ARIMEDEXO®

PLEASE READ THE PACKAGE INSERT CAREFULLY BEFORE USE.

Keep the package insert for reference. If you have any questions that are not addressed here, please consult your physician. This drug has been individually prescribed by your physician for personal use. Under no circumstances do not administer it to others, even if they appear with the same symptoms, it may harm them. If you notice any of the side effects stated in this package please notify your doctor or pharmacist immediately.

WHAT IS ARIMEDEXO

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

ARIMEDEXO 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’.

IMPORTANT INFORMATION

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

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

Talk to your doctor, or pharmacist or nurse before taking ARIMEDEXO.

• 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 ARIMEDEXO’).
• 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 ARIMEDEXO.

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

HOW TO USE ARIMEDEXO

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

• The recommended dose is 1x 1mg 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 ARIMEDEXO before, with or after food.

Keep taking ARIMEDEXO for as long as your doctor or pharmacist tells you to. It is a long-term treatment and you may need to take it for several years. Check with your doctor or pharmacist if you are not sure.

ARIMEDEXO SIDE EFFECTS

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

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).

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).
• 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 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)

• 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’.

ARIMEDEXO 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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.