LETROZOLE BLUEFISH 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Letrozol Bluefish 2.5 mg film-coated tablets EFG

Read all of this leaflet carefully before you start 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 or pharmacist.
• 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Letrozol Bluefish and what is it used for
2. What you need to know before you take Letrozol Bluefish
3. How to take Letrozol Bluefish
4. Possible side effects
5. Storage of Letrozol Bluefish
6. Contents of the pack and further information

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

Letrozol Bluefish contains the active substance letrozole. It belongs to a group of medicines called aromatase inhibitors. It is a hormonal (or "endocrine") treatment for breast cancer. The growth of breast cancer is usually stimulated by estrogens, which are female sex hormones. Letrozol reduces the amount of estrogen by blocking an enzyme (aromatase) involved in estrogen production and can therefore block the growth of breast cancers that need estrogens to grow. As a result, tumor cells grow more slowly or stop growing and/or spreading to other parts of the body.

What Letrozol Bluefish is used for

Letrozol is used to treat breast cancer in women who have gone through the menopause, i.e., the cessation of menstrual periods.

It is used to prevent the cancer from coming back. It can be used as the first treatment before breast cancer surgery, in case surgery is not immediately possible, or it can be used as the first treatment after breast surgery or after five years of treatment with tamoxifen. Letrozol is also indicated to prevent the breast tumor from spreading to other parts of the body in patients with advanced disease.

If you have any questions about how letrozol works or why you have been prescribed this medicine, ask your doctor.

2. What you need to know before you take Letrozol Bluefish

Do not take Letrozol Bluefish

• if you are allergic to letrozol or any of the other ingredients of this medicine (listed in section 6),
• if you still have menstrual cycles, i.e., you have not reached menopause,
• if you are pregnant,
• if you are breast-feeding.

If any of these cases apply to you, do not take this medicine and inform your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take letrozol:

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

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

Letrozol may cause tendon inflammation or tendon damage (see section 4). If you experience any signs of pain or inflammation of the tendons, rest the affected area and contact your doctor.

Children and adolescents (under 18 years of age)

Children and adolescents should not use this medicine.

Elderly patients (65 years of age and over)

This medicine can be used by people aged 65 and over at the same dose as for other adults.

Other medicines and Letrozol Bluefish

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Pregnancy, breast-feeding, and fertility

• You should only take letrozol when you have gone through the menopause. However, your doctor should discuss the use of effective contraception with you, as you could still become pregnant during treatment with letrozol
• Do not take letrozol if you are pregnant or breast-feeding, as it may harm your baby

Driving and using machines

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

Letrozol Bluefish contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Letrozol Bluefish contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Letrozol Bluefish

Follow exactly the instructions of your doctor for taking this medicine. If you are in doubt, consult your doctor or pharmacist again.

The usual dose is one letrozol tablet once a day. If you take the medicine at the same time every day, it will help you remember when to take the tablet.

The tablet can be taken with or without food and should be taken whole with a glass of water or other liquid.

How long to take Letrozol Bluefish

Keep taking this medicine every day for as long as your doctor tells you to. You may need to take it for months or even years. If you have any doubts about how long to keep taking letrozol, ask your doctor.

Monitoring of treatment with Letrozol Bluefish

You should only take this medicine under strict medical supervision. Your doctor will periodically check your condition to ensure that the treatment has the desired effect.

Letrozol may cause a decrease in bone density or bone loss (osteoporosis) due to the decrease in estrogens in the body. Your doctor may decide to perform bone density measurements (a way to monitor osteoporosis) before, during, and after treatment.

If you take more Letrozol Bluefish than you should

If you have taken too many letrozol tablets, or if someone else has taken your tablets, contact a doctor or go to the hospital immediately. Show them the medicine pack. You may need medical treatment.

In case of overdose or accidental ingestion, contact the Toxicological Information Service. Phone: 91 562 04 20.

If you forget to take Letrozol Bluefish

If it is almost time for your next dose (e.g., 2 or 3 hours), do not take the missed dose and take the next dose at the scheduled time. Otherwise, take the dose as soon as you remember, and then take the next dose as you would normally.

Do not take a double dose to make up for forgotten doses.

