Letrozole Bluefish 2.5 mg film-coated tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Letrozole Bluefish 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 others, 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 this leaflet:
- What Letrozole Bluefish is and what it is used for
- What you need to know before taking Letrozole Bluefish
- How to take Letrozole Bluefish
- Possible side effects
- How to store Letrozole Bluefish
- Contents of the pack and other information
1. What Letrozol Bluefish is and what it is used for
Letrozol Bluefish 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 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 stop growing and/or spreading to other parts of the body.
What Letrozol Bluefish is used for
Letrozol is used to treat breast cancer in women who have gone through menopause, that is, the cessation of menstrual periods.
It is used to prevent the cancer from coming back. It may be used as the first treatment before breast cancer surgery, if immediate surgery is not appropriate, or as initial treatment after breast surgery or after five years of treatment with tamoxifen. Letrozol is also indicated to prevent the spread of breast tumor to other parts of the body in patients with advanced disease.
If you have any questions about how letrozol works or why this medicine has been prescribed for you, please consult your doctor.
2. What you need to know before taking Letrozol Bluefish
Do not take Letrozol Bluefish
- 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 apply to you, do not take this medicine and inform your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before starting to take letrozol:
- 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 Bluefish” 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.
Letrozol may cause inflammation of the tendons 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)
Children and adolescents must not use this medicine.
Elderly patients (aged 65 years and older)
This medicine can be used by people aged 65 years and older at the same dose as for other adults.
Other medicines and Letrozol Bluefish
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including medicines obtained without a prescription.
Pregnancy, breastfeeding and fertility
- You should only take letrozol after you have reached menopause. However, your doctor should discuss with you the use of effective contraception, 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 Bluefish contains lactose
This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.
Letrozol Bluefish contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.
3. How to take Letrozol Bluefish
Follow exactly your doctor's instructions on how to take this medicine. If in doubt, consult your doctor or pharmacist again.
The usual dose is one tablet of letrozol once daily. Taking the medicine 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 another liquid.
How long to take Letrozol Bluefish
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 continue taking letrozol, consult your doctor.
Monitoring of treatment with Letrozol Bluefish
You should take this medicine only under strict medical supervision. Your doctor will monitor your condition periodically to ensure the treatment is having the desired effect.
Letrozol 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 Bluefish than you should
If you have taken too many letrozol tablets, or if someone else has accidentally taken the tablets, contact a doctor or go to the hospital immediately. Show them the medicine's packaging. You may require medical treatment.
In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20.
If you forget to take Letrozol Bluefish
If it is almost time for your next dose (e.g. only 2 or 3 hours remaining), 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 Bluefish
Do not stop taking this medicine unless your doctor tells you to. See also the section “How long to take Letrozol Bluefish”.
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 low estrogen levels.
Do not be alarmed by this list of possible adverse effects. You may not experience any of them.
Some adverse effects can be serious
Rare or uncommon adverse effects (i.e., may affect 1 to 100 out of 10,000 patients).
- Weakness, paralysis, or loss of sensation in any part of the body (particularly arm and 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 problems)
- Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin coloration, or sudden pain in the arm, leg, or foot (signs of a blood clot)
- 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)
- Severe, persistent blurred vision
- Uncommon - tendonitis or inflammation of a tendon (connective tissue linking muscles to bones)
- Rare - tendon rupture (connective tissue linking 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 letrozole:
- Swelling of the face and throat (symptoms of an allergic reaction)
- Yellowing of the skin and eyes, nausea, loss of appetite, dark-colored urine (symptoms of hepatitis)
- Redness, itching, blisters on lips, eyes or mouth, skin peeling, fever (symptoms of skin disorders)
Some adverse effects are very common (i.e., may affect more than 10 out of 100 patients).
- Hot flushes
- Increased cholesterol levels (hypercholesterolemia)
- Fatigue
- Increased sweating
- Bone and joint pain (arthralgia)
Inform your doctor immediately if any of these affect you severely.
Some adverse effects are common (i.e., 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
- Thinning or loss of bone (osteoporosis), which may lead to bone fractures in some cases (see also “Monitoring of Letrozol Bluefish 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
Inform your doctor immediately if any of these affect you severely.
Some adverse effects are uncommon (i.e., may affect 1 to 10 out of 1,000 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 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 levels of liver enzymes
- Yellowish discoloration of the skin and eyes
- Elevated blood levels of bilirubin (a breakdown product of red blood cells)
Adverse effects with unknown frequency
- Trigger finger, a condition in which the finger or thumb locks in a bent position.
If any of these affect you severely, inform your doctor.
If you experience any adverse effect, inform your doctor or pharmacist. This includes any adverse effect not mentioned in this leaflet.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an 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 Letrozole Bluefish
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.
Do not use any packaging that is damaged or shows signs of deterioration.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Instead, dispose of unused containers and medicines at the SIGRE Point located at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Letrozol Bluefish
The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
The excipients are: lactose monohydrate, corn starch, microcrystalline cellulose, sodium starch glycolate (type A) from potato, colloidal anhydrous silica, magnesium stearate; the coating consists of macrogol, hypromellose (E 464), talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).
Appearance of the product and contents of the pack
Film-coated tablet, yellow in colour, round, 6.1 mm (± 2 mm) in diameter and biconvex.
PVC/PE/PVDC/Aluminum blisters containing 30 and 100 tablets.
Only some pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Bluefish Pharmaceuticals AB;
P.O. Box 49013,
100 28 Stockholm,
Sweden
Manufacturer
Bluefish Pharmaceuticals AB
Gävlegatan 22
113 30 Stockholm;
Sweden
Genepharm S.A., 18 km Marathonos Avenue,
153 51 Pallini Attikis,
Greece
Further information on this medicinal product is available upon request to the local representative of the Marketing Authorization Holder:
Bluefish Pharma S.L.U.,
P.O. Box 36007
2832094 Madrid, Branch 36
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria | Letrozol Bluefish 2.5 mg film-coated tablets |
Germany | Letrozol Bluefish 2.5 mg film-coated tablets |
Denmark | Letrozol Bluefish 2.5 mg |
Spain | Letrozol Bluefish 2.5 mg film-coated tablets EFG |
Finland | Letrozole Bluefish 2.5 mg film-coated tablet Letrozole Bluefish 2.5 mg film-coated tablets |
France | Letrozole Bluefish 2.5 mg film-coated tablets |
Ireland | Letrozole Bluefish 2.5 mg film-coated tablets |
Italy | Letrozole Bluefish 2.5 mg film-coated tablets |
Iceland | Letrozole Bluefish 2.5 mg film-coated tablets |
Poland | Letrozole Bluefish 2.5 mg |
Sweden | Letrozole Bluefish 2.5 mg film-coated tablets |
Date of the most recent review of this leaflet: June 2020
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/