Sertam

Package leaflet: Information for the patient

Sertam 20 mg tablets

tamoxifen
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask 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 could be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Sertam is and what it is used for

Sertam contains the active substance tamoxifene, which belongs to a class of medicines called "non-steroidal antiestrogens", and works by blocking the activity of a hormone called oestrogen. In certain types of breast cancer, oestrogens can promote the growth of tumour cells. By blocking the effects of oestrogen, Sertam inhibits or slows down the growth of cancer cells.
Sertam is used in the treatment of breast carcinoma (breast cancer).

2. What you need to know before taking Sertam

Do not take Sertam:

• if you are allergic to tamoxifen or to any of the other ingredients of this medicine (listed in section 6)
• if you are undergoing preventive therapy and are at high risk of breast cancer
• if you have cancer localized within a specific area of the breast without invasion into surrounding tissues (ductal carcinoma in situ) and are concurrently taking anticoagulants (medicines that delay blood clotting), or if you have a history of deep vein thrombosis (blockage in a leg vein) or pulmonary embolism (blockage in a lung artery)
• if you are pregnant (see "Pregnancy, breastfeeding and fertility")

Warnings and precautions
Talk to your doctor or pharmacist before taking Sertam if:

• you have leukopenia (low white blood cell count) or thrombocytopenia (low platelet count); your doctor will arrange periodic blood tests
• you are taking any of the following medicines, as they may reduce the effect of tamoxifen:
  • paroxetine, fluoxetine and bupropion (antidepressants)
  • quinidine (used for heart rhythm disorders)
  • cinacalcet (used to reduce calcium levels in the blood).
• you have a history of hereditary angioedema, as Sertam may cause or worsen symptoms (swelling of the face, lips, tongue and/or throat with difficulty swallowing or breathing). Pay special attention with Sertam: Severe skin reactions have been reported in association with Sertam treatment, including Stevens-Johnson syndrome and toxic epidermal necrolysis (appearance of widespread red lesions or blisters and peeling, particularly on legs, arms, hands and feet, which may extend to the face and lips, occasionally accompanied by fever, and which can be life-threatening). In such cases, stop treatment with Sertam immediately and consult your doctor without delay. During treatment with tamoxifen, it is important to undergo regular genital tract examinations and to report any unusual vaginal bleeding occurring during or at any time after treatment with tamoxifen. If you are being treated with tamoxifen, you must inform your doctor immediately if you experience any of the following symptoms:
  • facial numbness or weakness in the arms or legs, speech or vision problems, as these may indicate a stroke (sudden interruption of blood flow to the brain)
  • chest pain or shortness of breath, as these may indicate a pulmonary embolism (blockage in the lung arteries)
  • abdominal pain or abnormal vaginal bleeding, as these may indicate uterine cancer
  • cough and breathing difficulties, as these may indicate interstitial pneumonia (lung inflammation).
  • .
  • A history of stroke, stroke-like episodes, thromboembolic events or uterine cancer should be investigated in patients to be treated. Inform your doctor if you have previously had a stroke, thrombosis or uterine cancer, as these conditions may recur during treatment with Sertam (see section 4. Possible side effects). If you have ductal carcinoma in situ (cancer confined to one area of the breast), discuss with your doctor the potential risks and benefits of treatment with Sertam. If you are hospitalized, inform medical staff that you are being treated with Sertam. Do not discontinue treatment with Sertam unless instructed by your doctor.

During breast reconstruction surgery (weeks or years after breast tumor removal surgery), Sertam may increase the risk of blood clots forming in the small vessels of the tissue flap used to shape the new breast, potentially leading to complications.
If you are premenopausal, menstruation may stop; however, this does not affect the antitumor activity of Sertam.

