Package leaflet: Information for the user

Gosuran 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, pharmacist or nurse.
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 effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Gosuran is and what it is used for

Gosuran contains an active substance called letrozole. It 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. Gosuran 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 Gosuran is used for
Gosuran is used to treat breast cancer in postmenopausal women, i.e. 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. Gosuran 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 Gosuran works or why this medicine has been prescribed for you, please consult your doctor.

2. What you need to know before taking Gosuran

Follow carefully all instructions given by your doctor. These may differ from the general
information reported in this leaflet.
Do not take Gosuran
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 Gosuran
if you have severe kidney disease;
if you have severe liver disease;
if you have a history of bone thinning or fragile bones (osteoporosis) or bone fractures
(see also “Monitoring of treatment with Gosuran” 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 Gosuran.
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 (aged 65 years and over)
Women aged 65 years and over may use this medicine at the same dose as adult women.

Other medicines and Gosuran
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines, including those without a prescription.

Pregnancy, breastfeeding and fertility

You must only take Gosuran 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 Gosuran.
You must not take Gosuran if you are pregnant or breastfeeding, as it may harm the baby.

Driving and using machines
If you feel dizzy, tired, sleepy or generally unwell, do not drive or operate machinery until you feel
normal again.

Gosuran contains lactose
Gosuran contains lactose (milk sugar). If your doctor has diagnosed you with an intolerance to
certain sugars, contact him before taking this medicine.

Gosuran contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

For athletes: The use of this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take Gosuran

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor, pharmacist, or nurse.
The recommended dose is one Gosuran tablet taken once daily.
Taking Gosuran at the same time each day will help you remember when to take the tablet.

How to take Gosuran
The tablet can be taken with or without food and must be swallowed whole with a glass of water or another drink.

How long to take Gosuran
Continue taking Gosuran every day for as long as your doctor has told you. 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 Gosuran, speak with your doctor.

Monitoring during treatment with Gosuran
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.
Gosuran may cause bone fragility or loss of bone mass (osteoporosis) due to decreased 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 Gosuran than you should
If you have taken too much Gosuran, 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 Gosuran

If you realize you have forgotten your tablet when it is almost time for your next dose (e.g., within 2 or 3 hours before your next dose), do not take the missed dose; instead, take your 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 the forgotten dose.

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

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 after a few 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 (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 condition).
Swelling and redness along a vein which is extremely tender and also painful to the touch.
High fever, chills or mouth ulcers caused by infections (lack of white blood cells).
Severe and persistent blurred vision.
Inflammation of a tendon or tendinitis (connective tissue connecting muscles to bones).

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

Difficulty breathing, chest pain, fainting, rapid heartbeat,
bluish discoloration of the skin, or sudden pain in the arm, leg or foot
(symptoms of possible blood clot formation).
Tendon rupture (connective tissue connecting 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 Gosuran:

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 lips, eyes or mouth, skin peeling, fever (signs of skin disorders).

Some side effects are very common (may affect more than 10 in 100 people):
Hot flushes;
Increased cholesterol levels (hypercholesterolaemia);
Fatigue;
Increased sweating;
Bone and joint pain (arthralgia).
If any of these effects become severe, inform your doctor immediately.

Some side effects are 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, diarrhoea;
Increased or decreased appetite;
Muscle pain;
Bone fragility or loss of bone mass (osteoporosis), which in some cases leads to bone fractures
(see also “Monitoring during treatment with Gosuran” in section 3);
Swelling of arms, hands, feet and ankles (oedema);
Depression;
Weight gain;
Hair loss;
Increased blood pressure (hypertension);
Abdominal pain;
Dry skin;
Vaginal bleeding;
Palpitations, rapid heartbeat (tachycardia);
Joint stiffness (arthritis);
Chest pain.
If any of these effects become severe, inform your doctor immediately.

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);
Reduced 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;
Inflammation of a tendon or tendinitis (connective tissues connecting muscles to bones);
Yellowing of the skin and eyes;
Elevated blood levels of bilirubin (a breakdown product of red blood cells).

Side effects with unknown frequency (frequency cannot be estimated from the available data):
Trigger finger, a condition in which one of the fingers of the hand remains locked in a bent position.
If any of these effects become severe, inform your doctor immediately.

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
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 Gosuran

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack
after Exp. The expiry date refers to the last day of the month.
Do not use a damaged package or one showing signs of tampering.
Store 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 Gosuran contains
The active substance is letrozole. Each film-coated 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 (E464)].
Description of the appearance of Gosuran and package contents
Gosuran is in the form of yellow, round, biconvex film-coated tablets.
Gosuran is available in a pack containing 30 film-coated tablets in PVC/PE/PVDC/aluminum blisters.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Genetic S.p.A. Via Della Monica n. 26 - 84083 Castel San Giorgio (SA), Italy
Manufacturer
Genetic S.p.A. Contrada Canfora - 84084 Fisciano (SA), Italy