TAMOXENE 10 mg Film-Coated Tablets

Зміст інструкції

1. TAMOXENE 10 mg film-coated tablets, 20 mg film-coated tablets
   1. What is TAMOXENE and what is it used for
   2. What you need to know before you take TAMOXENE
   3. How to take TAMOXENE
   4. Possible side effects
   5. How to store TAMOXENE
   6. Contents of the pack and other information

TAMOXENE 10 mg film-coated tablets, 20 mg film-coated tablets

Tamoxifene
Generic medicine

Read this leaflet carefully before you start 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is TAMOXENE and what is it used for

TAMOXENE contains the active ingredient tamoxifen.
Tamoxifen belongs to the class of medicines called “anti-estrogens”.
Estrogens are a substance naturally present in the body, known as “sex hormones”.
TAMOXENE works by blocking the effects of estrogens on your body.
TAMOXENE is indicated in the treatment of breast cancer.

2. What you need to know before you take TAMOXENE

Do not take TAMOXENE

• If you are allergic to tamoxifen or to any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant (see ‘Pregnancy and breastfeeding’).
• In case of preventative therapy because you are at high risk of developing breast cancer.
• If you have a particular form of breast cancer (ductal carcinoma in situ) and require concomitant therapy to thin the blood or if you have had a blood clot in a blood vessel (deep vein thrombosis or pulmonary embolism) in the past. If you are of pediatric age.
• Warnings and precautionsTalk to your doctor before taking TAMOXENE:
• If you have a low level of white blood cells (leukopenia) or platelets (thrombocytopenia), your doctor will ask you to undergo periodic blood tests.
• If you experience unusual vaginal bleeding, both during treatment with TAMOXENE and at any time after stopping it, your doctor will ask you to undergo immediate checks of the genital apparatus. Your doctor will also ask you to undergo periodic checks of the genital apparatus during treatment with TAMOXENE because changes can occur at the level of the uterus (endometrium), some of which may also be serious and could include a tumor.
• If you have had a stroke in the past, stroke-like events, diseases due to the formation and detachment of blood clots (thromboembolic) or uterine cancer, as these diseases could recur during treatment with TAMOXENE
  (see section 4 Possible side effects).

If you have a particular form of breast cancer (ductal carcinoma in situ). The decision to start therapy with tamoxifen must be discussed with your doctor, evaluating together the potential risks and benefits.

Menstrual periods may stop in premenopausal patients.

For athletes
The use of the drug without therapeutic necessity constitutes doping and may still result in
positive doping tests.

Children and adolescents
The use of TAMOXENE in children is not recommended, as safety and efficacy have not been
established

Other medicines and TAMOXENE
Tell your doctor if you are taking, have recently taken or may take any other
medicines.
In particular, tell your doctor if you are taking:

• paroxetine, fluoxetine (examples of antidepressants);
• bupropion (antidepressant or medication to help you quit smoking);
• quinidine (for example used in the treatment of heart arrhythmias);
• cinacalcet (for the treatment of parathyroid gland dysfunction);
• cytotoxic drugs (used in the treatment of tumors) as they may increase the formation of blood clots.

Your doctor will subject you to frequent blood tests if you are taking medicines to thin the
blood, called coumarin anticoagulants (e.g. warfarin). Tamoxifen can in fact
significantly increase the activity of these medicines.
The use of tamoxifen in association with another medicine for the treatment of breast cancer
(aromatase inhibitor) as adjuvant therapy has not shown better efficacy than
tamoxifen alone.
In some studies, a reduced efficacy of tamoxifen has been reported when administered in
concomitance with rifampicin and with some SSRI antidepressants (e.g. paroxetine)

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Do not take TAMOXENE if you are pregnant (see section 2 Do not take
TAMOXENE); avoid pregnancy and if sexually active, use barrier contraceptives (e.g.
condom or diaphragm) or other non-hormonal contraceptive methods during treatment with
TAMOXENE and for nine months after stopping therapy, as there may be
risks to the baby.
Consult your doctor for advice on contraception.
If you are premenopausal, before starting treatment, your doctor will perform careful checks to
exclude the possibility of an ongoing pregnancy.
Breastfeeding
The use of TAMOXENE during breastfeeding is not recommended, as limited data
suggest that TAMOXENE and its active metabolites are excreted and accumulate over time in
breast milk. The doctor will assess whether to stop breastfeeding or therapy with TAMOXENE.

Driving and using machines
Do not drive or use machines if you notice that your abilities are impaired. TAMOXENE can
cause fatigue.

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

TAMOXENE contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take TAMOXENE

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is from 20 to 40 mg in one or two daily administrations.
It is necessary to follow your doctor's instructions regarding how and how often to
take the tablets.

If you take more TAMOXENE than you should
In case of accidental ingestion/taking of an excessive dose of TAMOXENE, immediately notify
your doctor or go to the nearest hospital.

If you forget to take TAMOXENE
If you forget to take a dose, it is advisable to take it as soon as possible.
Do not take a double dose to make up for the missed tablet.

If you stop taking TAMOXENE
If you have any doubts 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 everyone will experience them.

Stop treatmentwith tamoxifene and consult your doctor immediatelyif any of the following symptoms occur:

• difficulty breathing;
• swelling of the face, lips, tongue or throat, difficulty swallowing or breathing (angioedema). TAMOXENE may cause or worsen the symptoms of hereditary angioedema;
• swelling of the hands, feet or ankles;
• urticaria (hives);
• flat, reddish patches on the trunk in a target or circular shape, often with central blisters, skin peeling, ulcers of 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.
• Inform your doctor immediatelyif you experience any of the following symptoms:
• numbness of the face or weakness of the arms or legs and changes in speech or vision that may indicate a lack of blood flow to the brain (stroke);
• chest pain or shortness of breath (dyspnea) which may be symptoms of a blood clot in the pulmonary artery (pulmonary embolism);
• abdominal pain or abnormal vaginal bleeding which may indicate a possible tumor of the uterus;
• cough and shortness of breath (dyspnea) which may be symptoms of inflammation of the lungs (interstitial pneumonia) characterized by some symptoms such as fever, cough, shortness of breath. During treatment with tamoxifene, as with any other medicine, side effects may occur, with the following frequency:

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

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

Common (may affect up to 1 in 10 people)

• decreased number of red blood cells in the blood (anemia)
• opacification of the lens of the eye, which is used to focus images (cataract)
• disease of the retina, the innermost membrane of the eye (retinopathy)
• allergic reactions
• elevated levels of fats in the blood (triglycerides)
• leg cramps
• muscle pain (myalgia)
• benign growths of the uterus (fibroids)
• sudden onset of weakness, paralysis of the arms or legs, sudden difficulty speaking, walking, difficulty holding things or difficulty thinking that may be due to reduced blood flow to the brain (e.g. stroke)
• headache
• dizziness
• sensory disturbances (including numbness and altered taste)
• itching of the external genitals
• changes in the endometrium (including hyperplasia and polyps)
• hair loss and alopecia
• vomiting
• diarrhea
• constipation
• changes in liver enzyme levels
• liver with fat accumulation (steatotic)
• 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)

• decreased number of platelets (thrombocytopenia)
• decreased number of white blood cells (leukopenia)
• visual disturbances
• inflammation of the pancreas, a gland of the body (pancreatitis)
• increased calcium in the blood (hypercalcemia), in patients with tumors spread to the bones
• cancer of the endometrium, the lining of the uterus (endometrial cancer)
• inflammation of the lungs (interstitial pneumonia)
• severe liver disease (cirrhosis)

