Letrozole Mylan Generics

Package leaflet: Information for the user

Letrozole Mylan Generics 2.5 mg film-coated tablets

Letrozole
Equivalent medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Letrozole Mylan Generics is and what it is used for
2. What you need to know before taking Letrozole Mylan Generics
3. How to take Letrozole Mylan Generics
4. Possible side effects
5. How to store Letrozole Mylan Generics
6. Contents of the pack and other information

1. What Letrozole Mylan Generics is and what it is used for

What Letrozole Mylan Generics is and how it works
Letrozole Mylan Generics tablets contain an active substance called letrozole. It belongs to a group of
medicines known as aromatase inhibitors. It is a hormonal (or "endocrine") treatment for breast cancer.
The growth of breast tumours is often stimulated by oestrogens, which are female sex hormones. Letrozole Mylan Generics reduces the amount of oestrogens by blocking an enzyme ("aromatase") involved in oestrogen production, and therefore can block the growth of breast tumours that require oestrogens to grow. As a result, the growth of tumour cells and/or their spread to other parts of the body is slowed down or stopped.
What Letrozole Mylan Generics is used for
Letrozole Mylan Generics is used for the treatment of breast cancer in postmenopausal women, i.e. women who no longer have menstrual periods.
It is used to help prevent the recurrence of breast cancer. It may be used as initial treatment before breast surgery when immediate surgery is not possible, or as initial treatment after breast surgery, or after five years of treatment with tamoxifen.
Letrozole Mylan Generics is also used to prevent the spread of breast cancer to other parts of the body in patients with advanced-stage breast cancer.
If you have any questions about how Letrozole Mylan Generics works or why this medicine has been prescribed for you, please consult your doctor.

2. What you need to know before taking Letrozole Mylan Generics

Carefully follow all instructions given by your doctor. These may differ from the general information
provided in this leaflet.
Do not take Letrozole Mylan Generics:

• if you are allergic (hypersensitive) to letrozole or to any of the other excipients of this medicine (listed in section 6)
• if you are still having menstrual periods, i.e. if you have not yet reached menopause
• if you are pregnant
• if you are breastfeeding If any of these conditions apply to you, do not take this medicine and inform your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Letrozole Mylan Generics:

• if you have severe kidney disease
• if you have severe liver disease
• if you have a history of osteoporosis or bone fractures (see also “Monitoring of treatment with Letrozole Mylan Generics” in section 3). If any of these conditions apply to you, inform your doctor. Your doctor will take this into account during your treatment with Letrozole Mylan Generics. Letrozole may cause inflammation of the tendons or tendon injury (see section 4). At the first sign of tendon pain or swelling, rest the affected area and contact your doctor.

Children and adolescents (under 18 years of age)
This medicine must not be used by children and adolescents.
Elderly (over 65 years of age)
Patients over 65 years of age can take this medicine at the same dosage as other adults.
Other medicines and Letrozole Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines,
including those obtained without a prescription.
For athletes: using this medicine without a medical need constitutes doping and may lead to a positive doping test.
Pregnancy, breastfeeding and fertility

• You must take Letrozole Mylan Generics only after you have entered menopause. However, your doctor will discuss with you the need to use an effective contraceptive method, as you could potentially become pregnant during treatment with Letrozole Mylan Generics.
• You must not take Letrozole Mylan Generics if you are pregnant or breastfeeding, as it may harm the baby.

Driving and operating machinery
If you experience dizziness, fatigue, drowsiness or generally feel unwell, do not drive and avoid using tools or
machinery until you feel well again.
Letrozole Mylan Generics contains lactose and sodium
If your doctor has informed you that you have an intolerance to certain sugars, such as lactose, contact him/her before
taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Letrozole Mylan Generics

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The usual dose of this medicine is one tablet once daily. Taking Letrozole Mylan Generics at the same time every day will help you remember when to take the tablet.
The tablet should be taken with or without food and must be swallowed whole with a glass of water or other liquid.

How long to take Letrozole Mylan Generics
Continue taking Letrozole Mylan Generics every day for as long as your doctor tells you to. You may need to take it for months or even years. If you have any questions about how long you should continue treatment with Letrozole Mylan Generics, speak to your doctor.

Monitoring during treatment with Letrozole Mylan Generics
You must take this medicine under close supervision by your doctor. Your doctor will regularly check your health to ensure the treatment is having the desired effect.
Letrozole Mylan Generics may cause bone fragility or loss of bone mass (osteoporosis) due to reduced estrogen levels in the body. Your doctor may decide to measure your bone density (a way of monitoring osteoporosis) before, during, and after treatment.

If you take more Letrozole Mylan Generics than you should
If you have taken more tablets than prescribed, or if someone else has accidentally taken your tablets, contact your doctor or hospital immediately for advice. Show them the tablet pack. Medical treatment may be necessary.

If you forget to take Letrozole Mylan Generics

• If it is almost time for your next dose (e.g., within 2 or 3 hours), skip the missed dose and take the next dose at the usual time.
• Otherwise, take the missed dose as soon as you remember, then take your next dose at the usual time.
• Do not take a double dose to make up for the missed one.

