MICRONOR ORAL CONTRACEPTIVE TABLETS

Active substance: NORETHISTERONE

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GB - AW_79877

GB - AW_79877

Micronor ®

Micronor ®

PACKAGE LEAFLET: INFORMATION FOR THE USER

© J-C 2012

Micronor ® oral contraceptive tablets
Norethisterone
Micronor is a registered trademark

Five important things to know about the Pill.

• Some women should not take the Pill because of current medical problems or illnesses. Please read the
leaflet to make sure Micronor is right for you.
• To prevent pregnancy it is important to take Micronor as instructed and start each strip on time.
Please make sure that you understand what to do if you miss a pill or think you are pregnant.

Read all of this leaflet carefully before you start taking this medicine.

In this leaflet:

• The Pill is a reliable contraceptive and may reduce your risk of cancer of the ovary and womb if used for
a long time.
• 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.

• Keep this leaflet. You may need to read it again.
• If you have any questions or need more advice, 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 any of the side effects gets severe, or if you notice any not listed in this leaflet, please tell your doctor,
family planning nurse or pharmacist.

1 What Micronor does
2 Make sure Micronor is OK for you
3 Taking Micronor
3.3 A missed pill
4 Possible side effects
5 How to store Micronor
6 What is in Micronor and who makes it

1 What Micronor does
Micronor is a 'progestogen only' oral contraceptive pill (POP or 'mini Pill''). You take it to stop getting
pregnant.
This low-dose contraceptive contains a female sex hormone called progestogen. This hormone changes
the lining of the womb and so prevents an egg from growing there. Also, Micronor makes the fluid (mucus)
in your cervix thicker which makes it more difficult for sperm to enter the womb.
Micronor is a 28-day Pill – you take one every day without a break.

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
Micronor will not protect you against sexually transmitted infections, such as Chlamydia or HIV.
Only condoms can help to do this.
Micronor needs to be taken as directed to prevent pregnancy.

2 Make sure Micronor is OK for you
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 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 specials 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 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 be advised to stop
taking the Pill 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.

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 to the lungs, it can cause chest pain, breathlessness, collapse or even death. This is called
a 'pulmonary embolism' and is very rare.

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 Micronor
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 Micronor 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.

• Of 10,000 women who have never taken the Pill:
• by the age of 30, 44 women will have breast cancer
• by the age of 40, 160 women will have breast cancer.
• Of 10,000 women who take the Pill for up to 5 years:
• and then stop by the age of 20, there will be less than 1 extra case of breast cancer diagnosed in the

next 10 years

• and then stop by the age of 30, there will be about 2 to 3 extra cases of breast cancer diagnosed in the

next 10 years

• and then stop by the age of 40, there will be about 10 extra cases of breast cancer diagnosed in the

next 10 years.
The risk of having breast cancer returns to normal within about 10 years of stopping the Pill.

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 Micronor.

2.3 Micronor 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 Micronor if any of the following apply to you:
• If you have breast cancer
• If you are allergic (hypersensitive) to any of the ingredients in Micronor.
➜ If you suffer from either of these, or get them for the first time while taking Micronor, contact your
doctor as soon as possible. Do not take Micronor as it may put your health at risk.

2.4 Micronor can make some illnesses worse

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 Micronor 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 or have had problems with your heart
• If you have had breast cancer
• If you have severe liver problems
• If you have the disease Systemic Lupus Erythematosus (SLE)
• If you have ever had a stroke (including a “mini-stroke” also known as “TIA”).
• If you have a blood problem called porphyria
➜ 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 Micronor and use another method of contraception, such as condoms.

2.5 Taking other medicines

• 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 Micronor
may not be suitable for you.

If you ever need to take another medicine at the same time as being on the Pill, always tell your doctor,
pharmacist or dentist that you're taking Micronor. Also check the leaflets that come with all your medicines
to see if they can be taken with hormonal contraceptives.
Some medicines can stop Micronor from working properly – for example:
• some medicines used to treat epilepsy (such as carbamazepine and phenytoin)
• bosentan (for high blood pressure in the blood vessels of the lungs)
• rifampicin and rifabutin (for the treatment of TB)
• griseofulvin (for fungal infections)
• certain sedatives (called 'barbiturates')
• St. John's Wort (a herbal remedy)
• anti-HIV medicines
• aprepitant and fosaprepitant (for prevention of nausea and vomiting caused by certain cancer drug treatments)
If you do need to take one of these medicines, Micronor 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.

