Bayer plc
400 South Oak Way, Reading, RG2 6AD
Telephone: +44 (0) 118 206 3000
Medical information: medical.information@bayer.co.uk.
www: http://www.bayer.co.uk

Due to regulatory changes, the content of the following Patient
Information Leaflet may vary from the one found in your medicine pack.
Please compare the 'Leaflet prepared/revised date' towards the end of
the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please contact
your doctor or pharmacist.

Package leaflet: Information for the user

Norgeston®
levonorgestrel
Four important things to know about the Pill.
▪ The Pill will not protect you against sexually transmitted diseases.
▪ This medicine can increase your risk of problems such as blood clots and breast cancer.
▪ Some women should not take the Pill because of current medical problems or illnesses.
Please read this leaflet to make sure Norgeston is right for you.
▪ To prevent pregnancy it is important to take Norgeston as instructed and start each pack ontime. Please make sure that you understand what to do if you miss a pill or if you think you
are pregnant.
Read all of this leaflet carefully before you start taking this medicine.
▪ Keep this leaflet. You may need to read it again.
▪ If you have any further questions, ask your doctor, family planning nurse or pharmacist.
▪ This medicine has been prescribed for you. Do not pass it on to others. It may harm them.
If you get any side effects, talk to your doctor, family planning nurse or pharmacist. This includes
any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1
What Norgeston does
2
What you need to know before you take Norgeston
3
Taking Norgeston
3.3
A missed pill
4
Possible side effects
5
How to store Norgeston
6
What is in Norgeston and who makes it

1What Norgeston does

Norgeston is an oral contraceptive pill (the ‘mini Pill’). You take it to stop you getting pregnant.
Norgeston contains a type of female sex hormone, called a progestogen. This hormone stops you
getting pregnant by working in three ways: by making the fluid (mucus) in your cervix thicker,
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v020_0which makes it more difficult for sperm to enter the womb; by preventing the lining of your womb
thickening enough for an egg to grow in it; and in some women it also stops the ovary releasing an
egg each month (ovulation).
Norgeston is taken every day without a break. You take a pill every day for 35 days.
Norgeston needs to be taken as directed to prevent pregnancy.
The likelihood of getting pregnant is slightly higher if you take a progestogen-only pill (POP) suchas Norgeston than with some other medicines for hormonal contraception such as combined
hormonal contraceptives containing an oestrogen and a progestogen. Your doctor can provide
further information on this. The effect of Norgeston is similar to that of other POPs. The failure rate
may increase if pills are missed or taken incorrectly (see section 3).
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
Norgeston will not protect you against sexually transmitted infections, such as Chlamydia or HIV.
Only condoms can help to do this.
Children and adolescents
Norgeston is not indicated for use before the first menstrual bleeding (menarche).
Use in older women
Norgeston is not intended for use after the menopause.
Women with liver impairment
Do not take Norgeston if you suffer from severe liver disease. See also sections 2.2 and 2.3.

2What you need to know before you take Norgeston

It’s important that you understand the benefits and risks of taking the Pill before you start taking it,or when deciding whether to carry on taking it. Although the Pill is suitable for most healthy women
it isn’t suitable for everyone.
➜
Tell your doctor if you have any of the illnesses or risk factors mentioned in this leaflet.
Before you start taking the Pill
▪ Your doctor will ask about you and your family’s medical problems and check your bloodpressure and exclude the likelihood of you being pregnant. You may also need otherchecks, such as a breast examination, but only if these examinations are necessary for youor if you have any special concerns.
While you’re on the Pill
▪ 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 seeor 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 canaffect 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
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v020_0of a blood clot (see section 2.1). Your doctor will tell you when you can start taking the Pillagain.
2.1 The Pill and blood clots
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 and blocks an artery in the lungs, it can cause chest pain, breathlessness, collapse oreven death. This is called a pulmonary embolism and is very rare.
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 blood clot:▪ as you get older▪ if you smoke▪ if you are seriously overweight▪ if you have some diseases of the heart and blood vessels▪ if you have diabetes▪ if you suffer from migraines▪ if you’re off your feet for a long time because of major surgery, injury or illness▪ if you or any of your close family have had blood clots▪ if you have varicose veins➜ Tell your doctor if any of these apply to you. Taking the Pill may add to this risk so Norgeston
may not be suitable for you.
Signs of a blood clot include:▪ a migraine for the first time, a migraine that is worse than normal or unusually frequent orsevere headaches▪ any sudden changes to your eyesight (such as loss of vision or blurred vision)▪ any sudden changes to your hearing, speech, sense of smell, taste or touch▪ pain or swelling in your leg▪ stabbing pain when you breathe▪ coughing for no apparent reason▪ pain and tightness in the chest▪ sudden weakness or numbness in one side or part of your body▪ dizziness or fainting➜
See a doctor as soon as possible. Do not take any more Norgeston until your doctor
says you can. Use another method of contraception, such as condoms, in the meantime.

