Tamoxifen ratiopharm

Patient Information Leaflet

Tamoxifene ratiopharm 20 mg Film-coated Tablets

tamoxifen citrate
Equivalent medicine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Tamoxifene ratiopharm is and what it is used for

Tamoxifene ratiopharm contains tamoxifene, a substance with anti-tumour properties that works by counteracting the action of oestrogens (sex hormones) present in your body. Tamoxifene is used to treat breast cancer.
Contact your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Tamoxifene ratiopharm

Do not take Tamoxifene ratiopharm

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant;
• if you are breastfeeding;
• to treat a child;
• for preventive anti-tumour therapy because you are at high risk of developing breast cancer;
• if you have a specific type of breast cancer (ductal carcinoma in situ) and require concomitant anticoagulant therapy (medicines that thin the blood), or if you have previously suffered from deep vein thrombosis or pulmonary embolism (blood clots in a blood vessel or in a pulmonary artery), unless your doctor considers it strictly necessary. See also section “Other medicines and Tamoxifene ratiopharm” for medicines that should be avoided when taking tamoxifene.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tamoxifene ratiopharm.
Pay special attention and consult your doctor before taking Tamoxifene ratiopharm if:

• your white blood cell levels are low (leucopenia);
• your blood calcium levels are high (hypercalcemia);
• your blood platelet levels are low (thrombocytopenia);
• you have previously had a stroke, stroke-like events, or thromboembolic events (blockage of peripheral vessels due to blood clots), or have previously had uterine cancer, as these conditions may recur during treatment with Tamoxifene ratiopharm. Furthermore, during treatment with Tamoxifene ratiopharm, you must pay particular attention and immediately inform your doctor if you experience even one of the following symptoms:
• unusual vaginal bleeding; note that such bleeding may also occur after stopping treatment. Whenever bleeding occurs, your doctor will perform a gynaecological examination, as these bleedings could indicate endometrial changes (lining of the internal cavity of the uterus), some of which may be serious and could include tumours (hyperplasia, polyps, and carcinoma);
• irregular menstrual periods, unusual vaginal discharge;
• sensation of pressure or abdominal pain: could be a symptom of uterine cancer;
• numbness of the face, weakness in arms or legs, difficulty speaking, and vision disturbances: could be symptoms of a stroke (sudden blockage or rupture of a blood vessel in the brain);
• chest pain or difficulty breathing (dyspnoea): could be symptoms of pulmonary embolism (blockage of a pulmonary artery due to a blood clot);
• cough and difficulty breathing (dyspnoea): could be symptoms of interstitial pneumonia (a rare form of pneumonia).

Please also note that if you are a pre-menopausal woman, treatment with Tamoxifene ratiopharm may stop your menstrual cycle; however, this does not affect the therapeutic action of the drug.

Laboratory tests
Depending on your health status before starting tamoxifene and your response to the drug, your doctor may prescribe tests to monitor your blood components (blood count), blood calcium levels, and liver function.
Additionally, if you are taking blood-thinning medicines (anticoagulants of the dicumarol-type), your doctor may perform periodic clinical checks to monitor your blood clotting factors, especially at the beginning of treatment with Tamoxifene ratiopharm (see also “Other medicines and Tamoxifene ratiopharm”).

For those engaged in sports activities
Using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

Other medicines and Tamoxifene ratiopharm
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
The use of Tamoxifene ratiopharm should be avoided together with:

• hormonal medicines, particularly estrogens such as oral contraceptives, as they may reduce the effectiveness of the drug;
• medicines that inhibit platelet aggregation (antiplatelet agents) to reduce the risk of bleeding when your blood platelet levels are low (thrombocytopenia). It is important to pay particular attention and inform your doctor if you are taking any of the following medicines:
• anticoagulant medicines of the dicumarol-type (which work by thinning the blood), as they significantly increase their anticoagulant activity, increasing the risk of bleeding when administered together with tamoxifene;
• cytotoxic medicines (used in cancer treatment), as they may increase the formation of blood clots (thromboembolic episodes) when administered together with tamoxifene.

Furthermore, the following medicines may reduce the effect of Tamoxifene ratiopharm when taken together:

• certain antidepressants (paroxetine, fluoxetine);
• medicines containing quinidine, used in the treatment of certain heart function disorders (cardiac arrhythmias);
• medicines containing cinacalcet, used in hyperparathyroidism (parathyroid gland dysfunction) and in hypercalcemia in patients with parathyroid tumours (tumours of the parathyroid glands);
• medicines containing bupropion, used as antidepressants or as an aid to quit smoking.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Tamoxifene ratiopharm must not be used during pregnancy (see section “Do not take Tamoxifene ratiopharm”).
You must avoid pregnancy during treatment with tamoxifene and for two months after stopping treatment. If you are sexually active, you must use a barrier contraceptive method (e.g. condom or diaphragm) or other non-hormonal contraceptive methods, as there may be risks to the unborn child (spontaneous abortions, congenital abnormalities, and fetal death).
If you are pre-menopausal, your doctor will perform careful tests before starting treatment to rule out the possibility of an existing pregnancy.

Breastfeeding
Tamoxifene ratiopharm must not be used during breastfeeding, as serious adverse effects may occur in your baby.

Driving and using machines
Tamoxifene ratiopharm may impair your ability to drive vehicles or operate machinery.
This medicine may cause visual disturbances or dizziness. Therefore, if you experience these symptoms, do not drive or operate machinery.

Tamoxifene ratiopharm contains: lactose: if your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine;
sodium: this medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially “sodium-free”.

