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NORIDAY

Active substance(s): NORETHISTERONE

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Package leaflet: Information for the user

Noriday®

FPO

What is in this leaflet
1. What Noriday is and what it is used for
2. What you need to know before you take Noriday
3. How to take Noriday (including what to do if you forget to
take a pill)
4. Possible side effects
5. How to store Noriday
6. Contents of the pack and other information
1. What Noriday is and what it is used for
Noriday is a progestogen-only contraceptive pill, or ‘POP’ for short.
Noriday contains the active ingredient norethisterone.
Noriday helps to prevent you becoming pregnant. It does this in
several ways
• It thickens the fluid at the entrance to your womb and this
makes it hard for sperm to travel through and enter the womb
• It also changes the lining of your womb so that a fertilised egg
cannot grow there
• Sometimes it stops your ovaries releasing an egg
2. What you need to know before you take Noriday
Do not take Noriday if you:
• are allergic to norethisterone or any of the other ingredients of
this medicine (listed in section 6)
• are or think you may be pregnant
• have had, or think you may have hormone-dependent cancer of
the breast, cervix, vagina, or womb
• have or ever had acute or severe chronic liver disease including:
• past or present tumours
• jaundice (yellowing of the skin or eyes) and other types of jaundice
such as Dubin-Johnson Syndrome and Rotor Syndrome
• have unexplained vaginal bleeding
• active liver disease
• have had the following during pregnancy:
• pruritus (itching of the whole body)
• jaundice (yellowing of the skin and eyes) for which your
doctor could not find a cause
• have disorders of lipid (fat) metabolism
• have never had a period or suffer from lack of periods (amenorrhoea)
• have inflamed veins (thrombophlebitis)
• have thrombosis (blood clots)
• have heart disease, or you have had a stroke
Warnings and precautions
Talk to your doctor before taking Noriday if you suffer from or have
ever suffered from:
• epilepsy
• multiple sclerosis
• porphyria (a rare inherited blood disease)
• tetany (muscle twitches)
• otosclerosis (an inherited form of deafness which sometimes
gets worse during pregnancy)
• diabetes or have a family history of diabetes
• gallstones
• impaired carbohydrate tolerance
• migraine headaches – if you develop migraine headaches you
should consult your doctor
• heart or kidney problems
• depression
• liver disease
• varicose veins
• high blood pressure
• asthma
Before you take Noriday you should also tell your doctor if you wear
contact lenses.
If you are obese or have history of pre-eclampsia and are more than
35 years of age, your doctor will discuss the risk/benefit of using oral
contraceptives as compared to other methods of contraception due
to additional risks.
Medical check-ups
Your doctor or clinic will give you regular check-ups while you are taking
Noriday. Your blood pressure will be checked before you start using the
pill and then at regular intervals whilst you are on the pill. If your blood
pressure goes up, your doctor may tell you to stop taking Noriday. They
may also check your breasts and reproductive organs. All women are
encouraged to undergo cervical smear tests at regular intervals.
Other medicines and Noriday
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.

