STANEXAM 25 mg Tabletki Powlekane

Treść ulotki

1. WHAT IS STANEXAM AND WHAT IS IT USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE STANEXAM
3. HOW TO TAKE STANEXAM
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE STANEXAM
6. PACKAGE CONTENTS AND OTHER INFORMATION

Stanexam 25 mg film-coated tablets
exemestane

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 could be harmful.
• If any of the side effects gets worse, or if you notice any side effect not listed in this leaflet, tell 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 you take 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 IS STANEXAM AND WHAT IS IT USED FOR

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

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

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

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE STANEXAM

Do not take Stanexam

• if you are or have previously been allergic to exemestane or any of theexcipientsof Stanexam (see section 6, ‘What Stanexam contains’ for a complete list of the excipients).
• if you are notyet postmenopausal, meaning you have a regular menstrual cycle.
• if you are pregnant or might become pregnant or if you are breastfeeding.

Warnings and precautions
Talk to your doctor before taking Stanexam.

• before starting treatment with Stanexam, your doctor may ask you to undergo blood tests to confirm that you have already entered menopause.
• before treatment, a routine assessment of vitamin D levels will also be performed, as its level may be very low in early breast cancers. If your levels are below normal, you will be given a vitamin D supplement.
• before Stanexam, tell your doctor if you have problems with your liveror kidneys.
• if you have a medical history or are affected by any disease that affectsbone strength. Your doctor may need to measure bone density before and during treatment with exemestane. This is because drugs belonging to this class lower the level of female hormones and this can lead to a loss of bone mineral content, which can become less resistant.

Other medicines and Stanexam
Tell your doctor if you are taking, have recently taken or might take
any other medicines, including those available without a prescription.
Exemestane must notbe administered together with hormone replacement therapy

(HRT).
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The following medicines must be used with caution when taking
exemestane. Tell your doctor if you are taking medicines such as:

• rifampicin(an antibiotic),
• carbamazepineor phenytoin(anticonvulsants used to treat epilepsy),
• the herbal medicine St John's Wort(Hypericum perforatum), used to treat depression and general inflammation, or preparations containing it.

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

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

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

3. HOW TO TAKE STANEXAM

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

Children
The use of exemestane is not indicated 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 room. 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 to take a tablet, take it as soon as you remember. If it is almost
time for the next dose, take it at the usual time.

If you stop taking Stanexam
Do not stop treatment with exemestane even if you feel well, unless
you are told to do so by your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

In general, this medicine is well tolerated and the following undesirable effects observed
in patients treated with this medicine are predominantly mild or
moderate in nature. Most undesirable effects are associated with estrogen deficiency
(for example, hot flushes).
Hypersensitivity, liver inflammation (hepatitis) and
inflammation of the bile ducts of the liver, which causes a yellowish discoloration of the skin
(cholestatic hepatitis) may occur. Symptoms include general malaise, nausea, jaundice
(yellowing of the skin and eyes), itching, abdominal pain on the right side and
loss of appetite. Contact your doctor promptly for urgent medical advice
if you think you have any of these symptoms.
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Very common side effects (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 ● Decreased number of white blood cells ● Abdominal pain ● Increased liver enzymes ● Elevated level of hemoglobin breakdown in the blood ● Elevated level of liver enzymes in the blood due to liver damage ● Pain

Common side effects (may affect up to 1 in 10 people)

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

Uncommon side effects(may affect up to 1 in 100 people)

• Hypersensitivity

Rare side effects(may affect up to 1 in 1,000 people)

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

Side effects of unknown frequency(frequency cannot be estimated on the
basis of available data)

• Low level of certain white blood cells in the blood

Changes in the amount of some blood cells (lymphocytes) and platelets
circulating in the blood may occur, especially in patients with pre-existing lymphopenia
(decreased lymphocytes in the blood).

Reporting of side effects
If any of the side effects gets worse, or if you notice any
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pharmacist. You can also report any side effects directly through
the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information about 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 particular storage conditions.
Do not use exemestane after the expiry date which is stated on the blister and on the
pack 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 to
protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Stanexam contains

• The active ingredient 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 carboxymethylcellulose type A, magnesium stearate, anhydrous colloidal silica.
• The excipients of the tablet coating are sodium carboxymethylcellulose (E466), maltodextrin, glucose monohydrate, titanium dioxide (E171), stearic acid (E570), yellow iron oxide (E172).

Description of the appearance of Stanexam and package contents
Exemestane is a yellow, biconvex, round (approximately 6 mm) film-coated tablet, embossed with ‘E9MT’ 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 packs 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 designations:

EstoniaExemestane Sanoswiss

FinlandXemestan 25 mg

GermanyExestan 25 mg Film-coated Tablets

HungaryTearan 25 mg filmtabletta

ItalyStanexam 25 mg

LithuaniaExemestane Sanoswiss 25 mg, film-coated tablets

LatviaExemestane Sanoswiss 25 mg apvalkotās tabletes

NetherlandsNateran 25 mg, film-coated tablets

RomaniaNateran 25 mg, film-coated tablets

SpainExemestano Desgen 25 mg film-coated tablets EFG

United KingdomExemestane 25 mg Film-coated Tablets
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