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

• decreased number of a type of white blood cells (neutropenia)
• severe decrease in the number of white blood cells (agranulocytosis)
• changes in the transparent membrane covering the eye (cornea)
• disease of the optic nerve, nerve that transmits images from the eye to the brain (optic neuropathy)
• tumor of the uterus
• growths (polyps) of the vagina
• worsening of a tumor (tumor recurrence)
• endometriosis (when cells that are normally found only in the lining of the uterus are
• present in other areas of the body, usually in other organs near the uterus)
• swelling of ovarian cysts
• severe inflammation of the optic nerve, nerve that transmits images from the eye to the brain (optic neuritis)
• inflammation of the liver (hepatitis)
• bile stasis (cholestasis)
• liver abnormalities
• liver damage (hepatocellular)
• death of liver cells (hepatic necrosis)
• allergic reaction characterized by swelling of the face, lips and throat (angioedema)
• inflammation of blood vessels with the formation of swellings and spots on the skin (cutaneous vasculitis)
• disease of the immune system characterized by the formation of swellings under the skin
• (bullous pemphigoid)
• allergic reaction characterized by spots on the skin (erythema multiforme).

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

• disease of the immune system that affects the skin with the formation of erythema, lesions, alopecia (cutaneous lupus erythematosus)
• disease caused by the accumulation of certain liver proteins, porphyrins, in the blood, which leads to
• the formation of blisters, lesions that turn into crusts and cysts on the skin (cutaneous porphyria)
• rash on the skin characterized by redness, swelling and/or formation of blisters after radiotherapy (radiation recall reaction).

*The risk of thromboembolic events is increased with the use of TAMOXENE in association with
cytotoxic substances
Other adverse effects reported in the literature are: dizziness, headache, depression, confusion and
fatigue
Menstrual disorders (including cessation of menstruation) have been reported.
From the results of a large study, lasting 5 years involving approximately 13,000 women at high
risk for the onset of breast cancer, an increase in the incidence of the following adverse reactions
was observed in women treated with tamoxifen compared to those not treated: uterine cancer
(endometrial adenocarcinoma and uterine sarcoma), pulmonary embolism, deep vein thrombosis,
stroke, cataract formation and cataract surgery. Some of the cases of uterine malignancies, cerebral stroke and pulmonary embolism were fatal.
Uterine fibroids, endometriosis and other endometrial alterations including hyperplasia and
polyps have been reported.
Interstitial pneumonia may occur, which may present with the same symptoms as pneumonia, such as
dyspnea and cough.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through 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 TAMOXENE

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 which is stated on the packaging after SCAD. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What TAMOXENE contains
TAMOXENE 10 mg film-coated tablets
The active ingredient is: tamoxifen citrate equivalent to 10 mg of tamoxifen.
The other ingredients are: lactose (see section 2. TAMOXENE contains lactose), corn starch,
gelatin, cross-linked sodium carboxymethylcellulose, magnesium stearate,
hydroxypropylmethylcellulose, polyethylene glycol 300, titanium dioxide.

TAMOXENE 20 mg film-coated tablets
The active ingredient is tamoxifen citrate equivalent to 20 mg of tamoxifen.
The other ingredients are: lactose (see section 2. TAMOXENE contains lactose), corn starch,
gelatin, cross-linked sodium carboxymethylcellulose, magnesium stearate,
hydroxypropylmethylcellulose, polyethylene glycol 300, titanium dioxide.

Description of the appearance of TAMOXENE and contents of the pack
TAMOXENE 10 mg film-coated tablets is available in blisters of 30 tablets
TAMOXENE 20 mg film-coated tablets is available in blisters of 20 tablets

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
SF Group S.r.l. – Via Tiburtina 1143 – 00156 Rome

Manufacturer
Genetic S.p.A. Contrada Canfora, 84084 Fisciano (SA) Italy
Laboratorio Italiano Biochimico Farmaceutico LISAPHARMA S.p.A.
Via Licinio, 11 - 22036 ERBA (CO)