PATIENT INFORMATION LEAFLET

Gepex 25 mg Coated Tablets

Exemestane

Read this leaflet carefully before you start taking this medicine. 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 or pharmacist.

?This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms, as it may harm them.

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

Content of the leaflet:

1.What Gepex 25 mg Coated Tablets are and what they are used for.

2.What you need to know before taking Gepex 25 mg Coated Tablets.

3.How to take Gepex 25 mg Coated Tablets.

4.Possible side effects.

5.Storage of Gepex 25 mg Coated Tablets.

6. Contents of the pack and additional information.

Exemestane belongs to a group of medicines called aromatase inhibitors. These medicines interfere with the 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.

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 tamoxifen medication.

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

Do not take Gepex:

• If you are allergic (hypersensitive) to exemestane or any of the other components of this medication. See the section 6 (“Composition of Gepex”) for the complete list of excipients
• 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 or pharmacist before starting to take Gepex.
• Before starting treatment with Exemestane, your doctor may perform a blood test to ensure that you have reached menopause.
• Your vitamin D levels will also be checked periodically before starting treatment, as they may be too low in the initial stages of breast cancer. You will be given a vitamin D supplement if your levels are below normal.

• Inform your doctor if you have any liver or kidney problems before taking Gepex.

• Inform your doctor if you have a history or are suffering from any disease that affects your bone resistance. Your doctor may analyze your bone density before and during treatment with Gepex. 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.

Other medications and Gepex

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Gepex should not be administered at the same time as hormone replacement therapy (HRT).

Other medications should be used with caution when taken with Exemestane. Inform your doctor if you are taking rifampicin (an antibiotic), carbamazepine, or phenytoin (used for epilepsy). You should also inform your doctor if you are taking St. John's Wort (Hypericum perforatum) or other preparations containing it.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Do not use Exemestane if you are pregnant or may become pregnant.

Do not use Exemestane if you are breastfeeding.

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 Exemestane, do not drive or operate machinery.

Gepex contains sucrose

This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one 25 mg tablet per day.

Gepex tablets should be taken orally after a meal, approximately at the same time every day. Your doctor will tell you how to take Gepex and for how long.

If you need to go to the hospital while on treatment with Gepex, inform the medical staff what medication you are taking.

Use in children

Gepex is not suitable for use in children.

If you take more Gepex 25 mg coated tablets than you should

If you have taken more Exemestane than you should, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91562 04 20, indicating the product and the amount administered. Bring this leaflet with you so that the hospital can easily identify the medication you have taken.

If you forget to take Gepex 25 mg coated tablets

Take another dose as soon as you remember. If it is close to the time of your next dose, take it at the usual time.

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

If you interrupt treatment with Gepex 25 mg coated tablets

Do not stop taking the tablets even if you 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 may cause side effects, although not everyone will experience them.

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

Very common(may affect more than 1 in 10 patients):

• Depression
• Hot flashes
• Dizziness
• Unpleasant sensation
• Headache
• Difficulty sleeping
• Increased sweating
• Fatigue
• Pain
• Abdominal pain
• Musculoskeletal and joint pain (including osteoarthritis, arthritis, back pain, and joint stiffness).
• Reduced white blood cell count
• Elevated liver enzyme levels
• Elevated hemoglobin breakdown levels in blood.
• Elevated blood enzyme levels due to liver damage

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

• Loss of appetite
• Carpal tunnel syndrome (a combination of tingling, numbness, and pain affecting the entire hand except the little finger) or skin prickling/tingling
• Indigestion, vomiting (unpleasant sensation), constipation, diarrhea
• Skin rash, urticaria, and itching
• Hair loss
• Swelling of hands and feet
• Osteoporosis, bone density reduction that may decrease bone resistance and cause fractures in some cases (breaks or cracking).
• Reduced platelet count in blood
• Feeling of weakness

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

• Hypersensitivity

Rare(may affect up to 1 in 1000 patients):

• Small blister-like rash on a skin area
• Drowsiness
• Liver inflammation
• Bile duct inflammation of the liver causing skin yellowing

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

• Low levels of certain white blood cells in blood

Hypersensitivity, liver inflammation (hepatitis), and bile duct inflammation of the liver causing skin yellowing (cholestatic hepatitis) may occur. Symptoms include general feeling of discomfort, nausea, jaundice (yellow skin and eyes), itching, right abdominal pain, and loss of appetite. Contact your doctor as soon as possible if you experience any of these symptoms.

If you have had a blood test, you may have seen 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 (lymphocyte reduction in blood).

Reporting of side effects:

If you experience side effects, consult your doctor or pharmacist, even if they do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children

Do not store above 30°C.

Do not use Gepex after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at your local SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Gepex 25 mg

The active ingredient is Exemestano.

Each tablet contains 25 mg of Exemestano.

The other components are:

Tablet core: microcrystalline cellulose, crospovidone, polisorbate, acetone, mannitol, anhydrous colloidal silica, magnesium stearate.

The sugar coating contains sucrose, gum acacia, purified talc, titanium dioxide (E-171), purified water, Opaglos, isopropyl alcohol.

Appearance of Gepex and content of the packaging

Sugar-coated, bicongcave tablet of white color.

Gepex 25 mg: Sugar-coated, bicongcave tablets of white color, each package contains 30 or 100 tablets.

Holder of the marketing authorization

GP-Pharm,S.A.

Industrial Estate Els Vinyets – Els Fogars, sector 2

Carretera Comarcal C-244, Km 22,

08777 – Sant Quintí de Mediona (Barcelona) SPAIN

Responsible for manufacturing

Tecnimede-Sociedade Técnico-Medicinal, S.A.

Quinta da Cerca, Caixaria, Dois Portos

2565-187 Portugal

Date of the last review of this leaflet: July 2021

Other sources of information

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