TAMOXIFENE TILLOMED 10 mg TABLETS

2. What you need to know before taking Tamoxifeno Tillomed

Do not taketamoxifeno

• 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 tamoxifeno.

Special care is required:

• if you have a significantly low level of platelets (thrombocytopenia) or white blood cells (leukopenia) or elevated calcium levels in the blood (hypercalcemia). In these circumstances, your doctor will ask you to have periodic 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 tamoxifeno
• 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 tamoxifeno should be discussed with your doctor to evaluate the potential risks and benefits.
• If you have high levels of certain lipids in the blood (triglycerides) during treatment with tamoxifeno. This medication may cause an alteration in the metabolism of lipids in the blood (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 tamoxifeno. In this case, you should be examined urgently by an ophthalmologist, as some changes, when recognized in the early stages, are reversible after discontinuation of treatment with tamoxifeno. In general, an ophthalmological examination should be performed before starting therapy with tamoxifeno.
• In delayed breast reconstruction surgery (weeks or years after primary breast surgery, when your own tissue is moved to shape a new breast), tamoxifeno may increase the risk of blood clot formation in the small blood vessels of the tissue graft, which can lead to complications.

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

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

During administration of tamoxifeno, 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 tamoxifeno, which may produce a positive result in doping tests.

Children and adolescents

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

Other medications and Tamoxifeno

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 to treat cardiac arrhythmia).
• Cinacalcet (for the treatment of parathyroid disorders)
• Cytotoxic medications (used to treat cancer) as they may increase the risk of blood clot formation.

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, tamoxifeno may significantly enhance the effect of these medications.

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

In some studies, a decrease in the efficacy of tamoxifeno has been reported when administered concomitantly with certain antidepressants (e.g., paroxetine).

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

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

• Anticoagulant medications. Do not combine tamoxifeno 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.
• Concomitant chemotherapy. There is some evidence that tamoxifeno may increase the formation of blood clots (thromboembolic events, including deep vein thrombosis and pulmonary embolism). This incidence increases with concomitant chemotherapy.

Decrease 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 tamoxifeno.

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.

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

In premenopausal women, tamoxifeno 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

Tamoxifeno inhibits lactation in humans at high doses, and milk production does not resume even after treatment is discontinued. It is unknown whether tamoxifeno is excreted in human breast milk. Therefore, you should not take tamoxifeno during breastfeeding. If treatment is justified, your doctor will evaluate 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 tamoxifeno, and you should exercise caution when driving or using machines while such symptoms persist.

Tamoxifeno 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.

Tamoxifeno 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 Tamoxifeno 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 tamoxifeno is generally long-term. Your doctor will indicate the duration of treatment. In adjuvant treatment of early breast cancer, the duration of treatment is usually 5 years.

If you take more Tamoxifeno 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, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Tamoxifeno

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 Tamoxifeno

Do not interrupt administration of tamoxifeno 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 seems similar, with the exception of those effects limited to the female sex.

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

• Difficulty breathing.
• Swelling of the face, lips, tongue, and/or throat that can 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 changes in speech or vision, any of which can 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 a 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 an increase in 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,
• vaginal discharge,
• changes 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 (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),
• allergic reactions (allergy),
• increased levels of fat in the blood (triglycerides in the blood),
• circulatory disorders of the blood vessels of the brain (stroke),
• leg cramps,
• muscle pain (myalgia),
• 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 metastases, 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 small 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),
• allergic 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 changes in the blood count (neutropenia, pancytopenia),
• abnormally high levels of certain lipids in the blood (hypertriglyceridemia), sometimes with pancreatitis,
• metabolic disorder with an increase in the 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 the 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 10 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 10 mg are white, round, convex tablets with a diameter of 8.0 mm, with the inscription “T10” on one face and are packaged in Alu-Alu blisters containing 30 and 100 tablets.

Only some package sizes may be commercialized.

Marketing Authorization Holder

Laboratorios Tillomed Spain, S.L.U

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

28016 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

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

Germany Tamoxifen Tillomed 10 mg Tabletten

Italy Tamed 10 mg compresse

France Tamoxifene Tillomed 10 mg comprimé

Spain Tamoxifeno Tillomed 10 mg comprimidos EFG

Romania Tamoxifen Tillomed 10 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)>