Letrozole Sandoz

Patient Information Leaflet

LETROZOLE SANDOZ 2.5 mg film-coated tablets

Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine, as 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

What Letrozole Sandoz is and how it works
Letrozole Sandoz contains an active substance called letrozole. It belongs to a group of medicines known as aromatase inhibitors. It is a hormone treatment (or "endocrine" therapy) for breast cancer. The growth of breast cancer is often stimulated by estrogens, which are female sex hormones. Letrozole Sandoz reduces the amount of estrogen by blocking an enzyme ("aromatase") involved in estrogen production, and therefore can block 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 Sandoz is used for
Letrozole Sandoz is used for the treatment of 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 Sandoz 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 doubts about how Letrozole Sandoz works or why this medicine has been prescribed for you, consult your doctor.

2. What you need to know before taking Letrozole Sandoz

Follow your doctor's instructions carefully. They may differ from the general information
provided in this leaflet.
Do not take Letrozole Sandoz

• if you are allergic to letrozole or to any of the other ingredients of this medicine (listed in section 6),
• if you still have your 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 Sandoz

• 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 Sandoz” in section 3). If any of these conditions apply to you, inform your doctor. This will be taken into consideration by your doctor during treatment with Letrozole Sandoz.

Children and adolescents (under 18 years of age)
Children and adolescents must not use this medicine.
Elderly (65 years of age and older)
Women aged 65 years and older can take this medicine at the same dose as adult women.
Other medicines and Letrozole Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines not requiring a prescription.
Pregnancy, breastfeeding and fertility

• You should take Letrozole Sandoz 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 Letrozole Sandoz.
• You must not take Letrozole Sandoz if you are pregnant or breastfeeding, as it may harm the baby.

Driving and using machines
If you feel dizzy, tired, drowsy or generally unwell, do not drive or operate tools or machinery until you feel well again.
Letrozole Sandoz contains lactose
Letrozole Sandoz contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Letrozole Sandoz contains less than 1 mmol of sodium (23 mg) per 2.5 mg film-coated tablet, i.e. is essentially ‘sodium-free’.

3. How to take Letrozole Sandoz

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The usual dose is one tablet of Letrozole Sandoz to be taken once daily. Taking Letrozole Sandoz 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 other beverage.

How long to take Letrozole Sandoz
Continue taking Letrozole Sandoz every day for the duration prescribed by your doctor. You may need to take it for months or even years. If you have any questions about how long to take Letrozole Sandoz, speak with your doctor.

Monitoring during treatment with Letrozole Sandoz
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 Sandoz 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 Sandoz than you should
If you have taken too much Letrozole Sandoz, 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 Sandoz

• 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, then take the next tablet at your usual time.
• Do not take a double dose to make up for the forgotten dose.

If you stop taking Letrozole Sandoz
Do not stop taking Letrozole Sandoz unless your doctor tells you to. See also the section above titled "How long to take Letrozole Sandoz".

4. Possible side effects

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

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 (particularly arm or leg), loss of coordination, nausea, or difficulty speaking or breathing (symptoms of a brain disorder, for example stroke).
• Sudden chest pain with a feeling of tightness (symptom of a heart disorder).
• Swelling and redness along a vein which is extremely sensitive and also painful to touch.
• High fever, chills or mouth ulceration due to infections (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 discolouration of the skin, or sudden pain in the arm, leg or foot (symptoms of possible blood clot formation).

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 Sandoz:

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

Some side effects are very common: may affect more than 1 in 10 people.

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

Some side effects are common: may affect up to 1 in 10 people.

• Palpitations, tachycardia
• Joint stiffness (arthritis)
• Chest pain
• Skin rash
• Headache
• Dizziness
• Malaise (usually a feeling of being unwell)
• 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 leads to bone fractures (see also “Monitoring during treatment with Letrozole Sandoz” 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
  If any of these effects occur severely, inform your doctor.

Other side effects are uncommon: may affect up to 1 in 100 people.

• Nervous system disorders such as anxiety, nervousness, irritability, drowsiness, memory problems, somnolence, insomnia
• Pain or burning sensation in the hands or wrist (carpal tunnel syndrome)
• Impaired sensation, especially to 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 (breakdown product of red blood cells)

Side effects with unknown frequency (frequency cannot be estimated from the available data):
trigger finger syndrome, a condition in which one of the fingers of the hand remains locked in a bent position.

If any of these effects occur severely, inform your doctor.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.

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.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Letrozole Sandoz

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 that month.
Do not store above 30°C.
Keep in the original packaging to protect the medicine from moisture.
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 Letrozolo Sandoz contains

• The active substance is letrozole. Each film-coated tablet contains 2.5 mg of letrozole.
• The other components are monohydrate lactose, microcrystalline cellulose (E460), maize starch, sodium carboxymethylstarch, magnesium stearate (E572) and anhydrous colloidal silica (E551). The components contained in the tablet coating are hypromellose (E464), talc (E553b), macrogol 8000, titanium dioxide (E171) and yellow iron oxide (E172).

Description of the appearance of Letrozolo Sandoz and pack sizes
The film-coated tablets are dark yellow in colour and round in shape. They are marked on one side with "FV" and with "CG" on the other side.
Each Alu/PVC/PE/PVDC blister contains 10, 14, 28, 30, 50, 56, 60, 84, 90, 98, 100, 100 (10x10), 112, or 120 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A. - Largo U. Boccioni 1 - 21040 Origgio (VA)

Manufacturer
Salutas Pharma GmbH – Otto Von Guericke Allee 1 – 39179 Barleben (Germany)

This medicinal product is authorised in EEA Member States under the following names
AT Letrozol Sandoz 2.5 mg - Filmtabletten
BE Letrozol Sandoz 2.5 mg filmomhulde tabletten
DK Letrozole "Sandoz"
FI Letrozole Sandoz 2.5 mg kalvopäällysteinen tabletti
FR LETROZOLE SANDOZ 2.5 MG, COMPRIMÉ PELLICULÉ
GR LETROZOLE/SANDOZ 2.5MG
IT LETROZOLO SANDOZ 2.5 mg compresse rivestite con film
NL Letrozol Sandoz 2.5 mg, filmomhulde tabletten
SE Letrozole Sandoz 2.5 mg filmdragerade tabletter