EXEMESTANE TEVA-RATIOPHARM 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Exemestane Teva-ratiopharm 25 mg film-coated tablets EFG

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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Exemestane Teva-ratiopharm and what is it used for
2. What you need to know before you take Exemestane Teva-ratiopharm
3. How to take Exemestane Teva-ratiopharm
4. Possible side effects
5. Storage of Exemestane Teva-ratiopharm
6. Contents of the pack and other information

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

This medicine is called Exemestane Teva-ratiopharm. Exemestane Teva-ratiopharm belongs to a group of medicines called aromatase inhibitors. These medicines interfere with a substance called aromatase, which is needed to produce female sex hormones, estrogens, especially in postmenopausal women. The reduction of estrogen levels in the body is a way to treat hormone-dependent breast cancer.

Exemestane Teva-ratiopharm 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 medicine tamoxifen.

In addition, Exemestane Teva-ratiopharm is used to treat advanced hormone-dependent breast cancer in postmenopausal women when other hormonal treatment has not been effective enough.

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

Do not take Exemestane Teva-ratiopharm

• if you are allergic to exemestane or any of the other ingredients of this medicine (listed in section 6).
• if you have not yet reached menopause, i.e., if you still have your period,
• if you are pregnant, think you may be pregnant, or are breast-feeding.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Exemestane Teva-ratiopharm

• Before starting treatment with Exemestane Teva-ratiopharm, your doctor may perform a blood test to make sure you have reached menopause.
• Before treatment with Exemestane Teva-ratiopharm, your doctor may perform 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 Exemestane Teva-ratiopharm, tell your doctor if you have any liver or kidney problems.
• Tell your doctor if you have a history of or suffer from any disease that affects the strength of your bones. Your doctor may measure your bone density before and during treatment with Exemestane Teva-ratiopharm. This is because medicines in this group reduce female hormone levels, which can lead to a loss of bone mineral content and may decrease bone strength.

Children and adolescents

The use of this medicine is not recommended in children and adolescents.

Other medicines and Exemestane Teva-ratiopharm

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

• rifampicin (an antibiotic),
• carbamazepine or phenytoin (antiepileptics used to treat epilepsy),
• the herbal medicine St. John's Wort (Hypericum perforatum), or preparations that contain it.

Pregnancy and breast-feeding

Do not take Exemestane Teva-ratiopharm if you are pregnant or breast-feeding.

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

Talk to your doctor about contraceptive measures if there is a possibility of becoming pregnant.

Driving and using machines

If you feel dizzy, drowsy, or tired while being treated with Exemestane Teva-ratiopharm, do not drive or operate machinery.

Exemestane Teva-ratiopharm contains sodium

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

3. How to take Exemestane Teva-ratiopharm

Follow exactly the instructions of your doctor or pharmacist. If you are in doubt, ask your doctor or pharmacist.

Adults and elderly

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

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

The recommended dose is one 25 mg tablet per day.

If you need to go to the hospital while being treated with Exemestane Teva-ratiopharm, inform the medical staff about the medication you are taking.

If you take more Exemestane Teva-ratiopharm than you should

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

If you forget to take Exemestane Teva-ratiopharm

Do not take a double dose to make up for the forgotten tablet.

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

If you stop taking Exemestane Teva-ratiopharm

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

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Hypersensitivity, liver inflammation (hepatitis), and inflammation of the bile ducts in the liver that cause yellowing of the skin (cholestatic hepatitis) may occur. The symptoms include general feeling of being unwell, nausea, yellowing of the skin and eyes (jaundice), itching, abdominal pain on the right side, and loss of appetite. Contact your doctor immediately to seek urgent medical help if you think you have any of these symptoms.

In general, Exemestane Teva-ratiopharm is well tolerated, and the following side effects observed in patients treated with Exemestane Teva-ratiopharm are mainly mild or moderate in nature. Most side effects are associated with the reduction of estrogens (such as hot flashes).

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

• Depression
• Difficulty sleeping
• Headache
• Hot flashes
• Dizziness
• Feeling unwell
• Increased sweating
• Muscle and joint pain (including osteoarthritis, back pain, arthritis, and joint stiffness)
• Fatigue
• Decreased white blood cell count
• Abdominal pain
• High levels of liver enzymes
• High levels of hemoglobin breakdown in the blood
• High levels of liver enzymes due to liver damage
• Pain

Common (affecting up to 1 in 10 people):

• Loss of appetite
• Carpal tunnel syndrome (a combination of tingling, numbness, and pain that affects the entire hand except the little finger), or tingling, skin itching.
• Nausea (feeling unwell), vomiting, constipation, indigestion, diarrhea
• Skin rash, hives, and itching
• Decreased bone density that may decrease bone strength (osteoporosis) and cause fractures in some cases (breaks or cracks)
• Swelling of hands and feet
• Decreased platelet count in the blood
• Feeling weak

Uncommon (affecting up to 1 in 100 people):

• Hypersensitivity

Rare (affecting up to 1 in 1,000 people):

• Painful rash with small blisters in an area of the skin.
• Drowsiness
• Liver inflammation
• Inflammation of the bile ducts in the liver that cause yellowing of the skin.

Not known (cannot be estimated from the available data):

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

Changes in the number of certain blood cells (lymphocytes) and platelets (cells that produce blood clotting) that circulate in the blood, especially in patients with pre-existing lymphopenia (decreased lymphocytes in the blood), may also be seen.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Exemestane Teva-ratiopharm

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

Do not use this medicine after the expiry date which is stated on the packaging and blister after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

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 protect the environment.

6. Contents of the pack and other information

Composition of Exemestane Teva-ratiopharm

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

The other ingredients are:

Core of the tablet:

Mannitol (E-421), Copovidone, Crospovidone, Microcrystalline cellulose silicate (containing microcrystalline cellulose and colloidal anhydrous silica), Sodium starch glycolate (Type A), Magnesium stearate.

Coating:

Hypromellose, Macrogol 400, Titanium dioxide (E171)

Appearance and packaging

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

Exemestane Teva-ratiopharm is available in pack sizes of:

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

Not all pack sizes may be marketed.

Marketing authorisation holderTeva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B

1º Planta, Alcobendas

28108 Madrid

Manufacturer

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 medicine is authorised in the Member States of the European Economic Area under the following names:

AT: Exemestan Teva 25 mg Filmtabletten

BE: Exemestane Teva 25 mg filmomhulde tabletten

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

CY: Exemestane Teva 25mg Επικαλυμ?να με λεπτ? υμ?νιο δισκ?α

CZ: Exemestan Teva 25mg

DE: Exemestan Teva 25 mg Filmtabletten

DK: Exemestane TEVA

EE: Exemestane Teva 25mg

EL: Exemestane / Teva 25mg Επικαλυμ?να με λεπτ? υμ?νιο δισκ?α

ES: Exemestano Teva-ratiopharm 25mg film-coated tablets 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

Date of last revision of this leaflet:April 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es