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TAJ PHARMA INDIA / Product / BRUMIDEX® (ANASTROZOLE) USP 1MG TABLETS
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BRUMIDEX® (ANASTROZOLE) USP 1MG TABLETS

Generic Name

Anastrozole


Brand Name

BRUMIDEX®


Dosage Form

Tablets


Strength and Dosage

1mg


Therapeutic Category

Aromatase inhibitors



Patient Information Leaflet

Summary of Product Characteristics pdfIcon

Product Description


BRUMIDEX® tablets contain a substance called anastrozole. This belongs to a group of medicines called ‘aromatase inhibitors’. These tablets are used to treat breast cancer in women who have gone through the menopause.
BRUMIDEX tablets work 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’.


BEFORE YOU TAKE

Do not take BRUMIDEX tablets if you
• Are allergic (hypersensitive) to BRUMIDEX or any of the other ingredients of BRUMIDEX tablets (see section section 6 Further information).
• Are pregnant or breast feeding (see the section called ‘Pregnancy and breast-feeding’).
• Do not take BRUMIDEX tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking BRUMIDEX tablets.

Take special care with BRUMIDEX tablets
Before treatment with BRUMIDEX tablets 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 BRUMIDEX tablets.
If you go into the hospital, let the medical staff know you are taking BRUMIDEX tablets.

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 BRUMIDEX tablets can affect the way some medicines work and some medicines can have an effect on BRUMIDEX tablets.

Do not take BRUMIDEX tablets 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 BRUMIDEX tablets 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 BRUMIDEX tablets if you are pregnant or breast-feeding. Stop taking BRUMIDEX tablets if you become pregnant and talk to your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
BRUMIDEX tablets are 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 BRUMIDEX tablets. If this happens to you, ask your doctor or pharmacist for advice.
Important information about some of the ingredients of BRUMIDEX tablets
BRUMIDEX tablets contain 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.


HOW TO TAKE

Always take BRUMIDEX 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 (1mg anastrozole) 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 BRUMIDEX tablets before, with or after food.
• Keep taking BRUMIDEX tablets 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
• BRUMIDEX tablets should not be given to children and adolescents.
• If you take more BRUMIDEX tablets than you should
• If you take more BRUMIDEX tablets than you should, talk to a doctor straight away.
• If you forget to take BRUMIDEX tablets
• 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 BRUMIDEX tablets
• 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.


POSSIBLE SIDE EFFECTS

Like all medicines, BRUMIDEX can cause side effects, although not everybody gets them.
Very common side effects (affects 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)
• Diarrhoea
• Being sick (vomiting)
• Changes in blood test 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
• Bleediing from the vagina (usually in the first few weeks of treatment – if the bleeding continues, talk to your doctor)

Uncommon side effects (affects 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 bend 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-Schönlein purpura’

Very rare side effects (affect less than 1 person 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
BRUMIDEX 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.


HOW TO STORE

• Keep out of the reach and sight of children. Keep your tablets in a safe place where children cannot see or reach them. Your tablets could harm them.
• This medicinal product does not require any special storage conditions.
• Do not use BRUMIDEX after the expiry date which is stated on the carton and blister after ‘EXP’. The first two digits indicate the month and the last four digits indicate the year. The expiry date refers to the last day of that 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.


FURTHER INFORMATION

What BRUMIDEX® tablets contain
The active substance is BRUMIDEX USP. Each film-coated tablet contains 1mg of anastrozole.
The other ingredients in the tablet core are lactose monohydrate, sodium starch glycolate, povidone (E1201) and magnesium stearate (E572).
The ingredients in the tablet coating are macrogol, hypromellose (E464) and titanium dioxide (E171).

What BRUMIDEX tablets look like and contents of the pack
BRUMIDEX is a white film-coated round tablet, with plain on both sides.
BRUMIDEX is available in blisters of 28 tablets.

Additional Information

If you are a distributor, please inquire with us about product , importing and/or marketing our products in your country or region. If you are a consumer, don’t hesitate to contact us about more information for this product.

To inquire more about cost effective Taj Brands products, hospital imports, non-available life saving products, please contact us.

The most common markets for this product include the following state . Please inquire with us if your state is not listed:

North India : Jammu & Kashmir ,Himachal Pradesh,Uttar Pradesh ,Uttaranchal , Punjab ,Haryana.
South India : Kerala, Karnataka ,Tamil Nadu,Andhra Pradesh.
East India : Assam ,Manipur, Meghalaya,West Bengal ,Orissa,Sikkim ,Mizoram, Tripura
West India : Goa ,Gujarat ,Rajasthan ,Maharashtra
Central India : Madhya Pradesh, Chattisgarh

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