Tamoxifen-egis

Leaflet attached to the packaging: information for the user

Tamoxifen-EGIS, 20 mg, tablets

Tamoxifen

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Tamoxifen-EGIS and what is it used for
• 2. Important information before taking Tamoxifen-EGIS
• 3. How to take Tamoxifen-EGIS
• 4. Possible side effects
• 5. How to store Tamoxifen-EGIS
• 6. Contents of the packaging and other information

1. What is Tamoxifen-EGIS and what is it used for

Tamoxifen-EGIS belongs to a group of anti-hormonal medicines, it is a non-steroidal medicine that in some tissues has the same effect as estrogen (female sex hormone), while in other tissues it inhibits the effect of estrogen.
This medicine, due to its complex effect, is intended for the treatment of breast cancer.

2. Important information before taking Tamoxifen-EGIS

When not to take Tamoxifen-EGIS

• If the patient is allergic to tamoxifen or any of the other ingredients of this medicine (listed in section 6);
• If the patient is pregnant.

Do not take Tamoxifen-EGIS if any of the above conditions apply to you. If in doubt, consult your doctor or pharmacist before starting treatment with Tamoxifen-EGIS.

Warnings and precautions

Before starting treatment with Tamoxifen-EGIS, discuss it with your doctor or pharmacist.
Other health problems may affect the possibility of taking this medicine, and therefore, you should inform your doctor:

• if you have liver function disorders,
• if you have had blood clots in the past and the doctor has not determined the cause,

caused by,

• if someone in your family has had blood clots of unknown cause,
• if the doctor has diagnosed a disease in you that is hereditary and increases the risk of blood clots,
• if you have bone metastases, as the treatment may increase the level of calcium in the blood,
• if you have high levels of lipids (cholesterol, triglycerides) in the blood, as the levels of lipids in the blood may increase during treatment,
• if you have thyroid disease, as Tamoxifen-EGIS may affect the results of thyroid function tests,
• if you have hematopoietic disorders (blood system diseases), as during treatment with Tamoxifen-EGIS, the number of blood cells may decrease,
• if you have eye problems (cataracts), as during treatment with Tamoxifen-EGIS, vision disturbances and eye problems have been reported.
• if you have had hereditary angioedema, as Tamoxifen-EGIS may cause or exacerbate symptoms of hereditary angioedema. If symptoms such as facial swelling, lip swelling, tongue swelling, and/or throat swelling and difficulty swallowing or breathing occur, you should contact your doctor immediately.

Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with the use of Tamoxifen-EGIS. If you notice any of the symptoms associated with these severe skin reactions, as described in section 4, you should stop taking Tamoxifen-EGIS and seek medical attention immediately.
You should avoid taking the following medicines at the same time, as they may weaken the effect of tamoxifen: paroxetine, fluoxetine (antidepressants), bupropion (antidepressant and smoking cessation aid), quinidine (used to treat heart rhythm disorders), and cinacalcet (used to treat parathyroid diseases).
In the case of delayed breast reconstruction (weeks or years after the first surgery, when the patient undergoes a tissue flap transplant to restore the shape of the breast), Tamoxifen-EGIS may increase the risk of thrombosis in the small vessels of the transplanted tissue flaps, which can lead to complications.

Surgical procedures

If you are scheduled for surgery (including planned surgery), you should tell your doctor that you are taking this medicine. Your doctor may recommend a temporary break in taking Tamoxifen-EGIS.

Children and adolescents

Tamoxifen-EGIS should not be used in children.

