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NORIMIN

Active substance: NORETHISTERONE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

NORIMIN®

1 milligram (mg)/35 micrograms (µg) Tablets
norethisterone/ethinylestradiol
Important things that you SHOULD know about your
medicine:
• NORIMIN is an oral contraceptive medicine for use
by women.
• This medicine has been prescribed for you. Do not
pass it on to others.
• You should take NORIMIN regularly as instructed by
your doctor or nurse, in order for it to be effective.
When taken as instructed, it is a very effective
contraceptive. See Section 3 “What if I forget to
take a tablet?”
• Most people do not have serious problems when
taking NORIMIN but side effects can occur – see
Section 4 for details. If any of the side effects gets
serious, or if you notice any side effects not listed
in this leaflet, please tell your doctor, nurse or
pharmacist.
• Taking some other medicines may stop NORIMIN
from working properly. See Section 2 for details.
Check with your doctor, nurse or pharmacist before
taking any other medicines while you are taking
NORIMIN.
Please read the rest of this leaflet. It includes other
important information on the safe and effective use of
this medicine that might be especially important to you.
If you have any further questions, ask your doctor, nurse
or pharmacist.
In this leaflet:
1. What NORIMIN is and what it is used for
2. Before you take NORIMIN
3. How to take NORIMIN
4. Possible side effects
5. How to store NORIMIN
6. Further information

diseased arteries (atherosclerosis), high blood pressure
during pregnancy (pre-eclamptic toxaemia), high blood
levels of cholesterol, and diabetes. If you have any of
these conditions, you should check with your doctor or
nurse to see if the Pill is suitable for you. Smokers over
35 are usually told to stop taking these pills.
Possible risk of Breast Cancer
Every woman is at risk of breast cancer whether or not
she takes the Pill. Breast cancer is rare under the age of
40 years, but the risk increases as a woman gets older.
Breast cancer has been found slightly more often in
women who take the Pill than in women of the same
age who do not take the Pill. If women stop taking the
Pill, this reduces the risk so that 10 years after stopping
the Pill, the risk of finding breast cancer is the same as
for women who have never taken the Pill. Breast cancer
seems less likely to have spread when found in women
who take the Pill than in women who do not take the Pill.
It is not certain whether the Pill causes the increased risk
of breast cancer. It may be that women taking the Pill are
examined more often, so that breast cancer is noticed
earlier. The risk of finding breast cancer is not affected
by how long a woman takes the Pill but by the age at
which she stops. This is because the risk of breast cancer
strongly increases as a woman gets older.
The chart below shows the background chances of breast
cancer at various ages for 10,000 women who have
never taken the Pill (black bars) and for 10,000 women
whilst taking the Pill and during the 10 years after
stopping it (pink bars). The small extra risk of finding
breast cancer can be seen for each age group. This small
possible additional risk in women who take the Pill has
to be balanced against the fact that the Pill is a very
effective contraceptive and it helps prevent cancer of the
womb or ovary.
Estimated number of breast cancers found in
10,000 women who took the Pill for 5 years then stopped,
or who never took the Pill
262

