1 mg film-coated tablets 
anastrozole

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Anastrozole Teva is and what it is used for 
2. What you need to know before you use Anastrozole Teva 
3. How to use Anastrozole Teva 
4. Possible side effects 
5. How to store Anastrozole Teva 6. Contents of the pack 
and other information 

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

  • Anastrozole Teva contains a substance called anastrozole. It belongs to a group of medicines called “aromatase inhibitors”. Anastrozole Teva is used to treat breast cancer in menopausal women.
  • Anastrozole Teva works by reducing the amount of a hormone called estrogen , which is produced in the body. It does this by blocking a natural substance (an enzyme ) in the body called “aromatase”.

Anastrozole contained in Anastrozole Teva may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.

What you need to know before using Anastrozole Teva

Do not use Anastrozole Teva

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

Do not take Anastrozole Teva if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Anastrozole Teva.

Warnings and cautions

Talk to your doctor or pharmacist before using Anastrozole Teva

  • if you are still menstruating and have not passed menopause.
  • if you are taking a medicine that contains tamoxifen or medicines that contain estrogen (see section “Other medicines and Anastrozole Teva”).
  • if you have ever had a condition that affects the strength of your skeleton ( osteoporosis, ie osteoporosis).
  • if you have liver or kidney problems.

Talk to your doctor or pharmacist before taking Anastrozole Teva if you are not sure if any of the above applies to you.

Tell your healthcare provider that you are taking Anastrozole Teva if you go to the hospital.

Children and young people

Anastrozole Teva should not be given to children and adolescents.

Other medicines and Anastrozole Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines and herbal medicines. This is because Anastrozole Teva may affect the way some other medicines work, and some medicines may affect Anastrozole Teva.

Do not use Anastrozole Teva if you are already taking any of the following medicines:

  • Certain drugs used to treat breast cancer (selective estrogen receptor modulators) e.g. medicines containing tamoxifen. This is because these medicines can prevent Anastrozole Teva from working properly.
  • Drugs that contain estrogen, such as hormone replacement therapy ( HRT ).

Ask your doctor or pharmacist for advice if this applies to you.

Tell your doctor or pharmacist if you are taking any of the following:

  • A drug called an “LHRH analog”. This includes gonadorelin, buserelin, goserelin, leuprorelin, and triptorelin. These drugs are used to treat breast cancer, certain gynecological diseases (gynecological conditions), and infertility.

Pregnancy and breastfeeding

Anastrozole Teva should not be used if you are pregnant or breast-feeding. If you become pregnant, stop taking Anastrozole Teva and talk to your doctor.

Driving and using machines

Anastrozole Teva is unlikely to affect your ability to drive or use tools or machines. However, some people may sometimes feel weak or drowsy when taking Anastrozole Teva. Ask your doctor or pharmacist for advice if this happens to you.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects . Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Anastrozole Teva contains lactose and sodium

Anastrozole Teva contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Anastrozole Teva contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, ie essentially ‘sodium-free’.

3. How to use Anastrozole Teva

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

  • The recommended dose is one tablet once a day.
  • Try to take the tablet at the same time each day.
  • Swallow the tablet whole with water.
  • It does not matter if you take Anastrozole Teva before, with, or after food.

Keep taking Anastrozole Teva for as long as your doctor tells you. It is a long-term treatment and you may need to take it for several years.

If you forget to use Anastrozole Teva

If you forget to take a dose, just take your next dose as usual. 
Do not take a double dose to make up for a forgotten dose.

If you stop using Anastrozole Teva

Do not stop taking your tablets even if you feel well unless your doctor recommends it.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

  • Headache
  • Hemorrhoids
  • Nausea
  • Rash
  • Pain or stiffness in the joints
  • Arthritis ( arthritis )
  • Feeling weak
  • Bone tissue loss ( osteoporosis ).

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

  • Loss of appetite
  • Elevated or high levels of a fatty substance called cholesterol in the blood. This can be seen in a blood test
  • Somnolence
  • Carpal tunnel syndrome (tingling, pain, cold, weakness in parts of the hand)
  • Diarrhea
  • Nausea (vomiting)
  • Changes in blood tests that show how well your liver is working
  • Sparser hair growth (hair loss)
  • Allergic reactions (hypersensitivity) involving the face, lips, or tongue
  • Skeletal pain
  • Vaginal dryness
  • Vaginal bleeding (usually during the first weeks of treatment – talk to a doctor if the bleeding continues)
  • Muscle pain.

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

  • Changes in some blood tests that show how your liver works (gamma-GT and bilirubin )
  • Inflammation of the liver ( hepatitis )
  • Hives
  • Trigger finger (a condition in which a finger or thumb gets stuck in a bent position)
  • The increased amount of calcium in the blood. If you experience nausea, vomiting, and thirst, you should contact your doctor or pharmacist as you may need to take blood samples.

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

  • A rare skin inflammation that can include red spots or blisters
  • Skin rash caused by hypersensitivity (which may be due to an allergic or anaphylactoid reaction)
  • Inflammation of the small blood vessels, which causes red or purple discoloration of the skin. Very rare symptoms of joint, stomach, and kidney pain may occur; this is called “Enoch-Schönlein’s purple”.

Very rare side effects (may affect up to 1 in 10,000 people)

  • An extremely serious skin reaction with sores or blisters on the skin. This is called “Stevens-Johnson syndrome”
  • Allergic reactions (hypersensitivity) with throat swelling that may make it difficult to swallow or breathe. This is called “angioedema”.

If any of these affect you, call an ambulance, or see a doctor immediately. You may need urgent medical attention.

Bone effects 
Anastrozole Teva reduces the levels of a hormone called estrogen in your body. This can reduce the mineral content of your skeleton. Your skeleton may become weaker and more easily affected by fractures. Your doctor will manage these risks according to treatment guidelines for the care of bone health in women who have passed menopause. Talk to your doctor about these risks and different treatment options.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Anastrozole Teva

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


Do not use this medicine after the expiry date which is stated after EXP. The expiration date is the last day of the specified month. 

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is anastrozole. Each film-coated tablet contains 1 mg of anastrozole.
  • The other ingredients are: 
    Tablet core: lactose monohydrate, magnesium stearate (E572), povidone K-30, sodium starch glycolate type A 
    Coating: hypromellose (E464), macrogol 400 and 6000, and titanium dioxide (E171).

What the medicine looks like and the contents of the pack

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer


Manufacturer:

Teva UK Ltd, Eastbourne, United Kingdom

Pharmachemie BV, Haarlem, The Netherlands

Galien LPS, Sens, France

Teva Pharmaceutical Works Private Limited Company, Debrecen, Hungary

Teva Pharmaceutical Works Private Limited Company, Gödöllö, Hungary

Teva Czech Industries sro, Opava, Czech Republic

Merckle GmbH, Blaubeuren, Germany

Muhammad Nadeem

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