1 mg film-coated tablets 
Anastrozole

Read all of this leaflet carefully before you start taking this medicine. Information to the user

  • Save this information, 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 you will find information about: 
1. What Anastelb is and what it is used for 
2. What you need to know before using Anastelb 
3. How to use Anastelb 
4. Possible side effects 
5. How to store Anastelb 
6. Contents of the packaging and other information 

1. What Anastelb is and what it is used for

Anastelb contains a substance called anastrozole. It belongs to a group of medicines called “aromatase inhibitors”. Anastelb is used to treat breast cancer in women who have passed menopause.

Anastelb works by reducing the amount of a hormone called estrogen, which is formed in the body. It does this by blocking a natural substance (an enzyme ) in the body called “aromatase”.

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

2. What you need to know before using Anastelb

Do not use Anastelb

  • 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 Anastelb if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Anastelb.

Warnings and cautions

Talk to your doctor or pharmacist before taking Anastelb

  • 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 Anastelb”)
  • 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 Anastelb if you are not sure if any of the above apply to you.

Tell your healthcare provider that you are taking Anastelb if you visit a hospital.

Other medicines and Anastelb

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 Anastelb can affect the way some other medicines work, and some medicines can affect Anastelb.

Do not take Anastelb 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 Anastelb 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 the following:

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Anastelb if you are pregnant or breast-feeding. Discontinue treatment with Anastelb and consult a doctor if you become pregnant.

Driving and using machines

Anastelb is unlikely to affect your ability to drive or use tools or machines. However, some people may sometimes feel weak or sleepy when taking Anastelb. 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 sharpened attention. 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. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Anastelb 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.

How to use Anastelb

Always take this medicine exactly as your doctor 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 Anastelb before, with, or after food.

Continue to take Anastelb for as long as your doctor tells you. It is a long-term treatment and you may need to take it for several years.

Use for children and adolescents

Anastelb should not be given to children and adolescents.

If you forget to use Anastelb

If you forget to take a dose, just take your next dose as usual.

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

If you stop using Anastelb

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

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

4. Possible side effects

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

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

  • headache
  • hot flashes
  • nausea
  • rash
  • pain or stiffness in the joints
  • inflammation of the joints ( arthritis )
  • impotence
  • bone loss ( osteoporosis )

Common side effects (affects 1 to 10 users in 100)

  • 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, and weakness in parts of the hand)
  • tickling / stinging sensation or numbness in the skin, lost/weakened sense of taste.
  • diarrhea
  • nausea (vomiting)
  • altered blood tests that show how your liver works
  • 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 (affects 1 to 10 users in 1,000)

  • changes in certain blood tests that show how your liver works (gamma-GT and bilirubin )
  • liver inflammation ( hepatitis )
  • hives ( urticaria )
  • trigger finger (a condition in which a finger or thumb gets stuck in a bent position)
  • increased amounts of calcium in the blood. If you experience nausea, vomiting, and thirst, you should talk to a doctor, pharmacist, or nurse, as you may need blood tests.

Rare side effects (affects 1 to 10 users in 10,000)

  • a rare type of skin inflammation that can cause red spots on the skin or blisters
  • skin rash caused by hypersensitivity ( allergy or other types of hypersensitivity)
  • 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 (affects less than 1 user in 10,000)

  • 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.

Effects on the skeleton

Anastrozole 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 Anastelb

Keep this medicine out of the sight and reach of children. Store your tablets in a safe place where children can not see or get hold of them. Your tablets can damage them.

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

Store the tablets in the original package.

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. One film-coated tablet contains 1 mg of anastrozole.

Other ingredients are:

Tablet core: lactose monohydrate , sodium starch glycolate (type A), povidone K25, magnesium stearate

Film coating: hypromellose, macrogol 6000, cottonseed oil, hydrated, starch, pregelatinized modified (origin: maize), titanium dioxide

What the medicine looks like and the contents of the pack

Anastelb 1 mg are white, round, film-coated tablets imprinted with ‘A1’ on one side.

Anastelb 1 mg film-coated tablets are available in the following packs:

28, 30, 50, 90, 98, 100 film-coated tablets

Not all packaging may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastr. 2-18

61118 Bad Vilbel

Germany

Other manufacturers:

Haupt Pharma Münster GmbH

Schleebrüggenkamp 15

48159 Münster

Germany

STADApharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Centrafarm Services BV

New Donk 9

4879 AC Etten Leur

Netherlands

Clonmel Healthcare Ltd.

Waterford Road, Clonmel

Co. Tipperary

Ireland

Local representative

STADA Nordic ApS

Marielundvej 46A

2730 Herlev

Denmark

Muhammad Nadeem

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