Letrozole Ratiopharm 2.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Letrozole ratiopharm 2.5 mg film-coated tablets EFG

Letrozole

Read the entire leaflet carefully before you start taking this medicine, as 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 others, even if they have the same symptoms as you, because it could 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 ratiopharm is and what it is used for
2. What you need to know before taking Letrozole ratiopharm
3. How to take Letrozole ratiopharm
4. Possible side effects
5. How to store Letrozole ratiopharm
6. Contents of the pack and other information

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

What Letrozol ratiopharm is and how it works

Letrozol ratiopharm 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 therefore can inhibit the growth of estrogen-dependent breast cancers. As a result, tumor cells grow more slowly, or their growth and spread to other parts of the body is halted.

What Letrozol ratiopharm is used for

Letrozol ratiopharm 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 following five years of treatment with tamoxifen. Letrozol ratiopharm 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 Letrozol ratiopharm works or why this medicine has been prescribed for you, please consult your doctor.

2. What you need to know before taking Letrozol ratiopharm

Carefully follow all instructions given by your doctor. They may differ from the information contained in this leaflet.

Do not take Letrozol ratiopharm

• if you are allergic to letrozol or to any of the other ingredients of this medicine (listed in section 6),
• if you still have menstrual cycles, that is, have not yet 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 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, inform your doctor. Your doctor will take this into account during your treatment with Letrozol ratiopharm.

Letrozol 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 (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.

Taking Letrozol ratiopharm with other medicines

Inform 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, breastfeeding and fertility

• You should only take Letrozol ratiopharm if you have passed the menopausal stage. However, your doctor should discuss with you the use of an effective method of contraception, as you may still become pregnant during treatment with Letrozol ratiopharm.
• You must not take Letrozol ratiopharm if you are pregnant or breastfeeding, as it may harm your baby.

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.

Important information for athletes

This medicine contains letrozol, which may produce a positive result in doping control tests.

Letrozol ratiopharm contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with your doctor 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 given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one Letrozol ratiopharm tablet once daily. Taking Letrozol ratiopharm 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 ratiopharm

Continue taking Letrozol ratiopharm every day for as long as your doctor has instructed. You may need to take it for months or even years. If you have any doubts about how long you should continue taking Letrozol ratiopharm, consult your doctor.

Monitoring of treatment with Letrozol ratiopharm

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

Letrozol ratiopharm 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 ratiopharm than you should

If you have taken too many Letrozol ratiopharm tablets, or if someone else has accidentally taken them, contact your doctor or go to the hospital immediately. Show them the tablet packaging. You may require medical treatment.

You may also call the Toxicology Information Service at telephone number: 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., only 2 or 3 hours left), do not take the missed dose; instead, take the next dose at your usual time.
• Otherwise, take the missed dose as soon as you remember, and then take the next dose at your regular time.
• 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 adverse effects

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

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

Some of the adverse effects, such as hot flushes, hair loss, or vaginal bleeding, may be due to lack of oestrogens.

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 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, e.g. stroke).
• Sudden, tight chest pain (signs of a heart disorder).
• Swelling and redness in a vein that is extremely tender and possibly painful to touch.
• High fever, chills, or mouth ulcers due to infections (lack of white blood cells).
• Severe, persistent blurred vision.

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

• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin colour, or sudden pain in the arm, leg, or foot (signs of blood clot formation).

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

You should also contact 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 (signs of hepatitis).
• Rash, skin redness, 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
• Elevated cholesterol levels (hypercholesterolaemia)
• Fatigue
• Increased sweating
• Bone and joint pain (arthralgia)

If any of these effects severely affect you, consult 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 ratiopharm 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 heart rate
• Joint stiffness (arthritis)
• Chest pain

If any of these severely affect you, 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 to touch
• Eye disorders such as blurred vision, eye irritation
• Skin disorders such as itching (urticaria)
• Vaginal discharge or dryness
• 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 skin and eyes
• Increased blood levels of bilirubin (a breakdown product of red blood cells)
• Tendinitis or inflammation of a tendon (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 available data):

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

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

Reporting of adverse effects

If you experience any type of 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 Letrozol ratiopharm

Keep out of the reach and sight of children.

Store in the original packaging to protect it from moisture.

Do not use Letrozol ratiopharm after the expiry date stated on the container after the abbreviation "EXP". The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Letrozol ratiopharm

• The active substance is letrozole. Each tablet contains 2.5 mg of letrozole.
• The other components are monohydrate lactose, corn starch, microcrystalline cellulose, sodium glycolate starch (Type A) from 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 contents of the pack

Letrozol ratiopharm is presented as film-coated, round, yellow tablets, convex on both sides. The tablets are packed in blisters containing 10, 30 and 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B 1st floor

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 medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/