Ortho Cyclen
(Ethinyl Estradiol/Norgestimate)
Brand Name Choices
Generic Choices
What Ortho Cyclen is and what it is used for
Cilest is a combined hormonal contraceptive pill (‘the Pill’). You take it to
stop getting pregnant.
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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, Cilest makes the fluid (mucus) in your
cervix thicker which makes it more difficult for sperm to enter the womb.
Cilest 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
Cilest will not protect you against sexually transmitted infections, such as
Chlamydia or HIV. Only condoms can help to do this.
Cilest needs to be taken as directed to prevent pregnancy.
How to take Ortho Cyclen
3.1 How to take it
To prevent pregnancy, always take Cilest as described below. Check with
your doctor or family planning nurse if you are not sure.
Take Cilest every day for 21 days
Cilest 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 pill marked with the correct day of the week.
• Follow the direction of the arrows on the strip. Take one pill each day.
• Swallow each pill whole, with water if necessary. Do not chew the pill.
Then have seven pill-free days
After you have taken all 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.
Then start your next strip
Start taking your next strip of Cilest after the seven pill-free days – even if you
are still bleeding. Always start the new strip on time.
As long as you take Cilest correctly, you will always start each new strip on
the same day of the week.
3.2 Starting Cilest
As a new user or starting the Pill again after a break
Either take your first Cilest 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 Cilest 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.
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Changing to Cilest from another contraceptive
If you are currently taking another Pill and you are taking it correctly, you can
start Cilest 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 Cilest after a miscarriage or abortion
If you have had a miscarriage or an abortion, your doctor may tell you to start
taking Cilest 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, you are more at risk of blood clots (see Section
2.1 ‘The Pill and blood clots’).
Ask your doctor when you can start taking Cilest again. If it is 21 days after
the birth, you will have contraceptive protection with your first pill.
If you start Cilest after this, you must use extra contraception, such as
condoms, until you have taken the first 7 pills correctly.
If you have sex before you start taking Cilest or before your first period, wait
until your period starts before you take Cilest and then take it on the first day
of bleeding.
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3.3 A missed pill
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.
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.
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.
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3.4 A lost pill
How many pills have you missed?
One pill Two or more pills
• 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.
• 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
Fewer than 7 pills left in the pack
• Use extra precautions for the next 7 days
• When you finish the strip, start the next strip the next
day without a break.
• If you do not have a withdrawal bleed after you have
finished the second strip, do a pregnancy test
7 or more pills left in the pack
• Use extra precautions for the next 7 days
• When you have finished the strip, leave the
usual 7-day break before starting the next strip.
• If you have missed any pills from the first
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.
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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.
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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 Cilest, 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 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.
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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 Cilest and see your doctor.
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3.7 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 or have some vaginal bleeding. Talk to your doctor if you have
any of these symptoms.
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3.8 You can delay a period
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.
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3.9 When you want to get pregnant
If you are planning a baby, it’s best to use another method of contraception
after stopping Cilest 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. The Pill may reduce the levels of folic acid in the blood. Talk to
your doctor, nurse or pharmacist as this could be important if you get pregnant
straight after stopping the Pill.
Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Tell your doctor, pharmacist or family planning nurse if you get any
side effect particularly if they are severe and persistent, or you have any
change in your health which you think may be due to Cilest.
4.1 Serious side effects – see a doctor straight away
Harmful blood clots in a vein or artery (frequency not known) for example:
•in a leg or foot (DVT)
•in a lung (PE)
•heart attack
•stroke
•mini-stroke or temporary stroke-like symptoms, known as a transient
ischaemic attack (TIA)
•blood clots in the stomach/intestines, kidneys or eye
•blood clots in the liver, which can cause an enlarged liver, pain and
swelling (Budd-Chiari syndrome).
An increased risk of blood clots in your veins (venous thromboembolism,
VTE) or arteries (arterial thromboembolism, ATE) is present for all women
taking the Pill. For more detailed information on the different risks from
taking the Pill, please see Section 2 ‘Make sure Cilest is OK for you’. The
chance of having a blood clot may be higher if you have any other conditions
that increase this risk (see Section 2.1 ‘The Pill and blood clots’ for more
information on the conditions that increase risk for blood clots and the
symptoms of a blood clot).
Breast cancer (frequency not known)
Signs include:
• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel.
Severe liver problems (rare
•affects fewer than 1 in 1000 patients)
Signs include:
• severe pain in your upper abdomen
• yellow skin or eyes (jaundice).
Other serious side effects include:
• increased blood pressure (uncommon
•affects fewer than 1 in 100
patients)
• fits (convulsions) (frequency not known)
• hives (urticaria) (uncommon
•affects fewer than 1 in 100 patients),
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 Cilest.
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4.2 Other possible side effects – tell your doctor
Very common side effects (affects more than 1 in 10 patients)
• Headache (but if severe, unusual or long lasting, see a doctor as soon
as possible)
• Stomach problems such as nausea, vomiting and diarrhoea
• Bleeding and spotting between your periods for the first few months
(though this usually stops when your body adjusts to Cilest) – see
section 4.3, Bleeding between periods should not last long
• Painful or unusual periods
Common side effects (affects more than 1 in 100 patients)
• Migraine (see a doctor as soon as possible if this is your first migraine
or it’s worse than usual)
• Swollen hands, ankles or feet
• Depression; mood changes; feeling nervous or dizzy
• Difficulty sleeping (insomnia)
• Stomach ache and bloating; constipation; wind
• Acne; rash
• Muscle spasms; pain in the legs, arms and back
• Painful breasts
• Urinary tract infections (pain on passing urine)
• Vaginal infections such as thrush
• Vaginal discharge
• No menstrual periods
• Feeling weak
• Weight gain.
Uncommon side effects (affects fewer than 1 in 100 patients)
• Breast problems, such as fuller breasts; producing fluid from the
nipples
• Abnormal cells in the cervix (identified by a smear test)
• Feeling anxious or faint; tingling sensation or numbness
• Changes in skin colour
• Skin problems such as redness and itchiness
• Hair thinning (alopecia), excessive hair growth
• Changes in appetite
• Weight may vary
• Change in sex drive
• Dry eyes
• Changes in vision
• Palpitations (feeling your heart beat)
• Hot flushes
• Muscle pain
• Vaginal dryness
• Ovarian cysts (may cause pain and swelling of the abdomen, changes
in periods)
Rare side effects (affects fewer than 1 in 1000 patients)
• Lumpy breasts
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• Loss of sex drive
• Feeling giddy
• Faster heart beat
• Pancreatitis (inflammation of the pancreas, which causes severe pain in
the abdomen and back)
• Increased sweating
• Sensitivity to light
Frequency not known
• Reduced amount of breast milk (if breast feeding)
• Contact lenses may feel uncomfortable
• Red painful lumpy swellings on the legs
• Changes in fat levels in the blood (seen by blood tests)
• Night sweats.
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. Also tell your doctor, pharmacist or nurse if any existing
conditions get worse while you are taking Cilest.
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4.3 Bleeding between periods should not last long
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 Cilest, especially during the first few months.
Normally, this bleeding is nothing to worry about and will stop after a day or
two. Keep taking Cilest 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 Cilest for a while
• carries on even after you’ve stopped taking Cilest.
How to Store Ortho Cyclen
Keep this medicines out of the sight and reach of children.
This medicine does not require any special temperature storage conditions.
Store strips in the original package in order to protect from light.
Do not use Cilest after the expiry date shown on the strip. The expiry date
refers to the last day of that month.
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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.
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