Letrozole Tecnigen

PACKAGE LEAFLET: INFORMATION FOR THE USER

Letrozole TecniGen 2.5 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before 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 could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet:

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

1. WHAT LETROZOLE TECNIGEN IS AND WHAT IT IS USED FOR

What Letrozole TecniGen is and how it works
Letrozole TecniGen contains the active substance called letrozole, which belongs to a group of medicines
called aromatase inhibitors. It is a hormonal (or "endocrine") treatment for breast cancer. The growth of
breast cancer is often stimulated by estrogens, which are female sex hormones. Letrozole TecniGen reduces
the amount of estrogen by blocking an enzyme ("aromatase") involved in estrogen production and therefore
can inhibit the growth of breast tumors that require estrogen to grow. As a result, the growth of cancer cells
and/or their spread to other parts of the body is slowed down or stopped.
What Letrozole TecniGen is used for
Letrozole TecniGen is used for the treatment of breast cancer in postmenopausal women, i.e. women who
no longer have menstrual periods.
Letrozole TecniGen 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, as initial treatment after breast surgery, or
after five years of treatment with tamoxifen. Letrozole TecniGen is also used to prevent the spread of
advanced-stage breast cancer.
If you have any questions about how Letrozole TecniGen works or why this medicine has been prescribed for you,
please consult your doctor.

2. WHAT YOU SHOULD KNOW BEFORE TAKING LETROZOLE TECNIGEN

Follow your doctor's instructions carefully. These may differ from the general information provided in this leaflet.
Do not take Letrozolo TecniGen

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• if you still have your menstrual cycle, i.e. if you are not yet in 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 Letrozolo TecniGen.

• 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 Letrozolo TecniGen” in section 3). If any of these conditions apply to you, inform your doctor. This will be taken into account by your doctor during treatment with Letrozolo TecniGen. 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. For individuals engaged in sports: using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

Children and adolescents (under 18 years of age)
Children and adolescents must not use this medicine.
Elderly (65 years of age and over)
Women aged 65 years and over can take this medicine at the same dose as adult women.
Other medicines and Letrozolo TecniGen
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 should take Letrozolo TecniGen only after you have entered menopause. However, your doctor will discuss with you the need to use an effective method of contraception, as you could potentially become pregnant during treatment with Letrozolo TecniGen.
• You must not take Letrozolo TecniGen if you are pregnant or breastfeeding, as it could be harmful to the baby.

Driving and using machines
If you experience dizziness, fatigue, drowsiness or general malaise, do not drive or operate machinery until you feel normal again.
Letrozolo TecniGen contains lactose
Letrozolo TecniGen contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. HOW TO TAKE LETROZOLE TECNIGEN

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one Letrozole TecniGen tablet to be taken once daily. Taking Letrozole TecniGen at the same time each day will help you remember when to take the tablet.
The tablet can be taken with or without food and must be swallowed whole with a glass of water or another beverage.

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

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

If you take more Letrozole TecniGen than you should
If you have taken too much Letrozole TecniGen, 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 TecniGen

• If it is almost time for your next dose (for example, 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, and then take the next tablet at your usual time.
• Do not take a double dose to make up for the forgotten tablet.

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Most of the adverse reactions are mild to moderate and usually disappear after a period of treatment ranging from a few days to a few weeks.
Some of these adverse reactions, such as hot flushes, hair loss or vaginal bleeding, may be caused by low levels of oestrogen in the body.
Do not be alarmed by this list of possible adverse reactions. You may not experience any of them.

Some adverse reactions can be serious:
Uncommon or rare reactions (may affect between 1 and 100 in 10,000 patients):

• 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 (symptoms of a brain disorder, such as stroke).
• Sudden chest pain with a feeling of tightness (symptom of a heart condition).
• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin colouration, or sudden pain in the arm, leg, or foot (symptoms of possible blood clot formation).
• Swelling and redness along a vein which is extremely tender and painful to the touch.
• High fever, chills, or mouth ulcers due to infections (caused by lack of white blood cells).
• Severe and persistent blurred vision.
• Tendon rupture (connective tissues linking muscles to bones).

If any of these effects occur, inform your doctor immediately.
You must contact your doctor immediately if any of the following symptoms occur during treatment with Letrozole TecniGen:

• Swelling, mainly of the face and throat (symptoms of an allergic reaction).
• Yellowing of the skin and eyes, nausea, loss of appetite, dark-coloured urine (signs of hepatitis).
• Skin rash, red skin, blisters on the lips, eyes or mouth, skin peeling, fever (signs of skin disorders).

Some adverse reactions are very common. These adverse reactions may affect more than 10 out of 100 patients.

• Hot flushes.
• Increased cholesterol levels (hypercholesterolaemia).
• Fatigue.
• Increased sweating.
• Bone and joint pain (arthralgia). If any of these effects become severe, inform your doctor.

Some adverse reactions are common. These adverse reactions may affect between 1 and 10 out of 100 patients.

• Skin rash.
• Headache.
• Dizziness.
• Malaise (usually a feeling of discomfort).
• Gastrointestinal disorders such as nausea, vomiting, indigestion, constipation, diarrhoea.
• Increased or decreased appetite.
• Muscle pain.
• Fragility or loss of bone mass (osteoporosis), which in some cases may lead to bone fractures (see also “Monitoring during treatment with Letrozole TecniGen” in section 3).
• Swelling of the arms, hands, feet, ankles (oedema).
• 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.
Other adverse reactions are uncommon. These adverse reactions may affect between 1 and 10 out of 1,000 patients.

• Nervous system disorders such as anxiety, nervousness, irritability, drowsiness, somnolence, memory problems, insomnia.
• Impaired sensation, especially of touch.
• Eye disorders such as blurred vision, eye irritation.
• Skin changes 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 liver enzyme levels.
• 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). If any of these effects become severe, inform your doctor.

Other adverse reactions are rare. These adverse reactions may affect between 1 and 10 out of 10,000 patients.

• Tendon rupture (connective tissues linking muscles to bones).

If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist.

5. HOW TO STORE LETROZOLE TECNIGEN

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original packaging to protect the medicine from moisture.
If your doctor tells you to stop taking Letrozole TecniGen, return any unused tablets to the pharmacist for proper disposal. Only keep the tablets if your doctor instructs you to do so.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Letrozolo TecniGen contains

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other components are (tablet core): monohydrate lactose, microcrystalline cellulose, maize starch,
  anhydrous colloidal silica, sodium starch glycolate, magnesium stearate; and (tablet coating):
  polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 3350, quinoline yellow aluminium lake, iron
  oxide red (E172) and iron oxide black (E172).

Description of the appearance of Letrozolo TecniGen and package contents
Letrozolo TecniGen is available as film-coated tablets. The tablets are round, with a white core and a dark yellow coating.
Pack sizes contain 30 tablets.

Marketing Authorization Holder
Tecnimede Sociedade Técnico-Medicinal S.A.
Rua da Tapada Grande nº 2, Abrunheira
2710-089 Sintra - Portugal

Sales Licensee:
Tecnigen S.r.l.
Via Galileo Galilei, 40
20092 Cinisello Balsamo (MI) - Italy

Manufacturer responsible for batch release:
Tecnimede – Sociedade Técnico Medicinal, S.A.
Quinta da Cerca, Caixaria
2565-187 Dois Portos - Portugal

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