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NORINYL-1

Active substance(s): MESTRANOL / NORETHISTERONE

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NORINYL-1®

1 milligram (mg)/50 micrograms (µg) Tablets
norethisterone/mestranol
Important things that you SHOULD know about your
medicine:
• Norinyl-1 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 Norinyl-1 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 Norinyl-1 but side effects can occur - see
Section 4 for details. If any of the side effects get
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 Norinyl-1
from working properly. See Section 2 for details.
Check with your doctor, nurse or pharmacist
before taking any other medicines while you are
taking Norinyl-1.
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.
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
• 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 only.
Do not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1. What Norinyl-1 is and what it is used for
2. What you need to know before you take Norinyl-1
3. How to take Norinyl-1
4. Possible side effects
5. How to store Norinyl-1
6. Contents of the pack and other information
1. What Norinyl-1 is and what it is used for
Norinyl-1 is one of a group of medicines called combined
oral contraceptives or “the Pill”.
Norinyl-1 contains two hormones - a progestogen hormone
called norethisterone and an estrogen hormone called
mestranol. These two hormones act together to prevent
pregnancy from occurring.
2. What you need to know before you take Norinyl-1
Ì Do not take Norinyl-1:
• if you are allergic to norethisterone, mestranol or any
of the other ingredients of this medicine (listed in
section 6).
• if you are currently pregnant.
• if you have had blood clots in the legs, blood clots
in varicose veins, the lungs, the brain or elsewhere
(coronary and cerebral thrombotic disorders).
• if you or a member of your family have ever had
a problem with blood clots, including deep vein
thrombosis (DVT).
• if you have had swelling (inflammation) of a vein
caused by a blood clot.
• if you have had a heart attack or stroke or have had
or have angina.
• if you have had or have high levels of fats in your blood
(hyperlipidaemia) or other disorders of body fats.
• if you have had or have cancer of the breast, cervix,
vagina or womb.
• if you have had the following during pregnancy:
o pruritus (itching of the whole body)
o jaundice (yellowing of the skin or eyes), for
which your doctor could not find the cause
o pemphigoid gestationis (a rash previously
known as herpes gestationis typically with
blistering of the palms of the hands and the
soles of the feet).
• if you have had or have severe chronic liver disease
(liver tumours, Dubin-Johnson or Rotor syndrome).
• if you have had or have vaginal bleeding, for which
your doctor could not find the cause.
• if you have had or have bad migraines.
Ì Warnings and precautions
Talk to your doctor or pharmacist before taking Norinyl-1
if you have any of the following conditions. This will help
them decide if Norinyl-1 is 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 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
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
300
262

Never took the Pill

Number of breast cancers

PACKAGE LEAFLET: INFORMATION FOR THE USER

250

230

Used the Pill for 5 years

200

181
160

150
100

100
44 48.7

50
50

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

4 4.5

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 Norinyl-1 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
estrogen-free hormonal contraceptive.
Your doctor or nurse will advise whether you can still take
Norinyl-1.
Medical check-ups
Your doctor or nurse will give you regular checkups while
you are taking Norinyl-1. Your blood pressure will be
checked before you start Norinyl-1 and then at regular
intervals whilst you are on Norinyl-1. 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
Norinyl-1 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
Other medicines and Norinyl-1
Tell your doctor or pharmacists if you are taking, have
recently taken, or might take any other medicines. This
includes the following medicines, as the effect of Norinyl-1
may be altered when they are taken at the same time:
• 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,
Norinyl-1 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 Norinyl-1.
Ì Laboratory Tests
Norinyl-1 may interfere with some tests, tell your doctor
or nurse if you need to give samples for laboratory
assessment.
Ì Taking Norinyl-1 with food and drink
Please refer to section 3.
Ì Pregnancy, breast-feeding and fertility
Do not take Norinyl-1 if you are pregnant or trying to
become pregnant.
Do not take Norinyl-1 if you are breast-feeding.
If you miss a period while you are taking Norinyl-1, 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 Norinyl-1.
You will need to have a pregnancy test before you continue
to take Norinyl-1.
Ì Driving and using machines
Norinyl-1 is not known to affect the ability to drive or use
machinery.
Ì Norinyl-1 contains lactose
Lactose is a type of sugar. 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 this medicine.
3. How to take Norinyl-1
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Norinyl-1 can be taken with or without food.

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 next 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 to take 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
If you notice a change in your 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 If you take more Norinyl-1 than you 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
If you forget to take Norinyl-1
• 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.

Reporting of side effects
If you get any side effects, talk to your doctor 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 effects you can help provide
more information on the safety of this medicine.
5. How to store Norinyl-1
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton and blister strip after EXP. The expiry
date refers to the last day of that month.
Do not store above 25°C. Keep the blister in the outer
carton in order to protect from light.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.
6. Contents of the pack and other information
What Norinyl-1 contains and its package
The active substances are norethisterone and mestranol.
Each Norinyl-1 tablet contains 1 milligram of norethisterone
and 50 micrograms of mestranolThe other ingredients are
maize starch, polyvidone, magnesium stearate and lactose
(see section 2 Norinyl-1 contains lactose)
What Norinyl-1 looks like and contents of the pack
Norinyl-1 tablets are white and have the word ‘SEARLE’
on one side and ‘1’ on the other side. They are packed
in blister strips of 21 tablets and come in cartons of
21 tablets or 63 tablets. Not all pack sizes may be
marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
UK
Manufacturer
Piramal Healthcare UK Limited
Morpeth
Northumberland
NE61 3YA
UK
This leaflet was last revised in 10/2014
Ref: NY 7_1

Ì If you want to stop taking Norinyl-1 or want to
have a baby?
If you stop taking Norinyl-1, 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 Norinyl-1 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 If you change brands of oral 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 break-through bleeding during the first few
days of the new blister strip. This is quite normal and
you will still be protected against pregnancy.
Ì
If you have a stomach upset or you are sick?
• Norinyl-1 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 If you 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
Norinyl-1 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 If you have just had a miscarriage or abortion
You may be able to start taking Norinyl-1 immediately.
If you can, you will be protected straight away. Ask your
doctor or nurse if you should do so.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine 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 Norinyl-1 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
• 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 Norinyl-1 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.

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2014/08/12B

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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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