3. How to take Tamoxifene ratiopharm

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is 1–2 tablets of 20 mg, taken once or twice daily, as directed by your doctor.
The tablets should be taken during meals with a little water, preferably at the same time each day. Swallow the tablets whole, without chewing them.
Treatment with tamoxifene is usually long-term. In particular, for the treatment following surgery for a specific type of breast cancer (early hormone receptor-positive estrogen receptor-positive breast cancer), a treatment period of at least 5 years is recommended.

If you take more Tamoxifene ratiopharm than you should
If you take more Tamoxifene ratiopharm than prescribed, inform your doctor immediately or go to the nearest hospital.
Some of the symptoms that may occur include: dizziness, tremors, exaggerated reflexes (hyperreflexia), movement problems (dysmetria), seizures, and a heart problem called "prolonged QT interval" (which shows up on an electrocardiogram, ECG).

If you forget to take Tamoxifene ratiopharm
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the forgotten dose.

If you stop taking Tamoxifene ratiopharm
Ask your doctor for advice if you intend to stop treatment.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment with Tamoxifene ratiopharm, you must pay particular attention and immediately inform your doctor if you experience even just one of the following symptoms (see also section “Warnings and precautions”):

• unusual vaginal bleeding or discharge;
• irregular menstrual periods;
• feeling of pressure or abdominal pain;
• numbness of the face, weakness in arms or legs, difficulty speaking, and vision changes;
• cough, chest pain or difficulty breathing (dyspnea);
• skin rash and itching, difficulty breathing (bronchospasm) or swallowing, swelling of the face, hands and feet, eyes, lips and/or tongue (angioedema). These may be signs of serious allergic reactions (hypersensitivity reaction).

Other possible side effects include:
Very common (may affect more than 1 in 10 people)

• vaginal discharge;
• changes in menstrual cycle (including cessation in pre-menopausal women);
• hot flushes;
• fatigue

Common (may affect up to 1 in 10 people)

• development of fatty liver (hepatic steatosis);
• excessive decrease in red blood cells (anaemia);
• excessive accumulation of fluid in the body causing abnormal swelling (fluid retention);
• increased blood triglycerides (severe hypertriglyceridaemia);
• feeling of light-headedness (confusion);
• headache;
• visual disturbances (cataract, retinopathy and corneal disorders), only partially reversible;
• insufficient blood supply to a more or less extensive area of the brain (cerebrovascular ischaemic events);
• embolism (including deep vein thrombosis, pulmonary embolism and pulmonary infarction);
• sudden severe muscle pain caused by involuntary contraction of one or more muscles (spasms);
• nausea;
• skin rash;
• hair loss (alopecia);
• vulvovaginal itching;
• vaginal bleeding;
• benign tumours (leiomyoma of the uterus);
• abnormal growth of cells in the endometrial tissue (endometrial pathology, uterine polyp, endometrial hyperplasia);
• abnormal tissue growth originating from the endometrial mucosa (endometrial polyps);
• bone pain and pain in the tissue area affected by the tumour;
• changes in normal liver enzyme levels.

Uncommon (may affect up to 1 in 100 people)

• reduction in white blood cells in the blood (leucopenia, neutropenia);
• transient reduction in the number of blood cells called platelets (thrombocytopenia) with values between 80,000 and 90,000/µl;
• increased calcium levels in the blood (hypercalcaemia), especially in patients with bone metastases, and particularly at the beginning of treatment;
• alteration in normal blood flow to the heart (infarction);
• vomiting;
• endometrial cancer (endometrial carcinoma);
• swelling of the face, hands and feet, eyes, lips and/or tongue (angioedema);
• severe allergic reactions (hypersensitivity reaction);
• liver cirrhosis.

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

• neurodegenerative disease affecting the optic nerve (optic neuropathy);
• inflammation of the optic nerve (optic neuritis);
• alteration in normal bile flow (cholestasis);
• alteration in liver function (hepatitis and jaundice);
• damage to liver cells;
• impaired liver function;
• irreversible loss of liver function (hepatic necrosis);
• cancer of the uterus (uterine sarcoma – malignant mixed Müllerian tumour of the uterus);
• ovarian cysts.

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

• severe reduction in the number of white blood cells (neutropenia);
• reduction in the number of all blood cells (pancytopenia);
• a particular form of pneumonia called interstitial lung disease;
• skin changes such as urticaria, formation of red papules or widespread blisters and peeling, particularly on legs, arms, hands and feet, which may extend to the face and lips, occasionally accompanied by fever (Stevens-Johnson syndrome and pemphigoid);
• alteration in pancreatic function (pancreatitis).

Not known (frequency cannot be estimated from the available data)

• severe decrease in white blood cells (agranulocytosis);
• uterine fibroids;
• endometriosis;
• diarrhoea;
• constipation;
• immune system disease affecting the skin with erythema, lesions, and hair loss (cutaneous lupus erythematosus);
• pain caused by the tumour;
• skin rash characterised by redness, swelling and/or blistering after radiotherapy (radiation recall phenomenon);
• vaginal growths (vaginal polyp).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tamoxifene ratiopharm

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the carton after “Expiry”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tamoxifene ratiopharm contains

• The active substance is tamoxifen citrate. Each film-coated tablet contains 20 mg of tamoxifen base (equivalent to 30.4 mg of tamoxifen citrate).
• The other components are: monohydrate lactose, maize starch, gelatin, sodium croscarmellose, magnesium stearate, hypromellose, macrogols, and titanium dioxide.

Description of the appearance of Tamoxifene ratiopharm and contents of the pack
Tamoxifene ratiopharm is presented in a box containing 20 film-coated tablets in blister packs.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
ratiopharm GmbH - Graf-Arco Strasse 3 - 89079 Ulm (Germany)
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC)