LETROZOLE 2.5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Letrozole Bluefish, 2.5 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet:
3. What is Letrozole Bluefish and what is it used for
   1. What is Letrozole Bluefish and how does it work
   2. What is Letrozole Bluefish used for
4. Important information before taking Letrozole Bluefish
   1. When not to take Letrozole Bluefish
   2. Warnings and precautions
   3. Children and adolescents (under 18 years of age)
   4. Elderly patients (65 years of age and older)
   5. Letrozole Bluefish and other medicines
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Letrozole Bluefish contains lactose
5. How to take Letrozole Bluefish
   1. How long to take Letrozole Bluefish
   2. Monitoring during treatment with Letrozole Bluefish
   3. Taking a higher dose of Letrozole Bluefish than recommended
   4. Missing a dose of Letrozole Bluefish
   5. Stopping treatment with Letrozole Bluefish
6. Possible side effects
   1. Some side effects can be serious:
   2. If any of the above symptoms occur, tell your doctor immediately.
   3. Side effects with unknown frequency
   4. Reporting side effects
7. How to store Letrozole Bluefish
8. Contents of the pack and other information
   1. What Letrozole Bluefish contains
   2. What Letrozole Bluefish looks like and what the pack contains
   3. Marketing Authorization Holder
   4. Manufacturer:
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Package Leaflet: Information for the User

Letrozole Bluefish, 2.5 mg, Film-Coated Tablets

(Letrozole)

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

• Keep this package leaflet, in case you need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet:

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

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

What is Letrozole Bluefish and how does it work

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

What is Letrozole Bluefish used for

Letrozole Bluefish is used to treat breast cancer in postmenopausal women, i.e., women who have stopped menstruating.
This medicine is used to prevent breast cancer recurrence. It can be used as the first treatment before breast cancer surgery, when immediate surgery is not recommended, or it can be used as the first treatment in patients after breast cancer surgery or after 5 years of tamoxifen treatment. Letrozole Bluefish is also used to prevent the spread of breast cancer in women with advanced breast cancer.
In case of doubts about the action of Letrozole Bluefish and why it was prescribed to the patient, the patient should ask their doctor.

2. Important information before taking Letrozole Bluefish

Always follow the doctor's instructions carefully. They may differ from the general information contained in this package leaflet.

When not to take Letrozole Bluefish

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

If any of the above conditions apply to the patient, do not take this medicine and tell your doctor.

Warnings and precautions

• Before starting treatment with Letrozole Bluefish, discuss it 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 "Monitoring during treatment with Letrozole Bluefish" in section 3).

If any of the above conditions apply to the patient, tell your doctor. The doctor will take this information into account during treatment with Letrozole Bluefish.
Letrozole may cause tendon inflammation or damage (see section 4). If the patient experiences pain or swelling of the tendons, they should rest the affected area and contact their 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)

Letrozole Bluefish can be used in patients aged 65 and older at the same doses as in other adult patients.

Letrozole Bluefish and other medicines

Tell your doctor or pharmacist about all medicines currently being taken or recently taken, as well as any medicines planned to be taken, including those available without a prescription.

Pregnancy, breastfeeding, and fertility

• Letrozole Bluefish 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 birth control, as the patient may still become pregnant during treatment with Letrozole Bluefish;
• Do not take Letrozole Bluefish during pregnancy or breastfeeding, as the medicine may harm the baby.

Driving and using machines

If dizziness, fatigue, drowsiness, or general malaise occur, do not drive or operate any tools or machines until normal well-being returns.

Letrozole Bluefish contains lactose

Letrozole Bluefish contains lactose (milk sugar). If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Letrozole Bluefish

This medicine should always be taken according to the doctor's instructions. In case of doubts, consult a doctor or pharmacist.
The usual dose of Letrozole Bluefish is one tablet once a day. Taking Letrozole Bluefish every day at the same time makes it easier to remember when to take the next dose.
The tablet can be taken with or without food and should be swallowed whole, washed down with a glass of water or another drink.

How long to take Letrozole Bluefish

Letrozole Bluefish should be taken every day, as long as the doctor recommends. It may be necessary to take the medicine for several months or even several years. In case of any questions about how long to take Letrozole Bluefish, consult a doctor.

Monitoring during treatment with Letrozole Bluefish

This medicine should always be taken under close medical supervision. The doctor will regularly check the patient's health to ensure that the treatment is effective.
Letrozole Bluefish may cause thinning or loss of bone tissue (osteoporosis) related to the decrease in estrogen levels in the body. The doctor may order a bone density test (osteoporosis screening) before, during, and after treatment.

