Tamoxifen Cinfa 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

tamoxifeno cinfa 20 mg tablets EFG

tamoxifen citrate

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What is tamoxifeno cinfa and what is it used for

tamoxifeno cinfa belongs to a group of medicines called anti-estrogens.

tamoxifeno cinfa is indicated for certain breast conditions.

2. What you need to know before taking tamoxifeno cinfa

Do not take tamoxifeno cinfa

• Tamoxifeno should not be administered to pediatric populations, as its safety and efficacy have not been established in this age group.
• These tablets are intended for your personal use only and should not be given to anyone else.
• If you are allergic to tamoxifeno or to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take tamoxifeno cinfa.

• You must never take any other medicine on your own initiative without your doctor's recommendation, as certain combinations should be avoided.
• Consult your doctor about the contraceptive methods you should use, as some may be affected by this medicine.
• Studies conducted in premenopausal women who took tamoxifeno to reduce the risk of breast cancer or to treat breast cancer have reported decreases in bone density. If you are a premenopausal woman being treated with tamoxifeno cinfa, consult your doctor for advice on maintaining bone health.
• It is important that you inform your doctor immediately if you experience any unusual vaginal bleeding or other gynecological symptoms (such as pelvic pain or pressure) during treatment with tamoxifeno or at any time thereafter. This is because certain changes in the lining of the uterus (endometrium) may occur, some of which may be serious.
• Concomitant administration with the following medicines should be avoided, as a reduction in the effects of tamoxifeno cannot be ruled out: paroxetine, fluoxetine (e.g., antidepressants), bupropion (antidepressant or used to quit smoking), quinidine (used in the treatment of cardiac arrhythmia), and cinacalcet (for the treatment of parathyroid gland disorders).
• Before starting treatment with this medicine, it is important that you inform your doctor if you or any family member has a history of blood clots or a known hereditary condition that increases the risk of developing blood clots.
• If you are admitted to hospital, inform healthcare staff that you are taking tamoxifeno cinfa.
• Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with tamoxifeno treatment. If you notice any of the symptoms related to these serious skin reactions described in section 4, stop using tamoxifeno and seek immediate medical attention.
• If you have heart disease, including heart rhythm problems (arrhythmias), such as a condition called long QT syndrome (prolongation of the QT interval), the risk of heart rhythm problems may increase if you take tamoxifeno cinfa.
• If you have a history of hereditary angioedema, as tamoxifeno may cause 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.

Other medicines and tamoxifeno cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

In particular, you should inform your doctor if you are taking anticoagulants such as warfarin (to prevent blood clots), 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), or medicines known to affect heart rhythm.

Tamoxifeno cinfa must not be used with aromatase inhibitors such as anastrozole, letrozole, or exemestane.

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.

Pregnant women or women who might be pregnant, and breastfeeding mothers, must not use this medicine during the two months following discontinuation of treatment.

Do not take tamoxifeno if you are breastfeeding, unless your doctor has evaluated the risks and benefits involved. It is not known whether tamoxifeno passes into human milk.

Children and adolescents

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

Driving and use of machines

This medicine is unlikely to affect your ability to drive or operate machinery.

tamoxifeno cinfa 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 cinfa

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

Remember to take your medicine.

Recommended dose for adults

• The recommended dose is 20 mg to 40 mg daily.
• Usually, this medicine is taken once or twice a day.

Method of administration

• 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 otherwise.

If you take more tamoxifeno cinfa than you should

If you take more tamoxifeno than you should, contact a doctor or the nearest hospital immediately.

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

If you forget to take tamoxifeno cinfa

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

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

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

If you stop taking tamoxifeno

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

• Vascular disorders: Hot flushes.

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

• Vascular disorders: Sudden onset of weakness or paralysis in arms or legs, sudden difficulty speaking, walking, holding objects, or thinking (any of these may occur due to reduced blood flow to the brain and may be signs of stroke), obstruction in blood vessels.
• Reproductive system and breast disorders: Vaginal bleeding, vaginal discharge, vaginal irritation, endometrial changes (lining of the uterus), menstrual irregularities.
• Gastrointestinal disorders: Gastrointestinal discomfort.
• Skin disorders: Hair loss, rash.
• Nervous system disorders: Headache, dizziness.
• General disorders: Symptoms related to your disease, fluid retention.
• Muscle disorders: Leg cramps.

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

• Eye disorders: Cataracts, changes in the retina.
• Reproductive system and breast disorders: Uterine fibroids, tumour in the endometrium (lining of the uterus).
• General disorders: Hypersensitivity reactions.
• Laboratory test abnormalities: Decreased platelet count, decreased white blood cell count, decreased neutrophil count, anaemia, changes in liver enzymes, increased blood lipid levels.

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

• Eye disorders: Changes in the cornea, optic nerve disorders, optic neuritis, and in a small number of cases, loss of vision (caused by optic nerve disturbance/inflammation).
• Reproductive system and breast disorders: Tumour in the uterus (womb), disorders of the inner tissue of the uterus, ovarian cysts.
• Gastrointestinal disorders: Pancreatitis.
• Hepatobiliary disorders: Fatty liver accumulation, bile flow obstruction, hepatitis.
• Laboratory test abnormalities: Increased blood calcium levels.

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

• Lung disorders: Pulmonary inflammation.
• Skin disorders: Severe skin reactions with lesions, ulcers, or blisters.

Adverse effects of unknown frequency (may affect up to 1 in 10,000 patients)

• Decrease in bone mineral density in premenopausal women.
• Changes in the electrical activity of the heart (electrocardiogram showing QT interval prolongation).

Stop taking this medicine and contact your doctor immediately if you experience any of the following:

• Symptoms suggesting a blood clot, such as swelling in the calf or leg, chest pain, shortness of breath, or sudden weakness.
• Raised, target-shaped or circular red skin rashes 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.
• Swelling of the face, lips, tongue, or throat, difficulty swallowing or breathing (angioedema). Tamoxifen may cause or worsen symptoms of hereditary angioedema.

Reporting of adverse effects

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

5. Storage of tamoxifen cinfa

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage conditions.

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 Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of tamoxifeno cinfa

The active substance is tamoxifeno. Each tablet contains 20 mg of tamoxifeno (as citrate).

The other components are: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium carboxymethyl starch (type A) (from potato), povidone, magnesium stearate and colloidal anhydrous silica.

Appearance of the medicine and contents of the pack:

tamoxifeno cinfa is presented as white, cylindrical biconvex tablets, with one side scored and marked "20" and the other side smooth.

It is available in PVC/ALU blisters. Each pack contains 30 or 60 tablets.

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Or

Laboratorios Cinfa, S.A.

Avda. Roncesvalles, s/n - Olloqui (Navarra) Spain

Or

Cyndea Pharma

Polígono Industrial Emiliano Revilla Sanz,

Av. Ágreda, 31, 42110 Ólvega, Soria. Spain.

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

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/63774/P_63774.html

QR code to: https://cima.aemps.es/cima/dochtml/p/63774/P_63774.html