ANASTROZOLO 1 mg Фильм-Coated Таблетки

Содержание инструкции

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

Anastrozolo Alter 1 mg film-coated tablets

Generic medicine

anastrozolo

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

1. What is Anastrozolo Alter and what it is used for

Anastrozolo Altercontains a substance called anastrozole, which belongs to a
group of medicines called “aromatase inhibitors”. Anastrozolo Alteris used for the
treatment of breast cancer in postmenopausal women.

Anastrozolo Alterworks by reducing the amount of hormones called estrogens produced
by the body. This happens by blocking a natural substance (enzyme) in your body,
called “aromatase”.

2. What you need to know before taking Anastrozolo Alter

Do not take Anastrozolo Alter:

• if you are allergic to anastrozole or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”).

Do not take Anastrozolo Alterif you are in one of the situations described above. If you are unsure,
consult your doctor or pharmacist before taking Anastrozolo Alter.

Warnings and precautions
Talk to your doctor or pharmacist before taking Anastrozolo Alter

• if you still have menstrual periods and are not yet postmenopausal.
• if you are taking a medicine that contains tamoxifen or medicines containing estrogens (see “Other medicines and Anastrozolo Alter”).
• if you have or have ever had a condition that alters bone strength (osteoporosis).
• if you have problems with your liver or kidneys.

If you are not sure if any of the above apply to you, consult your doctor or pharmacist
before taking Anastrozolo Alter.
If you are admitted to hospital, tell the medical staff that you are taking Anastrozolo
Alter.
For athletes
Using the medicine without a therapeutic need constitutes doping and may still
result in a positive doping test.

Other medicines and Anastrozolo Alter
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines. This includes medicines you can buy without a prescription and
herbal remedies. This is because Anastrozolo Altercan affect the way some
medicines work and some medicines can have an effect on Anastrozolo Alter.
Do not take Anastrozolo Alterif you are already taking any of the following medicines:

• some medicines used to treat breast cancer (selective estrogen receptor modulators), for example medicines containing tamoxifen. This is because these medicines can prevent Anastrozolo Alterfrom working correctly.
• medicines containing estrogens, for example hormone replacement therapy (HRT). If you are in one of these situations, ask your doctor or pharmacist for advice.

Tell your doctor or pharmacist ifyou are taking any of the following:

• A medicine known as an “LHRH analogue”. This includes gonadorelina, buserelina, goserelina, leuprorelina and triptorelina. These medicines are used to treat breast cancer, some women’s (gynaecological) conditions and infertility.

Pregnancy, breastfeeding and fertility
Do not take Anastrozolo Alterif you are pregnant or if you are breastfeeding.
Stop taking Anastrozolo Alterif you become pregnant and talk to your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
It is unlikely that Anastrozolo Alterwill affect your ability to drive or operate
tools or machines. However, some people may occasionally experience
weakness or drowsiness while taking Anastrozolo Alter. If this happens, ask
your doctor or pharmacist for advice.

Anastrozolo Altercontains lactose
Anastrozolo Alter contains lactose, a type of sugar. If you have been told by your
doctor that you have an intolerance to some sugars, contact them before taking this medicine.

Anastrozolo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say
essentially ‘sodium-free’.

3. How to take Anastrozolo Alter

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.

• The recommended dose is one tablet once a day.
• Try to take the tablet every day at the same time.
• Swallow the tablet whole with a sip of water.
• It does not matter if you take Anastrozolo Alter before, with or after meals. Continue to take Anastrozolo Alter for the entire period indicated by your doctor or pharmacist. This is a long-term treatment and you may need to take it for several years. If you have any doubts, ask your doctor or pharmacist.

Use in children and adolescents
Anastrozolo Alter must not be administered to children and adolescents.

If you take more Anastrozolo Alter than you should
If you take more Anastrozolo Alter than you should, inform your doctor immediately.

If you forget to take Anastrozolo Alter
If you forget to take a dose, take the next dose as usual.
Do not take a double dose (two doses at the same time) to make up for the missed dose.

If you stop taking Anastrozolo Alter
Do not stop taking the tablets unless instructed by your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Anastrozolo Alter and seek urgent medical attention if any of the following serious but very rare side effects occur:

• Extremely severe skin reaction, with the appearance of ulcers or blisters on the skin. This is known as “Stevens-Johnson syndrome”.
• Allergic reaction (hypersensitivity) with swelling of the throat, which can cause difficulty swallowing or breathing. Known as “angioedema”.

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

• Headache.
• Hot flushes.
• Feeling unwell (nausea).
• Skin rash.
• Pain or stiffness in the joints.
• Joint inflammation (arthritis).
• Feeling of weakness.
• Loss of bone density (osteoporosis).
• Depression

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

• Loss of appetite.
• Increased or high levels in the blood of a fatty substance known as cholesterol, verifiable with a blood test.
• Feeling sleepy.
• Carpal tunnel syndrome (tingling, pain, cold sensation, weakness, in some parts of the hand).
• Itching, tingling or numbness of the skin, loss/lack of taste.
• Diarrhea.
• Feeling sick (vomiting).
• Changes in blood tests relating to the function of your liver.
• Thinning hair (hair loss).
• Allergic reactions (hypersensitivity) including to the face, lips and tongue.
• Bone pain.
• Vaginal dryness.
• Vaginal bleeding (usually in the first few weeks of treatment - if bleeding continues, talk to your doctor).
• Muscle pain.

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

• Changes in some specific blood tests that highlight the function of your liver (gamma-GT and bilirubin).
• Inflammation of the liver (hepatitis).
• Hives.
• Trigger finger (a condition in which one of your fingers or thumb assumes a curved position).
• Increased amounts of calcium in your blood. If you experience nausea, vomiting and thirst, inform your doctor, pharmacist or nurse as a blood test may be necessary.

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

• Unusual skin inflammation that may include red spots or blisters.
• Skin erythema caused by hypersensitivity (this may be caused by an allergic or anaphylactic reaction).
• Inflammation of the capillaries that causes a red or purple discoloration of the skin. Very rarely, pain in the joints, stomach and kidneys may occur; this is known as “Henoch-Schönlein purpura”.

Effects on bones
Anastrozolo Alterreduces the amount of hormones called estrogens, present
in the body. This may reduce the mineral content of the bones; therefore, the bones may
be less strong and more prone to fractures. Your doctor will check these risks in accordance
with the treatment guidelines for the management of bone health in postmenopausal women.
Consult your doctor about these risks and treatment options.
If any of the side effects worsen, or if you notice any
side effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact 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 Anastrozolo Alter

Keep this medicine out of the sight and reach of children. Store the
tablets in a safe place where children cannot see or reach them. The
tablets may be dangerous to them.
Do not use this medicine after the expiry date which is stated on the pack after Exp.
The expiry date refers to the last day of the month.
Store the tablets in the original packaging.
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 Anastrozolo Alter contains

• The active ingredient is anastrozole. Each film-coated tablet contains 1 mg of anastrozole.
• The other ingredients are: Tablet core: lactose monohydrate, corn starch, povidone K-30, microcrystalline cellulose pH102, sodium starch glycolate Type A, anhydrous colloidal silica, magnesium stearate (E572), talc. Film coating: hypromellose 5cp (E464), macrogol 400, titanium dioxide (E171), talc.

Description of the appearance of Anastrozolo Alter and contents of the pack
Anastrozolo Alter tablets are white, round, film-coated with a diameter
of approximately 6.6 mm.
The tablets are available in blisters of 10 and 14 tablets.
Packs: 28 and 30 tablets.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Laboratori Alter s.r.l.
via Egadi, 7
20144 Milano
Italy
Manufacturer:
Remedica Ltd.
Limassol Industrial Estate
Aharnon Street
P.O Box 51706
3508 Limassol
Cyprus