NOLVADEX 10 мг Фильм-coated таблетки

Содержание инструкции

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

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

tamoxifene

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

1. What is Nolvadex and what is it used for

Nolvadex contains tamoxifene, which belongs to the class of medicines called “anti-estrogens”.
Estrogens are a substance naturally present in the body, known as “sex hormones”.
Nolvadex works by blocking the effects of estrogens on your body.
Nolvadex is indicated:

• in the treatment of breast cancer;
• in men in the prevention and treatment of breast enlargement (gynecomastia) and breast pain (mastalgia) caused by medicines called antiandrogens and used in the treatment of prostate cancer (prostatic carcinoma), a gland in men that produces seminal fluid.

Contact your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Nolvadex

Do not take Nolvadex

• If you are allergic to tamoxifen or any of the other ingredients of this medicine (listed in section 6).
• If you are pregnant (see ‘Pregnancy and breastfeeding’).
• If you are taking 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.

Warnings and precautions
Talk to your doctor before taking Nolvadex:

• 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 Nolvadex and at any time after stopping it. Your doctor will ask you to undergo periodic checks of the genital organs, because changes at the level of the uterus (endometrium) can occur, 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 Nolvadex (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.
• If you have a history of hereditary angioedema as Nolvadex 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, seek immediate medical attention.
• If you suffer from heart problems, including irregular heartbeat (arrhythmia), including a condition called long QT syndrome (prolongation of the QT interval), the risk of irregular heartbeat may increase during treatment with Nolvadex.

In the event of hospitalization, inform the medical staff that you are being treated with
Nolvadex.
In breast reconstruction surgery (weeks or years after breast surgery to remove
the tumor) Nolvadex may increase the risk of blood clots in the small vessels of the
flap of tissue used to shape the new breast, which can lead to complications.
Take particular care with Nolvadex:

• In association with treatment with Nolvadex, severe skin reactions have been reported, including Stevens-Johnson syndrome and toxic epidermal necrolysis. Stop treatment with Nolvadex and consult your doctor immediately if you observe any of the symptoms related to these severe skin reactions described in section 4.

For athletes
The use of the drug without therapeutic need constitutes doping and may still
result in a positive doping test.

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

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

• paroxetine, fluoxetine (examples of antidepressants);
• bupropion (antidepressant or support medicine for quitting 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;
• medicines that can affect the heart rhythm.

Your doctor will subject you to frequent blood tests if you are taking medicines to thin the
blood, called dicoumarolic 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 some SSRI antidepressants (e.g. paroxetine).

Pregnancy and breastfeeding

Pregnancy
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Nolvadex if you are pregnant (see section 2. Do not take Nolvadex); avoid
pregnancy and if sexually active, use barrier contraceptives (e.g. condom or
diaphragm) or other non-hormonal contraceptive methods during treatment with Nolvadex and for nine
months after stopping therapy, as there could 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 Nolvadex during breastfeeding is not recommended, as limited data
suggest that Nolvadex and its active metabolites are excreted and accumulate over time in
breast milk. The doctor will assess whether to stop breastfeeding or therapy with Nolvadex.

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

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

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

3. How to take Nolvadex

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 in the treatment ofbreast canceris from 20 to 40 mg in one or two
daily administrations.
The recommended dose in the prevention and treatment of breast enlargement and pain
caused by antiandrogen medications, used in the treatment of prostate cancer is 20
mg once a day.
It is necessary to follow your doctor's instructions regarding the method and frequency of
taking the tablets. The tablets must be taken whole with a little water,
preferably always at the same time.

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

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

If you stop taking Nolvadex
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
Treatment with tamoxifen should not be interrupted, even if your health improves, unless
requested by your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Experience with Nolvadex use in women is extensive. Although in men it is much more
limited, the overall profile of side effects appears similar, with the exception of events limited
to the female sex.

Stop treatmentwith tamoxifen 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). Nolvadex can cause or worsen symptoms of hereditary angioedema;
• swelling of the hands, feet or ankles;
• hives;
• flat, reddish patches on the trunk in a target or circular shape, often with central blisters, skin peeling, mouth, throat, nose, genitals and eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms [Stevens-Johnson syndrome, toxic epidermal necrolysis] - these side effects occur rarely.

Tell 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 which may be symptoms of inflammation of the lungs (interstitial pneumonia) characterized by fever, cough, shortness of breath, increased white blood cells, a type of blood cell (neutrophilia).

During treatment with tamoxifen, 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
• high levels of fats in the blood (triglycerides)
• leg cramps
• muscle pain (myalgia)
• benign growths in the uterus (uterine 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, the lining of the uterus (including hyperplasia and polyps)
• hair loss (alopecia)
• vomiting
• diarrhea
• constipation
• changes in liver enzyme levels
• 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)

• decreased number of platelets (thrombocytopenia)
• decreased number of white blood cells (leukopenia)
• visual disturbances
• inflammation of the pancreas, a gland in 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) characterized by fever, cough, shortness of breath, increased white blood cells
• 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, the 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, the 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)
• immune system disease 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)

• immune system disease that affects the skin with the formation of erythema, lesions, hair loss (cutaneous lupus erythematosus)
• disease caused by the accumulation in the blood of certain liver proteins, porphyrins, 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 blistering after radiation therapy (radiation recall reaction).

Other side effects reported in the literature are: dizziness, depression, confusion and fatigue.
From the results of a large study lasting 5 years involving approximately 13,000 women at high
risk 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, even those not listed in this leaflet, tell your
doctor or pharmacist. 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 Nolvadex

Do not store at a temperature above 30°C.
Store in the original package to protect the medicine from light.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is reported on the package after EXP. 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 Nolvadex contains
Nolvadex 10 mg film-coated tablets

• The active ingredient is tamoxifen citrate equivalent to tamoxifen 10 mg.
• The other ingredients are lactose monohydrate(see section 2. Nolvadex contains lactose), corn starch, gelatin, sodium croscarmellose, magnesium stearate, hypromellose, macrogol 300, titanium dioxide.

Nolvadex 20 mg film-coated tablets

• The active ingredient is tamoxifen citrate equivalent to tamoxifen 20 mg.
• The other ingredients are lactose monohydrate(see section 2. Nolvadex contains lactose), corn starch, gelatin, sodium croscarmellose, magnesium stearate, hypromellose, macrogol 300, titanium dioxide.

Description of the appearance of Nolvadex and contents of the pack
Nolvadex is presented as film-coated tablets of white colour.
Nolvadex 10 mg film-coated tablets is available in blisters of 30 tablets.
Nolvadex 20 mg film-coated tablets is available in blisters of 20 tablets.

Marketing authorisation holder and manufacturer
AstraZeneca S.p.A.
Viale Decumano 39, 20157 Milan

Manufacturer
AstraZeneca AB
Gärtunavägen
Södertälje, 152 57
Sweden