GepeX 25 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Gepex 25 mg film-coated tablets EFG

Exemestane

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

? Keep this leaflet, as you may need to read it again.

? If you have any doubts, consult your doctor or pharmacist.

? This medicine has been prescribed for you alone and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

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

Package leaflet contents:

1. What Gepex 25 mg coated tablets are and what they are used for.

2. What you need to know before starting to take Gepex 25 mg coated tablets.

3. How to take Gepex 25 mg coated tablets.

4. Possible adverse effects.

5. Storage of Gepex 25 mg film-coated tablets.

1. Contents of the pack and other information.

1. What Gepex 25 mg coated tablets are and what they are used for

Exemestane belongs to a group of medicines called aromatase inhibitors. These medicines interfere with aromatase, an enzyme needed to produce female sex hormones (estrogens), particularly in postmenopausal women. Reducing estrogen levels in the body is a way of treating hormone-dependent breast cancer.

Exemestane is used to treat early-stage hormone-dependent breast cancer 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 another form of hormonal treatment has not been sufficiently effective.

2. What you need to know before taking Gepex 25 mg coated tablets

Do not take Gepex:

• if you are allergic (hypersensitive) to exemestane or to any of the other components of this medicine. See section 6 (“Composition of Gepex”) for the complete list of excipients
• if you have not yet reached menopause, i.e., if you still have menstrual periods
• if you are pregnant, think you might 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 confirm that you have reached menopause.

• Periodically, your vitamin D levels will also be checked before starting treatment, as they may be too low in the early stages of breast cancer. You will be given a vitamin D supplement if your levels are below normal.

• Before taking Gepex, inform your doctor if you have any liver or kidney problems.

• Inform your doctor if you have a history of, or currently suffer from, any condition affecting bone strength. Your doctor may evaluate your bone density before and during treatment with Gepex. This is because medicines in this class reduce levels of female hormones, which may lead to loss of bone mineral content and could decrease bone strength.

Other medicines and Gepex

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

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

Other medicines should be used with caution together 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 the herbal remedy St. John's wort (Hypericum perforatum), or other products containing it.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

You must not use exemestane if you are pregnant or could become pregnant.

You must not use exemestane if you are breastfeeding.

Talk to your doctor about contraceptive measures if there is any possibility you could become pregnant.

Driving and use of machines:

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

Gepex contains sucrose

This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Gepex 25 mg coated tablets

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one 25 mg tablet daily.

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

If you need to go to the hospital while being treated with Gepex, inform the medical staff about the 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 have, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91562 04 20, indicating the product and the amount taken. Take this leaflet with you so that the hospital can easily identify the medicine you have taken.

If you forget to take Gepex 25 mg coated tablets

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

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

If you stop taking 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 further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

In general, Gepex is well tolerated, and the following adverse effects observed in patients treated with Gepex are mainly mild or moderate. Most adverse effects are associated with reduced estrogen levels (for example, hot flushes).

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

• Depression
• Hot flushes
• Dizziness
• Feeling unwell
• Headache
• Difficulty sleeping
• Increased sweating
• Fatigue
• Pain
• Abdominal pain
• Joint and muscle pain (including osteoarthritis, arthritis, back pain, and joint stiffness)
• Decreased number of white blood cells
• Elevated liver enzymes
• Elevated levels of hemoglobin breakdown products in the blood
• Elevated levels of blood enzymes 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 tingling/tingling sensations
• Indigestion, vomiting (feeling unwell), constipation, diarrhea
• Skin rash, hives, and itching
• Hair loss
• Swelling of hands and feet
• Osteoporosis, decreased bone density which may reduce bone strength and lead to fractures in some cases (breaks or cracks)
• Reduced number of platelets in the blood
• Feeling weak

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

• Hypersensitivity

Rare (may affect up to 1 in 1,000 patients):

• Skin eruption with small blisters in one area of the skin
• Somnolence
• Liver inflammation
• Inflammation of the liver's bile ducts causing yellowing of the skin

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

• Low levels of certain white blood cells in the blood

Hypersensitivity, liver inflammation (hepatitis), and inflammation of the liver's bile ducts causing yellowish discoloration of the skin (cholestatic hepatitis) may occur. Symptoms include feeling generally unwell, nausea, jaundice (yellowing 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 are experiencing any of these symptoms.

If you have had a blood test, you may have noticed 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 (reduced lymphocytes in the blood).

Reporting of adverse effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gepex 25 mg film-coated tablets

Keep out of sight and reach of children.

Do not store above 30°C.

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

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gepex 25 mg

The active substance is Exemestane.

Each tablet contains 25 mg of Exemestane.

The other components are:

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

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

Appearance of Gepex and contents of the pack

White, biconvex sugar-coated tablet.

Gepex 25 mg: White biconvex sugar-coated tablets. Each pack contains 30 or 100 tablets.

Marketing Authorization Holder

GP-Pharm, S.A.

Polígono Industrial Els Vinyets – Els Fogars, sector 2

Carretera Comarcal C-244, Km 22,

08777 – Sant Quintí de Mediona (Barcelona) SPAIN

Manufacturer

Tecnimede-Sociedade Técnico-Medicinal, S.A.

Quinta da Cerca, Caixaria, Dois Portos

2565-187 Portugal

Date of the most recent revision of this leaflet: July 2021

Other sources of information

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