Renazole

PACKAGE LEAFLET: INFORMATION FOR THE USER

Renazole 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 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 side effect, including those not listed in this leaflet, tell your doctor or pharmacist. Contents of this leaflet:
  1. What Renazole is and what it is used for
  2. What you need to know before taking Renazole
  3. How to take Renazole
  4. Possible side effects
  5. How to store Renazole
  6. Contents of the pack and other information

1. What Renazole is and what it is used for

Renazole contains a substance called anastrozole, which belongs to a group of medicines known as "aromatase inhibitors". Renazole is used to treat breast cancer in postmenopausal women.
Renazole 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 need to know before taking Renazole

Do not take Renazole:

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

Do not take Renazole if any of the above apply to you. If in doubt, consult your doctor or pharmacist before taking Renazole.

Take special care with Renazole
Talk to your doctor or pharmacist before taking Renazole:

• 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 Renazole 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 Renazole. If you are admitted to hospital, inform medical staff that you are taking Renazole.

Taking Renazole with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription and herbal remedies. Renazole may affect how some medicines work, and some medicines may affect Renazole.

Do not take Renazole 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 prevent Renazole from working properly.
• Medicines containing estrogens, for example, hormone replacement therapy (HRT). If you are taking any of these, ask your doctor or pharmacist for advice.

Tell your doctor or pharmacist if you are taking any of 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 Renazole if you are pregnant or breastfeeding. Stop taking Renazole if you become pregnant and speak to your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

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

Important information about some of the ingredients of Renazole
Renazole contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Renazole

Take this medicine exactly as directed 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 Renazole before, with, or after food. Continue taking Renazole for the entire duration prescribed by your doctor. This is a long-term treatment and you may need to take it for several years.

Use in children
Renazole must not be given to children and adolescents.
If you take more Renazole than you should
If you take more Renazole than you should, inform your doctor immediately.
If you forget to take Renazole
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 the missed dose.
If you stop taking Renazole
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, Renazole can cause side effects, although not everybody gets them.

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
• Loss of bone density (osteoporosis)
• Depression

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

• Loss of appetite
• Increased or high levels in the blood of a fat 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
• Diarrhea
• 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, speak to your doctor)
• Muscle pain

Uncommon side effects (may affect up to 1 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 side effects (may affect up to 1 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 side effects (may affect less than 1 in 10,000 people)

• A very 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 may cause difficulty swallowing or breathing. This is known as “angioedema”. If you experience any of these effects, call an ambulance or see a doctor immediately – urgent medical treatment may be required.

Effects on bones
Renazole reduces the amount of hormones called oestrogens 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 the management of bone health in postmenopausal women. Please discuss these risks and treatment options with your doctor.
Following the instructions in this leaflet helps reduce the risk of side effects.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Renazole

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 carton, the 28-tablet blister pack, or the tablet container. 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. Package contents and other information

What Renazole contains
The active substance is anastrozole. Each film-coated tablet contains 1 mg of anastrozole.
The other components are: monohydrate lactose, povidone (K30) (E1201), sodium starch glycolate (type
A), magnesium stearate (E572).
Tablet coating: hypromellose (E464), titanium dioxide (E171), Macrogol (400).
Description of the appearance of Renazole and contents of the pack
The tablet is white, round, biconvex, with "A 1" imprinted on one side and the other side smooth.
Packs:
28 tablets
Tablet container:
100 tablets
Marketing Authorization Holder
SF GROUP S.r.l.
Via Tiburtina, 1143
00156 – Rome - Italy
Responsible manufacturer for batch release
Laboratorio Italiano Biochimico Farmaceutico LISAPHARMA S.p.A.
Via Licinio 11
22036 Erba (CO)
Italy
This medicinal product is authorized in European Economic Area (EEA) Member States under the following
names:
IT: Renazole 1 mg film-coated tablets
This summary of product characteristics was last approved on