2.2 The Pill and cancer
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 tonormal within about 10 years of stopping it. Because breast cancer is rare in women under the ageof 40, the extra cases of breast cancer in current and recent Pill users is small. For example:
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v020_0▪

In 10,000 women who take progestogen-only pills like Norgeston for up to 5 years butstop taking it by the time they are aged 20, it is estimated that less than 1 additionalcase of breast cancer would be found up to 10 years afterwards, compared with thenumber found in 10,000 women who had never taken the Pill.

▪

For 10,000 women who take the Pill like Norgeston for 5 years and stop it by the ageof 30, there would be 2 or 3 extra cases of breast cancer found up to 10 years afterwards(in addition to the 44 cases of breast cancer found in 10,000 women in this age group who
had never taken the Pill).

▪

For 10,000 women who take Norgeston for 5 years and stop it by the age of 40, there
would be about 10 extra cases found up to 10 years afterwards (in addition to 160 cases ofbreast cancer found in 10,000 women in this age group who had never taken the Pill).

Your risk of breast cancer is higher:▪ 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 Norgeston.

2.3 Norgeston should not be taken by some women➜
Tell your doctor or family planning nurse if you have any medical problems or illnesses.
Do not take Norgeston if any of the following apply to you. Taking Norgeston would put yourhealth at risk.
▪
▪
▪
▪
▪
▪
▪
▪

If you are pregnant or might be pregnant
If you have ever had a severe liver disease and have been told by your doctor that yourliver function test results are not yet back to normal
If you have ever had liver tumours
If you have cancer affected by sex hormones –such as current or history of breast cancer
If you have vaginal bleeding that has not been explained by your doctor
If you have ever had a problem with your blood circulation. This includes a blood clot
(thrombosis) in the legs (deep vein thrombosis), lungs (pulmonary embolism), heart (heart
attack), brain (stroke) or any other parts of the body
If you have severe diabetes with changes to the blood vessels
If you are allergic (hypersensitive) to any of the ingredients in Norgeston.

➜If you suffer from any of these, or get them for the first time while taking Norgeston,contact your doctor as soon as possible. Do not take Norgeston and use another method ofcontraception.

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v020_02.4 Norgeston can make some illnesses worseSome of the conditions listed below can be made worse by taking Norgeston, or they may mean it
is less suitable for you. Remind your doctor:
▪
▪
▪
▪
▪
▪

If you have diabetes
If you have ever had a pregnancy develop outside the womb (an ectopic pregnancy) or
one of your Fallopian tubes is missing
If you have ovarian cysts
If you have ever suffered from yellowing of the skin (jaundice)
If you have ever suffered from persistent itching (pruritus)
If you have brown patches on your face or body (chloasma). If so avoid too much
exposure to the sun or ultraviolet radiation.

➜
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 Norgeston, or if any of these or any problems
which you had previously during pregnancy or whilst taking an oral contraceptive get worse orcome back, because you may need to stop taking Norgeston.
2.5

Psychiatric disorders

Some women using hormonal contraceptives including Norgeston have reported depression or
depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If you
experience mood changes and depressive symptoms contact your doctor for further medical
advice as soon as possible.
2.6 Taking other medicines
If you ever need to take another medicine, including medicines obtained without a prescription, atthe same time as being on the Pill, always tell your doctor, pharmacist or dentist that you’re taking
Norgeston. Also check the leaflets that come with all your medicines to see if they can be takenwith hormonal contraceptives.
Some medicines can stop Norgeston from working properly and cause unexpected bleeding – forexample:▪ some medicines used to treat epilepsy▪ some medicines used to treat HIV and Hepatitis C virus infections (so-called proteaseinhibitors and non-nucleoside reverse transcriptase inhibitors)▪ some medicines used to treat serious vomiting (e.g. aprepitant)▪ medicines used to treat high blood pressure in the blood vessels in the lungs (e.g.
bosentan)▪ some medicines used to treat certain heart diseases, high blood pressure (e.gverapamil, diltiazem)▪ griseofulvin (an anti-fungal medicine)▪ certain antibiotics▪ certain sedatives (called barbiturates)▪ St. John’s Wort (a herbal remedy)▪ grapefruit juice.
If you do need to take one of these medicines, Norgeston 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 isnecessary and for how long.

