Package leaflet: Information for the patient

Letrozole Teva 2.5 mg film-coated tablets

letrozole
Generic 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, because 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:

What Letrozole Teva is and what it is used for
What you need to know before taking Letrozole Teva
How to take Letrozole Teva
Possible side effects
How to store Letrozole Teva
Contents of the pack and other information

1. What Letrozole Teva is and what it is used for

What Letrozole Teva is and how it works
Letrozole Teva contains an active substance called letrozole. It belongs to a group of
medicines known as aromatase inhibitors. It is a treatment for hormone-dependent (or “endocrine”)
breast cancer. The growth of breast tumours is often stimulated by estrogens, which are female sex hormones. Letrozole Teva reduces the amount of estrogen by blocking an enzyme (“aromatase”) involved in estrogen production; therefore, it can block the growth of breast tumours that require estrogen 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 Teva is used for
Letrozole Teva is used to treat breast cancer in postmenopausal women, that is, women who no longer have menstrual periods.
It is used to 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 Teva 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 Teva works or why this medicine has been prescribed for you, consult your doctor.

2. What you need to know before taking Letrozole Teva

Carefully follow all instructions provided by your doctor. They may differ from the general information contained in this leaflet.
Do not take Letrozole Teva
if you are allergic to letrozole or to any of the other ingredients of this medicine (listed in section 6).
if you still have menstrual cycles, i.e. if you are not yet postmenopausal.
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 Teva
if you have severe kidney disease.
if you have severe liver disease.
if you have a history of osteoporosis or bone fractures (see also the section “Monitoring of treatment with Letrozole Teva” in section 3).
If you are in any of these conditions, inform your doctor. He or she will take this into account during treatment with Letrozole Teva.
Letrozole may cause tendon inflammation 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)
Children and adolescents must not use this medicine.
Elderly people (65 years of age and over)
Women aged 65 years and older can use this medicine at the same dose as other adults.
If you are engaged in sports: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Other medicines and Letrozole Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Pregnancy, breastfeeding and fertility
You must only take Letrozole Teva 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 Teva.
You must not take Letrozole Teva if you are pregnant or breastfeeding, as it may harm the baby.
Driving and using machines
If you experience dizziness, tiredness, drowsiness or general malaise, do not drive or operate tools or machinery until you feel well again.
Letrozole Teva contains lactose
This medicine contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Letrozole Teva contains aluminium lake tartrazine
This medicine contains aluminium lake tartrazine (E102), which may cause allergic reactions.
Letrozole Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially “sodium-free”.

3. How to take Letrozole Teva

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
The recommended dose is one tablet of Letrozole Teva to be taken once daily.
Taking Letrozole Teva at the same time each 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 another liquid.

How long to take Letrozole Teva
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 doubts about how long you should take Letrozole Teva, consult your doctor.

Monitoring during treatment with Letrozole Teva
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 Teva 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 Teva than you should
If you have taken too much Letrozole Teva or if someone else accidentally takes your tablets, contact your doctor or hospital immediately for advice. Show the tablet pack. Medical treatment may be necessary.

If you forget to take Letrozole Teva
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 tablet at the usual time.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Letrozole Teva
Do not stop taking Letrozole Teva unless instructed by your doctor. See also the previous section, "How long to take Letrozole Teva".
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Most of the side effects are mild to moderate and generally 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 estrogen levels in the body.
Do not be alarmed by this list of possible side effects. You may not experience any of them.

Some side effects may be serious:

Uncommon (may affect up to 1 in 100 people):
Weakness, paralysis, or loss of sensation in any part of the body (particularly arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (signs of a brain disorder, e.g., stroke).
Sudden, severe chest pain (signs of a heart disorder).
Swelling and redness along a vein, which is extremely tender and possibly painful to touch.
Severe fever, chills, or mouth ulcers due to infections (due to low white blood cell count).
Severe and persistent blurred vision.

Rare (may affect up to 1 in 1,000 people):
Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin discoloration, or sudden pain in the arm, leg, or foot (signs of blood clot formation).

If any of these effects occur, inform your doctor immediately.
You must contact your doctor immediately if you experience any of the following symptoms during treatment with Letrozole Teva:
Swelling, mainly of the face and throat (signs of an allergic reaction).
Yellowing of the skin and eyes, nausea, loss of appetite, dark-colored urine (signs of hepatitis).
Skin rash, red skin, blisters on the lips, eyes, or mouth, skin peeling, fever (signs of skin disorders).

Other side effects:

Very common (may affect more than 1 in 10 people):
Hot flushes.
Increased cholesterol levels (hypercholesterolemia).
Fatigue.
Increased sweating.
Bone and joint pain (arthralgia).
If any of these effects become severe, inform your doctor.

Common (may affect up to 1 in 10 people):
Skin rash.
Headache.
Dizziness.
Malaise (general feeling of being unwell).
Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhea.
Increased or decreased appetite.
Muscle pain.
Thinning or weakening of bones (osteoporosis), which in some cases may lead to bone fractures (see also “Monitoring during treatment with Letrozole Teva” in section 3).
Swelling of arms, hands, feet, ankles (edema).
Depression.
Weight gain.
Hair loss.
Increased blood pressure (hypertension).
Abdominal pain.
Dry skin.
Vaginal bleeding.
Palpitations, tachycardia.
Joint stiffness (arthritis).
Chest pain.
If any of these effects become severe, inform your doctor.

Uncommon (may affect up to 1 in 100 people):
Nervous system disorders such as anxiety, nervousness, irritability, lethargy, memory problems, drowsiness, insomnia.
Pain or burning sensation in the hands or wrist (carpal tunnel syndrome).
Sensory disturbances, especially of touch.
Eye disorders such as blurred vision, eye irritation.
Skin disorders such as itching (urticaria).
Vaginal dryness or discharge.
Breast pain.
Fever.
Thirst, taste disturbances, dry mouth.
Dryness of mucous membranes.
Weight loss.
Urinary tract infections, increased frequency of urination.
Cough.
Increased levels of liver enzymes.
Yellowing of the skin and eyes.
Elevated blood levels of bilirubin (a breakdown product of red blood cells).
Inflammation of a tendon 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 estimated from the available data):
Trigger finger, a condition in which one of the fingers of the hand becomes locked in a bent position.
If any of these effects become severe, inform your doctor.

Reporting of side effects
If you experience any side effects, 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 the following website:
https://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 Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "Exp". The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine 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 Teva contains
The active substance is letrozole. Each film-coated tablet contains 2.5 mg of
letrozole.
The other components are microcrystalline cellulose, starch (maize), magnesium stearate,
lactose monohydrate, colloidal anhydrous silica, sodium carboxymethyl starch (type A), and
Opadry II 85F32723 Yellow, which consists of yellow iron oxide (E172), macrogol 3350,
titanium dioxide (E171), talc, indigo carmine aluminium lake (E132), poly(vinyl
alcohol), and tartrazine aluminium lake (E102).
Description of the appearance of Letrozole Teva and contents of the pack
The film-coated tablets of Letrozole Teva 2.5 mg are standard, circular, biconvex, dark yellow tablets, imprinted with "93" on one side and "B1" on the other side.
The film-coated tablets of Letrozole Teva 2.5 mg are available in packs containing 1, 10, 14, 15, 20, 28, 30, 60, 90, 98 and 100 film-coated tablets; hospital packs containing 50 film-coated tablets are also available.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 – 20123 Milan, Italy
Manufacturer
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen (Hungary)