2.5 mg film-coated tablets
letrozole
What Letrozole Bluefish is and what it is used for
What Letrozole Bluefish is
Letrozole Bluefish contains an active substance called letrozole. Letrozole Bluefish belongs to a group of medicines called aromatase inhibitors. It is a hormonal (or “endocrine”) treatment for breast cancer. The growth of breast tumors is often stimulated by the female sex hormone estrogen. Letrozole reduces the amount of estrogen by blocking an enzyme (“aromatase”) that participates in the production of estrogen and can therefore stop the growth of breast tumors that need estrogen to grow. This slows or stops the growth of tumor cells and their spread to other parts of the body.
What Letrozole Bluefish is used for
Letrozole Bluefish is used to treat breast cancer in women who have undergone menopause, ie. no longer have menstruation.
It is used to prevent the recurrence of cancer. It can be used as first treatment before breast surgery when immediate surgery is not appropriate, or as first treatment after breast surgery or after five years of treatment with tamoxifen. Letrozole Bluefish is also used to prevent breast tumors from spreading to other parts of the body in patients with advanced breast cancer.
Ask your doctor if you are wondering how Letrozole Bluefish works or why you have been prescribed it.
What you need to know before you take Letrozole Bluefish
Carefully follow your doctor’s instructions. They may deviate from the general instructions in this leaflet.
Do not take Letrozole Bluefish
- if you are allergic to letrozole or any of the other ingredients of this medicine (listed in section 6).
- if you are still menstruating ie if you have not yet undergone menopause one
- if you are pregnant
- if you are breast-feeding
If any of these apply to you, do not take this medicine and talk to your doctor.
Warnings and cautions
Talk to your doctor or pharmacist before taking Letrozole Bluefish
- if you have severe kidney disease
- if you have severe liver disease
- if you have or have had osteoporosis or fractures (see also “Checks during treatment with Letrozole Bluefish” in section 3).
If any of these apply to you, tell your doctor. Your doctor will take this into account during your treatment with Letrozole Bluefish.
Letrozole may cause tendon inflammation or tendon damage (see section 4). In case of any sign of sensory pain or swelling – rest the painful area and consult a doctor.
Children and adolescents (under 18 years)
Children and adolescents should not use this medicine.
Elderly people (from 65 years)
People who are 65 years or older can use this drug in the same dose as other adults.
Other medicines and Letrozole Bluefish
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Pregnancy, breastfeeding and fertility
- You should only take Letrozole Bluefish after you have had a menopause (ie you are no longer menstruating). However, your doctor should talk to you about using an effective method of contraception as you may still become pregnant during treatment with Letrozole Bluefish.
- You must not take Letrozole Bluefish if you are pregnant or breast-feeding as it may harm your baby.
Driving and using machines
If you feel dizzy, tired, drowsy, or generally unwell, do not drive or use any tools or machines until you feel normal again.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Letrozole Bluefish contains lactose
Letrozole Bluefish contains lactose (milk sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Letrozole Bluefish contains sodium
Letrozole Bluefish contains less than 1 mmol (23 mg) sodium per 2.5 mg film-coated tablet, ie essentially ‘sodium-free’.
How to take Letrozole Bluefish
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The usual dose is one tablet once a day. Taking Letrozole Bluefish at the same time each day will make it easier to remember when to take the tablet.
The tablet can be taken with or without food and should be swallowed whole with a glass of water or other beverage.
How long to take Letrozole Bluefish
Continue to take Letrozole Bluefish every day for as long as your doctor prescribes it. You may need to take it for months or even years. Talk to your doctor if you are wondering how long to continue taking Letrozole Bluefish.
Check during treatment with Letrozole Bluefish
You should only take this medicine under the supervision of a doctor. Your doctor will regularly check your condition to make sure the treatment is having the right effect.
Letrozole Bluefish may cause osteoporosis ( osteoporosis ) because of the reduced amount of estrogen in the body. Your doctor may decide to measure your bone density (a way to check if you have osteoporosis ) before, during, and after treatment.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most of the side effects are mild to moderate and generally go away after a few days to a few weeks of treatment.
Some of these side effects, such as hemorrhages, hair loss, and vaginal bleeding can be due to estrogen deficiency in the body.
Do not let this list of possible side effects worry you. You may not get any of them.
Some side effects can be serious:
Rare or uncommon side effects (may affect up to 1 in 100 people in 10,000):
- weakness, paralysis or loss of sensation in any part of the body (especially an arm or a leg), impaired coordination, nausea, speech or breathing difficulties (signs of brain effects such as stroke )
- sudden oppressive chest pain (signs of heart disease)
- difficulty breathing, chest pain, fainting, rapid pulse , bluish discoloration of the skin or sudden pain in an arm, leg or foot (signs that a blood clot may have formed)
- swelling and redness along a vein that is very tender and possibly painful to the touch
- high fever, chills or cold sores due to infection (lack of white blood cells )
- severe, persistent blurred vision.
