NORIDAY® 28 Day Tablets
Norethisterone 350 micrograms
What is in this leaflet
This leaflet answers some common questions about NORIDAY 28 day tablets.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of
you taking NORIDAY against the benefits it is expected to have for you.
Use NORIDAY as directed by your doctor and follow advice given in this
leaflet.
If you have any concerns about taking this medicine, ask your doctor or
pharmacist.
What NORIDAY is used for
NORIDAY is a birth control pill commonly known as a "progestogen-only" pill
or "mini pill". NORIDAY is usually given to women who are unable to take other
types of birth control pills (combined oral contraceptives) or use
intrauterine devices (IUDs).
It is not known exactly how the "progestogen-only" pill works. However,
NORIDAY causes changes to the mucus of the cervix and the lining of the womb
and affects the hormonal control system of the body which may all contribute
to its effectiveness.
The effectiveness of the "progestogen-only" pill is lower than that of
other birth control pills.
If taken according to directions it is expected that if 100 women used the
progestogen-only pill for 1 year approximately 4 pregnancies may occur
compared to less than 1 pregnancy in women using an oral contraceptive
containing an oestrogen and progestogen.
NORIDAY (like all oral contraceptives) is intended to prevent pregnancy. It
does not protect against HIV infection (AIDS) and other sexually transmitted
diseases.
NORIDAY 28 day is only available on a prescription from your doctor.
This medicine is prescribed for you and should not be given to others.
Before you start to take NORIDAY
When you must not take it
NORIDAY 28 Day tablets are not suitable for some women.
If you have or have had any of these problems, do not take NORIDAY until
you have talked to your doctor:
Do not take it if:
- you have had a stroke or a heart attack.
- you have clotting in any blood vessel(s) or in the lung.
- you have liver disease (including tumours of any type), a history of
jaundice or cholestatic jaundice of pregnancy, or severe generalised itch in
the body during pregnancy; Dubin-Johnson Syndrome or Rotor Syndrome. - you have abnormal vaginal bleeding, the cause of which is unknown.
- you are pregnant or suspect that you may be pregnant.
- you have cancer or suspected cancer of the breast or sex organs (e.g.
cervix, ovaries, endometrium, womb). - you have a lipid metabolism disorder or severe arterial disease.
- you have a history of ectopic pregnancy (a pregnancy in the fallopian
tube rather than the womb). - you have an allergy to norethisterone or any of the ingredients listed
at the end of this leaflet
Symptoms of an allergic reaction may include:- asthma, wheezing or shortness of breath
- swelling of the face, lips or tongue which may cause difficulty in
swallowing or breathing - hives, itching or skin rash
- fainting
Tell your doctor about any existing medical condition as this may be
affected by taking the birth control pill.
Do not take NORIDAY if the packaging is torn or shows signs of tampering.
Before you start to take it
You must tell your doctor if:
- you are a heavy smoker (15 or more cigarettes per day), especially if
you are aged over 35 years
Oral contraceptives increase your risk of having a stroke or heart attack.
Smoking while taking oral contraceptives further increases this risk. - you have ever had a blood clot
- you have uterine fibroids
- you have or have had ovarian cysts
- you have malabsorption syndrome
- you have gall bladder disease
- you have diabetes
- you have high blood pressure
- you have high cholesterol
- you suffer from epilepsy
- you have migraine
- you have asthma
- you have heart or kidney disease
- you have or have had any form of depression
- any member of your family has suffered from blood clots, a stroke, or
heart attack. - you are lactose intolerant.
This medicine contains lactose.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines,
including any that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may alter the effectiveness of NORIDAY. These include
medicines such as:
- Rifampicin for the treatment of tuberculosis
- Antibiotics such as ampicillin, oxacillin, tetracyclines,
sulfamethoxazole and trimethoprim - Anti-fungal agents such as griseofulvin
- Barbiturates
- Medicines for epilepsy such as carbamazepine and phenytoin
- Medicines used to prevent or relieve the symptoms of allergy (such as
hay fever) - Medicines used to treat or prevent pain
- Anti-migraine preparations
- Phenylbutazone, a medicine used to relieve symptoms of inflammation,
including arthritis.
While you are taking these medicines you should use a non-hormonal
method of contraception (such as condoms or a diaphragm, but not the rhythm or
temperature methods). This is particularly important if you need to take
antibiotics or medicines for epilepsy.
NORIDAY may alter the effectiveness of some medicines. These include:
- Medicines for high blood pressure such as guanethidine
- Medicines to prevent blood clots
How to take NORIDAY
How to take it
Swallow one NORIDAY tablet with a glass of water at approximately the same
time each day.
Follow the instructions below carefully to ensure birth control
reliability.
- To begin NORIDAY 28 Day, take your first tablet on the first day
of your next period, that is, the day your bleeding begins. - Take your first tablet from the top row of the strip. Take the tablet
which corresponds to the appropriate day of the week. For example, if your
first day of bleeding is on TUESDAY, you should take the tablet marked "TUE"
from the top row. - Continue to take one tablet every day, following the arrows around the
strip, until you finish all 28 tablets. - When you have finished your first strip of tablets start the next strip
the following day by taking a white tablet from the top row that matches the
day of the week. - Repeat this sequence of tablet taking for as long as birth control is
required. Continue taking the tablets whether you have a period or not.
