Package Insert: Patient Information

Anastrozol Teva-ratio 1 mg Film-Coated Tablets

Read this package insert carefully before you start taking this medicine because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Anastrozol contains a substance called anastrozole and belongs to a group of medicines called “aromatase inhibitors”. Anastrozolis used to treat breast cancer in women who are in menopause.

Anastrozolacts by reducing the amount of hormones called estrogens that are produced by your body, by blocking a natural bodily substance (an enzyme) called “aromatase”.

Do not take Anastrozol Teva-ratio

• If you are allergic (hypersensitive) to anastrozole or to any of the other components of this medication (including those listed in section 6).

• If you are pregnant or breastfeeding (see the section called “Pregnancy and breastfeeding”).

Do not take Anastrozol Teva-ratio if you find yourself in any of the situations described above. If you are unsure, consult your doctor or pharmacist before taking Anastrozol Teva-ratio.

Warnings and precautions

Consult your doctor or pharmacist before taking Anastrozol Teva-ratio, and check with your doctor or pharmacist

• If you still have menstrual periods and have not yet reached menopause.
• If you are taking a medication that contains tamoxifen or medications that contain estrogen (see the section called “Use of Anastrozol Teva-ratio with other medications”).

• If you have ever had any alteration that affects the strength of your bones (osteoporosis).
• If you have any liver or kidney problems.

If you are unsure about any of this affecting you, consult your doctor or pharmacist before taking Anastrozol Teva-ratio.

Inform hospital staff that you are taking Anastrozol Teva-ratio.

Children and adolescents

Anastrozol ratio should not be administered to children and adolescents

Use of Anastrozol Teva-ratio with other medications

Inform your doctor or pharmacist if you are taking/using, have taken/used recently, or may need to take/use any other medication, including those acquired without a prescription and herbal remedies. This is because Anastrozol Teva-ratio may affect the activity of other medications, and some medications may have an effect on Anastrozol Teva-ratio.

Do not take Anastrozol Teva-ratio if you are already being treated with any of the following medications:

• Certain medications used to treat breast cancer (selective estrogen receptor modulators), such as medications containing tamoxifen. This is because these medications may make Anastrozol Teva-ratio ineffective.

• Medications that contain estrogens, such as hormone replacement therapy (HRT).

If you find yourself in any of these situations, seek advice from your doctor or pharmacist.

Consult your doctor or pharmacist if you are taking the following:

• A medication known as an “LHRH analogue”. This includes gonadorelin, buserelin, goserelin, leuprorelin, and triptorelin. These medications are used to treat breast cancer, certain gynecological health conditions, and infertility.

Pregnancy and breastfeeding

Do not take Anastrozol Teva-ratio if you are pregnant or breastfeeding. Stop taking Anastrozol Teva-ratio if you become pregnant and consult your doctor.

Driving and operating machinery

It is unlikely that Anastrozol Teva-ratio will affect your ability to drive or use any tool or machine. However, occasionally some patients may feel weakness or drowsiness while taking Anastrozol Teva-ratio. If this happens, seek advice from your doctor or pharmacist.

Important information for athletes

Warning to athletes: this medication contains a component that may result in a positive analytical test for doping control.

Anastrozol Teva-ratio contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Anastrozol Teva-ratio contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per coated tablet; that is, it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

• The recommended dose is one daily tablet.
• Try to take the tablet at the same time every day.
• Swallow the tablet whole with the help of water.
• You can take Anastrozol Teva-ratio before, during, or after meals.

Continue taking Anastrozol Teva-ratio for the time your doctor tells you to. This is a long-term treatment and you may need to take it for several years.

If you take more Anastrozol Teva-ratio than you should

If you take more Anastrozol Teva-ratio than you should, contact your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Anastrozol Teva-ratio

If you forget to take a dose, simply take the next dose normally.

Do not take a double dose (two doses at the same time) to compensate for the missed doses.

