Tamoxifen Teva 20 mg, tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tamoxifeno Teva 20 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because 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 medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Tamoxifeno Teva is and what it is used for

Tamoxifeno Teva belongs to a group of medicines called anti-oestrogens.

Tamoxifeno Teva is indicated in certain breast conditions.

2. What you need to know before taking Tamoxifeno Teva

Do not take Tamoxifeno Teva

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant or breastfeeding (see Pregnancy and breastfeeding).
• if you have previously had blood clots and your doctor does not know the cause.
• if someone in your family has had blood clots with an unknown cause.
• if your doctor has told you that you have a hereditary condition that increases the risk of blood clots.
• if you are pregnant (see section "Pregnancy, breastfeeding and fertility" below).

Do not take Tamoxifeno Teva if any of the above apply to you. If you are unsure, speak with your doctor or pharmacist before taking Tamoxifeno Teva.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Tamoxifeno Teva 20 mg.

• Discuss with your doctor which contraceptive methods you should use, as some may be affected by this medicine.
• It is important that you immediately inform your doctor if you experience any unusual vaginal bleeding or other gynecological symptoms (such as pelvic pain or pressure) during or at any time after treatment with tamoxifen. This is because certain changes may occur in the lining of the uterus (endometrium), some of which may be serious.
• You may experience suppression of menstruation during treatment with tamoxifen.
• Concomitant use with the following medicines should be avoided, as a reduction in the effects of tamoxifen cannot be ruled out: paroxetine, fluoxetine (e.g., antidepressants), bupropion (antidepressant or used to quit smoking), quinidine (used to treat cardiac arrhythmia), and cinacalcet (for treatment of parathyroid gland disorders).
• If you are admitted to hospital, inform healthcare staff that you are taking tamoxifen.
• If you are going to have surgery (including planned surgery), tell your doctor or pharmacist. They may advise you to stop taking tamoxifen for a short period.
• In delayed breast reconstruction surgery (weeks or years after initial 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 could lead to complications.
• This medicine contains tamoxifen, which may produce a positive result in doping control tests.
• If you have a history of hereditary angioedema, as tamoxifen may trigger or worsen symptoms of hereditary angioedema. If you experience symptoms such as swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing, contact a doctor immediately.

Take special care with tamoxifen:

Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with tamoxifen treatment. If you notice any symptoms related to these serious skin reactions described in section 4, stop taking Tamoxifeno Teva and seek medical attention immediately.

Children and adolescents

Tamoxifeno Teva must not be given to children or adolescents, as its safety and efficacy have not been established in this age group.

Taking Tamoxifeno Teva with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, you must inform your doctor if you are taking:

• anticoagulants such as warfarin (to prevent blood clots).
• rifampicin (for the treatment of tuberculosis).
• aromatase inhibitors such as anastrozole, letrozole, or exemestane (used to treat breast cancer).
• paroxetine, fluoxetine (antidepressants)
• bupropion (antidepressant or used to quit smoking)
• quinidine (used in the treatment of cardiac arrhythmia)
• cinacalcet (for the treatment of parathyroid gland disorders)

Pregnancy, breastfeeding and fertility

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

You must not be pregnant during treatment with Tamoxifeno Teva or during the two months following discontinuation of treatment.

Do not take Tamoxifeno Teva if you are breastfeeding.

Driving and use of machines

Tamoxifen is unlikely to affect your ability to drive or operate machinery. However, fatigue and visual disturbances have been reported with tamoxifen use; therefore, caution should be exercised when driving or operating machinery while these symptoms persist.

Tamoxifeno Teva contains sodium

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

3. How to take Tamoxifeno Teva

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

• The recommended dose is 1 tablet (20 mg) to 2 tablets (40 mg) daily.
• Usually, Tamoxifeno Teva 20 mg is taken once or twice a day.
• Swallow the tablets whole with water.
• Try to take the tablet at the same time every day.
• Do not stop taking your tablets even if you feel well, unless your doctor tells you to do so.

If you take more Tamoxifeno Teva than you should

If you have taken more Tamoxifeno Teva than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Tamoxifeno Teva

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 stop taking Tamoxifeno Teva

Your doctor will tell you how long you should take Tamoxifeno Teva. Do not stop treatment before your doctor tells you to do so.

