LETROZOLE 2.5 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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 2.5 mg is and what it is used for

• 2. What you need to know before you take Letrozole 2.5 mg

• 3. How to take Letrozole 2.5 mg

• 4. Possible side effects

• 5. How to store Letrozole 2.5 mg

• 6. Contents of the pack and other information

1. what letrozole 2.5 mg is and what it is used for

Letrozole 2.5mg 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.

Letrozole 2.5mg is used to treat breast cancer in women who have gone through the menopause i.e. cessation of periods. It is used to prevent cancer from happening again.

It can be used to prevent 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 2.5 mg 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 2.5mg works or why this medicine has been prescribed for you, ask your doctor.

2. what you need to know before you take letrozole 2.5 mg

Follow all the doctor’s instruc­tions carefully. They may differ from the general information in this leaflet

Do not take Letrozole 2.5 mg

• if you still have periods, i.e. if you have not yet gone through the menopause,
• if you are pregnant,

If any of these conditions apply to you,

Talk to your doctor or pharmacist before taking Letrozole 2.5mg

• if you have a severe kidney disease,
• if you have a severe liver disease,
• if you have a history of osteoporosis or bone fractures

(see also “Follow-up during Letrozole 2.5mg treatment” 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 2.5mg.

Letrozole 2.5mg may cause inflammation in tendons or tendon injury (see section 4). At any sign of tendon pain or swelling – rest the painful area and contact your doctor.

Children and adolescents (below 18 years)

Children and adolescents should not use this medicine.

Older people (aged 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 2.5mg

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• You must not take Letrozole 2.5mg if you are pregnant or breast-feeding as it may harm your baby.
• You should only take Letrozole 2.5mg 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 2.5mg.

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 2.5 mg 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 medicinal product.

3. how to take letrozole 2.5 mg

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 usual dose is one tablet of Letrozole 2.5mg to be taken once a day. Taking Letrozole

• 2.5mg 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 2.5mg

Continue taking Letrozole 2.5mg 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 2.5mg, talk to your doctor.

Follow-up during Letrozole 2.5mg treatment

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 2.5mg 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 2.5 mg than you should

If you have taken too much Letrozole 2.5mg, or if someone else accidentally takes your tablets, contact a doctor or hospital for advice immediately. Show them the pack of tablets. Medical treatment may be necessary.

If you forget to take Letrozole 2.5 mg

• 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 you 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 2.5 mg

Do not stop taking letrozole even if you are feeling well, unless your doctor tells you to. See also the section above “How long to take Letrozole 2.5mg”

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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 a few weeks of treatment. Some of these side effects, such as hot flushes, hair loss or vaginal bleeding, may be due to the lack of oestrogens in your body.

Do not alarmed by this list of possible side effects. You may not experience any of them.

Some side effects could be serious.

Rare or uncommon (may affect up to 1 in 1,000 people):

• Weakness, paralysis or loss of feeling in any part of the body (particularly arm or leg), loss of

coordination, nausea, or difficulty in speaking or breathing (sign of a brain disorder, e.g. stroke).

• Sudden oppressive chest pain (sign of a heart disorder).
• Difficulty in 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 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.

If any of the above occurs, tell your doctor straight away.

You should also inform the doctor straight away if you experience any of the following symptoms during treatment with Letrozole 2.5mg:

• 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).

Some side effects are very common. These side effects may affect more than 1 in 10 people:

• Hot flushes,
• Increased level of cholesterol
• Fatigue
• Increased sweating,
• Pain in bones and joints (arthralgia),

If any of these affects you severely, tell your doctor.

Some side effects are common. These side effects 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 muscles
• Thinning or wasting of your bones (osteoporosis), leading to bone fractures in some

cases (see also “Follow-up during Letrozole 2.5mg 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.
• Palpitations, rapid heart rate.
• Joint stiffness (arthritis).
• Chest pain.

If any of these affect you severely, tell your doctor.

Other side effects are uncommon These side effects may affect up to 1 in 100 people:

• Nervous disorders such as anxiety, nervousness, irritability
• Drowsiness, memory problems, somnolence, insomnia.
• Pain or burning sensation in the hands or wrist (carpal tunnel syndrome).
• Impairment of sensation, especially that of touch
• Eye disorders such as blurred vision, eye irritation.
• Skin disorders such as itching (urticaria)
• Inflammation of a tendon or tendonitis (connective tissues that connect muscles to bones).
• Vaginal discharge or dryness.
• Breast pain.
• Fever.
• Thirst, taste disorder, dry mouth.
• Dryness of mucous membranes.
• Weight decrease.
• Urinary tract infection, increased frequency of urination.
• Cough.
• Increased level of enzymes.
• Yellowing of the skin and eyes.
• High blood levels of bilirubin (a breakdown product of red blood cells).

Other side effects are rare. These side effects may affect up to 1 in 1,000 people.

• Rupture of a tendon (connective tissues that connect muscles to bones).

Not known. Frequency of these side effects cannot be estimated from the available data.

• Trigger finder, a condition in which your finger or thumb catches in a bent position.

If any of these affects you severely, tell your doctor.

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 the Yellow Card Scheme at:

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store letrozole 2.5 mg

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The first two digits indicate the month and the last four digits indicate the year. 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 medicines you no longer use. These measures will help protect the environment.

• 6. Further information

What Letrozole 2.5 mg contains

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg letrozole.
• The other ingredients are lactose monohydrate, cellulose microcrystalline (E460), maize starch pregelatinised, sodium starch glycolate, magnesium stearate (E572), colloidal silicon dioxide (E551).

What Letrozole 2.5 mg looks like and contents of the pack

Letrozole is a yellow film-coated round tablet, debossed with L900 on one side and 2.5 on the other side.

Letrozole is available in blisters of 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 or 120 tablets per box.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Zentiva, One Onslow Street, Guildford, Surrey, GUI 4YS, UK

Manufacturers:

Synthon BV, Microweg 22, 6545 CM Nijmegen, Netherlands

Synthon Hispania S.L., Castello 1, PoHgono Las Salinas, 08830 Sant Boi de Llobregat, Spain

Rottendorf Pharma GmbH, Ostenfelder strasse 51–61, 59320 Ennigerloh, Germany

This leaflet was last revised in September 2019

© 2019 Zentiva.