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v020_0Norgeston can also affect how well other medicines work. For example, taking Norgeston canmean that the levels of some drugs in your blood may either go up (e.g. ciclosporin) or go down(e.g. lamotrigine).
Norgeston may also increase or reduce the effects of some anticoagulant drugs (e.g. coumarins)
or inhibit the anticoagulant effect (e.g. phenindione).
Laboratory tests
Norgeston can interfere with the results of some blood tests, so always tell your doctor that you
are taking Norgeston if you have a blood test.
2.7 Taking Norgeston with food and drink
There are no special instructions about food while on Norgeston.
2.8 Pregnancy and breast-feeding
Do not use Norgeston if you are pregnant. If you think you might be pregnant, do a pregnancy
test to confirm that you are before you stop taking Norgeston.
Progestogen-only pills like Norgeston have not been shown to have any detrimental effect onbreast milk or the growth or development of a healthy baby.
2.9 Driving and using machines
Norgeston has no known effect on the ability to drive or use machines.
2.10 Norgeston contains lactose and sucrose
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor
before using Norgeston.

3 Taking Norgeston
3.1 How to take it
To prevent pregnancy, always take Norgeston as described below. Check with your doctor orfamily planning nurse if you are not sure.
Take Norgeston every day for 35 days
Norgeston comes in strips of 35 pills, each marked with a day of the week.
▪ Take your pill at the same time every day. Make sure that you are never more than threehours late with a pill otherwise the contraceptive protection may be lost.
▪ Start by taking a pill marked with the correct day of the week.
▪ Follow the direction of the arrows on the strip. Take one pill each day, until you havefinished all 35 pills.
▪ Swallow each pill whole, with water if necessary. Do not chew the pill.
Then start your next strip
Start your next strip of Norgeston the very next day after finishing the previous pack, again taking
a pill marked with the day of the week. Always start the new strip on time.
You will be taking pills through your periods and there must be no break between packs
As long as you take Norgeston correctly, you will always start each new strip on the same day of
the week.
3.2 Starting Norgeston
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v020_0As a new user or starting the Pill again after a break
It is best to take your first Norgeston pill on the first day of your next period. Another method ofcontraception will not be required.
Changing to Norgeston from another contraceptive Pill•••

If you are currently on a combined oral contraceptive, vaginal ring or patch: If you
have correctly and consistently used the previous combined Pill, start taking Norgeston the
day after your last active pill (discarding the placebo pills or disregarding the pill-freeinterval). If a vaginal ring or transdermal patch has been used correctly and consistently
before the switch, start using Norgeston on the day of removal of the last vaginal ring ortransdermal patch of a cycle pack and thereby omit the hormone-free interval of thisproduct. Another method of contraception will not be required.
Changing from another progestogen-only pill (POP or ‘mini Pill’): you can start taking
Norgeston at any time without the loss of contraceptive protection.
Changing from a progestogen-only parenteral method (implant, injection): additional
non –hormonal contraceptive protection (e.g. a condom) are not required if you start exactly
when the next implant or injection is due.

Starting Norgeston after a miscarriage or abortion
If you have had a miscarriage or an abortion during the first three months of pregnancy, yourdoctor may tell you to start taking Norgeston straight away, in which case another method ofcontraception will not be required.
Contraception after having a baby
If you have just had a baby your doctor will advise you to start taking Norgeston immediately after
delivery. If you start taking Norgeston later than this you should use another method ofcontraception, such as a condom for the first 7 days of pill taking. If you have already hadintercourse, then you should exclude the possibility of pregnancy before starting Norgeston or wait
until you have your first period.
If you have just had a baby and you are breast feeding please refer to section 2.8 Pregnancy andBreast-feeding.
3.3 A missed pill
If you are less than 3 hours late with a pill, take it straight away. Keep taking your pills at theusual time. This may mean taking two pills in one day. Don’t worry – your contraceptive protection
should not be reduced.
If you are more than 3 hours late with a pill, or you have missed more than one pill, yourcontraceptive protection may be reduced.
▪
▪

Continue to take your next pills at your usual time.
Use extra contraception for the next 7 days, such as condoms.

