Patient leaflet - Letrozole 2.5 mg film-coated tablets

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 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 tamixofen. Letrozole is also used to prevent breast tumor 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 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 or bone fractures (see also “Follow-up during Letrozole 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.

Letrozole 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 adolescent should not use 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 the use of 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.

Information on sodium content

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially ‘sodium-free’.

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 Letrozole 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 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 a 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 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

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

Package leaflet: information for the user Letrozole 2.5mg

film-coated tablets

Letrozole

As stated in design

Package leaflet

TW265920 (launch)

TW235302

Black C

Also TW281590 (BROMI) Some side effects could be serious:

Rare or uncommon side effects (i.e. they may affect between 1 to 100 in every 10,000 patients):

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 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:

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 10 in every 100 patients.

Hot flushes

Increased level of cholesterol (hypercholesterolaemia) 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 between 1 to 10 in every 100 patients.

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

Joint stiffness (arthritis)

Thinning or wasting of your bones (osteoporosis), leading to bone fractures in some cases (see also “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

Palpitations, rapid heart rate

Joint stiffness (arthritis)

Chest pain

If any of these affects you severely, tell your doctor. Other side effects are uncommon. These side effects may affect between 1 to 10 in every 1,000 patients.

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)

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)

Inflammation of a tendon or tendonitis (connective tissues that connect muscles to bones)

Rare side effects. These side effects may affect between 1 to 10 in every 10,000 patients.

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

Side effects with frequency not known

Trigger finger, 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions.

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. Contents of the pack and other information

What Letrozole contains

The active substance is letrozole. Each film-coated tablet contains 2.5mg letrozole

The other ingredients are lactose monohydrate, croscarmellose sodium, povidone, colloidal anhydrous silica, magnesium stearate, hypromellose, yellow iron oxide, titanium dioxide, macrogols and talc. What Letrozole looks like and contents of the pack

Letrozole is supplied as film-coated tablets. The film-coated tablets are dark-yellow and round. They are marked with ‘5’ on one side and ‘H’ on the other side

Each blister pack contains 10, 14, 28, 30, 60, 90, 98 or 100 tablets. Not all pack sizes may be available in your country. Marketing Authorisation Holder

Tillomed Laboratories Limited

220 Butterfield, Great Marlings

Luton, LU2 8DL, United Kingdom

Manufacturer