Arimidex 1mg Film-Coated Tablet

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, or pharmacist or nurse.
• 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

• are allergic to anastrozole or any of the other ingredients of this medicine (listed in section 6).
• are pregnant or breast-feeding (see the section called ‘Pregnancy and breast-feeding’).

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

Talk to your doctor, or pharmacist or nurse before taking Arimidex

• 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 oestrogen (see the section called ‘Other medicines and Arimidex’).
• if you have, or have ever had a condition that affects the strength of your bones (osteoporosis or osteopenia).
  Arimidex lowers the levels of female hormones and this may lead to a loss of the mineral content of bones, which might decrease their strength. You may have to have bone density tests during treatment. Your doctor can give you medicine to prevent or treat the bone loss. Women with severe osteoporosis are not suitable for anastrozole treatment.
• if you have problems with your liver or kidneys.
• if you have heart problems or have had a stroke.

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

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

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Arimidex can affect the way some medicines work and some medicines can have an effect on Arimidex.

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

• Certain medicines used to treat breast cancer (selective oestrogen receptor modulators), e.g. medicines that contain tamoxifen. This is because these medicines may stop Arimidex from working properly.
• Medicines that contain oestrogen, 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.

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

If you are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Arimidex is not likely to affect your ability to drive or use any tools or machines. However, some people may occasionally feel weak or sleepy while taking Arimidex. If this happens to you, ask your doctor or pharmacist for advice.

Arimidex contains lactose which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free’.

Arimidex should not be given to children and adolescents.

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

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

Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

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

Common (may affect up to 1 in 10 people):

• Allergic (hypersensitivity) reactions including face, lips, or tongue.

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

• Rare inflammation of your skin that may include red patches or blisters (erythema multiforme).

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

• An extremely severe skin reaction with ulcers or blisters on the skin. This is known as ‘Stevens-Johnson syndrome’
• Swelling of the throat that may cause difficulty in swallowing or breathing. This is known as ‘angioedema’.

Very common side effects (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)
• Depression.

Common side effects (affect 1 to 10 people in 100)

• Loss of appetite
• Raised or high levels of 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)
• 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 side effects (affect 1 to 10 people in 1,000)

• 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 side effects (affect 1 to 10 people in 10,000)

• 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’.

Arimidex 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.

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 via the Yellow Card Scheme Website: 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.

• The active substance is anastrozole. Each film-coated tablet contains 1 mg of anastrozole.
• The other ingredients are: lactose monohydrate, povidone, sodium starch glycollate, magnesium stearate, hypromellose, macrogol 300, titanium dioxide.

White, round, biconvex film-coated tablets of about 6.1 mm marked ‘A’ on one side and ‘Adx1’ on the other side.

Arimidex comes in blister packs of 28 tablets.

The Marketing Authorisation for Arimidex 1 mg film-coated tablets marketed in the UK is held by