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

4. Possible adverse effects

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

Stop taking Tamoxifeno Teva and seek immediate medical attention if you notice any of the following symptoms:

• Symptoms of a blood clot. These include swelling of the calf or leg, chest pain, shortness of breath, or sudden weakness.
• Sudden onset of weakness or paralysis in the arms or legs, sudden difficulty speaking or walking, difficulty holding objects, or difficulty thinking, any of which may occur due to reduced blood supply in the blood vessels of the brain. These symptoms could be signs of a stroke.
• Difficulty breathing.
• Swelling of the face, lips, tongue, or throat, difficulty swallowing or breathing (angioedema). Tamoxifeno may cause or worsen symptoms of hereditary angioedema.
• Swelling of the hands, feet, or ankles.
• Rash (also called 'hives' or 'urticaria').
• Flat, red, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, or ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms [Stevens-Johnson syndrome, toxic epidermal necrolysis] – these adverse effects occur rarely.

You should also contact your doctor immediately if you experience any of the following adverse effects:

• Unusual vaginal bleeding.
• Irregular periods.
• A feeling of discomfort in the lower abdomen (pelvis), such as pain or pressure.

These adverse effects may indicate changes in the lining of the uterus (the endometrium). Sometimes these adverse effects are serious and may include cancer. They may occur during or after treatment with tamoxifeno.

Other possible adverse effects:

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

• Vaginal bleeding, vaginal discharge
• Nausea
• Fatigue
• Skin rash
• Hot flushes
• Fluid retention

Common adverse effects (may affect up to 1 in 10 people):

• Blockage in blood vessels (such as deep vein thrombosis, microvascular thrombosis, and pulmonary embolism)
• Itching around the vagina
• Menstrual irregularities
• Changes in the endometrium
• Polyps in the endometrium
• Gastrointestinal discomfort
• Vomiting
• Diarrhea
• Constipation
• Hair loss
• Headache, dizziness
• Taste disturbance (dysgeusia)
• Tingling sensation (paraesthesia)
• Strokes
• Anaemia
• Cataracts, retinal disorders
• Increased levels of fats in the blood
• Uterine fibroids
• Hypersensitivity reactions (allergy), including angioedema (rapid swelling of the face, lips, tongue, and/or throat)
• Changes in liver enzymes
• Fat accumulation in the liver
• Leg cramps
• Muscle pain

Uncommon adverse effects (may affect up to 1 in 100 people):

• Tumour in the endometrium (inside the womb)
• Decreased platelet count
• Decreased white blood cell count (leucopenia)
• Cirrhosis
• Increased calcium levels in blood
• Visual disturbances
• Interstitial pneumonia
• Inflammation of the pancreas (pancreatitis)

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

• Tumour in the uterus
• Tumour flare
• Disorders in the inner tissue of the womb
• Ovarian cysts
• Vaginal polyps
• Blockage of bile flow
• Hepatitis
• Liver failure
• Hepatocellular injury
• Liver necrosis
• Corneal disorders
• Optic nerve disorders, optic neuritis, and in a small number of cases, loss of vision (caused by optic nerve disorders and inflammation)
• Severe skin reactions, with lesions, ulcers, or blisters
• Cutaneous vasculitis
• Decreased neutrophil count (neutropenia and agranulocytosis)

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

• Cutaneous lupus erythematosus (skin inflammation characterized by a rash or redness, mainly in areas exposed to light)
• Porphyria cutanea tarda (blisters in light-exposed areas due to increased production of a special group of cellular pigments (porphyrins) in the liver)

Frequency not known (cannot be estimated from available data):

• Radiation reaction (skin) (skin rash accompanied by redness, swelling, and/or blisters after receiving radiation treatment)

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamoxifen Teva

Keep this medicine out of sight and reach of children.

Store in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tamoxifeno Teva 20 mg tablets EFG

• The active substance is tamoxifeno. Each tablet contains 20 mg of tamoxifeno (as citrate).
• The other components (excipients) are: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium carboxymethyl starch (type A) from potato, povidone, magnesium stearate, colloidal silicon dioxide.

Appearance of the medicine and contents of the pack

This medicine is presented as white or almost white, round, biconvex tablets, marked with “TN20” and with a score line on one side, smooth on the other.

Each pack contains 30 or 60 tablets.

Marketing Authorisation Holder and Manufacturer

Holder

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1ª planta,

Alcobendas, 28108 Madrid (Spain)

Manufacturer

MERCKLE GMBH Ludwig-Merckle-Strasse, 3 (Blaubeuren) - D-89143 - Germany

Haupt Pharma Münster GmbH, Schleebrüggenkamp 15, 48159 Münster, Germany

Date of the most recent revision of this leaflet: February 2026

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