STANEXAM

PACKAGE LEAFLET: INFORMATION FOR THE USER

Stanexam 25 mg film-coated tablets

exemestane
Please read this leaflet carefully before using this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

1. What Stanexam is and what it is used for
2. What you need to know before taking Stanexam
3. How to take Stanexam
4. Possible side effects
5. How to store Stanexam
6. Contents of the pack and other information.

1. WHAT STANEXAM IS AND WHAT IT IS USED FOR

Exemestane belongs to a group of medicines known as aromatase inhibitors.
These drugs interfere with a substance called aromatase, which is required
for the production of female sex hormones, estrogens, particularly in postmenopausal women.
Reducing estrogen levels in the body is a method of treating hormone-dependent breast cancer.
Exemestane is used to treat

• early hormone-dependent breast cancer in postmenopausal women who have completed 2-3 years of treatment with the medicine tamoxifen, and

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• advanced breast cancer in postmenopausal women, when other hormonal treatments have not worked adequately.

2. WHAT YOU NEED TO KNOW BEFORE TAKING STANEXAM

Do not take Stanexam

• if you are or have previously been allergic to exemestane or to any of the excipients of Stanexam (see section 6, ‘What Stanexam contains’, for the full list of excipients).
• if you have not yet entered menopause, i.e. you still have regular menstrual cycles.
• if you are pregnant, could become pregnant, or are breastfeeding.

Warnings and precautions
Talk to your doctor before taking Stanexam.

• before starting treatment with Stanexam, your doctor may ask you to have blood tests to confirm that you have already entered menopause.
• prior to treatment, your vitamin D levels may be routinely assessed, as they may be very low in early breast cancer. If your levels are below normal, you will be given a vitamin D supplement.
• before taking Stanexam, inform your doctor if you have any liver or kidney problems.
• if you have a personal history or currently suffer from any disease affecting bone strength. Your doctor may consider it necessary to measure your bone mineral density before and during treatment with exemestane. This is because medicines in this class reduce levels of female hormones, which may lead to loss of bone mineral content and weaker bones.

Other medicines and Stanexam
Inform your doctor if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Exemestane must not be taken together with hormone replacement therapy (HRT).
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The following medicines should be used with caution when taking exemestane. Inform your doctor if you are taking medicines such as:

• rifampicin (an antibiotic),
• carbamazepine or phenytoin (anticonvulsants used to treat epilepsy),
• the herbal medicine St John’s wort (Hypericum perforatum), used to treat depression and general inflammation, or products containing it.

Pregnancy and breastfeeding
Do not take exemestane if you are pregnant or breastfeeding.
Ask your doctor for advice before taking this medicine.
Discuss with your doctor appropriate contraceptive methods if there is any possibility you could become pregnant.

Driving and using machines
If you experience drowsiness, dizziness, or weakness while taking Stanexam, do not drive or operate machinery.

Stanexam contains glucose and sodium
If you have previously been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. HOW TO TAKE STANEXAM

Adults and elderly
Always take this medicine exactly as instructed by your doctor. If you
have any doubts, consult your doctor or pharmacist.
Exemestane tablets must be taken orally every day after a
meal, approximately at the same time each day. Your doctor will advise you on how to take
Stanexam and for how long.
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The recommended dose is one 25 mg tablet daily.
If you need to go to hospital during treatment with exemestane, inform the
medical staff which medicines you are taking.

Children
Exemestane is not indicated for use in children.

If you take more Stanexam than you should
If you have taken too many exemestane tablets, contact your doctor or go immediately
to the nearest emergency department. Show them the exemestane packaging.

If you forget to take Stanexam
Do not take a double dose to make up for a forgotten tablet. If you forget a dose,
take it as soon as you remember. If it is almost time for your next dose,
take the next tablet at the usual time.