The following medicines may stop Noriday from working properly (the
condition they treat is 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)
• ampicillin (bacterial infection)
• doxycycline (bacterial infection)
• modafinil (narcolepsy i.e. daytime sleep)
If you do need to take any of the medicines listed above, Noriday may
not be suitable for you. Your doctor will advise you whether to stop
taking these medicines or use an additional contraceptive method,
such as a condom whilst taking Noriday.
Noriday may change the effects of other medicines. Tell your doctor
if you are taking prednisone, prednisolone, cloprednol or any other
corticosteroids, as Noriday may not be suitable for you.
Pregnancy, breast-feeding and fertility
If you think you may have become pregnant whilst using Noriday, tell
your doctor immediately. If you become pregnant while you are taking
this type of pill there is a slightly higher chance that it could be an
ectopic pregnancy (a pregnancy developing outside the womb).
Do not take Noriday if you are pregnant or trying to become pregnant.
If you miss two consecutive periods while you are taking Noriday, tell
your doctor or pharmacist. They will inform you about the increased
risk to the foetus if you have become pregnant while taking Noriday. You
will need to have a pregnancy test before you continue to take Noriday.
Noriday does not prevent the breast from producing milk. However,
it is better for the baby that for the first few weeks after birth its
mother’s milk contains no trace of any medicines, including Noriday.
Sexually transmitted diseases
Noriday helps to prevent you from becoming pregnant. It will not
protect you against sexually-transmitted diseases, including AIDS. For
safer sex, use a condom as well as your usual contraceptive.
Driving and using machines
No effects on the ability to drive or use machines have been seen with
Noriday.
Smoking
Smoking increases the risk to your health and increases some of the
risks of the combined pill. It is not known if these risks also apply
to the progestogen-only pill. It is recommended that you give up
smoking.
Noriday contains lactose monohydrate
If you have been told by your doctor that you have intolerance to some
sugars; contact your doctor before taking this medicinal product.
3. How to take Noriday
Always take this medicine exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure.
• Start on the first day of your next period. This is ‘day one’ of
your cycle, the day when bleeding starts
• Take one pill each day and swallow the pill with water
• You can take the pill at any time that suits you, but you must
take it at about the same time each day
• The pack is marked with the days of the week to help you
remember to take your pills
• Follow the direction of the arrows on the pack and take a pill
every day until the pack is empty When you finish the first pack,
start a new pack on the next day. This means that you will be
taking pills through your period
• There must be no breaks between packs
• For the first seven days of the first pack you should also use a
condom, or a cap and spermicide
• If you are three or more hours late taking your pill, follow the
instructions under ’What do I do if I forget to take a pill?’
What do I do if I forget to take a pill?
• If you are three or more hours late taking your pill you may not
be protected from pregnancy

Colours
Printing
Black
PMS 2583

Non-Printing

FPO

Norethisterone
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, pharmacist or nurse.
• 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
See section 4.

25 Nov 2015

• feeling nervous
• feeling depressed
• high blood pressure
• irregular periods
Possible risk of breast cancer
Every woman is at risk of breast cancer whether or not she takes the
oral contraceptives (OC). Breast cancer is rare under the age of 40 but
the risk increases as a woman gets older.
Whilst taking the OC there is a slightly higher incidence of breast cancer
when comparing women of the same age. When you stop taking the OC,
the risk is reduced such that 10 years after stopping OC, the risk of finding
breast cancer is the same as for women who have never taken the OC.
Where breast cancer is identified it seems less likely to have spread in
women who take OC than in women who do not.
It is not certain whether the OC causes the increased risk of breast
cancer. It may be that women taking the OC 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
a pill like Noriday, POP, but by the age at which she stops. This is because the
risk of breast cancer strongly increases as a woman gets older.
For 10.000 women who take a POP for 5 years and then stop any
increased risk of finding breast cancer in the following 10 years
increases with age, as shown below:
Age at time of stopping
20 30 40
Number of cases in those who have never taken the Pill 4 44 160
Additional cases in those who have used the Pill
1 2-3 10
The possible small extra risk of being diagnosed with breast
cancer has to be weighed against the known benefits of taking the
progestogen-only pill.
Taking any medicine carries some risk. You can use the information in
this leaflet, and the advice your doctor or clinic has given you to weigh
up the risks of taking the OC. Don’t be embarrassed, ask as many
questions as you need to.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
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 Noriday
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 on the blister after EXP. The expiry date refers to the last
day of that month.
Store in a cool, dry place, away from direct sunlight.
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 Noriday contains
• The active substance is norethisterone. Each pill contains
350 micrograms of norethisterone.
• The other ingredients in each tablet are maize starch, povidone,
magnesium stearate and lactose monohydrate. Please also
refer to Section 2, ‘Noriday contains lactose monohydrate’.
What Noriday looks like and contents of the pack
Noriday pills are white, round tablets and have ‘SEARLE’ debossed on
one side and ‘NY’ on the other side. Noriday tablets are supplied in
blister strips in cartons containing 28 or 84 tablets. Not all pack sizes
may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
Manufacturer:
Piramal Healthcare UK Limited
Morpeth
Northumberland
NE61 3YA
.
This leaflet was last revised in 11/2015
Ref: NO 4_1 UK

