EXEMESTANO 25 mg Film-Coated Tablets

Contents of the leaflet

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

Introduction

Package Leaflet: Information for the User

Exemestane 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 or pharmacist.

-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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Exemestane ratiopharm and what is it used for
2. What you need to know before you take Exemestane ratiopharm
3. How to take Exemestane ratiopharm
4. Possible side effects
5. Storage of Exemestane ratiopharm

6 Contents of the pack and further information

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

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

Exemestane 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.

It is also 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 ratiopharm

Do not takeExemestane ratiopharm

• if you are or have been previously allergic to exemestane (the active ingredient of Exemestane ratiopharm) or to any of the other ingredients of this medicine (listed in section 6).
• if you have notyet reached menopause, i.e., if you still have your menstrual period,
• if you are pregnant, think you may be pregnant, or are breast-feeding.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Exemestane ratiopharm

• Before starting treatment with Exemestane ratiopharm, your doctor may perform a blood test to make sure you have reached menopause.
• Before taking Exemestane ratiopharm, tell your doctor if you have any liver or kidney problems.
• If you have a history of or suffer from any disease that affects bone strength. 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. You may need to undergo a bone density test before and during treatment. Your doctor may give you medicines to prevent or treat bone loss.

Taking Exemestane ratiopharm with other medicines

Tell your doctor if you are using or have recently used or may need to use any other medicines, including those obtained without a prescription.

Exemestane 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 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 containing it.

Pregnancy, breast-feeding, and fertility

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

Tell your doctor if you are pregnant or think you may be pregnant.

Talk to your doctor about contraceptive measures if there is any chance you may become pregnant.

Driving and using machines

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

3. How to take Exemestane ratiopharm

Follow exactly the administration instructions of this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again. Your doctor will tell you how to take Exemestane ratiopharm and for how long.

Adults and elderly

The normal dose is one 25 mg film-coated tablet per day.

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

Use in children and adolescents

Exemestane ratiopharm is not suitable for use in children and adolescents.

If you take more Exemestane 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 ratiopharm packaging.

If you forget to take Exemestane ratiopharm

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

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 ratiopharm

Do not stop 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Exemestane ratiopharm can cause side effects, although not everybody gets them. In general, Exemestane ratiopharm is well tolerated, and the following side effects observed in patients treated with Exemestane ratiopharm are mainly mild or moderate in nature. Most side effects are associated with the reduction of estrogens (such as hot flashes).

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

• Difficulty sleeping
• Headache
• Hot flashes
• Feeling unwell
• Increased sweating
• Muscle and joint pain (including osteoarthritis, back pain, arthritis, and joint stiffness)
• Fatigue

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

• Lack of appetite
• Depression
• Dizziness, carpal tunnel syndrome (a combination of tingling, numbness, and pain that affects the entire hand except the little finger), altered sensation (paresthesia)
• Stomach pain, vomiting (feeling unwell), constipation, indigestion, diarrhea
• Skin rash, hair loss, skin disorders such as itching (urticaria)
• Decreased bone density which may decrease bone strength (osteoporosis) and cause fractures in some cases (breaks or cracks)
• Pain, swelling of hands and feet

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

• Numbness
• Muscle weakness
• Hypersensitivity
• Increased liver enzymes, liver inflammation (hepatitis) associated with nausea, jaundice (yellowing of the skin and eyes), itching, abdominal pain, and loss of appetite. Skin reaction with small blisters associated with fever (acute generalized exanthematous pustulosis)
• Decrease in the number of white blood cells (leukopenia)

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

• Decrease in the number of platelets (thrombocytopenia)

Frequency not known(cannot be estimated from the available data).

• Decrease in the number of white blood cells (lymphocytes)

If you have had a blood test, you may have seen that there have been changes in liver function. There may be changes in the number of certain blood cells (lymphocytes) and platelets (cells that produce blood clotting) circulating in the blood, especially in patients with pre-existing lymphopenia (decrease in lymphocytes in the blood).

Reporting of side effects

If you experience 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 listed in the Spanish Medicines Agency's website: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Exemestane 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 after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Exemestane ratiopharm

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

The other ingredients are:

Core of the tablet:

Mannitol, Copovidone, Crospovidone, Microcrystalline cellulose silicate, Sodium starch glycolate (Type A), Magnesium stearate.

Coating:

Hypromellose, Macrogol 400, Titanium dioxide (E171)

Appearance of the product and packaging

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

Exemestane ratiopharm is available in pack sizes of: 30 film-coated tablets.

Marketing authorisation holder and manufacturer

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1ª planta

28108 Alcobendas, Madrid (Spain)

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

TEVA Pharmaceutical Works Private Limited Company

H-2100 Gödöllo, Táncsics Mihály út 82

Hungary

or

Pharmachemie B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

or

Teva Pharma B.V.,

Swensweg 5, 2031 GA Haarlem

Netherlands

Date of last revision of this leaflet: March 2016

"Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/"