Letrozole genthon

Letrozole Pharmalab, 2.5 mg, film-coated tablets
Letrozolum
Please read the entire leaflet before using the medicine, as it contains important information
for the patient.

• Keep this leaflet for future reference.
• Consult your doctor or pharmacist if you need advice or further information.
• This medicine has been prescribed for a specific individual and should not be passed on to others, as it may harm them even if their symptoms are the same.
• If any of the side effects worsen or if any side effects occur, including those not listed in this leaflet, inform your doctor or pharmacist (see section 4).

Leaflet contents:

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

1. What Letrozole Pharmalab is and what it is used for

What is Letrozole Pharmalab and how does it work?
Letrozole Pharmalab contains an active substance called letrozole. It belongs to a group of medicines known as aromatase inhibitors. It is used for hormonal (i.e. endocrine) treatment of breast cancer. The growth of breast cancer is often stimulated by estrogens, which are female sex hormones. Letrozole reduces the amount of estrogen by blocking an enzyme ("aromatase") involved in estrogen production, and therefore may inhibit the growth of estrogen-dependent malignant breast tumors. As a result, progression or spread of tumor cells to other parts of the body may be slowed down or stopped.

For what purpose is Letrozole Pharmalab used?
Letrozolum is used in the treatment of breast cancer in postmenopausal women, i.e. women who have stopped menstruating.
This medicine is used to prevent recurrence of breast cancer. It may be used as initial treatment before breast surgery when immediate surgery is not recommended, or as initial treatment after breast surgery, or following five years of tamoxifen therapy. Letrozole Pharmalab is also used to prevent the spread of breast tumor to other parts of the body in patients with advanced breast cancer.
If you have any questions regarding how Letrozole Pharmalab works or why it has been prescribed, please consult your doctor.

2. Important information before using Letrozole Pharmalab

Follow your doctor's instructions. They may differ from the general information provided
in this leaflet.
Do not use Letrozole Pharmalab

• If you are allergic to letrozole or any of the other ingredients of the medicine (listed in section 6). In women who are still menstruating, i.e. in women before menopause.
• In women who are pregnant.
• In women who are breast-feeding. Do not take this medicine if any of these points apply to you – consult your doctor.

Warnings and precautions
Before starting treatment with Letrozole Pharmalab, consult your doctor or
pharmacist

• if you have severe kidney disease,
• if you have severe liver disease,
• if you have osteoporosis or have previously experienced bone fractures (see also section “Monitoring during treatment with Letrozolum” in section 3). If any of these points apply to you, inform your doctor. Your doctor will take these factors into account during treatment with Letrozole Pharmalab.

Letrozole may cause inflammation or damage to tendons (see section 4). If you
experience pain or swelling in a tendon, rest the affected area and contact your doctor.
Children and adolescents (under 18 years of age)
This medicine must not be used in children and adolescents.
Elderly patients (aged 65 years and over)
Patients aged 65 years and older may take the medicine at the same dosage as other adult
patients.
Letrozole Pharmalab and other medicines
Inform your doctor or pharmacist about any medicines you are currently taking, have recently taken,
or plan to take, including medicines obtained without a prescription.
Pregnancy, breast-feeding and fertility

• Letrozole Pharmalab should be used only in women who are postmenopausal. However, your doctor will discuss the need for an effective method of contraception, as pregnancy may still occur during treatment with Letrozole Pharmalab.
• Letrozole Pharmalab must not be used if you are pregnant or breast-feeding, as treatment may harm the unborn or nursing child. If you are pregnant or breast-feeding, suspect you may be pregnant, or are planning to have a child, you should consult your doctor or pharmacist before taking this medicine.

Driving and operating machinery
If you experience dizziness, drowsiness or general malaise, do not drive a car or operate any tools or machinery until these symptoms have resolved.
Letrozole Pharmalab contains lactose and sodium
Letrozole Pharmalab contains lactose. If you have been diagnosed with intolerance to certain sugars,
you should consult your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is considered essentially "sodium-free".

3. How to use Letrozole Pharmalab

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
The usual dose is one tablet of Letrozole Pharmalab taken once daily.
Taking Letrozole Pharmalab at the same time each day will help you remember to take your tablet.
The tablet may be taken with or without food and should always be swallowed whole with a glass of water or another liquid.

How long to take Letrozole Pharmalab
You should take Letrozole Pharmalab every day for as long as your doctor has instructed. Treatment may need to continue for several months or even years. If you have any questions about how long you should take Letrozole Pharmalab, consult your doctor.

Monitoring during treatment with Letrozole Pharmalab
This medicine must always be used under strict medical supervision. Your doctor will regularly monitor your health to ensure the treatment is effective.
Letrozole Pharmalab may cause thinning or loss of bone tissue (osteoporosis) due to reduced estrogen levels in the body. Your doctor may order a measurement of your bone density (osteoporosis monitoring test) before, during, and after treatment.

Overdose of Letrozole Pharmalab
If a higher than recommended dose of Letrozole Pharmalab has been taken, or if someone accidentally swallows tablets, contact your doctor immediately or go to a hospital. Show the medicine packaging. Treatment may be necessary.

Missed dose of Letrozole Pharmalab

• If the next dose is approaching (e.g. within 2 to 3 hours), skip the missed dose and take the next dose at the usual time.
• Otherwise, take the missed dose as soon as you remember, then take the next tablet at the usual time.
• Do not take a double dose to make up for a missed dose.

Stopping Letrozole Pharmalab
Do not stop taking Letrozole Pharmalab unless instructed by your doctor. See also the section above, "How long to take Letrozole Pharmalab".

