Drug Ingredient Information
NORETHISTERONE-5MG
NORETHISTERONE
| Information for
patients
|
| Drug Information |
Norethisterone is a combined oral contraceptive pill (‘the Pill’). You take it to stop
getting pregnant.
This contraceptive contains two types of female sex hormones, oestrogen
and progestogen. These hormones prevent an egg being released from your
ovaries so you can’t get pregnant. Also, Norethisterone makes the fluid (mucus) in
your cervix thicker which makes it more difficult for sperm to enter the womb.
Norethisterone is a 21-day Pill - you take one each day for 21 days, followed by 7
days when you take no pills.
The benefits of taking the Pill include:
it is one of the most reliable reversible methods of contraception if
used correctly it doesn’t interrupt sex
it usually makes your periods regular, lighter and less painful
it may help with pre-menstrual symptoms.
Norethisterone will not protect you against sexually transmitted infections, such as
Chlamydia or HIV. Only condoms can help to do this.
Norethisterone needs to be taken as directed to prevent pregnancy. |
| Drug Alert |
| Alert |
Your doctor will ask about you and your family’s medical problems and
check your blood pressure. You may also need other checks, such as a
breast examination but only if these are necessary for you or you have
any special concerns |
| Before Consuming
the Medicine
|
| Avoid Drug |
You will need regular check-ups with your doctor or family planning
nurse, usually when you need another prescription of the Pill.
You should go for regular cervical smear tests.
Check 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.
If you need a blood test tell your doctor that you are taking the Pill,
because the Pill can affect the results of some tests.
If you’re going to have an operation, make sure your doctor knows
about it. You may need to stop taking the Pill about 4–6 weeks before
the operation. This is to reduce the risk of a blood clot (see section 2.1).
Your doctor will tell you when you can start taking the Pill again |
| Drug Special Care |
The Pill may slightly increase your risk of having a blood clot (called a
thrombosis), especially in the first year of taking it.
A clot in a leg vein – a deep vein thrombosis (or DVT) – is not always serious.
However, if it moves up the veins to the lungs, it can cause chest pain,
breathlessness, collapse or even death. This is called a ‘pulmonary
embolism’ and is very rare.
Your chances of having a blood clot are only increased slightly by
taking the Pill.
Of 100,000 women who are not on the Pill and not pregnant, about 5
will have a blood clot in a year.
Of 100,000 women taking a Pill such as Norethisterone, about 15 will have a
blood clot in a year. You are more at risk of having a blood clot in your veins:
as you get older
if you are seriously overweight
if you smoke
if you or any of your close family have had blood clots
if you have any blood clotting problem that needs treatment with a
medicine such as warfarin
if you’re off your feet for a long time because of major surgery, injury
or illness
if you have had one or more miscarriages
if you have recently had a baby
?Tell your doctor if any of these risk factors apply to you. Taking the Pill
may add to this risk so Norethisterone may not be suitable for you.
Signs of a blood clot include:
painful swelling in your leg
sudden chest pain, difficulty breathing
sudden changes in eyesight (such as loss of vision or blurred vision)
?See a doctor as soon as possible. Do not take any more Norethisterone until
your doctor says you can. Use another method of contraception, such as
condoms, in the meantime.
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 heart attack or stroke:
as you get older
if you have high blood pressure
if you smoke or drink too much alcohol
if you have high levels of fat in your blood or are seriously
overweight
if you have an irregular heartbeat (atrial fibrillation), problems with
heart valves or heart failure
if you or someone in your close family has had a heart attack or stroke
at a young age
if you have migraines
if you have diabetes
if you have a blood problem called sickle cell anaemia
?Tell your doctor if any of these risk factors apply to you. Taking the Pill
may add to this risk so Norethisterone may not be suitable for you.