During the first two weeks of the course only, it is important to use an
additional non-hormonal birth control method to provide added protection (such
as condoms or a diaphragm with contraceptive gel, but not the rhythm or
temperature methods).
Make sure you always have a new strip of tablets available so
that you can continue to take the tablets without interruption.
If you are switching to NORIDAY 28 Day from another 21 or 28 Day oral
contraceptive, please see your doctor or pharmacist for directions.
If you suffer from a stomach upset which results in vomiting or diarrhoea,
the effectiveness of NORIDAY will be reduced.
During any period of vomiting or diarrhoea, continue taking NORIDAY
tablets. Also use a non-hormonal method of contraception (such as condoms or a
diaphragm with contraceptive gel, but not the rhythm or temperature methods)
until your next period occurs.
When to take it
Take your tablet at approximately the same hour each day. Taking
your tablet at the same time each day will also help you remember when to take
the tablets.
If you forget to take a tablet
If you forget to take NORIDAY it may not work as well in protecting you
from becoming pregnant.
Do not try to make up for missed doses by taking more than one tablet at
a time.
If you miss a tablet:
If you are less than 3 hours late in taking your tablet, you should take
that tablet at once and then take the next one at the usual time, even if it
means taking two tablets in the same day.
If you are more than 3 hours late in taking your tablet, still take the
tablet, but an additional, non-hormonal method of contraception must also be
used for the next 14 days, whether bleeding occurs or not (such as condoms or
a diaphragm with contraceptive gel, but not the rhythm or temperature
methods).
If you miss two or more tablets:
Stop taking NORIDAY immediately and use a non-hormonal method of birth
control (such as condoms or a diaphragm with contraceptive gel, but not the
rhythm or temperature methods). Continue this until your period has
occurred or until your doctor has confirmed that you are not pregnant.
When you begin taking NORIDAY again, start the tablets from a new strip
and follow the instructions as if starting NORIDAY therapy for the first time.
During the first 2 weeks of this first course only, it is important to use
an additional, non-hormonal method of contraception (such as condoms or a
diaphragm with contraceptive gel, but not the rhythm or temperature methods).
If your doctor has told you to take NORIDAY differently, or you are unclear
about the above directions, discuss this with him or her.
If you have trouble remembering to take your tablets, ask your pharmacist
for some hints.
If you miss a period
If you have taken all the tablets correctly, you should not be concerned
if you have missed a period. Continue to take your tablets as usual.
However, if you have missed two periods, you should stop taking NORIDAY
immediately and use a non-hormonal method of birth control (such as condoms or
a diaphragm with contraceptive gel, but not the rhythm or temperature
methods). Continue this until your doctor has confirmed that you are not
pregnant.
If you have missed taking one or more tablets or have not taken them
correctly, and you miss a period, you should stop taking the tablets
immediately and use another non-hormonal method of birth control (such as
condoms or a diaphragm with contraceptive gel, but not the rhythm or
temperature methods). Continue this until your doctor has confirmed that
you are not pregnant.
If you take too much (overdose)
Immediately telephone your doctor or pharmacist or the National Poisons
Centre (telephone 0800 POISON or 0800 764 766) or go to Accident and Emergency
at your nearest hospital if you think you or someone else may have taken too
much NORIDAY. Do this even if there are no signs of discomfort or poisoning.
Serious ill effects have not been reported in young children who
have taken large doses of birth control pills.
Overdosage may cause nausea or vomiting. This may be followed by vaginal
bleeding and breast enlargement in some women.
While you are taking NORIDAY
Things you must do
Tell all doctors, dentists and pharmacists who are treating you that you
are taking NORIDAY.
Tell the hospital doctor that you are taking NORIDAY birth control pills
if you need to have an operation, or go to hospital in an emergency.
If you are about to be started on any new medicine, tell your doctor or
dentist and your pharmacist that you are taking NORIDAY.
If you become pregnant while taking NORIDAY, see your doctor
immediately.
Visit your doctor regularly for medical check-ups, which may include
blood tests. Your doctor will advise you of the type and frequency of any
tests required.
Perform regular, breast self-examination.
Examining your breasts for lumps or any changes in size or shape can help
you find a breast cancer early.
If you are unsure, ask your doctor about breast self-examination.
If you are worried about contracting a sexually transmitted disease
(STD) use a barrier contraceptive method.
NORIDAY does not protect against the transmission of STDs such as HIV-AIDS,
chlamydia, genital herpes and warts, gonorrhoea, hepatitis B or human
papilloma virus. To protect against STDs ask your partner to wear a condom
when having sexual intercourse with you.
Tell your doctor if you feel depressed, think you are retaining water,
experience headaches or experience persistent or recurrent irregular bleeding.
Your doctor will make an assessment of your condition and advise whether
or not you should continue to take NORIDAY.
