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1.

WHAT ANASTROZOLE TABLETS ARE AND  if you still have menstrual periods and have
ANASTROZOLE TABLETS IP WHAT THEY ARE USED FOR not yet gone through the menopause.
1 MG  if you are taking a medicine that contains
Anastrozole tablets contain a substance called tamoxifen or medicines that contain estrogen
Package leaflet: Information for the patient anastrozole. This belongs to a group of medicines (see the section called ‘Other medicines and
called ‘aromatase inhibitors’. Anastrozole tablets Anastrozole tablets ’).
Anastrozole tablets 1 mg tablet are used to treat breast cancer in women who  if you have ever had a condition that affects
have gone through the menopause. the strength of your bones (osteoporosis).
Read all of this leaflet carefully before you start  if you have problems with your liver or
taking this medicine because it contains important
Anastrozole tablets work by cutting down the
amount of the hormone called estrogen that your kidneys.
information for you.
- Keep this leaflet. You may need to read it again. body makes. It does this by blocking a natural
- If you have any further questions, ask your doctor or substance (an enzyme) in your body called If you are not sure if any of the above applies to
pharmacist. ‘aromatase’. you, talk to your doctor or pharmacist before
- This medicine has been prescribed for you only. Do not taking Anastrozole tablets.
pass it on to others. It may harm them, even if their 2. WHAT YOU NEED TO KNOW BEFORE YOU
signs of illness are the same as yours. TAKE ANASTROZOLE TABLETS If you go into the hospital, let the medical staff
- If you get any side effects, talk to your doctor or know you are taking Anastrozole tablets.
pharmacist. This includes any possible side effects not Do not take Anastrozole tablets if you
listed in this leaflet (see section 4). Other medicines and Anastrozole tablets
Tell your doctor or pharmacist if you are taking,
 are allergic to anastrozole or any of the other
have recently taken or might take any other
-The full name of the product is Anastrozole 1mg ingredients of this medicine (listed in section
Film-coated Tablets but within the leaflet it will be medicines.
section 6 ).
referred to as Anastrozole tablets.  are pregnant or breast feeding (see the This includes medicines that you buy without a
section called ‘Pregnancy and breast- prescription and herbal medicines. This is because
What is in this leaflet feeding’). Anastrozole tablets can affect the way some
medicines work and some medicines can have an
1. What Anastrozole tablets are and what they Do not take Anastrozole tablets if any of the above effect on Anastrozole tablets.
are used for apply to you. If you are not sure, talk to your
2. What you need to know before you take Do not take Anastrozole tablets if you are already
doctor or pharmacist before taking Anastrozole
Anastrozole tablets taking any of the following medicines:
tablets.
3. How to take Anastrozole tablets
4. Possible side effects Warnings and precautions  Certain medicines used to treat breast cancer
5. How to store Anastrozole tablets Talk to your doctor or pharmacist before taking (selective estrogen receptor modulators), e.g.,
6. Contents of the pack and other information Anastrozole tablets: medicines that contain tamoxifen. This is
because these medicines may stop
Anastrozole tablets from working properly.
 Medicines that contain estrogen, such as 3. HOW TO TAKE ANASTROZOLE TABLETS If you stop taking Anastrozole tablets
hormone replacement therapy (HRT). Do not stop taking your tablets, unless your doctor
Always take this medicine exactly as your doctor
If this applies to you, ask your doctor or tells you to.
has told you. Check with your doctor or
pharmacist for advice.
pharmacist if you are not sure. If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
Tell your doctor or pharmacist if you are taking the
 The recommended dose is one tablet (1mg
following:
anastrozole) once a day.
4. POSSIBLE SIDE EFFECTS
 Try to take your tablet at the same time each
 A medicine known as an ‘LHRH analogue’. Like all medicines, this medicine can cause side
day.
This includes gonadorelin, buserelin,
 Swallow the tablet whole with a drink of effects, although not everybody gets them.
goserelin, leuprorelin and triptorelin. These
water.
medicines are used to treat breast cancer, Serious side effects:
 It does not matter if you take Anastrozole
certain female health (gynaecological) If you get any of the following serious side effects,
tablets before, with or after food.
conditions, and infertility. call an ambulance or see a doctor straight away -
you may need urgent medical treatment.
Keep taking Anastrozole tablets for as long as your
Pregnancy and breast-feeding
doctor tells you to.
Do not take Anastrozole tablets if you are  An extremely severe skin reaction with ulcers
pregnant or breast-feeding. Stop taking It is a long-term treatment and you may need to or blisters on the skin. This is known as
Anastrozole tablets if you become pregnant and take it for several years. ‘Stevens-Johnson syndrome’. Very rare (may
