Anastrozole PensA

Patient Information Leaflet: Information for the User

Anastrozolo Pensa 1 mg Film-coated Tablets

anastrozole
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 you, because it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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

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

Anastrozolo Pensa contains a substance called anastrozole, which belongs to a group of medicines known as "aromatase inhibitors". Anastrozolo Pensa is used for the treatment of breast cancer in women who have gone through menopause.
Anastrozolo Pensa works by reducing the amount of hormones called estrogens produced by the body.
This occurs by blocking a natural substance (enzyme) in your body called "aromatase".

2. What you need to know before taking Anastrozole Pensa

Do not take Anastrozole Pensa

• 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 Anastrozole Pensa if any of the above situations apply to you. If in doubt, consult your doctor or pharmacist before taking Anastrozole Pensa.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Anastrozole Pensa:

• 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 Anastrozole Pensa 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 situations apply to you, consult your doctor or pharmacist before taking Anastrozole Pensa.
If you are admitted to hospital, inform medical staff that you are taking Anastrozole Pensa.
For those engaged in sports: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Other medicines and Anastrozole Pensa
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription and herbal medicines. This is because Anastrozole Pensa may affect how some medicines work, and some medicines may affect Anastrozole Pensa.
Do not take Anastrozole Pensa 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, as they may interfere with the proper action of Anastrozole Pensa.
• Medicines containing estrogens, for example hormone replacement therapy (HRT). If this applies to you, 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, or triptorelin. These medicines are used to treat breast cancer, certain gynecological conditions, and infertility.

Pregnancy and breastfeeding
Do not take Anastrozole Pensa if you are pregnant or breastfeeding. Stop taking Anastrozole Pensa 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 Anastrozole Pensa will affect your ability to drive or operate machinery. However, some people may occasionally experience weakness or drowsiness while taking Anastrozole Pensa. If this occurs, consult your doctor or pharmacist.
Anastrozole Pensa contains lactose
Anastrozole Pensa contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Anastrozole Pensa contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Anastrozolo Pensa

Take Anastrozolo Pensa 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 Anastrozolo Pensa before, with, or after food.

Continue taking Anastrozolo Pensa for the entire duration indicated by your doctor. This is a long-term treatment and you may need to take it for several years.
Use in children and adolescents
Anastrozolo Pensa must not be given to children and adolescents.
If you take more Anastrozolo Pensa than you should
If you take more Anastrozolo Pensa than you should, inform your doctor immediately.
If you forget to take Anastrozolo Pensa
If you forget to take a dose, take the next dose at the usual time.
Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
If you stop taking Anastrozolo Pensa
Do not stop taking the tablets unless instructed by your doctor.
If you have any questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Anastrozole Pensa and seek urgent medical attention if you experience any of the following very rare but serious side effects:

• A severe skin reaction, with the appearance of ulcers or blisters 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”.

Very common side effects (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 weak.
• Bone loss (osteoporosis).
• Depression.

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

• Loss of appetite.
• Increase or high levels in the blood of a fatty substance known as cholesterol, detectable by a blood test.
• Feeling sleepy.
• Carpal tunnel syndrome (tingling, pain, cold sensation in parts of the hand).
• Itching, tingling or numbness of the skin, loss or absence of taste.
• Diarrhoea.
• Feeling unwell (vomiting).
• Changes in blood tests relating to liver function.
• Thinning 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).
• Muscle pain.

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

• Changes in specific blood tests showing liver function (gamma-GT and bilirubin).
• Inflammation of the liver (hepatitis).
• Urticaria.
• Trigger finger (a condition in which one of your fingers or thumb becomes bent).
• Increased levels of calcium in the blood. If you experience nausea, vomiting and thirst, inform your doctor, pharmacist or nurse, as you may need blood tests.

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

• Unusual skin inflammation which may include red spots or blisters.
• Skin rash 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”.

Side effects with frequency not known (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 joining muscles to bones).
• Tendon rupture (connective tissue joining muscles to bones).
• Memory impairment.

Effects on bones
Anastrozole Pensa reduces the amount of hormones called estrogens 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 managing bone health in postmenopausal women. Please consult your doctor regarding these risks and treatment options.
If any of the side effects worsen, or if you notice any side effects 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, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Anastrozole Pensa

This medicine does not require any special storage conditions.
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 for them.
Do not use this medicine after the expiry date stated on the packaging and on the blister. The expiry date refers to the last day of that month.
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. Package contents and other information

What Anastrozolo Pensa contains
The active substance is anastrozole. Each film-coated tablet contains 1 mg of anastrozole.
The other components are:

• Tablet core: monohydrate lactose, lactose, sodium starch glycolate, microcrystalline cellulose PH-102, anhydrous colloidal silica, and magnesium stearate.
• Coating excipients: hypromellose, titanium dioxide (E171), and polyethylene glycol 6000.

Description of the appearance of Anastrozolo Pensa and contents of the pack
White, round, 5.5 mm in diameter, biconvex, film-coated tablets, smooth on both sides.
Anastrozolo Pensa is available in blister packs containing 28 or 30 film-coated tablets.

Marketing Authorization Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli, 6
20154 Milan
Italy

Manufacturers
SAG Manufacturing, S.L.U.
Ctra. N-I, Km 36
28750 San Agustín de Guadalix, Madrid, Spain
Galenicum Health, S.L.U.
Sant Gabriel, 50,
Esplugues de Llobregat
08950 Barcelona, Spain

This medicinal product is authorized in the European Economic Area countries under the following names:

• Portugal: Anastrozol Tolife
• Italy: Anastrozolo Pensa

This Patient Information Leaflet was last approved in March 2026