Anastrozole teva

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Anastrozol Teva (Anastrozol 1 PCH)
1 mg, film-coated tablets
Anastrozolum
Anastrozol Teva and Anastrozol 1 PCH are different brand names for the same medicine.
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What Anastrozol Teva is and what it is 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 Anastrozol Teva is and what it is used for

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

2. Important information before using Anastrozol Teva

When NOT to use Anastrozol Teva

• If the patient is allergic 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 situations listed above apply to the patient, Anastrozol Teva must not be used.
If in doubt, consult a doctor or pharmacist.

Warnings and precautions

Before starting treatment with Anastrozol Teva, discuss with a doctor or pharmacist if:

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

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If in doubt, consult a doctor or pharmacist.
If admitted to hospital, inform the medical staff that you are taking Anastrozol Teva.

Children and adolescents

Anastrozol Teva must not be used in children and adolescents.

Anastrozol Teva and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, 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.

Do not use Anastrozol Teva if the patient is already taking any of the following medicines:

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

Tell the doctor if:

• the patient is taking any medicine belonging to the group of LHRH analogues, such as: gonadorelin, buserelin, goserelin, leuprorelin, triptorelin. These medicines are used in the treatment of breast cancer, certain gynaecological disorders, and infertility.

Pregnancy and breastfeeding

Anastrozol Teva must not be used during pregnancy or while breastfeeding. Treatment with Anastrozol Teva must be stopped and medical advice sought immediately if pregnancy occurs.

Driving and operating machinery

It is unlikely that Anastrozol Teva impairs the ability to drive or operate machinery. However, weakness and drowsiness have been observed in some patients taking Anastrozol Teva. If this applies to the patient, contact a doctor or pharmacist.

Anastrozol Teva contains lactose monohydrate

If the patient has been diagnosed with an intolerance to certain sugars, consult a doctor before taking this medicine.

Anastrozol Teva contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, i.e. it is considered "sodium-free".

3. How to use Anastrozol Teva

This medicine should always be used exactly as your doctor or pharmacist has told you.
If you are unsure, ask your doctor or pharmacist.

• The recommended dose is 1 tablet once daily.
• The medicine should be taken regularly at the same time each day.
• The tablet should be swallowed whole with water.
• Anastrozol Teva can be taken with or without food.

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Anastrozol Teva should be taken for as long as your doctor recommends. Treatment is long-term and may last several years.
Taking more Anastrozol Teva than recommended
If you take more than the recommended dose, contact your doctor immediately.
Missing a dose of Anastrozol Teva
If you miss a dose, take the next dose at your usual time the next day.
Do not take a double dose (two doses at the same time) to make up for a missed dose.
Stopping Anastrozol Teva treatment
Do not stop taking Anastrozol Teva without consulting your doctor.
If you have any further questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient experiences any of the following severe but very rare adverse reactions,
treatment with Anastrozol Teva must be discontinued and the patient should immediately contact a
doctor:

• extremely severe skin reactions with skin ulceration or blistering, known as Stevens-Johnson syndrome;
• allergic reactions (hypersensitivity) with swelling of the throat, which may cause difficulty in swallowing or breathing, known as angioedema.

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

• depression
• headache
• hot flushes
• nausea
• rash
• joint pain and stiffness
• joint inflammation (osteoarthritis)
• fatigue
• bone demineralization (osteoporosis).

Common adverse reactions (may affect up to 1 in 10 patients):

• loss of appetite
• increased or high serum cholesterol levels (shown in blood tests)
• drowsiness
• carpal tunnel syndrome (tingling, pain, coldness, weakness in part of the hand)
• skin pruritus, tingling or numbness, loss or absence of taste
• diarrhoea
• vomiting
• increased liver enzyme activity shown in blood tests
• thinning and loss of hair (alopecia)
• allergic reactions (hypersensitivity) affecting the face, mouth, tongue
• bone pain
• vaginal dryness

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• vaginal bleeding (mainly observed during the first weeks of treatment – if bleeding persists, contact your doctor)
• muscle pain.

Uncommon adverse reactions (may affect up to 1 in 100 patients):

• changes in blood test results indicating liver function (increased gamma-GT activity and serum bilirubin concentration)
• hepatitis
• urticaria or rash
• trigger finger (difficulty bending and straightening the finger)
• increased calcium levels in the blood. If the patient experiences nausea, vomiting, and thirst, inform the doctor or pharmacist, as blood tests may be required.

Rare adverse reactions (may affect up to 1 in 1000 patients):

• skin inflammation, possibly including red patches or scales
• skin rashes due to hypersensitivity (caused by allergy or anaphylactoid reaction)
• inflammation of small blood vessels causing purplish skin discoloration. Very rarely, joint, stomach, or kidney pain may occur, known as Henoch-Schönlein purpura.

Effect on bones
Anastrozol Teva reduces estrogen levels in the blood and may lead to decreased bone mineral density. Therefore, in some patients, the risk of bone fractures may increase. The treating physician will assess the existing risk and, in accordance with treatment guidelines, ensure healthy bones in postmenopausal women.
Please discuss with your doctor the existing risks and possible treatments.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products at the 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 adverse reactions helps provide more information on the safety of this medicine.

5. How to store Anastrozol Teva

Keep the medicine out of the 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 stated month.
No special storage instructions apply.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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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• Other ingredients are: tablet core: lactose monohydrate, magnesium stearate (E 572), povidone K 30, sodium carboxymethyl starch (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, film-coated tablet. One side of the tablet is marked with the number "93" and the other side with "A10".
• Anastrozol Teva is available in packs containing 30 tablets.

For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in the Netherlands, the country of export:
Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, the Netherlands
Manufacturer:
TEVA Pharmaceutical Works, Pallagi út 13, 4042 Debrecen, Hungary
Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, the 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 in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in the Netherlands, the country of export: RVG 34122
Parallel import authorisation number: 20/24
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