Lametta

Package leaflet: Information for the user

LAMETTA, 2.5 mg, coated tablets
Letrozole
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Lametta is and what it is used for
2. What you need to know before taking 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 a medicine 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 inhibiting the activity of an enzyme (aromatase) involved in estrogen production. Therefore, it may inhibit the growth of malignant breast tumors that require estrogens for their development. 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 Lametta is used for
Lametta is used in the treatment of breast cancer in postmenopausal women, that is, 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. Lametta 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 Lametta works or why it has been prescribed, please consult your doctor.

2. Important information before using Lametta

Follow your doctor's instructions. They may differ from the general information contained in this leaflet.

When not to use Lametta

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

If any of these points apply to the patient, do not use the medicine and consult a doctor.

Warnings and precautions

Before starting treatment with Lametta, discuss the following with your doctor or pharmacist:

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

If any of these points apply to the patient, inform the doctor. The doctor will take these factors into account during treatment with Lametta.

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 Lametta at the same dosage as other adult patients.

Lametta and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription, as well as any medicines the patient plans to take.

Pregnancy, breastfeeding and fertility

Lametta should only be used when the patient is postmenopausal. However, the doctor will discuss with the patient the need to use an effective method of contraception, as pregnancy may still occur during treatment with Lametta.

Lametta 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 fatigue, dizziness, drowsiness or general malaise, she must not drive or operate tools and machinery until normal well-being returns.

Letrozole may cause inflammation or damage to tendons (see section 4). If the patient experiences tendon pain or swelling, the affected area should be rested and the doctor should be contacted.

Lametta contains lactose

Lametta 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.

Lametta contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is considered "sodium-free".

Lametta contains an azo dye – Orange Yellow, lac (E 110)

Lametta contains an azo dye and may cause allergic reactions.

3. How to use Lametta

Lametta must always be used as directed by the physician. If in doubt, consult the doctor or pharmacist again.

The recommended dose of Lametta is one tablet once daily, taken orally. Taking Lametta at the same time each day will help ensure the tablet is not forgotten.

The tablet may be taken with or without food. It should be swallowed whole with a glass of water or other liquid.

How long to use Lametta
Lametta should be taken every day for as long as directed by the physician. Treatment may need to continue for several months or even years. If the patient has any questions regarding the use of Lametta, she should speak with her doctor.

Monitoring during treatment with Lametta
This medicine must always be used under strict medical supervision. The doctor will regularly monitor the patient's health to ensure the treatment is effective and appropriate.

Lametta may cause thinning or loss of bone tissue (osteoporosis) due to reduced estrogen levels in the body. The doctor may order a measurement of the patient's bone density (osteoporosis monitoring test) before, during, and after treatment.

Overdose of Lametta
If a dose of Lametta higher than recommended has been taken, or if someone else has accidentally ingested the tablets, contact a doctor or go to a hospital immediately. Show the medicine's packaging. Medical assistance may be required.

Missed dose of Lametta

• 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 remembered, then continue with the next dose at the usual time.
• Do not take a double dose to make up for a missed dose.

Stopping Lametta
Do not stop taking Lametta without consulting the doctor. See also the section "How long to use Lametta".

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Most of the observed side effects were mild to moderate and resolved within a few days to
a few weeks after completion of treatment.
Some of the side effects, such as hot flushes, hair loss or vaginal bleeding, may be
caused by low estrogen levels in the body.
Do not be alarmed by all the possible side effects of the medicine listed below.
They may not occur at all.
Some side effects may be serious.
These side effects are rare or uncommon (i.e. 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 motor coordination, nausea, or difficulty speaking or breathing (symptoms of brain dysfunction, e.g. stroke);

• sudden, constricting chest pain (symptoms of heart disorder);

• difficulty breathing, chest pain, fainting, rapid heartbeat, skin discoloration, or sudden pain in the arm, leg, or foot (symptoms suggesting possible blood clot formation in a blood vessel);

• swelling and redness along a vein, with marked tenderness and pain on touch;

• high fever, chills, or oral ulceration due to infections (caused by absence or reduced number of white blood cells);

• severe, persistent vision disturbances;

• tendon rupture (soft tissue connecting muscles and bones).

If any of the above symptoms occur, inform your doctor immediately.
You should also inform your doctor immediately if any of the following symptoms occur during treatment with Lametta:

• 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);
• skin rash, redness of the skin, formation of blisters on the lips, eyes or in the 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 flushes;
• increased cholesterol levels (hypercholesterolemia);
• feeling of fatigue;
• excessive sweating;
• bone and joint pain. If any of these symptoms occur severely, inform your doctor.

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

• 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), which in some cases may lead to bone fractures (see also section 3 "Monitoring during treatment with Lametta");
• swelling of arms, hands, feet, ankles;
• depression;
• weight gain;
• hair loss;
• increased blood pressure (hypertension);
• abdominal pain;
• dry skin;
• vaginal bleeding;
• palpitations, rapid heartbeat;
• joint stiffness (arthritis);
• chest pain.

If any of these symptoms are severe, inform 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, drowsiness, memory disturbances, somnolence, insomnia;
• pain or burning sensation in the hands or wrist (carpal tunnel syndrome);
• sensory disturbances, usually of touch;
• eye disorders such as blurred vision, eye irritation;
• skin disorders such as itching (urticaria);
• vaginal discharge or vaginal dryness;
• breast pain;
• fever;
• thirst, taste disturbances, dry mouth;
• inflammatory changes in the mucous membranes of the mouth;
• dryness of mucous membranes;
• weight loss;
• urinary tract infections, increased frequency of urination;
• cough;
• increased enzyme activity;
• yellowing of the skin and eyes;
• high blood levels of bilirubin (a breakdown product of red blood cells);
• tendonitis (inflammation of the tendon, the soft tissue connecting muscles and bones).

Side effects with unknown frequency
Trigger finger, a condition in which a patient's finger or thumb remains bent.
If any of these symptoms are severe, inform your doctor.
Reporting of side effects
If any side effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Side effects can also be reported to the marketing authorization holder.
Reporting of side effects helps to provide more information on the safety of this medicine.

5. How to store Lametta

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following "EXP".
The expiry date refers to the last day of the stated 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. Such measures help protect the environment.

6. Contents of the pack and other information

What Lametta contains
The active substance is letrozole.
Each tablet contains 2.5 mg of letrozole.
The other ingredients are:

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

What Lametta looks like and contents of the pack
Lametta is a green coated tablet.
The cardboard box contains 30 coated tablets packed in blisters.
Marketing authorisation 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]