Exemestane Aurovitas Spain 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Exemestane Aurovitas Spain 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

In this leaflet:

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

1. What Exemestano Aurovitas Spain is and what it is used for

This medicine is called Exemestano Aurovitas Spain. Exemestane 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.

This medicine is used to treat early hormone-dependent breast cancer in postmenopausal women after completing 2–3 years of treatment with tamoxifen.

It is also used to treat advanced hormone-dependent breast cancer in postmenopausal women when alternative hormonal treatments have not been effective.

2. What you need to know before starting to take Exemestano Aurovitas Spain

Do not take Exemestano Aurovitas Spain

• if you are allergic to exemestane or to any of the other ingredients of this medicine (listed in Section 6)
• if you have not reached menopause, e.g. if you still have menstrual periods
• if you are pregnant, may become pregnant, or breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine:

• Before starting treatment with this medicine, your doctor may decide to perform blood tests to confirm that you have reached menopause.
• Before starting treatment with this medicine, inform your doctor if you have any liver or kidney disease.
• If you have had or currently have any condition affecting bone strength. This is because this type of medicine reduces levels of female hormones, which may lead to loss of bone mineral content and consequently reduce bone strength. Your doctor may decide to monitor your bone density before and during treatment with exemestane. Your doctor may prescribe medication or vitamin D supplements to prevent bone loss.

Other medicines and Exemestano Aurovitas Spain

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

This medicine must not be taken at the same time as hormone replacement therapy (HRT). The following medicines should be used with caution when administered simultaneously with exemestane. Inform your doctor if you are taking medicines such as:

• 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, breastfeeding and fertility

Do not take this medicine if you are pregnant or breastfeeding.

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Discuss with your doctor the use of contraceptive methods if there is any possibility you could become pregnant.

Driving and using machines

If you feel dizzy, drowsy or tired while taking exemestane, do not drive or operate machinery during treatment.

Exemestano Aurovitas Spain contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially “sodium-free”.

3. How to take Exemestane Aurovitas Spain

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.

Adults and elderly patients

Exemestane should be taken orally, after a meal, approximately at the same time each day. Your doctor will instruct you on how to take this medicine and for how long. The recommended dose is one 25 mg tablet daily.

Use in children

The use of this medicine is not recommended in children.

If you take more Exemestane Aurovitas Spain than you should

If you accidentally take too many tablets, contact your doctor immediately or go directly to the nearest hospital emergency department. Show them the Exemestane Aurovitas Spain packaging.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Exemestane Aurovitas Spain

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

If you forget to take your tablet, take it as soon as you remember. If it is almost time for your next dose, take the next dose at the scheduled time.

If you stop taking Exemestane Aurovitas Spain

Do not stop taking exemestane 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, pharmacist, or nurse.

4. Possible adverse effects

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

Hypersensitivity, liver inflammation (hepatitis), and inflammation of the liver's bile ducts causing yellowing of the skin (cholestatic hepatitis) may occur. Symptoms include general 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.

In general, exemestane is well tolerated, and the following adverse effects observed in patients treated with this medicine are mild or moderate in nature. Most adverse effects are related to estrogen deficiency (for example, hot flushes).

Very common adverse effects (may affect more than 1 in 10 people):

• Depression
• Difficulty sleeping
• Headache
• Hot flushes
• Dizziness
• Feeling unwell
• Increased sweating
• Joint and muscle pain (including osteoarthritis, back pain, arthritis, and joint stiffness)
• Fatigue
• Decreased number of white blood cells
• Abdominal pain
• Elevated liver enzymes
• Elevated levels of hemoglobin breakdown products in the blood
• Elevated levels of blood enzymes due to liver damage
• Pain

Common adverse effects (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/tingling sensations
• Nausea (feeling sick), vomiting, constipation, indigestion, diarrhea
• Hair loss
• Skin rash, hives, and itching
• Loss of bone mass that may reduce bone strength (osteoporosis) and occasionally lead to fractures (breaks or cracks)
• Swelling of hands and feet
• Reduced number of platelets in the blood
• Feeling of muscle weakness

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

• Hypersensitivity

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

• Appearance of small blisters in a skin rash
• Somnolence
• Liver inflammation
• Inflammation of the liver bile ducts causing yellowing of the skin

Frequency not known (cannot be estimated from available data):

• Low levels of certain white blood cells in the blood

There may also be changes in the number of certain blood cells (lymphocytes) and platelets circulating in the blood, especially in patients with pre-existing lymphopenia (low lymphocyte count in the blood).

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products, Website: www.notificaRAM.es

5. Storage of Exemestane Aurovitas Spain

This medicine does not require special storage conditions.

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

Do not use Exemestane Aurovitas Spain after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

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

6. Contents of the container and additional information

Composition of Exemestane Aurovitas Spain

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

The other components are:

Tablet core: Mannitol, copovidone, crospovidone, silicified microcrystalline cellulose, sodium starch glycolate (Type A) from potato, magnesium stearate.

Tablet coating: Hypromellose, polyethylene glycol 400, and titanium dioxide.

Appearance of the product and contents of the container

Film-coated, round, white or almost white tablets, with "25" engraved on one side and smooth on the other.

Exemestane Aurovitas Spain is available in blister packs (10 tablets) containing 30 and 100 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos 16-D

28036 Madrid

Spain

Manufacturer:

EirGen Pharma Limited

Westside Business Park

Old Kilmeaden Road

Waterford (Ireland)

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

United Kingdom: Exemestane 25mg Film-coated tablets

Spain: Exemestano Aurovitas Spain 25 mg comprimidos recubiertos con película EFG

Date of the most recent review of this leaflet: April 2022

Detailed 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/.