Signs of a heart attack or stroke include:
sudden crushing pains in your chest which may reach your left arm
sudden weakness or numbness in one side or part of your body
severe headache or migraine for the first time or worse than normal
slurred speech or any other difficulties affecting your speech
any sudden changes to your eyesight (such as loss of vision or
blurred vision)
Do not take Norethisterone if any of the following apply to you:
If you are breast feeding and your baby is less than 6 weeks old
If you have breast or liver cancer
If you have an irregular heartbeat (atrial fibrillation), problems with
heart valves or heart failure
If you have ever had a problem with your blood circulation. This includes
blood clots, for example in the legs (deep vein thrombosis) or lungs
(pulmonary embolism), or a heart attack or stroke
If you have any conditions which make you more at risk of a blood
clot (thrombosis – see section 2.1), such as having an operation and
being off your feet for a long time
If you have very high blood pressure
If you smoke 15 or more cigarettes a day and you are 35 years old or
more
If you have migraines which affect your vision
If you have had diabetes for more than 20 years or have diabetes with
secondary problems
If you have or have recently had a severe liver disease
If you have the disease Systemic Lupus Erythematosus (SLE) with or
without Raynaud’s disease
If you are allergic (hypersensitive) to any of the ingredients in Norethisterone.
?If you suffer from any of these, or get them for the first time while taking
Norethisterone, contact your doctor as soon as possible. Do not take Norethisterone as it
may put your health at risk. |
| Drug Drug Interactions |
Some medicines can stop Norethisterone from working properly – for example:
some medicines used to treat epilepsy
certain antibiotics
griseofulvin (for fungal infections)
certain sedatives (called ‘barbiturates’)
St. John’s Wort (a herbal remedy)
certain laxatives and charcoal
If you do need to take one of these medicines, Norethisterone may not be suitable
for you or 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.
Norethisterone 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 while you take Norethisterone. Your doctor will tell you if this is necessary |
| Drug Pregnancy Interaction |
Do not start to use Norethisterone if you are pregnant. If you think you might be
pregnant while taking Norethisterone, do a pregnancy test to confirm that you are
before you stop taking it |
| Drug Breast feeding Interaction |
If you are breast-feeding, your doctor or family planning nurse may advise
you not to take Norethisterone. Talk to them about alternative contraception.
Breast-feeding may not stop you getting pregnant. |
| Drug Machinery Interaction |
Norethisterone has no known effect on the ability to drive or use machines |
| Drug More Information |
The Pill reduces your risk of cancer of the ovary and womb if used for a long
time. However, it also seems to slightly increase your risk of cancer of the
cervix – although this may be due to having sex without a condom, rather
than the Pill. All women should have regular smear tests.
If you have breast cancer, or have had it in the past, you should not take the
Pill. The Pill slightly increases your risk of breast cancer. This risk goes up the
longer you’re on the Pill, but returns to normal within about 10 years of
stopping it. Because breast cancer is rare in women under the age of 40, the
extra cases of breast cancer in current and recent Pill users are small. For
example:
Of 10,000 women who have never taken the Pill, about 16 will have
breast cancer by the time they are 35 years old.
Of 10,000 women who take the Pill for 5 years in their early twenties,
about 17–18 will have breast cancer by the time they are 35 years old.
Of 10,000 women who have never taken the Pill, about 100 will have
breast cancer by the time they are 45 years old.
Of 10,000 women who take the Pill for 5 years in their early thirties,
about 111 will have breast cancer by the time they are 45 years old.
Your risk of breast cancer is higher:
as you get older
if you have a close relative (mother, sister or grandmother) who has had
breast cancer
if you are seriously overweight
?See a doctor as soon as possible if you notice any changes in your
breasts, such as dimpling of the skin, changes in the nipple or any lumps you
can see or feel.
Taking the Pill has also been linked to liver diseases, such as jaundice and
non-cancer liver tumours, but this is rare. Very rarely, the Pill has also been
linked with some forms of liver cancer in women who have taken it for a long
time.
?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 taking
Norethisterone.
