LETROZOLE RATIOPHARM 2.5 mg FILM-COATED TABLETS

Introduction

PATIENT INFORMATION LEAFLET

Letrozol ratiopharm 2.5 mg film-coated tablets EFG

Letrozol

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this 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 pack

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

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

What is Letrozol ratiopharm and how does it work

Letrozol ratiopharm 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 often stimulated by estrogens, which are female sex hormones. Letrozol 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 is Letrozol ratiopharm used for

Letrozol ratiopharm 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 5 years of treatment with tamoxifen. Letrozol ratiopharm 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 ratiopharm works or why you have been prescribed this medicine, ask your doctor.

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

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

Do not take Letrozol ratiopharm

• 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 yet reached the 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 ratiopharm

• 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 ratiopharm" in section 3).

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

Letrozol 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 (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 ratiopharm with other medicines

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

Pregnancy, breast-feeding and fertility

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

Important information for athletes

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

Letrozol ratiopharm contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Letrozol ratiopharm contains sodium

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

3. How to take Letrozol ratiopharm

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

The recommended dose is one Letrozol ratiopharm tablet once a day. If you take Letrozol ratiopharm 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 ratiopharm

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

Monitoring of treatment with Letrozol ratiopharm

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

Letrozol ratiopharm 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 ratiopharm than you should

If you have taken too many Letrozol ratiopharm 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: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Letrozol ratiopharm

• 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 the missed dose.

If you stop taking Letrozol ratiopharm

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

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 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 experience 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 a part of the body (especially arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (sign of a brain disorder, e.g. stroke).
• Chest pain (sign of a heart disorder).
• 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).
• 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 of a blood clot).

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

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

• 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 affect you severely, talk to 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 bone (osteoporosis), which can cause bone fractures in some cases (see also the section "Monitoring of treatment with Letrozol ratiopharm" 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
• Stiffness in the joints (arthritis)
• Chest pain

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 touch
• Eye disorders such as blurred vision, eye irritation
• Skin disorders such as itching (urticaria)
• Vaginal discharge or dryness
• Breast pain
• Fever
• Thirst, taste disorder, dry mouth
• Dryness of the mucous membranes
• Weight loss
• Urinary tract infection, increased frequency of urination
• Cough
• Increased enzyme levels
• Yellowing of the skin and eyes
• High blood levels of bilirubin (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)

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

• Trigger finger, a condition in which your finger or thumb gets stuck in a bent position.

If any of these affect 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 leaflet. You can also report side effects directly to the Spanish Medicines and Health Products Agency (AEMPS) via their website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Letrozol ratiopharm

Keep out of the reach and sight of children.

Store in the original package to protect from moisture.

Do not use Letrozol ratiopharm after the expiry date stated on the pack after the abbreviation EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return the packages and any unused medicine to a pharmacy for proper disposal. This will help protect the environment.

6. Contents of the pack and further information

Composition of Letrozol ratiopharm

• The active substance is letrozole. Each tablet contains 2.5 mg of letrozole.
• The other ingredients are lactose monohydrate, corn starch, microcrystalline cellulose, sodium starch glycolate (Type A) potato, hypromellose, hydroxypropyl cellulose, magnesium stearate, talc, cottonseed oil, yellow iron oxide (E-172), red iron oxide (E-172), titanium dioxide (E-171).

Appearance of the product and pack contents

Letrozol ratiopharm 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 authorisation holder and manufacturer

Marketing authorisation holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B 1ª planta

28108 Alcobendas, Madrid (Spain)

Manufacturer:

MERCKLE GMBH

Ludwig Merckle Strasse 3

89143 Blaubeuren

Germany

This leaflet was approved in 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/