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NORISTERAT 200MG SOLUTION FOR INTRAMUSCULAR INJECTION

Active substance: NORETHISTERONE ENANTHATE

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Package leaflet: Information for the user

1 What Noristerat does

Noristerat is an injectable (depot)
contraceptive. It is intended as a short-term
method of contraception, for example in women
Noristerat®
whose partners are undergoing vasectomy,
until the vasectomy is effective. It is also for
use in women immunised against rubella, to
prevent pregnancy while the virus is active.
You use it to stop you getting pregnant.
Noristerat contains a type of female sex
Norethisterone enantate
hormone, called a progestogen.
! Three important things to know
about this medicine.
This hormone stops you getting pregnant by
It will not protect you against sexually
working in three ways: by preventing an egg
transmitted diseases.
being released from your ovaries; by making
This medicine can increase your risk of
the fluid (mucus) in your cervix thicker, which
problems such as blood clots
makes it more difficult for sperm to enter the
Some women should not use this medicine
womb; and by preventing the lining of your
because of current medical problems or
illnesses. Please read this leaflet to make sure womb thickening enough for an egg to grow
in it.
Noristerat is right for you.
This leaflet gives you some important
The benefits of using Noristerat include:
information about your medicine
Keep this leaflet. You may need to read it again. it is one of the most reliable reversible
methods of contraception if used correctly
If you have any questions or need more advice,
you only have to remember to visit your
ask your doctor, family planning nurse or
doctor after 8 weeks for a second injection
pharmacist.
Noristerat is given by injection for
it doesn’t interrupt sex
contraception
Noristerat will not protect you against sexually
If any of the side effects gets severe, or if
transmitted infections, such as Chlamydia or
you notice any not listed in this leaflet, please HIV. Only condoms can help to do this.



tell your doctor, family planning nurse or
pharmacist.

13.05.2013 07:49:35

In this leaflet:
1. What Noristerat does
2. Make sure Noristerat is OK for you
3. Starting Noristerat
4. Possible side effects
5. How to store Noristerat
6. What is in Noristerat and who makes it

 Tell your doctor if you have any of the
illnesses or risk factors mentioned in this
leaflet.
Before you are given Noristerat
Your doctor will ask about you and your
family’s medical problems, check your blood
pressure and exclude the likelihood of you
being pregnant. You may also need other
checks, such as a breast examination, but
only if these examinations are necessary for
you, or if you have any special concerns.
While you’re on Noristerat
Check your breasts and nipples every
month for changes – tell your doctor if you
can see or feel anything odd, such as lumps
or dimpling of the skin.
If you need a blood test tell your doctor
that you are using Noristerat, because it can
affect the results of some tests.
If you’re going to have an operation,
make sure your doctor knows about it. You
may need to avoid having a second injection
of Noristerat before the operation. This is to
reduce the risk of a blood clot (see section
2.1).

2.1 Noristerat and blood clots

Noristerat may slightly increase your risk
of having a blood clot (called a thrombosis),
especially in the first year of using it.
2 Make sure Noristerat is OK for
A clot in a leg vein – a deep vein thrombosis (or
you
DVT) – is not always serious. However, if it
It’s important that you understand the benefits moves up the veins and blocks an artery in the
lungs, it can cause chest pain, breathlessness,
and risks of using Noristerat before you are
collapse or even death. This is called a
given it, or when deciding whether to have a
second injection. Although Noristerat is suitable pulmonary embolism and is very rare.
Very rarely, blood clots can also form in the
for most healthy women it isn’t suitable for
blood vessels of the heart (causing a heart
everyone.