Some of the conditions listed below can be made worse by taking the Pill. Or
they may mean it is less suitable for you. You may still be able to take
Norethisterone but you need to take special care and have check-ups more often.
Tell your doctor or family planning nurse if any of these apply to you:
If you have problems with your heart, circulation or blood clotting, such
as high blood pressure
If you have diabetes without secondary problems
If you have gall bladder problems
If you have porphyria
If you have a history of migraines
If you have brown patches on your face or body (chloasma) as you
may need to keep out of the sun
If you have had any of the following problems while pregnant or during
previous Pill use, such as itchy skin or blister-like rash, yellowing of
skin or eyes, hearing problem, systemic lupus erythematosus (SLE),
severe headaches
?Tell your doctor or family planning nurse if any of these apply to you.
Also tell them if you get any of these for the first time while taking the
Pill, or if any get worse or come back, because you may need to stop taking
Norethisterone and use another method of contraception, such as condoms
If you start a new strip of pills late, or make your ‘week off’ longer than
eight days, you may not be protected from pregnancy. If you had sex in the
last seven days, ask your doctor, family planning nurse or pharmacist for
advice. You may need to consider emergency contraception. You should also
use extra contraception, such as a condom, for seven days
3.4 A lost pill
If you lose a pill, just take a pill of the same colour from a spare strip. Then
take all the other pills from your current strip as usual. You can then keep the
opened spare strip in case you lose any more pills.
_____________________________________________________________
3.5 If you are sick or have diarrhoea
If you are sick or have very bad diarrhoea, your body may not get its usual
dose of hormones from that pill. If you have been sick within 2 hours of
taking Norethisterone, just take a pill of the same colour from a spare strip. Carry
on taking your pills as normal if you can. You won’t need to use extra
contraception.
If you are still sick or have diarrhoea for more than 1 day, follow the
instructions for a missed pill – see section 3.3, A missed pill.
?Talk to your doctor if your stomach upset carries on or gets worse. He
or she may recommend another form of contraception.
_____________________________________________________________
3.6 Missed a period – could you be pregnant?
Occasionally, you may miss a withdrawal bleed. This could mean that you are
pregnant, but that is very unlikely if you have taken your pills correctly. Start
your next strip at the normal time. If you think that you might have put yourself
at risk of pregnancy (for example, by missing pills or taking other medicines),
or if you miss a second bleed, you should do a pregnancy test. You can buy
these from the chemist or get a free test at your family planning clinic or
doctor’s surgery. If you are pregnant, stop taking Norethisterone and see your
doctor.
If you want to delay having a period, finish the strip of pills you are taking.
Start the next strip the next day without a break. Pill taking should then
continue as usual.
When you use the second strip, you may have some unexpected bleeding or
spotting on the days that you take the pill, but don’t worry. Take the next strip
after the usual 7 day break even if you are still bleeding or spotting |
| How to take the
Medicine
|
| Consumption Info |
There are no special instructions about food and drink while on Norethisterone.If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before using Norethisterone
As a new user or starting the Pill again after a break
Either take your first Norethisterone pill up to and including day 5 of your next
period (counting the first day of your period as day 1). This way, you will have
contraceptive protection with your first pill.
Or start taking Norethisterone at any time, if you are sure you are not already
pregnant. But then you must use extra contraception, such as condoms, until
you have taken the first 7 pills correctly.
Changing to Norethisterone from another contraceptive
If you are currently taking another Pill and you are taking it correctly, you can
start Norethisterone at any time, if you are sure you are not already pregnant. There
is no need to wait for your next period to start and you don’t need extra
contraception. If you are currently using a non-hormonal method and your
period started more than 5 days ago, you must use extra contraception, such
as condoms, until you have taken the first 7 pills correctly.
Starting Norethisterone after a miscarriage or abortion
If you have had a miscarriage or an abortion, your doctor may tell you to start
taking Norethisterone straight away. This means that you will have contraceptive
protection with your first pill.