4. Possible adverse effects

Like all medicines, letrozole may cause adverse effects, although not everyone experiences them.
Most of the adverse effects are mild or moderate in severity and usually resolve after a few
days or weeks of treatment. Some of these effects, such as hot flushes, hair loss and vaginal bleeding, may be due to oestrogen deficiency in the body.
Some adverse effects may be serious
The following adverse effects occur rarely or uncommonly (i.e. occur in 1 to 100 per 10,000 treated individuals).

• If weakness, numbness or loss of sensation in the arm, leg or any other part of the body, lack of coordination, nausea or difficulty speaking or breathing occur (symptoms of brain disease, e.g. stroke)
• If sudden, crushing chest pain occurs (symptom of heart disease)
• If difficulty breathing, chest pain, fainting, rapid heartbeat, skin discolouration or sudden pain in the arm or leg (foot) occur (symptom of blood clot formation)
• If swelling and redness along the course of a vein occur, with tenderness or severe pain on touch
• If high fever, chills or oral ulcers due to infection occur (due to lack of white blood cells)
• If serious, persistent blurred vision occurs.

If any of the above symptoms occur, contact a doctor immediately.
You should also contact the doctor immediately if any of the following symptoms occur in a patient being treated with Trozel:

• Swelling, mainly of the face and throat (symptoms of allergic reaction)
• Yellowing of the skin and eyes, nausea, loss of appetite, dark urine (symptoms of hepatitis)
• Rash, skin redness, formation of blisters on the lips, eyes or in the mouth, skin peeling, fever (symptoms of skin disorders).

Other possible adverse effects:
Very common (occurring in at least 1 in 10 treated individuals)

• Hot flushes
• Increased cholesterol levels (hypercholesterolaemia)
• Feeling of fatigue
• Excessive sweating
• Bone and joint pain (arthralgia)

If any of these symptoms become severe, inform the doctor.
Common (occurring in at least 1 in 100, but less than 1 in 10 treated individuals)

• Skin rash
• Headaches
• Dizziness
• General malaise
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhoea
• Increased or decreased appetite
• Muscle pain
• Thinning or loss of bone tissue (osteoporosis), leading in some cases to bone fractures (see also section "Monitoring during treatment with Trozel" in section 3)
• Swelling of arms, hands, feet, ankles (oedema)
• Depression
• Weight gain
• Hair loss (alopecia)
• Increased blood pressure (hypertension)
• Abdominal pain
• Dry skin
• Vaginal bleeding
• Palpitations, rapid heartbeat
• Joint stiffness (arthritis)
• Chest pain If any of these symptoms become severe, inform the doctor.

Uncommon (occurring in at least 1 in 1,000, but less than 1 in 100 treated individuals)

• Nervous system disorders such as anxiety, nervousness, irritability, drowsiness, memory disturbances, somnolence, insomnia
• Sensory disturbances, especially touch
• Eye disorders such as blurred vision or eye irritation
• Skin disorders such as itching (urticaria)
• Vaginal discharge or vaginal dryness
• Breast pain
• Fever
• Increased thirst, taste disturbances, dry mouth
• Dryness of mucous membranes
• Weight loss
• Urinary tract infections, frequent urination
• Cough
• Increased enzyme activity
• Yellowing of the skin and eyes
• High bilirubin levels in the blood (a breakdown product of red blood cells)
• Tendonitis (soft tissue connecting muscles and bones)

Rare

• Tendon rupture (soft tissue connecting muscles and bones)

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform the doctor. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw; tel.: + 48 22 49 21 301; fax: + 48 22 49 21 309
e-mail: [email protected]
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Letrozole Pharmalab

Keep out of the reach and sight of children.
No special storage instructions apply to Letrozole Pharmalab.
Do not use letrozole after the expiry date stated on the blister pack and the cardboard
pack after the words ‘expiry date’. The first two digits indicate the month and the last four digits
indicate the year. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask
your pharmacist what to do with medicines no longer required. This will help
protect the environment.

6. Other information

What Letrozole Pharmalab contains

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other ingredients are: monohydrate lactose, microcrystalline cellulose (E460), pregelatinized maize starch, sodium carboxymethyl starch (type A), magnesium stearate (E572), colloidal anhydrous silica (E551).
• Ingredients of the tablet coating: macrogol, talc (E553b), hypromellose (E464), titanium dioxide (E171), iron oxide yellow (E172).

What Letrozole Pharmalab looks like and contents of the pack
Yellow, round, film-coated tablet, embossed with the code L900 on one side and 2.5 on the other side.
Letrozole Pharmalab is available in blister packs in cartons containing 28, 30 or 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pharmalab Poland Sp. z o.o.
ul. Siemianowicka 84
41-902 Bytom
Poland

Manufacturers:
Synthon BV
Microweg 22
6545 CM Nijmegen
The Netherlands
Synthon Hispania S.L.
C/Castelló,1,
Poligono Las Salinas
08330 Sant Boi de Llobregat
Barcelona
Spain
Rottendorf Pharma GmbH
Ostenfelder strasse 51-61
59320 Ennigerloh
Germany
Industria Quimica y FCA VIR, S.A.
C/Laguna 66-70, Pol. Industrial Urtinsa II
28923 Alcorcón - Madrid
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
Bulgaria Letrozole Alvogen
Spain Letrozol Genthon 2.5 mg EFG
Hungary Letrozol Alvogen 2.5 mg
The Netherlands Letrozol Genthon 2.5 mg, filmomhulde tabletten
Poland Letrozole Pharmalab
Portugal Letrozol Genthon 2.5 mg
Romania Letrozol Alvogen 2.5 mg
Slovenia Letrozol Genthon 2.5 mg filmsko obložene tablete