Loxifan 2.5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Loxifan 2.5 mg film-coated tablets

Letrozole

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these effects are not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Loxifan is and what it is used for

What Loxifan is and how it works

Loxifan contains an active substance called letrozole. It belongs to a group of medicines known as 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 therefore can inhibit the growth of breast cancers that require estrogen to grow. As a result, tumor cells grow more slowly, or their growth and/or spread to other parts of the body is halted.

What Loxifan is used for

Loxifan is used to treat breast cancer in women who have undergone menopause, that is, the cessation of menstrual periods.

It is used to prevent breast cancer from recurring. It may be used as initial treatment before breast cancer surgery, when immediate surgery is not appropriate, or as initial treatment after breast cancer surgery, or after five years of treatment with tamoxifen. Loxifan is also used to prevent the spread of breast cancer to other parts of the body in patients with advanced breast cancer.

If you have any questions about how Loxifan works or why this medicine has been prescribed for you, please consult your doctor.

2. What you need to know before taking Loxifan

Carefully follow all instructions provided 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 to any of the other ingredients of this medicine (listed in section 6),
• 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 situations apply to you, do not take this medicine and inform your doctor.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take 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 situations 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 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 18 years of age)

This medicine must not be used in children and adolescents.

Elderly patients (aged 65 years and over)

Patients aged 65 years and over can take this medicine at the same dose as adults.

Other medicines and Loxifan

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

Pregnancy, breast-feeding and fertility

• You should only take Loxifan if you have passed the menopausal stage. However, your doctor should discuss with you the need for effective contraception, as you may still be able to become pregnant during treatment with Loxifan.
• You must not take Loxifan if you are pregnant or breastfeeding, as it may harm your baby.

Driving and use of machines

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

Loxifan contains lactose and sodium

If your doctor has informed you of an intolerance to certain sugars, consult him 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 result in a positive test in doping controls.

3. How to take Loxifan

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The usual dose is one Loxifan tablet once daily. Taking Loxifan at the same time each day will help you remember when to take the tablet.

The tablet may 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 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 you should take Loxifan, consult your doctor.

Monitoring of Loxifan treatment

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

Loxifan may cause a decrease in bone thickness or bone loss (osteoporosis) due to reduced estrogen levels in the body. Your doctor may decide to perform bone density measurements (a way of monitoring 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 tablet packaging. You may require medical treatment. You can also call the Toxicology Information Service, Tel: 915620420, stating the medication 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 away), do not take the missed dose and take the next dose at your usual time.
• Otherwise, take the missed dose as soon as you remember, and then take the next tablet as you would normally.
• Do not take a double dose to make up for a missed dose.

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 adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

Some of these adverse effects, such as hot flushes, hair loss, or vaginal bleeding, may be due to low estrogen levels.

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

Some adverse effects may be serious:

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

• Weakness, paralysis, or loss of sensation in any part of the body (especially arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (signs of a brain disorder, e.g., stroke).
• Sudden, pressing chest pain (signs of a heart disorder).
• Swelling and redness in a vein that is extremely tender and possibly painful to touch.
• Severe fever, chills, or mouth ulcers due to infections (due to low white blood cells).
• Severe, persistent blurred vision.
• Tendinitis or inflammation of a tendon (connective tissue that connects muscles to bones).

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

• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin coloration, or sudden pain in the arm, leg, or foot (signs of a blood clot).
• 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 an allergic reaction).
• Yellowing of the skin and eyes, nausea, loss of appetite, darkening of urine (signs of hepatitis).
• Skin rash, redness, blisters on the lips, eyes, or mouth, skin peeling, fever (signs of a skin disorder).

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

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

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

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

• Skin rash
• Headache
• Dizziness
• General malaise
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
• Increased or decreased appetite
• Muscle pain
• Thinning or loss of bone (osteoporosis), which may lead to bone fractures in some cases (see also section “Monitoring of Loxifan treatment” in section 3).
• Swelling of arms, hands, feet, or 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

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

Some adverse effects are uncommon (may affect up to 1 in 100 patients):

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

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

Trigger finger, a condition in which your finger or thumb becomes locked in a bent position.

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

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Loxifan

• Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

• Do not store above 30°C.

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

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

• Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Loxifan

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other components (excipients) are lactose monohydrate, microcrystalline cellulose, maize starch, sodium carboxymethylstarch (type A) from 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 of the product and contents of the pack

• Loxifan is presented as film-coated tablets. The tablets are dark yellow and round. They are marked with “FV” on one side and “CG” on the other.
• Each blister pack 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, 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 HUNGARIA KFT.

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

or

NOVARTIS PHARMA GMBH

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

or

NOVARTIS PHARMA BV

Haaksbergweg 16, 1101 BX Amsterdam - The Netherlands

or

NOVARTIS FARMA S.P.A.

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

or

NOVARTIS SRO

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

or

NOVARTIS FARMA-PRODUCTOS FARMACÉUTICOS, 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: November/2020

Other sources of information

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS):

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