Contraception after having a baby
If you have just had a baby, your doctor may tell you to start taking Norethisterone
21 days after the birth. This means that you will have contraceptive protection
with your first pill.
If you start Norethisterone after this, you must use extra contraception, such as
condoms, until you have taken the first 7 pills correctly |
| Drug quanitty |
Norethisterone comes in a strip of 21 pills, each marked with a day of the week.
Take your pill at the same time every day.
Start by taking a white pill marked with the correct day of the week.
Follow the direction of the arrows on the strip. Take one white pill each
day, until you have finished all of them.
Then take a peach-coloured pill marked with the correct day of the
week Follow the direction of the arrows on the strip. Take one peach-coloured
pill each day, until you have finished all of them.
Swallow each pill whole, with water if necessary. Do not chew the pill.
Then have seven pill-free days
After you have taken al 21 pills in the strip, you have seven days when you
take no pills. So if you take the last pill of one pack on a Friday, you will take
the first pill of your next pack on the Saturday of the following week.
Within a few days of taking the last pill from the strip, you should have a
withdrawal bleed like a period. This bleed may not have finished when it is
time to start your next strip of pills.
You don’t need to use extra contraception during these seven pill-free days –
as long as you have taken your pills correctly and start the next strip of pills
on time |
| Drug Dose |
To prevent pregnancy, always take Norethisterone as described below. Check with
your doctor or family planning nurse if you are not sure
Then start your next strip
Start taking your next strip of Norethisterone after the seven pill-free days – even if
you are still bleeding. Always start the new strip on time.
As long as you take Norethisterone correctly, you will always start each new strip
on the same day of the week. |
| Excess Drug Consumption |
It is unlikely that taking more than one pill will do you any harm, but you may
feel sick, vomit or have some vaginal bleeding. Talk to your doctor if you have
any of these symptoms |
| Forgot Drug Consumption |
Missing pills or starting a strip late may make your pill less effective. The
chance of pregnancy after missing pills depends on when pills are missed
and how many pills are missed.
Missing one pill anywhere in your strip or starting a new strip one day late is
not a problem. Missing more than one or starting a strip more than one day
late may affect your contraceptive cover.
It is more risky to start a strip late and miss more than one pill.
How many pil s have you missed?
.
One pil
Take the missed pill straight
away, and further pills as
usual. This may mean
taking two pills in one day.
Continue taking the rest of
the strip as usual.
Don’t worry - your
contraceptive protection
should not be reduced.
Two or more pil s
Take the most recently missed pill straight away
Leave any earlier missed pills in the strip
Take your next pill at the usual time. This may mean taking two pills in one day
Continue taking the rest of the strip as usual.
Use extra precautions (condoms, for instance) for the next 7 days.
Check how many pills are left in the strip after the most recently missed pill
7 or more pil s left in the pack Fewer than 7 pil s left in the pack
Use extra precautions for the next 7 days Use extra precautions for the next 7 days
When you have finished the strip, leave the When you finish the strip, start the next strip the
usual 7-day break before starting the next next day without a break.
strip. If you do not have a withdrawal bleed after you
If you have missed any pil s from the first have finished the second strip, do a pregnancy test
week of your strip and you had sex in that
week, you could become pregnant. Contact
your doctor, family planning nurse or
pharmacist for advice as soon as possible.
They may recommend you use emergency
contraception.
If you have missed any of the pills in a strip, and you do not bleed in the first
pill-free break, you may be pregnant. Contact your doctor or family planning
clinic, or do a pregnancy test yourself |
| Stop Drug Consumption |
If you are planning a baby, it’s best to use another method of contraception
after stopping Norethisterone until you have had a proper period. Your doctor or
midwife relies on the date of your last natural period to tell you when your
baby is due. However, it will not cause you or the baby any harm if you get
pregnant straight away |
| Possible Side
Effects
|
| General Information |
increased blood pressure
hives (urticaria), swelling of the face, lips, mouth, tongue or throat which
may cause difficulty in swallowing or breathing. These may be signs of
allergy.