If you stop taking Stanexam
Do not stop treatment with exemestane even if you feel well, unless instructed by your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

In general, this medicine is well tolerated and the following adverse reactions observed
in patients treated with this medicine are mainly mild or
moderate in nature. Most of the adverse reactions are related to
estrogen deficiency (e.g., hot flushes).
Hypersensitivity, liver inflammation (hepatitis), and inflammation of the liver's bile ducts,
which causes yellowing of the skin (cholestatic hepatitis), may occur. Symptoms include general malaise, nausea, jaundice (yellowing of the skin and eyes), itching, right-sided abdominal pain, and loss of appetite. Contact your doctor immediately for urgent medical advice
if you think you have any of these symptoms.
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Very common adverse reactions (may affect more than 1 in 10 people)

• Depression ● Difficulty sleeping ● Headache ● Hot flushes ● Dizziness ● Nausea ● Increased sweating ● Muscle and joint pain (including joint inflammation, back pain, and joint stiffness) ● Fatigue ● Decrease in white blood cell count ● Abdominal pain ● Increased liver enzymes ● Elevated levels of hemoglobin breakdown products in the blood ● Elevated liver enzyme levels in the blood due to liver damage ● Pain

Common adverse reactions (may affect up to 1 in 10 people)

• Loss of appetite ● A combination of tingling, numbness, and pain in the whole hand except the little finger (carpal tunnel syndrome), or skin itching/tingling ● Stomach discomfort, vomiting, constipation, indigestion, diarrhea ● Skin rash, hair loss ● Thinning of the bones that may weaken (osteoporosis), leading in some cases to bone fractures (breaks or cracks) ● Pain, swelling in hands and feet

Uncommon adverse reactions (may affect up to 1 in 100 people)

• Hypersensitivity

Rare adverse reactions (may affect up to 1 in 1,000 people)

• Appearance of small blisters on an area of skin in a skin rash ● Drowsiness ● Liver inflammation, inflammation of the liver bile ducts causing yellowing of the skin

Adverse reactions of unknown frequency (frequency cannot be determined from the available data)

• Low levels of certain white blood cells in the blood

Changes in the number of certain blood cells (lymphocytes) and platelets circulating in the blood may occur, particularly in patients with pre-existing lymphopenia (reduced lymphocyte count in the blood).
Reporting of adverse reactions
If any of the adverse reactions worsens, or if you notice any adverse reaction not listed in this
package leaflet, inform your doctor or
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pharmacist. You can also report any adverse reaction directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicinal product.

5. HOW TO STORE STANEXAM

Keep this medicine out of the reach and sight of children.
This medicine does not require any special storage conditions.
Do not use exemestane after the expiry date stated on the blister and on the
packaging after Exp. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help
protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Stanexam contains

• The active substance is exemestane. Each film-coated tablet contains 25 mg of exemestane.
• The excipients are mannitol (E421), hypromellose, crospovidone (type B), polysorbate 80, microcrystalline cellulose, sodium carboxymethyl starch (type A), magnesium stearate, anhydrous colloidal silica.
• The excipients in the tablet coating are sodium carmellose (E466), maltodextrin, glucose monohydrate, titanium dioxide (E171), stearic acid (E570), yellow iron oxide (E172).

Description of the appearance of Stanexam and contents of the pack
Exemestane is a yellow, biconvex, round (approximately 6 mm) film-coated tablet, with “E9MT” engraved in relief on one side and “25” on the other.
Exemestane tablets are available in blister packs of
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30, 90 and 100 tablets; unit dose pack of 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Elleva Pharma S.r.l., Via San Francesco n. 5/7, 80034 Marigliano (NA), Italy

Manufacturers:

• Synthon BV, Microweg 22, 6545 CM, Nijmegen, Netherlands
• Synthon Hispania S.L., Castello 1, Poligono Las Salinas, 08830 Sant Boi de Llobregat, Spain
• Laboratorio Generfarma S.L, Ronda Isaac Peral, 6 Paterna 46980 (Parque Tecnológico), Valencia, Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Estonia: Exemestane Sanoswiss
Finland: Xemestan 25 mg
Germany: Exestan 25 mg Filmtabletten
Hungary: Tearan 25 mg filmtabletta
Italy: Stanexam 25 mg
Lithuania: Exemestane Sanoswiss 25 mg, plévele dengtos tabletés
Latvia: Exemestane Sanoswiss 25 mg apvalkotās tabletes
Netherlands: Nateran 25 mg, filmomhulde tabletten
Romania: Nateran 25 mg, comprimate filmate
Spain: Exemestano Desgen 25 mg comprimidos recubiertos con película EFG
United Kingdom: Exemestane 25 mg Film-coated Tablets
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This summary of product characteristics was last approved on 03/2023
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