- Uncommon – inflammation of a tendon or tendinitis (connective tissue that connects muscles to the skeleton)
- Rare – rupture of a tendon (connective tissue that connects muscles to the skeleton)
If you experience any of these symptoms, tell your doctor immediately.
You should also tell your doctor immediately if you get any of the following symptoms during treatment with Letrozole Bluefish:
- Swelling of the face and neck in particular (signs of allergic reaction ).
- Yellow skin and eyes, nausea, decreased appetite, dark urine (signs of jaundice).
- Skin rash, redness of the skin, blisters on the lips, eyes or mouth, skin rash, fever (signs of skin disease).
Some side effects are very common. These side effects may affect more than 10 in 100 patients:
- hot flashes
- elevated cholesterol ( hypercholesterolemia )
- fatigue
- increased sweating
- skeletal or joint pain ( arthralgia ).
Tell your doctor immediately if the side effects are perceived as serious.
Some side effects are common. These side effects may affect 1 to 10 users in 100.
- rash
- headache
- dizziness
- general malaise
- gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
- increased or decreased appetite
- muscle aches
- bone loss ( osteoporosis ) which in some cases may lead to fracture s (see also “Monitoring during treatment with Letrozole Blue Fish” in section 3)
- swelling of hands, arms, feet and ankles ( edema )
- Depression
- weight gain
- hair loss
- high blood pressure ( hypertension )
- abdominal pain
- dry skin
- vaginal bleeding
- palpitation er, fast heart rate
- joint stiffness ( arthritis )
- chest pain.
Tell your doctor immediately if the side effects are perceived as serious.
Other side effects are less common. These side effects may affect 1 to 10 users in 1,000:
- nervous conditions such as anxiety, nervousness, irritability, drowsiness, memory problems, drowsiness, insomnia
- pain or a burning sensation in the hands or wrists ( carpal tunnel syndrome )
- impaired sensation, especially sensitivity to touch
- eye problems such as blurred vision, eye irritation
- skin problems such as itching ( hives )
- vaginal discharge or dryness
- chest pain
- fever
- thirst, taste disturbances, dry mouth
- dry mucous membranes
- weight loss
- urinary tract infection, more frequent need to urinate
- cough.
- elevated levels of enzyme er
- yellowing of the skin or eyes
- high levels of bilirubin in the blood (a breakdown product of red blood cells ).
The side effect is without any known frequency
- Trigger finger, ie a condition where some finger or thumb locks in a bent position.
Tell your doctor immediately if the side effects are perceived as serious.
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information.
How to store Letrozole Bluefish
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiration date is the last day of the specified month.
Do not use damaged or opened packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is letrozole. One film-coated tablet contains 2.5 mg letrozole.
The other ingredients in the tablet are lactose monohydrate, corn starch, microcrystalline cellulose, sodium starch glycolate (type A), anhydrous colloidal silica, magnesium stearate.
The film coating contains macrogol, hypromellose, talc, titanium dioxide (E 171), iron oxide yellow (E172), and iron oxide red (E172).
What the medicine looks like and contents of the pack
Letrozole Bluefish are yellow, round, 6.1 mm (± 0.2 mm) in diameter, biconvex film-coated tablets.
The tablets are packed in blister packs of 30, 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Bluefish Pharmaceuticals AB
PO Box 49013
100 28 Stockholm
Sweden
Manufacturer
Bluefish Pharmaceuticals AB
Gävlegatan 22
113 30 Stockholm
Sweden
Genepharm SA
18th Marathonos Avenue
153 51 Pallini Attikis
Greece
This medicine is authorized in the EFA member countries under the following names:
| Member State | Product name |
| Denmark | Letrozole Bluefish |
| Finland | Letrozole Bluefish 2.5 mg tablets, calvapäällysteineLetrozole Bluefish 2.5 mg film-coated tablets |
| France | Letrozole Bluefish 2.5 mg compressed tablets |
| Ireland | Letrozole Bluefish 2.5 mg film-coated tablets |
| Iceland | Letrozole Bluefish 2.5 mg film-coated tablets |
| Italy | Brestoral 2.5 mg compress rivestite with film |
| Poland | Letrozole Bluefish |
| Spain | Letrozole Bluefish 2.5 mg compresses recovered with film |
| Sweden | Letrozole Bluefish 2.5 mg film-coated tablets |
| Germany | Letrozole Bluefish 2.5 mg film tablets |
| Austria | Letrozole Bluefish 2.5 mg film tablets |