Simex

Package Leaflet: Information for the Patient

Symex, 25 mg, Coated Tablets

Exemestane

Read the Package Leaflet Carefully Before Taking the Medication, 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. 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Symex and What is it Used For
• 2. Important Information Before Taking Symex
• 3. How to Take Symex
• 4. Possible Side Effects
• 5. How to Store Symex
• 6. Package Contents and Other Information

1. What is Symex and What is it Used For

Exemestane belongs to a group of medicines known as aromatase inhibitors. These medicines work by interfering with an enzyme called aromatase, which is involved in the production of female sex hormones, estrogens, especially in post-menopausal women. Reducing estrogen levels in the body is a method of treating hormone-dependent breast cancer.

Exemestane is used:

• in the treatment of early hormone-dependent breast cancerin post-menopausal women who have completed 2-3 years of tamoxifen therapy.
• in the treatment of advanced hormone-dependent breast cancerin post-menopausal women, in whom other hormonal treatments have not been effective.

2. Important Information Before Taking Symex

When Not to Take Symex

• if you are allergic to exemestane or any of the other ingredients of this medicine (listed in section 6),
• if you are not yet post-menopausal, i.e., you have not yet stopped menstruating,
• if you are pregnantor may be pregnant,
• if you are breastfeeding.

Warnings and Precautions

Before starting treatment with Symex, discuss it with your doctor or pharmacist.

• Before taking Symex, your doctor may perform blood tests to confirm that you are post-menopausal.
• Before starting treatment, your doctor may recommend routine measurement of vitamin D levels, as they may be low in early breast cancer. Women with vitamin D deficiency should receive supplementary treatment.
• Before taking Symex, tell your doctor if you have any liver or kidney problems.
• Tell your doctor if you have or have had a condition that affects bone strength. Your doctor may order a bone density test before or during treatment with Symex. This is because medicines in this group can reduce the activity of female sex hormones, which can lead to bone mineral loss and reduced bone strength.

Symex and Other Medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.

Symex should not be taken at the same time as hormone replacement therapy (HRT).

The following medicines should be used with caution during treatment with Symex. You should tell your doctor if you are taking medicines such as:

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

Symex with Food

Symex should be taken preferably after a meal.

Pregnancy and Breastfeeding

Do not take Symex if you are pregnant or breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.

Discuss contraception with your doctor if there is a chance of becoming pregnant.

Driving and Operating Machines

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

Symex Contains Sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

3. How to Take Symex

Always take this medicine exactly as your doctor has told you.

Dosage

The recommended dose is one 25 mg tablet per day.

Method of Administration

Symex should be taken orally, after a meal, at approximately the same time each day.

Your doctor will inform you how and for how long to take the medicine.

If hospitalization is necessary during exemestane treatment, inform the medical staff about the medicines you are currently taking.

Use in Children

Symex is not indicated for use in children.

Overdose of Symex

If you have taken more than the prescribed dose, contact your doctor or the nearest hospital immediately. Bring the Symex package with you.

Missed Dose of Symex

Do not take a double doseto make up for a missed tablet.

Take the missed tablet as soon as possible. If it is almost time for the next dose, take it at the usual time.

Stopping Symex Treatment

Do not stop taking the medicine even if you feel better, unless your doctor tells you to.

4. Possible Side Effects

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

Symex is generally well-tolerated, and the following side effects observed in patients treated with Symex are mostly mild or moderate in severity.

Most side effects are related to estrogen deficiency (e.g., hot flashes).

The following side effects may occur: hypersensitivity, liver inflammation, and bile duct inflammation, which can cause yellowing of the skin (liver inflammation with cholestasis). Symptoms include: general malaise, nausea, jaundice (yellowing of the skin and eyes), itching, abdominal pain on the right side, and loss of appetite.

If you notice any of these symptoms, contact your doctor immediately for medical attention.

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

• Depression
• Insomnia
• Headache
• Hot flashes
• Dizziness
• Nausea
• Increased sweating
• Muscle and joint pain (including osteoarthritis, back pain, joint inflammation, and stiffness)
• Fatigue
• Decreased white blood cell count
• Abdominal pain
• Increased liver enzyme activity
• Increased blood levels of hemoglobin breakdown products
• Increased liver enzyme activity due to liver damage
• Pain

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

• Loss of appetite
• Carpal tunnel syndrome (numbness, tingling, and pain in the entire hand except the little finger) or tingling/burning sensation of the skin
• Abdominal pain, vomiting, constipation, indigestion, diarrhea
• Hair loss
• Rash, hives, and itching
• Bone thinning, which can lead to reduced bone strength (osteoporosis), resulting in fractures (fractures or cracks) in some cases
• Pain, swelling of hands and feet
• Decreased platelet count
• Muscle weakness

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

• Hypersensitivity

Rare side effects (may affect less than 1 in 1,000 patients):

• Transformation of small blisters on the skin into a rash
• Drowsiness
• Liver inflammation
• Bile duct inflammation causing yellowing of the skin

Unknown frequency (cannot be estimated from available data):

• Low levels of certain white blood cells

Changes in blood counts may also occur: in the number of certain blood cells (lymphocytes) and platelets, especially in patients who had lymphopenia (low lymphocyte count) before starting treatment.

Reporting Side Effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.

Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw

Tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of this medicine.

5. How to Store Symex

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister packs after: EXP.

The expiry date refers to the last day of the month stated.

No special precautions for storage are necessary.

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. Package Contents and Other Information

What Symex Contains

• The active substance is exemestane. Each coated tablet contains 25 mg of exemestane.
• The other ingredients are: colloidal anhydrous silica, crospovidone, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, sodium carboxymethylcellulose (type A), macrogol 400, titanium dioxide (E 171), talc, macrogol 6000.

What Symex Looks Like and Contents of the Package

Symex is a white, round, biconvex coated tablet with a diameter of approximately 5.7 mm.

Symex is available in PVC/PVDC/Aluminum blister packs containing 10, 15, 20, 30, 90, 100, 105, and 120 coated tablets, in a cardboard box.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Farmak International Sp. z o.o.

ul. Koszykowa 65

00-667 Warsaw

tel.: +48 22 822 93 06

e-mail: biuro@farmakinternational.pl

Manufacturer

Remedica Ltd.

Aharnon Street, Limassol Industrial Estate

3056 Limassol

Cyprus

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Poland: Symex

Date of Last Revision of the Leaflet:April 2025