Zoltron

Package leaflet: Information for the patient

Zoltron 2.5 mg film-coated tablets

Letrozole
Generic 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 may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

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

1. What Zoltron is and what it is used for

Zoltron contains the active substance 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 female sex hormones (estrogens). Zoltron reduces the amount of estrogen by blocking an enzyme (aromatase) involved in estrogen production, and therefore can inhibit the growth of estrogen-dependent breast cancer. As a result, the growth of cancer cells and/or their spread to other parts of the body is slowed down or stopped.
Zoltron should only be used for the treatment of breast cancer in postmenopausal women, i.e. women who no longer have menstrual periods.
Zoltron is used to prevent the recurrence of breast cancer. It may be used as initial treatment following breast surgery or after five years of treatment with tamoxifen. Zoltron 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 Zoltron works or why this medicine has been prescribed for you, consult your doctor.

2. What you should know before taking Zoltron

Follow carefully all instructions given by your doctor. These may differ from the general information
provided in this leaflet.
Do not take Zoltron
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 periods, that is, 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 Zoltron
if you have severe kidney disease;
if you have severe liver disease;
if you have a history of bone fragility (osteoporosis) or bone fractures (see “Monitoring of
treatment with Zoltron” in section 3).
Zoltron may cause thinning or weakening of the bones (osteoporosis) due to reduced estrogen levels in the body.
Your doctor may decide to measure your bone density (a way to monitor osteoporosis) before, during, and after
treatment.
If any of these conditions apply to you, inform your doctor. Your doctor will take them into account during
treatment with Zoltron.
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
This medicine must not be used in children and adolescents under 18 years of age.
Elderly
Women aged 65 years or older can take this medicine at the same dose as adult women.
For those engaged in sports
Using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.
Other medicines and Zoltron
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Do not take Zoltron if you are pregnant or breastfeeding, as it may harm the baby.
You should only take Zoltron 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 Zoltron.
Driving and using machines
If you feel dizzy, tired, sleepy, or experience a general feeling of unwellness, do not drive or operate machinery until these symptoms resolve.
Zoltron contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this
medicine.
Zoltron contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How to take Zoltron

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
The usual dose is 1 Zoltron tablet taken once daily.
Take Zoltron at the same time every day. This will help you remember when to take the tablet.
Swallow the tablet whole with a glass of water or another drink. The tablet may be taken with or without food.

How long to take Zoltron
Continue taking Zoltron every day for as long as your doctor has instructed. You may need to take it for several months or even for several years. If you have any questions about how long you should take Zoltron, ask your doctor.

Monitoring during treatment with Zoltron
You must take this medicine under close medical supervision. Your doctor will regularly check your health to ensure the treatment is having the desired effect.
Zoltron 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 of monitoring osteoporosis) before, during, and after treatment.

If you take more Zoltron than you should
If you have taken too much Zoltron, or if someone else has accidentally taken your tablets, contact your doctor or hospital immediately for advice. Show them the tablet packaging.
Medical treatment may be necessary.

If you forget to take Zoltron

• If you realize you have missed your tablet when it is almost time for the next dose (for example, within 2 or 3 hours before the next dose), do not take the missed dose but 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 the usual time.
• Do not take a double dose to make up for the forgotten dose.

If you stop taking Zoltron
Do not stop taking Zoltron unless your doctor tells you to. See also the section above, “How long to take Zoltron”.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most of the side effects are mild to moderate and usually disappear within the first days or weeks of treatment.
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 (especially 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 condition);
• Swelling and redness along a vein which is extremely tender and painful to touch;
• High fever, chills or mouth ulcers due to infections (lack of white blood cells);
• Severe and persistent blurred vision;
• Inflammation of a tendon or tendinitis (connective tissues linking muscles to bones).

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

• Difficulty breathing, chest pain, fainting, rapid heartbeat, bluish skin colouration or sudden pain in the arm, leg or foot (signs of possible blood clot formation);
• Rupture of a tendon (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 ZOLTRON:

• Swelling, mainly of the face and throat (signs of 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).

Very common (may affect more than 1 in 10 people):
Hot flushes;
Malaise (usually feeling unwell);
Increased cholesterol levels (hypercholesterolaemia);
Feeling of tiredness (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 (cephalalgia);
Dizziness (vertigo);
Digestive disorders such as nausea, vomiting, indigestion, constipation, diarrhoea;
Increased or decreased appetite;
Muscle pain;
Loss or weakening of bones (osteoporosis), which in some cases may lead to bone fractures (see also “Monitoring of Zoltron treatment” in section 3);
Swelling of arms, hands, feet and ankles (oedema);
Feeling of sadness (depression);
Weight gain;
Hair loss;
Increased blood pressure (hypertension);
Abdominal pain;
Dry skin;
Vaginal bleeding;
Palpitations;
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, drowsiness (stupor), memory problems, somnolence, insomnia;
Tachycardia;
Pain or burning sensation in hands or wrist (carpal tunnel syndrome);
Altered sensation, particularly of touch;
Eye disorders, such as blurred vision, eye irritation;
Itching (urticaria);
Vaginal discharge or vaginal dryness;
Breast pain;
Fever;
Thirst, altered taste, dry mouth;
Dryness of mucous membranes;
Weight loss;
Urinary tract infection, increased frequency of urination;
Cough;
Increased liver enzyme levels;
Yellowing of the skin and eyes;
Elevated bilirubin levels in the blood (a by-product of red blood cell metabolism).

Not known (frequency cannot be estimated from the available data):

• Severe allergic reaction;
• Swelling mainly of the face and throat (signs of allergic reaction);
• Skin rash, red skin, blisters on the lips, eyes or mouth, skin peeling, fever (signs of skin disorders);
• Trigger finger, 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 immediately.

Reporting of side effects
If you get any side effects, including ones 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 Zoltron

This medicine does not require any special storage temperature.
Keep in the original packaging to protect the medicine from moisture.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
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 Zoltron contains

• The active substance is letrozole. Each tablet contains 2.5 mg of letrozole.
• The other components are: Tablet core: lactose, microcrystalline cellulose, maize starch, sodium starch glycolate, anhydrous colloidal silica, magnesium stearate. Tablet coating: opadry yellow 02B38014 [titanium dioxide (E171), yellow iron oxide (E172), macrogol 4000, red iron oxide (E172), talc, hypromellose].

Description of the appearance of Zoltron and pack contents
Zoltron tablets are yellow, round, biconvex, film-coated tablets.
Zoltron tablets are available in packs of 30 film-coated tablets in blisters.
Marketing Authorization Holder:
Istituto Gentili S.r.l. – Via San Giuseppe Cottolengo 15, 20143 Milano (MI)
Manufacturer
Genetic S.p.A. – Contrada Canfora - 84084 Fisciano (SA)
This patient information leaflet was last updated on