Exemestane Normon 25 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Exemestano Normon 25 mg film-coated tablets EFG

Exemestane

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, 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 they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

Exemestano Normon belongs to a group of medicines called aromatase inhibitors. These drugs 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 Normon 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 Normon is used to treat advanced hormone-dependent breast cancer in postmenopausal women when another form of hormonal treatment has not been sufficiently effective.

2. What you need to know before taking Exemestano Normon

Do not take Exemestano Normon

• if you are allergic (hypersensitive) 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

• Before starting treatment with this medicine, your doctor may carry out a blood test to confirm that you have reached menopause.
• Before taking exemestane, 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 assess your bone density before and during treatment with exemestane. This is because medicines in this group reduce levels of female hormones, which may lead to a loss of bone mineral content and could decrease bone strength.

Other medicines and Exemestano Normon

Tell your doctor if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

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 (antiepileptics used to treat epilepsy),
• the herbal remedy St. John’s wort (Hypericum perforatum), or preparations containing it.

Taking Exemestano Normon with food and drink

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

Pregnancy and breastfeeding

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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and using machines

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

Use in athletes

This medicine contains exemestane, which may cause a positive result in doping control tests.

Exemestano Normon contains sodium

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

3. How to take Exemestane Normon

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

Adults and elderly patients

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

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

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

Use in children

Exemestane Normon is not suitable for use in children.

If you take more Exemestane Normon than you should

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 taken.

If you forget to take Exemestane Normon

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 almost time for your next dose, take the next dose at the usual time.

If you have any further questions about the use of this product, 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 this medicine 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)
• Tiredness

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)
• Stomach pain, vomiting (feeling unwell), constipation, indigestion, diarrhea
• Skin rash, hair loss
• 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):

• Numbness
• Muscle weakness

Liver inflammation (hepatitis) may occur. Symptoms include general feeling of being unwell, 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 circulating in the blood, especially in patients with pre-existing lymphopenia (low lymphocyte count in the blood).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist as soon as possible.

Reporting of adverse effects

If you experience any type of 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Exemestane Normon

This medicine does not require any special storage conditions.

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.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at 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 container and other information

Composition of Exemestane Normon

• The active substance is exemestane. Each coated tablet contains 25 mg of exemestane.
• The other components are microcrystalline cellulose, mannitol, crospovidone, sodium carboxymethylstarch type A (from potato), low-substituted hydroxypropylcellulose, hydroxypropylmethylcellulose, polyethylene glycol 6000, polysorbate 80, colloidal silica, magnesium stearate, titanium dioxide (E-171) and talc.

Appearance of the product and contents of the pack

Exemestane Normon are white or almost white, round, biconvex, coated tablets, printed with "E" on one side (imprinted with a punch).

Exemestane Normon is available in blister packs containing 30 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6-28760 Tres Cantos-Madrid (SPAIN)

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