Aromek

Package Leaflet: Information for the Patient

AROMEK 2.5 mg, film-coated tablets

Letrozole

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist.

Table of Contents of the Leaflet:

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

1. What AROMEK is and what it is used for

AROMEK is a white, round, film-coated tablet containing 2.5 mg of letrozole. It is a medicine used in the treatment of breast cancer in postmenopausal women with hormone receptor-positive advanced breast cancer.
AROMEK is also indicated for the treatment of advanced breast cancer in women with natural or artificially induced menopause who have previously been treated with drugs that block estrogen receptors and have experienced a relapse or progression of the disease.
AROMEK is indicated for adjuvant treatment in postmenopausal women with hormone receptor-positive early breast cancer.
AROMEK is indicated for extended adjuvant treatment in postmenopausal women with hormone receptor-positive early breast cancer, after surgery and standard adjuvant treatment with tamoxifen.
Estrogens are sex hormones that can stimulate the growth of some types of breast cancer. AROMEK works by inhibiting the enzyme aromatase, which leads to a decrease in the production of sex hormones - estrogens. The efficacy of the medicine has not been established in patients with breast cancer that does not have estrogen receptors.

2. Important information before taking AROMEK

When not to take AROMEK:

Warnings and precautions

Before starting treatment with AROMEK, consult your doctor or pharmacist.
Particular caution should be exercised:

You should discuss this with your doctor even if the above warnings apply to situations that have occurred in the past.
During treatment, your doctor may order a bone density test. Letrozole belongs to a group of medicines that lower the level of hormones responsible, among other things, for maintaining normal bone density in women. Decreased bone density can lead to osteoporosis and fractures.

Children

AROMEK is not intended for use in children.

Other medicines and AROMEK

Tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

AROMEK should not be taken during pregnancy.
AROMEK should not be taken during breastfeeding.

Driving and using machines

Some people may experience fatigue or dizziness. If you experience these symptoms, do not drive, operate machinery, or perform tasks that require full concentration.

AROMEK contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take AROMEK

Always take this medicine exactly as described in the patient information leaflet or as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one 2.5 mg tablet taken orally once a day.
Swallow the tablet with a small amount of liquid. The duration of treatment is determined by your doctor.

Overdose of AROMEK

If you have taken more than the recommended dose of the medicine, consult your doctor or pharmacist immediately.

Missed dose of AROMEK

If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, AROMEK can cause side effects, although not everybody gets them.
Many of the observed side effects are mild to moderate and rarely severe enough to require discontinuation of the medicine. Many side effects may be symptoms of the underlying disease or a consequence of the inhibition of estrogen production in the body (e.g., hot flashes or hair loss). Not all side effects have to occur, but if they do, medical intervention may be necessary. You should consult your doctor if side effects do not disappear during treatment or are troublesome.
Side effects may occur:

very commonly (occurring in more than 1 in 10 patients),
commonly (occurring in more than 1 in 100 but less than 1 in 10 patients),
uncommonly (occurring in more than 1 in 1000 but less than 1 in 100 patients),
rarely (occurring in more than 1 in 10,000 but less than 1 in 1000 patients),
very rarely (occurring in less than 1 in 10,000 patients).
The following side effects have been observed with letrozole:

Infections and infestations:

Uncommonly: urinary tract infections

Benign, malignant, and unspecified neoplasms (including cysts and polyps):

Uncommonly: tumor pain

Blood and lymphatic system disorders:

Uncommonly: leukopenia

Metabolism and nutrition disorders:

Commonly: decreased appetite, increased appetite, increased serum cholesterol levels
Uncommonly: hypercholesterolemia, general edema

Psychiatric disorders:

Commonly: depression
Uncommonly: anxiety, including nervousness and irritability

Nervous system disorders:

Commonly: headache, dizziness
Uncommonly: somnolence, insomnia, memory impairment, abnormal sensation, including paresthesia, hypoaesthesia
Rarely: cerebrovascular accident

Eye disorders:

Uncommonly: cataract, eye irritation, visual disturbances

Cardiac disorders:

Uncommonly: palpitations, tachycardia

Vascular disorders:

Uncommonly: thrombophlebitis, including superficial and deep vein thrombophlebitis, hypertension, myocardial ischemia
Rarely: pulmonary embolism, arterial thrombosis, ischemic cerebrovascular accident

Respiratory, thoracic, and mediastinal disorders:

Uncommonly: dyspnea

Gastrointestinal disorders:

Commonly: nausea, vomiting, dyspepsia, constipation, diarrhea
Uncommonly: abdominal pain, stomatitis, dry mouth

Skin and subcutaneous tissue disorders:

Commonly: alopecia, increased sweating, rash (including erythematous, maculopapular, and papulovesicular 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 urinary frequency

Reproductive system and breast disorders:

Uncommonly: vaginal bleeding, vaginal discharge, vaginal dryness, breast pain

General disorders and administration site conditions:

Very commonly: hot flashes
Commonly: fatigue, including asthenia, malaise, peripheral edema
Uncommonly: fever, dryness of mucous membranes, thirst

Investigations:

Commonly: weight gain
Uncommonly: weight loss, increased liver enzymes

In some individuals, other side effects may occur during treatment with AROMEK. If you experience any other symptoms not listed in this leaflet, please inform your doctor.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products {current address, phone number, and fax of the Department}
e-mail: [email protected]

5. How to store AROMEK

Keep the medicine out of the sight and reach 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 month.
Store in the original packaging.
Do not use the medicine if the packaging has been tampered with or damaged.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What AROMEK contains

The active substance is letrozole.
The other ingredients are: microcrystalline cellulose, lactose monohydrate, corn starch, sodium carboxymethylcellulose, magnesium stearate.
Coating (Opadry AMB White):
polyvinyl alcohol, titanium dioxide (E 171), talc, soy lecithin, xanthan gum.

What AROMEK looks like and contents of the pack

White, round, biconvex, film-coated tablets.
One container contains 30 film-coated tablets.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization 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.
Marymoncka 15
05-152 Kazuń Nowy
To obtain more detailed information, please contact the Marketing Authorization Holder.
To protect the medicine from unauthorized access and children, the cap of the packaging is equipped with a seal and a child-resistant opening mechanism.
Follow the instructions below to open the packaging correctly:
 PRESS THE CAP
TURN BY HALF
TURN
Date of last revision of the leaflet:03.2018
 PRESS THE CAP
STRONGLY