Simex

Package Leaflet: Information for the Patient

Symex, 25 mg, Effervescent 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 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 those not listed in this leaflet, please inform 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. Contents of the Pack and Other Information

1. What is Symex and What is it Used For

This medicine contains the active substance exemestane. Exemestane belongs to a group of medicines known as aromatase inhibitors. These medicines work by interacting 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:

• in the treatment of early hormone-dependent breast cancerin postmenopausal women who have completed 2-3 years of tamoxifen therapy.
• in the treatment of advanced hormone-dependent breast cancerin postmenopausal women, in whom other hormone therapy has not produced sufficient results.

2. Important Information Before Taking Symex

When Not to Take Symex

not yet "postmenopausal",e.g. your periods have not stopped,pregnantor may be pregnant,

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 postmenopausal.
• Before starting treatment, your doctor may recommend routine measurement of vitamin D levels, as they may be very low in early breast cancer. Women with vitamin D deficiency should receive supplementary treatment for this deficiency.
• Before taking Symex, tell your doctor if you have any liver or kidney problems.
• Tell your doctor if you have ever 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 a loss of minerals in bones and a decrease in their strength.

Symex and Other Medicines

Tell your doctor about all medicines you are taking, or have recently taken, and about any medicines you plan to take. 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 inform 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) or preparations containing St. John's Wort.

Symex with Food

Symex should be taken 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 are planning to have a baby, ask your doctor for advice before taking this medicine. Discuss contraception with your doctor if there is a chance of becoming pregnant.

Driving and Using Machines

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

Symex Contains Sucrose

If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to Take Symex

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor.

Dosage

The recommended dose is one 25 mg tablet per day.

Method of Administration

Symex should be taken orally, after a meal, at about 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 at the hospital 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 immediately or go to the nearest hospital. Take the Symex packaging with you.

Missed Dose of Symex

Do not take a double doseto make up for a missed tablet. Take the missed dose as soon as possible. If it is almost time for the next dose, take it at the usual time.

Stopping Treatment with Symex

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. Usually, Symex is 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, you should contact your doctor immediately for medical advice. 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, arthritis, and joint stiffness)
• Fatigue
• Decreased white blood cell count
• Abdominal pain
• Increased liver enzyme activity
• Increased blood levels of hemoglobin breakdown products
• Increased liver enzyme levels due to liver damage
• Pain

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

• Loss of appetite
• Carpal tunnel syndrome (tingling, numbness, 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, urticaria, and itching
• Bone thinning, which can lead to a decrease in 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 1000 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 the 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 in the blood) before starting treatment.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products of the Office for Registration 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. By reporting side effects, you can help provide 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 on the blisters after: EXP. The expiry date refers to the last day of that month. Do not store above 30°C. 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 Symex Contains

• The active substance is exemestane. Each effervescent tablet contains 25 mg of exemestane.
• The other ingredients are: microcrystalline cellulose, crospovidone XL 10, polysorbate 80, mannitol, silica colloidal anhydrous, magnesium stearate, sucrose, spray-dried acacia, talc, titanium dioxide (E 171), Opaglos 6000: anhydrous ethanol, shellac, white wax, Carnauba wax.

What Symex Looks Like and Contents of the Pack

Symex is a white or almost white, round, biconvex effervescent tablet without engraving. Symex is available in PVC/PVDC/Aluminum/PVDC blisters containing 10, 15, 20, 30, 90, 100, 105, and 120 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Symphar Sp. z o.o. ul. Koszykowa 65 00-667 Warsaw tel.: +48 22 822 93 06 e-mail: symphar@symphar.com

Manufacturer/Importer

Symphar Sp. z o.o. ul. Chełmżyńska 249 04-458 Warsaw

Date of Last Revision of the Leaflet: