Prospect: information for the patient

Letrozol Mylan 2.5 mg film-coated tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is Letrozol Mylan and for what it is used

2.What you need to know before starting to take Letrozol Mylan

3.How to take Letrozol Mylan

4.Possible adverse effects

5.Storage of Letrozol Mylan

6.Contents of the package and additional information

What is Letrozol Mylan and how it works

Letrozol Mylan contains an active ingredient called letrozol. It belongs to a group of medicines called aromatase inhibitors. It is a hormone treatment (or "endocrine") for breast cancer. The growth of breast cancer is usually stimulated by estrogens, which are the female sex hormones. Letrozol Mylan reduces the amount of estrogen by blocking an enzyme ("aromatase") involved in estrogen production and therefore can block the growth of breast cancers that need estrogens to grow. As a result, tumor cells grow more slowly or stop growing and/or spreading to other parts of the body.

What is Letrozol Mylan used for

Letrozol Mylan is used to treat breast cancer in women who have gone through menopause, that is, the cessation of menstrual periods.

It is used to help prevent breast cancer from recurring. It can be used as the first treatment before breast cancer surgery, if immediate surgery is not suitable, or it can be used as the first treatment after breast cancer surgery, or after five years of treatment with tamoxifen. Letrozol Mylan is also used to prevent breast cancer from spreading to other parts of the body in patients with advanced breast cancer.

If you have any questions about how Letrozol Mylan works or why you have been prescribed this medicine, consult your doctor.

Follow carefully all the instructions given by your doctor. They may be different from the general information contained in this leaflet.

Do not take Letrozol Mylan

• if you are allergic to letrozol or any of the other ingredients of this medicine (listed in section 6),
• if you still have menstrual cycles, that is, you have not reached menopause,
• if you are pregnant,
• if you are breastfeeding.

If any of these cases apply to you,do not take this medicine and inform your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Letrozol Mylan

• 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 “Treatment control with Letrozol Mylan” in section 3).

If any of these cases apply to you,inform your doctor. Your doctor will take this into account during your treatment with letrozol.

This medicine may cause tendon inflammation or tendon injury (see section 4). If you experience any sign of pain or tendon inflammation, rest the painful area and inform your doctor.

Children and adolescents (under 18 years)

Children and adolescents should not use this medicine.

Older patients (65 years and over)

People 65 years and over may use this medicine at the same dose as for adults.

Taking Letrozol Mylan with other medicines

Inform your doctor or pharmacist of any other medicine you are taking, have recently taken or might have to take, including non-prescription medicines.

Pregnancy, breastfeeding and fertility

• You should only take Letrozol Mylan after menopause. However, your doctor will discuss with you the use of effective contraception, as you may still become pregnant during treatment with Letrozol Mylan.
• You should not take Letrozol Mylan if you are pregnant or breastfeeding, as it may harm your baby.

Driving and operating machines

If you feel dizzy, tired, sleepy or unwell, do not drive or operate tools or machines until you feel better again.

Letrozol Mylan contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, such as lactose, consult with him before taking this medicine.

This medicine containsless than 23 mg of sodium (1mmol) per ; this is essentially “sodium-free”

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The usual dose is one Letrozol Viatris tablet once a day. If you take Letrozol Viatris at the same time every day, it will help you remember when to take the tablet.

The tablet can be taken with or without food and should be swallowed whole with a glass of water or other liquid.

How long to take Letrozol Viatris

Continue taking Letrozol Viatris every day for the time your doctor tells you to. You may need to take it for months or even years. If you have any doubts about how long you should take Letrozol Viatris, consult your doctor.

Monitoring during treatment with Letrozol Viatris

You should only take this medication under strict medical supervision. Your doctor will periodically check your condition to ensure that the treatment is having the desired effect.

Letrozol Viatris may cause a decrease in bone thickness or bone loss (osteoporosis) due to the decrease in estrogen in the body. Your doctor may decide to perform bone density measurements(a way to monitor osteoporosis) before, during, and after treatment.

If you take more Letrozol Viatris than you should

If you have taken too many Letrozol Viatris tablets, or if someone else has accidentally taken the tablets, contact your doctor or go to the hospital immediately. Show them the packaging of the tablets. You may need medical treatment. You can also call the Toxicology Information Service, Tf:915620420, indicating the medication and the amount taken.

If you forget to take Letrozol Viatris

• If it is almost time for your next tablet (e.g. 2 or 3 hours away), do not take the missed dose and take the next dose at the usual time.
• Otherwise, take the missed dose as soon as you remember, and take the next tablet as you normally would.
• Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Letrozol Viatris

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Most side effects are mild to moderate and usually disappear within a few days or weeks of treatment.

Some of these side effects, such as hot flashes, hair loss, or vaginal bleeding, may be due to a lack of estrogen.

