EXEMESTANE STADA 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Exemestano Stada 25 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Exemestano Stada and what is it used for
2. What you need to know before you take Exemestano Stada
3. How to take Exemestano Stada
4. Possible side effects.
5. Storage of Exemestano Stada
6. Contents of the pack and further information

1. What is Exemestano Stada and what is it used for

This medicine is called Exemestano Stada. Exemestano belongs to a group of medicines called aromatase inhibitors. These medicines interfere with a substance called aromatase, which is necessary for producing female sex hormones, estrogens, especially in postmenopausal women.

Reducing estrogen levels in the body is a way of treating hormone-dependent breast cancer.

Exemestano Stada is used to treat hormone-dependent breast cancer in early stages in postmenopausal women after they have completed 2-3 years of treatment with the medicine tamoxifen.

Exemestano Stada is also used to treat advanced hormone-dependent breast cancer in postmenopausal women when other hormonal treatment has not been effective enough.

2. What you need to know before you take Exemestano Stada

Do not take Exemestano Stada

• if you are or have been previously allergic to exemestane or any of the other ingredients of this medicine (listed in section 6).
• if you have not yet reached menopause, i.e., if you still have your period,
• if you are pregnant, think you may be pregnant, or are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before taking Exemestano Stada

• if you have any liver or kidney problems.
  • if you have a history of or suffer from any disease that affects bone strength. This is because medicines in this group reduce female hormone levels, which can lead to a loss of bone mineral content and may decrease bone strength. Your doctor may analyze bone density before and during treatment. Your doctor may prescribe a medicine to prevent or treat bone loss.
  • if you have a vitamin D deficiency.

Before starting treatment with exemestane, your doctor may perform a blood test to ensure you have reached menopause.

Important information for athletes

Athletes are informed that this medicine contains a component that may result in a positive doping test.

Using Exemestano Stada with other medicines

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Exemestane should not be administered at the same time as hormone replacement therapy (HRT).

The following medicines should be used with caution if you are being treated with exemestane.

Tell your doctor if you are taking any of these medicines:

• rifampicin (an antibiotic),
• carbamazepine or phenytoin (anticonvulsants used to treat epilepsy),
• the herbal medicine St. John's Wort (Hypericum perforatum), or preparations that contain it.

Pregnancy and breastfeeding

Do not take exemestane if you are pregnant or breastfeeding. Tell your doctor if you are pregnant or think you may be pregnant.

Talk to your doctor about contraceptive measures if there is any chance you may become pregnant.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

If you feel dizzy, drowsy, or tired while being treated with exemestane, you should not drive or operate machinery.

Exemestano Stada contains sodium

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

3. How to take Exemestano Stada

Follow exactly the administration instructions of this medicine as indicated by your doctor. In case of doubt, consult your doctor or pharmacist. Your doctor will tell you how to take exemestane and for how long.

Adults and elderly patients

The recommended dose is one 25 mg tablet per day.

Exemestane tablets should be taken orally after a meal, approximately at the same time every day.

Use in children and adolescents

Exemestane is not suitable for use in children and adolescents.

If you take more Exemestano Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Exemestano Stada

Do not take a double dose to make up for forgotten doses.

If you forget to take a tablet, take it as soon as you remember. If it is near the time of the next dose, take it at the usual time.

If you stop taking Exemestano Stada

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 are mainly mild or moderate. Most side effects are associated with the reduction of estrogens (such as hot flashes).

Very common: may affect more than 1 in 10 people

• Difficulty sleeping
• Headache
• Hot flashes
• Feeling unwell
• Increased sweating
• Muscle and joint pain (including osteoarthritis, back pain, arthritis, and joint stiffness)
• Fatigue

Common: may affect up to 1 in 10 people

• Lack of appetite
• Depression
• Dizziness, carpal tunnel syndrome (a combination of tingling, numbness, and pain that affects the entire hand except the little finger), tingling (paresthesia)
• Stomach pain, vomiting (feeling unwell), constipation, indigestion, diarrhea
• Skin rash, hair loss, hives, itching.
• Decreased bone density that may decrease bone strength (osteoporosis) and cause fractures in some cases (breaks or cracks)
• Pain, swelling of hands and feet

Uncommon: may affect up to 1 in 100 people

• Hypersensitivity
• Numbness
• Acute generalized exanthematous pustulosis (skin rash characterized by pustules and may be accompanied by fever)
• Muscle weakness

It may cause liver inflammation (hepatitis). The symptoms include general feeling of being unwell, nausea, jaundice (yellow color of the skin and eyes), itching, pain in the right upper abdomen, and loss of appetite. Contact your doctor as soon as possible if you think you have any of these symptoms.

If you have had a blood test, you may have seen that there have been changes in liver function. There may be changes in the number of certain blood cells (lymphocytes) and platelets (the blood cells responsible for clotting) that circulate in the blood, especially in patients with pre-existing lymphopenia (decrease in lymphocytes in the blood).

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Exemestano Stada

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Exemestano Stada

• The active substance is exemestane.

Each film-coated tablet contains 25 mg of exemestane.

• The other ingredients are:

Core of the tablet:

Mannitol, copovidone, crospovidone, silified microcrystalline cellulose, sodium carboxymethyl starch (Type A) (from potato), magnesium stearate.

Coating:

Hypromellose, macrogol 400, titanium dioxide.

Appearance and packaging

Round, white to off-white tablet, marked with "25" on one side and smooth on the other.

Exemestano Stada is available in blister packs of:

10, 30, 60, 90, 100, and 120 (blisters of 10) film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

EirGen Pharma Ltd.

Westside Business Park,

Old Kilmeaden Road, Waterford

Ireland

or

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

Eurogenerics N.V.

Heizel Esplanade B22

1020 Brussels

Belgium

or

Pharmacare Premium Ltd

HHF003 Hal Far Industrial Estate

Birzebbugia, BBG3000

Malta

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany: Exemestan Stada 25 mg film-coated tablets

Denmark: Exemestan Stada

Spain: Exemestano Stada 25 mg film-coated tablets EFG

France: EXEMESTANE EG 25 mg, film-coated tablet

Hungary: Funamel 25 mg film-coated tablet

Italy: Exemestane EG 25mg film-coated tablets

Netherlands: Exemestaan CF 25 mg, film-coated tablets

Portugal: Exemestano Stada

Romania: Memelin 25mg, film-coated tablets

Sweden: Exemestan Stada 25 mg film-coated tablets

Slovak Republic: Exemestan Stada 25 mg

Date of last revision of this leaflet:August 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/