AROMASIN 25 mg Film-Coated Tablets

Зміст інструкції

1. Aromasin 25 mg Coated Tablets
   1. What Aromasin is and what it is used for
   2. What you need to know before taking Aromasin
   3. How to take Aromasin
   4. Possible side effects
   5. How to store Aromasin
   6. Package Contents and Other Information

Aromasin 25 mg Coated Tablets

(Exemestane)

Read this leaflet carefully before you start taking this medicine as 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 their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Aromasin is and what it is used for

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

2. What you need to know before taking Aromasin

Do not take Aromasin

• If you are allergic to exemestane (the active ingredient of Aromasin) or to any of the other ingredients of this medicine (listed in section 6).
• If you have notyet 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 using Aromasin
• Before treatment with Aromasin, your doctor may request blood samples to make sure that you have reached menopause.
• Before treatment, routine checks of your vitamin D levels will also be performed, as they can 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 Aromasin, tell your doctor if you have problems with your liver or kidneys.
• Tell your doctor if you have a history or suffer from any condition that affects bone strength. Your doctor may need to measure your bone density before and during treatment with Aromasin. This is because medicines belonging to this class lower the Pag. 1of 5

level of female hormones and this can lead to a loss of mineral content of the bones which
can become less resistant.

Other medicines and Aromasin
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Aromasin must not be given together with hormone replacement therapy (HRT).
The following medicines must be used with caution when taking Aromasin. Tell 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 athletes: 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 Aromasin 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 Aromasin, do not drive
vehicles or use machines.

Aromasin contains sucrose, sodium and methyl-parahydroxybenzoate

• If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.
• Aromasin contains a small amount of methylparahydroxybenzoate, which may cause allergic reactions (possibly delayed); if this happens to you, contact your doctor.

3. How to take Aromasin

Adults and elderly patients
Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor.
Aromasin tablets should be taken by mouth every day after meals at approximately the same time.
Your doctor will inform you how to take Aromasin 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 Aromasin, inform the medical staff
about the medicines you are taking.

Use in children
The use of Aromasin is not indicated in children.

If you take more Aromasin 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 Aromasin tablets pack.
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If you forget to take Aromasin
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 Aromasin
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, Aromasin can cause side effects, although not everybody gets them.
Hypersensitivity, liver inflammation (hepatitis) and inflammation of the bile ducts of the liver, which can
cause yellowing of the skin (cholestatic hepatitis), can occur. Symptoms include a general feeling of
being unwell, 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.
Aromasin is well tolerated and the side effects listed below, observed in patients treated with
Aromasin, 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 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 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 can 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

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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 Aromasin

• Keep this medicine out of the sight and reach of children.
• 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 any particular storage conditions.

Do not dispose of any medicine in the drain or in 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 Aromasin contains

• The active ingredient is exemestane. Each coated tablet contains 25 mg of exemestane.
• The other ingredients are: hydrated colloidal silica, crospovidone, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, sodium carboxymethylcellulose (type A), polysorbate, polyvinyl alcohol, simethicone, sucrose macrogol, light magnesium carbonate, methyl parahydroxybenzoate (E218), cetyl esters wax, talc, carnauba wax, ethyl alcohol, lacquer, titanium dioxide (E171) and iron oxides (E172).

Description of the appearance of Aromasin and package contents
Aromasin tablets are coated, round, biconvex, whitish in color,
marked 7663 on one side.
Aromasin is available in blister packs of 15, 20, 30, 90, 100 and 120 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
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Pfizer Italia S.r.l., via Isonzo 71 – 04100 Latina

Manufacturer:
Pfizer Italia S.r.l
Località Marino del Tronto 63100 – Ascoli Piceno (AP)
Italy.

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Austria, Belgium, Denmark, Finland, Germany,
Greece, Iceland, Ireland, Italy, Luxembourg,
Netherlands, Portugal, Sweden, United Kingdom Aromasin
France Aromasine
Spain Aromasil
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