Package Insert: Information for the Patient

Letrozol STADA 2.5 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert as you may need to refer to it again.

• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you alone, and you should not give it to others 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 package insert. See section 4.

1. What you need to know before starting to take Letrozol STADA

1. How to take Letrozol STADA

1. Possible adverse effects

1. Storage of Letrozol STADA

1. Contents of the package and additional information

What is Letrozol STADA and how it works

Letrozol STADA contains an active ingredient called letrozol. It belongs to a group of medicines called aromatase inhibitors. It is a hormone (endocrine) treatment for breast cancer. The growth of breast cancer is usually stimulated by estrogens, which are the female sex hormones. Letrozol 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 STADA used for

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

It is used to 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 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 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 STADA

• if you are allergic to letrozol or any of the other ingredients in 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.

• 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 STADA” 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.

Letrozol may cause tendon inflammation or tendon injuries (see section 4). If you experience any signs of pain or tendon inflammation, rest the painful area and contact your doctor.

Children and adolescents

Children and adolescents should not use this medicine.

Older patients

People aged 65 years or older may use this medicine at the same dose as for adults.

Other medicines and Letrozol STADA

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Pregnancy, breastfeeding and fertility

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

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before taking this medicine.

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 STADA contains lactose and sodium

Lactose: If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Sodium: This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free

Important information for athletes

This medicine contains letrozol which may produce a positive result in doping control tests.

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

The recommended dose is one Letrozol STADA tablet once a day. If you take Letrozol 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 STADA

Continue taking Letrozol 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 doubts about how long you should take Letrozol, consult your doctor.

Monitoring Treatment with Letrozol STADA

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

Letrozol 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 STADA Than You Should

If you have taken too many Letrozol tablets, or if someone else has taken the tablets by mistake, 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, Phone 91 562 04 20, indicating the medication and the amount taken.

If You Forget to Take Letrozol STADA

• 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 then take the next tablet as you normally would.
• Do not take a double dose to make up for the missed doses.

If You Stop Taking Letrozol STADA

Do not stop taking Letrozol unless your doctor tells you to. See also the section “How Long to Take Letrozol STADA”.

If you have any other questions about using this medication, ask your doctor or pharmacist.

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

Most side effects are mild to moderate and usually disappear after 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 can be serious:

Rare or uncommon(may affect 1 to 100 of every 10,000 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 a brain alteration, such as a stroke)
• Oppressive and sudden chest pain (sign of a heart alteration)
• Difficulty breathing, chest pain, fainting, rapid heart rate, bluish discoloration of the skin, or sudden pain in the arm, leg, or foot (signs of a blood clot formation)
• Swelling and redness in 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)
• Continuous blurred vision

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

You should also inform your doctor immediately if you experience any of the following symptoms during treatment with letrozol:

• Swelling mainly in the face and throat (signs of an allergic reaction).
• Yellow color in the skin and eyes, nausea, loss of appetite, darkening of urine color (signs of hepatitis).
• Rash, skin redness, blisters on the lips, eyes, or mouth, skin peeling, fever (signs of skin alteration).

Very common.May affect more than 1 in 10 people.

• Hot flashes
• Elevated cholesterol levels (hypercholesterolemia)
• Fatigue
• Increased sweating
• Bone and joint pain (arthralgia)

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

Common.May affect up to 1 in 10 people.

• Skin rash
• Headache
• Dizziness
• General discomfort
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea
• Increased or decreased appetite
• Muscle pain
• Osteoporosis, which causes bone fractures in some cases (see also the "Letrozol STADA treatment control" section in section 3)
• Swelling of arms, hands, feet, ankles (edema)
• Depression
• Weight gain
• Hair loss
• High blood pressure (hypertension)
• Abdominal pain
• Skin dryness
• Vaginal bleeding
• Palpitations, rapid heart rate
• Joint stiffness (arthritis)
• Chest pain

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

Uncommon.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
• Palpitations, rapid heart rate
• Skin disorders such as itching (urticaria)
• Vaginal discharge or dryness
• Joint stiffness (arthritis)
• Chest pain
• Fever
• Thirst, taste disorder, dry mouth
• Membrane mucosa dryness
• Weight loss
• Urinary tract infection, increased frequency to urinate
• Cough
• Increased enzyme levels
• Yellowish discoloration of the skin and eyes
• High bilirubin levels in the blood (a product of red blood cell breakdown)
• Tendinitis or inflammation of a tendon (connective tissue that connects muscles to bones)

Rare.May affect up to 1 in 1,000 people.

• Tendon rupture (connective tissue that connects muscles to bones)

Unknown.The frequency cannot be estimated from available data.

• Trigger finger, a situation in which your finger or thumb stays locked in a bent position.

If any of these affect 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 prospectus. You can also report them directly through the Spanish System for 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.

Store in the original packaging to protect it from moisture.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Letrozol STADA Composition

• The active ingredient is letrozol. Each tablet contains 2.5 mg of letrozol.

• The other components are lactose monohydrate, cornstarch, microcrystalline cellulose, sodium starch glycolate (Type A), hydroxypropylmethyl cellulose (6 mPas), hydroxypropyl cellulose, magnesium stearate, talc, cottonseed oil, yellow iron oxide (E 172), red iron oxide (E 172), titanium dioxide (E171).

Appearance of the product and contents of the packaging

Letrozol STADA 2.5 mg is presented as film-coated tablets, round, yellow in color, and with both surfaces convex.

The tablets are packaged in blisters containing 10, 30, and 100 tablets.

Only some packaging sizes may be commercially marketed

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible Manufacturer

Haupt Pharma Münster GmbH

Schleebrüggenkamp 15

D-48159 Münster

Germany

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

This medicine is authorized in the EEA Member States with the following names:

Germany:Letrostad 2.5 mg Filmtabletten

Spain:Letrozol STADA 2.5 mg film-coated tablets EFG

Last review date of the leaflet: October 2019

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