PACKAGE LEAFLET: INFORMATION FOR THE USER

EXTROPLEX 1 mg film-coated tablets

Anastrozole
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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

What EXTROPLEX is and what it is used for
What you need to know before taking EXTROPLEX
How to take EXTROPLEX
Possible side effects
How to store EXTROPLEX
Contents of the pack and other information

1. WHAT EXTROPLEX IS AND WHAT IT IS USED FOR

EXTROPLEX contains a substance called anastrozole, which belongs to a group of medicines known as "aromatase inhibitors". EXTROPLEX is used for the treatment of breast cancer in postmenopausal women.
EXTROPLEX works by reducing the amount of hormones called estrogens produced by the body. This is achieved by blocking a natural substance (enzyme) in your body called "aromatase".

2. WHAT YOU SHOULD KNOW BEFORE TAKING EXTROPLEX

Do not take EXTROPLEX:

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

Do not take EXTROPLEX if any of the above apply to you. If in doubt, consult your doctor or pharmacist before taking EXTROPLEX.
Warnings and precautions
Talk to your doctor or pharmacist before taking EXTROPLEX:
if you are still having menstrual periods and have not yet reached menopause.
if you are taking a medicine containing tamoxifen or medicines containing estrogens (see section "Other medicines and EXTROPLEX").
if you have or have ever had a condition affecting bone strength (osteoporosis).
if you have liver or kidney problems.
If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before taking EXTROPLEX.
If you are hospitalized, inform medical staff that you are taking EXTROPLEX.
Other medicines and EXTROPLEX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. EXTROPLEX may affect how some medicines work, and some medicines may affect EXTROPLEX.
Do not take EXTROPLEX if you are already taking any of the following medicines:
Certain medicines used to treat breast cancer (selective estrogen receptor modulators), for example, medicines containing tamoxifen. This is because these medicines may prevent EXTROPLEX from working properly.
Medicines containing estrogens, for example, hormone replacement therapy (HRT).
If any of these apply to you, ask your doctor or pharmacist for advice.
Inform your doctor or pharmacist if you are taking the following:
A medicine known as an “LHRH analogue”, such as gonadorelin, buserelin, goserelin, leuprorelin, and triptorelin. These medicines are used to treat breast cancer, certain gynecological conditions, and infertility.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take EXTROPLEX if you are pregnant or breastfeeding. Discontinue EXTROPLEX if you become pregnant and speak with your doctor.
Driving and operating machinery
It is unlikely that EXTROPLEX will affect your ability to drive or operate tools or machinery. However, some people may occasionally experience weakness or drowsiness while taking EXTROPLEX. If this occurs, consult your doctor or pharmacist.
Important information about some of the excipients in EXTROPLEX
EXTROPLEX contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.
For individuals engaged in sports: using this medicine without a therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

3. HOW TO TAKE EXTROPLEX

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

The recommended dose is one tablet once daily.
Try to take the tablet at the same time each day.
Swallow the tablet whole with a glass of water.
It does not matter whether you take EXTROPLEX before, with, or after food.

Continue taking EXTROPLEX for the entire period indicated by your doctor. This is a long-term treatment and you may need to take it for several years.
Use in children
EXTROPLEX must not be given to children and adolescents.
If you take more EXTROPLEX than you should
If you take more EXTROPLEX than you should, inform your doctor immediately.
If you forget to take EXTROPLEX
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 a missed dose.
If you stop taking EXTROPLEX
Do not stop taking the tablets unless instructed by your doctor.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Very common adverse reactions (affects more than 1 in 10 people):
Depression
Headache
Hot flushes
Feeling unwell (nausea)
Skin rash
Joint pain or stiffness
Inflammation of the joints (arthritis)
Feeling of weakness
Loss of bone density (osteoporosis)

Common adverse reactions (affects 1 to 10 in 100 people):
Loss of appetite
Increased or high blood levels of a fatty substance known as cholesterol, detectable by a blood test
Drowsiness
Carpal tunnel syndrome (tingling, pain, cold sensation in parts of the hand)
Diarrhea
Malaise (vomiting)
Changes in liver function blood tests
Hair thinning (hair loss)
Allergic reactions (hypersensitivity), including of the face, lips, and tongue
Bone pain
Vaginal dryness
Vaginal bleeding (usually during the first weeks of treatment – if bleeding continues, discuss with your doctor)
Itching, tingling, or numbness of the skin, loss or absence of taste
Muscle pain

Uncommon adverse reactions (affects 1 to 10 in 1,000 people):
Changes in specific blood tests indicating liver function (gamma-GT and bilirubin)
Inflammation of the liver (hepatitis)
Hives (urticaria)
Trigger finger (a condition in which a finger or thumb becomes locked in a bent position)
Increased levels of calcium in the blood. If nausea, vomiting, and thirst occur, inform your doctor, pharmacist, or nurse, as blood tests may be needed.

Rare adverse reactions (affects 1 to 10 in 10,000 people):
Unusual skin inflammation that may include red spots or blisters
Cutaneous erythema due to hypersensitivity (this may be caused by an allergic or anaphylactic reaction)
Inflammation of the capillaries causing red or purple skin discoloration. Very rarely, joint, stomach, and kidney pain may occur; this is known as “Henoch-Schönlein purpura”.

Very rare adverse reactions (affects less than 1 in 10,000 people):

Extremely severe skin reaction, with ulcers or blisters appearing on the skin. This is known as “Stevens-Johnson syndrome”.
Allergic reactions (hypersensitivity) with swelling of the throat, which may cause difficulty swallowing or breathing. This is known as “angioedema”. If you experience any of these reactions, call an ambulance or seek immediate medical attention – urgent medical treatment may be required.

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data):
Dry eyes
Lichenoid eruption (small itchy red or purple bumps on the skin)
Inflammation of a tendon or tendinitis (connective tissue connecting muscles to bones)
Tendon rupture (connective tissue connecting muscles to bones)
Memory impairment

Effects on bones
EXTROPLEX reduces the amount of hormones called estrogens in the body. This may reduce bone mineral content; therefore, bones may become weaker and more prone to fractures. Your doctor will monitor these risks in accordance with treatment guidelines for managing bone health in postmenopausal women. Please consult your doctor regarding these risks and available treatment options.

If any of the adverse reactions worsen or if you notice any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.

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

5. HOW TO STORE EXTROPLEX

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 harmful to them.
Do not use this medicine after the expiry date stated on the outer packaging. The expiry date refers to the last day of that month.
Store the tablets in their original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What EXTROPLEX contains
The active substance is anastrozole. Each film-coated tablet contains 1 mg of anastrozole.
The other components are:
Tablet core:
monohydrate lactose, maize starch, povidone K-30, microcrystalline cellulose pH102, sodium starch glycolate
Type A, colloidal anhydrous silica, magnesium stearate (E572), talc.
Film coating:
hypromellose 5cp (E464), macrogol 400, titanium dioxide (E171), talc.
Description of the appearance of EXTROPLEX and pack contents
The tablet is white, round, film-coated, with a diameter of approximately 6.6 mm.
The tablets are supplied in blisters of 10 and 14 tablets.
Pack sizes: 28 and 30 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SOPHOS BIOTECH S.r.l.
Via Modica 6
20143 Milan, Italy
Manufacturer responsible for batch release
Remedica Ltd.
Limassol Industrial Estate
P.O Box 51706
CY-3508 Limassol, Cyprus
This medicinal product is authorised in European Economic Area member states under the following
names:
Italy: EXTROPLEX