Tamoxifen-EGIS and other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
This is because Tamoxifen-EGIS may affect the action of certain medicines, and some medicines may affect Tamoxifen-EGIS.
In particular, you should tell your doctor about taking medicines such as:

• medicines such as warfarin, which are used to thin the blood. They are known as anticoagulant medicines
• rifampicin, which is used to treat tuberculosis
• medicines such as anastrozole, letrozole, and exemestane, known as aromatase inhibitors, which are used to treat breast cancer
• paroxetine, fluoxetine (antidepressants)
• bupropion (antidepressant and smoking cessation aid)
• quinidine (used to treat heart rhythm disorders)
• cinacalcet (used to treat parathyroid diseases)

Tamoxifen-EGIS with alcohol

It is not recommended to consume alcohol while taking Tamoxifen-EGIS.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Do not take Tamoxifen-EGIS if you are pregnant, as it may affect the unborn child. In women of childbearing age, before starting treatment, pregnancy should be excluded, and during the entire treatment period and for an additional 2 months after its completion, appropriate non-hormonal contraception should be used. If you become pregnant while taking tamoxifen, you should inform your doctor as soon as possible.
It is not known whether Tamoxifen-EGIS is excreted in breast milk, and therefore, it is not recommended to take it during breastfeeding. If treatment is necessary for the mother, breastfeeding should be discontinued.

Driving and using machines

Tamoxifen-EGIS does not affect the ability to drive or operate machines. However, due to reported fatigue after taking tamoxifen, caution should be exercised when driving or operating machines if such symptoms persist.

Tamoxifen-EGIS contains lactose and sodium

Each tablet contains 216.4 mg of lactose.
If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free".

3. How to take Tamoxifen-EGIS

Take this medicine always as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The recommended dose is:
In the treatment of breast cancer, the recommended dose is 20 mg to 40 mg per day, given in divided doses 2 times a day or as 1 dose once a day. The treatment is long-term and may last many years.

Taking a higher dose of Tamoxifen-EGIS than recommended

If you take a higher dose of Tamoxifen-EGIS than recommended, you should immediately consult your doctor.

Missing a dose of Tamoxifen-EGIS

If you miss a dose of Tamoxifen-EGIS, you should take it as soon as you remember. However, if it is almost time for your next dose, you should skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for the missed tablet.

Stopping treatment with Tamoxifen-EGIS

Do not stop taking Tamoxifen-EGIS unless your doctor tells you to, as this may worsen your condition.
If you have any further doubts about taking 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.

Stop taking Tamoxifen-EGIS and seek medical attention immediately if you experience any of the following side effects, as you may need urgent medical attention:

• symptoms of a blood clot. These include swelling of the leg or foot, chest pain, shortness of breath, or sudden weakness,
• symptoms of a stroke. These include sudden weakness of the arms or legs, paralysis of the arms or legs, sudden difficulty speaking, walking, or holding objects, difficulty thinking.
• difficulty breathing,
• swelling of the face, lips, tongue, or throat, which may cause difficulty swallowing,
• swelling of the hands, feet, or ankles,
• hives,
• red, flat, target-like, or circular patches on the torso, often with central blisters, peeling skin, ulcers of the mouth, throat, nose, genitals, and eyes. Such symptoms of severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis) - these side effects are rare.
• swelling of the face, lips, tongue, or throat, difficulty swallowing or breathing (angioedema). Tamoxifen-EGIS may cause or exacerbate symptoms of hereditary angioedema.

Tell your doctor immediately if you experience any of the following conditions:

• unusual vaginal bleeding,
• discharge (unusual vaginal discharge),
• a feeling of discomfort in the lower abdomen, such as tension or pain. These symptoms may indicate changes in the lining of the uterus (endometrium). Sometimes, changes can be severe and may include the development of cancer. Changes can occur during or after treatment with Tamoxifen-EGIS.

