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NORISTERAT 200MG SOLUTION FOR INTRAMUSCULAR INJECTION

Active substance: NORETHISTERONE ENANTHATE

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84365262_04.indd 1

Norethisterone enantate
Three important things to know
! about this medicine.
RIt will not protect you against sexually
transmitted diseases.
RThis medicine can increase your risk of
problems such as blood clots
RSome women should not use this medicine
because of current medical problems or
illnesses. Please read this leaflet to make
sure Noristerat is right for you.
Read all of this leaflet carefully before you
start taking this medicine because it
contains important information for you.
R Keep this leaflet. You may need to read it
again.
RIf you have any further questions, ask your
doctor, family planning nurse or pharmacist.
RNoristerat is given by injection for
contraception
RIf you get any side effects, talk to your
doctor, family planning nurse or pharmacist.
This includes any possible side effects not
listed in this leaflet. See section 4.

Noristerat®

Package leaßet: Information for the user

Noristerat is an injectable (depot)
contraceptive. It is intended as a short-term
method of contraception, for example in women
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
hormone, called a progestogen.
This hormone stops you getting pregnant by
working in three ways: by preventing an egg
being released from your ovaries; by making
the fluid (mucus) in your cervix thicker, which
makes it more difficult for sperm to enter the
womb; and by preventing the lining of your
womb thickening enough for an egg to grow
in it.
The benefits of using Noristerat include:
Rit is one of the most reliable reversible
methods of contraception if used correctly
Ryou only have to remember to visit your
doctor after 8 weeks for a second injection
Rit doesn’t interrupt sex
Noristerat will not protect you against sexually
transmitted infections, such as Chlamydia or
HIV. Only condoms can help to do this.

1. What Noristerat does

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

Noristerat may slightly increase your risk of
having a blood clot (called a thrombosis),
especially in the first year of using it.

2.1 Noristerat and blood clots

It’s important that you understand the benefits
and risks of using Noristerat before you are
given it, or when deciding whether to have a
second injection. Although Noristerat is suitable
for most healthy women it isn’t suitable for
everyone.
M Tell your doctor if you have any of the
illnesses or risk factors mentioned in this
leaflet.
Before you are given Noristerat
RYour 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
RCheck 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.
RIf you need a blood test tell your doctor
that you are using Noristerat, because it can
affect the results of some tests.
RIf 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. Make sure Noristerat is OK for
you

A clot in a leg vein – a deep vein thrombosis (or
DVT) – is not always serious. However, if it
moves up the veins and blocks an artery in the
lungs, it can cause chest pain, breathlessness,
collapse or even death. This is called a
pulmonary embolism and is very rare.
Very rarely, blood clots can also form in the
blood vessels of the heart (causing a heart
attack) or the brain (causing a stroke). In
healthy young women the chance of having a
heart attack or stroke is extremely small.
You are more at risk of having a blood clot:
Ras you get older
Rif you smoke
Rif you are seriously overweight
Rif you have some diseases of the heart and
blood vessels
Rif you suffer from migraines
Rif you have recently had a baby
Rif you’re off your feet for a long time
because of major surgery, injury or illness
M Tell your doctor if any of these risk
factors apply to you. Noristerat may not be
suitable for you.
Signs of a blood clot include:
Ra migraine for the first time, a migraine
that is worse than normal, or unusually
frequent or severe headaches
Rany sudden changes to your eyesight (such
as loss of vision or blurred vision)
Rany sudden changes to your hearing,
speech, sense of smell, taste or touch
Rpain or swelling in your leg
Rstabbing pain when you breathe
Rcoughing for no apparent reason
Rpain and tightness in the chest
Rsudden weakness or numbness in one side
or part of your body

07.01.2015 13:39:13

Some of the conditions listed below can be
made worse by using Noristerat. Or they may
mean it is less suitable for you. You may still be
able to be given Noristerat but you need to take
special care.
RIf you have had severe depression
RIf you have ever had liver problems, e.g.
jaundice (yellow skin or eyes)
RIf you have any disease that tends to get
worse during pregnancy
RIf you have an irregular menstrual pattern
together with stomach pains
RIf you have abnormal vaginal bleeding
RIf you have diabetes
RIf you have ever had an ectopic pregnancy
or fallopian tube removed.

2.4 Noristerat can make some
illnesses worse

RIf you have severe diabetes affecting your
blood vessels
RIf you have very high blood pressure
RIf you have disorders of blood fat (lipid)
metabolism
RIf you have or suspect you have cancer
affected by sex hormones – such as some
cancers of the breast or womb lining or
have ever had either of these conditions
RIf you have an inherited disease called
porphyria
RIf you are allergic (hypersensitive) to any of
the ingredients in Noristerat.
M If you suffer from any of these, or get
them for the first time while using
Noristerat, contact your doctor as soon as
possible. It may not be suitable for you to
have a second injection of Noristerat.

