TAMOXIFENE TILLOMED 20 mg TABLETS

Introduction

Patient Information Leaflet

Tamoxifen Tillomed 20 mg Tablets EFG

tamoxifen citrate

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

1. What is Tamoxifen Tillomed and what is it used for
2. What you need to know before taking Tamoxifen Tillomed
3. How to take Tamoxifen Tillomed
4. Possible side effects
5. Storage of Tamoxifen Tillomed
6. Package contents and additional information

1. What is Tamoxifen Tillomed and what is it used for

Tamoxifen belongs to the group of medications known as "anti-estrogens".

Estrogens are natural substances found in the body, also known as "sex hormones". Tamoxifen works by blocking the effects of estrogens in the body.

Tamoxifen is indicated:

• For adjuvant therapy after initial treatment of breast cancer and treatment of secondary tumors (metastases) of a breast cancer.
• In adult men for the prevention of breast enlargement (gynecomastia) and breast pain (mastalgia) caused by medications called anti-androgens used in the treatment of prostate cancer (prostatic carcinoma).

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Tamoxifen Tillomed

Do not taketamoxifen

• if you are allergic to tamoxifen citrate or any of the other components of this medication (listed in section 6).
• If you are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take tamoxifen.

Special care is required:

• if you have a significantly low platelet count (thrombocytopenia) or white blood cell count (leukopenia) or high calcium levels in the blood (hypercalcemia). In these circumstances, your doctor will ask you to have regular blood tests.
• If you have ever had a lack of blood flow to the brain (stroke), similar events to stroke, conditions resulting from the formation and release of blood clots (thromboembolism) or uterine cancer, as these conditions may occur again during treatment with tamoxifen.
• If you have a particular type of breast cancer (ductal carcinoma in situ), specifically if you are receiving simultaneous treatment to thin the blood or if you have had a blood clot in a blood vessel (deep vein thrombosis or pulmonary embolism) in the past, the decision to start therapy with tamoxifen should be discussed with your doctor to assess the risks and potential benefits.
• If you have high levels of certain lipids in the blood (triglycerides) during treatment with tamoxifen. This medication can cause an alteration in blood lipid metabolism (hypertriglyceridemia).
• If you have postmenopausal bleeding or irregular bleeding before menopause. The cause of such bleeding should be clarified immediately with a gynecologist. Additionally, you should discuss the need for an annual gynecological examination with your doctor to determine changes in the endometrium or other investigations.
• If you experience visual disturbances during treatment with tamoxifen. In this case, you should be urgently examined by an ophthalmologist, as some changes, when recognized in the early stages, are reversible after discontinuation of treatment with tamoxifen. In general, an ophthalmological examination should be performed before starting therapy with tamoxifen.
• In delayed breast reconstruction surgery (weeks or years after primary breast surgery, when your own tissue is moved to shape a new breast), tamoxifen may increase the risk of blood clot formation in the small vessels of the tissue graft, which can lead to complications.

In case of hospitalization, inform the healthcare staff that you are taking tamoxifen:

Surgery and immobility

If you are going to undergo surgery or will be unable to move for a long time, you should take the following precautions:

• If you are taking tamoxifen for breast cancer or for the prevention of gynecomastia: your doctor should decide whether it is best for you to continue taking tamoxifen. You may need to wear special compression stockings while hospitalized or be given an anticoagulant. These reduce the risk of a blood clot.

During administration of tamoxifen, your doctor will need to periodically monitor your blood profile, calcium levels in the blood, and liver function. You should also have your triglyceride levels in the blood checked.

Use in athletes:

This medication contains tamoxifen, which can produce a positive result in doping tests.

Children and adolescents

Tamoxifen should not be administered to children/adolescents, as its safety and efficacy in this age group have not been established.

Other medications and Tamoxifen

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those obtained without a prescription.

In particular, you should inform your doctor if you are taking any of the following medications:

• Paroxetine, fluoxetine (antidepressants).
• Bupropion (antidepressant or used to quit smoking).
• Quinidine (used in the treatment of cardiac arrhythmia).
• Cinacalcet (for the treatment of parathyroid disorders)
• Cytotoxic medications (used to treat cancer) as they may increase the formation of blood clots.

Your doctor should perform frequent blood tests if you are taking medications to thin the blood, called anticoagulants of the dicumarin type (e.g., warfarin). In fact, tamoxifen can significantly potentiate the effect of these medications.

The use of tamoxifen in combination with another medication for the treatment of breast cancer (aromatase inhibitor) as adjuvant therapy has not shown greater efficacy compared to tamoxifen alone.

In some studies, a decrease in the efficacy of tamoxifen has been registered when administered concomitantly with certain antidepressant ISRS (e.g., paroxetine).

The effect of the following medications or groups of preparations may be influenced by concomitant therapy with tamoxifen.

Potentiates the effect up to a greater risk of side effects:

• Anticoagulant medications. Do not combine tamoxifen with these medications unless your doctor has given you specific instructions. Due to the increased tendency to bleed, laboratory appointments should be followed with great care.
• Simultaneous chemotherapy. There is some evidence that tamoxifen may increase the formation of blood clots (thromboembolic events, including deep vein thrombosis and pulmonary embolism). This incidence increases with simultaneous chemotherapy.

Decreases the effect of:

• Hormonal preparations, specifically estrogen compounds (such as "the pill"): a mutual decrease in effects is possible. Therefore, these medications should not be taken during treatment with tamoxifen.

Pregnancy andbreastfeeding

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Due to the lack of sufficient experience with the use of tamoxifen during pregnancy, you should not take tamoxifen during pregnancy. Pregnancy should be ruled out before starting treatment. Women of childbearing age should use an effective non-hormonal contraceptive method (such as barrier or non-hormonal contraceptive methods) until two months after discontinuing treatment, as there may be risks to the child. (See also "Other medications and tamoxifen").

In premenopausal women, tamoxifen may suppress menstrual bleeding (see section 4 "Possible side effects"). Therefore, your doctor should perform tests to exclude the possibility of pregnancy before starting treatment.

Breastfeeding

Tamoxifen inhibits lactation in humans at high doses, and milk production does not resume even after treatment is discontinued. It is unknown whether tamoxifen is excreted in human breast milk. Therefore, you should not take tamoxifen during breastfeeding. If treatment is justified, your doctor will assess the risk-benefit before administering this medication to you.

Driving and using machines

It is unlikely that this medication will affect your ability to drive vehicles or operate hazardous machinery. However, fatigue, drowsiness, and visual disturbances have been reported with the use of tamoxifen, and you should exercise caution when driving or using machines while such symptoms persist.

Tamoxifen Tillomed contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Tamoxifen Tillomed contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Tamoxifen Tillomed

Follow the instructions for administration of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Oral use only. Swallow the tablet whole, without chewing, with sufficient liquid (such as a glass of water), preferably with a meal.

The recommended dose for the treatment of breast cancer is 20 to 40 mg per day. It is usually taken once or twice a day. In general, a dose of 20 mg is sufficiently effective.

The recommended dose for the prevention of breast enlargement and pain caused by anti-androgen medications used in the treatment of advanced prostate cancer is 20 mg once a day.

Treatment with tamoxifen is generally long-term. Your doctor will indicate the duration of treatment. In adjuvant therapy for early breast cancer, the duration of treatment is usually 5 years.

If you take more Tamoxifen than you should

If you ingest a dose higher than normal, contact your doctor or the nearest hospital.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Tamoxifen

If you forget a dose, take it as soon as you remember.

Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Tamoxifen

Do not interrupt administration of tamoxifen without consulting your doctor first, as the success of your treatment may be at risk.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

There is extensive experience with the use of tamoxifen in women. Although in men it is more restricted, the overall profile of adverse effects appears similar, with the exception of those effects limited to the female sex.

If you suffer from any of the following symptoms, discontinue treatment and inform your doctor immediately:

• Difficulty breathing.
• Swelling of the face, lips, tongue, and/or throat that may make swallowing difficult.
• Swelling of the hands, feet, or ankles,
• Hives (rash).

Inform your doctor immediately if you experience any of the following symptoms:

• Numbness or weakness of the face or arms or legs and speech or vision disturbances, any of which may occur due to reduced blood supply in the blood vessels of the brain (stroke).
• Chest pain or difficulty breathing (dyspnea) that could be symptoms of a blood clot in the pulmonary artery (pulmonary embolism)
• Stomach pain or abnormal vaginal bleeding that could indicate possible uterine cancer.
• Cough and shortness of breath that could be symptoms of lung inflammation (interstitial pneumonia) characterized by fever, cough, shortness of breath, and increased white blood cells, a type of blood cell, (neutrophilia).

If you are administered tamoxifen, the adverse effects you may experience are included below:

Very Common (may affect more than 1 in 10 patients):

• Nausea,
• skin rash,
• fluid retention in tissues,
• hot flashes,
• fatigue (fatigue),
• vaginal discharge,
• alterations in the menstrual cycle up to complete suppression before menopause,
• vaginal bleeding.