The division of other possible side effects of Tamoxifen-EGIS according to their frequency is as follows:
Very common(may occur more often than 1 in 10 people)

• nausea
• fluid retention
• skin rash
• hot flashes
• fatigue
• genital bleeding
• discharge

Common(may occur no more often than 1 in 10 people)

• anemia (a blood problem that means there are too few red blood cells)
• changes in vision due to cataracts or changes in the retina
• increased levels of fats in the blood (detected in blood tests)
• allergic reactions
• leg cramps
• changes in the uterus (changes in the lining of the uterus and benign hyperplasia)
• ischemic cerebral incidents
• headaches
• feeling of emptiness in the head
• itching of the genitals
• hair loss
• vomiting
• diarrhea
• constipation
• changes in liver function test results
• formation of fat cells in the liver
• muscle pain
• changes in sensation (including taste disorders and numbness or tingling of the skin)
• increased risk of thrombosis (blood clots in small vessels)

Uncommon(may occur no more often than 1 in 100 people)

• blood problems; easy bruising, serious infections, feeling extremely tired or short of breath
• vision changes and difficulty seeing
• pancreatitis; may cause moderate to severe abdominal pain
• changes in calcium levels in the blood; symptoms include feeling extremely tired, severe nausea, or thirst. You should tell your doctor about them, as they may order blood tests.
• endometrial cancer
• pulmonary inflammation; symptoms may resemble pneumonia (e.g., shortness of breath and cough).
• liver cirrhosis (liver problems)

Rare(may occur no more often than 1 in 1000 people)

• acute blood problems; easy bruising, tendency to serious infections; feeling tired or short of breath.
• changes in the cornea of the eye
• problems with the nerves connecting the retina to the brain
• swelling of the optic nerve
• occasionally, acute liver diseases have ended in patient death; these liver diseases include hepatitis, cirrhosis, liver cell damage, cholestasis, liver failure. Symptoms may include general malaise with or without jaundice (yellowing of the skin and whites of the eyes).
• vascular damage causing the formation of red or purple spots on the skin
• acute skin diseases; symptoms include redness, blistering, peeling of the skin
• the occurrence of endometrial cells in other parts of the body, ovarian cysts, or tumors (symptoms mentioned earlier)
• non-cancerous thickening of the inner lining of the vagina (called vaginal polyps)
• tumor enlargement
• angioedema

Very rare(may occur no more often than 1 in 10,000 people)

• skin inflammation characterized by a rash or redness, often in areas exposed to light (cutaneous lupus erythematosus).
• skin disorder characterized by peeling of the skin in areas exposed to light, caused by increased production of pigment cells (porphyrins) by the liver.
• recurrence of radiation symptoms - skin inflammation including redness, swelling, and/or blistering of the skin at the site of previous radiation therapy.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Tamoxifen-EGIS

Store in a temperature below 25°C. Store in the original packaging to protect from light.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date (month, year) stated on the carton after the term "Expiry Date (EXP)". The expiry date refers to the last day of the stated month.
Do not use this medicine if you notice visible signs of deterioration (discoloration).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Tamoxifen-EGIS contains

The active substance of the medicine is tamoxifen.
Each tablet contains 20 mg of tamoxifen in the form of tamoxifen citrate.
The other ingredients are: lactose monohydrate (216.4 mg), starch, microcrystalline cellulose, povidone, sodium carboxymethylcellulose (type A), magnesium stearate.

What Tamoxifen-EGIS looks like and what the pack contains

Appearance:
White or off-white, round, flat with beveled edges tablets, odorless or almost odorless, with the inscription "ZT20" on one side and a dividing line on the other side. The breakable surface is white or off-white.
The tablet can be divided into equal doses.
Packaging:
Blisters of aluminum-OPA/Aluminum/PVC in a cardboard box.
30 tablets (3 blisters of 10 tablets)

Marketing authorization holder

Egis Pharmaceuticals PLC
1106 Budapest, Keresztúri út. 30-38
HUNGARY

Manufacturer

Egis Pharmaceuticals PLC
1165 Budapest, Bökényföldi út 118-120.
HUNGARY
To obtain more detailed information, please contact the Representative of the Marketing Authorization Holder.
EGIS Poland Sp. z o.o.
ul. Komitetu Obrony Robotników 45 D
02-146 Warsaw
tel. +48 22 417 92 00

Date of last revision of the leaflet: