Letrozole Cinfa 2.5 mg film-coated tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package Leaflet: Information for the Patient
letrozol cinfa 2.5 mg film-coated tablets EFG
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
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Keep this leaflet as you may need to read it again.
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If you have any questions, ask your doctor or pharmacist.
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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.
Leaflet Contents
- What letrozol cinfa is and what it is used for
- What you need to know before taking letrozol cinfa
- How to take letrozol cinfa
- Possible side effects
- How to store letrozol cinfa
- Contents of the pack and other information
1. What is letrozol cinfa and what is it used for
What is letrozol cinfa and how does it work
This medicine 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 cinfa 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 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 cinfa is used for
Letrozol is used to treat breast cancer in women who have undergone menopause, that is, who have stopped menstruating.
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. Letrozole 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 this medicine works or why it has been prescribed for you, please consult your doctor.
2. What you need to know before taking letrozol cinfa
Carefully follow all instructions provided by your doctor. These may differ from the general information contained in this leaflet.
Do not take letrozol cinfa
- 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 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 treatment with letrozol cinfa
- 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 cinfa” 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 cinfa.
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.
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 may use this medicine at the same dosage as adults.
Taking letrozol cinfa 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
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
You should only take letrozol if you have passed the menopausal stage. However, your doctor should discuss with you the use of an effective contraceptive method, as you could still become pregnant during treatment with letrozol.
Do not take letrozol 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.
letrozol cinfa contains lactose
If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.
letrozol cinfa contains tartrazine
This medicine may cause allergic reactions because it contains tartrazine (E102). It may provoke asthma, particularly in patients allergic to acetylsalicylic acid.
letrozol cinfa contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially “sodium-free”.
Use in athletes
This medicine contains letrozol, which may lead to a positive result in doping control tests.
3. How to take letrozole cinfa
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, please consult your doctor or pharmacist again.
The usual dose is one tablet once daily. Taking letrozole cinfa 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 cinfa
Continue taking this medicine 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 this medicine, consult your doctor.
Monitoring of treatment with letrozole cinfa
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 cinfa than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take letrozole cinfa
- If it is almost time for your next tablet (e.g., only 2 or 3 hours remaining), 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 following dose at your regular time.
- Do not take a double dose to make up for a missed dose.
If you stop taking letrozole cinfa
Do not stop taking this medicine unless your doctor tells you to. See also the section “How long to take letrozole cinfa”.
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 these adverse effects are mild or 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 oestrogen deficiency.
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 patients):
- 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, oppressive chest pain (sign 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 (caused by lack of white blood cells).
- Persistent, severe blurred vision.
- Tendinitis or inflammation of a tendon (connective tissue connecting muscles to bones).
Rare (may affect up to 1 in 1000 patients):
- Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin colour, or sudden pain in the arm, leg, or foot (signs of blood clot formation).
- Tendon rupture (connective tissue connecting 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 letrozole:
- 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 patients):
- Hot flushes.
- Elevated cholesterol levels (hypercholesterolaemia).
- Fatigue.
- Increased sweating.
- Bone and joint pain (arthralgia).
If any of these effects affect you severely, consult your doctor.
Some adverse effects are common (may affect up to 1 in 10 patients):
- Skin rash.
- Headache.
- Dizziness.
- General malaise.
- Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhoea.
- Increased or decreased appetite.
- Muscle pain.
- Bone thinning or loss (osteoporosis), which may lead to bone fractures in some cases (see also section “Monitoring of letrozol cinfa 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 affect you severely, inform your doctor.
Some adverse effects are uncommon (may affect up to 1 in 100 patients):
- 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 related to touch.
- Eye disorders such as blurred vision, eye irritation.
- Skin disorders such as itching (urticaria).
- Vaginal dryness or discharge.
- 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).
Adverse effects with unknown 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, 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 letrozole cinfa
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
No special storage conditions are required.
Medicines should 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 properly dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of letrozol cinfa
- The active substance is letrozol. Each film-coated tablet contains 2.5 mg of letrozol.
- The other components are: monohydrate lactose, sodium carboxymethyl starch (type A) (from potato), microcrystalline cellulose, hypromellose, anhydrous colloidal silica, and magnesium stearate. The tablet coating components, Opadry Yellow, are: hypromellose, macrogol 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 cinfa are cylindrical, yellow, biconvex film-coated tablets marked with the letter "L" on one side.
Each blister pack contains 30 or 100 tablets (clinical pack).
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta.
31620 Huarte (Navarra) - Spain
Date of the most recent revision of this leaflet: October 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/
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/72125/P_72125.html
QR code link: https://cima.aemps.es/cima/dochtml/p/72125/P_72125.html