Lametta

Package Leaflet: Information for the User

LAMETTA, 2.5 mg, film-coated tablets

Letrozole

Read all of this leaflet carefully before taking this medicine because 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Lametta is and what it is used for

What Lametta is and how it works

Lametta 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. Lametta reduces the amount of estrogen by blocking the enzyme (aromatase) involved in estrogen production, and can therefore slow down the growth of breast cancer cells that need estrogens to grow. As a result of this effect, cancer cells stop growing or grow more slowly and (or) stop spreading to other parts of the body.

What Lametta is used for

Lametta is used to treat breast cancer in post-menopausal women, i.e., women who have stopped menstruating.
This medicine is used to prevent the return 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 5 years of treatment with tamoxifen. Lametta 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 Lametta works or why it has been prescribed for you, ask your doctor.

2. Before you take Lametta

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

When not to take Lametta

• if you are allergic to letrozole or any of the other ingredients of this medicine (listed in section 6);
• if you are still menstruating, i.e., you are still pre-menopausal;
• if you are pregnant;
• if you are breast-feeding. If any of these apply to you, do not take the medicine and consult your doctor.

Warnings and precautions

Before taking Lametta, discuss with your doctor or pharmacist

• if you have severe kidney disease;
• if you have severe liver disease;
• if you have a history of osteoporosis or bone fractures (see also section 3 "Monitoring during treatment with Lametta").

If any of these apply to you, tell your doctor. Your doctor will take this information into account during treatment with Lametta.

Children and adolescents (under 18 years old)

This medicine should not be used in children and adolescents.

Elderly patients (65 years and older)

Patients aged 65 and over can take the medicine at the same dose as other adult patients.

Lametta and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, including those obtained without a prescription.

Pregnancy, breast-feeding, and fertility

Lametta should only be taken if you are post-menopausal. However, your doctor will discuss with you the need for effective contraception, as you may still become pregnant during treatment with Lametta.
Do not take Lametta if you are pregnant or breast-feeding, as the treatment may harm the baby.

Driving and using machines

If you feel tired, dizzy, sleepy, or unwell, do not drive or operate machinery until you feel better.
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.

Lametta contains lactose

Lametta contains lactose (a sugar). If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Lametta contains sodium

The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

Lametta contains the azo dye - orange yellow S (E 110)

Lametta contains an azo dye and may cause allergic reactions.

3. How to take Lametta

Always take Lametta exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
The recommended dose of Lametta is one tablet once daily by mouth. Taking Lametta at the same time every day will help you remember to take your tablet.
The tablet can be taken with or without food. Swallow the tablet whole with a glass of water or another liquid.

How long to take Lametta

Take Lametta every day for as long as your doctor tells you to. You may need to take it for several months or even years. If you have questions about taking Lametta, talk to your doctor.

Monitoring during treatment with Lametta

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.
Lametta 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 (osteoporosis screening) before, during, and after treatment.

If you take more Lametta than you should

If you have taken more Lametta than prescribed or if someone else has taken your tablets, contact your doctor or go to the hospital immediately. Show the doctor the pack of the medicine.
Medical attention may be necessary.

If you forget to take Lametta

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

Stopping treatment with Lametta

Do not stop taking Lametta without talking to your doctor first. See also "How long to take Lametta".

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most of the observed side effects were mild to moderate and disappeared after a few days to a few weeks after the end of treatment.
Some of the side effects, such as hot flashes, hair loss, or vaginal bleeding, may be due to the lack of estrogen in the body.
Do not be concerned about all the possible side effects listed below. They may not occur.

Some side effects can be serious.

These side effects are rare or not very common(i.e., they may occur in 1 to 100 out of 10,000 patients):

• 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);

chest pain (symptoms of heart disorders);

• difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin discoloration, or sudden pain in the arm, leg, or foot (symptoms indicating a possible blood clot in a blood vessel);
• swelling and redness along a vein, with severe tenderness and pain on touch;
• high fever, chills, or mouth ulcers due to infections (low white blood cell count);
• severe, persistent vision disturbances;
• tendon rupture (soft tissue connecting 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 Lametta:
swelling, mainly of the face and throat (symptoms of an allergic reaction);
yellowing of the skin and eyes, nausea, loss of appetite, dark urine (symptoms of liver inflammation);
rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (symptoms of skin disorders).
Some side effects are very common.These side effects may occur in more than 10 out of 100 patients.

• hot flashes;
• high cholesterol levels (hypercholesterolemia);
• fatigue;
• increased sweating;
• bone and joint pain. If any of these symptoms occur severely, tell your doctor.

Some side effects are common.These side effects may occur in 1 to 10 out of 100 patients.

• skin rash;
• headache;
• dizziness;
• general feeling of being unwell;
• gastrointestinal disorders, such as nausea, vomiting, indigestion, constipation, diarrhea;
• increased or decreased appetite;
• muscle pain;
• thinning or loss of bone tissue (osteoporosis), leading to bone fractures in some cases (see also section 3 "Monitoring during treatment with Lametta");
• swelling of the arms, hands, feet, ankles;
• depression;
• weight gain;
• hair loss;
• high blood pressure (hypertension);
• abdominal pain;
• dry skin;
• vaginal bleeding;
• rapid or irregular heartbeat;
• joint stiffness (arthritis);
• chest pain.

If any of these symptoms occur severely, tell your doctor.
Other side effects are uncommon.These side effects may occur in 1 to 10 out of 1,000 patients.

• nervous system disorders, such as anxiety, nervousness, irritability, lethargy, memory disorders, sleepiness, insomnia;
• hand or wrist pain or burning sensation (carpal tunnel syndrome);
• sensory disturbances, usually 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;
• inflammation of the mucous membranes in the mouth;
• dry mucous membranes;
• weight loss;
• urinary tract infections, frequent urination;
• cough;
• increased enzyme activity;
• yellowing of the skin and eyes;
• high bilirubin levels (a product of red blood cell breakdown) in the blood;
• tendon inflammation (soft tissue connecting muscles and bones).

Side effects with unknown frequency

Trigger finger, a condition in which the finger or thumb remains bent.
If any of these symptoms occur severely, tell your doctor.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.
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 Lametta

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP".
The expiry date refers to the last day of that month.
Do not store above 25°C.
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 Lametta contains

The active substance is letrozole.
One tablet contains 2.5 mg of letrozole.
The other ingredients are:

• tablet core: microcrystalline cellulose, anhydrous colloidal silica, lactose monohydrate, corn starch, sodium carboxymethylcellulose, magnesium stearate;
• tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, quinoline yellow (E 104), orange yellow S (E 110), indigo carmine (E 132).

What Lametta looks like and contents of the pack

Lametta is a green, film-coated tablet.
A carton contains 30 film-coated tablets in blisters.

Marketing authorization holder and manufacturer

Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
tel.: +48 22 679 51 35
fax: +48 22 678 92 87
e-mail: [email protected]

Date of last revision of the leaflet: