Package Insert: Information for the Patient

Tamoxifeno Teva 20 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Tamoxifeno Teva and how is it used

2. What you need to know before starting to take Tamoxifeno Teva

3. How to take Tamoxifeno Teva

4. Possible adverse effects

5. Storage of Tamoxifeno Teva

6. Contents of the package and additional information

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

Tamoxifeno Teva is indicated for certain breast diseases.

Do not take Tamoxifeno Teva

• if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6)
• if you are pregnant or breastfeeding (see Pregnancy and breastfeeding)
• if you have had blood clots in the past and your doctor did not know what caused them
• if someone in your family has had blood clots with an unknown cause
• if your doctor has told you that you have a family disease that increases the risk of blood clots
• if you are pregnant (see Pregnancy, breastfeeding and fertility below)

Do not take Tamoxifeno Teva if any of the above applies to you. If you are unsure, talk to your doctor or pharmacist before taking Tamoxifeno Teva.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Tamoxifeno Teva 20 mg.

• 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 afterwards. This is because certain changes may occur in the lining of the uterus (endometrium), some of which may be serious.
• The concomitant administration with the following medications should be avoided as it cannot be ruled out that there may be a reduction in the effects of tamoxifen: 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).
• Inform hospital staff that you are taking tamoxifen.
• If you are to undergo surgery (including planned surgery), inform your doctor or pharmacist. They may suggest that you stop taking tamoxifen for a short period.
• 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 clots in the 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.
• If you have a history of hereditary angioedema, as tamoxifen may provoke or worsen the symptoms of hereditary angioedema. If you experience symptoms such as facial swelling, lips, tongue, and/or throat with difficulty swallowing or breathing, contact a doctor immediately.

Be especially careful with tamoxifen:

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 taking Tamoxifeno Teva and seek medical attention immediately.

Children and adolescents

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

Taking Tamoxifeno Teva with other medications

Inform your doctor or pharmacist if you are using/taking, have used/taken recently, or may need to use/take any other medication. In particular, you should inform your doctor if you are taking:

• anticoagulants such as warfarin (to prevent blood clots)
• rifampicin (for the treatment of 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 if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not become pregnant during treatment with Tamoxifeno Teva and for two months after stopping treatment.

Do not take Tamoxifeno Teva if you are breastfeeding.

Driving and operating machinery

Tamoxifen is unlikely to affect your ability to drive or operate machinery. However, fatigue and visual disturbances have been reported with the use of tamoxifen, and therefore, you should exercise caution when driving or operating machinery while such symptoms persist.

Tamoxifeno Teva 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.

• The recommended dose is 1 tablet (20 mg) to 2 tablets (40 mg) daily.
• Tamoxifeno Teva 20 mg is usually taken once or twice a day.
• Swallow the tablets whole with the help of 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 Tamoxifeno Teva than you should

If you have taken more Tamoxifeno Teva than you should, 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 forget to take Tamoxifeno Teva

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

If you interrupt treatment with Tamoxifeno Teva

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

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

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

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

• Signs of a blood clot. These include swelling of the calf or leg, chest pain, shortness of breath, or a sudden feeling of weakness.
• Sudden onset of weakness or paralysis of the arms or legs, sudden difficulty speaking, walking, difficulty holding things, or difficulty thinking, any of which may occur due to a reduction in blood supply to the brain's blood vessels. These symptoms may be signs of a stroke.
• Difficulty breathing.
• Swelling of the face, lips, tongue, or throat,difficulty swallowing or breathing (angioedema). Tamoxifeno may cause or worsen symptoms of hereditary angioedema.
• Swelling of the hands, feet, or ankles.
• Rash (also known as 'hives’ or ‘urticaria').
• Flat red spots, in the shape of a bull's-eye 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.

You must also contact your doctorimmediatelyif you experience any of the following side effects:

• Unusual vaginal bleeding.
• Irregular periods.
• A feeling of discomfort in the lower part of the abdomen (pelvis), such as pain or pressure.

These side effects may mean that there have been changes in the lining of the uterus (endometrium). Sometimes these side effects are severe and may include cancer. They may occur during or after treatment with tamoxifeno.

Other possible side effects:

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

• Vaginal bleeding, vaginal discharge
• Nausea
• Fatigue
• Skin rash
• Hot flushes.
• Fluid retention.

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

• Obstruction in blood vessels (such as deep vein thrombosis, microvascular thrombosis, and pulmonary embolism).
• Itching around the vagina
• Irregular periods
• Changes in the endometrium
• Endometrial polyps
• Gastrointestinal discomfort
• Vomiting
• Diarrea
• Constipation.
• Hair loss.
• Headache, dizziness
• Alteration of taste (dysgeusia)
• Itching sensation (paresthesia)
• Cerebrovascular accidents.
• Anemia
• Cataracts, retinal changes.
• Increased levels of fats in the blood.
• Uterine fibroids
• Hypersensitivity reactions (allergy), including angioedema (rapid inflammation of the face, lips, tongue, and/or throat).
• Changes in liver enzymes
• Fatty liver accumulation.
• Leg cramps
• Muscle pain.

Rare side effects (may affect up to 1 in 100 people):

• Endometrial cancer (interior of the uterus).
• Decreased number of platelets
• Decreased number of white blood cells (leucopenia).
• Cirrhosis
• Elevated calcium levels in the blood.
• Visual changes
• Interstitial pneumonia
• Pancreatitis (inflammation of the pancreas)

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

• Lupus erythematosus cutáneo (skin inflammation characterized by a rash or redness, especially in exposed areas),
• Porphyria cutanea tarda (blisters in exposed areas, due to increased production of a special group of cellular pigments (porphyrins) in the liver.

Unknown frequency(cannot be estimated from available data)

• Reaction (cutaneous) to radiation (skin rash with redness, swelling, and/or blisters after receiving treatment).

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 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.

Store in the original packaging to protect it from light.

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 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 unused packaging and medications. By doing so, you will help protect the environment.

Composition of Tamoxifeno Teva 20 mg tablets EFG

- The active ingredient is tamoxifeno. Each tablet contains 20 mg of tamoxifeno (as citrato).

- The other components (excipients) are: dihydrate calcium phosphate, microcrystalline cellulose, sodium carboxymethyl starch (type A) from potato, povidone, magnesium stearate, colloidal silica.

Appearance of the product and content of the packaging

This medicine is presented in the form of white or off-white, round, biconvex tablets, marked with “TN20” and with a notch on one face, and smooth on the other.

Each package consists of 30 or 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid (Spain)

Responsible for manufacturing

MERCKLE GMBH Ludwig-Merckle-Strasse, 3 (Blaubeuren) - D-89143 - Germany

–

Haupt Pharma Münster GmbH, Schleebrüggenkamp 15, 48159 Münster, Germany

Last review date of this leaflet: November 2021

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