Never took the Pill

2. Before you take NORIMIN
Ì Do not take NORIMIN if :
• You are hypersensitive (allergic) to norethisterone,
ethinylestradiol or any of the other ingredients listed
in Section 6.
• You are currently pregnant.
• You have had blood clots in the legs, blood clots in
varicose veins, the lungs, the brain or elsewhere
(coronary and cerebral thrombotic disorders).
• You have had a heart attack or stroke or have had or
have angina.
• You have had or have high levels of fats in your
blood (hyperlipidaemia) or other disorders of body
fats.
• You have had or have cancer of the breast, cervix,
vagina or womb.
• You have had the following during pregnancy:
• pruritus (itching of the whole body);
• jaundice (yellowing of the skin or eyes), for which
your doctor could not find the cause;
• pemphigoid gestationis (a rash previously known
as herpes gestationis typically with blistering of
the palms of the hands and the soles of the feet).
• You have had or have severe chronic liver disease
(liver tumours, Dubin-Johnson or Rotor syndrome).
• You have had or have vaginal bleeding, for which
your doctor could not find the cause.
• You have had or have bad migraines.
Ì Take special care with NORIMIN
If you suffer from or have suffered from any of the
following conditions, tell your doctor or nurse because
NORIMIN may not be suitable for you:
• Migraine
• Headaches
• Slow or sudden development of visual disturbances
such as complete or partial loss of vision
• Asthma
• Epilepsy (a condition where you suffer from fits)
• Diseases of the heart and blood vessels
(cardiovascular disease)
• High blood pressure (hypertension)
• Kidney disease
• Diabetes
• Multiple sclerosis (a problem of the nervous system)
• Tetany (muscle twitches)
• Breast problems of any sort
• Varicose veins (widened or twisted vein usually in
the leg)
• Liver dysfunction
• Severe depression
• Fibroids in your uterus
• Irregular periods
• Sharp pain in your abdomen
• Gallstones
• Sickle-cell anaemia
• Otosclerosis (an inherited form of deafness)
• Porphyria (a metabolic disease)
• Chloasma (brown patches on your skin which
can happen during pregnancy but may not fade
completely)
• Any disease that is likely to get worse during
pregnancy.
Possible risk of Thrombosis (Blood Clot)
Some evidence suggests that women who take the
Pill are more likely to develop various blood circulation
disorders than women who don’t take the Pill.
A thrombosis is a blood clot. A thrombosis can develop in
veins or in arteries and can cause a blockage. The chance
of a thrombosis forming in women taking the Pill and
women not taking the Pill is rare. When blood clots form
in arteries they can cause chest pain (angina), strokes
(blood clots in or bleeding from the blood vessels in the
brain) and heart attacks.
If blood clots form in the veins they can often be treated,
with no long-term danger. On rare occasions a piece of
thrombosis may break off. It can travel to the lungs to
cause a condition called pulmonary embolism. Therefore
in rare cases a thrombosis can cause serious permanent
disability or could even be fatal.
It is important to note that a thrombosis can form in
people who are not taking the Pill as well as those who
are taking it. The risk is higher in women who take the
Pill than in women who don’t take the Pill, but is not as
high as the risk during pregnancy. The excess risk of
thrombosis is highest during the first year a woman ever
uses a combined oral contraceptive pill.
For healthy non-pregnant women: the chance of having a
blood clot is about 5 in 100,000 each year.
For women taking the Pill containing either levonorgestrel
or norethisterone (a second generation Pill): the chance of
having a blood clot is about 15 in 100,000 each year.
For women taking the Pill containing desogestrel or
gestodene (a third generation Pill): the chance of having a
blood clot is about 25 in 100,000 each year.
For women who are pregnant: the chance of having a
blood clot is about 60 in 100,000 pregnancies.
The risk of heart attacks and strokes for women who use
the combined Pill increases with age and smoking. Other
conditions also increase the risk of blood clots in the
arteries. These include being greatly overweight, having

Number of breast cancers

1. What NORIMIN is and what it is used for
NORIMIN is one of a group of medicines called combined
oral contraceptives or “the Pill” for short.
NORIMIN contains two hormones - a progestogen
hormone called norethisterone and an oestrogen hormone
called ethinylestradiol. These two hormones act together
to prevent pregnancy from occuring.

Used the Pill for 5 years
181
160

100

44
4 4.5

Took the Pill at
these ages:
Cancers found up
to the age of:

230

11
1

48.7

16 17.5

Under 20

20-24

25-29

30-34

35-39

40-44

30

35

40

45

50

55

• There have been some reports on the risk of liver
tumors and cervical cancer associated with the use
of oral contraceptives.
• There is evidence to suggest that the use of
combined oral contraceptives offers protection
against both ovarian and endometrial cancer.
Cervical cancer
Some research suggests an increased risk of getting
cancer of the cervix (neck of the uterus or womb) in
women who take combined oral contraceptives for a long
time. However, this may be due to other causes, such as
sexual behaviour.
Liver cancer
Very rarely, tumours of the liver have been seen in
women taking combined oral contraceptives, especially if
they have been taken for a long time.
If you are worried about any of these things or if you have
had cancer in the past, talk to your doctor to see if you
should take the combined oral contraceptive pill.
Endometrial and ovarian cancer
Research shows that combined oral contraceptives
protect against cancer of the ovary and cancer of the
endometrium (lining of the womb).
If you are going to have a major operation
Make sure your doctor knows about it. You may need to
stop taking NORIMIN about 4 weeks before the operation
until at least 2 weeks after the operation and until you are
fully mobile. Alternatively, your doctor may prescribe an
oestrogen-free hormonal contraceptive.
Your doctor or nurse will advise whether you can still take
NORIMIN.
Medical check-ups
Your doctor or nurse will give you regular checkups while
you are taking NORIMIN. Your blood pressure will be
checked before you start NORIMIN and then at regular
intervals whilst you are on NORIMIN. You may be required
to have an examination of your breasts, abdomen and
pelvis including a cervical smear test at regular intervals,
if this is considered necessary by the doctor.
Sexually transmitted diseases
NORIMIN helps to prevent pregnancy. It will not protect
against sexually transmitted diseases including AIDS.
For safer sex, use a condom as well as your usual
contraceptive.
Ì Taking other medicines
The following medicines may stop NORIMIN from
working properly (the condition they treat being shown in
brackets):
• the herbal remedy St John’s Wort – Latin name
Hypericum perforatum (depression)
• carbamazepine (epilepsy)
• oxacarbazepine (epilepsy)
• phenytoin (epilepsy)
• phenobarbital (sleeplessness, anxiety, epilepsy)
• primidone (epilepsy)
• topiramate (epilepsy)
• nelfinavir (HIV – Human Immunodeficiency Virus infection)
• nevirapine (HIV infection and AIDS)
• ritonavir (HIV infection and AIDS)
• rifabutin (bacterial infection)
• rifampicin (bacterial infection)
• griseofulvin (fungal infection)
• modafinil (narcolepsy i.e. daytime sleepiness).
If you do need to take any of the medicines listed above,
NORIMIN may not be suitable for you. Your doctor or nurse
will advise you whether to stop taking these medicines
or use an additional contraceptive method, such as a
condom whilst taking NORIMIN.
Ì Laboratory Tests
NORIMIN may interfere with some tests, tell your doctor
or nurse if you need to give samples for laboratory
assessment.
Ì Taking NORIMIN with food and drink
NORIMIN can be taken with or without food.
Ì Pregnancy and breast-feeding
Do not take NORIMIN if you are pregnant or trying to
become pregnant.
Do not take NORIMIN if you are breast-feeding.
If you miss a period while you are taking NORIMIN, tell
your doctor, nurse or pharmacist. Your doctor, nurse or
pharmacist will inform you about the increased risk to
the foetus if you have become pregnant while taking
NORIMIN. You will need to have a pregnancy test before
you continue to take NORIMIN.
Ì Driving and using machinery
NORIMIN is not known to affect the ability to drive or use
machinery.

Ì mportant information about some of the
I
ingredients of NORIMIN
NORIMIN tablets contain lactose. If you suffer from
diabetes or you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor
before taking NORIMIN.
3. How to take NORIMIN
One blister strip of NORIMIN contains 21 white tablets.
Starting your first blister strip
• Take the first tablet on your first day of bleeding.
This is the day when your period starts. If you are
not having periods, ask your doctor or clinic when
you should start taking your tablets.
• Take the tablet marked with the correct day of the
week.
• You will be protected at once as long as you take a
tablet every day.
• You can take the tablet at a time that suits you, but
you must take it at about the same time every
day.
• Take a tablet every day until you finish a blister strip.
• If you cannot start the tablet on the first day of your
period you may start to take it on any day up to the
fifth day. However, if you do this, you may not be
protected for the first seven days, so you should use
another method of contraception such as a condom
during those days.
Starting the next blister strip
• Once you have finished all 21 tablets, stop for
seven days. You will probably bleed during some or
all of these seven days.
• Then, start the blister strip. Do this whether or not
you are still bleeding. You will always start the next
blister strip on the same day of the week.
• You are protected during the seven day break, but
only if you start the next blister strip on time. The
first tablet in your blister strip is the worst pill of all
to miss or take late.
Ì What if I notice a change in my periods?
It is normal that your periods may become irregular and
you may notice some bleeding between periods. Your
periods may become lighter and you may occasionally
have no bleeding during the tablet free days. Make a note
of what happens so that you can tell your doctor or nurse
at your next check-up.
Ì What if I forget to take a tablet?
• If you forget to take a tablet take it as soon as you
remember and take the next one at your normal
time. This may mean taking two tablets on the same
day.
• If you are 12 or more hours late in taking one or
more tablets, it may not work. As soon as you
remember, take your last missed tablet and carry
on taking them normally. However, you may not be
protected for the next seven days, so either avoid
sexual intercourse or use an extra contraceptive
method, such as a condom.
• If you have fewer than seven tablets in your blister
strip after you have missed taking a dose, you
should complete the blister strip and start the next
blister strip without a break. This will give you
protection from when you took the last missed
tablet. You may not have a period until the end of
two blister strips, but this will not harm you. You may
also have some bleeding on days when you take the
tablets.

