PACKAGE LEAFLET: INFORMATION FOR THE USER

Letralan 2.5 mg film coated tablets

Letrozole

The name of your medicine is Letralan 2.5 mg film coated tablets, which will be referred to as Letrozole tablets throughout the rest of this document.

Read all of this leaflet carefully before you start taking this medicine 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 your 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.

What is in this leaflet

1.    What Letrozole tablets are is and what they are used for

2.    What you need to know before you take Letrozole tablets

3.    How to take Letrozole tablets

4.    Possible side effects

5.    How to store Letrozole tablets

6.    Contents of the pack and other information

1. What Letrozole tablets are and what they are used for

What Letrozole tablets are and how they works

Letralan 2.5 mg film coated tablets contain 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 tablets reduce 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 tablets are used for

Letrozole tablets are 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 tablets are 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 tablets work or why this medicine has been prescribed for you, ask your doctor.

2. What you need to know before you take Letrozole tablets

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

Do not take Letrozole tablets

-    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 tablets

-    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 tablets 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 tablets.

Children and adolescents (below 18 years)

Children and adolescents 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 tablets

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 tablets when you have gone through the menopause. However, your doctor should discuss with you about using effective contraceptive, as you may still have the potential to become pregnant during treatment with Letrozole tablets.

-    You must not take Letrozole tablets 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.

3. How to take Letrozole tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is one tablet of Letrozole tablets to be taken once a day. Taking Letrozole tablets 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 do take Letrozole tablets

Continue taking Letrozole tablets every day for as long as your doctor tells you. You may need to take them for months or even years. If you have any questions about how long to keep taking Letrozole tablets, talk to your doctor.

Follow-up during Letrozole tablets 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 tablets 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 tablets than you should

If you have taken too much Letrozole tablets, 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 tablets

-    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 tablets

Do not stop taking Letrozole tablets unless your doctor tells you to. See also the section above “ How long to take Letrozole tablets”.

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. 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 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 tablets:

-    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

-    Thinning or wasting of your bones (osteoporosis), leading to bone fractures in some cases (see also “Follow-up during Letrozole tablets treatment” in section 3)

-    Swelling of arms, hands, feet, ankles (oedema)

-    DepressionWeight increase

-    Hair loss

-    Raised blood pressure (hypertension)

-    Abdominal pain

-    Dry skin

-    Vaginal bleeding

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

-    Impairment of sensation, especially that of touch

-    Eye disorders such as blurred vision, eye irritation

-    Palpitations, rapid heart rate

-    Skin disorders such as itching (urticaria) Vaginal discharge or dryness

-    Joint stiffness (arthritis)

-    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

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

You may also have some blood test disorders while taking Letrozole tablets, such as high levels of cholesterol (hypercholesterolemia) or high levels of liver enzymes.

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

5.    How to store Letrozole tablets

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 and the 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 medicines you no longer use. These measures will help protect the environment.

6.    Content of the pack and other information What Letrozole tablets contain:

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

-    The other ingredients are cellulose microcrystalline, silica colloidal anhydrous, sodium starch glycolate, and magnesium stearate. The coating is composed of polyvinyl alcohol, polyethylene glycol, titanium dioxide (E171), talc, yellow iron oxide (E172), Sunset Yellow FCF (E110).

What Letrozole tablets looks like and contents of the pack

Letrozole tablets are supplied as film-coated tablets. The film-coated tablets are yellow and round, biconvex in shape, with "2.5" imprinted on one side of the tablet and plain on the reverse. Each blister pack contains 10, 14, 28, 30, 90 or 100 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

The marketing authorisation holder is ICN Polfa Rzeszow S.A., ul. Przemyslowa 2, 35-959 Rzeszow, Poland.

Manufacturer:

EirGen Pharma Limited 64/65 Westside Business Park,

Old Kilmeaden Road, Waterford,

Ireland

Genepharm S.A.

18 th Km. Marathon Ave.,

153 51 Pallini,

Greece

ICN Polfa Rzeszow S.A 2 Przemyslowa Street 35-959 Rzeszow Poland

Valeant sp. z o.o. sp.j. 2 Przemyslowa Street 35-959 Rzeszow Poland

This medicinal product is authorised in the Member States of the EEA under the following names:

Czech Republic - Brenea 2.5 mg

Poland - Letralan

Slovak Republic - Brenea 2.5 mg

United Kingdom - Letralan 2.5 mg film-coated tablets

This leaflet was last revised in 12/2013

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