Axelta

Italy
Brand name Axelta
Form tablets, film-coated
Active substance / Dosage
EXEMESTANE
Prescription type Prescription only
ATC code
L02BG06
Registration number 040012
Manufacturer ISTITUTO GENTILI S.R.L.

Table of Contents

Package leaflet: Information for the user

AXELTA 25 mg film-coated tablets

Exemestane
Generic medicine
Read this entire 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 questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, because it could be harmful.
  • If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What AXELTA is and what it is used for

Your medicine is called AXELTA. AXELTA contains the active substance exemestane, which belongs to a
class of medicines known as "aromatase inhibitors". These medicines interfere with a substance called aromatase,
which is required for the production of female sex hormones, the estrogens, particularly in postmenopausal women.
Reducing estrogen levels in the body is a way of treating hormone-dependent breast cancer.
AXELTA is used to treat postmenopausal women with early-stage hormone-dependent breast cancer who have
completed approximately 2 to 3 years of prior therapy with the medicine tamoxifen.
It is also indicated for the treatment of advanced hormone-dependent breast cancer in postmenopausal women
in whom prior hormonal therapy with another anti-estrogen medicine has not been effective.

2. What you need to know before taking AXELTA

Do not take AXELTA
if you are allergic to the active substance exemestane or to any of the other ingredients of this
medicinal product (listed in section 6);
if you are not yet menopausal, i.e. if you still have regular menstrual cycles;
if you are pregnant, suspect you may be pregnant, or if you are breastfeeding (see section
“Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking AXELTA:
if you have liver or kidney problems;
if you have had or currently have any condition affecting bone strength. Your doctor may perform tests to measure your bone density before and during treatment with AXELTA, because medicines in this class reduce levels of female hormones, which may lead to loss of bone mineral content and reduced bone strength.
Before starting treatment, your doctor may request blood samples to confirm that you have reached menopause.
Before starting treatment with AXELTA, your doctor may also request blood tests to check your vitamin D levels, as these may be very low in the early stages of breast cancer. If your levels are below normal, your doctor will prescribe a vitamin D supplement.

Other medicines and AXELTA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
AXELTA must not be administered concurrently with hormone replacement therapy (HRT). The following medicines should be used with caution while taking AXELTA. Inform your doctor if you are taking medicines such as:
rifampicin (an antibiotic);
carbamazepine or phenytoin (anticonvulsants used in the treatment of epilepsy);
St. John’s wort (Hypericum perforatum), or preparations containing it.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding with breast milk, consult your doctor or pharmacist before taking this medicine.
You must not take AXELTA if you are pregnant or breastfeeding.
Inform your doctor if you are pregnant or think you might be pregnant.
Discuss effective methods of contraception with your doctor if there is any possibility that you could become pregnant during treatment.

Driving and using machines
If you experience drowsiness, dizziness, or weakness while taking AXELTA, you should not drive or operate machinery.

AXELTA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.
For individuals engaged in sports activities: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to take AXELTA

Take this medicine exactly as your doctor or pharmacist has told you. If you are
unsure, consult your doctor or pharmacist.
Your doctor will tell you how to take AXELTA and for how long.
If you need to go to hospital during treatment with AXELTA, inform the medical
staff about the medicines you are taking.

Adult and elderly patients
The usual dose is one 25 mg coated tablet daily.
Take the tablets after a meal, every day at approximately the same time.

Use in children and adolescents
The use of AXELTA in children and adolescents is not recommended.

If you take more AXELTA 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 AXELTA packaging.

If you forget to take AXELTA
Do not take a double dose to make up for the forgotten dose.
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 tablet at the scheduled time.

If you stop taking AXELTA
Do not stop taking the tablets even if you feel well, unless your doctor decides otherwise.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Hypersensitivity, liver inflammation (hepatitis), and inflammation of the liver's bile ducts which may cause yellowing of the skin (cholestatic hepatitis) may occur. Symptoms include general malaise, nausea, yellowing of the skin and eyes (jaundice), 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.

AXELTA has generally been well tolerated, and the following side effects listed below, observed in patients treated with this medicine, have been mild to moderate in severity. Most adverse reactions can be attributed to oestrogen deficiency (e.g. hot flushes).

Very common: may affect more than 1 in 10 people

  • depression;
  • difficulty sleeping;
  • headache;
  • hot flushes;
  • nausea;
  • dizziness;
  • increased sweating;
  • muscle and joint pain (including arthralgia, osteoarthritis, back pain, arthritis, myalgia, and joint stiffness);
  • fatigue;
  • reduced number of white blood cells in the blood;
  • abdominal pain;
  • elevated liver enzymes;
  • increased level of an enzyme in the blood due to liver damage;
  • elevated level of a haemoglobin breakdown product in the blood;
  • tenderness.

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, constipation, indigestion, diarrhoea;
  • skin rash, urticaria, itching;
  • hair loss;
  • thinning of the bones which could weaken (osteoporosis), possibly leading to bone fracture (break or crack) in some cases;
  • swelling of the hands and feet;
  • reduced 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
Liver inflammation (hepatitis) may also occur. Symptoms include:

  • drowsiness;
  • appearance of a skin rash with small blisters;
  • inflammation of the liver's bile ducts which may cause yellowing of the skin and eyes (jaundice);
  • liver inflammation.

Not known: frequency cannot be estimated from the available data

  • Low level of a certain type of blood cells.

Changes in blood cell counts (lymphocytes) and platelets (cells responsible for blood clotting) may also occur, particularly in patients with pre-existing lymphopenia (reduced number of lymphocytes).

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 AXELTA

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 refers to the last day of that month.
This medicine does not require any 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 AXELTA contains

  • the active substance is: exemestane. Each coated tablet contains 25 mg of exemestane;
  • the other components are: Tablet core: polysorbate 80, mannitol, hypromellose 5cP, crospovidone, microcrystalline cellulose, sodium starch glycolate type A, anhydrous colloidal silica, magnesium stearate. Coating: titanium dioxide (E171), propylene glycol, hypromellose 5cP.

Description of the appearance of AXELTA and pack contents
White, round, biconvex coated tablets.
The pack contains 30 coated tablets in a blister pack.
Marketing Authorization Holder
Istituto Gentili S.r.l. - Via San Giuseppe Cottolengo 15, 20143 Milano (MI)
Manufacturer
Genetic S.p.A. - Contrada Canfora, 84084 Fisciano (SA), Italy
This leaflet was last updated on