Package Insert: Information for the User

Exemestane Ratiopharm 25 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

-Keep this package insert, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to others, even if they have the same symptoms of the disease as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6Contents of the pack and additional information

This medicine is called Exemestano ratiopharm. Exemestano ratiopharm 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 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 tamoxifen medicine.

It is also used to treat advanced hormone-dependent breast cancer in postmenopausal women when another hormonal treatment has not been sufficiently effective.

Do not takeExemestano ratiopharm

• if you are or have been allergic to exemestane (the active ingredient in Exemestano ratiopharm) or to any of the other ingredients of this medication (listed in section 6).
• if you have not yet reached menopause, that is, if you still have your periods,
• if you are pregnant, think you may be pregnant, or are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeExemestanoratiopharm

• Before starting treatment with Exemestanoratiopharm, your doctor may perform a blood test to ensure that you have reached menopause.
• Before taking Exemestanoratiopharm, inform your doctor if you have any liver or kidney problems.
• If you have a history or are suffering from any disease that affects your bone resistance. This is because medications in this group reduce female hormone levels, which can lead to a loss of bone mineral content, and may decrease your resistance. You may need to undergo a bone density test before and during treatment. Your doctor may prescribe medications to prevent or treat bone loss.

Taking Exemestano ratiopharm with other medications

Inform your doctor if you are using or have used recently or may need to use any other medication, including those purchased without a prescription.

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

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

Pregnancy, breastfeeding, and fertility

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

Inform your doctor if you are pregnant or may be pregnant.

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 ratiopharm, do not drive or operate machinery.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Your doctor will tell you how to take Exemestano ratiopharm and for how long.

Adults and elderly people

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

Exemestano ratiopharm film-coated tablets should be taken by mouth after a meal, approximately at the same time every day.

Use in children and adolescents

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

If you take more Exemestano ratiopharm than you should

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

If you forget to take Exemestano ratiopharm

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

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 the treatment with Exemestano ratiopharm

Do not interrupt the 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 or pharmacist.

Like all medications, Exemestano ratiopharm may cause side effects, although not everyone will experience them. In general, Exemestano ratiopharm is well tolerated, and the following side effects observed in patients treated with Exemestano ratiopharm are mainly of mild or moderate nature. Most side effects are associated with estrogen reduction (such as hot flashes).

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

• Difficulty sleeping
• Headache
• Hot flashes
• Uncomfortable feeling
• 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):

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

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

• Numbness
• Muscle weakness
• Hypersensitivity
• Increased liver enzymes, inflammation of the liver (hepatitis) associated withnausea, jaundice (yellow skin and eyes), itching, pain in the right upper abdomen, and loss of appetite. Skin reaction with small blisters associated with fever (acute generalized pustular exanthema)
• Decrease in the number of white blood cells (leucopenia)

Rare side effects (may affect up to 1 in 1000 people)

• Decrease in the number of platelets (thrombocytopenia)

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

• Decrease in the number of lymphocytes

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly throughthe national notification system included inthe Spanish System for Pharmacovigilance of Medicines for Human Use Website:www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

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 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 packaging and medications you no longer need at > the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need..By doing so, you will help protect the environment.

Composition of Exemestano ratiopharm

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

The other components are:

Tablet core:

Manitol, Copovidona, Crospovidona, Silicated microcrystalline cellulose, Sodium glycolate starch (Type A), Magnesium stearate.

Film coating:

Hydroxypropyl methylcellulose, Macrogol 400, Titanium dioxide (E171)

Appearance of the product and content of the container

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

Exemestano ratiopharm is available in container sizes of:30 film-coated tablets.

Holder of the marketing authorization and Responsible for manufacturing

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid (Spain)

Responsible for manufacturing

EirGen Pharma Ltd.

Westside Business Park, Old Kilmeaden Road, Waterford

Ireland

or

TEVA PharmaceuticalWorks 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

Last review date of this leaflet: March 2016

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”