If you interrupt treatment with Anastrozol Teva-ratio

Do not stop taking your medication unless your doctor tells you to.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Anastrozol Teva-ratio and seek urgent medical treatment if you experience any of the following rare but serious side effects:

• A severe skin reaction with blisters or ulcers on the skin. This is known as “Stevens-Johnson syndrome”.
• Allergic reactions (hypersensitivity) with swelling of the throat that can cause difficulty swallowing or breathing. This is known as “angioedema”.

Other side effects:

Very common side effects (can affect more than 1 in 10 people)

• Depression
• Headache.

• Hot flashes.
• Sensation of dizziness (nausea).
• Skin rash.
• Pain or stiffness in the joints
• Joint inflammation (arthritis).
• Weakness
• Bone loss (osteoporosis).

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

• Loss of appetite.
• Increased or high levels of a fatty compound in the blood known as cholesterol, which would be observed in a blood test.
• Drowsiness.
• Carpal tunnel syndrome (tingling, pain, sensation of coldness, weakness in areas of the hand).
• Itching, tingling or numbness of the skin, loss / lack of taste.
• Diarrhea.
• Vomiting.
• Changes in blood tests that show how well your liver is functioning.
• Thinning of hair (hair loss).
• Allergic reactions (hypersensitivity) including face, lips or tongue.
• Bone pain.

• Vaginal dryness.
• Vaginal bleeding, (usually in the first weeks of treatment – if bleeding continues, talk to your doctor)
• Muscle pain.

Rare side effects (can affect up to 1 in 100 people)

• Changes in special blood tests that show how well your liver is functioning (gamma-GT and bilirubin).
• Liver inflammation (hepatitis).
• Hives or welts.

• Trigger finger (alteration in which one of the fingers of the hand stays in a bent position).
• Increased amount of calcium in the blood. If you experience nausea, vomiting and thirst, you should inform your doctor, pharmacist or nurse as it may be necessary for them to perform a blood test

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

• Rare skin inflammation that may include red patches or blisters.
• Skin rash caused by hypersensitivity (this may be due to an allergic reaction or anaphylactoid reaction).
• Inflammation of small blood vessels causing red or purple discoloration of the skin. Very rarely, symptoms of joint pain, stomach and kidney pain may occur; this is known as “Henoch-Schönlein purpura”.

Effects on your bones

Anastrozol Teva-ratio reduces the levels of hormones called estrogens present in your body. This can reduce the mineral content of your bones. These may be less strong and make fractures more likely. Your doctor will monitor these risks according to the treatment guidelines for bone health in postmenopausal women. You should talk to your doctor about the risks and treatment options.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use, https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

• The active ingredient is anastrozole. Each film-coated tablet contains 1mg of anastrozole.

• The other components are:

Lactose monohydrate, magnesium stearate (E572),povidone K-30,carboxymethylcellulose sodium (type A) from potato

Coating: hypromellose (E464), macrogol 400 and 6000 and titanium dioxide (E171).

Appearance of the product and contents of the package.

• Anastrozole Teva-ratio 1mg film-coated tablets, are white to off-white round tablets. One side of the tablet is marked with “93”and the other side with “A10” .
• Anastrozole Teva-ratio 1mg film-coated tablets, are available in package sizes of 1, 10, 14, 20, 28, 30 (3 x 10), 50, 56, 60, 84, 90, 98, 100 and 300 tablets. Hospital packs of 84 tablets and hospital packs with single dose units of 10 (10 x 1) and 50 (50 x 1) film-coated tablets are also available.

Only some package sizes may be marketed.

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st Floor

28108 Alcobendas, Madrid

Spain

Responsible for manufacturing

Teva Pharmaceutical Works Private Limited Company

Pallagi Street 13

H-4042 Debrecen

Hungary

or

Pharmachemie B. V.

Swensweg 5, Postbus 552, 2003 RN Haarlem

Netherlands

or

Teva Czech Industries s.r.o.

Ostravská 29, c.p. 305, 747 70 Opava -Komárov

Czech Republic

Teva Pharma S.LU.

C/ C, n° 4, Industrial Estate Malpica,

50016 Zaragoza

Merckle GmbH

Ludwig-Merckle-Strasse 3, 89143 Blaubeuren

Germany

Revision date of this leaflet: July 2021

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”

You can access detailed and updated information on this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76081/P_76081.html