Taking a higher dose of Letrozole Bluefish than recommended

In case of taking too many Letrozole Bluefish tablets or if someone else has taken them by mistake, contact a doctor or go to the hospital immediately.
Show the packaging of the tablets. Appropriate treatment may be necessary.

Missing a dose of Letrozole Bluefish

• If it is almost time for the next dose (e.g., in 2 or 3 hours), do not take the missed dose, just take the next dose at the usual time.
• In other cases, take the dose as soon as possible, and the next tablet at the usual time.
• Do not take a double dose to make up for the missed dose.

Stopping treatment with Letrozole Bluefish

Do not stop taking Letrozole Bluefish unless the doctor advises it. See also the "Duration of treatment" section above.

4. Possible side effects

Like all medicines, Letrozole Bluefish can cause side effects, although not everybody gets them.
Most side effects are mild to moderate and usually disappear within a few days or weeks of treatment.
Some side effects, such as hot flashes, hair loss, or vaginal bleeding, may be caused by the lack of estrogen in the body.
Do not be concerned by the following list of possible side effects. You may not get any of them.

Some side effects can be serious:

Rare or uncommonside effects (i.e., may affect 1 to 100 out of 10,000 patients)

• Weakness, paralysis, or numbness in any part of the body (especially in the arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (symptoms of brain dysfunction, such as a stroke);
• Sudden, crushing chest pain (symptoms of heart problems);
• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish discoloration of the skin, sudden pain in the arms, legs, or feet (symptoms indicating possible blood clots);
• Swelling and redness along a vein, with severe tenderness and sensitivity to touch;
• High fever, chills, or mouth sores caused by infections (due to a decrease in white blood cells);
• Severe, persistent blurred vision;
• Uncommon - tendon inflammation (inflammation of the soft tissue that connects muscles and bones);
• Rare - tendon rupture (rupture of the soft tissue that connects muscles and bones).

If any of the above symptoms occur, tell your doctor immediately.

Also, tell your doctor immediately if any of the following symptoms occur while taking Letrozole Bluefish:

• 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.They may affect more than 10 out of 100 patients.

• Hot flashes;
• increased cholesterol levels (hypercholesterolemia).
• fatigue;
• increased sweating;
• bone and joint pain.

If any of the above side effects are severe, tell your doctor.
Some side effects are common.They may affect 1 to 10 out of 100 patients.

• skin rash;
• headache;
• dizziness;
• general malaise;
• gastrointestinal disorders, such as nausea, vomiting, indigestion, constipation, diarrhea;
• increased or decreased appetite;
• muscle pain;
• thinning or destruction of bone tissue (osteoporosis), which can sometimes lead to bone fractures (see also section 3 "Monitoring during treatment with Letrozole Bluefish");
• swelling of the hands, feet, or 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 the above side effects are severe, tell your doctor.
Some side effects are uncommon.They may affect 1 to 10 out of 1,000 patients.

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

Side effects with unknown frequency

• trigger finger, a condition in which the finger or thumb remains bent.

If any of the above side effects are severe, tell your doctor.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: + 48 22 49 21 309, e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Letrozole Bluefish

• There are no special storage instructions for the medicine.
• Keep the medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton after "Expiry Date (EXP)". The expiry date refers to the last day of the month.
• Do not use if signs of damage or opening of the packaging are visible.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Letrozole Bluefish contains

The active substance of the medicine is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
The other ingredients of the medicine are: lactose monohydrate, cornstarch, microcrystalline cellulose, sodium carboxymethylcellulose (type A), colloidal silicon dioxide, anhydrous, magnesium stearate.
The ingredients of the Opadry 02B38014 coating are: macrogol 4000, hypromellose 5 cP, talc, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

What Letrozole Bluefish looks like and what the pack contains

Letrozole Bluefish is a yellow, round, biconvex film-coated tablet, 6.1 mm (± 0.2 mm) in diameter.
The medicine is available in blisters, in packs containing 30 or 100 tablets.

Marketing Authorization Holder

Bluefish Pharmaceuticals AB, P.O. Box 49013, 100 28 Stockholm, Sweden

Manufacturer:

Bluefish Pharmaceuticals AB, Gävlegatan 22, 113 30 Stockholm, Sweden.
Genepharm S.A., 18 km Marathonos Avenue, 153 51 Pallini Attikis, Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the package leaflet:2019-09-26