Package Insert: Information for the Patient

Loxifan 2.5 mg Film-Coated Tablets

Letrozol

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
  -If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

1. What is Loxifan and what is it used for

2. What you need to know before starting to take Loxifan

3. How to take Loxifan

4. Possible adverse effects

5. Storage of Loxifan

6. Contents of the package and additional information

What is Loxifan and how it works

Loxifan contains an active ingredient called letrozol. It belongs to a group of medicines called aromatase inhibitors. It is a hormone (or "endocrine") treatment for breast cancer. The growth of breast cancer is usually stimulated by estrogens, which are the female sex hormones. Loxifan reduces the amount of estrogen by blocking an enzyme ("aromatase") involved in estrogen production and therefore 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 menopause, that is, the cessation of menstrual periods.

It is used to prevent breast cancer from recurring. It can be used as the first treatment before breast cancer surgery, if immediate surgery is not suitable, or it can be used as the first treatment after breast cancer surgery, or after five years of treatment with tamoxifeno. Loxifan is also used to prevent breast cancer 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, consult your doctor.

Follow carefully all instructions from your doctor. They may be different from the general information contained in this prospectus.

Do not take Loxifan

• if you are allergic to letrozol or any of the other components of this medication (including those listed in section6),
• if you still have menstrual cycles, that is, 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 medication and inform your doctor.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Loxifan:

• if you have a severe kidney disease,
• if you have a severe liver disease,
• if you have a history of osteoporosis or bone fractures (see also “Treatment control with Loxifan” in section3).

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

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

Children and adolescents (under 18years)

Children and adolescents should not use this medication.

Older adults (65years and older)

People 65years and older may use this medication at the same dose as adults.

Other medications and Loxifan

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications.

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

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

Loxifan contains lactose and sodium

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

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

Use in athletes

This medication contains letrozol, which may produce a positive result in doping control tests.

Follow exactly the administration instructions for this medication as indicated 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 to. 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 treatment with Loxifan

You should only take this medication under strict medical supervision. Your doctor will periodically monitor your condition to check that the treatment is having the desired effect.

Loxifan may cause a decrease in bone thickness or bone loss (osteoporosis) due to a decrease in estrogen 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 Loxifan than you should

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

If you forget to take Loxifan

• If it is almost time for your next tablet (e.g. 2 or 3 hours), do not take the dose you missed and take the next dose at the time it is due.
• Otherwise, take the dose as soon as you remember, and then take the next tablet as you normally would.
• Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Loxifan

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

Like all medications, this medication may cause side effects, although not everyone will experience 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 a 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:

Rare(may affect up to 1 in 100patients):

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

Very rare(may affect up to 1 in 1,000patients):

• Difficulty breathing, chest pain, fainting, rapid heart rate, blue 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).

Inform your doctor immediately if you experience any of the following:

Also, inform your doctor immediately if you experience any of the following symptoms during treatment with Loxifan:

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

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

Consult your doctor if any of these affect you severely.

Some side effects are common(may affect up to 1 in 10patients):

• Skin rash
• Headache
• Dizziness
• General discomfort
• Tract gastrointestinales disorders such as nausea, vomiting, indigestion, constipation, diarrhea.
• Increased or decreased appetite
• Muscle pain
• Osteoporosis, which causes bone fractures in some cases (see also the section “Control of Loxifan treatment in section 3”).
• Swelling of arms, hands, feet, ankles (edema).
• Depression
• Weight gain
• Hair loss
• High blood pressure (hypertension)
• Abdominal pain
• Skin dryness
• Vaginal bleeding
• • Palpitations, rapid heart rate
• Joint stiffness (arthritis)
• Chest pain

Inform your doctor if any of these affect you severely.

Some side effects are infrequent(may affect up to 1 in 100patients):

• Tract nervous disorders such as anxiety, nervousness, irritability, numbness, memory problems, drowsiness, insomnia.
• Dorsal or wrist pain (carpal tunnel syndrome).
• Sensory problems, especially tactile.
• Eye problems such as blurred vision, eye irritation.
• Tract skin problems such as itching (urticaria)
• Vaginal discharge or dryness
• Breast pain
• Fever
• Thirst, taste disorder, dry mouth
• Membrane mucosa dryness
• Weight loss
• Urinary tract infection, increased frequency to urinate
• Cough
• Elevated levels of enzymes
• Yellow discoloration of the skin and eyes
• Elevated bilirubin levels in the blood (a product of red blood cell breakdown).

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

Trigger finger, a situation in which your finger or thumb stays locked in a bent position.

Inform your doctor if any of these affect you severely.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

-Keep this medication out of the sight and reach of children.

• Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

• Do not store at a temperature above30ºC.

• Store in the original packaging to protect it from moisture.

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

• Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Loxifan

• The active ingredient is letrozol. Each film-coated tablet contains 2.5mg of letrozol.
• The other components (excipients) arelactose monohydrate, microcrystalline cellulose, cornstarch, sodium carboxymethylcellulose (type A) from potato, magnesium stearate, anhydrous colloidal silica. The coating is composed of hypromellose (E-464), talc, macrogol 8000, titanium dioxide (E-171) and yellow iron oxide (E-172).

Appearance of the product and contents of the package

-Loxifan is presented as film-coated tablets. The tablets are dark yellow and round. They have the mark “FV” on one face and “CG” on the other face.

-Each package with blisters contains 10, 14, 28, 30 or 100 tablets. Not all packages may be available in your country.

Marketing Authorization Holder

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 – Barcelona, España

Responsible for manufacturing

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona, España

or

NOVARTIS PHARMA GMBH

Roonstrasse 25 (Nürnberg) - D-90429 - Alemania

or

NOVARTIS PHARMA, S.A.S.

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

or

SALUTAS PHARMA GMBH

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

or

NOVARTIS SVERIGE AB

Torshamnsgatan 48, 164 40 Kista, Suecia

or

NOVARTIS FINLAND OY

Metsanneidonkujaq (Espoo) - FIN-02130 - Finlandia

or

NOVARTIS HUNGARIA KFT.

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

or

NOVARTIS PHARMA GMBH

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

or

NOVARTIS PHARMA BV

Haaksbergweg 16, 1101 BX Amsterdam - Paises Bajos

or

NOVARTIS FARMA S.P.A.

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

or

NOVARTIS PHARMA NV/SA

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

or

NOVARTIS HEALTHCARE A/S

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

or

NOVARTIS SRO

Na Pankraci 1724/129 Nusle (Praga) - 14000 - República Checa

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 RoadAthinon-Lamias, MetamorphosisAttiki- 14451 - Grecia

or

Novartis Pharma GmbH

Sophie-Germain-Strasse 10, Nuremberg 90443, Alemania

or

NOVARTIS FARMA S.P.A.

Viale Luigi Sturzo 43, 20154, Milán (MI), Italia

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:November/2020

Other sources of information

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es/