Anastrozol Teva

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Anastrozol Teva (Anastrozol 1 PCH)

1 mg, coated tablets

Anastrozolum
Anastrozol Teva and Anastrozol 1 PCH are different trade names for the same medicine.

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

• 1. What is Anastrozol Teva and what is it used for
• 2. Important information before taking Anastrozol Teva
• 3. How to take Anastrozol Teva
• 4. Possible side effects
• 5. How to store Anastrozol Teva
• 6. Contents of the pack and other information

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 blocking a substance called aromatase.

2. Important information before taking Anastrozol Teva

When NOT to take Anastrozol Teva

• If the patient has been diagnosed with an allergy to anastrozole or any of the other ingredients of this medicine (listed in section 6).
• If the patient is pregnant or breastfeeding (see "Pregnancy and breastfeeding").

If any of the above situations apply to the patient, Anastrozol Teva should not be taken. In case of doubts, the doctor or pharmacist should be consulted.

Warnings and precautions

Before starting to take Anastrozol Teva, the doctor or pharmacist should be consulted 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.

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In case of doubts, the doctor or pharmacist should be consulted.
If the patient is hospitalized, the medical staff should be informed about the use of Anastrozol Teva.

Children and adolescents

Anastrozol Teva should not be taken by children and adolescents.

Anastrozol Teva and other medicines

The doctor or pharmacist should be informed about all medicines taken or used by the patient, including those obtained without a prescription and herbal medicines, as Anastrozol Teva may affect the way some medicines work, and some medicines may affect Anastrozol Teva.
Anastrozol Teva should not be taken if the patient is 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 not work properly,
• medicines containing estrogen, such as hormone replacement therapy (HRT). If this situation applies to the patient, the doctor or pharmacist should be consulted.

The doctor should be informed if:

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

Pregnancy and breastfeeding

Anastrozol Teva should not be taken during pregnancy and breastfeeding. The use of Anastrozol Teva should be stopped and the doctor consulted if the patient becomes pregnant.

Driving and using machines

It is unlikely that Anastrozol Teva will affect the ability to drive or use machines. However, patients taking Anastrozol Teva have experienced weakness and drowsiness. If this situation applies to the patient, the doctor or pharmacist should be consulted.

Anastrozol Teva contains lactose monohydrate

If the patient has been diagnosed with intolerance to certain sugars, they should consult 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 as directed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.

• 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.

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

Overdose of Anastrozol Teva

In case of an overdose, the doctor should be consulted immediately.

Missed dose of Anastrozol Teva

If a dose is missed, the next dose should be taken the next day at the usual time.
A double dose should not be taken to make up for a missed dose.

Stopping Anastrozol Teva

Anastrozol Teva should not be stopped without consulting the doctor.
In case of any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

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 seek medical attention immediately:

• 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 thinning).

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

• loss of appetite
• increased or high levels of cholesterol 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

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• vaginal bleeding (mainly observed in the first weeks of treatment - if the bleeding persists, the doctor should be consulted)
• muscle pain.

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

• changes in blood test results for liver function (increased gamma-GT and bilirubin levels in the blood)
• liver inflammation
• 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, including red spots or scales
• skin rashes due to hypersensitivity (due to allergy or anaphylactoid reaction)
• inflammation of small blood vessels, causing 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, following the guidelines for treatment.
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, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Anastrozol Teva

Store in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Anastrozol Teva contains

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

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• The other ingredients are: tablet core: lactose monohydrate, magnesium stearate (E 572), povidone K 30, sodium carboxymethylcellulose (type A); coating: hypromellose (E 464), macrogol 400 and 6000, and titanium dioxide (E 171).

What Anastrozol Teva looks like and contents of the pack

• 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 the code "A10".
• Anastrozol Teva is available in packs of 30 tablets.

For more detailed information, the marketing authorization holder or parallel importer should be consulted.

Marketing authorization holder in the Netherlands, the country of export:

Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, Netherlands

Manufacturer:

TEVA Pharmaceutical Works, Pallagi út 13, 4042 Debrecen, Hungary
Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, Netherlands
TEVA Czech Industries s.r.o., Ostravská 29, č.p. 305, 747 70 Opava-Komárov, Czech Republic
Merckle GmbH, Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Netherlands marketing authorization number: RVG 34122

Parallel import authorization number: 20/24

Date of revision of the leaflet: 16.01.2024

[Information about the trademark]
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