Package Leaflet: Information for the User

Tamoxifeno Vir 20 mg Tablets EFG

Read this 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, ask your doctor or pharmacist.
• This medicine has been prescribed 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.

Table of Contents:

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

Tamoxifeno Vir belongs to a group of medications known as anti-estrogens.

Estrogen is present in your body and is a natural substance known as a “sex hormone”. Tamoxifeno acts by blocking the effects of estrogen.

Tamoxifeno Vir is indicated for certain breast pathologies.

Do not take Tamoxifeno Vir

?If you are allergic to tamoxifen or any of the other components of this medication (listed in section 6).

• If you are pregnant (see “Pregnancy, breastfeeding and fertility”).

Warnings and precautions

Consult your doctor or pharmacist before taking tamoxifen.

• The concomitant administration with the following medications should be avoided, as the effects of tamoxifen 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/cinaclet (for the treatment of parathyroid gland disorders).
• If you are using a contraceptive method. 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 uterus (endometrium), some of which may be severe.
• 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 blood clot formation.
• Inform hospital staff that you are taking tamoxifen if you are admitted to a hospital.
• In a delayed breast reconstruction surgery (weeks or years after the primary breast surgery, when your own tissue is moved to shape a new breast), tamoxifen may increase the risk of blood clot formation in small blood vessels of the tissue graft, which may lead to complications.
• This medication contains tamoxifen, which may produce a positive result in doping control tests.
• Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with tamoxifen treatment. If you experience any symptoms related to these severe skin reactions described in section 4, stop using Tamoxifeno Vir and seek medical attention immediately.
• If you have a history of hereditary angioedema, as Tamoxifeno Vir may provoke or worsen angioedema symptoms. If you experience symptoms such as facial swelling, lips, tongue, and/or throat with difficulty swallowing or breathing, contact a doctor immediately.

Children and adolescents

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

Use of Tamoxifeno Vir with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Never take another medication on your own initiative without your doctor's recommendation, as some combinations should be avoided.

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

• Warfarin (an oral anticoagulant to prevent blood clots)
• Rifampicin (for 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, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

You should not be pregnant during treatment with tamoxifen or for two months after stopping treatment.

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

Driving and operating machinery

The influence of tamoxifen on the ability to drive and operate machinery is small.

However, fatigue has been reported with tamoxifen use, so you should exercise caution when driving or operating machinery while these symptoms persist.

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

Tamoxifeno Dosage

?The recommended dose is one tablet (20 mg) to two tablets (40 mg) per day.

?Tamoxifeno Vir is usually taken one or two times 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.

Use in Children and Adolescents

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

If You Take More Tamoxifeno Vir Than You Should:

If you have taken more tamoxifeno 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.

If You Forget to Take Tamoxifeno Vir:

If you forget a dose, take it as soon as you remember. Do not take a double dose to make up for the missed dose.

If You Interrupt Treatment with Tamoxifeno Vir

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

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

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

Stop using Tamoxifeno Vir and seek medical attention immediately if you notice any of the following symptoms:

Flat, red, circular, or target-like patches 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 symptoms similar to Stevens-Johnson syndrome or toxic epidermal necrolysis – these side effects occur rarely.

Swelling of the face, lips, tongue, or throat, difficulty swallowing or breathing (angioedema). Tamoxifeno Vir may cause or worsen symptoms of hereditary angioedema.

If you experience symptoms of blood clot formation such as swelling in the calf or leg, chest pain, shortness of breath, or sudden weakness. INTERRUPT administration of tamoxifeno and contact your doctor immediately.

Reporting of 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 leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products 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. Keep the tablets in the original packaging.

No requires 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 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.

Tamoxifeno Vir Composition

The active ingredient is tamoxifen. Each tablet contains 20 mg of tamoxifen (as citrate).

The other components are: calcium hydrogen phosphate, microcrystalline cellulose, sodium starch glycolate (type A) (gluten-free), povidone K25, magnesium stearate, anhydrous colloidal silica.

Product Appearance and Packaging Content

This medication is presented in the form of white, round, scored tablets in blister packs containing 30 or 60 tablets..

Only some package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Industria Química y Farmacéutica VIR, S.A.

C/Laguna 66-70.Polígono Industrial URTINSA II 28923 Alcorcón (Madrid)

(Spain)

Responsible Manufacturer

Excella GmbH

Nürnberger str. 12.

90537 Feucht (Germany).

Last Review Date of this Leaflet:May 2021

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