Exemestane Aurobindo Italia

Package leaflet: Information for the user

Exemestane Aurobindo Italia 25 mg film-coated tablets

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Exemestane Aurobindo Italia is and what it is used for

Your medicine is called Exemestane Aurobindo Italia. Exemestane Aurobindo Italia belongs to a group of medicines known as aromatase inhibitors. These medicines interfere with a substance called aromatase, which is necessary 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.
Exemestane Aurobindo Italia 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.
Exemestane Aurobindo Italia 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 Exemestane Aurobindo Italia

Do not take Exemestane Aurobindo Italia

• if you are or have been allergic to exemestane (the active substance in Exemestane Aurobindo Italia), to soy, or to lecithin, 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 periods;
• if you are pregnant, suspect you may be pregnant, or are breastfeeding.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Exemestane Aurobindo Italia.

• Before starting treatment with Exemestane Aurobindo Italia, your doctor may request 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 early stages of breast cancer. If your levels are below normal, you will be given a vitamin D supplement.
• Before taking Exemestane Aurobindo Italia, 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 Exemestane Aurobindo Italia. 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 Exemestane Aurobindo Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Exemestane must not be administered together with hormone replacement therapy (HRT).
The following medicines should be used with caution during treatment with Exemestane Aurobindo Italia.
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.

Pregnancy and breastfeeding
Do not take Exemestane Aurobindo Italia 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 using machines
If you experience drowsiness, dizziness, or weakness during treatment with Exemestane Aurobindo Italia, you must not drive or operate machinery.

Exemestane Aurobindo Italia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. it is essentially ‘sodium-free’.

Exemestane Aurobindo Italia contains lecithin (soy)
Exemestane Aurobindo Italia contains lecithin derived from soy. If you are allergic to soy, do not use this medicine (see section 2 ‘Do not take Exemestane Aurobindo Italia’).

3. How to take Exemestane Aurobindo Italia

Adults and elderly patients
Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, consult your doctor or pharmacist.
Exemestane Aurobindo Italia tablets must be taken orally once daily after a meal, at approximately the same time each day. Your doctor will advise you on how to take Exemestane Aurobindo Italia and for how long to take it.
The recommended dose is one 25 mg tablet once daily.
If you need to go to hospital during treatment with Exemestane Aurobindo Italia, inform the medical staff about the medicines you are taking.

Use in children
Exemestane Aurobindo Italia is not indicated for use in children.

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

If you forget to take Exemestane Aurobindo Italia
Do not take a double dose to make up for the forgotten 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 Exemestane Aurobindo Italia
Do not stop taking the tablets even if you feel well, unless instructed by your doctor.
If you have any questions about using this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience 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, jaundice (yellowing of the skin and eyes), itching, pain in the right side of the abdomen, and loss of appetite. If you think you have any of these symptoms, contact your doctor immediately to receive urgent medical assistance.

Exemestane Aurobindo Italia is well tolerated, and the side effects listed below observed in patients treated with Exemestane Aurobindo Italia are mainly mild or moderate in severity. Most of these side effects are related to 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 white blood cell count
• Abdominal pain
• Elevated liver enzymes
• Elevated levels of a haemoglobin breakdown product in the blood
• Elevated levels 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/pricking sensation
• Vomiting (nausea), constipation, indigestion, diarrhoea
• Hair loss
• Skin rash, hives, and itching
• Thinning and weakening of bones (osteoporosis), which may in some cases lead 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

• Skin rash with small blisters
• Drowsiness
• Liver inflammation
• Inflammation of the liver's bile ducts, which may cause yellowing of the skin

Not known: frequency cannot be estimated from the available data

• Low levels 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 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 Exemestane Aurobindo Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and blister after EXP.
The expiry date refers to the last day of that month.
No special storage conditions are required for this medicine.
Do not dispose of medicines 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 Exemestane Aurobindo Italia contains
The active substance is exemestane.
Each tablet contains 25 mg of exemestane.
The other components are:
Tablet core: Pregelatinized starch, Corn starch, Microcrystalline cellulose (grade 101),
Microcrystalline cellulose (grade 102), Crospovidone (type A), Sodium starch glycolate (type A), Povidone (K
30), Polysorbate 80, Hydroxypropylcellulose (2.0–2.9 mPa.s), Talc, Anhydrous colloidal silica, Magnesium stearate.
Film coating: Polyvinyl alcohol, Titanium dioxide (E171), Talc, Lecithin (soy) (E322), Xanthan gum.

Description of the appearance of Exemestane Aurobindo Italia and the contents of the pack
Film-coated tablet.
Film-coated tablets, white to off-white, round, biconvex, with bevelled edges, approximately 6 mm in diameter, marked "25" on one side and smooth on the other.
Exemestane Aurobindo Italia film-coated tablets are available in blister packs containing 28, 30, 60, 98, 100 and 120 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Eugia Pharma (Malta) Limited
Vault 14, Level 2, Valletta Waterfront,
Floriana FRN 1914, Malta

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua Joao De Deus, no 19,
Venda Nova, 2700-487 Amadora
Portugal
Arrow Génériques,
26 Avenue Tony Garnier,
Lyon, 69007
France

This medicinal product is authorized in the European Economic Area Member States under the following names:
France: Exemestane ARROW LAB 25 mg, comprimé pelliculé.
Germany: Exemestan PUREN 25 mg Filmtabletten
Italy: Exemestane Aurobindo Italia
Malta: Exemestane Eugia 25 mg film-coated tablets
Portugal: Exemestano Generis
Spain: Exemestano Aurovitas 25 mg comprimidos recubiertos con película EFG