Astexana

Package Leaflet: Information for the Patient

Astexana, 25 mg, coated tablets
( Exemestane)

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents:

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

1. What is Astexana and what is it used for

Astexana belongs to a group of medicines called aromatase inhibitors. These medicines work by blocking the enzyme aromatase, which is involved in the production of the female sex hormone estrogen, especially in post-menopausal women. Reducing estrogen levels in the body is a way to treat hormone-dependent breast cancer.
Astexana is used to treat early-stage hormone-dependent breast cancer in post-menopausal women after 2-3 years of tamoxifen treatment.
The medicine is also used to treat advanced hormone-dependent breast cancer in post-menopausal women who have not responded to other hormonal treatments.

2. Important information before taking Astexana

When not to take Astexana:

• if you are allergic (hypersensitive) to exemestane (the active substance of Astexana) or any of the other ingredients of Astexana (see section 6);
• in pre-menopausal women,
• in pregnant or breastfeeding women.

Warnings and precautions

• before starting treatment with Astexana, your doctor may recommend blood tests to confirm that you have gone through menopause.
• if you have kidney or liver problems, tell your doctor before starting treatment with Astexana.
• if you have or have had a condition that affects bone density. This is because medicines in this group reduce estrogen levels, which can lead to a decrease in bone mineral density and, consequently, a decrease in bone strength. You may need to have a bone density test before or during treatment. Your doctor may recommend medicines to prevent or treat bone mineral loss.

Astexana and other medicines

Tell your doctor about all the medicines you have taken recently or plan to take.
Astexana must not be taken at the same time as hormone replacement therapy (HRT).
Be careful when taking the following medicines during Astexana treatment. Tell your doctor if you are taking any of these medicines:

• rifampicin (an antibiotic),
• carbamazepine or phenytoin (anti-epileptic medicines used to treat epilepsy),
• herbal products containing St. John's Wort ( Hypericum perforatum)

Pregnancy, breastfeeding, and fertility

Astexana is contraindicated in pregnant or breastfeeding women.
If you suspect you are pregnant or are pregnant, tell your doctor immediately. Women of childbearing age should use effective contraception while taking Astexana.

Driving and using machines

If you feel drowsy, dizzy, or weak while taking Astexana, do not attempt to drive or operate machinery.

Astexana contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

Astexana contains mannitol

The medicine may have a mild laxative effect.

3. How to take Astexana

Astexana should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist again. Your doctor will decide how and for how long to take Astexana.

Adults and elderly patients

The recommended dose of Astexana is one 25 mg tablet once daily.
Astexana coated tablets should be taken orally, after a meal, preferably at the same time each day.

Use in children and adolescents

Astexana is not recommended for use in children and adolescents.

Overdose

If you accidentally take more Astexana than prescribed, contact your doctor or the nearest emergency department immediately, with the packaging of Astexana.

Missed dose

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

Stopping treatment

Only your doctor can decide to stop treatment. Do not stop treatment without consulting your doctor.

4. Possible side effects

Like all medicines, Astexana can cause side effects, although not everybody gets them. In general, exemestane is well tolerated, and the following side effects observed in patients treated with exemestane were mild to moderate.
Most side effects are related to the decrease in estrogen levels in the blood (e.g., hot flashes).

Very common side effects (occurring in more than 1 in 10 patients):

• insomnia,
• headache,
• hot flashes,
• feeling unwell,
• increased sweating,
• muscle and joint pain (including osteoarthritis, back pain, arthritis, and joint stiffness),
• feeling extremely tired.

Common side effects (occurring in less than 1 in 10 patients):

• loss of appetite,
• depression,
• dizziness, carpal tunnel syndrome (a combination of tingling, numbness, and pain in the hand, except for the little finger),
• abdominal pain, vomiting, constipation, nausea, diarrhea,
• rash, hair loss,
• decreased bone density, which can lead to bone weakening (osteoporosis), in some cases resulting in fractures or bone breaks,
• pain, swelling of hands and feet

Uncommon side effects (occurring in less than 1 in 100 patients):

• drowsiness,
• muscle weakness

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 if you experience any of these symptoms.
When blood tests are performed, changes in liver function may be observed. Changes in the number of certain blood cells (lymphocytes) and platelets (cells that cause blood to clot) may occur, especially in patients who have previously been diagnosed with lymphopenia (reduced lymphocyte count in the blood).
If any side effect gets worse or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, e-mail: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Astexana

Keep out of sight and reach of children.
Do not use Astexana after the expiry date (EXP) stated on the packaging.
The expiry date refers to the last day of the month.
No special storage conditions are required.
Medicines should not be disposed of via wastewater or household waste. 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

What Astexana contains

The active substance is exemestane. Each coated tablet contains 25 mg of exemestane. The other ingredients are:
Core:
mannitol, copovidone (K 28), crospovidone (type A), microcrystalline cellulose silicified, sodium glycolate starch (type A), magnesium stearate.
Coating (Aquarius Prime BAP218010 White):
hypromellose, macrogol 400, titanium dioxide.

What Astexana looks like and contents of the pack

Round, white coated tablets marked with the number "25" on one side, smooth on the other side.
Astexana is available in PVC-PVdC/aluminum blisters:
30, 90, and 100 coated tablets in blisters.
Not all pack sizes may be marketed.

Marketing authorization holder

Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
tel.: (+48 22) 679 51 35
fax: (+48 22) 678 92 87
e-mail: vipharm@vipharm.com.pl

Manufacturer

EirGen Pharma Ltd.
Westside Business Park, Old Kilmeaden Road, Waterford
Ireland
Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki

This medicinal product has been authorized in the EEA Member States under the following names:

CZ: Astexana 25 mg
PL: Astexana
SK: Astexana 25 mg
Date of revision of the leaflet:24.06.2021