• you have sudden and unusual severe headaches
• you experience dizziness or you faint
• you develop a problem with your sight or speech.
Other side effects NORIMIN may cause are:
• feeling sick
• stomach upset
• weight gain
• changes in appetite
• changes in the way your body breaks down sugars,
fats or vitamins
• headache
• high blood pressure
• depression
• swollen or sore breasts
• change in sex drive
• worsening of womb disorders
• irregular vaginal bleeding.
Taking any medicine carries some risk. You can use the
information in this leaflet, and the advice your doctor or
nurse has provided you to weigh up the risks and benefits
of taking the Pill. Don’t be embarrassed, ask as many
questions as you need to.
If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor.
5. How to store NORIMIN
Keep your tablets out of the reach and sight of children.
Do not use NORIMIN after the expiry date which is stated
on the carton. The expiry date refers to the last day of
that month.
Do not store above 25°C.
Store in a dry place away from direct sunlight.
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 NORIMIN contains and its package
The active ingredients are norethisterone and
ethinylestradiol.
Each NORIMIN tablet contains:
• 1 milligram of norethisterone and 35 micrograms of
ethinylestradiol (the ‘active’ ingredients); and
• maize starch, polyvidone, magnesium stearate and
lactose (the ‘inactive’ ingredients).
Norimin tablets are white and have the word ‘SEARLE’ on
one side and ‘BX’ on the other side. They are packed in
blister strips and come in packs of 63 tablets.
Marketing Authorisation Holder
Pharmacia Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
UK
Manufacturer
Piramal Healthcare UK Limited
Morpeth
Northumberland
NE61 3YA
UK
Date last revised: 06/2013
Ref: Ref: NM 5_1

Ì What if I take more tablets than I should?
Taking too many tablets at once may make you sick,
cause vaginal bleeding or breast swelling. Contact your
doctor or go to your nearest hospital casualty department
immediately.
Ì  hat if I want to stop taking NORIMIN or want to
W
have a baby?
If you stop taking NORIMIN, this will result in the loss of
contraceptive protection and the risk of pregnancy.
If you wish to become pregnant, you should contact your
doctor or nurse about stopping the tablets. It is advisable
to stop taking NORIMIN 3 months before you want to start
trying to have a baby.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.
Ì  hat if I am changing brands of oral
W
contraceptive?
• Take the first tablet of your new blister strip on the
day immediately after you have finished your old
blister strip. Your period will usually be delayed until
the new blister strip is finished, but you may have
some breakthrough bleeding during the first few
days of the new blister strip. This is quite normal and
you will still be protected against pregnancy.
Ì What if I have a stomach upset or I am sick?
• NORIMIN may not work if you are sick or have
severe diarrhoea. You should carry on taking the
tablets as normal, but use a condom while you are
ill and for the next seven days. If these seven days
run beyond the end of the blister strip, start the next
pack without a break.
• If you do have a break, ask your doctor or nurse
whether you need an extra contraceptive method,
such as a condom.
Ì What if I have just had a baby?
• If you are breast feeding, you should not take the
combined oral contraceptive. This is because the
oestrogen in the tablets may reduce the amount of
milk you produce. You should be able to take another
type of contraceptive instead. Ask your doctor or
nurse for advice.
• If you are not breast feeding, you may start taking
NORIMIN 21 days after your baby is born. This will
protect you immediately. If you start later than this,
you may not be protected until you have taken the
tablets for seven days.
Ì What if I have just had a miscarriage or abortion?
You may be able to start taking NORIMIN immediately.
If you can, you will be protected straight away. Ask your
doctor or nurse if you should do so.
4. Possible side effects
Like all medicines, NORIMIN can cause side effects
although not everybody gets them.
Tell your doctor or call an ambulance immediately
if you experience any of the following symptoms of an
allergic reaction after taking this medicine. Although they
are rare, the symptoms can be severe and you may need
urgent medical attention or hospitalisation.
• Sudden wheeziness, difficulty in breathing, chest
pain, fever, sudden swellings, rash or itching
(especially affecting the whole body).
Stop taking NORIMIN and contact your doctor straight
away if you notice any of the following serious side
effects. These may be signs of a blood clot.
• you are coughing up blood
• you have swelling or tenderness in your stomach
• you have a sudden sharp or severe pain in the chest
• you suddenly become short of breath or find
breathing is painful
• you have painful or inflamed veins in your legs
• you have a first attack of migraine (a bad headache
with sickness)
• you have migraines which get worse, especially if
your sight is affected, you see flashing lights, your
limbs feel weak, you lose the sensation or feel a
different sensation in your limbs, or you have a fit
20715518

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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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