Clarzole

Package leaflet: Information for the patient

Clarzole, 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 for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Clarzole is and what it is used for

What Clarzole is and how it works
Clarzole contains an active substance called letrozole. It belongs to a group of medicines known as aromatase inhibitors. It is used in hormonal (endocrine) treatment of breast cancer.
The growth of breast cancer is often stimulated by estrogens, which are female sex hormones. Clarzole reduces the amount of estrogen by inhibiting the activity of an enzyme (aromatase) involved in estrogen production. Therefore, it may inhibit the growth of estrogen-dependent malignant breast tumors. As a result of this action, tumor cells stop growing or grow more slowly and (or) stop spreading to other parts of the body.

What Clarzole is used for
Clarzole is used to treat 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 after five years of tamoxifen therapy. Clarzole 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 about how Clarzole works or why it was prescribed, please consult your doctor.

2. Information before using Clarzole

Follow your doctor's advice, as it may differ from the general information
provided in this leaflet.
When not to use Clarzole

• if the patient is allergic to letrozole or to any of the other ingredients of this medicine (listed in section 6)
• if the patient is still having menstrual periods, i.e. has not yet reached menopause
• if the patient is pregnant
• if the patient is breastfeeding.

Do not take this medicine if any of these situations apply to the patient – consult a doctor.
Warnings and precautions
Before starting treatment with Clarzole, discuss this with your doctor or pharmacist.

• if the patient has severe kidney disease
• if the patient has severe liver disease
• in case of osteoporosis or if the patient has previously experienced bone fractures (see “Monitoring during treatment with Clarzole” in section 3). If any of these situations apply, inform the doctor. The doctor will consider this information during treatment with Clarzole.

Letrozole may cause tendon inflammation or tendon damage (see section 4). If the patient
experiences tendon pain or swelling, the affected area should be rested and the patient should contact
a doctor.
Children and adolescents (under 18 years of age)
This medicine should not be used in children and adolescents.
Elderly patients (65 years of age and older)
Patients aged 65 years and older may take the same dose as other adult patients.
Clarzole and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient intends to take.
Pregnancy, breastfeeding and fertility

• Clarzole should only be used when the patient is postmenopausal. However, the doctor will discuss with the patient the need for an effective method of contraception, as pregnancy may still occur during treatment with Clarzole.
• Clarzole must not be used if the patient is pregnant or breastfeeding, as treatment may harm the unborn or breastfed child.

Driving and operating machinery
If the patient experiences dizziness, fatigue, drowsiness or general malaise,
she must not drive or operate tools and machinery until her condition returns
to normal.
Clarzole contains lactose
Clarzole contains lactose (milk sugar). If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.
Clarzole contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Clarzole

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult
your doctor or pharmacist.
The usual dose is one coated tablet of Clarzole taken once daily.
Taking Clarzole 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 be swallowed whole with a glass of water or another liquid.

How long to take Clarzole
You should take Clarzole 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 Clarzole, consult your doctor.

Monitoring during treatment with Clarzole
This medicine should always be used under strict medical supervision. Your doctor will regularly monitor your health to ensure the treatment is effective.
Clarzole 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.

Taking more Clarzole than prescribed
If you have taken more Clarzole than prescribed, or if someone accidentally swallows tablets, contact your doctor immediately or go to hospital. Show the medicine packaging. Treatment may be necessary.

Missed dose of Clarzole

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

Stopping Clarzole treatment
Do not stop taking Clarzole unless your doctor tells you to do so (see section "How long to take Clarzole").
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Most of the observed adverse reactions are mild to moderate in intensity
and generally appear within a few days to a few weeks of starting treatment.
Some of them, such as hot flushes, hair loss or vaginal bleeding, may be
consequences of estrogen deficiency in the body.
Do not be alarmed by all the possible adverse reactions of the medicine listed below.
They may not occur at all.
Some adverse reactions may be serious:
Uncommon (may affect up to 1 in 100 people)

• weakness, paralysis or loss of sensation in any part of the body (especially in the arm or leg), loss of coordination, nausea or difficulty speaking or breathing (symptoms of brain disorders, e.g. stroke)
• sudden, pressing chest pain (symptom of heart disorders)
• swelling and redness along a vein, extremely tender and painful to touch
• high fever, chills or mouth ulcers due to infections (lack of white blood cells)
• severe, persistent vision disturbances
• tendon inflammation (soft tissue connecting muscles and bones).

