Anastrozol Teva

1. WHAT IS ANASTROZOL TEVA AND WHAT IS IT USED FOR

Anastrozol Teva contains the active substance anastrozole. Anastrozole belongs to a group of medicines called aromatase inhibitors. Anastrozol Teva is used to treat breast cancer in postmenopausal women.
Anastrozol Teva reduces the amount of the female sex hormone, estrogen, produced by the body, by inhibiting a substance called aromatase.

2. IMPORTANT INFORMATION BEFORE TAKING ANASTROZOL TEVA

When NOT to take Anastrozol Teva

If any of the above situations apply to the patient, they should not take Anastrozol Teva. In case of doubt, they should consult a doctor or pharmacist.

Warnings and precautions

Before starting to take Anastrozol Teva, the patient should discuss it with their doctor or pharmacist if:

• the patient is still menstruating (has not yet reached menopause),
• the patient is taking a medicine containing tamoxifen or medicines containing estrogens (see "Anastrozol Teva and other medicines"),
• the patient has or has had any bone diseases (osteoporosis),
• the patient has kidney or liver disease.

In case of doubt, the patient should consult a doctor or pharmacist.
If the patient is hospitalized, they should inform the medical staff that they are taking Anastrozol Teva.

Children and adolescents

Anastrozol Teva should not be taken by children and adolescents.
Internal Use Only

Anastrozol Teva and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
This includes medicines that are available without a prescription and herbal medicines, as Anastrozol Teva may affect the way some medicines work, and some medicines may affect Anastrozol Teva.
The patient should not take Anastrozol Teva if they are already taking one of the following medicines:

• certain medicines used to treat breast cancer (selective estrogen receptor modulators), such as tamoxifen, as Anastrozol Teva may stop working properly,
• medicines containing estrogen, such as hormone replacement therapy (HRT). If this situation applies to the patient, they should contact their doctor or pharmacist.

The patient should tell their doctor if:

• they are taking any medicine from the group of LHRH analogs, such as gonadorelin, buserelin, goserelin, leuprorelin, or triptorelin. These are medicines used to treat breast cancer, certain gynecological diseases, and infertility.

Pregnancy and breastfeeding

Anastrozol Teva should not be taken during pregnancy and breastfeeding. The patient should stop taking Anastrozol Teva and consult their doctor if they become pregnant.

Driving and operating machinery

It is unlikely that Anastrozol Teva will affect the patient's ability to drive or operate machinery. However, in patients taking Anastrozol Teva, cases of weakness and drowsiness have been observed. If this situation applies to the patient, they should contact their doctor or pharmacist.

Anastrozol Teva contains lactose

If the patient has been diagnosed with intolerance to certain sugars, they should contact their doctor before taking the medicine.

Anastrozol Teva contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it is considered "sodium-free".

3. HOW TO TAKE ANASTROZOL TEVA

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.

• The recommended dose is one tablet once a day.
• The medicine should be taken regularly at the same time every day.
• The tablet should be swallowed whole and washed down with water.
• Anastrozol Teva can be taken with or without food.

Anastrozol Teva should be taken for as long as the doctor prescribes. The treatment is long-term and may last for several years.

Taking a higher dose of Anastrozol Teva than recommended

If the patient takes a higher dose of the medicine than recommended, they should immediately consult their doctor.
Internal Use Only

Missing a dose of Anastrozol Teva

If the patient misses a dose, they should take the next dose the next day at the usual time.
The patient should not take a double dose (two doses at the same time) to make up for the missed dose.

Stopping treatment with Anastrozol Teva

The patient should not stop taking Anastrozol Teva without consulting their doctor.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Anastrozol Teva can cause side effects, although not everybody gets them.

If the patient experiences any of the following serious but very rare side effects, they should stop taking Anastrozol Teva and immediately consult their doctor:

• severe skin reactions with ulcers or blisters on the skin, known as Stevens-Johnson syndrome;
• allergic reactions (hypersensitivity) with swelling of the throat, which can cause difficulty swallowing or breathing, known as angioedema.

Other side effects:

Very common side effects (may affect more than 1 in 10 patients):

• depression
• headache
• hot flashes
• nausea
• rash
• joint pain and stiffness
• arthritis (osteoarthritis)
• weakness
• osteoporosis (bone loss)

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

• loss of appetite
• increased or high cholesterol levels in the blood (shown by blood tests)
• drowsiness
• carpal tunnel syndrome (tingling, pain, coldness, weakness in the hand)
• tingling, numbness, or prickling sensation on the skin, loss of taste
• diarrhea
• vomiting
• increased liver enzyme activity shown by blood tests
• thinning and hair loss
• allergic reactions (hypersensitivity) on the face, lips, tongue
• bone pain
• vaginal dryness
• vaginal bleeding (mainly observed in the first weeks of treatment - if bleeding persists, the patient should consult their doctor)
• muscle pain

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

• changes in blood test results that measure liver function (increased gamma-GT and bilirubin levels in the blood)
• hepatitis
• hives or rash
• trigger finger (difficulty bending and straightening fingers)
• increased calcium levels in the blood. If the patient experiences nausea, vomiting, and thirst, they should inform their doctor or pharmacist, as blood tests may be necessary.

Rare side effects (may affect up to 1 in 1000 patients):

• inflammatory skin conditions, which may include red patches or scales
• skin rashes caused by hypersensitivity (due to allergy or anaphylactoid reaction)
• inflammation of small blood vessels, which can cause purple discoloration of the skin. Very rarely, joint pain, stomach pain, kidney pain, known as Henoch-Schönlein purpura, may occur

Effect on bones

Anastrozol Teva reduces estrogen levels in the blood and may cause a decrease in bone mineral density. Therefore, some patients may be at increased risk of bone fractures. The treating doctor will assess the existing risk to ensure healthy bones in postmenopausal women, according to treatment guidelines.
The patient should discuss the existing risk and possible treatment with their doctor.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. HOW TO STORE ANASTROZOL TEVA

Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP" and on the blister after "Expiry date". The expiry date refers to the last day of the month.
The batch number on the packaging is after the abbreviation "Lot".
Tablets should be stored in the original packaging.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. CONTENTS OF THE PACKAGING AND OTHER INFORMATION

What Anastrozol Teva contains

• The active substance of the medicine is anastrozole. Each coated tablet contains 1 mg of anastrozole.

Internal Use Only

• The medicine also contains: tablet core: lactose monohydrate, magnesium stearate (E572), povidone K-30, sodium carboxymethyl cellulose (type A), coating: hypromellose 5cP 2910 (E464), macrogol 400 and 6000, and titanium dioxide (E171).

What Anastrozol Teva looks like and contents of the packaging

• Anastrozol Teva is a white or almost white, round, coated tablet. One side of the tablet is marked with the number "93", and the other side is marked with "A10".
• Anastrozol Teva is available in packs of 14, 28, or 30 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel.: (22) 345 93 00

Manufacturer

Pharmachemie B.V., Swensweg 5, Postbus 552, 2003 Haarlem, Netherlands
TEVA Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042 Debrecen, Hungary
Teva Czech Industries, s.r.o., Ostravská 29, č.p. 305, 747 70 Opava-Komárov, Czech Republic
Merckle GmbH, Ludwig-Merckle-Str. 3, 89143 Blaubeuren, Germany

Date of approval of the leaflet: June 2021