Anastrozol Hetero 1 mg, filmomhulde tabletten

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

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

Do not take Anastrozole Hetero:

• if you are allergic (hypersensitive) to anastrozole or any of the other ingredients of Anastrozole Hetero (see Section 6: Contents of the pack and other information).
• if you are pregnant or breast-feeding (see the section called “Pregnancy, breast-feeding and fertility” overleaf.)

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

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Anastrozole Hetero

• 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 “Taking other medicines”).
• 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, pharmacist or nurse before taking Anastrozole Hetero.

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

Other medicines and Anastrozole Hetero

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 Anastrozole Hetero can affect the way some medicines work and some medicines can have an effect on Anastrozole Hetero.

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

• Certain medicines used to treat breast cancer (selective estrogen receptor moduladors), e.g., medicines that contain tamoxifen. This is because these medicines may stop Anastrozole Hetero 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 Hetero if you are pregnant or breast-feeding. Stop Anastrozole Hetero if you become pregnant and talk to your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Anastrozole Hetero 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 Anastrozole Hetero. If this happens to you, ask your doctor or pharmacist for advice.

Anastrozole Hetero contains lactose

Anastrozole Hetero 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 medicine.

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

• The usual 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 Hetero before, with or after food.

Keep taking Anastrozole Hetero 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

Anastrozole Hetero should not be given to children.

If you take more Anastrozole Hetero than you should

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

If you forget to take Anastrozole Hetero

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 Hetero

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, pharmacist or nurse.

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

Very common side effects (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 side effects (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).
• 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).

Uncommon side effects (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).

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

• Changes 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”.

Very rare side effects (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”.
• Allergic (hypersensitivity) reactions with swelling of the throat that may cause difficulty in swallowing or breathing. This is known as “angioedema”.

If any of these happen to you, call an ambulance or see a doctor straight away – you may need urgent medical treatment.

Effects on your bones

Anastrozole Hetero 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.

Keep 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. The expiry date refers to the last day of that month.

Keep your tablets in the container they came in.

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

• • The active substance is anastrozole. Each film tablet contains 1 mg of anastrozole.

• The other ingredients are: lactose monohydrate, sodium starch glycolate, povidone, magnesium stearate, hypromellose, titanium dioxide (E171), macrogol 400 (see Section 2: What you need to know before you take Anastrozole Hetero)

What Anastrozole Hetero looks like and contents of the pack

Anastrozole Hetero 1 mg film coated tablets.

White coloured, round shaped biconvex, film-coated tablets debossed with '1' on one side and 'H' on the other side.

Anastrozole Hetero is supplied in the following pack sizes:

PVC/Aluminium foil blisters in cartons of 10, 20, 28, 30, 84, 98, 100 and 300 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Hetero Europe, S.L.

Viladecans Business Park - Edificio Brasil

Catalunya 83-85 - 08840 Viladecans

Barcelona - Spain

Manufacturer

Pharmadox Healthcare, Ltd.

KW20A Kordin Industrial Park, Paola, PLA 3000

Malta

In het register ingeschreven onder: RVG 111265

This leaflet was last revised in april 2013.

Detailed information on this medicine is available on the web site of CBG.