Letrozole Kern Pharma 2.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

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

1. What Letrozol Kern Pharma Is and What It Is Used For

What Letrozol Kern Pharma Is and How It Works

Letrozol Kern Pharma 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 Kern Pharma reduces the amount of estrogen by blocking an enzyme ("aromatase") involved in estrogen production, and therefore can inhibit 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 Kern Pharma Is Used For

Letrozol Kern Pharma is used to treat breast cancer in women who have gone through menopause, that is, the cessation of menstrual periods.

It is used to help prevent breast cancer from returning. It may be used as the first 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 Kern Pharma is also used to help prevent breast cancer from spreading to other parts of the body in patients with advanced breast cancer.

If you have any questions about how Letrozol Kern Pharma works or why this medicine has been prescribed for you, please consult your doctor.

2. What you need to know before starting to take Letrozol Kern Pharma

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

Do not take Letrozol Kern Pharma

• 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, 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 starting to take Letrozol Kern Pharma

• 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 Kern Pharma" 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 Kern Pharma.

Letrozol may cause tendon inflammation or tendon injuries (see section 4). If you experience any signs of tendon pain or inflammation, rest the affected area and contact your doctor immediately.

Children and adolescents (under 18 years of age)

Children and adolescents must not use this medicine.

Elderly patients (aged 65 years and older)

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

Taking Letrozol Kern Pharma with other medicines

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

Pregnancy, breastfeeding, and fertility

• You should only take Letrozol Kern Pharma if you have passed the menopausal stage. However, your doctor should discuss with you the need to use an effective method of contraception, as you may still be able to become pregnant during treatment with Letrozol Kern Pharma.
• You must not take Letrozol Kern Pharma 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.

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Use in athletes:

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

3. How to take Letrozole Kern Pharma

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The usual dose is one tablet of Letrozole Kern Pharma once daily. Taking Letrozole Kern Pharma 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 Letrozole

Continue taking Letrozole Kern Pharma every day for as long as your doctor tells you to. You may need to take it for months or even years. If you have any doubts about how long you should take Letrozole Kern Pharma, consult your doctor.

Monitoring of treatment with Letrozole Kern Pharma

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 Letrozole Kern Pharma than you should

If you have taken too many Letrozole Kern Pharma 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 915620420, stating the name of the medicine and the amount taken.

If you forget to take Letrozole Kern Pharma

• If it is almost time for your next dose (e.g. within 2 or 3 hours), 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 next dose at your regular time.
• Do not take a double dose to make up for a missed dose.

If you stop taking Letrozole Kern Pharma

Do not stop taking Letrozole Kern Pharma unless your doctor tells you to. See also the section “How long to take Letrozole Kern Pharma”.

4. Possible adverse effects

Like all medicines, this medicine may 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 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:

Rare or uncommon adverse effects (i.e., may affect between 1 and 100 out of 10,000 patients):

• Weakness, paralysis, or loss of sensation in any part of the body (especially arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (signs of a brain disorder, e.g., stroke).
• Sudden, crushing chest pain (sign of heart disorder).
• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin coloration, or sudden pain in the arm, leg, or foot (signs of blood clot formation).
• Swelling and redness along 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).
• Severe, persistent blurred vision.
• Rare – tendon rupture (connective tissue that connects muscles to bones).

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

You should also inform your doctor immediately if you experience any of the following symptoms during treatment with Letrozol Kern Pharma:

• Swelling, mainly in the face and throat (signs of 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. These may affect more than 10 out of 100 patients.

• 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. These may affect between 1 and 10 out of 100 patients.

• 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 may lead to bone fractures in some cases (see also section “Monitoring of treatment with Letrozol Kern Pharma” 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. These may affect between 1 and 10 out of 1,000 patients.

• Nervous system disorders such as anxiety, nervousness, irritability, numbness, memory problems, drowsiness, insomnia
• Sensory disturbances, especially related 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 discoloration of the skin and eyes
  • Elevated blood levels of bilirubin (a product of red blood cell breakdown)
  • Tendinitis or inflammation of a tendon (connective tissue that connects muscles to bones)

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 an adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Letrozol Kern Pharma

• Keep this medicine out of the sight and reach of children.
• Do not use Letrozol Kern Pharma after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
• No special storage conditions are required.
• Store in the original packaging to protect it from moisture.
• Do not use any packaging that is damaged or shows signs of tampering.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Letrozol Kern Pharma

• The active substance is letrozol. Each film-coated tablet contains 2.5 mg of letrozol.
• The other components are: lactose monohydrate (lactose), sodium carboxymethyl starch from potato (potato starch), colloidal anhydrous silica, microcrystalline cellulose, crospovidone, pregelatinized corn starch (corn starch), and magnesium stearate (E-470b). The components of the tablet coating are: hypromellose (E-464), polyethylene glycol 400, titanium dioxide (E-171), and yellow iron oxide (E-172).

Appearance of the product and contents of the pack

Letrozol Kern Pharma is presented as film-coated tablets. The tablets are yellow and round. Each blister pack contains 30 tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

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 of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/