Packaging Technology Berlin pewi
page 1
Bayer Pharma AG
client: 0021
item-no.: 84365262
PZ: 2516E-4A
code-no.:
name: LF-Noristerat AMP
country: GB/-/BPH
colors: Black
version: 07.01.2015/04
approval:
dimension: 130 x 300 mm

M Tell your doctor or family planning
nurse if you have any medical problems or
illnesses.
Do not use Noristerat if you have any of the
problems listed below. Using Noristerat
would put your health at risk.
RIf you are pregnant or might be pregnant
RIf you have ever had a problem with your
blood circulation. This includes a blood
clot (thrombosis) in the legs (deep vein
thrombosis), lungs (pulmonary embolism),
heart (heart attack), brain (stroke) or any
other parts of the body
RIf you have or have ever had severe liver
disease, and you have been told by your
doctor that your liver function test results
are not yet back to normal
RIf you have or have ever had liver tumours

2.3 Noristerat should not be used by
some women

Noristerat has also been linked to liver diseases,
such as jaundice and non-cancer liver tumours,
but this is rare. Very rarely, Noristerat has also
been linked with some forms of liver cancer in
women who have used it for a long time.
M See a doctor as soon as possible if you
get severe pain in your stomach, or
yellow skin or eyes (jaundice). You may
need to stop using Noristerat .

2.2 Noristerat and cancer

Rdizziness or fainting.
M See a doctor as soon as possible. Do not
have a further injection until your doctor
says you can. Use another method of
contraception, such as condoms, in the
meantime.

i

1.3.2.2

1

84365262_04.indd 2

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:
Rcertain sedatives (called barbiturates)
Rsome medicines used to treat epilepsy
Rgriseofulvin (an anti-fungal medicine)
Rphenylbutazone (an anti-inflammatory
medicine)
Rcertain antibiotics
RSt 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.

2.5 Taking other medicines

M Tell your doctor or family planning
nurse if any apply to you. Also tell them
if you get any of these for the first time
after being given Noristerat, or if any get
worse or come back, because it may not be
suitable for you to have a second injection
of Noristerat.

1.3.2.2

2

07.01.2015 13:39:49

3. Starting Noristerat

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

2.8 Driving and using machines

You should not be given Noristerat if you are
pregnant. If you think you might be pregnant,
do a pregnancy test to confirm that you are and
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.

2.7 Pregnancy and breast-feeding

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

If, when the second injection is due, you have
not had a further period since the first injection,
it is unlikely that you are pregnant, but the
second injection should not be given until
pregnancy has been ruled out.

3.5 Missed a period – could you be
pregnant?

You may be able to have an injection
immediately. Your doctor will advise you.

3.4 Starting Noristerat after having a
miscarriage or an abortion

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

3.3 Starting Noristerat after having a
baby

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.

3.2 Further injections of Noristerat

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
just after a pregnancy or an abortion). The
injection is given into the muscle.
By starting in this way you will have
contraceptive protection at once.

3.1 How to start

2.6 Using Noristerat with food and
drink

Signs of a blood clot:
Ra migraine for the first time, a migraine
that is worse than normal, or unusually
frequent or severe headaches
Rany sudden changes to your eyesight (such
as loss of vision or blurred vision)
Rany sudden changes to your hearing,
speech, sense of smell, taste or touch
Rpain or swelling in your leg
Rstabbing pain when you breathe
Rcoughing for no apparent reason
Rpain and tightness in the chest
Rsudden weakness or numbness in one side
or part of your body
Rdizziness or fainting.
Signs of a severe allergic reaction to
Noristerat:
Rswelling of the face, lips, mouth, tongue or
throat.

4.1 Serious side effects – see a doctor
straight away

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

4. Possible side effects

Overdosage is unlikely but if it does occur no
serious ill-effects are expected.

3.6 Being given more Noristerat than
you should

This leaflet was last updated in
January 2015.

Noristerat is made by:
Bayer Pharma AG, Berlin, Germany.

84365262

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.

6. What is in Noristerat and who
makes it

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

5. How to store Noristerat

effects you can help provide more information
on the safety of this medicine.

Packaging Technology Berlin pewi
page 2
Bayer Pharma AG
client: 0021
item-no.: 84365262
PZ: 2516E-4A
code-no.:
name: LF-Noristerat AMP
country: GB/-/BPH
colors: Black
version: 07.01.2015/04
approval:
dimension: 130 x 300 mm

Rirregular bleeding
Rbloating
Rtender breasts
Rheadaches
Rdepressive moods
Rdizziness
Rfeeling sick
Rputting on weight
Rskin reactions (e.g. pain or itchy rash) at the
injection site
Rrarely coughing for no apparent reason,
shortness of breath and disturbances of
the circulatory system may develop while
you are having your injection, or
immediately after.
M Tell your doctor or family planning
nurse if you are worried about any side
effects which you think may be due to
Noristerat. Also tell them if any existing
conditions get worse while you are using
Noristerat.
Reporting of side effects
If you get any side effects, talk to your doctor,
family planning nurse or pharmacist. This
includes any possible side effects not listed in
this leaflet. You can also report side effects
directly via the Yellow Card Scheme at: www.
mhra.gov.uk/yellowcard. By reporting side

4.2 Less serious side effects

M If you think you may have any of these,
see a doctor straight away. You may
need to stop using Noristerat.

Signs of severe liver problems include:
Rsevere pain in your upper abdomen
Ryellow skin or eyes (jaundice)
Rinflammation of the liver (hepatitis)
Ryour whole body starts itching.

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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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