?If you think you may have any of these, see a doctor straight away.
You may need to stop taking Norethisterone. |
| Common Drug Side Effects |
Signs of a blood clot in a vein include:
painful swelling in your leg
sudden chest pain, difficulty breathing
sudden changes in eyesight (such as loss of vision or blurred vision).
Signs of heart attack or stroke include:
a severe headache or migraine for the first time, or worse than normal
sudden changes in eyesight (such as loss of vision or blurred vision)
sudden weakness or numbness in one side or part of your body
slurred speech or any other difficulties affecting your speech
sudden crushing pains in your chest which may reach your left arm.
Signs of breast cancer include:
dimpling of the skin
changes in the nipple
any lumps you can see or feel.
Signs of severe liver problems include:
severe pain in your upper abdomen
yellow skin or eyes (jaundice)
Headache |
| Rare Drug Side Effects |
Swollen hands, ankles or feet
Depression; feeling irritable
Stomach cramps and bloating
Acne
Tender breasts |
| Very Rare Drug Side Effects |
Migraine (see a doctor as soon as possible if this is your first migraine
or it’s worse than usual)
Painful or sore breasts
Mood changes
Rash; patches of darkened skin (which may not disappear)
Hair thinning (alopecia), excessive hair growth
Nausea, vomiting
Changes in appetite
Weight gain or loss
Change in sex drive
Vaginal thrush (fungal infection)
No withdrawal periods
Bleeding and spotting between your periods for the first few months
(though this usually stops when your body adjusts to Norethisterone) – see
section 4.3, Bleeding between periods should not last long.
Contact lenses may feel uncomfortable |
| Drug Side Effects Symptoms |
Gynaecological problems:
Vaginal problems, such as more secretions
Heavy or unusual periods
Fibroids (disorder of the womb) may get worse
Delayed return to fertility after stopping the Pill
Cancer of the cervix (vaginal discharge that smells and contains blood,
unusual vaginal bleeding, pelvic pain, painful sex)
Breast problems such as fuller breasts; producing a milky fluid from the
nipples, reduced amount of breast milk (if breast feeding)
Oily skin
Small red blisters or pimples on the hands or arms, red painful
lumpy swellings on the legs
Stomach ache
Premenstrual syndrome (PMS)
Gallstones
A problem with the nervous system (chorea).
?Tell your doctor, pharmacist or family planning nurse if you are worried
about any side effects which you think may be due to Norethisterone. Also tell them
if any existing conditions get worse while you are taking Norethisterone.
Usually you should only have a withdrawal bleed like a period during the
seven pill-free days. However, a few women have a little unexpected bleeding
or spotting while they are taking Norethisterone, especially during the first few
months. Normally, this bleeding is nothing to worry about and will stop after a
day or two. Keep taking Norethisterone as usual. The problem should disappear
after the first few strips.
You may also have unexpected bleeding if you are not taking your pills
regularly, so try to take your pill at the same time every day. Also, unexpected
bleeding can sometimes be caused by other medicines.
?Make an appointment to see your doctor if you get breakthrough
bleeding or spotting that:
carries on for more than the first few months
starts after you’ve been taking Norethisterone for a while
carries on even after you’ve stopped taking Norethisterone. |
| How to Store the
Medicine
|
| How to Store the Medicine |
Keep all medicines out of the reach and sight of children.
Store Norethisterone below 25°C. Store it in the original package to protect it from
light and moisture.
Do not use Norethisterone after the expiry date shown on the strip. The expiry date
refers to the last day of that month.
Do not throw away any medicines down a drain or into a bin. Ask your
pharmacist what to do with any medicines you do not want. This will help to
protect the environment |
|
Substitute Drugs
|
Sign In
Create New Account