Signs of a heart attack or stroke include:

2.6 Taking Micronor with food and drink

You are more at risk of having a heart attack or stroke:

• 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)
➜ See a doctor as soon as possible. Do not take any more Micronor until your doctor says you can.
Use another method of contraception, such as condoms, in the meantime.

2.2 The Pill and cancer

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, you should not take the Pill. The Pill slightly increases your risk of breast cancer.
Breast cancer is rare in women under the age of 40 whether or not they are on the Pill. The age you stop taking
the Pill is the most important risk factor for breast cancer. There is slightly more chance of you having breast
cancer the older you are when you stop taking the Pill, compared to women who have never taken the Pill.

There are no special instructions about food and drink while on Micronor.

2.7 Pregnancy and breast-feeding

Do not start to use Micronor if you are pregnant. If you think you might be pregnant while taking Micronor,
do a pregnancy test to confirm that you are before you stop taking it. If you do get pregnant while taking this
Pill, there is a slightly greater chance that it could form outside of the womb (ectopic pregnancy).
If you are breast-feeding, your doctor or family planning nurse may advise you not to take Micronor.
Talk to them about alternative contraception. Breast-feeding may not stop you getting pregnant.

2.8 Driving and using machines

Micronor has no known effect on the ability to drive or use machines.

2.9 Micronor contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before using Micronor.

3 Taking Micronor
3.1 How to take it

Changing to Micronor from a contraceptive implant

Take Micronor every day

Changing to Micronor from a contraceptive injection

To prevent pregnancy, always take Micronor as described below. Check with your doctor or family planning
nurse if you are not sure.
Micronor comes in a strip of 28 pills, each marked with a day of the week.
• Take your pill at the same time every day. (Take special care when travelling between different time zones.)
• Start by taking a pill marked with the correct day of the week.
• Follow the direction of the arrows on the strip.
• Swallow each pill whole, with water if necessary. Do not chew the pill.

Starting a new strip

When you have taken all 28 pills in the strip, start a new strip on the next day. Do not have any pill-free days.
As long as you take Micronor correctly, you will always start each new strip on the same day of the week.

3.2 Starting Micronor

• Start taking Micronor the same day the implant is removed. You will have contraceptive protection with your
first pill.
• Start taking Micronor on, or before, the day the repeat injection is due. You will have contraceptive
protection with your first pill.

Changing to Micronor from a coil

• Either start taking Micronor 2 days before the coil is removed. You will have contraceptive protection with
your first pill.
• Or, if you start taking Micronor the same day as removal of the coil, if possible you must use extra
contraception, such as condoms, for 7 days before removal and until you have taken the first 2 pills
correctly.

Starting Micronor after a miscarriage or abortion

You must take your first Micronor pill up to and including day 5 of your next period. (By starting in this way,
you will have contraceptive protection with your first pill.)

If you have had a miscarriage or an abortion, your doctor may tell you to start taking Micronor straight away.
This means that you will have contraceptive protection with your first pill.
If you start more than 1 day after a miscarriage or abortion, use extra precautions (for instance condoms)
for the next 2 days.

Changing to Micronor from another contraceptive Pill

Contraception after having a baby

As a new user or starting the Pill again after a break

• If you are currently taking a 21-day Pill, start Micronor the next day after the end of the strip. You will
have contraceptive protection with your first pill.
• If you are taking a 28-day Pill, start taking Micronor the day after your last active pill. You will have
contraceptive protection with your first pill.
• If you are taking another progestogen-only Pill (POP or 'mini Pill'), start Micronor the next day after the
end of the previous strip. You will have contraceptive cover straight away.

Start taking Micronor straight away after your baby is born. This means that you will have contraceptive
protection with your first Pill.
If you start later than this, use extra precautions (for instance condoms) for the next 2 days.
Ask your doctor for advice about contraception.

