Anastrozole 1 Mg Film-Coated Tablets
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INFORMATION FOR THE USER
Anastrozole 1 mg film-coated tablets
anastrozole
The name of the medicine is Anastrozole 1 mg film-coated tablets, called Anastrozole in the rest of the leaflet.
Read 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 takeAnastrozole
3. How to take Anastrozole
4. Possible side effects
5. How to store Anastrozole
6. Further Information.
1. WHAT ANASTROZOLE IS AND WHAT IT IS USED FOR
Anastrozole tablets 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. BEFORE YOU TAKE ANASTROZOLE Do not take Anastrozole:
- if you are allergic (hypersensitive) to anastrozole or any of other ingredients of Anastrozole tablets (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 apply 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 the hospital, let the medical staff know 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. This includes medicines that you buy without a prescription and herbal 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 and breast-feeding
Do not take anastrozole if you are pregnant or breast-feeding. Stop anastrozole 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 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. If this happens to you, ask your doctor or pharmacist for advice.
Important information about some of the ingredients of Anastrozole tablets
Anastrozole tablets 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.
3. HOW TO TAKE ANASTROZOLE
Always take Anastrozole tablets 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 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, Anastrozole can cause side effects, although not everybody gets them.
Very common (affects more than 1 users in 10)
• Hot flushes.
• Feeling weak.
• Pain or stiffness in your joints.
• Skin rash.
• Feeling sick (nausea).
• Headache.
• Inflammation of the joints (arthritis).
• Bone loss (osteoporosis).
Common (affects 1 to 10 users in 100)
• Vaginal dryness. ^
• Bleeding from the vagina (usually in the first few weeks of
treatment - if the bleeding continues, talk to your doctor). g
• Thinning ofyour hair (hair loss).
• Diarrhoea.
• Loss of appetite.
• Raised or high levels of a fatty sub stance known as cholesterol in your blood. This would be seen in a blood test.
• Being sick (vomiting).
• Feeling sleepy.
• Carpal tunnel syndrome (tingling, pain, coldness, weakness in parts ofthe hand).
• Changes in blood tests that show how well your liver is working.
• Allergic (hypersensitivity) reactions including face, lips, or tongue.
• Bone pain.
Uncommon (affects 1 to 10 users in 1,000)
• Trigger finger (a condition in which your finger or thumb catches in a bent position).
• Changes in special blood tests that show how your liver is working (gamma-GT and bilirubin).
• Inflammation ofthe liver (hepatitis).
• Hives or nettle rash.
Rare (affect 1 to 10 users 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 (affects less than 1 users 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
Keep out ofthe reach and sight of children.
Keep your tablets in a safe place where children cannot see or reach them. Your tablets could harm them.
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 that month.
This medicinal product does not require any special storage conditions.
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: lactose monohydrate, sodium starch glycolate (Type A), povidone K-30 (E1201), magnesium stearate (E572), hypromellose 5 cP (E464), macrogol 400 and titanium dioxide (E171).
What Anastrozole look like and contents of the pack
Anastrozole tablets are white to off white, circular, film coated biconvex tablets, debossed with 'DB02' on one side and plain on other side. The tablets are provided in PVC/ Aluminium blister of 10 and 14 tablets; in packs of 14, 28, 30, 90, 98 and 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Fresenius Kabi Oncology Plc.
Lion Court, Farnham Road Bordon, Hampshire, GU35 0NF United Kingdom
This medicinal product is authorised in the Member States of the EEA under the following names:
Austria Anastrozol Kabi 1 mg Filmtabletten
Belgium Anastrozole Fresenius Kabi 1 mg,
filmomhulde tabletten
Bulgaria AHacTpo3on Ka6n 1 mg ^MMHpaHH
TadneTKH
Cyprus Anastrozole Kabi, 1 mg/tab,
ErciKaA,up,p,svo p,s Xemo uphvio SiokIo Czech Republic Anastrozol Kabi 1 mg Potahovane tablety Germany Anastrozol Kabi 1 mg Filmtabletten
Greece Anastrozole Kabi, 1 mg/tab,
ErciKaA,up,p,svo p,s Xemo uphvio SiokIo Hungary Anastrozol Kabi 1 mg filmtabletta
Ireland Anastrozole 1 mg film-coated tablets
Italy Anastrozolo Kabi
Luxembourg Anastrozol Kabi 1 mg Filmtabletten
The Netherlands Anastrozol Fresenius Kabi 1 mg filmomhulde tabletten
Portugal Anastrozol Kabi
Romania Anastrozol Kabi 1 mg comprimate filmate
Slovenia Anastrozol Kabi 1 mg filmsko oblozene
tablete.
United Kingdom Anastrozole 1 mg film-coated tablets
This leaflet was last approved in 09/2011.
ANASTROZOLE1 MG FILM-COATED TABLETS
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