Leaflet: information for the user

tamoxifeno cinfa 10 mg tablets EFG

citrate of tamoxifen

Read the entire leaflet carefully before starting to take the medicine.

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

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

tamoxifeno cinfa is indicated for certain breast pathologies.

Do not take tamoxifen cinfa

• Tamoxifen should not be administered to the pediatric population, as its safety and efficacy have not been established in this age group.
• These tablets are for your exclusive use only and should not be provided to anyone else.
• If you are allergic to tamoxifen or any of the other components of this medication (listed in section 6).
• If you are pregnant.

Warnings and precautions

Consult your doctor or pharmacist before starting to take tamoxifen cinfa.

• Never take another medication on your own initiative without your doctor's recommendation, as some combinations should be avoided.
• Consult your doctor about the contraceptive methods you should use, as some may be affected by this medication.
• It is essential to inform your doctor immediately if you experience any unusual vaginal bleeding or other gynecological symptoms (such as pelvic pain or pressure) during treatment with tamoxifen or at any time thereafter. This is because certain changes may occur in the lining of the uterus (endometrium), some of which may be severe.
• The concomitant administration with the following medications should be avoided, as it cannot be ruled out that the effects of tamoxifen may be reduced: paroxetine, fluoxetine (e.g., antidepressants), bupropion (antidepressant or used to quit smoking), quinidine (used in the treatment of cardiac arrhythmia), and cinacalcet/cinacalcet (for the treatment of parathyroid gland disorders).
• Before starting treatment with this medication, it is essential to inform your doctor if you or any family member has a history of blood clots or any known hereditary condition that increases the risk of forming these clots.
• In case of hospital admission, inform the healthcare staff that you are taking tamoxifen cinfa.
• Severe 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 severe skin reactions described in section 4, stop using tamoxifen and seek medical attention immediately.
• If you have a history of hereditary angioedema, as tamoxifen may provoke or worsen angioedema symptoms. If you experience symptoms such as facial swelling, lips, tongue, and/or throat swelling with difficulty swallowing or breathing, contact a doctor immediately.

Other medications and tamoxifen cinfa

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Particularly, you should inform your doctor if you are using 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).

Tamoxifen cinfa should not be used with aromatase inhibitors such as anastrozole, letrozole, or exemestane.

Pregnancy, breastfeeding, and fertility

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

Pregnant women or women who may be pregnant and breastfeeding women should not use this medication during the two months following its discontinuation.

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

Children and adolescents

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

Driving and operating machinery

This medication is unlikely to affect your ability to drive vehicles or operate hazardous machinery.

Tamoxifen cinfa contains sodium

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

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

Remember to take your medication.

Recommended dose for adults

• The recommended dose is 20 mg to 40 mg daily.
• This medication is usually taken once or twice a day.

Administration form

• Swallow the whole tablets 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.

If you take more Tamoxifen Cinfa than you should

If you take more Tamoxifen than you should, contact your doctor or the nearest hospital immediately.

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

If you forgot to take Tamoxifen Cinfa

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

Take the missed dose as soon as you remember.

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

If you interrupt treatment with Tamoxifen

Your doctor will tell you the duration of your treatment with Tamoxifen. Do not stop treatment before your doctor tells you to.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

• Vascular changes: Hot flashes.

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

• Vascular changes: Sudden weakness or paralysis of the arms or legs, sudden difficulty speaking, walking, holding things, or thinking (any of these may occur due to decreased blood flow to the brain and these symptoms may be a sign of a stroke), blockage in blood vessels.
• Reproductive and breast system changes: Vaginal bleeding, vaginal discharge, vaginal itching, endometrial changes (interior of the uterus), irregular menstrual periods.
• Gastrointestinal changes: Gastrointestinal discomfort.
• Skin changes: Hair loss, rash.
• Nervous system changes: Headache, dizziness.
• General changes: Symptoms related to your illness, fluid retention.
• Muscle changes: Leg cramps.

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

• Vision changes: Cataracts, changes in the retina.
• Reproductive and breast system changes: Uterine fibroids, endometrial tumors (interior of the uterus).
• General changes: Hypersensitivity reactions.
• Laboratory changes: Decreased platelet count, decreased white blood cell count, decreased neutrophil count, anemia, changes in liver enzymes, increased blood lipid levels.

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

• Vision changes: Changes in the cornea, optic nerve changes, inflammation of the optic nerve, and in a small number of cases, loss of vision (caused by alteration/inflammation of the optic nerve).
• Reproductive and breast system changes: Uterine tumors, endometrial tissue disorders, ovarian cysts.
• Gastrointestinal changes: Pancreatitis.
• Liver and bile changes: Fatty liver accumulation, bile flow obstruction, hepatitis.
• Laboratory changes: Elevated calcium levels in the blood.

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

• Lung changes: Pulmonary inflammation.
• Skin changes: Severe skin reactions, with lesions, ulcers, or vesicles.

Stop taking this medicineand contact your doctor immediately in any of the following situations:

• If you experience symptoms of blood clot formation such as swelling in the calf or leg, chest pain, shortness of breath, or sudden weakness.
• Reddish patches without relief, in the shape of a target or circles on the trunk, often with central blisters, skin peeling, 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 side effects occur rarely.
• Swelling of the face, lips, tongue, or throat, difficulty swallowing or breathing (angioedema). Tamoxifen can cause or worsen symptoms of hereditary angioedema.

Reporting side effects

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

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Tamoxifen cinfa composition

The active ingredient is tamoxifen. Each tablet contains 10 mg of tamoxifen (as citrate).

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

Appearance of the product and contents of the packaging

tamoxifen cinfa is presented in the form of white, biconvex, cylindrical tablets with one face grooved with the inscription 10 and the other face smooth.

It is presented in PVC/ALU blisters. Each package contains 30 or 100 tablets.

Marketing authorization holder

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – España

Responsible for manufacturing:

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – España

Or

Laboratorios Cinfa, S.A

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

Or

Cyndea Pharma

Polígono Industrial Emiliano Revilla Sanz,

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

Last review date of this leaflet: December 2021

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/63754/P_63754.html

QR code to: https://cima.aemps.es/cima/dochtml/p/63754/P_63754.html