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NASTROSA 1MG FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Nastrosa 1mg film-coated tablets
Anastrozole
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 Nastrosa 1mg Film-Coated Tablets
can affect the way some medicines work
and some medicines can have an effect
on Nastrosa 1mg Film-Coated Tablets.
Do not take Nastrosa 1mg Film-Coated
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 Nastrosa 1mg FilmCoated 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
1. WHAT NASTROSA 1mg FILM-COATED
triptorelin. These medicines are used to
TABLETS ARE AND WHAT THEY ARE
treat breast cancer, certain female
USED FOR
health (gynaecological) conditions, and
Nastrosa 1mg Film-Coated Tablets contain
infertility.
a substance called Anastrozole. This
Pregnancy and breast-feeding
belongs to a group of medicines called
Do not take Nastrosa 1mg Film-Coated
‘aromatase inhibitors’. Nastrosa 1mg FilmTablets if you are pregnant or breast
coated Tablets are used to treat breast
feeding. Stop Nastrosa 1mg Film-Coated
cancer in women who have gone through
Tablets if you become pregnant and talk to
the menopause.
your doctor.
Nastrosa 1mg Film-coated Tablets work by
Ask your doctor or pharmacist for advice
cutting down the amount of the hormone
before taking any medicine.
called estrogen that your body makes. It
Driving and using machines
does this by blocking a natural substance
Nastrosa 1mg Film-Coated Tablets is not
(an enzyme) in your body called
likely to affect your ability to drive or use any
‘aromatase’.
tools or machines. However, some people
may occasionally feel weak or sleepy while
2. BEFORE YOU TAKE NASTROSA 1mg
taking Nastrosa 1mg Film-Coated Tablets. If
FILM-COATED TABLETS
this happens to you, ask your doctor or
Do not take Nastrosa 1mg Film-Coated
pharmacist for advice.
Tablets
Important information about some of the
• if you are allergic (hypersensitive) to
ingredients of Nastrosa
anastrozole or any of the other
ingredients of Nastrosa 1mg Film-Coated Nastrosa 1mg Film-Coated Tablets contain
Tablets (see section 6: Further information) lactose. If you have been told by your
• if you are pregnant or breast feeding (see doctor that you have an intolerance to
some sugars, contact your doctor before
the section called ‘Pregnancy and
taking this medicine.
breast-feeding’).
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 Nastrosa 1mg Film-Coated Tablets
are and what they are used for
2.Before you take Nastrosa 1mg FilmCoated Tablets
3.How to take Nastrosa 1mg Film-Coated
Tablets
4.Possible side effects
5.How to store Nastrosa 1mg Film-Coated
Tablets
6.Further information

Do not take Nastrosa 1mg Film-Coated
Tablets if any of the above apply to you. If
you are not sure, talk to your doctor or
pharmacist before taking Nastrosa 1mg
Film-Coated Tablets.
Take special care with Nastrosa 1mg FilmCoated Tablets
Before treatment with Nastrosa 1mg FilmCoated 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 Nastrosa 1mg
Film-Coated Tablets.
If you go into the hospital, let the medical
staff know you are taking Nastrosa 1mg
Film-Coated Tablets.
Taking other medicines
Please tell your doctor or pharmacist if you

3. HOW TO TAKE NASTROSA 1mg FILMCOATED TABLETS
Always take Nastrosa 1mg Film-Coated
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 Nastrosa
1mg Film-Coated Tablets before, with or
after food.
Keep taking Nastrosa 1mg Film-Coated
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
Nastrosa 1mg Film-Coated Tablets should
not be given to children and adolescents.
If you take more Nastrosa 1mg FilmCoated Tablets than you should
If you take more Nastrosa 1mg Film-Coated
Tablets than you should, talk to a doctor
straight away.
If you forget to take Nastrosa 1mg FilmCoated 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 Nastrosa 1mg FilmCoated Tablets
Do not stop taking your tablets even if you
are feeling well, 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, Nastrosa 1mg FilmCoated Tablets can cause side effects,
although not everybody gets them.
Very common side effects (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).
• 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 (affect 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 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-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
Nastrosa 1mg Film-Coated Tablets 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 NASTROSA 1mg
FILM-COATED TABLETS
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 Nastrosa 1mg Film-Coated
Tablets after the expiry date which is stated
on the outer packaging / blister after ‘EXP’.
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.

6. FURTHER INFORMATION
What Nastrosa 1mg Film-Coated Tablets
contain
• The active substance is anastrozole. Each
film-coated tablet contains 1 mg
anastrozole.
• The other ingredient(s) are:
• Tablet core: lactose monohydrate,
sodium starch glycolate (type A),
magnesium stearate
• Film-coating:Opadry II white 85F18422
consisting of poly (vinyl alcohol) – partially
hydrolysed, titanium dioxide, macrogol
3350, talc.
What Nastrosa 1mg Film-Coated Tablets
look like and contents of the pack
• Nastrosa 1mg Film-Coated Tablets tablets
are white, round, film-coated tablets, with
the number ‘1’ on one side and plain on
the reverse.
• Nastrosa 1mg Film-Coated Tablets are
available in pack sizes of 20, 28, 30, 84,
98, 100 and 300 tablets contained in a
carton. Not all pack sizes may be
marketed.
Marketing Authorisation Holder
Niche Generics Limited,
1 The Cam Centre, Wilbury Way, Hitchin,
Herts SG4 0TW, United Kingdom.
Manufacturers
Niche Generics Limited,
1 The Cam Centre, Wilbury Way, Hitchin,
Herts SG4 0TW, United Kingdom.
Eirgen Pharma Limited,
64-65 Westside Business Park,
Old Kilmeaden Road, Waterford, Ireland.
Distributed by
Discovery Pharmaceuticals,
The Old Vicarage, Market Place,
Castle Donington, Derbyshire DE74 2JB, UK
This medicinal product is authorised in the
Member States of the EEA under the
following names:
UK: Nastrosa 1mg Film-Coated Tablets
IE: Anastrozole Niche 1 mg Film-Coated
Tablets
This leaflet was last approved in: June 2012

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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