You may take NORIDAY if you are breastfeeding. NORIDAY appears to
have no effect on milk production or the nursing child.
Things you must not do
Do not smoke while you are taking oral contraceptives. Cigarette
smoking increases the risk of blood clotting and damage to the heart and blood
vessels from birth control pills. The risk increases with age and with heavy
smoking (15 or more cigarettes per day) and is quite marked in women over 35
years of age.
Do not stop taking your tablets if a full monthly period or slight
spotting starts before all tablets have been taken. Slight spotting during
tablet taking is normally of no significance. See your doctor if bleeding
persists, or if heavier bleeding occurs.
Do not take NORIDAY past the expiry date shown on the label. If you
take the tablets after the expiry date has passed, they may not work as well.
Things to be careful of
Slight breast tenderness or a feeling of sickness may occur in the first
few months of use. This usually improves or stops with continued use.
If vaginal irritation or discharge occurs, it may be an indication of yeast
infection for which treatment is available from your doctor.
Women who take NORIDAY may find a change in the pattern of their period.
Changes may occur to the amount of flow as well as the duration of the period.
A change in length of your menstrual cycle may also occur. See your doctor
if such bleeding persists, or if heavier bleeding occurs.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel
well while you are taking NORIDAY.
All medicines can have side effects. Sometimes they are serious, most of
the time they are not. You may need medical treatment if you get some of the
side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
- break-through bleeding
- spotting
- change in menstrual flow
- absence of periods
- changes in cervical secretions and erosions
- breast changes (tenderness, enlargement and secretion)
- gastric or stomach discomforts including nausea and vomiting
- change in weight
- retention of fluids
- dark discolouration of the skin
- blotchy discolouration on the face or arms or legs (which may persist
after the tablets have been stopped) - rash (with or without itching)
- depression
- excessive hair growth
Since the effects of long term use of "progestogen-only" pills are not
known, women should be aware of the serious side effects which have occurred
with other oral contraceptives known as "Combined Oral Contraceptives". The
"Combined Oral Contraceptives" contain oestrogen and progestogen hormones.
The most serious known side effect with Combined Oral Contraceptive use is
abnormal blood clotting which may have serious consequences. Deaths have
occurred in some women as a result of blood clots carried by the blood stream
causing obstruction of blood vessels in the lungs or in the brain. The risk of
developing blood clotting disorders and other blood vessel diseases in oral
contraceptive users increases with age from 30 years onwards. Cigarette
smoking also increases the risk. These problems may persist after a woman has
stopped taking the birth control pill.
The use of a Combined Oral Contraceptive can increase the risk of a woman
having a heart attack. Other risk factors for a heart attack include cigarette
smoking; high blood pressure; high cholesterol; obesity; diabetes; a history
of pre-eclamptic toxaemia in pregnancy and age over 40 years.
Tell your doctor immediately or go to Accident and Emergency at your
nearest hospital if you notice any of the following:
- unexplained or persistent pains in the head, chest, stomach or legs
- gradual or sudden, partial or complete loss of vision
- double vision, or symptoms of severe vision impairment
- eye protrusion, swelling of the eye or eye lesions
- migraine headaches for the first time
- more frequent or severe migraines if you already suffer from them
- breast lumps
- jaundice or a yellowing of the skin or eyes, often with fever, fatigue,
loss of appetite, dark coloured urine, nausea and vomiting. Taking oral
contraceptives may be associated with liver disease, including liver cancer - rise in blood pressure
- swelling of the face, lips, tongue or other parts of the body, shortness
of breath, wheezing or trouble breathing.
Rarer side effects associated with the use of NORIDAY and combined oral
contraceptives are not listed here. You may wish to discuss these, or any of
the side effects listed above, with your doctor if you are concerned.
Side effects not previously reported with NORIDAY may also occur. If you
notice anything unusual while you are taking NORIDAY, see your doctor.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
After stopping NORIDAY
Delays in becoming pregnant may occur after NORIDAY therapy is stopped.
This is more likely to occur in women whose periods were irregular before
using birth control pills.
See your doctor if you continue to experience difficulties in falling
pregnant.
After taking NORIDAY
Storage
Keep your tablets in a safe place away from the sight and reach of
children.
A locked cupboard at least one-and-a-half metres above the ground is a good
place to store medicines.
Keep your NORIDAY tablets in a dry place, at a temperature below 25°C.
Do not keep your tablets in the refrigerator.
Do not store NORIDAY or any other medicine in the bathroom or near a
sink.
Do not leave it in the car on hot days or on window sills.
Heat and dampness can destroy some medicines.
Disposal
If your doctor tells you to stop taking NORIDAY or if the tablets have
passed their expiry date, ask your pharmacist what to do with any that are
left over.
Product description
What it looks like
NORIDAY 28 Day is available in calendar packs consisting of three strips of
tablets (3 months supply) each with 28 white tablets marked "SEARLE" on one
side and "NY" on the other.
Ingredients
Each white tablet contains
- norethisterone 350 micrograms (µg).
- magnesium stearate
- povidone
- maize starch
- lactose
NORIDAY does not contain sucrose, gluten or tartrazine.