PACKAGE LEAFLET: INFORMATION FOR THE USER

XELAMIN 25 mg film-coated tablets

Exemestane
Generic medicine
Please 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, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

What XELAMIN is and what it is used for
What you need to know before taking XELAMIN
How to take XELAMIN
Possible side effects
How to store XELAMIN
Contents of the pack and other information

1. What XELAMIN is and what it is used for

Your medicine is called XELAMIN. XELAMIN belongs to a class of medicines known as aromatase inhibitors. These medicines interfere with a substance called aromatase, which is needed for the production of female sex hormones, estrogens, particularly in postmenopausal women. Reducing estrogen levels in the body is a way of treating hormone-dependent breast cancer.

XELAMIN is used to treat early-stage hormone-dependent breast cancer in postmenopausal women who have completed 2-3 years of therapy with the medicine tamoxifen.

XELAMIN is also used to treat advanced-stage hormone-dependent breast cancer in postmenopausal women when hormonal therapy with another medicine has not been sufficiently effective.

2. What you need to know before taking XELAMIN

Do not take XELAMIN

If you are allergic to exemestane (the active substance in XELAMIN) or to any of the other ingredients of this medicine (listed in section 6).
If you have not yet reached menopause, i.e. you still have regular menstrual cycles.
If you are pregnant, think you may be pregnant, or are breastfeeding.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking XELAMIN.
Before starting treatment with XELAMIN, your doctor may require blood tests to confirm that you have reached menopause.
Routine checks of your vitamin D levels may also be performed before treatment begins, as these levels can be very low in the early stages of breast cancer. If your levels are below normal, you will be given a vitamin D supplement.
Before taking XELAMIN, inform your doctor if you have 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 consider it necessary to measure your bone mineral density before and during treatment with XELAMIN. This is because medicines in this class reduce levels of female hormones, which may lead to loss of bone mineral content and weaker bones.

Other medicines and XELAMIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
XELAMIN must not be taken at the same time as hormone replacement therapy (HRT).
The following medicines should be used with caution when taking XELAMIN. Inform your doctor if you are taking:

rifampicin (an antibiotic),
carbamazepine or phenytoin (anticonvulsants used in the treatment of epilepsy),
St. John’s wort (Hypericum perforatum), or preparations containing it.

For individuals engaged in sports: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Pregnancy and breastfeeding
Do not take XELAMIN during pregnancy or while breastfeeding.
Inform your doctor if you are pregnant or think you may be pregnant.
Women who could become pregnant during treatment are advised to discuss with their doctor the use of an effective method of contraception.
Driving and use of machines
If you experience drowsiness, dizziness, or weakness during treatment with XELAMIN, you should not drive or operate machinery.
XELAMIN contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take XELAMIN

Adults and elderly patients
Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.
XELAMIN tablets must be taken orally every day after meals, approximately at the same time each day. Your doctor will inform you how to take XELAMIN and for how long.
The recommended dose is one 25 mg tablet once daily.
If you need to go to hospital during treatment with XELAMIN, inform the medical staff about the medicines you are taking.

Use in Children
XELAMIN is not indicated for use in children.

If you take more XELAMIN than you should
If you accidentally take too many tablets, contact your doctor immediately or go to the nearest hospital emergency department, and show them the XELAMIN tablet packaging.

If you forget to take XELAMIN
Do not take a double dose to make up for the missed 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 XELAMIN
Do not stop taking the tablets even if you feel well, unless instructed by your doctor.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, XELAMIN may cause side effects, although not everyone experiences them.
Hypersensitivity, liver inflammation (hepatitis), and inflammation of the liver bile ducts may occur, which can cause yellowing of the skin (cholestatic hepatitis). 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. If you think you are experiencing any of these symptoms, contact your doctor immediately to receive urgent medical assistance.

XELAMIN is well tolerated, and the side effects listed below observed in patients treated with XELAMIN are mainly mild or moderate in severity. Most of these side effects are related to oestrogen deficiency (e.g. hot flushes).

Very common: may affect more than 1 in 10 people

Depression
- Difficulty sleeping
- Headache
- Hot flushes
- Dizziness
- Nausea
- 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 level of a haemoglobin breakdown product in the blood
- Elevated level of an enzyme in the blood due to liver damage
- Pain

Common: may affect up to 1 in 10 people

Loss of appetite
Carpal tunnel syndrome (a sensation of pins and needles, numbness, and pain in the hand except the little finger) or skin tingling/prickling
Vomiting (nausea), constipation, indigestion, diarrhoea
Hair loss
Rash, urticaria, and itching
Thinning of bones which may become weakened (osteoporosis), possibly leading in some cases to bone fractures (breaks or cracks)
Swelling of hands and feet
Reduced platelet count in the blood
Feeling of weakness

Uncommon: may affect up to 1 in 100 people

Hypersensitivity

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

Appearance of a skin rash with small blisters
Drowsiness
Hepatitis (liver inflammation)
Inflammation of the liver bile ducts which may cause yellowing of the skin

Not known: frequency cannot be estimated from the available data

Low level of a certain type of white blood cells in the blood

Changes in the number of certain blood cells (lymphocytes) and circulating platelets may also occur, particularly in patients with pre-existing lymphopenia (reduced number of lymphocytes in the blood).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store XELAMIN

Keep this medicine out of the sight and reach of children. Store the tablets in a safe place where children cannot see or reach them.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What XELAMIN contains

The active substance is Exemestane. Each film-coated tablet contains 25 mg of exemestane.
The other components are: Polysorbate 80, Mannitol, Hypromellose 5cP, Crospovidone (Type A), Microcrystalline cellulose, Sodium starch glycolate (Type A), Anhydrous colloidal silica, Magnesium stearate and Opadry white OY-S-9622 (which consists of: titanium dioxide (E171), Propylene glycol, Hypromellose 5cP, purified water).

Description of the appearance of XELAMIN and package contents
XELAMIN tablets are white, round, biconvex film-coated tablets (approximately 6 mm),
marked with "E" on one side.
XELAMIN is available in blister packs containing 30 film-coated tablets.
Marketing Authorization Holder:
LANOVA FARMACEUTICI S.r.l.
Via Conca D’Oro, 212 – 00141 Rome, Italy
Manufacturer

Genepharm S.A., 18 Km Marathon Avenue, 15351 Pallini, Greece This leaflet was last approved on