2.5 mg film-coated tablet
Letrozole
What Letrozole Stada is and what it is used for
What Letrozole Stada is and how it works
Letrozole Stada 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 Stada 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 Stada is used for
Letrozole Stada 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 Stada 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 Stada works or why you have been prescribed it.
Letrozole contained in Letrozole Stada 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 using Letrozole Stada
Do not use Letrozole Stada
Carefully follow your doctor’s instructions. They may deviate from the general instructions in this leaflet.
Do not take Letrozole Stada
- 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 Stada.
- 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 Stada 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 Stada.
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 young people
Children and adolescents should not use this medicine.
Older
People 65 years of age or older can use this medicine at the same dose as other adults.
Other medicines and Letrozole Stada
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
- You should only take Letrozole Stada 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 Stada.
- You must not take Letrozole Stada if you are pregnant or breast-feeding as it may harm your baby.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
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 Stada contains lactose and sodium
Lactose: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Sodium: This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Letrozole Stada
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is one tablet once a day. Taking Letrozole Stada 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 Stada
Continue to take Letrozole Stada 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 Stada.
Check during treatment with Letrozole Stada
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 STADA 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:
Rare or uncommon (may affect 1 to 100 users in 10,000):
- 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 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, foot or leg (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 ).
- Difficult, persistent blurred vision.
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 Stada:
- 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).
Very common (may affect more than 1 user in 10):
- Hemorrhoids.
- Elevated cholesterol ( hypercholesterolemia ).
- Fatigue.
- Increased sweating.
- Pain in the skeleton and joints ( arthralgia ).
Tell your doctor immediately if the side effects are perceived as serious.
Common (may affect up to 1 in 10 people):
- Rash
- Headache
- Dizziness
- Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
- Increased or decreased appetite
- Muscle aches
- Brittle bones ( osteoporosis ), which in some cases can lead to fracture of you (see also “Follow-up during treatment with Letrozole STADA” in Section 3)
- Swelling of arms, hands, feet, 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, worry, 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 (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 the unknown number of users):
- 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.
How to store Letrozole Stada
Keep this medicine out of the sight and reach of children.
Store in the original package. Moisture sensitive.
Do not use this medicine after the expiry date which is stated on both the blister and the carton after EXP. The expiration date is the last day of the specified month.
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 in the tablet are lactose monohydrate , corn starch, microcrystalline cellulose, sodium starch glycolate (type A), hydroxypropyl methylcellulose (6 mPas), hydroxypropylcellulose, magnesium stearate, talc, cottonseed oil, iron oxide yellow (E171) and red (E171) and.
What the medicine looks like and contents of the pack
Letrozole Stada film-coated tablets are round and yellow, and both surfaces are convex. The tablets come in blister packs of 10, 30, and 100 tablets.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15, 48159 Münster, Germany
Stada Arzneimittel GmbH
Muthgasse 36, 1190 Vienna, Austria
Eurogenerics NV
Heizel Esplanade B22, 1020 Brussels, Belgium
Clonmel Healthcare Ltd.
Waterford Road, Clonmel, Co. Tipperary, Ireland
STADA pharm GmbH
Stadastrasse 2 – 18, 61118 Bad Vilbel, Germany
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark