GEPEX 25 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Gepex 25 mg film-coated tablets EFG

Exemestane

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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Contents of the pack:

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1. Contents of the pack and other information.

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

Exemestane belongs to a group of medicines called aromatase inhibitors. These medicines interfere with 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 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. What you need to know before you take Gepex 25 mg film-coated tablets

Do not take Gepex:

• if you are allergic (hypersensitive) to exemestane or any of the other ingredients of this medicine. See section 6 (“Composition of Gepex”) for the complete list of excipients
• if you have not reached menopause, i.e., 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.
• Periodically, your vitamin D levels will also be reviewed 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.

• Tell your doctor if you have a history of or suffer from any disease that affects bone strength. Your doctor may analyze your bone density before and during treatment with Gepex. 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.

Other medicines and Gepex

Tell your doctor or pharmacist if you are taking, have recently taken, or might 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 in combination with Exemestane. Let your doctor know 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 medicine St. John's Wort (Hypericum perforatum) or other preparations that contain it.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

You must not use Exemestane if you are pregnant or think you may be pregnant.

You must not use Exemestane if you are breastfeeding.

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

Driving and using machines:

If you feel dizzy, drowsy, or tired while taking Exemestane, do not drive or operate machinery.

Gepex contains sucrose

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

3. How to take Gepex 25 mg film-coated tablets

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If in 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 taking 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 film-coated tablets than you should

If you have taken more Exemestane than you should, consult your doctor or pharmacist immediately or call the Toxicology 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 medicine you have taken.

If you forget to take Gepex 25 mg film-coated tablets

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

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

If you stop taking Gepex 25 mg film-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 on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

• Depression
• Hot flashes
• Dizziness
• Feeling unwell
• Headache
• Difficulty sleeping
• Increased sweating
• Fatigue
• Pain
• Abdominal pain
• Joint and muscle pain (including osteoarthritis, arthritis, back pain, and joint stiffness).
• Reduced white blood cell count
• High liver enzyme levels
• High levels of hemoglobin breakdown in the blood.
• High levels of liver enzymes in the blood due to liver damage

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

• Lack of appetite
• Carpal tunnel syndrome (a combination of tingling, numbness, and pain that affects the entire hand except the little finger) or tingling/numbness of the skin
• Indigestion, nausea (feeling unwell), constipation, diarrhea
• Skin rash, hives, and itching
• Hair loss
• Swelling of hands and feet
• Osteoporosis, decreased bone density that may decrease bone strength and cause fractures in some cases (breaks or cracks).
• Reduced platelet count 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):

• Small blistering rash on an area of skin
• Drowsiness
• Liver inflammation
• Inflammation of the liver's bile ducts that causes yellowing of the skin

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

• Low levels of certain white blood cells in the blood

Hypersensitivity, liver inflammation (hepatitis), and inflammation of the liver's bile ducts that cause yellowing of the skin (cholestatic hepatitis) may occur. 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 (reduced lymphocytes in the blood).

Reporting of side effects:

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side 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 pack. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. 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 ingredients are:

Core of the tablet: 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 authorisation 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 last revision of this leaflet: July 2021

Other sources of information

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.es/.