EXEMESTANO 25 mg Film-Coated Tablets

Contents of the leaflet

1. Introduction
2. What Exemestane Kern Pharma is and what it is used for
3. Before taking Exemestane Kern Pharma
4. How to take Exemestane Kern Pharma
5. Possible side effects
6. Storage of Exemestane Kern Pharma
7. Further information

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Exemestane Kern Pharma 25 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as 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. Do not pass it on to others, as it may harm them, even if their symptoms 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.

Contents of the pack:

1. What Exemestane Kern Pharma is and what it is used for
2. Before taking Exemestane Kern Pharma
3. How to take Exemestane Kern Pharma
4. Possible side effects
5. Storage of Exemestane Kern Pharma
6. Further information

1. What Exemestane Kern Pharma is and what it is used for

This medicinal product is called Exemestane Kern Pharma. Exemestane belongs to a group of medicines called aromatase inhibitors. These drugs interfere with a substance called aromatase, which is necessary for producing female sex hormones, estrogens, especially in postmenopausal women. Reducing estrogen levels in the body is a way to treat hormone-dependent breast cancer.

Exemestane 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.

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

2. Before taking Exemestane Kern Pharma

Do not take Exemestane Kern Pharma

• if you are or have been previously allergic (hypersensitive) to exemestane or any of the other ingredients of Exemestane Kern Pharma. See section 6 ("Composition of Exemestane Kern Pharma") for the complete list of excipients.
• if you have notyet reached menopause, i.e., if you still have your period,
• if you are pregnant, think you may be pregnant, or are breastfeeding.

Be cautious with Exemestane Kern Pharma

• Before starting treatment with Exemestane, your doctor may perform a blood test to ensure you have reached menopause.
• Before taking Exemestane, inform 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 bone strength. Your doctor may analyze bone density before and during treatment with Exemestane. 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.

Using other medicines

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

Exemestane 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 Exemestane. Inform 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 and breastfeeding

Do not take Exemestane if you are pregnant or breastfeeding.

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

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

Driving and using machines

If you experience dizziness, drowsiness, or fatigue while being treated with Exemestane, do not drive or operate machinery.

3. How to take Exemestane Kern Pharma

Adults and elderly

Exemestane tablets should be taken orally after a meal, approximately at the same time every day. Your doctor will tell you how to take Exemestane and for how long. The recommended dose is one 25 mg tablet per day.

Do not stop taking the tablets even if you feel well, unless your doctor tells you to.

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

Children

Exemestane is not suitable for use in children.

If you take more Exemestane Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

Important information for athletes

Athletes are warned that this medicine contains a component that may result in a positive doping test

If you forget to take Exemestane Kern Pharma

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.

4. Possible side effects

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

Very common side effects (affecting 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 (affecting between 1 and 10 people in 100):

• Lack of appetite

• Depression
• Dizziness, carpal tunnel syndrome (a combination of tingling, numbness, and pain that affects the entire hand except the little finger)
• Stomach pain, vomiting (feeling unwell), constipation, indigestion, diarrhea
• Rash, hair loss
• Decreased bone density that may decrease bone strength (osteoporosis) and cause fractures in some cases (breaks or cracks)
• Pain, swelling of hands and feet

Uncommon side effects (affecting between 1 and 10 people in 1,000):

• Numbness
• Muscle weakness

There may be inflammation of the liver (hepatitis). Symptoms include feeling unwell, nausea, jaundice (yellow color of the skin and eyes), itching, pain in the right side of the abdomen, and loss of appetite. Contact your doctor as soon as possible if you think you have any of these symptoms.

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 circulating in the blood, especially in patients with pre-existing lymphopenia (decrease in lymphocytes in the blood).

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. Storage of Exemestane Kern Pharma

This medicinal product does not require any special storage conditions.

Keep the tablets in their original packaging.

Keep out of sight and reach of children

Do not use Exemestane Kern Pharma after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

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

6. Further information

Composition of Exemestane Kern Pharma

• The active substance is exemestane. Each film-coated tablet contains 25 mg of exemestane.
• The other ingredients are: mannitol (E421), microcrystalline cellulose, crospovidone, sodium starch glycolate type A (potato starch), hypromellose, polysorbate 80, colloidal anhydrous silica, magnesium stearate, and white opadry [hypromellose, macrogol, and titanium dioxide (E171)].

Appearance and packaging of the product

Exemestane Kern Pharma is a film-coated tablet, round, biconvex, white, marked with E25 on one side.

Exemestane Kern Pharma is available in blister packs of 30 tablets.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

This leaflet was approved in January 2011