Rare (may affect up to 1 in 1000 people)

• difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin discoloration or sudden pain in the arm, leg or foot (symptoms indicating blood clot formation)
• tendon rupture (soft tissue connecting muscles and bones).

If any of the above symptoms occur, inform the doctor immediately.
You should also inform the doctor immediately if any of the following symptoms occur in a patient during treatment with Clarzole:

• 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 liver inflammation)
• rash, skin redness, blistering of the lips, eyes or mouth, skin peeling, fever (symptoms of skin disorders).

Other adverse reactions
Very common (may affect more than 1 in 10 people)

• hot flushes
• increased cholesterol levels (hypercholesterolemia)
• feeling of fatigue
• excessive sweating
• bone and joint pain. If any of these symptoms occur severely in a patient, inform the doctor.

Common (may affect up to 1 in 10 people)

• skin rash
• headache
• dizziness
• general malaise
• gastrointestinal disorders such as: nausea, vomiting, indigestion, constipation, diarrhoea
• increased appetite or loss of appetite
• muscle pain
• thinning or loss of bone tissue (osteoporosis), which in some cases may lead to bone fractures (see "Monitoring during treatment with Clarzole" in section 3)
• swelling of arms, hands, feet and ankles (oedema)
• depression
• weight gain
• hair loss
• increased blood pressure (hypertension)
• abdominal pain
• dry skin
• genital bleeding
• palpitations, rapid heartbeat
• joint stiffness (arthritis)
• chest pain. If any of these symptoms occur severely in a patient, inform the doctor.

Uncommon (may affect up to 1 in 100 people)

• nervous system disorders such as anxiety, nervousness, irritability, drowsiness, memory problems, feeling sleepy, insomnia
• pain or burning in the hands or wrist (carpal tunnel syndrome)
• sensory disturbances, especially touch
• eye disorders such as blurred vision, eye irritation
• skin disorders such as itching (urticaria)
• genital discharge or vaginal dryness
• breast pain
• fever
• thirst, taste disturbances, dry mouth
• inflammation of the mouth and lips
• dryness of mucous membranes
• weight loss
• urinary tract infection, more frequent urination
• cough
• increased enzyme activity
• . yellowing of the skin and whites of the eyes
• high bilirubin levels in blood (a breakdown product of red blood cells)

Unknown (frequency cannot be estimated from available data)

• triggering tendon inflammation – a condition in which a finger or thumb locks in a bent position.

If any of these symptoms occur severely in a patient, inform the doctor.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder. By reporting adverse reactions, more information on the safety of the medicine can be collected.

5. How to store Clarzole

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Clarzole contains

• The active substance is letrozole. Each coated tablet contains 2.5 mg of letrozole.
• Other ingredients are:
• Tablet core: lactose monohydrate, corn starch, sodium carboxymethyl starch (type A), microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.
• Tablet coating: polyvinyl alcohol, talc, macrogol 3350, titanium dioxide (E 171), iron oxide yellow (E 172).

What Clarzole looks like and contents of the pack
Clarzole 2.5 mg, coated tablets, are yellow, round, biconvex.
The medicine is available in the following pack sizes:
Blister packs: 30, 60 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Actavis Group PTC ehf.
220 Hafnarfjörður
Iceland

Manufacturer
S.C. Sindan – Pharma S.R.L.
11 Ion Mihalache Blvd
011171 Bucharest
Romania

For further information, contact the marketing authorisation holder's representative:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.