2.5 mg film-coated tablet
letrozole
What Letrozole Mylan is and what it is used for
What Letrozole Mylan is and how it works
The active substance in Letrozole Mylan is letrozole. It 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 Mylan is used for
Letrozole Mylan 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 Mylan 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 Mylan works or why you have been prescribed it.
Letrozole contained in Letrozole Mylan may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Letrozole Mylan
Do not use Letrozole Mylan
Carefully follow your doctor’s instructions. They may deviate from the general instructions in this leaflet.
Do not use Letrozole Mylan
- 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 reached menopause
- if you are pregnant
- if you are breast-feeding
If any of the above applies to you, do not take this medicine and talk to your doctor.
Warnings and cautions
Talk to your doctor or pharmacist before taking Letrozole Mylan
- if you have severe kidney disease
- if you have severe liver disease
- if you have or have had osteoporosis or fractures (see also “Follow-up during treatment with Letrozole Mylan” 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 Mylan.
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 (65 years or older)
People who are 65 years or older can use this drug in the same dose as other adults.
Other medicines and Letrozole Mylan
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 Mylan 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 Mylan.
- You must not take Letrozole Mylan if you are pregnant or breast-feeding as it may harm your baby.
Driving and using machines
If you feel dizzy, tired or drowsy, or generally unwell, do not drive or use any tools or machines until you feel well again.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. 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 Mylan contains lactose and sodium
If you can not tolerate certain sugars, such as lactose, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to take Letrozole Mylan
Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist.
The usual dose of Letrozole Mylan is one tablet once a day. If the tablet is taken at the same time each day, it is easier to remember to take it.
The tablet can be taken with or without food and should be swallowed whole with a glass of water or other liquid.
How long to take Letrozole Mylan
You should continue to take Letrozole Mylan daily for as long as your doctor prescribes it. You may need to use Letrozole Mylan for several months or even several years. If you have any further questions on the use of this product, ask your doctor.
Check during your treatment with Letrozole Mylan
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 Mylan 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.
Many of the side effects that have been observed have been mild to moderate and they usually go away within a few days or a few weeks after starting treatment.
Some side effects such as hot flashes, hair loss, and vaginal bleeding can be caused by a lack of estrogen in your body.
Do not worry about this list of possible side effects. You may not be affected by any of them.
Some side effects can be serious.
Uncommon (may affect up to 1 in 100 people):
- feeling of 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 (symptoms of brain effects such as stroke )
- sudden oppressive chest pain (symptoms of heart problems)
- swelling and redness along a blood vessel that is extremely sensitive and possibly tender to the touch
- high fever, chills, sores in the oral cavity caused by infection (decreased number of white blood cells )
- persistent severe blurred vision.
Rare (may affect up to 1 in 1,000 people):
- difficulty breathing, chest pain, fainting, increased heart rate (heart rate), bluish skin color, sudden pain in arms and legs or feet (possible symptoms of blood clots).
Has been reported (occurs in an unknown number of users):
- swelling of the face and neck in particular (which is a sign of an allergic reaction ).
- yellowing of the skin and eyes, nausea, decreased appetite, dark-colored urine (signs of jaundice).
- rash, redness of the skin, blisters on the lips, eyes or mouth, skin rash, fever (signs of skin disease).
If any of the above occur, tell your doctor immediately.
Other possible side effects are
Very common (may affect more than 1 user in 10):
- hot flashes
- elevated cholesterol ( hypercholesterolemia )
- fatigue
- increased sweating
- joint pain ( arthralgia )
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Common (may affect up to 1 in 10 people):
- palpitations, increased heart rate (heart rate)
- chest pain
- rash
- joint stiffness ( arthritis )
- headache
- dizziness
- general malaise
- gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
- increased or decreased appetite
- pain in muscles or bones
- brittle bones ( osteoporosis ), which in some cases can lead to bone fractures (see also “Monitoring during your treatment with Letrozole Mylan” 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
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Uncommon (may affect up to 1 in 100 people):
- nervous problems such as anxiety, nervousness, irritability, drowsiness, memory impairment, drowsiness, insomnia
- pain or burning sensation in hands or wrists ( carpal tunnel syndrome )
- abnormal / worsening of sensations, especially of feeling
- eye problems such as blurred vision, eye irritation
- yellowing skin and eyes
- high levels of bilirubin (a red blood cell breakdown product )
- skin problems such as itching ( hives )
- vaginal discharge or dryness
- chest pain
- fever
- thirst, taste changes, dry mouth
- dry mucous membranes
- weight loss
- urinary tract infection, more frequent need to urinate
- cough
- elevated levels of enzyme er
- inflammation of a tendon (connective tissue that connects muscles to the skeleton)
Rare – (may affect up to 1 in 1,000 people)
- rupture of a tendon (connective tissue that connects muscles to the skeleton)
Has been reported (occurs in an unknown number of users):
- trigger finger, a condition in which your finger or thumb gets stuck in a bent position.
If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
How to store Letrozole Mylan
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 label and carton after EXP. date. The expiration date is the last day of the specified month.
No special storage instructions.
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. Each film-coated tablet contains 2.5 mg letrozole.
- The other ingredients are lactose monohydrate (see section 2, “Letrozole Mylan contains lactose and sodium”), microcrystalline cellulose, maize starch, anhydrous colloidal silica, sodium starch glycolate and magnesium stearate.
- The film coating contains iron oxides (E 172), hypromellose, polydextrose, macrogol, triacetin, quinoline yellow (E 104) and titanium dioxide (E 171).
What the medicine looks like and contents of the pack
Letrozole Mylan 2.5 mg are dark yellow, capsule-shaped film-coated tablets marked with “LZ 2.5” on one side and “G” on the other.
Pack sizes:
Pressure pack or can: 7, 10, 14, 20, 28, 30, 30×1 (perforated unit dose blisters), 56, 60, 84, 90, 98, 100, 112, 120, 180, 200 and 500 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Mylan AB
Box 23033
104 35 Stockholm
Sweden
Tel: 08-555 227 50, Fax: 08-555 227 51
Email: inform@mylan.se
Manufacturer:
Delpharm Lille SAS, Roubaix Est Activity Park, 22 rue de Toufflers, -CS 50070, 59452 Lys LeZ Lannoy,
France
Mylan Hungary Kft
Mylan utca 1, Komarom
2900, Hunga