Letrozole 2.5 Mg Film-Coated Tablets
Package leaflet: Information for the patient
Letrozole 2.5 mg Film-coated Tablets letrozole
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Letrozole is and what it is used for
2. What you need to know before you take Letrozole
3. How to take Letrozole
4. Possible side effects
5. How to store Letrozole
6. Contents of the pack and other information
1. What Letrozole is and what it is used for What Letrozole is and how it works
Letrozole contains an active substance called letrozole. It belongs to a group of medicines called aromatase inhibitors. It is a hormonal (or “endocrine”) breast cancer treatment. Growth of breast cancer is frequently stimulated by oestrogens which are female sex hormones. Letrozole reduces the amount of oestrogen by blocking an enzyme (“aromatase”) involved in the production of oestrogens and therefore may block the growth of breast cancer that needs oestrogens to grow. As a consequence tumour cells slow or stop growing and/or spreading to other parts of the body.
What Letrozole is used for
Letrozole is used to treat breast cancer in women who have gone through menopause i.e. cessation of periods.
It is used to help prevent the cancer from happening again. It can be used as first treatment before breast cancer surgery in case immediate surgery is not suitable or it can be used as first treatment after breast cancer surgery or following five years treatment with tamoxifen. Letrozole is also used to prevent breast tumour spreading to other parts of the body in patients with advanced breast cancer.
If you have any questions about how Letrozole works or why this medicine has been prescribed for you, ask your doctor.
2. What you need to know before you take Letrozole
Follow all the doctor’s instructions carefully. They may differ from the general information in this leaflet.
Do not take Letrozole
• if you are allergic to letrozole or to any of the other ingredients of this medicine (listed in section 6).
• if you still have periods, i.e. if you have not yet gone through the menopause.
• if you are pregnant.
• if you are breast-feeding.
If any of these conditions apply to you, do not take this medicine and talk to your doctor. Warnings and precautions
Talk to your doctor or pharmacist before taking Letrozole if you have a severe kidney disease,
• if you have a severe liver disease,
• if you have a history of osteoporosis (thinning or wasting of bones) or bone fractures (see also ‘Follow-up during your treatment with Letrozole’ in section 3).
If any of these conditions apply to you, tell your doctor. Your doctor will take this into account during your treatment with Letrozole.
Children and adolescents (below 18 years)
Children and adolescents should not take this medicine.
Older people (age 65 years and over)
People aged 65 years and over can use this medicine at the same dose as for other adults. Other medicines and Letrozole
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, breast-feeding and fertility
• You should only take Letrozole when you have gone through the menopause. However, your doctor should discuss with you about using effective contraception, as you may still have the potential to become pregnant during treatment with Letrozole.
• You must not take Letrozole 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 operate any tools or machines until you feel normal again.
Letrozole contains lactose
Letrozole 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.
3. How to take Letrozole
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet of Letrozole to be taken once a day. Taking Letrozole at the same time each day will help you remember when to take your tablet.
The tablet can be taken with or without food and should be swallowed whole with a glass of water or another liquid.
How long to take Letrozole
Continue taking Letrozole every day for as long as your doctor tells you. You may need to take it for months or even years. If you have any questions about how long to keep taking Letrozole, talk to your doctor.
Follow-up during your treatment with Letrozole
You should only take this medicine under strict medical supervision. Your doctor will regularly monitor your condition to check whether the treatment is having the right effect.
Letrozole may cause thinning or wasting of your bones (osteoporosis) due to the reduction of oestrogens in your body. Your doctor may decide to measure your bone density (a way of monitoring for osteoporosis) before, during and after treatment.
If you take more Letrozole than you should
If you have taken too much Letrozole or if someone else accidentally takes your tablets, contact your doctor or hospital for advice immediately. Show them the pack of tablets. Medical treatment may be necessary.
If you forget to take Letrozole
• If it is almost time for your next dose (e.g. within 2 or 3 hours), skip the dose you missed and take your next dose when you are meant to.
• Otherwise, take the dose as soon as your remember, and then take the next tablet as you would normally.