20151123A

11:10

Colours
Printing
Black
PMS 2583

Non-Printing

FPO

FPO

• T ake the pill as soon as you remember, and take the next one at
the normal time
• This may mean taking two pills in one day
• Continue to take your pills as normal but also use a condom for
the next seven days
What do I do if my periods are different?
This is quite normal with the progestogen-only pill. Sometimes the
time between periods, and the length of the periods is different. There
may be bleeding between periods, called ‘breakthrough bleeding’.
This tends to happen more in the first few months of taking Noriday.
If your periods seem different, do not stop taking Noriday but mention
it to your doctor or healthcare professional at your next check-up.
What do I do if I miss a period?
This may happen with this type of pill. If you have taken all your pills properly,
you are very unlikely to be pregnant. Take your next pack as normal. If you
miss a second period see your doctor or healthcare professional at once.
What do I do if I take too many Noriday pills?
If you take more than one pill there should be no problems, but you
may experience feeling sick or actually being sick, breast enlargement
and vaginal bleeding.
If you take too many pills or you find out that someone else has taken
a lot of pills, contact a doctor immediately.
What do I do if I have a stomach upset or I am sick?
Noriday may not work if you are sick or have diarrhoea. Continue to
take your pills as normal but use a condom while you are ill and for
the next seven days.
What do I do if I am having an operation?
If you are going to have an operation, or if you are ill or injured and
there may be a risk of blood clots, please mention to your doctor that
you take Noriday. Noriday should be discontinued 4 weeks prior to
surgery and can normally be re-started 2 weeks following surgery.
Your doctor will discuss what is relevant for you.
What do I do if I am changing pill brands?
Take the first pill of your new pack on the day after you finish your old
pack. Do not leave any break at all.
What do I do if I want a baby?
Stop taking Noriday if you want to have a baby. It is helpful to wait until
your regular periods return before you try to get pregnant. Therefore it is
recommended that you stop taking Noriday tablets three months before
a planned pregnancy. You can use another type of contraceptive, such
as a condom until then. Once you have had a period it will be easier to
work out when the baby is due. However, if you get pregnant as soon
as you stop taking Noriday, this is not harmful.
If you wish to become pregnant, you should contact your doctor or
healthcare professional about stopping Noriday.
What do I do if I have just had a baby?
You can use Noriday after having a baby whether you are breast-feeding
or not. You can start taking the pill from day 21 after childbirth. This
protects you as soon as you have taken the first pill. If you start later
than this you may not be protected until you have taken the pill for
another seven days. If you have had a miscarriage or abortion you
can start taking the pill straightaway and will be protected immediately.
What do I do if I have had a miscarriage or abortion?
You can start taking the pill straight away and will be protected immediately.
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.
If any of the side effects gets serious, or if you notice any side effects
not listed in the leaflet please tell your doctor.
These effects should become less of a problem as your body gets
used to the pills.
Reasons to get medical help immediately
Stop taking the pills at once and tell your doctor if:
• You become jaundiced (your skin or the whites of your eyes look
yellow)
Also seek medical attention immediately if:
• You have a sudden, severe pain in your chest
• You suddenly become short of breath
• You have an unusual, severe or long headache
• Your sight is affected in any way
• You find it difficult to speak
• You collapse or faint
• Any part of your body suddenly feels weak or numb
• You have a severe pain in one of your calves
These could be warning signs of thrombosis (a blood clot).
Other side effects that you might have include:
• stomach upsets
• changes in your weight
• swollen or sore breasts
• headaches
• changes in sex drive
• migraines
• changes in appetite
• gallstones
• a rash
• feeling tired

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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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