What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 31750/0040 .


Anastrozole 1 mg film-coated tablets

Package leaflet: Information for the user

Anastrozole 1 mg film-coated tablets

Anastrozole

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep 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 pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1. What Anastrozole is and what it is used for

Anastrozole contains a substance called anastrozole. This belongs to a group of medicines called ‘aromatase inhibitors’. Anastrozole is used to treat breast cancer in women who have gone through the menopause.

Anastrozole works by cutting down the amount of the hormone called estrogen that your body makes. It does this by blocking a natural substance (an enzyme) in your body called ‘aromatase’.

2. What you need to know before you take Anastrozole

Do not take Anastrozole

  • 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 the section called ‘Pregnancy and breast-feeding’).

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Anastrozole

  • if you still have menstrual periods and have not yet gone through the menopause
  • if you are taking a medicine that contains tamoxifen or medicines that contain estrogen (see the section called ”Other medicines and Anastrozole’)
  • if you have ever had a condition that affects the strength of your bones (osteoporosis)
  • if you have problems with your liver or kidneys.

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

If you go into the hospital, let the medical staff know you are taking Anastrozole.

Other medicines and Anastrozole

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Anastrozole can affect the way some medicines work and some medicines can have an effect on Anastrozole.

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

  • certain medicines used to treat breast cancer (selective estrogen receptor modulators), e.g., medicines that contain tamoxifen. This is because these medicines may stop Anastrozole from working properly.
  • medicines that contain estrogen, such as hormone replacement therapy (HRT).

If this applies to you, ask your doctor or pharmacist for advice.

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

  • a medicine known as an ‘LHRH analogue’. This includes gonadorelin, buserelin, goserelin, leuprorelin and triptorelin. These medicines are used to treat breast cancer, certain female health (gynaecological) conditions, and infertility.

Pregnancy, breast-feeding and fertility

Do not take Anastrozole if you are pregnant or breast-feeding. Stop Anastrozole if you become pregnant and talk to your doctor.

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.

Driving and using machines

Anastrozole is unlikely to affect your ability to drive or use any tools or machines. However, some people may occasionally feel weak or sleepy while taking Anastrozole. If this happens to you, ask your doctor or pharmacist for advice.

Anastrozole contain lactose monohydrate

Anastrozole 1 mg film coated tablets contain 68.75mg lactose monohydrate per tablet. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Anastrozole

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

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

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

Use in children and adolescents

Anastrozole should not be given to children and adolescents.

If you take more Anastrozole than you should

If you take more Anastrozole than you should, talk to a doctor straight away.

If you forget to take Anastrozole

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

Do not take a double dose to make up for a forgotten dose.

If you stop taking Anastrozole

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

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

4. Possible side effects

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

Stop taking Anastrozole and seek urgent medical treatment, if you experience any of the following serious but very rare side effects:

  • an extremely severe skin reaction with ulcers or blisters on the skin. This is known as ‘Stevens-Johnson syndrome’.
  • allergic (hypersensitivity) reactions with swelling of the throat that may cause difficulty in swallowing or breathing. This is known as ‘angioedema’.

Very common (may affect more than 1 in 10 people)

  • headache
  • hot flushes
  • feeling sick (nausea)
  • skin rash
  • pain or stiffness in your joints
  • inflammation of the joints (arthritis)
  • feeling weak
  • bone loss (osteoporosis).

Common (may affect up to 1 in 10 people)

  • loss of appetite
  • raised or high levels of a fatty substance known as cholesterol in your blood. This would be seen in a blood test.
  • feeling sleepy
  • carpal tunnel syndrome (tingling, pain, coldness, weakness in parts of the hand)
  • tickling, tingling or numbness of skin, loss/lack of taste
  • diarrhoea
  • being sick (vomiting)
  • changes in blood tests that show how well your liver is working
  • thinning of your hair (hair loss)
  • allergic (hypersensitivity) reactions including face, lips, or tongue
  • bone pain
  • vaginal dryness
  • bleeding from the vagina (usually in the first few weeks of treatment – if the bleeding continues, talk to your doctor)
  • muscle pain.

Uncommon (may affect up to 1 in 100 people)

  • changes in special blood tests that show how your liver is working (gamma-GT and bilirubin)
  • inflammation of the liver (hepatitis)
  • hives or nettle rash
  • trigger finger (a condition in which your finger or thumb catches in a bent position)
  • increased amounts of calcium in your blood. If you experience nausea, vomiting and thirst, you should tell your doctor, or pharmacist or nurse as you may need to have blood tests.

Rare (may affect 1 in 1,000 people)

  • rare inflammation of your skin that may include red patches or blisters
  • skin rash caused by hypersensitivity (this can be from allergic or anaphylactoid reaction)
  • inflammation of the small blood vessels causing red or purple colouring of the skin. Very rarely symptoms of joint, stomach, and kidney pain may occur; this is known as ‘Henoch-Schönlein purpura’.

Effects on your bones

Anastrozole lowers the amount of the hormone called estrogen that is in your body. This may lower the mineral content of your bones. Your bones may be less strong and may be more likely to fracture. Your doctor will manage these risks according to treatment guidelines for managing bone health in women who have gone through the menopause. You should talk to your doctor about the risks and treatment options.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Anastrozole

Keep this medicine out of the sight and reach of children. Keep your tablets in a safe place where children cannot see or reach them. Your tablets could harm them.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions. Store in the original package.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Anastrozole contains

  • The active substance is anastrozole.
  • Each film-coated tablet contains 1 mg anastrozole.
  • The other ingredients in the tablet core are lactose monohydrate, povidone K30 (E1201), sodium starch glycolate (type A), magnesium stearate (E572).
    The tablet cores are coated with film-coating agent Opadry white consisting of hypromellose 6CP (E464), titanium dioxide (E171), macrogol 400.

What Anastrozole looks like and contents of the pack

Anastrozole 1 mg film-coated tablets are white to off white circular, biconvex, film-coated tablets debossed with “A1” on one side.

The film-coated tablets are marketed in PVC/Al blisters of 10 or 14 tablets in boxes of 28, 30, 84 or 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

This medicinal product is authorised in the Member States of the EEA under the following names:

Germany: Anastrozol SUN 1 mg Filmtabletten

Italy: Anastrozolo SUN 1 mg compresse rivestite con film

The Netherlands: Anastrozol SUN 1 mg, filmomhulde tabletten

United Kingdom: Anastrozole 1 mg Film-coated Tablets

This leaflet was last revised in 01/2018

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