Other medicines and Sertam
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
The effects of tamoxifen may be influenced by, or may influence, the following medicines:

• anticoagulants (used to delay blood clotting), because tamoxifen can significantly increase their activity; therefore, your doctor will prescribe blood tests;
• cytotoxic medicines (used in chemotherapy), because concomitant use with tamoxifen may increase the risk of thrombosis (blockage of a blood vessel due to clot formation) and embolism (blockage caused by a clot breaking loose and traveling through the bloodstream);
• paroxetine, fluoxetine and bupropion (antidepressants), which may reduce the effectiveness of tamoxifen;
• quinidine (used for heart rhythm disorders);
• cinacalcet (used to reduce calcium levels in the blood); mitomycin (used for certain cancers), because in combination with tamoxifen it may increase the risk of hemolytic uremic syndrome (a serious disease caused by small clots damaging various organs), anemia (reduced hemoglobin levels, a protein in red blood cells that carries oxygen in the blood) and thrombocytopenia (low platelet count).

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

Pregnancy
Sertam must not be used during pregnancy (see "Do not take Sertam").

Breastfeeding
The use of Sertam during breastfeeding is not recommended. Your doctor will decide whether breastfeeding should be discontinued or whether Sertam treatment should not be started.

Contraception
To avoid pregnancy, use barrier contraception (e.g. condom or diaphragm) or other non-hormonal contraceptive methods during treatment with Sertam and for nine months after stopping therapy. If you are premenopausal, your doctor will perform careful checks before starting treatment to rule out an existing pregnancy.

Driving and using machines
Sertam may cause dizziness (sensation of movement, spinning and loss of balance), headache, blurred vision, loss of visual acuity and visual disturbances, and somnolence; therefore, it may impair your ability to drive vehicles or operate machinery (see "Possible side effects").

For athletes
Using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

Sertam contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Sertam

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 20 to 40 mg given in one or two daily administrations.
You must follow your doctor's instructions regarding the method and frequency of taking the tablets.
The tablets should be taken whole with some water, preferably always at the same time each day.

Use in children and adolescents
Sertam is not recommended for use in children and adolescents, as its safety and efficacy have not been established.

If you take more Sertam than you should
In case of accidental ingestion or overdose, contact your doctor or the nearest hospital immediately.

If you forget to take Sertam
Do not take a double dose to make up for the forgotten tablet.
If you miss a dose, take it as soon as possible.

If you stop taking Sertam
Improvement in your health condition should not lead to discontinuation of treatment unless instructed by your doctor.
If you have any questions about the use of 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.
The experience with Sertam in women is extensive. Although experience in men is more limited, the overall profile of side effects appears similar, except for those side effects specific to the female sex.
Stop treatment with tamoxifen and contact your doctor immediately if you experience any of the following symptoms:

• difficulty breathing
• swelling of the hands, feet or ankles
• hives (urticaria)
• Reddish, flat spots on the trunk shaped like targets or rings, sometimes with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms. These side effects occur rarely and may be caused by Stevens-Johnson syndrome or toxic epidermal necrolysis
• Swelling of the face, lips, tongue, or throat, difficulty swallowing or breathing. Sertam may cause or worsen symptoms of hereditary angioedema. Contact your doctor immediately if you experience:
• facial numbness or weakness in the arms or legs, and disturbances in speech or vision, which may indicate a stroke (lack of blood flow to the brain)
• chest pain or dyspnea (difficulty breathing), which may be due to pulmonary embolism (blockage of a pulmonary artery)
• abdominal pain or abnormal vaginal bleeding, which may indicate a possible uterine tumour
• cough and difficulty breathing, which may be due to interstitial pneumonia (inflammation of the lungs)

During treatment with tamoxifen, the following side effects may occur:

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

• nausea
• fluid retention
• vaginal bleeding
• vaginal discharge
• rash
• hot flushes
• fatigue
• depression

Common (may affect up to 1 in 10 people)

• anaemia (reduced haemoglobin levels; haemoglobin is a protein in red blood cells that carries oxygen in the blood)
• cataract (clouding of the lens of the eye, which focuses images)
• retinopathy (disease of the retina, the innermost layer of the eye)
• allergic reactions
• elevated triglycerides (fats in the blood)
• leg cramps
• myalgia (muscle pain)
• uterine fibroids (benign tumours of the uterus)
• sudden onset of weakness, paralysis of arms or legs, sudden difficulty speaking or walking, difficulty holding objects, or cognitive difficulties, which may be due to reduced blood flow to the brain (e.g. stroke)
• headache
• dizziness (sensation of movement, spinning, and loss of balance)
• sensory disturbances, including paraesthesia (abnormal sensations such as tingling, prickling, itching, numbness, or burning) and dysgeusia (altered taste)
• vulvar pruritus (itching of the external female genitalia)
• endometrial changes, including endometrial hyperplasia and polyps
• alopecia (hair loss)
• vomiting
• diarrhoea
• constipation
• changes in transaminases (enzymes indicating liver function)
• fatty liver (steatosis)
• formation and detachment of blood clots in blood vessels (including deep vein thrombosis, microvascular thrombosis, and pulmonary embolism)

Uncommon (may affect up to 1 in 100 people)

• thrombocytopenia (reduced platelet count)
• leucopenia (reduced white blood cell count)
• visual disturbances
• pancreatitis (inflammation of the pancreas, a gland)
• hypercalcaemia (increased calcium levels in the blood in patients with tumours that have spread to the bones)
• endometrial cancer (cancer of the endometrium, the lining of the uterus)
• interstitial pneumonia (inflammation of the lungs, characterised by fever, cough, difficulty breathing, and increased white blood cell count)
• hepatic cirrhosis (severe liver disease)

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

• neutropenia (reduced number of a type of white blood cell)
• agranulocytosis (severe reduction in white blood cells)
• corneal changes (cornea is the transparent membrane covering the eye)
• optic neuropathy (disease of the optic nerve, which transmits images from the eye to the brain)
• uterine sarcoma (malignant tumour of the uterus)
• vaginal polyps (growths)
• tumour flare (worsening of a tumour)
• endometriosis (presence of uterine-lining cells in other nearby organs)
• enlargement of ovarian cysts
• optic neuritis (severe inflammation of the optic nerve, which transmits images from the eye to the brain)
• hepatitis (inflammation of the liver)
• cholestasis (reduced or stopped bile flow; bile is a fluid produced by the liver that aids digestion in the intestine)
• liver abnormalities
• liver damage
• hepatic necrosis (death of liver cells)
• angioedema (allergic reaction characterised by swelling of the face, lips, and throat)
• Stevens-Johnson syndrome and toxic epidermal necrolysis (development of red lesions or widespread blisters and skin peeling, particularly on the legs, arms, hands, and feet, which may spread to the face and lips, occasionally accompanied by fever, and potentially life-threatening)
• cutaneous vasculitis (inflammation of blood vessels causing swellings and skin spots)
• bullous pemphigoid (autoimmune disease characterised by development of blisters under the skin)
• erythema multiforme (allergic reaction characterised by redness and blisters on the skin)

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

• cutaneous lupus erythematosus (autoimmune disease affecting the skin, causing patches, rashes, and ulcers)
• porphyria cutanea tarda (a disease characterised by excessive skin sensitivity to light, leading to blister formation)
• radiation recall reaction (redness, swelling, pain, and skin peeling in an area previously treated with radiotherapy)
• exacerbation of hereditary angioedema (worsening of symptoms such as swelling of the face, lips, tongue, and/or throat, with difficulty swallowing or breathing)

At the beginning of treatment, a temporary worsening of disease symptoms may occur, such as increased pain and/or enlargement of the affected area.

Other side effects reported in the literature include: dizziness (sensation of movement, spinning, and loss of balance), confusion, and cataract surgery. Results from a large 5-year study involving approximately 13,000 women at high risk of developing breast cancer showed an increased incidence of the following adverse reactions in women treated with tamoxifen compared to untreated women. Some reported cases of malignant uterine tumours, cerebral stroke, and pulmonary embolism resulted in death.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform 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 Sertam

Store below 30°C, in the original packaging to protect the medicine from light.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “Exp.”. 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 Sertam contains

• The active substance is tamoxifene citrate 30.40 mg (equivalent to tamoxifene base 20 mg)
• The other ingredients are: lactose monohydrate, corn starch, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide.

Description of the appearance of Sertam and package contents
20 mg tablets.
Pack sizes of 20 and 60 tablets in PVC/PVDC/Al blisters.
Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
S.F. Group S.r.l. – Via Tiburtina, 1143 – 00156 Rome
Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC) – Italy.