KESSAR 20 mg Tablets

Зміст інструкції

1. Kessar 20 mg tablets
   1. What is Kessar and what is it used for
   2. What you need to know before taking Kessar
   3. How to take Kessar
   4. Possible side effects
   5. How to store Kessar
   6. Contents of the pack and other information

Kessar 20 mg tablets

tamoxifene

Read this leaflet carefully before 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Kessar and what is it used for

Kessar contains the active substance tamoxifene, belongs to the class of medicines called
“non-steroidal antiestrogens” and works by blocking the activity of a hormone called
estrogen. In some types of breast cancer, estrogens can help the growth of
cancer cells. By blocking the activity of estrogens, Kessar blocks or slows the growth of
cancer cells.
Kessar is used in the treatment of breast cancer (mammary carcinoma).
It has been observed that tamoxifene also shows estrogenic effects on the bones,
the endometrium, and on blood lipids.
If you have had recent laboratory tests showing that the cancer cells are not
sensitive to estrogens, it is likely that you will respond less to therapy with Kessar.

2. What you need to know before taking Kessar

Do not take Kessar:

• if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6)
• if you are undergoing preventative therapy with a high risk of breast cancer
• if you have cancer localized within an area of the breast, without invasion of other areas (ductal carcinoma in situ) and are simultaneously taking therapy

with medicines that thin the blood (anticoagulants) or have a history of blockage in a
deep vein (deep vein thrombosis) or in a pulmonary artery (pulmonary
embolism)

• if you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”)
• if you are a child.

Warnings and precautions
Talk to your doctor or pharmacist before taking Kessar:

• if you are taking other medicines, especially those that thin the blood (anticoagulants such as warfarin)
• if you are using a contraceptive method, as tamoxifen can affect the effectiveness of some contraceptives and women taking tamoxifen should avoid pregnancy
• if you have a low number of certain blood cells (leukopenia or thrombocytopenia) your doctor will have you undergo periodic checks (complete blood count, blood smear and platelet count)
• if you are taking any of the following medicines, as they may reduce the effect of tamoxifen:
• paroxetine, fluoxetine (antidepressants)
• bupropion (antidepressant to help you quit smoking)
• quinidine (used in the treatment of heart rhythm abnormalities)
• cincalet/cinacalcet (for the treatment of disorders of a gland called the parathyroid)
• if you have a history of hereditary angioedema as Kessar may cause or worsen the symptoms of hereditary angioedema. If you experience symptoms such as swelling of the face, lips, tongue and/or throat with difficulty swallowing or breathing, seek immediate medical attention.

It is important, during therapy with tamoxifen, to undergo periodic checks of the
genital organs and immediately report to your doctor if you have or have had unusual vaginal bleeding both
during treatment with tamoxifen, and at any time after its discontinuation. This
is because changes can occur at the level of the uterus (endometrium), some of which
may also be serious and could include cancer.
If you are being treated with tamoxifen, you should immediately inform your doctor if you experience any of the
following symptoms:

• numbness of the face or weakness of the arms or legs and speech or vision problems as these may indicate damage to the blood vessels in the brain (stroke)
• chest pain or difficulty breathing (dyspnea) which may be symptoms of a blockage in the pulmonary arteries (pulmonary embolism)
• abdominal pain or abnormal vaginal bleeding which may indicate a possible cancer of the uterus
• cough and difficulty breathing (dyspnea) which may be symptoms of pneumonia (interstitial pneumonia). You should inform your doctor if you have a history of lesions in the blood vessels of the brain (stroke), similar events (to stroke), deep vein obstruction with or without obstruction of a pulmonary artery (thromboembolic diseases) or cancer of the uterus.

If you have cancer localized within an area of the breast, without invasion of other
areas (ductal carcinoma in situ) discuss with your doctor the decision to start therapy with
tamoxifen, evaluating together the potential risks and benefits.
In the event of hospitalization, inform the medical staff that you are being treated with
Kessar.
In breast reconstruction surgery (weeks or years after breast surgery for
tumor removal) Kessar may increase the risk of blood clot formation in the
small vessels of the tissue flap used to shape the new breast, which can lead to
complications.
Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with Kessar treatment.
Stop treatment with Kessar and consult your doctor immediately if you notice any of the
symptoms related to these severe skin reactions described in section 4.

Treatment with Kessar must not be interrupted unless requested by your
doctor.
If the tumor has spread to the bones (bone metastases), the doctor will have you undergo blood tests in the first few weeks of therapy
to closely monitor calcium levels in the
blood as they may increase (hypercalcemia).
Taking Kessar at the recommended dose can cause heart problems, especially in
people who already have heart problems or are at risk of heart rhythm disturbances
(prolongation of the QT interval). If you have heart problems or risk factors, your doctor may
advise you to have regular check-ups with an electrocardiogram (ECG) and to monitor levels of
certain salts in the blood (electrolytes).
Kessar is not indicated in healthy women and in conditions of benign breast disease.

Children
Kessar is contraindicated in children.

Other medicines and Kessar
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
The effects of Kessar may be affected by or affect the following medicines:

• coumarin-type anticoagulants (to thin the blood) as tamoxifen can significantly increase the blood-thinning (anticoagulant) activity; in this case, your doctor will subject you to frequent blood tests
• cytotoxic medicines (used in chemotherapy) as concomitant use of tamoxifen may increase the risk of increased blood clotting (thromboembolic events)
• medicines that decrease calcium elimination from the kidneys (thiazide diuretics) because they can increase calcium concentration in the blood (hypercalcemia)
• mitomycin (antibiotic) because in association with tamoxifen it can increase the risk of blood problems (hemolytic uremic syndrome, anemia and thrombocytopenia)
• medicines that inhibit certain enzymes (CYP3A4) because tamoxifen is metabolized by these enzymes
• paroxetine, fluoxetine (antidepressants)
• bupropion (antidepressant or to help you quit smoking)
• quinidine (used in the treatment of heart rhythm abnormalities)
• cinacalcet (for the treatment of disorders of a gland called the parathyroid)

The use of tamoxifen in association with another medicine for the treatment of breast
cancer (aromatase inhibitor) as adjuvant therapy has not shown better efficacy
than tamoxifen alone.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Kessar should not be administered during pregnancy (see “What you need to know before
taking Kessar”).
Do not take Kessar if you are pregnant (see section 2. Do not take Kessar); avoid
pregnancy for the nine months following discontinuation of therapy and if sexually active, use
barrier contraceptives (e.g. condom or diaphragm) or other non-hormonal contraceptive methods
during treatment with Kessar and for nine months after discontinuation of therapy, as
there may be risks to the baby.
If you are premenopausal, before starting treatment, your doctor will perform careful checks to
rule out a current pregnancy.

Breastfeeding
The use of Kessar during breastfeeding is not recommended, as it is not known whether it passes into
breast milk. Your doctor will assess whether to discontinue breastfeeding or Kessar therapy.

Driving and operating machinery
Do not drive or operate machinery if you notice that your abilities are impaired. Kessar may cause
fatigue.

Kessar contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

Other ingredients
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
“sodium-free”.

For athletes
The use of the drug without therapeutic necessity constitutes doping and may still
result in positive doping tests.

3. How to take Kessar

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended daily dose is normally 20 mg of tamoxifen, administered in two
separate doses per day or in a single daily dose (up to 40 mg
of tamoxifen per day may be administered).

Use in children
Kessar is contraindicated in children.

If you take more Kessar than you should
In case of accidental ingestion/intake of an excessive dose of Kessar, inform
your doctor immediately or go to the nearest hospital.

If you forget to take Kessar
Do not take a double dose to make up for the missed tablet.
If you forget to take a dose, you should take it
as soon as possible.

If you stop taking Kessar
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
Treatment with tamoxifen should not be interrupted, even if your health improves, unless
requested by your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop treatment with Kessar and consult your doctor immediatelyif you experience any of the following symptoms:

• difficulty breathing;
• swelling of the face, lips, tongue and/or throat which may cause difficulty swallowing;
• swelling of the hands, feet or ankles;
• hives
• reddish, non-raised spots on the trunk in a target or circular shape, often with central blisters, skin peeling, mouth, throat, nose, genitals and eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [Stevens-Johnson syndrome, toxic epidermal necrolysis] - these side effects occur rarely
• swelling of the face, lips, tongue or throat, difficulty swallowing or breathing (angioedema). Kessar may cause or worsen the symptoms of hereditary angioedema

Inform your doctor immediatelyif you experience any of the following symptoms:

• numbness of the face or weakness of the arms or legs and changes in speech or vision that may indicate a lack of blood supply to the brain (stroke)
• chest pain or shortness of breath (dyspnea) which may be symptoms of a blood clot in the pulmonary artery (pulmonary embolism)
• abdominal pain or abnormal vaginal bleeding which may indicate a possible tumor of the uterus
• cough and shortness of breath which may be symptoms of inflammation of the lungs (interstitial pneumonia) characterized by fever, cough, shortness of breath, increased white blood cells, a type of blood cell (neutrophilia).

During treatment with tamoxifen, as with any other medicine, side effects may occur, with the following frequency:

Very common (may affect more than 1 in 10 people)

• nausea
• fluid retention causing swelling
• vaginal bleeding
• vaginal discharge
• skin rash
• hot flushes
• fatigue

Common (may affect up to 1 in 10 people)

• decreased number of red blood cells in the blood (anemia)
• opacification of the crystalline lens, the lens of the eye used to focus images (cataract)
• disease of the retina, the innermost membrane of the eye (retinopathy)
• allergic reactions
• elevated levels of fats in the blood (triglycerides)
• leg cramps
• muscle pain (myalgia)
• benign growths in the uterus (uterine fibroids)
• sudden onset of weakness, paralysis of the arms or legs
• sudden difficulty speaking, walking, difficulty holding things or difficulty thinking, which may be due to reduced blood flow to the brain (e.g. stroke)
• headache
• dizziness
• sensory disturbances (including numbness and altered taste)
• itching of the external genitals
• changes in the endometrium, the lining of the uterus (including hyperplasia and polyps)
• hair loss (alopecia)
• vomiting
• diarrhea
• constipation
• changes in liver enzyme levels
• fatty liver (steatosis)
• formation and detachment of blood clots in blood vessels (including deep vein thrombosis, microvascular thrombosis and pulmonary embolism).

Uncommon (may affect up to 1 in 100 people)

• decreased number of platelets (thrombocytopenia)
• decreased number of white blood cells (leukopenia)
• visual disturbances
• inflammation of the pancreas, a gland of the body (pancreatitis)
• increased calcium in the blood (hypercalcemia), in patients with tumors spread to the bones
• cancer of the endometrium, the lining of the uterus (endometrial cancer)
• inflammation of the lungs (interstitial pneumonia) characterized by fever
• cough, shortness of breath, increased white blood cells
• severe liver disease (cirrhosis).

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

• decreased number of a type of white blood cells (neutropenia)
• severe decrease in the number of white blood cells (agranulocytosis)
• changes in the transparent membrane covering the eye (cornea)
• disease of the optic nerve, the nerve that transmits images from the eye to the brain (optic neuropathy)
• tumor of the uterus
• growths (polyps) of the vagina
• worsening of a tumor (tumor recurrence)
• endometriosis (when cells that are normally found only in the lining of the uterus are present in other areas of the body, usually in other organs near the uterus)
• swelling of ovarian cysts
• severe inflammation of the optic nerve, the nerve that transmits images from the eye to the brain (optic neuritis)
• inflammation of the liver (hepatitis)
• bile stasis (cholestasis)
• liver abnormalities
• liver damage (hepatocellular)
• death of liver cells (hepatic necrosis)
• allergic reaction characterized by swelling of the face, lips and throat (angioedema)
• inflammation of blood vessels with formation of swellings and spots on the skin (cutaneous vasculitis)
• immune system disease characterized by the formation of swellings under the skin (bullous pemphigoid)
• allergic reaction characterized by spots on the skin (erythema multiforme).

Very rare (may affect up to 1 in 10,000 people)

• immune system disease that affects the skin with the formation of erythema, lesions, hair loss (cutaneous lupus erythematosus)
• disease caused by the accumulation in the blood of certain liver proteins, porphyrins, which leads to the formation of blisters, lesions that turn into crusts and cysts on the skin (cutaneous porphyria tarda).
• rash on the skin characterized by redness, swelling and/or formation of blisters after radiotherapy (radiation recall reaction). At the beginning of treatment, a worsening of the symptoms of the disease such as increased pain and/or size of the affected area may occur. You should see a doctor if you experience excessive nausea, vomiting and thirst. This may indicate changes in the amount of calcium in the blood (hypercalcemia), for this reason the doctor will ask you to undergo some blood tests.

Very rarely, cases of interstitial pneumonia have been reported.
Other effects published in scientific journals are: dizziness, headache, depression, confusion,
easy fatigue and muscle cramps.
From the results of a clinical study conducted on women at high risk for breast cancer,
it emerged that women treated with tamoxifen, compared to those not treated, have an
increased risk of developing the following adverse reactions:

• cancer of the uterus (endometrial adenocarcinoma and uterine sarcoma), sometimes fatal;
• increased solidification (coagulation) of the blood (thromboembolic events including deep vein thrombosis and pulmonary embolism), sometimes fatal;
• lesions of the blood vessels of the brain (cerebral stroke), sometimes fatal;
• opacification of the eye (cataract formation and cataract surgery).

Uterine fibroids, endometriosis and other endometrial alterations including
hyperplasia and polyps have been reported.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through
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 Kessar

Do not store at a temperature above 25 °C.
Store in the original package to protect the medicine from light.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the package after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Kessar contains

• The active ingredient is tamoxifen citrate. One tablet contains 30.4 mg of tamoxifen citrate, equivalent to 20 mg of tamoxifen.
• The other ingredients are: corn starch, lactose monohydrate, polyvinylpyrrolidone, magnesium stearate, sodium carboxymethylamide.

Description of the appearance of Kessar and contents of the pack
Kessar is available in tablet form.
One pack contains 30 tablets of 20 mg.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Orion Corporation
Orionintie, 1 - FI 02200 Espoo (Finland)
Manufacturer
Orion Corporation
Orion Pharma
Orionintie, 1 - FI 02200 Espoo (Finland)
Orion Corporation
Orion Pharma
Joensuunkatu 7 - FI 24100 Salo (Finland)
Distributor
Orion Pharma s.r.l. - Milan