Clazhole

Package Leaflet: Information for the Patient

Clarzole, 2.5 mg, Film-Coated Tablets

Letrozole

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

• 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. 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. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Clarzole and what is it 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 is Clarzole and what is it used for

What is Clarzole and how does it work

Clarzole contains the active substance letrozole. It belongs to a group of medicines called aromatase inhibitors. It is used in the 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 the enzyme (aromatase) involved in the production of estrogens, and thus can slow down the growth of malignant breast tumors that need estrogens to grow. As a result of this effect, cancer cells stop growing or grow slowly and (or) stop spreading to other parts of the body.

What is Clarzole 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 the recurrence of breast cancer. It can be used as the first treatment before breast surgery, when immediate surgery is not recommended, or as the first treatment after breast surgery, or after five years of tamoxifen treatment. Clarzole is also used to prevent the spread of breast cancer to other parts of the body in patients with advanced breast cancer. If you have any questions about how Clarzole works or why it has been prescribed for you, ask your doctor.

2. Important information before taking Clarzole

Follow the instructions of your doctor. They may be different from the general information in this leaflet.

When not to take Clarzole

Do not takethis medicine if any of these points apply to you - consult your doctor.

Warnings and precautions

Before starting treatment with Clarzole, discuss it with your doctor or pharmacist.

tell your doctor. Your doctor will take this information into account during treatment with Clarzole.

Letrozole may cause inflammation or damage to tendons (see section 4). If you experience pain or swelling of a tendon, rest the affected area and contact your 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 and over can use this medicine at the same dose as other adult patients.

Clarzole and other medicines

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

Pregnancy, breastfeeding, and fertility

• Clarzole should only be used when you are postmenopausal. However, your doctor will discuss with you the need for effective contraception, as you may still become pregnant during treatment with Clarzole.
• Do not take Clarzole if you are pregnant or breastfeeding, as treatment may harm your baby.

Driving and using machines

If you experience dizziness, fatigue, drowsiness, or general malaise, do not drive or operate machinery until your condition improves.

Clarzole contains lactose

Clarzole contains lactose (milk sugar). If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine.

Clarzole contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which is considered to be "sodium-free".

3. How to take Clarzole

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The usual dose is one film-coated tablet of Clarzole taken once a day. Taking Clarzole at the same time every day will help you remember to take your tablet. You can take the tablet with or without food, and you should swallow it whole with a glass of water or another liquid.

How long to take Clarzole

Take Clarzole every day for as long as your doctor has prescribed it. You may need to take it for several months or even years. If you have any questions about how long to take Clarzole, ask your doctor.

Monitoring during Clarzole treatment

This medicine should always be taken under close medical supervision. Your doctor will regularly check your health to ensure that the treatment is working properly. Clarzole may cause thinning or loss of bone tissue (osteoporosis) related to the decrease in estrogen levels in the body. Your doctor may order a bone density test before, during, and after treatment to check for osteoporosis.

Taking more than the prescribed dose of Clarzole

If you have taken more than the prescribed dose of Clarzole or if someone has accidentally taken your tablets, contact your doctor or go to the hospital immediately. Show them the medicine pack. You may need treatment.

Missing a dose of Clarzole

Stopping treatment with Clarzole

Do not stop taking Clarzole unless your doctor tells you to (see "How long to take Clarzole" in section 3). If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Clarzole can cause side effects, although not everybody gets them. Most of the observed side effects are mild to moderate and usually appear within a few days to a few weeks of treatment. Some of them, such as hot flashes, hair loss, or vaginal bleeding, may be a consequence of the lack of estrogen in the body. Do not be concerned about all the possible side effects listed below. They may not occur at all.

Some side effects can 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 cerebral disorders, such as stroke)
• sudden crushing chest pain (symptom of heart disorders)
• swelling and redness along a vein, extremely tender and painful to the touch
• high fever, chills, or mouth ulcers caused by infections (lack of white blood cells)
• severe, persistent vision disturbances
• tendon inflammation (inflammation of the soft tissue that connects muscles and bones).

Rare(may affect up to 1 in 1,000 people)

• difficulty breathing, chest pain, fainting, rapid heartbeat, blue discoloration of the skin, or sudden pain in the arm, leg, or foot (symptoms of blood clots)
• tendon rupture (inflammation of the soft tissue that connects muscles and bones).

If you experience any of these symptoms, tell your doctor immediately.

You should also tell your doctor immediately if you experience any of the following symptoms during treatment with Clarzole:

• swelling, mainly of the face and throat (symptoms of allergic reactions)
• yellowing of the skin and eyes, nausea, loss of appetite, dark urine (symptoms of liver inflammation)
• rash, redness of the skin, blistering of the lips, eyes, or mouth, peeling of the skin, fever (symptoms of skin disorders).

Other side effects
Very common(may affect more than 1 in 10 people)

• hot flashes
• increased cholesterol levels (hypercholesterolemia)
• fatigue
• increased sweating
• bone and joint pain. If any of these symptoms occur in a severe form, tell your doctor.

Common(may affect up to 1 in 10 people)

• skin rash
• headache
• dizziness
• general malaise
• gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
• increased or decreased appetite
• muscle pain
• thinning or loss of bone tissue (osteoporosis), which can lead to bone fractures (see "Monitoring during Clarzole treatment" in section 3)
• swelling of the arms, hands, feet, and ankles (edema)
• depression
• weight gain
• hair loss
• high blood pressure (hypertension)
• abdominal pain
• dry skin
• vaginal bleeding
• palpitations, rapid heartbeat
• joint stiffness (arthritis)
• chest pain. If any of these symptoms occur in a severe form, tell your doctor.

Uncommon(may affect up to 1 in 100 people)

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

Unknown(frequency cannot be estimated from the available data)

• trigger finger - a condition in which the finger or thumb catches or locks when bent.

If any of these symptoms occur in a severe form, tell your doctor.

Reporting 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 Drug Safety Monitoring, 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, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

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 month. 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 Clarzole contains

• The active substance of Clarzole is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other ingredients are:
• Tablet core: lactose monohydrate, cornstarch, sodium carboxymethylcellulose (type A), microcrystalline cellulose, silicon dioxide, magnesium stearate. Tablet coating: polyvinyl alcohol, talc, macrogol 3350, titanium dioxide (E 171), yellow iron oxide (E 172).

What Clarzole looks like and contents of the pack

Clarzole, 2.5 mg, film-coated tablets are yellow, round, and biconvex. The medicine is available in packs of:
Blisters: 30, 60 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization 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 authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.
Date of last revision of the leaflet:May 2023.