Do not take a double dose to make up for the one that you missed.
If you stop taking Letrozole
Do not stop taking Letrozole unless your doctor tells you to. See also the section above “How long to take Letrozole.
4. 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 will generally disappear after a few days to few weeks of treatment.
Some of them such as hot flushes, hair loss or vaginal bleeding, may be due to the lack of oestrogen in your body.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Some side effects can be serious:
• Weakness, paralysis or loss of feeling in any part of the body (particularly arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (sign of a brain disorder, e.g. stroke).
• Sudden oppressive chest pain (sign of a heart disorder).
• Swelling and redness along a vein which is extremely tender and possibly painful when touched.
• Severe fever chills or mouth ulcers due to infections (lack of white blood cells).
• Severe persistent blurred vision.
• Difficulty breathing, chest pain, fainting, rapid heart rate, bluish skin discoloration, or sudden arm, leg or foot pain (signs that a blood clot may have formed).
• Swelling mainly of the face and throat (signs of allergic reaction).
• Yellow skin and eyes, nausea, loss of appetite, dark-coloured urine (signs of hepatitis).
• Rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever (signs of skin disorder).
If any of the above occurs, tell your doctor straight away.
Other possible side effects
Very common (may affect more than 1 in 10 people)
• Hot flushes
• Increased levels of cholesterol (hyperchloesterolaemia)
• Fatigue
• Increased sweating
• Pain in bones and joints (arthralgia)
Common (may affect up to 1 in 10 people)
• Skin rash
• Headache
• Dizziness
• Malaise (generally feeling unwell)
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhoea
• Increase in or loss of appetite
• Pain in your muscles
• Thinning or wasting of bones (osteoporosis), leading to bone fractures in some cases (see ‘Follow up during Letrozole treatment’ in section 3)
• Swelling of arms, hands, feet, ankles (oedema)
• Depression
• Weight increase
• Hair loss
• Raised blood pressure (hypertension)
• Abdominal pain
• Dry skin
• Vaginal bleeding
Uncommon (may affect up to 1 in 100 people)
• Nervous disorders (anxiety, nervousness, irritability, drowsiness, memory problems, somnolence, insomnia)
• Pain or burning sensation in the hands or wrist (carpal tunnel syndrome)
• Reduced sensation, especially that of touch, feelings like pins and needles or a burning sensation.
• Eye disorders such as eye irritation, blurred vision
• Palpitations, rapid heart rate (tachycardia)
• Skin disorders such as itching, (urticaria)
• Vaginal discharge or dryness
• Joint stiffness (arthritis)
• Breast pain.
• Fever
• Thirst, taste disorder, dry mouth
• Dryness of mucous membrane
• Weight decrease
• Urinary tract infections, increased frequency of urination
• Cough
• Increased level of enzymes
Not known (frequency cannot be estimated from the available data)
• Trigger finger, a condition in which your finger or thumb catches in a bent position
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Letrozole
• Keep this medicine out of the sight and reach of children.
• This medicinal product does not require any special storage conditions.
• Do not use the tablets after the expiry date, which is shown on the carton and blister after EXP. The expiry date refers to the last day of that month
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.
6. Contents of pack and other information
What Letrozole contains:
Each film-coated tablet contains 2.5 mg letrozole.
The other ingredients are:
Tablet core: lactose monohydrate (see section 2, “Letrozole contains lactose”), maize starch, hypromellose, sodium starch glycolate, microcrystalline cellulose, colloidal anhydrous silica and magnesium stearate.
Film-coating: hypromellose, titanium dioxide E171, iron oxide yellow E172, macrogol and talc.
What Letrozole looks like and content of the pack:
Your medicine comes as yellow, round, biconvex, film coated tablets, plain on both sides. Letrozole are packed in blisters of 28, 30, 90 and 100 tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder:
Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL, UK Manufacturer:
Accord Healthcare Ltd, Sage House, 319 Pinner Road, North Harrow, HA1 4HF, United Kingdom
McDermott Laboratories Ltd t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
This leaflet was last revised in August 2015