Common Adverse Effects (may affect up to 1 in 10 patients):

• reduction of red blood cells (temporary anemia),
• headache, dizziness, drowsiness,
• sensory disturbances (including taste disturbances and deafness or tingling),
• visual disturbances due to opacity of the lens of the eye that serves to focus images (cataracts) and/or retinal disease, the innermost membrane of the eye (retinopathies). The risk of cataracts increases with the duration of treatment with tamoxifen,
• vomiting, diarrhea, constipation,
• hair loss (alopecia),
• lung inflammation - pneumonia (interstitial pneumonitis),
• hypersensitivity reactions (allergy),
• increased levels of fat in the blood (triglycerides in blood),
• circulatory disturbances of the blood vessels of the brain (cerebrovascular accidents),
• leg cramps,
• muscle pain (myalgias),
• obstruction in blood vessels (such as deep vein thrombosis and pulmonary embolism, vascular obstructions that can lead to ischemia),
• increased frequency of thrombosis and embolism with simultaneous chemotherapy,
• change in liver enzymes, development of hepatic steatosis*,
• itching around the vagina (vulvar pruritus),
• benign uterine tumors (uterine fibroids),
• tumors and polyps (hyperplasia and polyps) in the endometrium, inside the uterus.

Uncommon Adverse Effects (may affect up to 1 in 100 patients):

• decrease in the number of white blood cells (leukopenia) and temporary decrease in the number of platelets (thrombocytopenia),
• visual disturbance,
• inflammation of the pancreas (pancreatitis),
• elevation of calcium in the blood in patients with bone metastasis, especially when starting treatment,
• decrease in blood flow to the brain leading to cell death (stroke),
• severe chronic liver disease (liver cirrhosis)*,
• malignant tumors in the endometrium,
• severe allergic reactions with the formation of boils and pimples (Stevens-Johnson syndrome),
• allergic reactions characterized by skin lesions (erythema multiforme),
• immune system disease characterized by the formation of blisters on the skin (pemphigoid blisters).

Rare Adverse Effects (may affect up to 1 in 1,000 patients)

• absence of a specific type of white blood cell (agranulocytosis), a reduction in the number of white blood cells (neutropenia),
• damage to the optic nerve, the nerve that transmits images from the eye to the brain (optic neuropathy), (loss of vision in a reduced number of cases),
• changes in the transparent layer that covers the eye (corneal opacity),
• inflammation of the optic nerve, the nerve that transmits images from the eye to the brain (optic neuritis),
• inflammation of the blood vessels of the skin that can cause rashes (cutaneous vasculitis),
• hypersensitivity reactions (allergy) with inflammation of the face, lips, and throat (angioedema),
• at the beginning of treatment, bone pain and pain in the area of the diseased tissue,
• decrease in bile flow (cholestasis), liver inflammation (hepatitis), jaundice, destruction of liver cells (liver necrosis), liver cell damage, liver failure*,
• inflammation of ovarian cysts,
• endometriosis (abnormal location of the membrane that lines the uterus),
• malignant tumors in the uterus (uterine sarcoma),
• worsening of a tumor (cancer recurrence),
• benign growths of tissue in the vagina (vaginal polyps).

Very Rare Adverse Effects (may affect up to 1 in 10,000 patients):

• severe alterations in the blood test (neutropenia, pancytopenia),
• abnormally high levels of certain lipids in the blood (hypertriglyceridemia), sometimes with pancreatitis,
• metabolic disorder with increased production of certain cellular pigments (called porphyrins) in the liver, associated with blisters in areas of the skin exposed to light (porphyria cutanea tarda),
• skin inflammation characterized by a rash or redness, especially in areas of the skin exposed to sunlight (lupus erythematosus),
• skin rash along with redness, swelling, and/or blisters on the skin after receiving radiation therapy (called radiation skin reaction).

*Certain cases of severe liver failure can be fatal.

Other reported adverse effects include dizziness, depression, confusion, and fatigue.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Tamoxifeno Tillomed

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or into the trash. Deposit the containers and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Tamoxifeno Tillomed

• The active ingredient is tamoxifen. Each tablet contains 20 mg of tamoxifen (as citrate).
• The other components are lactose monohydrate, microcrystalline cellulose, povidone K-30, sodium croscarmellose, and magnesium stearate.

Appearance of the Product and Package Contents

Tamoxifeno Creativa Pharma Solutions 20 mg are white, round, convex tablets with a diameter of 9.5 mm, with the inscription “T20” on one face and are packaged in Alu-Alu blisters containing 20, 30, 60, and 100 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Laboratorios Tillomed Spain, S.L.U

C/ Cardenal Marcelo Spínola 8, 1st floor, door F

28041 Madrid

Spain

Manufacturer

MIAS Pharma Limited

Suite 2, Stafford House,

Strand Road, Portmarnock, Co. Dublin,

Ireland.

Tillomed Pharma GmbH

Mittelstraße 5/5a

12529 Schönefeld

Germany

Emcure Pharma UK Ltd

Basepoint Business Centre,

110 Butterfield, Great Marlings,

Luton, LU2 8DL

United Kingdom

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany Tamoxifen Tillomed 20 mg Tabletten

Italy Tamed 20 mg compresse

France Tamoxifene Tillomed 20 mg comprimé

Spain Tamoxifeno Tillomed 20 mg comprimidos EFG

Romania Tamoxifen Tillomed 20 mg comprimate

Date of the last revision of this prospectus:August 2019.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)>