Letrozole Edigen 2.5 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Letrozol Edigen 2.5 mg film-coated tablets EFG
Letrozole
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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
Leaflet contents
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What Letrozol Edigen is and what it is used for
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What you need to know before taking Letrozol Edigen
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How to take Letrozol Edigen
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Possible side effects
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Storage of Letrozol Edigen
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Contents of the pack and other information
1. What Letrozol Edigen is and what it is used for
What Letrozol Edigen is and how it works
Letrozol Edigen 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 Edigen 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 Edigen is used for
Letrozol Edigen 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 after five years of treatment with tamoxifeno. Letrozol Edigen 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 Edigen works or why this medicine has been prescribed for you, please consult your doctor.
2. What you need to know before taking Letrozol Edigen
Carefully follow all instructions provided by your doctor. These may differ from the general information contained in this leaflet.
Do not take Letrozol Edigen
- 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
Talk to your doctor or pharmacist before starting treatment with Letrozol Edigen
- 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 Edigen” 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 Edigen.
Children and adolescents
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 Edigen with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy, breast-feeding and fertility
- You should only take Letrozol Edigen if you have passed the menopausal stage. However, your doctor should discuss with you the need to use effective contraception, as you could still become pregnant during treatment with Letrozol Edigen.
- You must not take Letrozol Edigen if you are pregnant or breastfeeding, as it may harm your baby.
Driving and using machines
If you feel dizzy, tired, sleepy, or unwell, do not drive or operate tools or machinery until you feel well again.
Important information about some of the ingredients of Letrozol Edigen
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.
Use in athletes
This medicine contains letrozol, which may produce a positive result in doping control tests.
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.
3. How to take Letrozol Edigen
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.
The recommended dose is one Letrozol Edigen tablet once daily. Taking Letrozol Edigen 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 Edigen
Continue taking Letrozol Edigen every day for as long as your doctor has prescribed it. You may need to take it for months or even years. If you have any doubts about how long you should take Letrozol Edigen, consult your doctor.
Monitoring of treatment with Letrozol Edigen
You should only take this medicine under strict medical supervision. Your doctor will monitor your condition periodically to ensure the treatment is having the desired effect.
Letrozol Edigen 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 to monitor osteoporosis) before, during, and after treatment.
If you take more Letrozol Edigen than you should
If you have taken too many Letrozol Edigen tablets, or if someone else has accidentally taken the tablets, contact your doctor or go to the hospital immediately. Show them the tablet packaging. You may require medical treatment. You can also call the Toxicology Information Service at telephone number 915620420, indicating the medicine and the amount taken.
If you forget to take Letrozol Edigen
- If it is almost time for your next dose (e.g. 2 or 3 hours before), 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 usual time.
- Do not take a double dose to make up for forgotten doses.
If you stop taking Letrozol Edigen
Do not stop taking Letrozol Edigen unless your doctor tells you to. See also the section "How long to take Letrozol Edigen".
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 estrogen 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:
Rare or uncommon effects (may affect 1 to 100 in every 10,000 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 (signs of heart disorder)
- Breathing difficulty, chest pain, fainting, rapid heartbeat, bluish skin discoloration, or sudden pain in the arm, leg, or foot (signs of blood clot formation)
- 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 low white blood cell count)
- Persistent, severe blurred vision
- Tendon rupture (connective tissue that connects 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 Edigen:
- 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 adverse effects (may affect more than 10 out of 100 patients):
- Hot flushes
- Elevated cholesterol levels (hypercholesterolemia)
- Increased sweating
- Bone and joint pain (arthralgia)
If any of these affect you severely, inform your doctor.
Common adverse effects (may affect 1 to 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
- Bone thinning or bone loss (osteoporosis), which may lead to bone fractures in some cases (see also section “Monitoring of Letrozol Edigen 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 heartbeat
- Joint stiffness (arthritis)
- Chest pain
If any of these affect you severely, inform your doctor.
Uncommon adverse effects (may affect 1 to 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 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)
- 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, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through 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 Edigen
Keep this medicine out of the sight and reach of children.
Do not use Letrozol Edigen after the expiry date 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.
Store in the original packaging to protect it from moisture.
Do not use any pack that is damaged or shows signs of tampering.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused packs and medicines at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of packs and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Letrozol Edigen
- The active substance is letrozol. Each film-coated tablet contains 2.5 mg of letrozol.
- The other components (excipients) are:
Excipients of the core: Monohydrate lactose, corn starch, microcrystalline cellulose, sodium starch glycolate (Type A) from potato (potato starch), talc, magnesium stearate.
Excipients of the film coating: Aquopolish® yellow composed of: Hydroxypropyl methylcellulose, hydroxypropyl cellulose, talc, cottonseed oil, yellow iron oxide, red iron oxide, titanium dioxide.
Appearance of the product and contents of the pack
Letrozol Edigen is presented in packs containing 30 and 100 film-coated tablets. The film-coated tablets are round, biconvex, and yellow in color.
Marketing Authorization Holder
Aristo Pharma Iberia, S.L.
C/ Solana, 26
28850, Torrejón de Ardoz
Madrid, Spain
Manufacturer
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
D-48159 Münster
Germany
or
Tecnimede – Sociedade Técnico-Medicinal, S.A.
Quinta da Cerca, Caixaria, Dois Portos – 2565-187
Portugal
Date of the most recent review 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/