If you stop taking Letrozol Bluefish

Do not stop taking this medicine unless your doctor tells you to. See also the section "How long to take Letrozol Bluefish".

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Most of these side effects are mild or moderate and usually disappear after a few days or weeks of treatment.

Some of these side effects, such as hot flashes, hair loss, or vaginal bleeding, may be due to the lack of estrogens.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Some side effects can be serious

Rare or very rare side effects (i.e., may affect 1 to 10 out of 10,000 patients).

• Weakness, paralysis, or loss of sensation in any part of the body (especially arm and leg), loss of coordination, nausea, or difficulty speaking or breathing (sign of a brain disorder, e.g., stroke)
• Chest pain or tightness (sign of heart disorder)
• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish discoloration of the skin, or sudden pain in the arm, leg, or foot (signs of blood clots)
• Swelling and redness in a vein that is extremely soft and possibly painful to the touch
• High fever, cold, or mouth ulcers due to infections (lack of white blood cells)
• Severe blurred vision
• Rare - tendonitis or tendon inflammation (connective tissue that connects muscles to bones)
• Very rare - tendon rupture (connective tissue that connects muscles to bones)

If you experience any of the above, tell your doctor immediately.

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

• Facial and throat swelling (symptoms of an allergic reaction)
• Yellowing of the skin and eyes, nausea, loss of appetite, dark urine color (symptoms of hepatitis)
• Redness, itching, blisters on the lips, eyes, or mouth, skin peeling, fever (symptoms of skin disorders)

Some side effects are very common (i.e., may affect more than 10 out of 100 patients).

• Hot flashes
• Increased cholesterol levels (hypercholesterolemia)
• Fatigue
• Increased sweating
• Bone and joint pain (arthralgia)

Tell your doctor immediately if any of these affect you severely.

Some side effects are common (i.e., may affect 1 to 10 out of 100 patients).

• Rash
• Headache
• Dizziness
• General malaise
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
• Increased or decreased appetite
• Muscle pain
• Thinning or bone loss (osteoporosis), which can cause bone fractures in some cases (see also "Monitoring of treatment with Letrozol Bluefish" in section 3)
• Swelling of arms, hands, feet, ankles (edema)
• Depression
• Weight gain
• Hair loss
• Increased blood pressure (hypertension)
• Abdominal pain
• Dry skin
• Vaginal bleeding
• Palpitations, rapid heartbeat
• Joint stiffness (arthritis)
• Chest pain

Tell your doctor immediately if any of these affect you severely.

Some side effects are uncommon (i.e., may affect 1 to 10 out of 1,000 patients).

• Nervous system disorders such as anxiety, nervousness, irritability, numbness, memory problems, sleepiness, insomnia
• Pain or burning sensation in the hands or wrists (carpal tunnel syndrome)
• Sensitivity disorders, especially touch
• Eye disorders such as blurred vision, eye irritation
• Skin disorders such as itching (urticaria)
• Vaginal discharge or dryness
• Breast pain
• Fever
• Thirst, taste disorder, dry mouth
• Dryness of mucous membranes
• Weight loss
• Urinary tract infection, increased frequency of urination
• Cough
• Increased enzyme levels
• Yellowing of the skin and eyes
• Elevated blood levels of bilirubin (a product of red blood cell breakdown)

Side effects with unknown frequency

• Trigger finger, a condition in which the finger or thumb becomes bent.

If any of these affect you severely, tell your doctor.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (AEMPS) website: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Letrozol Bluefish

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 after "EXP". The expiry date refers to the last day of the month stated.

Do not use any pack that is damaged or shows signs of deterioration.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Letrozol Bluefish

The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.

The excipients are: lactose monohydrate, corn starch, microcrystalline cellulose, sodium starch glycolate (type A) potato, anhydrous colloidal silica, magnesium stearate; the coating is macrogol, hypromellose (E 464), talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Appearance of the product and pack contents

Yellow, round, biconvex film-coated tablet, 6.1 mm (± 2 mm) in diameter.

PVC/PE/PVDC/Aluminum blister pack with 30 and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

You can obtain further information on this medicine from the local representative of the marketing authorization holder:

Bluefish Pharma S.L.U.,

AP 36007

2832094 Madrid, Sucursal 36

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

Date of last revision of this leaflet:June 2020

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/