Exemestane Teva-Ratiopharm 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Exemestane Teva-ratiopharm 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, pharmacist or nurse.
• 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 side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Exemestano Teva-ratiopharm is and what it is used for

This medicine is called Exemestano Teva-ratiopharm. Exemestano Teva-ratiopharm belongs to a group of medicines known as aromatase inhibitors. These medicines interfere with a substance called aromatase, which is required 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 Teva-ratiopharm 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.

Additionally, Exemestano Teva-ratiopharm is used to treat advanced hormone-dependent breast cancer in postmenopausal women when another type of hormonal treatment has not been sufficiently effective.

2. What you need to know before starting to take Exemestano Teva-ratiopharm

Do not take Exemestano Teva-ratiopharm

• if you are allergic to exemestane or to any of the other ingredients of this medicine (listed in section 6),
• if you have not yet reached menopause, that is, 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, pharmacist, or nurse before starting to take Exemestano Teva-ratiopharm

• Before starting treatment with Exemestano Teva-ratiopharm, your doctor may perform a blood test to confirm that you have reached menopause.
• Before starting treatment with Exemestano Teva-ratiopharm, your doctor may carry out a blood test to measure your Vitamin D levels. This is because severe Vitamin D deficiency is common in women with early breast cancer. If your Vitamin D levels are low, your doctor will prescribe a vitamin D supplement.
• Before taking Exemestano Teva-ratiopharm, inform your doctor if you have any liver or kidney problems.
• Inform your doctor if you have a history of, or currently suffer from, any condition affecting bone strength. Your doctor may measure your bone mineral density before and during treatment with Exemestano Teva-ratiopharm. This is because medicines in this class reduce levels of female hormones, which may lead to loss of bone mineral content and could decrease bone strength.

Children and adolescents

This medicine is not recommended for use in children and adolescents.

Other medicines and Exemestano Teva-ratiopharm

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

Exemestano Teva-ratiopharm must not be taken at the same time as hormone replacement therapy (HRT). The following medicines should be used with caution if you are being treated with Exemestano Teva-ratiopharm. Inform your doctor if you are taking any of these medicines:

• rifampicin (an antibiotic),
• carbamazepine or phenytoin (antiepileptic medicines used to treat epilepsy),
• the herbal preparation St. John’s wort (Hypericum perforatum), or products containing it.

Pregnancy and breastfeeding

Do not take Exemestano Teva-ratiopharm if you are pregnant or breastfeeding.

If you are pregnant or think you may be pregnant, consult your doctor.

Talk to your doctor about contraceptive measures if there is any possibility you could become pregnant.

Driving and using machines

If you experience dizziness, drowsiness, or fatigue while being treated with Exemestano Teva-ratiopharm, do not drive or operate machinery.

Exemestano Teva-ratiopharm contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; essentially “sodium-free”.

3. How to take Exemestano Teva-ratiopharm

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Adults and elderly patients

Exemestano Teva-ratiopharm film-coated tablets should be taken orally after a meal, approximately at the same time each day.

Your doctor will advise you on how to take Exemestano Teva-ratiopharm and on the duration of treatment.

The recommended dose is one 25 mg tablet per day.

If you need to go to the hospital while being treated with Exemestano Teva-ratiopharm, inform the medical staff about the medication you are taking.

If you take more Exemestano Teva-ratiopharm than you should

If you accidentally take too many tablets, contact your doctor immediately, go directly to the nearest hospital emergency department, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount taken. Show them the Exemestano Teva-ratiopharm packaging.

If you forget to take Exemestano Teva-ratiopharm

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

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 Teva-ratiopharm

Do not interrupt treatment even if you do not feel well, unless your doctor tells you to.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Hypersensitivity may occur, and can lead to liver inflammation (hepatitis) and inflammation of the liver bile ducts causing yellowing of the skin (cholestatic hepatitis). Symptoms include general malaise, nausea, jaundice (yellowing of the skin and eyes), itching, right-sided abdominal pain, and loss of appetite. Contact your doctor immediately or seek urgent medical help if you think you may have any of these symptoms.

In general, Exemestane Teva-ratiopharm is well tolerated, and the following adverse effects observed in patients treated with Exemestane Teva-ratiopharm are mainly mild or moderate in nature. Most adverse effects are related to reduced estrogen levels (such as hot flushes).

