelling of hands and feet
• Reduced number of platelets in the blood
• Feeling of weakness.

Uncommon(may affect up to 1 in 100 people):

• Hypersensitivity

Rare (may affect up to 1 in 1000 people)

• Painful rash with small vesicles in an area of the skin.
• Drowsiness
• Liver inflammation
• Inflammation of the bile ducts of the liver that causes yellow discoloration of the skin.

Unknown (cannot be estimated from available data)).

• Low level of certain white blood cells in the blood.

You may also see changes in the number of certain blood cells (lymphocytes) and platelets (cells that produce coagulation) circulating in the blood, especially in patients with pre-existing lymphopenia (reduced lymphocytes in the blood).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse even if it is a possible side effect that does not appear in this prospectus. You can also report them directly throughthrough the Spanish Medicines for Human Use Pharmacovigilance System Website:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and on the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Exemestane Teva

The active ingredient is exemestane. Each film-coated tablet contains 25 mg of exemestane.

The other components are:

Core tablet:

Manitol (E-421), Copovidona, Crospovidona, Silicated microcrystalline cellulose (containing microcrystalline cellulose and anhydrous colloidal silica), Sodium starch glycolate (Type A), Magnesium stearate.

Film coating::

Hydroxypropyl methylcellulose, Macrogol 400, Titanium dioxide (E171)

Appearance of the product and contents of the package

White to off-white, round, convex film-coated tablets, 6 mm in diameter, with “25”on one side and smooth on the other side.

Exemestane Teva is available in package sizes of:

10, 14, 20, 30, 50x1, 60, 90, 100 (blister packs of 10, 14 or 30) film-coated tablets.

Only some package sizes may be marketed.

Marketing Authorization HolderTeva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B

1st Floor, Alcobendas

28108 Madrid

Responsible for manufacturing

EirGen Pharma Ltd.

Westside Business Park, Old Kilmeaden Road, Waterford

Ireland

or

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

or

Teva Pharma B.V.,

Computerweg 10, 3542DR Utrecht

Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

AT:Exemestan Teva 25 mg Filmtablettenten

BE: Exemestane Teva 25 mg filmomhulde tabletten

BG: Alnair 25 mg?????????????????

CY:Exemestane Teva 25mgΕπικαλυμ?ναμελεπτ?υμ?νιοδισκ?α

CZ:Exemestan Teva 25mg

DE: Exemestan Teva 25 mg Filmtabletten

DK:Exemestane TEVA

EE:Exemestane Teva 25mg

EL:Exemestane / Teva 25mgΕπικαλυμ?ναμελεπτ?υμ?νιοδισκ?α

ES:Exemestano Teva 25mg comprimidos recubiertos con película EFG

FR: Exemestane Teva 25 mg, comprimé pelliculé

HU:Exemestan Teva 25 mg filmtabletta

IT:Exemestane Teva 25mg compresse rivestite

LT:Exemestane Teva

LU:Exemestane Teva 25 mg comprimés pelliculés

LV:Exemestane Teva 25 mg apvalkotas tabletes

NL:Exemestaan 25 mg Teva, filmomhulde tabletten

NO:Exemestane Teva 25mg filmdrasjerte tabletter

PL:Exemestane PharOS Generics

PT:Exemestano Teva

RO:Exemestan Teva 25 mg, comprimate filmate

SE: Exemestane Teva 25mg filmdragerade tabletter

SK: Exemestan Teva 25mg

UK: Exemestane 25mg Film-coated tablets

Last review date of this leaflet:abril 2020

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es