TAMOXIFEN TEVA 20 mg TABLETS

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

Do not take Tamoxifeno Teva

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant or breast-feeding (see Pregnancy and breast-feeding)
• 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 history of blood clots
• if you are pregnant (see section "Pregnancy, breast-feeding and fertility" below)

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

Warnings and precautions

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

• Talk to your doctor about the contraceptive methods you should use. Some may be affected by this medicine.
• It is important that you immediately inform your doctor if you experience any unusual vaginal bleeding or other gynaecological symptoms (such as pelvic pain or pressure) during treatment with tamoxifen or at any time afterwards. This is because certain changes can occur in the lining of the womb (endometrium), some of which can be serious.
• Concomitant administration with 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 stop smoking), quinidine (used to treat heart rhythm disorders) and cinacalcet (for the treatment of parathyroid gland disorders)
• If you are admitted to hospital, inform the medical staff that you are taking tamoxifen.
• If you are going to have surgery (including planned surgery), tell your doctor or pharmacist. They may suggest that you stop taking tamoxifen for a short period of time.
• In delayed breast reconstruction surgery (weeks or years after the primary breast surgery, when your own tissue is moved to form a new breast), tamoxifen may increase the risk of blood clots in the small blood vessels of the tissue graft, which can lead to complications.
• This medicine contains tamoxifen which may produce a positive result in doping tests.
• 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.

Be 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 of the 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 given to children or adolescents as its safety and efficacy have not been established in this age group.

Taking Tamoxifeno Teva with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, you should tell 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 stop smoking)
• quinidine (used to treat heart rhythm disorders)
• 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

During treatment with Tamoxifeno Teva and for two months after stopping treatment, you should not become pregnant.

Do not take Tamoxifeno Teva if you are breast-feeding.

Driving and using machines

Tamoxifen is unlikely to affect your ability to drive or use machines. However, fatigue and visual disturbances have been reported with tamoxifen use, and therefore caution should be exercised when driving or using machines while such symptoms persist.

Tamoxifeno Teva contains sodium

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

3. How to take Tamoxifeno Teva

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Remember to take your medicine.

• 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 a little 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, talk to a doctor or pharmacist immediately or call the Toxicology Information Service on +34 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Tamoxifeno Teva

If you miss 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 Teva

Your doctor will tell you how long to take Tamoxifeno Teva. Do not stop treatment before your doctor tells you to.

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

• Symptoms of a blood clot. These include swelling of the calf or leg, chest pain, shortness of breath or sudden feeling of weakness.
• Sudden onset of weakness or paralysis of the arms or legs, difficulty speaking, walking, difficulty holding things or difficulty thinking, any of which may occur due to reduced blood supply in the blood vessels of the brain. These symptoms could be signs of a stroke.
• Difficulty breathing.
• Swelling of the face, lips, tongue or throat, difficulty swallowing or breathing (angioedema). Tamoxifen may cause or worsen the symptoms of hereditary angioedema.
• Swelling of the hands, feet or ankles.
• Rash (also called 'hives' or 'urticaria')
• Red patches, target-like or circular 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 flu-like symptoms [Stevens-Johnson syndrome, toxic epidermal necrolysis] – these side effects are rare.

You should also contact your doctor immediately if you experience any of the following side effects:

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

These side effects may mean that there have been changes in the lining of the womb (endometrium). Sometimes these side effects can be serious and may include cancer. They can occur during or after treatment with tamoxifen.

Other possible side effects:

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

• Vaginal bleeding, vaginal discharge
• Nausea
• Fatigue
• Rash
• Hot flushes
• Fluid retention

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

• Blockage of blood vessels (such as deep vein thrombosis, microvascular thrombosis and pulmonary embolism)
• Itching around the vagina
• Menstrual irregularities
• Changes in the endometrium
• Endometrial polyps
• Gastrointestinal upset
• Vomiting
• Diarrhoea
• Constipation
• Hair loss
• Headache, dizziness
• Taste disturbance (dysgeusia)
• Feeling of tingling (paraesthesia)
• Stroke
• Anaemia
• Cataracts, retinal changes
• Increased levels of fats in the blood
• Uterine fibroids
• Allergic reactions (including angioedema (rapid swelling of the face, lips, tongue and/or throat))
• Changes in liver enzymes
• Fatty liver
• Leg cramps
• Muscle pain

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

• Endometrial tumour (inside the womb)
• Decreased platelet count
• Decreased white blood cell count
• Cirrhosis
• High levels of calcium in the blood
• Visual disturbances
• Interstitial pneumonia
• Pancreatitis (inflammation of the pancreas)

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

• Uterine tumour
• Tumour flare
• Disorders of the tissue inside the womb
• Ovarian cysts
• Vaginal polyps
• Bile flow stoppage
• Hepatitis
• Liver failure
• Liver cell damage
• Liver cell death
• Corneal changes
• Optic nerve changes, optic neuritis and in a small number of cases, loss of vision (caused by optic nerve changes and inflammation)
• Severe skin reactions with lesions, ulcers or blisters
• Cutaneous vasculitis
• Decreased neutrophil count (neutropenia and agranulocytosis)

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

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

Frequency not known(cannot be estimated from the available data)

• Radiation recall reaction (skin rash with redness, swelling and/or blisters on the skin after receiving treatment)

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 via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Tamoxifeno Teva

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

Store in the original package to protect from light.

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

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

Tamoxifeno Teva 20 mg tablets EFG composition

• The active substance is tamoxifen. Each tablet contains 20 mg of tamoxifen (as citrate).
• The other ingredients are: calcium phosphate dihydrate, microcrystalline cellulose, sodium starch glycollate (type A) potato, povidone, magnesium stearate, colloidal silica.

Appearance and packaging

This medicine is presented as white or almost white, round, biconvex tablets, marked with "TN20" and with a score line on one face, and smooth on the other.

Each pack contains 30 or 60 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1ª planta,

Alcobendas, 28108 Madrid (Spain)

Manufacturer

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

–

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

Date of last revision of this leaflet: November 2021

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