Anastrozole 1mg Film Coated Tablets
Out of date information, search anotherRead all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Anastrozole is and what it is used for
2. Before you take Anastrozole
3. How to take Anastrozole
4. Possible side effects
5. How to store Anastrazole
6. Further information
1. WHAT ANASTROZOLE IS AND WHAT IT IS USED FOR
Anastrozole belongs to a group of medicines called aromatase inhibitors. This means that it interferes with some of the actions of aromatase, an enzyme within the body which affects the level of certain female sex hormones such as oestrogens.
Anastrozole is used in the treatment of breast cancer in women who have gone through the menopause.
2. BEFORE YOU TAKE ANASTROZOLE Do not take Anastrozole
• if you are allergic (hypersensitive) to anastrozole or any of the other ingredients of Anastrozole (see section 6: Further information).
• if you are pregnant or breast feeding (see the section called 'Pregnancy and breast-feeding').
Do not take Anastrozole if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Anastrozole.
Take special care with Anastrozole
Before treatment with Anastrozole check with your doctor or pharmacist
• 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 or pharmacist before taking Anastrozole.
If you go into hospital let the medical staff know that you are taking anastrozole.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines. The reason is that 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. These medicines may stop Anastrozole from working properly.
• Medicines that contain estrogen, such as hormone replacement therapy (HRT).
If these apply 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 and breast-feeding
Do not take Anastrozole if you are pregnant or if you are breast-feeding. Please stop treatment and contact your doctor immediately if you think you may be pregnant.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Anastrozole is unlikely to adversely affect your ability to drive a car or to operate machinery. However, you may occasionally feel weak or sleepy. If this happens to you, ask your doctor for advice.
Important information about some of the ingredients of Anastrozole
Anastrozole 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.
3. HOW TO TAKE ANASTROZOLE
Always take Anastrozole exactly as your doctor has told you. You should 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 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:
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 (two doses at the same time) to make up for a forgotten dose.
If you stop taking Anastrozole
Do not stop taking your tablets even if you are feeling well, unless your doctor tells you.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Anastrozole can cause side effects, although not everybody gets them.
The following side effects are possible for anastrozole:
Very common (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 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).
• Vaginal dryness.
• Hair thinning (hair loss).
• Diarrhoea.
• Being sick (vomiting).
• Changes in blood tests that show how well your liver is working.
• Allergic (hypersensitivity) reactions including face, lips, or tongue.
• Bone pain.
• Bleeding from the vagina (usually in the first few weeks of treatment - if the bleeding continues, talk to your doctor).
Uncommon side effects (affect 1 to 10 people in 1000)
• 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 (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-Schonlein purpura'.
Very rare side effects (affect less than 1 people 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 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.
5. HOW TO STORE ANASTROZOLE
This medicinal product does not require any special storage conditions. Keep out of the reach and sight of children.
Do not use Anastrozole after the expiry date which is stated on the carton after <EXP>.
The expiry date refers to the last day of the month.
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. FURTHER INFORMATION
What Anastrozole contains
The active substance is anastrozole. Each film-coated tablet contains 1 mg anastrozole.
The other ingredients are:
Tablet core:
Lactose monohydrate, Maize starch, Povidone, Microcrystalline cellulose, Sodium starch glycolate Type A, Colloidal anhydrous silica, Magnesium stearate, Talc Film-coating:
Hypromellose, Macrogol 400, Titanium dioxide (E171), Talc
What Anastrozole looks like and contents of the pack
Anastrozole tablets are white, round, film-coated tablets.
The tablets are provided in blisters of 10 and 14.
20, 28, 30, 98 or 100 film-coated tablets Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Hikma Fa rmaceutica (Portugal), S.A.
Estrada do Rio da Mo, n°8, 8A e 8B Fervenqa
2705-906 Terrugem SNT Portugal
Manufacturer
Remedica Ltd Limassol Industrial Estate Aharnon Street, P.O.Box 51706 Cyprus
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria: Anastrozol Hikma 1 mg FUmtabietten
Germany: Ribomidex 1 mg Filmtabletten
Ireland: Anastrozole Hikma 1 mg film-coated tablets
Portugal: Anastrozol Hikma 1 mg comprimido revestido por
pelicula
Spain: Anastrozol Hikma comprimidos recubiertos con
pelicula de 1 mg
The Netherlands: Anastrozol Hikma 1 mg filmomhulde tabletten United Kingdom: Anastrozole 1 mg film-coated tablets
This leaflet was last approved in 07/2012