2.2 Noristerat and cancer

If you have or suspect you have cancer
affected by sex hormones – such as some
Noristerat has also been linked to liver diseases,
cancers of the breast or womb lining or
such as jaundice and non-cancer liver tumours,
have ever had either of these conditions
You are more at risk of having a blood clot: but this is rare. Very rarely, Noristerat has also
If you have an inherited disease called
been linked with some forms of liver cancer in
as you get older
porphyria
women who have used it for a long time.
if you smoke
If you are allergic (hypersensitive) to any of
 See a doctor as soon as possible if you
if you are seriously overweight
the ingredients in Noristerat.
get severe pain in your stomach, or
if you have some diseases of the heart and
 If you suffer from any of these, or
yellow skin or eyes ( jaundice). You may
blood vessels
get them for the first time while using
need to stop using Noristerat .
if you suffer from migraines
Noristerat, contact your doctor as soon as
if you have recently had a baby
possible. It may not be suitable for you to
2.3 Noristerat should not be used by
if you’re off your feet for a long time
have a second injection of Noristerat.
some women
because of major surgery, injury or illness
2.4 Noristerat can make some
 Tell your doctor or family planning
 Tell your doctor if any of these risk
nurse if you have any medical problems
illnesses worse
factors apply to you. Noristerat may not be
or illnesses.
suitable for you.
Some of the conditions listed below can be
Do not use Noristerat if you have any of
made worse by using Noristerat. Or they may
Signs of a blood clot include:
the problems listed below. Using Noristerat
mean it is less suitable for you. You may still be
a migraine for the first time, a migraine
would put your health at risk.
able to be given Noristerat but you need to take
that is worse than normal, or unusually
special care.
If you are pregnant or might be pregnant
frequent or severe headaches
If you have had severe depression
any sudden changes to your eyesight (such If you have ever had a problem with your
blood circulation. This includes a blood
If you have ever had liver problems, e.g.
as loss of vision or blurred vision)
clot (thrombosis) in the legs (deep vein
jaundice (yellow skin or eyes)
any sudden changes to your hearing,
thrombosis), lungs (pulmonary embolism),
If you have any disease that tends to get
speech, sense of smell, taste or touch
heart (heart attack), brain (stroke) or any
worse during pregnancy
pain or swelling in your leg
other parts of the body
If you have an irregular menstrual pattern
stabbing pain when you breathe
If you have or have ever had severe liver
together with stomach pains
coughing for no apparent reason
disease, and you have been told by your
If you have abnormal vaginal bleeding
pain and tightness in the chest
doctor that your liver function test results
If you have diabetes
sudden weakness or numbness in one side
are not yet back to normal
If you have ever had an ectopic pregnancy
or part of your body
If you have or have ever had liver tumours
or fallopian tube removed.
dizziness or fainting.
If you have severe diabetes affecting your  Tell your doctor or family planning
 See a doctor as soon as possible. Do
blood vessels
nurse if any apply to you. Also tell them
not have a further injection until your
If you have very high blood
if you get any of these for the first time
doctor says you can. Use another method
pressure
after being given Noristerat, or if any get
of contraception, such as condoms, in the If you have disorders of blood fat (lipid)
worse or come back, because it may not be
meantime.
metabolism
suitable for you to have a second injection
of Noristerat.
attack) or the brain (causing a stroke). In
healthy young women the chance of having a
heart attack or stroke is extremely small.



81145180_05.indd 2

2.5 Taking other medicines

If you ever need to take another medicine at the
same time, always tell your doctor, pharmacist
or dentist that you’ve been given Noristerat.
Also check the leaflets that come with all your
medicines to see if they can be taken with
hormonal contraceptives.
Some medicines can stop Noristerat from
working properly – for example:
certain sedatives (called barbiturates)
some medicines used to treat epilepsy
griseofulvin (an anti-fungal medicine)
phenylbutazone (an anti-inflammatory
medicine)
certain antibiotics
St John’s Wort (a herbal remedy).
If you do need to take one of these medicines,
you may need to use extra contraception for a
while. Your doctor, pharmacist or dentist can
tell you if this is necessary and for how long.
Noristerat can also affect how well other
medicines work. For example, if you have
diabetes, you may need to take more insulin
or other anti-diabetic drugs after being given
Noristerat. Your doctor will tell you if this is
necessary.

