XELAMIN 25 mg Film-Coated Tablets

Зміст інструкції

1. XELAMIN film-coated tablets 25 mg
   1. What is XELAMIN and what is it used for
   2. What you need to know before you take XELAMIN
   3. How to take XELAMIN
   4. Possible side effects
   5. How to store XELAMIN
   6. Contents of the pack and other information

XELAMIN film-coated tablets 25 mg

Exemestane
Generic medicine

Read this leaflet carefully before 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 could harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes

What is in this leaflet

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

1. What is XELAMIN and what is it used for

Your medicine is called XELAMIN. XELAMIN belongs to the category of medicines known as aromatase inhibitors.
These medicines interfere with a substance called aromatase, which is necessary for the
production of female sex hormones, estrogens, especially in postmenopausal women. Reducing the level of
estrogens in the body is a way of treating hormone-dependent breast cancer.
XELAMIN is used in the treatment of hormone-dependent breast cancer in the early stage in
postmenopausal women who have completed 2-3 years of therapy with the medicine tamoxifene.
XELAMIN is also used in the treatment of hormone-dependent breast cancer in the advanced stage
in postmenopausal women when hormonal therapy with another medicine has not worked
well enough.

2. What you need to know before you take XELAMIN

Do not take XELAMIN

• If you are allergic to exemestane (the active ingredient of XELAMIN) or to any of the other ingredients of this medicine (listed in section 6).
• If you have not yet gone through menopause, i.e. you have a regular menstrual cycle.
• If you are pregnant, if you are likely to become pregnant or if you are breastfeeding.

Warnings and precautions

• Talk to your doctor, pharmacist or nurse before taking XELAMIN
• Before treatment with XELAMIN, your doctor may request blood samples to ensure that you have reached menopause.
• Before treatment, routine checks of your vitamin D levels will also be performed, as they may be very low in the early stages of breast cancer. If the levels are below normal, you will be given a vitamin D supplement.
• Before taking XELAMIN, tell your doctor if you have liver or kidney problems.
• Tell your doctor if you have a history or suffer from any condition that affects bone strength. Your doctor may need to measure bone density before and during treatment with XELAMIN. This is because medicines belonging to this class lower the level of female hormones and this can lead to a loss of bone mineral content which can become less resistant.

Other medicines and XELAMIN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those without a prescription.
XELAMIN must not be given at the same time as hormone replacement therapy (HRT).
The following medicines must be used with caution when taking XELAMIN. Tell your doctor if
you are taking:

• rifampicin (an antibiotic),
• carbamazepine or phenytoin (anticonvulsants used to treat epilepsy),
• St John's Wort (Hypericum perforatum), or preparations containing it.

For those who play sports: the use of the drug without therapeutic necessity constitutes doping and may
still result in a positive doping test.

Pregnancy and breastfeeding
Do not take XELAMIN during pregnancy or breastfeeding.
Tell your doctor if you are pregnant or if you think you might 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 using machines
If you experience drowsiness, dizziness or weakness during treatment with XELAMIN, do not drive vehicles or
use 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 following exactly the instructions of your doctor. If you have any doubts, consult your
doctor.
XELAMIN tablets must be taken by mouth every day after meals at approximately the same time. Your
doctor will inform you on how to take XELAMIN and for how long.
The recommended dose is one 25 mg tablet once a day.
If you need to go to hospital during treatment with XELAMIN, inform the medical staff about the
medicines you are taking.

Use in Children
The use of XELAMIN is not indicated in children.

If you take more XELAMIN than you should
If you have accidentally taken too many tablets, contact your doctor immediately or go to the Accident and
Emergency Department of the nearest hospital and show them the XELAMIN tablets pack.

If you forget to take XELAMIN
Do not take a double dose to make up for a missed tablet.
If you forget to take a tablet, take it as soon as you remember. If it is almost time to take the
next dose, take it at the usual time.

If you stop taking XELAMIN
Do not stop taking the tablets even if you feel well, unless your doctor tells you to.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, XELAMIN can cause side effects, although not everybody gets them.
Hypersensitivity, liver inflammation (hepatitis) and inflammation of the bile ducts of the
liver may occur, which can cause yellowing of the skin (cholestatic hepatitis). Symptoms include a
general feeling of unwellness, nausea, jaundice (yellowing of the skin and eyes), itching, pain on the right
side of the abdomen and loss of appetite. If you think you have any of these symptoms, contact your doctor
immediately for 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 side effects are
associated with estrogen 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 number of white blood cells
• Abdominal pain
• Elevated liver enzymes
• Elevated level of a hemoglobin degradation 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 for the little finger) or tingling/pins and needles of the skin
• Vomiting (nausea), constipation, indigestion, diarrhea
• Hair loss
• Skin rash, urticaria and itching
• Thinning of the bones which may weaken (osteoporosis), leading in some cases to bone fractures (breaks or cracks)
• Swelling of hands and feet
• Decreased number of platelets 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
• Liver inflammation
• Inflammation of the bile ducts of the liver which can 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 some blood cells (lymphocytes) and circulating platelets may also be observed, especially in patients with pre-existing lymphopenia (decreased number of lymphocytes in the blood).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through 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 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 which is stated on the package and on the blister after “Exp.”. The
expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What XELAMIN contains

• The active ingredient is Exemestane. Each film-coated tablet contains 25 mg of exemestane.
• The other ingredients 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 contents of the pack
XELAMIN tablets are white, round, biconvex, film-coated tablets (approximately 6 mm),
marked with “E” on one side.
XELAMIN is available in blister packs of 30 film-coated tablets.

Marketing Authorisation Holder:
LANOVA FARMACEUTICI S.r.l.
Via Conca D’Oro, 212 – 00141 Roma

Manufacturer

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