TAMOXIFENE CINFA 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

Tamoxifen Cinfa 20 mg Tablets EFG

Tamoxifen Citrate

Read all of this leaflet carefully before you start taking this medicine.

• 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 symptoms are the same as yours.
• If you experience 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 Tamoxifen Cinfa and what is it used for
2. What you need to know before taking Tamoxifen Cinfa
3. How to take Tamoxifen Cinfa
4. Possible side effects
5. Storage of Tamoxifen Cinfa
6. Contents of the pack and further information

1. What is Tamoxifen Cinfa and what is it used for

Tamoxifen Cinfa belongs to a group of medicines called anti-oestrogens.

Tamoxifen Cinfa is indicated for certain breast conditions.

2. What you need to know before taking Tamoxifen Cinfa

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 and should not be given to anyone else.
• If you are allergic to tamoxifen or any of the other ingredients of this medicine (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 medicine 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 medicine.
• It is essential that you immediately inform your doctor if you experience any unusual vaginal bleeding or other gynecological symptoms (such as pain or pelvic pressure) during treatment with tamoxifen or at any time thereafter. This is because certain changes may occur inside the uterus (endometrium), some of which can be serious.
• The concomitant administration of the following medicines should be avoided, as it cannot be excluded 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 (for the treatment of parathyroid gland disorders).
• Before starting treatment with this medicine, it is essential that you inform your doctor if you or a family member has a history of blood clots or any known hereditary situation that increases the risk of forming these clots.
• In case of hospitalization, 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, stop using tamoxifen and seek medical attention immediately.
• If you have a history of hereditary angioedema, as tamoxifen 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.

Other Medicines and Tamoxifen Cinfa

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

In particular, 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), or cinacalcet (for the treatment of parathyroid gland disorders).

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

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnant or potentially pregnant women and breast-feeding mothers should not use this medicine during the two months following treatment cessation.

Do not take tamoxifen if you are breast-feeding, unless your doctor has analyzed the risks and benefits involved. It is not known whether 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 Using Machines

It is unlikely that this medicine will affect your ability to drive or operate machinery.

Tamoxifen Cinfa contains Sodium

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

3. How to take Tamoxifen Cinfa

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of 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.
• Normally, 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 to do so.

If you take more Tamoxifen Cinfa than you should

If you take more tamoxifen 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, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Tamoxifen 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 on the use of this medicine, ask your doctor or pharmacist.

If you stop taking Tamoxifen

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

4. Possible side effects

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

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

• Vascular disorders: Hot flashes.

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

• Vascular disorders: 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 of blood vessels.
• Reproductive system and breast disorders: Vaginal bleeding, vaginal discharge, itching around the vagina, endometrial changes (inside the uterus), menstrual irregularities.
• Gastrointestinal disorders: Gastrointestinal upset.
• Skin and subcutaneous tissue disorders: Hair loss, rash.
• Nervous system disorders: Headache, dizziness.
• General disorders: Symptoms related to your disease, fluid retention.
• Musculoskeletal and connective tissue disorders: Leg cramps.

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

• Eye disorders: Cataracts, retinal changes.
• Reproductive system and breast disorders: Uterine fibroids, endometrial tumor (inside the uterus).
• General disorders: Hypersensitivity reactions.
• Investigations: Decreased platelet count, decreased white blood cell count, decreased neutrophil count, anemia, changes in liver enzymes, increased blood fat levels.

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

• Eye disorders: Corneal changes, optic nerve disorders, optic neuritis, and in a small number of cases, vision loss (caused by optic nerve disorder/inflammation).
• Reproductive system and breast disorders: Uterine tumor (uterus), disorders of the endometrial tissue, ovarian cysts.
• Gastrointestinal disorders: Pancreatitis.
• Hepatobiliary disorders: Fatty liver, bile flow stoppage, hepatitis.
• Investigations: Elevated blood calcium levels.

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

• Respiratory, thoracic, and mediastinal disorders: Inflammation of the lung area.
• Skin and subcutaneous tissue disorders: Severe skin reactions, with lesions, ulcers, or blisters.

Stop taking this medicine and contact your doctor immediatelyin 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 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 can 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, and/or throat with difficulty swallowing or breathing (angioedema). Tamoxifen may cause or worsen the symptoms of hereditary angioedema.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is 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 Tamoxifen Cinfa

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

This medicine does 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. Contents of the pack and further information

Composition of Tamoxifen Cinfa

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

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

Appearance of the product and pack contents:

Tamoxifen Cinfa is presented as white, cylindrical, biconvex tablets with one face scored and marked with "20" and the other face smooth.

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

Marketing Authorisation 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 last revision of this leaflet:December 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/

You can access detailed and updated information about 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/63774/P_63774.html

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