LOXIFAN 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Loxifan 2.5mg film-coated tablets

Letrozole

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, 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 is Loxifan and what is it used for
2. What you need to know before you take Loxifan
3. How to take Loxifan
4. Possible side effects
5. Storing Loxifan
6. Contents of the pack and other information

1. What is Loxifan and what is it used for

What is Loxifan and how does it work

Loxifan 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. Loxifan reduces the amount of estrogen by blocking an enzyme (aromatase) involved in estrogen production, and thus can 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 is Loxifan used for

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

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

2. What you need to know before you take Loxifan

Follow carefully all instructions given to you by your doctor. They may differ from the general information contained in this leaflet.

Do not take Loxifan

• if you are allergic to letrozole 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 breastfeeding.

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting treatment with Loxifan:

• 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 Loxifan" in section 3).

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

Letrozole 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)

Children and adolescents should not use this medicine.

Elderly patients (65 years and over)

People aged 65 and over can use this medicine at the same dose as for adults.

Other medicines and Loxifan

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

Pregnancy, breastfeeding, and fertility

• You should only take Loxifan if you have gone through the menopause. However, your doctor should discuss with you the use of effective contraception, as you may still become pregnant during treatment with Loxifan.
• Do not take Loxifan if you are pregnant or breastfeeding, 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.

Loxifan contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

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

Use in athletes

This medicine contains letrozole, which may produce a positive result in doping tests.

3. How to take Loxifan

Follow exactly the instructions for administration of this medicine given to you by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The usual dose is one Loxifan tablet once a day. If you take Loxifan 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 swallowed whole with a glass of water.

How long to take Loxifan

Continue taking Loxifan every day for the time your doctor tells you. You may need to take it for months or even years. If you have any doubts about how long you should take Loxifan, consult your doctor.

Monitoring of treatment with Loxifan

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.

Loxifan may cause a decrease in bone thickness or bone loss (osteoporosis) due to the decrease in estrogen in the body. Your doctor may decide to perform bone density measurements (a way to check for osteoporosis) before, during, and after treatment.

If you take more Loxifan than you should

If you have taken too many Loxifan tablets, or if someone else has taken your tablets, contact your doctor or go to the hospital immediately. Show them the pack of tablets. You may need medical treatment. You can also call the Toxicology Information Service, Tel: 915620420, indicating the medicine and the amount taken.

If you forget to take Loxifan

• 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 missed doses.

If you stop taking Loxifan

Do not stop taking Loxifan unless your doctor tells you to. See also the section "How long to take Loxifan".

4. Possible side effects

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

Most side effects are mild to 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 estrogen.

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

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 (particularly arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (sign of a brain disorder, e.g., stroke).
• Chest pain or sudden onset (sign of heart disorder).
• Swelling and redness in a vein that is extremely soft and possibly painful to the touch.
• Severe fever, cold, or mouth ulcers due to infections (lack of white blood cells).
• Severe blurred vision.
• Tendinitis or tendon inflammation (connective tissue that connects muscles to bones).

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

• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish discoloration of the skin, or sudden pain in the arm, leg, or foot (signs that a blood clot has formed).
• Tendon rupture (connective tissue that connects muscles to bones).

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

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

• Swelling mainly in the face and throat (signs of allergic reaction).
• Yellowing of the skin and eyes, nausea, loss of appetite, darkening of urine color (signs of hepatitis).
• Rash, redness of the skin, blisters on the lips, eyes, or mouth, skin peeling, fever (signs of skin disorder).

Some side effects are very common(may affect more than 1 in 10 people):

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

If any of these side effects bother you seriously, consult your doctor.

Some side effects are 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 bone loss (osteoporosis), which can cause bone fractures in some cases (see also "Monitoring of treatment with Loxifan" in section 3).
• Swelling of arms, hands, feet, 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 side effects bother you seriously, inform your doctor.

Some side effects are uncommon(may affect up to 1 in 100 people):

• 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
• High blood levels of bilirubin (a product of red blood cell breakdown).

Side effects with unknown frequency(cannot be estimated from available data):

Trigger finger, a condition where your finger or thumb gets stuck in a bent position.

If any of these side effects bother you seriously, inform your doctor.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Loxifan

• 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 shown.

• Do not store above 30°C.

• Store in the original package to protect from moisture.

• Do not use any packaging that is damaged or shows signs of tampering.

• 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 other information

What Loxifan contains

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other ingredients (excipients) are lactose monohydrate, microcrystalline cellulose, maize starch, sodium carboxymethyl starch (type A) potato, magnesium stearate, anhydrous colloidal silica. The coating consists of hypromellose (E-464), talc, macrogol 8000, titanium dioxide (E-171), and yellow iron oxide (E-172).

Appearance and packaging

• Loxifan is presented as film-coated tablets. The tablets are yellow and round. They have the mark "FV" on one side and "CG" on the other side.
• Each pack with blisters contains 10, 14, 28, 30, or 100 tablets. Not all pack sizes may be available in your country.

Marketing authorization holder

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 – Barcelona, Spain

Manufacturer

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona, Spain

or

NOVARTIS PHARMA GMBH

Roonstrasse 25 (Nuremberg) - D-90429 - Germany

or

NOVARTIS PHARMA, S.A.S.

8-10 Rue Henri Sainte-Claire Deville Rueil Malmaison - F-92500 - France

or

SALUTAS PHARMA GMBH

Otto Von Guericke Alle, 1 (Barleben) - D-39179 - Germany

or

NOVARTIS SVERIGE AB

Torshamnsgatan 48, 164 40 Kista, Sweden

or

NOVARTIS FINLAND OY

Metsanneidonkujaq (Espoo) - FIN-02130 - Finland

or

NOVARTIS HUNGARIA KFT.

Bartok Bela ut 43-47 (Budapest) - 1114 - Hungary

or

NOVARTIS PHARMA GMBH

Jakov-Lind-Straβe 5, Top 3.05, 1020 Wien - Austria

or

NOVARTIS PHARMA BV

Haaksbergweg 16, 1101 BX Amsterdam - Netherlands

or

NOVARTIS FARMA S.P.A.

Via Provinciale Schito 131 (Torre Annunziata) - 80058 - Italy

or

NOVARTIS PHARMA NV/SA

Medialaan, 40 (Vilvoorde) - B-1800 - Belgium

or

NOVARTIS HEALTHCARE A/S

Edvard Thomsens Vej 14,3. (Copenhagen) - DK-2300 - Denmark

or

NOVARTIS SRO

Na Pankraci 1724/129 Nusle (Prague) - 14000 - Czech Republic

or

NOVARTIS FARMA-PRODUCTOS FARMACEUTICOS, S.A.

Avenida Professor Doutor Cavaco Silva, nº 10E (Taguspark, Porto Salvo) - 2740-255 – Portugal

or

NOVARTIS (HELLAS) S.A.

12th Km National Road Athinon-Lamias, Metamorphosis Attiki - 14451 - Greece

or

Novartis Pharma GmbH

Sophie-Germain-Strasse 10, Nuremberg 90443, Germany

or

NOVARTIS FARMA S.P.A.

Viale Luigi Sturzo 43, 20154, Milan (MI), Italy

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

Date of last revision of this leaflet:November/2020

Other sources of information

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/