3.3 A missed pill
How late are you?
Less than 3 hours late
• Take the delayed pill straight away, and further pills as usual.
• Continue taking the rest of the strip as usual.
• Don't worry, your contraceptive protection should not be reduced.

More than 3 hours late, or have missed one or more pill
• 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 2 days.
• If you have had unprotected sex in these 2 days, 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 within 45 days of your last period, you may be pregnant. Stop taking Micronor and contact your doctor or family planning clinic, or do a pregnancy test
yourself.

3.4 A lost pill

3.7 Taking more than one pill should not cause harm

3.5 If you are sick or have diarrhoea

3.8 When you want to get pregnant

If you lose a pill, just take a pill 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.

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 3 hours of taking Micronor, just take a pill from a spare strip. Carry on taking
your pills as normal if you can. You won't need to use extra contraception.
If you have been sick more than 3 hours after taking Micronor, carry on taking your pills as normal and
use extra contraception for 2 days after you are better.
➜ Talk to your doctor if your stomach upset carries on or gets worse. He or she may recommend
another form of contraception.

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.

If you are planning a baby, it's best to use another method of contraception after stopping Micronor until you
have regular periods. 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.

3.6 Missed a period – could you be pregnant?

Occasionally, you may miss a period. 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 Micronor and see your doctor.

4 Possible side effects
Like all medicines, Micronor 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 Micronor.

4.1 Serious side effects – see a doctor straight away
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 any that is 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).

Other serious side effects include:

• hives (urticaria), swelling of the face, lips, mouth, tongue or throat which may cause difficulty
in swallowing or breathing. These may be signs of severe allergy
• severe bleeding from the vagina
• severe pain in the lower abdomen, bleeding or collapse (may be signs of pregnancy outside
the womb)
➜ If you think you may have any of these, see a doctor straight away. You may need to stop taking
Micronor.

4.2 Other possible side effects – tell your doctor
Very common side effects (affects more than 1 in 10 patients)
• Bleeding and spotting between your periods

Common side effects (affects more than 1 in 100 patients)
• Headache, (but if severe, unusual or long lasting, see a doctor as soon as possible)
• Feeling dizzy
• Feeling sick or being sick
• No menstrual periods
• Tender breasts
• Feeling tired
• Weight gain.
Uncommon side effects (affects fewer than 1 in 100 patients)
• Depression; feeling nervous
• Stomach pain and other stomach problems
• Acne
• Rash
• Hair thinning (alopecia), excessive hair growth
• Pain in legs
• Painful periods with heavy bleeding
• Vaginal discharge
• Ovarian cyst (may cause pain and swelling of the abdomen, changes in periods)
Rare side effects (affects fewer than 1 in 1000 patients)
• Hypersensitivity (allergic reaction)
Frequency not known
• Itchy rash
• Breast problems such as painful breasts; reduced amount of breast milk (if breast feeding)
• Irregular periods
• Bleeding when stopping Micronor
➜ Tell your doctor, pharmacist or family planning nurse if you are worried about any side effects which
you think may be due to Micronor. Also tell them if any existing conditions get worse while you are taking
Micronor.

4.3 Bleeding between periods should not last long

A few women have a little unexpected bleeding or spotting while they are taking Micronor, especially during
the first few months. Normally, this bleeding is nothing to worry about and will stop after a day or two. Keep
taking Micronor 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 Micronor for a while
• carries on even after you've stopped taking Micronor.

5 How to store Micronor
Keep all medicines out of the reach and sight of children.
Store Micronor below 25°C. Store it in the original package to protect it from light.

Do not use Micronor 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.

6 What is in Micronor and who makes it
What is in Micronor

Each box of Micronor contains three strips each containing 28 tablets.
The tablets are round and white, and engraved 'C035'.
Each tablet contains 350 micrograms norethisterone.
Micronor also contains the inactive ingredients: lactose (a type of sugar), magnesium stearate and
pregelatinised starch.
The company that holds the product licence for Micronor:
Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire HP12 4EG, UK
Micronor is made by:
Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
OR
McGregor Cory Ltd, Middleton Close, Banbury, Oxfordshire OX 16 4RS, UK

For information in large print, tape, CD or Braille, telephone
0800 7318450.
This leaflet was last revised in September 2012

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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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