Glandex

Package Leaflet: Information for the Patient

GLANDEX, 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 those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Glandex and what is it used for

Glandex is a medicine that contains the active substance exemestane, which belongs to a group of medicines called aromatase inhibitors.
This substance blocks the action of the aromatase enzyme necessary for the production of female sex hormones - estrogens, especially in postmenopausal women. Reducing the amount of estrogen in the body is a way to treat hormone-dependent breast cancer.
Glandex is intended for the treatment of early hormone-dependent breast cancer in postmenopausal women, after 2-3 years of initial treatment with tamoxifen. The medicine is also used to treat advanced breast cancer in postmenopausal women, in whom the disease has progressed despite the use of other hormonal medicines.

2. Important information before taking Glandex

When not to take Glandex:

if you are allergic to exemestane or any of the other ingredients of this medicine (listed in section 6);
in premenopausal women, i.e. those who still menstruate;
in women who are pregnant or breastfeeding;
in women who are planning to become pregnant.

Warnings and precautions

Before starting treatment with Glandex, discuss it with your doctor or pharmacist.
Your doctor will order a blood test to determine if you are in a state of natural or treatment-induced menopause;
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You should inform your doctor about any worrying symptoms related to liver or kidney problems;
You should inform your doctor about any events or facts that may be relevant to the assessment of bone health and the risk of osteoporosis. This type of medicine significantly reduces the activity of female sex hormones, so you can expect a decrease in bone mechanical strength. When starting treatment and during treatment, bone health (densitometric examination) should be monitored;
Before starting treatment, your doctor may recommend checking vitamin D levels, as a significant deficiency is often found in women with early breast cancer. If a deficiency is found, your doctor will recommend taking vitamin D.

Glandex and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Glandex should not be taken with medicines that contain estrogens, such as those used in hormone replacement therapy (HRT).
Caution is advised when taking Glandex with:

• certain antibiotics (rifampicin);
• certain anti-epileptic medicines used to treat epilepsy (carbamazepine, phenytoin);
• medicines and other products containing St. John's wort (Hypericum perforatum).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Glandex should not be taken during pregnancy.
Glandex should not be taken during breastfeeding, due to the lack of complete data on the penetration of exemestane into breast milk.
You should discuss the use of appropriate contraception with your doctor, including women who may become pregnant (including those in the perimenopausal period and women who have recently stopped menstruating, until the cycle permanently stops).

Driving and using machines

It has been found that taking Glandex can sometimes cause weakness, drowsiness, dizziness, and decreased physical performance, which may impair the ability to drive or operate machinery.

3. How to take Glandex

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, ask your doctor. Your doctor will tell you how to take Glandex and how long the treatment will last.

Adults and elderly patients (over 65 years)

One coated tablet (25 mg) should be taken once daily.
Glandex coated tablets should be taken after a meal, at the same time every day.
Your doctor will inform you about the duration of treatment.
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If you need to be hospitalized while taking Glandex, inform the hospital staff that you are taking this medicine.
In patients with early breast cancer, Glandex should be taken for 2 to 3 years, as a continuation of previous tamoxifen therapy, so that the total treatment time is 5 years. If the tumor recurs, treatment with Glandex can be stopped earlier.
In patients with advanced breast cancer, Glandex should be continued until significant disease progression is observed.

Use in children and adolescents

Glandex is not recommended for use in children and adolescents.

Use in patients with renal and hepatic impairment

The medicine should be used with caution in patients with renal and hepatic impairment.
No dose adjustment is required in patients with renal or hepatic impairment.

Use in elderly patients (over 65 years)

No dose adjustment is required in elderly patients.

Overdose of Glandex

Do not take more than the recommended dose of Glandex.
In case of overdose, contact your doctor immediately, showing them the packaging or patient information leaflet of the medicine. Depending on the symptoms, your doctor will provide appropriate treatment.

Missed dose of Glandex

Do not take a double dose to make up for a missed dose.
Take the medicine as soon as possible, but if it is almost time for the next dose, take it as scheduled.

Stopping treatment with Glandex

Only your doctor can decide to stop treatment with exemestane.
Do not stop treatment without consulting your doctor. Do not stop taking the medicine if you feel better, without consulting your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Glandex can cause side effects, although not everybody gets them.
Glandex is well tolerated, and the side effects reported by patients taking Glandex were mild or moderate. Most side effects are related to the reduction of estrogen levels (e.g., hot flashes).
Very common side effects(affecting more than 1 in 10 people):
insomnia,
headache,
hot flashes,
nausea,
increased sweating,
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joint and musculoskeletal pain (including joint pain, less frequently limb pain, osteoarthritis, back pain, arthritis, muscle pain, and joint stiffness),
feeling of excessive tiredness.
Common side effects(affecting 1 to 10 people in 100):
loss of appetite,
depression,
carpal tunnel syndrome (tingling sensation in the hand, except for the little finger), paresthesia (unpleasant sensations, usually resembling tingling or numbness),
dizziness,
vomiting, diarrhea, constipation, dyspepsia, abdominal pain,
hair loss, rash, urticaria, itching,
bone fractures, osteoporosis (reduced bone mineralization and density),
pain, swelling of hands and feet.
Uncommon side effects(affecting 1 to 10 people in 1,000):
leukopenia (reduced white blood cell count),
hypersensitivity,
drowsiness,
hepatitis, cholestatic hepatitis (hepatitis caused by bile stasis), increased liver enzyme activity, increased bilirubin and alkaline phosphatase levels in the blood,
acute generalized exanthematous pustulosis,
weakness.
Rare side effects(affecting 1 to 10 people in 10,000):
thrombocytopenia (reduced platelet count).
Unknown frequency of side effects(frequency cannot be estimated from available data):
lymphopenia (reduced lymphocyte count in the blood).

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 the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw,
phone: +48 22 49 21 301, fax: +48 22 49 21 309,
e-mail: ndl@urpl.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 the medicine.

5. How to store Glandex

No special precautions for storage are necessary.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
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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 Glandex contains

• -The active substance of Glandex is exemestane. One coated tablet contains 25 mg of exemestane.
• The other excipients are: mannitol, copovidone (K=28), crospovidone, microcrystalline cellulose (microcrystalline cellulose, silicon dioxide), sodium carboxymethylcellulose (type A), magnesium stearate, and coating (hypromellose, macrogol 400, titanium dioxide - E 171).

What Glandex looks like and contents of the pack

Glandex is a white or almost white, round, biconvex coated tablet, engraved with the number 25 on one side and smooth on the other.
One pack contains 30 coated tablets (3 blisters of 10 tablets each) in a cardboard box.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information about the medicine
phone: +48 (22) 742 00 22
e-mail: informacjaoleku@hasco-lek.pl

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland – Glandex

Date of last revision of the leaflet:12.02.2019 r.
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