2.6 Using Noristerat with food and
drink

There are no special instructions about food
and drink while on Noristerat

3 Starting Noristerat
3.1 How to start

Your doctor or family planning clinic will give
you the first injection of Noristerat within the
first five days of your period (unless you start
2.7 Pregnancy and breast-feeding
You should not be given Noristerat if you are just after a pregnancy or an abortion). The
injection is given into the muscle.
pregnant. If you think you might be pregnant,
do a pregnancy test to confirm that you are and By starting in this way you will have
contraceptive protection at once.
do not have your second injection.
Noristerat has not been shown to reduce
the amount of milk you produce which is an
advantage if you wish to breastfeed your baby.
Very small amounts of the hormone are found
in breast milk. There is no evidence to suggest
that the small amounts of the hormone that
appear in the milk are harmful to a healthy
baby. However, if your baby has severe or
long-lasting jaundice that requires medical
treatment you should not breast-feed your baby
after having your injection.

2.8 Driving and using machines

Noristerat has no known effect on the ability to
drive or use machines.

3.2 Further injections of Noristerat

One injection will give you contraception for
8 weeks. After 8 weeks a second injection can
be given. You must make sure that you leave
no longer than 8 weeks between injections or
contraceptive protection will be lost.

3.3 Starting Noristerat after having a
baby
Noristerat can normally be used straight after
having a baby. Your doctor will advise you on
when to start.

3.4 Starting Noristerat after having a
miscarriage or an abortion
You may be able to have an injection
immediately. Your doctor will advise you.

3.5 Missed a period – could you be
pregnant?

3.6 Being given more Noristerat than
you should
Overdosage is unlikely but if it does occur no
serious ill-effects are expected.

4 Possible side effects
Like all medicines, Noristerat can cause side
effects, although not everybody gets them.
 Tell your doctor, pharmacist or family
planning nurse if you are worried about
any side effects which you think may be
due to Noristerat.

Signs of severe liver problems include:
severe pain in your upper abdomen
yellow skin or eyes ( jaundice)
inflammation of the liver (hepatitis)
your whole body starts itching.
 If you think you may have any of these,
see a doctor straight away. You may
need to stop using Noristerat.

4.2 Less serious side effects

irregular bleeding
bloating
tender breasts
headaches
4.1 Serious side effects – see a doctor depressive moods
dizziness
straight away
feeling sick
Signs of a blood clot:
putting on weight
a migraine for the first time, a migraine
skin reactions (e.g. pain or itchy rash) at the
that is worse than normal, or unusually
injection site
frequent or severe headaches
rarely coughing for no apparent reason,
any sudden changes to your eyesight (such
shortness of breath and disturbances
as loss of vision or blurred vision)
of the circulatory system may develop
any sudden changes to your hearing,
while you are having your injection, or
speech, sense of smell, taste or touch
immediately after.
pain or swelling in your leg
 Tell your doctor or family planning
stabbing pain when you breathe
nurse if you are worried about any side
effects which you think may be due to
coughing for no apparent reason
Noristerat. Also tell them if any existing
pain and tightness in the chest
conditions get worse while you are using
sudden weakness or numbness in one side
Noristerat.
or part of your body
dizziness or fainting.

13.05.2013 07:50:08

If, when the second injection is due, you have
Signs of a severe allergic reaction to
not had a further period since the first injection, Noristerat:
it is unlikely that you are pregnant, but the
swelling of the face, lips, mouth, tongue or
second injection should not be given until
throat.
pregnancy has been ruled out.

5 How to store Noristerat
Keep all medicines out of the reach and sight
of children.
Store below 25°C. Protect from light.
Noristerat should not be used after the expiry
date shown on the packaging.

6 What is in Noristerat and who
makes it
What is in Noristerat
Each ampoule of Noristerat contains 200mg
of the progestogen norethisterone enantate in
1ml of oily solution for injection into a muscle.
Noristerat also contains the inactive
ingredients:
benzyl benzoate (which may increase the risk
of jaundice in newborn babies), castor oil for
injection.
Noristerat is supplied in single packs of 1
ampoule.
The company that holds the product licence
for Noristerat is:
Bayer plc, Bayer House, Strawberry Hill,
Newbury, Berkshire RG14 1JA.
Noristerat is made by:
Bayer Pharma AG, Berlin, Germany.
This leaflet was last updated in April 2013.

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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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