Exemestane STADA 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Exemestane Stada 25 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Exemestane Stada is and what it is used for
2. What you need to know before taking Exemestane Stada
3. How to take Exemestane Stada
4. Possible adverse effects
5. How to store Exemestane Stada
6. Contents of the pack and other information

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

This medicine is called Exemestano Stada. Exemestano belongs to a group of medicines known as aromatase inhibitors. These medicines interfere with a substance called aromatase, which is needed to produce female sex hormones, estrogens, particularly in postmenopausal women.

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

Exemestano Stada is used to treat early-stage hormone-dependent breast cancer 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 another hormonal treatment has not been sufficiently effective.

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

Do not take Exemestano Stada

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Exemestano Stada

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

Before starting treatment with exemestane, your doctor may carry out a blood test to confirm that you have reached menopause.

Important information for athletes

Athletes should be aware that this medicine contains a component that may result in a positive doping test.

Taking Exemestano Stada with other medicines

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

Exemestane must 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.

Inform your doctor if you are taking any of the following medicines:

• rifampicin (an antibiotic),
• carbamazepine or phenytoin (anticonvulsants used to treat epilepsy),
• the herbal remedy St John’s wort (Hypericum perforatum), or preparations containing it.

Pregnancy and breastfeeding

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

Talk to your doctor about contraceptive measures if there is any possibility of becoming pregnant.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

If you experience dizziness, drowsiness or fatigue while taking 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; essentially “sodium-free”.

3. How to take Exemestano Stada

Follow exactly the instructions for use of this medicine provided by your doctor. If in doubt, consult your doctor or pharmacist. Your doctor will advise you on 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, at approximately the same time each 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, contact your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service at: 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 a missed dose.

If you forget to take a tablet, take it as soon as you remember. If it is almost time for your next dose, take the next dose 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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. In general, exemestane is well tolerated, and the following adverse effects observed in patients treated with exemestane are mainly mild or moderate. Most of the adverse effects are associated with reduced estrogen levels (for example, hot flushes).

Very common: may affect more than 1 in 10 people

• Difficulty sleeping
• Headache
• Hot flushes
• 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

• Loss of appetite
• Depression
• Dizziness, carpal tunnel syndrome (a combination of tingling, numbness, and pain affecting the whole hand except the little finger), tingling (paraesthesia)
• Stomach pain, vomiting (feeling unwell), constipation, indigestion, diarrhoea
• Skin rash, hair loss, hives, itching
• Decreased bone density which may reduce bone strength (osteoporosis) and lead to fractures in some cases (breaks or cracks)
• Pain, swelling of hands and feet

Uncommon: may affect up to 1 in 100 people

• Hypersensitivity
• Numbness
• Generalized acute exanthematous pustulosis (skin eruption characterized by pustules, which may be accompanied by fever)
• Muscle weakness

Liver inflammation (hepatitis) may occur. Symptoms include general feeling of malaise, nausea, jaundice (yellowing of the skin and eyes), itching, pain in the right side of the abdomen, and loss of appetite. Contact your doctor as soon as possible if you think you are experiencing any of these symptoms.

If you have had a blood test, you may have noticed changes in liver function. There may be changes in the levels of certain blood cells (lymphocytes) and platelets (blood cells responsible for clotting) circulating in the blood, especially in patients with pre-existing lymphopenia (reduced lymphocyte count in the blood).

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Exemestane Stada

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Exemestano Stada

• The active substance is exemestane.

Each film-coated tablet contains 25 mg of exemestane.

• Other components are:

Tablet core:

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

Coating:

Hypromellose, macrogol 400, titanium dioxide.

Appearance of the medicine and contents of the pack

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

Exemestano Stada is available in blister packs containing:

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

Only some 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 medicinal product is authorised in the Member States of the European Economic Area under the following names:

Germany: Exemestan Stada 25 mg Filmtabletten

Denmark: Exemestan Stada

Spain: Exemestano Stada 25 mg film-coated tablets EFG

France: EXEMESTANE EG 25 mg, comprimé pelliculé

Hungary: Funamel 25 mg filmtabletta

Italy: Exemestane EG 25mg compresse rivestite con film

Netherlands: Exemestaan CF 25 mg, filmomhulde tabletten

Portugal: Exemestano Stada

Romania: Memelin 25mg, comprimate filmate

Sweden: Exemestan Stada 25 mg filmdragerade tabletter

Slovak Republic: Exemestan Stada 25 mg

Date of the most recent revision of this leaflet: August 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/