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

Some side effects may be serious:

Rare(may affect up to 1 in 100 people)

• Weakness, paralysis, or loss of sensation in some part of the body (particularly arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (sign of brain alteration, e.g. stroke).
• Oppressive and sudden chest pain (sign of heart alteration).
• Swelling and redness along a vein that is extremely soft and possibly painful to the touch.
• Severe fever, cold, or mouth ulcers due to infections (lack of white blood cells).
• Continued severe blurred vision.

Uncommon(may affect up to 1 in 1,000 people)

• Difficulty breathing, chest pain, fainting, rapid heart rate, blue discoloration of the skin, or sudden pain in the arm, leg, or foot (signs that a blood clot has formed).

Frequency not known(cannot be estimated from available data)

If you experience any of the above, inform your doctor immediately.

Other possible side effects

Very common(may affect more than 1 in 10 people)

• Hot flashes.
• High cholesterol levels (hypercholesterolemia).
• Fatigue.
• Increased sweating.
• Pain in bones and joints (arthralgia).

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

Common(may affect up to 1 in 10 people)

• Palpitations, rapid heart rate.
• Chest pain.
• Rash on the skin.
• Joint stiffness (arthritis).
• Headache.
• Dizziness.
• General discomfort.
• Gastrointestinal disturbances such as nausea, vomiting, indigestion, constipation, diarrhea.
• Increased or decreased appetite.
• Muscle pain.
• Weight loss or bone loss (osteoporosis), which may cause bone fractures in some cases (see also the section “Monitoring during your treatment with Letrozol Mylan in section 3).
• Swelling of arms, hands, feet, ankles (edema).
• Depression.
• Weight gain.
• Hair loss.
• High blood pressure (hypertension).
• Abdominal pain.
• Dry skin.
• Vaginal bleeding.

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

Rare(may affect up to 1 in 100 people)

• Nervous system disorders such as anxiety, nervousness, irritability, numbness, memory problems, drowsiness, insomnia.
• Pain or burning sensation in the hands or wrists (carpal tunnel syndrome).
• Sensitivity problems, especially in touch.
• Eye disorders such as blurred vision, eye irritation.
• Yellow discoloration of the skin and eyes.
• High bilirubin levels (a product of red blood cell degradation). Skin disorders such as itching (urticaria).
• Vaginal dryness or secretions.
• Chest pain.
• Fever.
• Thirst, taste disturbance, dry mouth.
• Dryness of mucous membranes.
• Weight loss.
• Urinary tract infection, increased frequency to urinate.
• Cough.
• Increased enzyme levels.
• Tendon inflammation or tendinitis (connective tissues that connect muscles to bones).

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

– Tendon rupture (connective tissues that connect muscles to bones).

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

Frequency not known(cannot be estimated from available data)

• Trigger finger (a condition in which the finger or thumb assumes a bent position).

If this affects you severely, inform your doctor.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use Letrozol Mylan after the expiration date that appears on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Letrozol Mylan Composition

The active ingredient is letrozol. Each film-coated tablet contains 2.5 mg of letrozol.

The other components (excipients) are lactose monohydrate (see section 2, "Letrozol Mylan contains lactose and sodium"), microcrystalline cellulose, cornstarch, anhydrous colloidal silica, sodium carboxymethylcellulose (potato) and magnesium stearate. The coating consists of yellow iron oxide (E-172), hypromellose, polydextrose, macrogol, triacetin, yellow quinoline colorant (E-104) and titanium dioxide (E-171).

Appearance of the product and contents of the package

Letrozol Mylan is presented as film-coated tablets. The tablets are dark yellow in color, capsule-shaped, with the inscription "LZ 2.5" on one face and "G" on the other face.

Letrozol Mylan is available in blisters or bottles of 7, 10, 14, 20, 28, 30, 56, 60, 84, 90, 98, 100, 112, 120, 180, 200 and 500 tablets and in perforated single-dose blisters of 30 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Mylan Pharmaceuticals, S.L.

C/ Plom, 2-4, 5th floor

08038 - Barcelona

Spain

Responsible for manufacturing

Delpharm Lille S.A.S

Parc d’activités Roubaix-Est

22 rue de Toufflers – CS 50070

59452 Lys-Lez-Lannoy

France

Or

Mylan Hungary Kft.

Mylan utca 1

Komárom, 2900

Hungary

This medicine is authorized in the member states of the European Economic Area with the following names:

Austria:Letrozol Arcana

Cyprus:Letrozole / Generics

Czech Republic:Letmylan

Denmark:Letrozol Mylan

Finland:Letrozol Mylan

France:Letrozole Mylan

Greece:Letrozole Mylan

Ireland:Letrozole Mylan

Italy:Letrozolo Mylan Generics

Netherlands:Letrozole Mylan

Norway:Letrozol Mylan

Portugal:Letrozol Mylan

Spain:Letrozol Mylan

Sweden:Letrozol Mylan

Last revision date of this leaflet:12/2019

Further information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/