talk to your doctor. affect less than 1 person in 10,000 people);
Use in children and adolescents  Allergic (hypersensitivity) reactions with
Ask your doctor or pharmacist for advice before Anastrozole tablets should not be given to swelling of the throat that may cause
taking any medicine. children and adolescents. difficulty in swallowing or breathing. This is
Driving and using machines If you take more Anastrozole tablets than you known as ‘angioedema’. Very rare (may affect
Anastrozole tablets are not likely to affect your should less than 1 person in 10,000 people);
ability to drive or use any tools or machines. If you take more Anastrozole tablets than you
However, some people may occasionally feel weak should, talk to a doctor straight away. Other side effects:
or sleepy while taking Anastrozole tablets. If this
happens to you, ask your doctor or pharmacist for If you forget to take Anastrozole tablets Very common side effects (may affect more
advice. If you forget to take a dose, just take your next than 1 in 10 people):
dose as normal. Do not take a double dose (two
Anastrozole tablets contain lactose doses at the same time) to make up for a  Headache
If you have been told by your doctor that you have forgotten dose.  Hot flushes
an intolerance to some sugars, contact your  Feeling sick (nausea)
doctor before taking this medicine.  Skin rash
 Pain or stiffnessin your joints
 Inflammation of the joints (arthritis)  Trigger finger (a condition in which your Keep this medicine out of sight and reach of
 Feeling weak finger or thumb catches in a bent position) children. Keep your tablets in a safe place where
 Bone loss (osteoporosis) children cannot see or reach them. Your tablets
Rare side effects (may affect 1 to 10 people in could harm them.
Common side effects (may affect 1 to 10 people 10,000): This medicinal product does not require any
in 100): special storage conditions.
 Rare inflammation of your skin that may
 Loss of appetite include red patches or blisters Do not use this medicine after the expiry date
 Raised or high levels of a fatty substance  Skin rash caused by hypersensitivity (this can which is stated on the carton and blister after
known as cholesterol in your blood. This be from allergic or anaphylactoid reaction) ‘EXP’. The first two digits indicate the month and
would be seen in a blood test  Inflammation of the small blood vessels the last four digits indicate the year. The expiry
 Feeling sleepy causing red or purple colouring of the skin. date refers to the last day of that month.
 Carpal Tunnel syndrome (tingling, pain, Very rarely symptoms of joint, stomach, and Do not throw away any medicines via wastewater
coldness, weakness in parts of the hand) kidney pain may occur; this is known as or household waste. Ask your pharmacist how to
 Diarrhoea ‘Henoch-Schönlein purpura’ throw away medicines you no longer use. These
 Being sick (vomiting) measures will help protect the environment.
 Changes in blood tests that show how well Effects on your bones Anastrozole lowers the
your liver is working amount of the hormone called estrogen that is in 6. CONTENTS OF THE PACK AND FURTHER
INFORMATION
 Thinning of your hair (hair loss) your body. This may lower the mineral content of
 Allergic (hypersensitivity) reactions including your bones. Your bones may be less strong and
face, lips, or tongue may be more likely to fracture. Your doctor will What Anastrozole tablets contain
 Bone pain manage these risks according to treatment
 Vaginal dryness guidelines for managing bone health in women  The active substance is anastrozole. Each
 Bleeding from the vagina (usually in the first who have gone through the menopause. You film-coated tablet contains 1mg of
few weeks of treatment – if the bleeding should talk to your doctor about the risks and anastrozole.
continues, talk to your doctor) treatment options.  The other ingredients in the tablet core are
lactose monohydrate, sodium starch
Reporting of side effects
Uncommon side effects (may affects 1 to 10 glycolate, povidone (E1201) and magnesium
If you get any side effects, talk to your doctor,
people in 1,000): stearate (E572).
pharmacist or nurse. This includes any possible
 The ingredients in the tablet coating are
side effects not listed in this leaflet. By reporting
macrogol, hypromellose (E464) and titanium
 Changes in special blood tests that show how side effects you can help provide more
dioxide (E171).
your liver is working (gamma- GT and information on the safety of this medicine.
bilirubin)
5.HOW TO STORE ANASTROZOLE TABLETS What Anastrozole tablets look like and
 Inflammation of the liver (hepatitis)
contents of the pack
 Hives or nettle rash
Anastrozole is a white film-coated round tablet.
Each film coated tablet contains:
Anastrozole IP 1mg
Excipients q.s.
Color: Titanium Dioxide IP
Anastrozole is available in hospital blisters of 28
tablets.

Manufactured in India by:


TAJ PHARMACEUTICALS LTD.
Mumbai, India
at SURVEY NO. 188/1, 190/1 TO 4, ATHIYAWAD ,
DABHEL, DAMAN- 396210 (INDIA)
Mfg. Lic. No: DD/xxxxx/2018-A

This leaflet was last revised in Nov 2018

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