Very common (affects more than 1 in 10 people):

• Depression
• Difficulty sleeping
• Headache
• Hot flushes
• Dizziness
• Malaise
• Increased sweating
• Muscle and joint pain (including osteoarthritis, back pain, arthritis, and joint stiffness)
• Fatigue
• Decreased white blood cell count
• Abdominal pain
• Elevated liver enzymes
• Elevated levels of hemoglobin breakdown products in blood
• Elevated blood enzyme levels due to liver damage
• Pain

Common (may affect up to 1 in 10 people):

• Loss of appetite
• Carpal tunnel syndrome (a combination of tingling, numbness, and pain affecting the entire hand except the little finger), or skin tingling and itching
• Vomiting (feeling unwell), constipation, indigestion, diarrhea
• Skin rash, hives, and itching
• Decreased bone density, which may reduce bone strength (osteoporosis) and lead to fractures in some cases (breaks or cracks)
• Swelling of hands and feet
• Reduced platelet count in blood
• Feeling of weakness

Uncommon (may affect up to 1 in 100 people):

• Hypersensitivity

Rare (may affect up to 1 in 1,000 people):

• Painful rash with small blisters in one area of the skin
• Somnolence
• Liver inflammation
• Inflammation of the liver bile ducts causing yellowing of the skin

Not known (cannot be estimated from available data):

• Low levels of certain white blood cells in blood

Changes in the number of certain blood cells (lymphocytes) and platelets (cells involved in blood clotting) may also occur, particularly in patients with pre-existing lymphopenia (low lymphocyte count in blood).

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, 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 Medicines website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Exemestane Teva-ratiopharm

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

Do not use this medicine after the expiry date stated on the packaging and blister 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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Exemestano Teva-ratiopharm

The active substance is exemestane. Each film-coated tablet contains 25 mg of exemestane.

The other components are:

Tablet core:

Mannitol (E-421), Copovidone, Crospovidone, Silicified microcrystalline cellulose (containing microcrystalline cellulose and colloidal anhydrous silica), Sodium starch glycolate from potato (Type A), Magnesium stearate.

Film coating:

Hypromellose, Macrogol 400, Titanium dioxide (E171)

Appearance of the product and contents of the pack

Film-coated tablets, white to off-white, round, convex, 6 mm in diameter, marked "25" on one side and smooth on the other.

Exemestano Teva-ratiopharm is available in pack sizes of:

10, 14, 20, 30, 50x1, 60, 90, 100 film-coated tablets (blister packs of 10, 14 or 30 tablets).

Only certain pack sizes may be marketed.

Marketing Authorization Holder
Teva Pharma, S.L.U.
C/ Anabel Segura 11, Edificio Albatros B
1st Floor, Alcobendas
28108 Madrid, Spain

Manufacturer

EirGen Pharma Ltd.
Westside Business Park, Old Kilmeaden Road, Waterford
Ireland

or

TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen
Hungary

or

Pharmachemie B.V.
Swensweg 5, 2031 GA Haarlem
The Netherlands

This medicinal product is authorized in the European Economic Area member states under the following names:

AT: Exemestan Teva 25 mg Filmtabletten
BE: Exemestane Teva 25 mg filmomhulde tabletten
BG: Alnair 25 mg ????????? ????????
CY: Exemestane Teva 25mg Επικαλυμ?να με λεπτ? υμ?νιο δισκ?α
CZ: Exemestan Teva 25mg
DE: Exemestan Teva 25 mg Filmtabletten
DK: Exemestane TEVA
EE: Exemestane Teva 25mg
EL: Exemestane / Teva 25mg Επικαλυμ?να με λεπτ? υμ?νιο δισκ?α
ES: Exemestano Teva-ratiopharm 25mg comprimidos recubiertos con película EFG
FR: Exemestane Teva 25 mg, comprimé pelliculé
HU: Exemestan Teva 25 mg filmtabletta
IT: Exemestane Teva 25mg compresse rivestite
LT: Exemestane Teva
LU: Exemestane Teva 25 mg comprimés pelliculés
LV: Exemestane Teva 25 mg apvalkotas tabletes
NL: Exemestaan 25 mg Teva, filmomhulde tabletten
NO: Exemestane Teva 25mg filmdrasjerte tabletter
PL: Exemestane PharOS Generics
PT: Exemestano Teva
RO: Exemestan Teva 25 mg, comprimate filmate
SE: Exemestane Teva 25mg filmdragerade tabletter
SK: Exemestan Teva 25mg
UK: Exemestane 25mg Film-coated tablets

Date of the most recent review of this leaflet: April 2020

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

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included on the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/73282/P_73282.html

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