2.5 mg film-coated tablets
letrozole
What you need to know before you take Letrozole Sandoz
Carefully follow your doctor’s instructions. They may deviate from the general instructions in this leaflet.
Do not take Letrozole Sandoz
- 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 Sandoz
- if you have a serious kidney disease,
- if you have severe liver disease,
- if you have or have had osteoporosis or fractures (see also “Checks during treatment with Letrozole Sandoz” 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 Sandoz.
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 65 years of age or older can use this medicine at the same dose as other adults.
Other medicines and Letrozole Sandoz
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 Sandoz 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 Sandoz.
- You must not take Letrozole Sandoz 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 Sandoz contains lactose and sodium
Letrozole Sandoz 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 Sandoz contains less than 1 mmol (23 mg) sodium per 2.5 mg film-coated tablet, ie essentially ‘sodium-free’.
How to take Letrozole Sandoz
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 of Letrozole Sandoz once a day. Taking Letrozole Sandoz 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 Sandoz
Continue to take Letrozole Sandoz 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 Sandoz.
Check during treatment with Letrozole Sandoz
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 Sandoz 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.
If you take more Letrozole Sandoz than you should
If you have taken too many Letrozole Sandoz tablets, or if someone else accidentally takes your tablets, contact your doctor or hospital staff immediately and show them the package with the tablets. Overdose may require 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 Sandoz:
- 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).
Some side effects are very common (may affect more than 1 user in 10):
- Hemorrhoids
- Elevated cholesterol ( hypercholesterolemia )
- Fatigue
- Increased sweating
- Pain in the bones and joints ( arthralgia )
Tell your doctor immediately if the side effects are perceived as serious.
Some side effects are common (may affect up to 1 in 10 people):
- Palpitation is, fast heart rate
- Joint stiffness ( arthritis )
- Chest pain
- 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 “Controls during treatment with Letrozole Sandoz” 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
Tell your doctor immediately if the side effects are perceived as serious.
Other side effects are less common (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)
Other side effects are rare (may affect up to 1 in 1,000 people):
- Rupture of a tendon (connective tissue that connects muscles to the skeleton)
Adverse reactions that have been reported (affects unknown 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 Sandoz
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 carton after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
Store in the original package. Moisture sensitive.
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 are lactose monohydrate, microcrystalline cellulose (E460), corn starch, sodium starch glycolate, magnesium stearate (E572), and anhydrous colloidal silica (E551). The constituents of the film coating are hypromellose (E464), talc (E553b), macrogol (PEG 8000), titanium dioxide (E171), and yellow iron oxide (E172).
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer:
Novartis Farma SPA, Via Provinciale Schito 131, 80058 Torre Annunziata (NA), Italy