Package leaflet: Information for the patient

AROMEK 2.5 mg, film-coated tablets
Letrozole
Please read the entire leaflet carefully before starting treatment, as it contains important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately.

Table of contents:

What A is and what it is used for
Important information before taking A
How to take A
Possible side effects
How to store A
Contents of the pack and other information

1. What A is and what it is used for
A is a white, round, film-coated tablet containing 2.5 mg of letrozole. It is a medicine used in
postmenopausal women for the first-line treatment of advanced hormone receptor-positive
breast cancer.
A is also indicated for the treatment of advanced breast cancer in postmenopausal women
(naturally or artificially induced menopause) who have previously been treated with anti-estrogen receptor agents and in whom disease has recurred or progressed.
A is indicated as adjuvant therapy in postmenopausal women with early-stage hormone-dependent breast cancer.
A is indicated for extended adjuvant therapy in postmenopausal women with early-stage hormone-dependent breast cancer, following surgery and standard adjuvant therapy with tamoxifen.
Estrogens are sex hormones that may stimulate the growth of certain types of breast cancer. A inhibits the aromatase enzyme and works by suppressing the production of sex hormones – estrogens. The efficacy of the drug has not been demonstrated in patients with breast cancer lacking estrogen receptors.

2. Important information before taking A

When not to take A:

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
if the patient is pregnant or breastfeeding;
if the patient is premenopausal (women who still menstruate);
if the patient has severe liver disease.

Warnings and precautions
Before starting treatment with A, consult your doctor or pharmacist.
Exercise particular caution:

if the patient has severe renal impairment;
if the patient is receiving hormone replacement therapy;
if the patient is taking other medicines indicated for cancer treatment.

Discuss with your doctor even if the above warnings refer to conditions that occurred in the past.
During treatment, your doctor may recommend a bone density test. Letrozole belongs to a group of medicines that reduce hormone levels, including those responsible for maintaining normal bone density in women. Decreased bone density may lead to osteoporosis and bone fractures.
Children
A should not be used in children.
Other medicines and A
Inform your doctor about all medicines currently used, recently taken, or planned for use.
Pregnancy, breastfeeding and effects on fertility
A must not be used during pregnancy.
A must not be used during breastfeeding.
Driving and operating machinery
Fatigue or dizziness have been observed in some patients. If these symptoms occur, do not drive, operate machinery, or perform tasks requiring full concentration.
A contains lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.

3. How to take medicine A

This medicine should always be taken exactly as described in the patient leaflet or as directed by
your doctor. If in doubt, consult your doctor or pharmacist.
The recommended dose is one 2.5 mg tablet taken orally, once daily.
The tablet should be swallowed with a small amount of liquid. The duration of treatment will be determined by the attending physician.
Taking more medicine A than recommended
If you take more medicine than recommended, seek medical advice immediately from your doctor
or pharmacist.
Missing a dose of medicine A
If a dose has been missed at the usual time, take it as soon as possible. However, if it is almost time for the next dose, do not take a double dose to make up for the missed dose.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences
them.
Many of the observed adverse reactions are mild to moderate in severity and rarely so severe
that discontinuation of the medicine is required. Many adverse reactions may be symptoms of
the underlying disease or a consequence of inhibition of estrogen production in the body (e.g.
hot flushes or hair loss). Not all of these adverse reactions will necessarily occur, but if they do
occur, medical intervention may be necessary. You should contact your doctor if adverse
reactions do not resolve during treatment or are bothersome.
Adverse reactions may occur:
very commonly (occur in more than 1 in 10 patients),
commonly (occur in more than 1 in 100 but less than 1 in 10 patients),
uncommonly (occur in more than 1 in 1000 but less than 1 in 100 patients),
rarely (occur in more than 1 in 10,000 but less than 1 in 1000 patients),
very rarely (occur in less than 1 in 10,000 patients).
The following adverse reactions have been observed with the use of letrozole:
Infections and parasitic infections:
Uncommonly: urinary tract infections
Benign, malignant and unspecified neoplasms (including cysts and polyps):
Uncommonly: tumour pain
Blood and lymphatic system disorders:
Uncommonly: leukopenia
Metabolism and nutrition disorders:
Commonly: loss of appetite, increased appetite, increased serum cholesterol
Uncommonly: hypercholesterolaemia, generalised oedema
Psychiatric disorders:
Commonly: depression
Uncommonly: anxiety, including nervousness and irritability
Nervous system disorders:
Commonly: headache, dizziness
Uncommonly: somnolence, insomnia, memory disorders, abnormal sensation, including
paraesthesia, hypoesthesia, taste disturbances
Rarely: stroke
Eye disorders:
Uncommonly: cataract, eye irritation, visual disturbances
Cardiac disorders:
Uncommonly: palpitations, tachycardia
Vascular disorders:
Uncommonly: thrombophlebitis, including superficial and deep thrombophlebitis,
hypertension, myocardial ischaemia
Rarely: pulmonary embolism, arterial thrombosis, ischaemic stroke
Respiratory, thoracic and mediastinal disorders:
Uncommonly: dyspnoea
Gastrointestinal disorders:
Commonly: nausea, vomiting, dyspepsia, constipation, diarrhoea
Uncommonly: abdominal pain, stomatitis, dry mouth
Skin and subcutaneous tissue disorders:
Commonly: alopecia, increased sweating, rash (including erythematous rash, maculopapular
rash resembling psoriatic lesions, vesicular rash)
Uncommonly: pruritus, dry skin, urticaria
Musculoskeletal and connective tissue disorders:
Commonly: musculoskeletal pain (including muscle, bone and joint pain)
Renal and urinary disorders:
Uncommonly: increased frequency of urination
Reproductive system and breast disorders:
Uncommonly: genital bleeding, profuse leucorrhoea, vaginal dryness, breast pain
General disorders and administration site conditions:
Very commonly: hot flushes
Commonly: fatigue including asthenia, malaise, peripheral oedema
Uncommonly: fever, dry mucous membranes, thirst
Investigations:
Commonly: weight gain
Uncommonly: weight loss, increased aminotransferase activity
In some individuals, other adverse reactions may occur during treatment with medicine A.
If any adverse reactions not listed in this leaflet occur, they should be reported to the doctor.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, you
should inform your doctor or pharmacist. Adverse reactions can be reported directly to the
Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal
Products, Medical Devices and Biocidal Products {current address, telephone and fax number of
the above Department}
e-mail: [email protected]

5. How to store medicine A

Keep the medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Store in the original packaging.
Do not use the medicine if the purchased packaging shows any signs of having been opened or damaged.
Medicines must not be disposed of via sewage systems or household waste bins. Ask your pharmacist how to properly dispose of medicines that are no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What A contains
The active substance is letrozole.
The other ingredients are: microcrystalline cellulose, lactose monohydrate, corn starch,
sodium carboxymethyl starch, magnesium stearate.
Film-coating composition (Opadry AMB White):
polyvinyl alcohol, titanium dioxide (E 171), talc, soybean lecithin, xanthan gum.

What A looks like and contents of the pack
White, round, biconvex film-coated tablets.
Each container contains 30 film-coated tablets.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Celon Pharma S.A.
Ogrodowa 2A, Kiełpin
05-092 Łomianki
Tel.: (22) 751-59-33, e-mail: [email protected]

Manufacturer:
Celon Pharma S.A.
ul. Marymoncka 15
05-152 Kazuń Nowy

For further information, please contact the Marketing Authorisation Holder.

To protect the medicine from access by unauthorized persons and children, the container cap is equipped with a seal and a child-resistant closure mechanism.
Follow the instructions in the figures below to open the container correctly:
 PRESS DOWN FIRMLY  WHILE PRESSING, TURN THE CAP
HALF A TURN