If you stop taking Letrozole Mylan Generics
Do not stop taking Letrozole Mylan Generics unless your doctor tells you to. See also the previous section “How long to take Letrozole Mylan Generics”.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Most of the side effects are mild or moderate and usually disappear after a few days or weeks of treatment.
Some of these side effects, such as hot flushes, hair loss or vaginal bleeding, may be due to low oestrogen levels in the body.
Do not be alarmed by this list of possible side effects. It is possible that none of them will occur.

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 arm or leg), loss of coordination, nausea, difficulty speaking or breathing (signs of brain disorders, e.g. stroke)
• Sudden chest pain with a feeling of tightness (sign of heart problems)
• Swelling and redness along a vein which is extremely tender and painful to touch
• High fever, chills or mouth ulcers caused by infections (due to lack of white blood cells)
• Severe and persistent blurred vision

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

• Breathing difficulties, chest pain, fainting, rapid heartbeat, bluish skin discolouration, or sudden pain in the arm, leg or foot (symptoms of possible blood clot formation)

Not known (frequency cannot be determined from available data):

• Swelling mainly of the face and throat (signs of allergic reaction)
• Yellowing of the skin and eyes, nausea, loss of appetite, dark urine (signs of hepatitis)
• Skin rash, redness, blistering of the lips, eyes or mouth, skin peeling, fever (signs of skin disorders)

If any of these effects occur, inform your doctor immediately.

Other possible side effects
Very common (may affect up to 1 in 10 people):

• Hot flushes
• Increased cholesterol levels (hypercholesterolaemia)
• Tiredness
• Increased sweating
• Joint pain (arthralgia)

If any of these side effects occur severely, inform your doctor.

Common (may affect up to 1 in 10 people):

• Palpitations, rapid heartbeat
• Chest pain
• Skin rashes
• Joint stiffness (arthritis)
• Headache
• Dizziness
• Malaise
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhoea
• Increased or decreased appetite
• Muscle or bone pain
• Thinning or changes in bones (osteoporosis), which in some cases may lead to bone fractures (see also section 3 “Monitoring during treatment with Letrozole Mylan Generics”)
• Swelling of arms, hands, feet, ankles (oedema)
• Depression
• Weight gain
• Hair loss
• Increased blood pressure (hypertension)
• Abdominal pain
• Dry skin
• Vaginal bleeding

If any of these side effects occur severely, inform your doctor.

Uncommon (may affect up to 1 in 100 people):

• Nervous system disorders such as anxiety, nervousness, irritability, mental clouding, memory problems, drowsiness or insomnia
• Pain or burning sensation in hands or wrists (carpal tunnel syndrome)
• Altered sensation, especially to touch
• Eye disorders such as blurred vision, eye irritation
• Yellowing of the skin and eyes
• High levels of bilirubin (a breakdown product of red blood cells)
• Skin disorders such as itching (urticaria)
• Vaginal discharge or dryness
• Breast pain
• Fever
• Thirst, taste disturbances, dry mouth
• Dryness of mucous membranes
• Weight loss
• Urinary tract infections, increased frequency of urination
• Cough
• Increased liver enzyme levels
• Tendon inflammation or tendinitis (connective tissues linking muscles to bones)

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

• Tendon rupture (connective tissues linking muscles to bones)

Not known (frequency cannot be determined from available data):

• Trigger finger, a condition in which fingers or thumb get stuck in a bent position

If any of these side effects occur severely, inform your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Letrozole Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and blister after the word
"Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Letrozole Mylan Generics contains
The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
The excipients are: monohydrate lactose (see section 2 "Letrozole Mylan Generics contains lactose and sodium"),
microcrystalline cellulose, maize starch, anhydrous colloidal silica, sodium glycolate starch and magnesium stearate.
The tablet coating contains: iron oxide (E172), hypromellose, polydextrose, macrogol, triacetin, quinoline yellow (E104) and titanium dioxide (E171).
Description of the appearance of Letrozole Mylan Generics and pack contents
Letrozole Mylan Generics 2.5 mg tablets are dark yellow, capsule-shaped, slightly biconvex, film-coated, marked with "LZ 2.5" on one side and "G" on the other.
Letrozole Mylan Generics is available in blister packs or bottles containing 7, 10, 14, 20, 28, 30, 56, 60, 84, 90, 98, 100, 112, 120, 180, 200 and 500 tablets, and in divisible blister packs with a 30x1 tablet pack size.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan, Italy
Manufacturers
Delpharm Lille S.A.S
Parc d’activités de Roubaix Est
22 Rue de Toufflers, CS 50070
59452 Lys Lez Lannoy
France
Mylan Hungary Kft
Mylan utca 1, Komarom
2900, Hungary
This medicinal product is authorised in the European Economic Area Member States under the following
names:
Austria: Letrozol Arcana
Cyprus: Letrozole / Generics
Czech Republic: Letmylan
Denmark: Letrozol Mylan
France: Letrozole Mylan
Greece: Letrozole / Mylan
Ireland: Letrozole Mylan
Italy: Letrozolo Mylan Generics
Netherlands: Letrozole Mylan
Norway: Letrozol Mylan
Poland: Letrogen
Portugal: Letrozol Mylan
Slovenia: Letrozol Mylan
Spain: Letrozol Mylan
Sweden: Letrozol Mylan