If you have missed any of the pills in a strip and had intercourse in the week before missing
the tablets, there is a possibility of becoming pregnant. The more consecutive tablets you
have missed, the higher the risk that the contraceptive efficacy is decreased.
3.4 A lost pill
If you lose a pill,

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v020_0Either take the last pill of the strip in place of the lost pill. Then take all the other pills on theirproper days. When you start your next pack you will have a new starting day, one day earlier than
before.
Or if you have another pack and do not want to change the starting day of your next strip, take apill from that pack. 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 (vomit) within 2 hours of taking a tablet your body may not get its usual dose ofhormones from that pill and you should take another pill as soon as possible. Follow the
instructions in section 3.4 A lost pill. If you are not able to take another pill within 3 hours use
extra contraception for the next 7 days, such as condoms
If you are persistently sick or have very bad diarrhoea, use extra contraception during theillness and for the 7 days after recovery, such as condoms
3.6 Taking more than one pill should not cause harm
It is unlikely that taking more than one pill will do you any harm, but you may feel sick, vomit orhave some vaginal bleeding. Talk to your doctor if you have any of these symptoms.
3.7 When you want to get pregnant
If you are planning a baby, it’s best to use another method of contraception after stopping
Norgeston until you have had a proper period. Your doctor or midwife relies on the date of yourlast 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.

4 Possible side effects
Like all medicines, Norgeston can cause side effects, although not everybody gets them.
➜Tell your doctor, pharmacist or family planning nurse if you are worried about any side
effects which you think may be due to Norgeston.
4.1 Serious side effects – see a doctor straight away
Signs of a blood clot:▪ a migraine for the first time, a migraine that is worse than normal, or unusually frequent orsevere headaches▪ any sudden changes to your eyesight (such as loss of vision or blurred vision)▪ any sudden changes to your hearing, speech, sense of smell, taste or touch▪ pain or swelling in your leg▪ stabbing pain when you breathe▪ coughing for no apparent reason▪ pain and tightness in the chest▪ sudden weakness or numbness in one side or part of your body▪ dizziness or fainting.
Signs of a severe allergic reaction to Norgeston:▪ swelling of the face, lips, mouth, tongue or throat.
Signs of breast cancer include:▪ dimpling of the skin
▪ changes in the nipple
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v020_0▪

any lumps you can see or feel.

Signs of severe liver problems include:▪ severe pain in your upper abdomen▪ yellow skin or eyes (jaundice)▪ inflammation of the liver (hepatitis)▪ your whole body starts itching.
➜
If you think you may have any of these, see a doctor straight away. You may need tostop taking Norgeston.
4.2 Less serious side effects
▪
▪
▪
▪
▪
▪
▪
▪

bleeding and spotting between your periods
no periods
allergic reactions, including wheezing, rash or reddened skin.
depressive moods, loss of interest in sex
headaches or migrainedizzinessfeeling sick or being sickputting on weight or losing weight.

➜
Tell your doctor, pharmacist or family planning nurse if you are worried about any side
effects which you think may be due to Norgeston. Also tell them if any existing conditions getworse while you are taking Norgeston.
4.3 If your periods seem different
A few women have irregular periods, a little unexpected bleeding or spotting or no periods at all
while they are taking Norgeston, especially during the first few months. Normally, these changes
are nothing to worry about and require no treatment. Keep taking Norgeston 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 takeyour pill at the same time every day. Also, unexpected bleeding can sometimes be caused byother medicines.
➜▪

▪

Make an appointment to see your doctor if
you get breakthrough bleeding or spotting that:o carries on for more than the first few months
o starts after you’ve been taking Norgeston for a while
o carries on even after you’ve stopped taking Norgeston.
you have had no period for 6 weeks.

Reporting of side effects
If you get any side effects, talk to your doctor or 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 or search for MHRA Yellow Card in the Google Play orApple App Store. By reporting side effects you can help provide more information on the safety ofthis medicine.

5 How to store Norgeston
Keep this medicine out of the sight and reach of children.
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v020_0Do not use this medicine after the expiry date which is stated on the packaging after EXP. 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 withany medicines you do not want. This will help to protect the environment.

6 What is in Norgeston and who makes it
What is in Norgeston
Each box of Norgeston contains one memo strip of 35 white, round, coated tablets.
Each tablet contains: 30 micrograms of the progestogen levonorgestrel.
Norgeston also contains the inactive ingredients:
lactose, maize starch, povidone, macrogol 6000, calcium carbonate (E170), talc, magnesium
stearate (E 572), sucrose, glycol montanate.
The company that holds the product licence for Norgeston is:
Bayer plc, 400 South Oak Way, Reading, RG2 6AD
Norgeston is made by:Bayer AG, Mullerstrasse 178, 13353 Berlin, Germany or Bayer Weimar GmbH & Co KG, Weimar,
Germany.
This leaflet was last revised in January 2021.

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