Letrozole Alter 2.5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Letrozole Alter 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 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.

Leaflet contents

1. What Letrozole Alter is and what it is used for
2. What you need to know before taking Letrozole Alter
3. How to take Letrozole Alter
4. Possible side effects
5. How to store Letrozole Alter
6. Contents of the pack and other information

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

What Letrozol Alter is and how it works

Letrozol Alter 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. Letrozol Alter reduces the amount of estrogen by blocking an enzyme ("aromatase") involved in estrogen production, and therefore can block the growth of breast cancers that require estrogens 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 Alter is used for

Letrozol Alter 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 as initial treatment after breast cancer surgery, or after five years of treatment with tamoxifen. Letrozol Alter 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 Letrozol Alter works or why this medicine has been prescribed for you, consult your doctor.

2. What you need to know before starting to take Letrozol Alter

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

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 immediately.

Do not take Letrozol Alter

• 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, i.e. you have not yet reached menopause,
• if you are pregnant,
• if you are breastfeeding.

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

Warnings and precautions

Consult your doctor or pharmacist before taking Letrozol Alter

• 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 Alter” in section 3).

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

Children and adolescents (under 18 years of age)

Children and adolescents must not use this medicine.

Elderly patients (aged 65 years and over)

Patients aged 65 years and over may use this medicine at the same dosage as adults.

Taking Letrozol Alter with other medicines

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

Driving and use of machines

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

Letrozol Alter contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

Letrozol Alter contains tartrazine

It may cause allergic-type reactions.

Use in athletes

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

3. How to take Letrozol Alter

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

The usual dose is one Letrozol Alter tablet once daily. Taking Letrozol Alter 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 Alter

Continue taking letrozol every day for as long as your doctor has prescribed. You may need to take it for months or even years. If you have any doubts about how long you should take this medicine, consult your doctor.

Monitoring of treatment with Letrozol Alter

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.

Letrozol may cause a reduction in bone thickness or bone loss (osteoporosis) due to decreased 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 Alter than you should

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

You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount taken.

If you forget to take Letrozol Alter

• If it is almost time for your next dose (e.g., only 2 or 3 hours left), do not take the missed dose and take the next dose at the usual time.
• Otherwise, take the missed dose as soon as you remember, and then take the following dose at the usual time.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Letrozol Alter

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

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 may cause adverse effects, although not everyone experiences 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 low estrogen levels.

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, crushing chest pain (signs of a heart disorder).
• Swelling and redness in a vein that is extremely tender and possibly painful to touch.
• Severe fever, chills, or mouth ulcers due to infections (due to low white blood cell count).
• Persistent, severe blurred vision.
• Tendinitis or inflammation of a tendon (connective tissue connecting muscles to bones).

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

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

Rupture of a tendon (connective tissue connecting muscles to bones).

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 Letrozol Alter:

• 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 lips, eyes or mouth, skin peeling, fever (signs of skin disorder).

Some adverse effects are very common (may affect more than 1 in 10 people):

• Hot flushes
• Elevated cholesterol levels (hypercholesterolemia)
• Fatigue
• Increased sweating
• Bone and joint pain (arthralgia)

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

Some adverse effects are 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
• Bone thinning or bone loss (osteoporosis), which may lead to bone fractures in some cases (see also section “Monitoring of Letrozol Alter treatment” in section 3)
• Swelling of arms, hands, feet, ankles (edema)
• 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 affect you severely, inform your doctor.

Some adverse effects are 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 in 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 discoloration of the skin and eyes
• Elevated blood levels of bilirubin (a product of red blood cell breakdown)

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

Adverse effects with frequency not known (frequency cannot be estimated from 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, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Alter

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

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

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Letrozol Alter

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other components (excipients) are: lactose monohydrate, sodium carboxymethyl starch (type A) (derived from potato starch), microcrystalline cellulose, hypromellose, anhydrous colloidal silica and magnesium stearate. The coating consists of Opadry Yellow, which is composed of: hypromellose, polyethylene glycol 6000, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) and tartrazine (E102).

Appearance of the product and contents of the pack

Letrozol Alter is presented as film-coated tablets. The tablets are cylindrical, yellow, biconvex and marked with the letter "L" on one side.

Each pack contains 30 tablets in blister packs.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Manufacturer

Laboratorios Cinfa, S.A.

C/ Olaz-Chipi 10, Polígono Industrial Areta

31620 Huarte, Navarra

Spain

Date of the most recent revision of this leaflet: October 2019.

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