2.5 mg film-coated tablets
letrozole
What Letrozole Teva is and what it is used for
What Letrozole Teva is and how it works
Letrozole Teva contains an active substance called 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 Teva 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 Teva is used for
Letrozole Teva is used to treat breast cancer in women who have undergone menopause , ie. no longer have menstruation.
It is used to prevent 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 Teva 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 Teva works or why you have been prescribed it.
Letrozole contained in Letrozole Teva may also be approved for the treatment of other conditions not mentioned in this product information. 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 take Letrozole Teva
Follow your doctor’s instructions carefully. They may differ from the general information contained in this leaflet.
Do not take Letrozole Teva
- 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 Teva
- if you have a serious 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 Teva” 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 Teva.
Letrozole may cause tendon inflammation or tendon damage (see section 4). At 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 65 years of age or older can use this medicine at the same dose as other adults.
Other medicines and Letrozole Teva
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 Teva if 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 Teva.
You must not take Letrozole Teva 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 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 Teva contains lactose
This medicine 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 Teva contains tartrazine aluminum paint
This medicine contains tartrazine aluminum lacquer (E102) and may cause allergic reactions.
Letrozole Teva contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, ie essentially ‘sodium-free’.
How to take Letrozole Teva
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is one tablet of Letrozole Teva once daily. Taking Letrozole Teva 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 Teva
Continue to take Letrozole Teva 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 Teva.
Follow-up during treatment with Letrozole Teva
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 Teva 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 side effects worry you. You may not get any of them.
Some side effects can be serious:
Uncommon (may affect up to 1 in 100 people):
- Weakness, paralysis or loss of sensation in any part of the body (especially an arm or a leg), impaired coordination, nausea, difficulty speaking or difficulty breathing (signs of brain effects, eg stroke ).
- Sudden, oppressive chest pain (signs of heart disease).
- 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 ).
- Difficult, persistent blurred vision.
Rare ( may affect up to 1 in 1,000 people):
- Difficulty breathing, chest pain, fainting, rapid pulse , bluish discoloration of the skin or sudden pain in an arm, foot or leg (signs that a blood clot may have formed).
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 Teva:
- Swelling, mainly on the face and neck (signs of an allergic reaction ).
- Yellow skin and yellow whites of the eyes, nausea, decreased appetite, dark urine (signs of hepatitis ).
- Skin rash, red skin, blisters on the lips, eyes or mouth, skin rash, fever (signs of a skin disease).
Other side effects:
Very common (may affect more than 1 in 10 people)
- Hemorrhoids
- Elevated cholesterol ( hypercholesterolemia )
- Fatigue
- Increased sweating
- Pain in the bones and joints ( 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)
- Rash
- Headache
- Dizziness
- General malaise
- Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
- Increased or decreased appetite
- Muscle aches
- Brittle bones ( osteoporosis ), which in some cases leads to fracture s (see also “Follow-up during treatment with Letrozole Teva” in Section 3)
- Swelling of arms, hands, feet and ankles ( edema )
- Depression
- Weight gain
- Hair loss
- High blood pressure ( hypertension )
- Abdominal pain
- Dry skin
- Vaginal bleeding
- Palpitation is, fast heart rate
- Joint stiffness, arthritis
- Chest pain
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 conditions such as anxiety, anxiety irritability, drowsiness, memory problems, drowsiness, difficulty sleeping
- 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 disorders, such as itching ( urticaria )
- Vaginal discharge or dryness
- Chest pain
- Fever
- Thirst, taste disturbances, dry mouth
- Dry mucous membranes
- Weight loss
- Urinary tract infection, increased bladder emptying frequency
- Cough
- Elevated levels of enzyme s
- Yellowing of the skin or eyes
- High levels of bilirubin in the blood (a breakdown product of red blood cells )
- inflammation of a tendon or tendinitis (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)
Side effects are without any known frequency (frequency can not be calculated from available
data)
- Trigger finger, ie a condition in which a finger or thumb locks 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 Teva
- 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 blister and the carton after EXP.
- No special storage instructions.
- Do not use this medicine for visible signs of injury.
- 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 microcrystalline cellulose, maize starch, magnesium stearate, lactose monohydrate , colloidal anhydrous silica, sodium starch glycolate (Type A) and yellow opadry II 85F32723, which consists of yellow iron oxide (E172), macrogol 3350, E-titanium min ), polyvinyl alcohol and tartrazine aluminum lacquer (E102).
What the medicine looks like and contents of the pack
- Letrozole Teva 2.5 mg film-coated tablets are dark yellow, convex, round film-coated tablets, debossed with “93” on one side and “B1” on the other side.
- Letrozole Teva 2.5 mg film-coated tablets are available in pack sizes of 1, 10, 14, 15, 20, 28, 30, 60, 90, 98 and 100 film-coated tablets; hospital packs with 50 film-coated tablets.
Not all pack sizes may be marketed.