Letrozole Stada 2.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Letrozole STADA 2.5 mg film-coated tablets EFG

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 or pharmacist.

• 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 may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

2. What you need to know before taking Letrozole STADA

3. How to take Letrozole STADA

4. Possible side effects

5. How to store Letrozole STADA

6. Contents of the pack and other information

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

What Letrozol STADA is and how it works

Letrozol STADA 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. Letrozole reduces the amount of estrogen by blocking an enzyme ("aromatase") involved in estrogen production, and thus can block 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 Letrozol STADA is used for

Letrozole 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 the initial treatment before breast cancer surgery, when immediate surgery is not appropriate, or it may be used as the first treatment after breast cancer surgery, or after five years of treatment with tamoxifen. Letrozole is also used to prevent breast tumors 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, consult your doctor.

2. What you need to know before taking Letrozol STADA

Carefully follow all instructions from your doctor. They may differ from the general information contained in this 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 breastfeeding

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 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 injury (see section 4). If you experience any signs of tendon pain or inflammation, rest the affected area and contact your doctor.

Children and adolescents

Children and adolescents must not use this medicine.

Elderly patients

Patients aged 65 years and older may use this medicine at the same dose as adults.

Other medicines and Letrozol STADA

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

Pregnancy, breastfeeding and fertility

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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

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

Letrozol STADA contains lactose and sodium

Lactose: If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

Sodium: This medicine contains less than 1 mmol of sodium (23 mg) per tablet; thus, it is essentially “sodium-free”.

Important information for athletes

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

3. How to take Letrozol STADA

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

The recommended dose is one letrozole tablet once daily. Taking letrozole 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 or other liquid.

How long to take Letrozol STADA

Continue taking letrozole every day for as long as 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 letrozole, consult your doctor.

Monitoring of treatment with Letrozol STADA

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.

Letrozole 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 Letrozol STADA than you should

If you have taken too many letrozole tablets, or if someone else has accidentally taken them, contact your doctor or go to hospital immediately. Show them the tablet packaging. You may require medical treatment. You may 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 tablet (e.g. 2 or 3 hours before), 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 following tablet at your usual time.
• Do not take a double dose to make up for a missed dose.

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 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 oestrogen deficiency.

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 or rare (may affect 1 to 100 in every 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 (signs of a brain disorder such as stroke)
• Sudden, crushing chest pain (sign of a heart disorder)
• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin colour, or sudden pain in the arm, leg, or foot (signs of a blood clot)
• Swelling and redness in a vein that is extremely tender and possibly painful to touch
• High fever, chills, or mouth ulcers due to infections (signs of low white blood cell count)
• Persistent blurred vision

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 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 (signs of hepatitis)
• Skin 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 flushes
• High cholesterol levels (hypercholesterolaemia)
• Fatigue
• Increased sweating
• Bone and joint pain (arthralgia)

If any of these effects affect you severely, inform 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, diarrhoea
• 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 Letrozol STADA treatment” in section 3)
• Swelling of arms, hands, feet, ankles (oedema)
• 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 effects affect you severely, inform your doctor.

Uncommon: May affect up to 1 in 100 people.

• 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 touch sensitivity
• Eye disorders such as blurred vision, eye irritation
• Palpitations, rapid heart rate
• Skin disorders such as itching (urticaria)
• Vaginal discharge or dryness
• Joint stiffness (arthritis)
• 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
• Yellowing of the skin and eyes
• High levels of bilirubin in the blood (a breakdown product of red blood cells)
• Tendinitis or inflammation of a tendon (connective tissue connecting muscles to bones)

Rare: May affect up to 1 in 1,000 people.

• Tendon rupture (connective tissue connecting muscles to bones)

Not known: Frequency cannot be estimated from the 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 effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Letrozole STADA

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

Store in the original packaging to protect it from moisture.

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

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Letrozol STADA

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

• The other components are monohydrate lactose, corn starch, microcrystalline cellulose, sodium starch glycolate (Type A), hypromellose (6 mPas), hydroxypropyl cellulose, magnesium stearate, talc, cottonseed oil, yellow iron oxide (E 172), red iron oxide (E 172), titanium dioxide (E171).

Appearance of the medicine and contents of the pack

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

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 authorised in EEA Member States under the following names:

Germany: Letrostad 2.5 mg Filmtabletten

Spain: Letrozol STADA 2.5 mg film-coated tablets EFG

Date of the most recent review of the 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 (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) http://www.aemps.gob.es/