LETROZOLE VIATRIS 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Letrozol Mylan 2.5 mg film-coated tablets EFG

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

• Keep this package 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 symptoms 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 package leaflet. See section 4.

Contents of the package leaflet

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

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

What is Letrozol Mylan and how does it work

Letrozol Mylan 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 Mylan 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 Letrozol Mylan used for

Letrozol Mylan 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 help 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. Letrozol Mylan 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 Letrozol Mylan works or why you have been prescribed this medicine, ask your doctor.

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

Follow carefully all instructions given by your doctor. They may be different from the general information contained in this package leaflet.

Do not take Letrozol Mylan

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

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

Warnings and precautions

Tell your doctor or pharmacist before you start taking Letrozol Mylan

• 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 during treatment with Letrozol Mylan" in section 3).

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

This medicine may cause tendon inflammation or tendon injury (see section 4). If you notice any signs of pain or inflammation of the tendon, rest the affected area and tell 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.

Taking Letrozol Mylan with other medicines

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

Pregnancy, breast-feeding, and fertility

• You should only take Letrozol Mylan if you have gone through the menopause. However, your doctor should discuss with you the use of effective contraception, as you could still become pregnant during treatment with Letrozol Mylan.
• Do not take Letrozol Mylan 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 Mylan contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, such as lactose, ask your doctor before taking this medicine.

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

3. How to take Letrozol Mylan

Follow exactly the instructions given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again.

The usual dose is one Letrozol Mylan tablet once a day. If you take Letrozol Mylan 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 or other liquid.

How long to take Letrozol Mylan

Keep taking Letrozol Mylan every day for as long as your doctor tells you to. You may need to take it for months or even years. If you are unsure how long to take Letrozol Mylan, ask your doctor.

Monitoring during treatment with Letrozol Mylan

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

Letrozol Mylan may cause a decrease in bone density 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 Letrozol Mylan than you should

If you have taken too many Letrozol Mylan 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, phone: 915620420, stating the medicine and the amount taken.

If you forget to take Letrozol Mylan

• 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 usual 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 a forgotten dose.

If you stop taking Letrozol Mylan

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

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 get 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 (sign of heart disorder).
• Swelling and redness along 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(may affect up to 1 in 1,000 people)

• Difficulty breathing, chest pain, fainting, rapid heartbeat, blue discoloration of the skin, or sudden pain in the arm, leg, or foot (signs that a blood clot has formed).

Frequency not known(cannot be estimated from the available data)

• 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).

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

Other possible side effects

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 affect you severely, talk to your doctor.

Common(may affect up to 1 in 10 people)

• Pounding heart or rapid heartbeat.
• Chest pain.
• Skin rash.
• Joint stiffness (arthritis).
• Headache.
• Dizziness.
• General feeling of being unwell.
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea.
• Increased or decreased appetite.
• Muscle pain.
• Thinning or loss of bones (osteoporosis), which can cause bone fractures in some cases (see also the section "Monitoring during treatment with Letrozol Mylan" 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.

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

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 to touch.
• Eyelid disorders such as blurred vision, eye irritation.
• Yellowing of the skin and eyes.
• High bilirubin levels (a breakdown product of red blood cells). Skin disorders such as itching (urticaria).
• Vaginal dryness or discharge.
• 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.
• Tendon inflammation or tendinitis (connective tissue that connects muscles to bones).

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

• Tendon rupture (connective tissue that connects muscles to bones).

Frequency not known(cannot be estimated from the available data)

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

If this affects you severely, tell your doctor.

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 package leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Letrozol Mylan

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

Do not use Letrozol Mylan after the expiry date stated on the pack after EXP. The expiry date refers to the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. 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 Mylan

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

The other ingredients (excipients) are lactose monohydrate (see section 2, "Letrozol Mylan contains lactose and sodium"), microcrystalline cellulose, maize starch, colloidal anhydrous silica, sodium carboxymethyl starch (potato), and magnesium stearate. The coating consists of yellow iron oxide (E-172), hypromellose, polydextrose, macrogol, triacetin, quinoline yellow (E-104), and titanium dioxide (E-171).

Appearance and packaging of the product

Letrozol Mylan is presented as film-coated tablets. The tablets are yellow, capsule-shaped, with "LZ 2.5" engraved on one side and "G" on the other side.

Letrozol Mylan is available in blister packs or bottles of 7, 10, 14, 20, 28, 30, 56, 60, 84, 90, 98, 100, 112, 120, 180, 200, and 500 tablets, and in unit dose blister packs of 30 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Mylan Pharmaceuticals, S.L.

C/ Plom, 2-4, 5th floor

08038 - Barcelona

Spain

Manufacturer

Delpharm Lille S.A.S

Parc d’activités Roubaix-Est

22 rue de Toufflers – CS 50070

59452 Lys-Lez-Lannoy

France

Or

Mylan Hungary Kft.

Mylan utca 1

Komárom, 2900

Hungary

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

Austria: Letrozol Arcana

Cyprus: Letrozole / Generics

Czech Republic: Letmylan

Denmark: Letrozol Mylan

Finland: Letrozol Mylan

France: Letrozole Mylan

Greece: Letrozole Mylan

Ireland: Letrozole Mylan

Italy: Letrozolo Mylan Generics

Netherlands: Letrozole Mylan

Norway: Letrozol Mylan

Portugal: Letrozol Mylan

Spain: Letrozol Mylan

Sweden: Letrozol Mylan

Date of last revision of this package leaflet:12/2019

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/