TAMOXIFENE VIR 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

Tamoxifeno Vir 20 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

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

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

Oestrogen is present in your body and is a natural substance known as a "sex hormone". Tamoxifeno works by blocking the effects of oestrogen.

Tamoxifeno Vir is indicated for certain breast disorders.

2. What you need to know before you take Tamoxifeno Vir

Do not take Tamoxifeno Vir

If you are allergic to tamoxifeno or any of the other ingredients of this medicine (listed in section 6).

• If you are pregnant (see "Pregnancy, breast-feeding and fertility").

Warnings and precautions

Consult your doctor or pharmacist before taking tamoxifeno.

• The concomitant administration with the following medicines should be avoided, as it cannot be excluded that the effects of tamoxifeno are resolved: 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).
• If you are using a contraceptive method. Consult your doctor about the contraceptive methods you should use, as some may be affected by this medicine.
• It is important that you immediately inform your doctor if you present any unusual vaginal bleeding or other gynaecological symptoms (such as pelvic pain or pressure) during treatment with tamoxifeno or at any time thereafter. This is because certain changes may occur inside the uterus (endometrium), some of which may be serious.
• Before starting treatment with this medicine, it is important that you inform your doctor if you or a member of your family has a history of blood clots or any known hereditary situation that originates a greater risk of formation of these clots.
• In case of hospitalization, inform the healthcare staff that you are taking tamoxifeno.
• In a deferred breast reconstruction surgery (weeks or years after the 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 vessels of the tissue graft, which can lead to complications.
• This medicine contains tamoxifeno that may produce a positive result in doping tests.
• Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with Tamoxifeno Vir treatment. If you notice any of the symptoms related to these serious 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 cause or worsen the 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.

Children and adolescents

Tamoxifeno 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 medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Never take another medicine 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 medicines:

• 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, breast-feeding and fertility

If you are pregnant or breast-feeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

During treatment with tamoxifeno or during the two months following treatment discontinuation, you should not become pregnant.

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

Driving and using machines

The influence of tamoxifeno on the ability to drive and use machines is small.

However, fatigue has been reported with the use of tamoxifeno, so caution should be exercised when driving or using machines while these symptoms persist.

3. How to take Tamoxifeno Vir

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

Taking tamoxifeno

The recommended dose is one tablet (20 mg) to two tablets (40 mg) daily.

Tamoxifeno Vir is usually taken once or twice a day.

Swallow the tablets whole with a little water.

Try to take the tablet at the same time each day.

Do not stop taking your tablets even if you feel well, unless your doctor tells you to do so.

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 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. Telephone 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 forgotten doses.

If you stop taking Tamoxifeno Vir

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Red patches without relief, in a target or circular shape 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 those of [Stevens-Johnson syndrome, 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 the symptoms of hereditary angioedema.

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tamoxifeno Vir

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

This medicine does not require any special storage conditions. Keep the tablets in the original package.

Do not require special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Further information

Composition of Tamoxifeno Vir

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

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

Appearance of the product and pack contents

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Industria Química y Farmacéutica VIR, S.A.

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

(Spain)

Manufacturer

Excella GmbH

Nürnberger str. 12.

90537 Feucht (Germany).

Date of last revision of this leaflet:May 2021

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/