Eristrol

PACKAGE LEAFLET: INFORMATION FOR THE USER

ERISTROL 1 mg film-coated tablets

Anastrozole
Generic medicine
Please read all of this leaflet carefully before you start 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist or nurse.

Contents of this leaflet:

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

1. WHAT ERISTROL IS AND WHAT IT IS USED FOR

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

2. WHAT YOU SHOULD KNOW BEFORE TAKING ERISTROL

Do not take ERISTROL:

• if you are allergic (hypersensitive) to anastrozole or to any of the excipients in ERISTROL (see section 6: Further information).
• if you are pregnant or breastfeeding (see section "Pregnancy and breastfeeding").

Do not take ERISTROL if any of the above apply to you. If in doubt, consult your doctor or pharmacist before taking ERISTROL.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking ERISTROL:

• 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 "Taking ERISTROL with other medicines").
• 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 ERISTROL.
If you are admitted to hospital, inform the medical staff that you are taking ERISTROL.
For those engaged in sports: using the medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

Other medicines and ERISTROL
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines, including those obtained without a prescription and herbal remedies. ERISTROL may affect how some medicines work, and some medicines may affect ERISTROL.
Do not take ERISTROL 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 tamoxifene. These medicines may interfere with the proper action of ERISTROL.
• Medicines containing estrogens, for example, hormone replacement therapy (HRT). If you are in any of these situations, consult your doctor or pharmacist.

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
Do not take ERISTROL if you are pregnant or breastfeeding.
Discontinue ERISTROL if you become pregnant and speak with your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
It is unlikely that ERISTROL affects your ability to drive or operate machinery.
However, some people may occasionally experience weakness or drowsiness while taking ERISTROL. If this occurs, consult your doctor or pharmacist.

ERISTROL contains lactose
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 film-coated tablet, i.e. essentially "sodium-free".

3. HOW TO TAKE ERISTROL

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 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 ERISTROL before, with, or after food.

Continue taking ERISTROL for the entire duration 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, consult your doctor or pharmacist.
Use in children and adolescents
ERISTROL must not be given to children and adolescents.
If you take more ERISTROL than you should
If you take more ERISTROL than you should, inform your doctor immediately.
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If you forget to take ERISTROL
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 forgotten dose.
If you stop taking ERISTROL
Do not stop taking the tablets unless instructed by your doctor.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. POSSIBLE ADVERSE REACTIONS

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

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

• 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 (may affect 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
• Feeling unwell (vomiting)
• Changes in liver function tests in blood examinations
• Thinning or loss of hair (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 this with your doctor)
• Tingling or numbness of the skin, loss or absence of taste
• Muscle pain

Uncommon adverse reactions (may affect 1 to 10 in 1,000 people):

• Changes in specific blood tests indicating liver function (gamma-GT and bilirubin)
• Inflammation of the liver (hepatitis)
• Urticaria (hives)
• Trigger finger (a condition in which a finger or thumb locks 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 required.

Rare adverse reactions (may affect 1 to 10 in 10,000 people):

• Unusual skin inflammation that may include red spots or blisters
• Skin erythema due to hypersensitivity (this may be caused by an allergic or anaphylactic reaction)
• Inflammation of small blood vessels causing red or purple skin discolouration. Very rarely, joint, stomach and kidney pain may occur; this is known as “Henoch-Schönlein purpura”

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

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

Effects on bones
ERISTROL reduces the amount of hormones called oestrogens in the body. This may reduce the mineral content of bones; therefore, bones may become weaker and more prone to fractures. Your doctor will monitor these risks in accordance with treatment guidelines for bone health management 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, pharmacist or nurse. 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 ERISTROL

Keep this medicine out of the sight and reach of children. Store the tablets in a secure place where children cannot see or reach them. The tablets may be dangerous for them.
Do not use this medicine after the expiry date stated on the outer packaging and on the blisters. 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 you no longer use. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What ERISTROL contains

• The active substance is anastrozole. Each film-coated tablet contains 1 mg of anastrozole.
• The other components are:
  o Tablet core: lactose monohydrate, sodium starch glycolate (type A), magnesium stearate.
  o Film coating: Opadry II white 85F18422 composed of partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol 3350, talc.

Description of the appearance of ERISTROL and packaging contents
The tablet is white, round, film-coated, with the number “1” imprinted on one side and smooth on the other.
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Packaging:
ERISTROL 1 mg film-coated tablets are available in a pack containing 28 tablets in a cardboard carton.

Marketing Authorisation Holder:
JUST PHARMA S.r.l.

Manufacturers responsible for batch release:
Depo-Pack s.n.c. di Del Deo Silvio e C., Via Morandi 28, 21047 Saronno (VA), Italy
Genepharm SA Pallini Attiki, 15351, Greece

This medicinal product is authorised in the European Economic Area Member States under the following names:
Italy: ERISTROL

This Patient Information Leaflet was last approved on:
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