Letrozole Viatris 2.5 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Letrozole Mylan 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.
Leaflet contents
- What Letrozole Mylan is and what it is used for
- What you need to know before taking Letrozole Mylan
- How to take Letrozole Mylan
- Possible adverse effects
- How to store Letrozole Mylan
- Contents of the pack and other information
1. What Letrozol Mylan is and what it is used for
What Letrozol Mylan is and how it works
Letrozol Mylan contains an active substance called letrozol. 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 Mylan 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 spread to other parts of the body is stopped.
What Letrozol Mylan is used for
Letrozol Mylan is used to treat breast cancer in women who have passed the menopause, that is, the cessation of menstrual periods.
It is used to help 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 after five years of treatment with tamoxifen. Letrozol Mylan 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 Mylan works or why you have been prescribed this medicine, please consult your doctor.
2. What you need to know before starting Letrozol Mylan
Carefully follow all instructions given by your doctor. They may differ from the general information contained in this leaflet.
Do not take Letrozol Mylan
- 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 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
Talk to your doctor or pharmacist before starting Letrozol Mylan
- 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 Mylan” 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.
This medicine 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 inform your doctor.
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 dose as adults.
Taking Letrozol Mylan with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including medicines without a prescription.
Pregnancy, breastfeeding and fertility
- You should only take Letrozol Mylan if you have passed the menopausal stage. However, your doctor should discuss with you the use of effective contraception, as you may still become pregnant during treatment with Letrozol Mylan.
- You must not take Letrozol Mylan 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 Mylan contains lactose and sodium
If your doctor has informed you of an intolerance to certain sugars, such as lactose, consult with him before taking this medicine.
This medicine contains less than 23 mg of sodium (1 mmol) per dose; this is essentially “sodium-free”.
3. How to take Letrozol Viatris
Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.
The usual dose is one Letrozol Viatris tablet once daily. Taking Letrozol Viatris 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 Viatris
Continue taking Letrozol Viatris 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 Viatris, consult your doctor.
Monitoring during treatment with Letrozol Viatris
You should take this medicine only under strict medical supervision. Your doctor will periodically monitor your condition to ensure the treatment is having the desired effect.
Letrozol Viatris 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 Viatris than you should
If you have taken too many Letrozol Viatris tablets, or if someone else has accidentally taken them, contact your doctor or go to the hospital immediately. Show them the medicine's packaging. You may require medical treatment. You can also call the Toxicology Information Service, Tel: 915620420, stating the medicine and the amount taken.
If you forget to take Letrozol Viatris
- If it is almost time for your next dose (e.g., only 2 or 3 hours left), do not take the missed dose. 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 missed dose.
If you stop taking Letrozol Viatris
Do not stop taking Letrozol Viatris unless your doctor tells you to. See also the section “How long to take Letrozol Viatris”.
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 estrogen deficiency.
Do not be alarmed by this list of possible adverse effects. You may not experience any of them.
Some adverse effects can 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, pressing chest pain (signs of heart disorder).
- Swelling and redness along a vein that is extremely soft 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 (may affect up to 1 in 1,000 people)
- Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin discoloration, or sudden pain in the arm, leg, or foot (signs of blood clot formation).
Frequency not known (cannot be estimated from available data)
- 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 the lips, eyes, or mouth, skin peeling, fever (signs of skin disorder).
If you experience any of the above, inform your doctor immediately.
Other possible adverse effects
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.
Common (may affect up to 1 in 10 people)
- Palpitations, rapid heartbeat.
- Chest pain.
- Skin rash.
- Joint stiffness (arthritis).
- Headache.
- Dizziness.
- General malaise.
- Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea.
- Increased or decreased appetite.
- Muscle pain.
- Thinning or loss of bones (osteoporosis), which may lead to bone fractures in some cases (see also section “Monitoring during your treatment with Letrozol Mylan” 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.
If any of these 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.
- Yellowing of the skin and eyes.
- High levels of bilirubin (a breakdown product of red blood cells). Skin disorders such as itching (urticaria).
- Vaginal dryness or discharge.
- Breast pain.
- Fever.
- Thirst, taste disturbance, dry mouth.
- Dryness of mucous membranes.
- Weight loss.
- Urinary tract infection, increased frequency of urination.
- Cough.
- Increased enzyme levels.
- Tendon inflammation or tendinitis (connective tissues connecting muscles to bones).
Rare (may affect up to 1 in 1,000 people)
- Tendon rupture (connective tissues connecting muscles to bones).
If any of these affect you severely, inform your doctor.
Frequency not known (cannot be estimated from available data)
- Trigger finger (a condition in which the finger or thumb locks in a bent position).
If this affects you severely, inform your doctor.
Reporting of adverse effects:
If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects 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 Mylan
Keep this medicine out of sight and reach of children.
Do not use Letrozol Mylan after the expiry date stated on the packaging after EXP or CAD. The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Letrozol Mylan
The active substance is letrozol. Each film-coated tablet contains 2.5 mg of letrozol.
The other components (excipients) are monohydrate lactose (see section 2, "Letrozol Mylan contains lactose and sodium"), microcrystalline cellulose, corn starch, anhydrous colloidal silicon dioxide, sodium carboxymethyl starch (from potato), and magnesium stearate. The coating consists of yellow iron oxide (E-172), hypromellose, polydextrose, macrogol, triacetin, quinoline yellow dye (E-104), and titanium dioxide (E-171).
Appearance of the product and contents of the pack
Letrozol Mylan is presented as film-coated tablets. The tablets are dark yellow, capsule-shaped, with the imprint “LZ 2.5” on one side and “G” on the other side.
Letrozol Mylan is available in blisters or bottles containing 7, 10, 14, 20, 28, 30, 56, 60, 84, 90, 98, 100, 112, 120, 180, 200, and 500 tablets, and in single-dose perforated blisters containing 30 tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
Mylan Pharmaceuticals, S.L.
C/ Plom, 2-4, 5th floor
08038 - Barcelona
Spain
Manufacturer
Delpharm Lille S.A.S
Parc d’activités Roubaix-Est
22 rue de Toufflers – CS 50070
59452 Lys-Lez-Lannoy
France
Or
Mylan Hungary Kft.
Mylan utca 1
Komárom, 2900
Hungary
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria: Letrozol Arcana
Cyprus: Letrozole / Generics
Czech Republic: Letmylan
Denmark: Letrozol Mylan
Finland: Letrozol Mylan
France: Letrozole Mylan
Greece: Letrozole Mylan
Ireland: Letrozole Mylan
Italy: Letrozolo Mylan Generics
Netherlands: Letrozole Mylan
Norway: Letrozol Mylan
Portugal: Letrozol Mylan
Spain: Letrozol Mylan
Sweden: Letrozol Mylan
Date of the most recent review of this leaflet: 12/2019
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/