LETROZOLE STADA 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Letrozol STADA 2.5 mg film-coated tablets EFG

Read the 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 signs of illness are the same as yours.
• If you get 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 package leaflet

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

1. What you need to know before you take Letrozol STADA

1. How to take Letrozol STADA

1. Possible side effects

1. Storage of Letrozol STADA

1. Contents of the pack and further information

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

What is Letrozol STADA and how does it work

Letrozol STADA 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. Letrozole 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 STADA is used for

Letrozole 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. Letrozole 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 letrozole works or why you have been prescribed this medicine, ask your doctor.

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

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

DO NOT take Letrozol STADA

• 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 breast-feeding

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

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with letrozole.

• 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 STADA" 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 letrozole.

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

Children and adolescents should not use this medicine.

Elderly patients

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

Other medicines and Letrozol STADA

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy, breast-feeding, and fertility

• You should only take letrozole 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 letrozole.
• Do not take letrozole if you are pregnant or breast-feeding, as it may harm your baby.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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 STADA contains lactose and sodium

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

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

Important information for athletes

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

3. How to take Letrozol STADA

Follow exactly the instructions for administration of this medicine given to you by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is one letrozole tablet once a day. If you take letrozole 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 STADA

Continue taking letrozole 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 letrozole, consult your doctor.

Monitoring of treatment with Letrozol STADA

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.

Letrozole 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 monitor osteoporosis) before, during, and after treatment.

If you take more Letrozol STADA than you should

If you have taken too many letrozole tablets or if someone else has taken your tablets, contact your doctor or go to the hospital immediately. Show them the package of tablets. You may need medical treatment. You can also call the Toxicology Information Service, telephone 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Letrozol STADA

• 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 forgotten doses.

If you stop taking Letrozol STADA

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

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 or rare(may affect 1 to 100 out of 10,000 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, such as a stroke)
• Chest pain or discomfort (sign of a 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 a blood clot)
• 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)
• Blurred vision

If you experience any of these, tell your doctor immediately.

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

• 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 color (signs of hepatitis).
• Rash, redness of the skin, blisters on the lips, eyes, or mouth, skin peeling, fever (signs of skin disorder).

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, tell your doctor.

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 loss of bones (osteoporosis), which can cause bone fractures in some cases (see also "Monitoring of treatment with Letrozol STADA" 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, 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 touch
• Eye disorders such as blurred vision, eye irritation
• Palpitations, rapid heartbeat
• Skin disorders such as itching (urticaria)
• Vaginal discharge or dryness
• Joint stiffness (arthritis)
• Chest 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 bilirubin levels in the blood (a breakdown product of red blood cells)
• Tendinitis or tendon inflammation (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)

Not known.Frequency cannot be estimated from the 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, 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 leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Letrozol STADA

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

Store in the original package to protect from moisture.

Do not use this medicine after the expiry date stated on the package. The expiry date is the last day of the month stated.

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 STADA

• The active substance is letrozole. Each tablet contains 2.5 mg of letrozole.

• The other ingredients are lactose monohydrate, cornstarch, microcrystalline cellulose, sodium starch glycolate (Type A), hypromellose (6 mPa.s), hydroxypropyl cellulose, magnesium stearate, talc, cottonseed oil, yellow iron oxide (E 172), red iron oxide (E 172), titanium dioxide (E 171).

Appearance and packaging of the product

Letrozol STADA 2.5 mg is presented as film-coated tablets, round, yellow, and with both surfaces convex.

The tablets are packaged in blisters containing 10, 30, and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Haupt Pharma Münster GmbH

Schleebrüggenkamp 15

D-48159 Münster

Germany

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

This medicine is authorized in the EEA Member States under the following names:

Germany: Letrostad 2.5 mg film-coated tablets

Spain: Letrozol STADA 2.5 mg film-coated tablets EFG

Date of last revision of the package leaflet: October 2019

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