Tamoxifen Vir 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Tamoxifen Vir 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Package leaflet 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 other information.

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

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

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

Tamoxifeno Vir is indicated in certain breast conditions.

2. What you need to know before taking Tamoxifeno Vir

Do not take Tamoxifeno Vir

• If you are allergic to tamoxifen or to 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

Talk to your doctor or pharmacist before taking tamoxifen.

• Concomitant use with the following medicines should be avoided, as an interaction reducing 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 (for the treatment of parathyroid gland disorders).

• If you are using contraception. Consult your doctor about the contraceptive methods you should use, as some may be affected by this medicine.

• 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 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 serious.

• Before starting treatment with this medicine, it is important that you inform your doctor if you or a family member have 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 tamoxifen.

• In delayed breast reconstruction surgery (weeks or years after the initial breast surgery, when your own tissue is moved to shape a new breast), tamoxifen may increase the risk of blood clots forming in the small blood vessels of the tissue graft, which could lead to complications.

• This medicine contains tamoxifen, which may produce a positive result in doping control 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 immediate medical attention.

• If you have a history of hereditary angioedema, as Tamoxifeno Vir 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.

Children and adolescents

Tamoxifen must not be given 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 taking, have recently taken, or might need to take any other medicines.

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

You must not become pregnant during tamoxifen treatment or during the two months following the end of treatment.

Do not take tamoxifen while breast-feeding unless your doctor has evaluated the risks and benefits involved. It is not known whether tamoxifen passes into human milk.

Driving and use of machines

The effect of tamoxifen on the ability to drive and use machines is minor.

However, fatigue has been reported with the use of tamoxifen; therefore, caution should be exercised when driving or operating machinery while these symptoms persist.

3. How to take Tamoxifeno Vir

Follow exactly the instructions for using this medicine as given by your doctor. If in 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 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 must not be given 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 your nearest hospital immediately. In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Poison Information Service immediately at telephone number 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 advise you on the duration of your treatment with tamoxifeno. Do not stop treatment before your doctor tells you to do so.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

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

Red, non-elevated, target-like or circular skin rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital, or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms [Stevens-Johnson syndrome, toxic epidermal necrolysis] – these adverse reactions are rare.

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 indicating the formation of a blood clot, such as swelling in the calf or leg, chest pain, shortness of breath, or sudden weakness. DISCONTINUE TREATMENT with tamoxifen and contact your doctor immediately.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, 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 packaging.

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 must 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 are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Additional Information

Composition of Tamoxifeno Vir

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

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

Appearance of the medicinal product and contents of the container

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 latest revision of this leaflet: May 2021

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