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OVRANETTE 150/30 MICROGRAMS COATED TABLETS

Active substance(s): ETHINYLOESTRADIOL / LEVONORGESTREL

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1. What Ovranette is and

2. What you need to know

Ovranette is a combined oral contraceptive pill (‘the
Pill’). You take it to stop you getting pregnant.

Do not take Ovranette:

2.1 The Pill and blood clots

2.2 The Pill and cancer

2.3 Ovranette should not be taken by some women

2.4 Ovranette can make some illnesses worse

• If you are pregnant, think you might be pregnant or
breast-feeding
• If you or anyone in your close family has ever had a
problem with their 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 any condition which makes you more at
risk of a blood clot (thrombosis – see The Pill and
blood clots under Warnings and precautions)
• If you are 35 years old or over and smoke 15 or more
cigarettes per day
• If you have very high or uncontrolled blood
pressure
• If you have an irregular heartbeat (atrial fibrillation)
or a heart valve disorder
• If you have migraine with visual disturbances
• If you have diabetes which has affected your
circulation
• If you have the disease systemic lupus
erythematosus (SLE)
• If you have ever had liver tumours or severe liver
disease and been told by your doctor that your
liver function tests are not yet back to normal
• If you have cancer affected by sex hormones – such
as some cancers of the breast or ovary
• If you have vaginal bleeding that has not been
explained by your doctor
• If you are allergic to levonorgestrel or ethinylestradiol
or any of the other ingredients of this medicine (listed
in section 6).

The Pill may slightly increase your risk of having a
blood clot (called a thrombosis), especially in the
first year of taking it.

The Pill reduces your risk of cancer of the ovary and
womb if used in the long term. 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.

➜ Tell your doctor or family planning nurse if you have
any medical problems or illnesses.

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 Ovranette but you
need to take special care and have check-ups more
often.
• If you have problems with your heart, circulation or
blood clotting, such as:
◦ heart disease
◦ high blood pressure for which you take
medicines
◦ diabetes
• If you have ever had liver problems, or have had
gallstones in the past
• If you have high levels of cholesterol or lipids (fats) in
the blood (hyperlipidaemia)
• If you have had migraines
• If you have had any illness that worsened during
pregnancy or previous use of the Pill.
➜ 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 Ovranette.

Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
• 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
only. Do not pass it on to others. It may
harm them, even if their signs of illness are
the same as yours.
• 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.

This contraceptive contains two types of female sex
hormones, estrogen and progestogen. These hormones
prevent an egg being released from your ovaries so
you can’t get pregnant. Also, Ovranette makes the fluid
(mucus) in your cervix thicker which makes it more
difficult for sperm to enter the womb.
Ovranette 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.
Ovranette will not protect you against sexually
transmitted infections, such as Chlamydia or HIV. Only
condoms can help to do this.
Ovranette needs to be taken as directed to prevent
pregnancy.

Warnings and precautions
Talk to your doctor, pharmacist or family planning nurse
before taking Ovranette.
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 check/confirm that you are not
pregnant then ask about you and your family’s
medical problems and check your blood pressure.
You may also need other checks, such as a breast,
abdomen or pelvic examination but only if these
examinations are necessary for you, or if you have
any special concerns.

What is in this leaflet
1. What Ovranette is and what it is used
for
2. What you need to know before you take
Ovranette
3. How to take Ovranette
5. How to store Ovranette
6. Contents of the pack and other
information

Date: 28 Aug 2017 Time: 11:39
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You are more at risk of having a blood clot in your
veins:
• as you get older
• if you are seriously overweight
• if you or any of your close family have had blood
clots
• if you have certain rare medical conditions such as
systemic lupus erythematosus (SLE)
• 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 Ovranette
may not be suitable for you.
Signs of a blood clot include:
• painful swelling in your leg
• sudden chest pain
• difficulty breathing.
➜ See a doctor as soon as possible. Do not take any
more Ovranette 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
• if you have a disease affecting your heart valves or
an irregular heartbeat (atrial fibrillation)
• if you have certain rare medical conditions such as
systemic lupus erythematosus (SLE)
• 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.
➜ Tell your doctor if any of these risk factors apply to
you. Taking the Pill may add to this risk so Ovranette
may not be suitable for you.
Signs of a heart attack or stroke include:
• sudden sharp pains in your chest which may reach
your left arm
• sudden weakness or numbness in one side or part
of your body
• if you have a migraine for the first time or any
migraine that is worse than normal
• any sudden changes to your eyesight (such as loss
of vision or blurred vision)
• problems with speech (such as slurred speech or
difficulty talking)
• dizziness, fainting, collapse or seizures.
➜ See a doctor as soon as possible. Do not take any
more Ovranette until your doctor says you can. Use
another method of contraception, such as condoms, in
the meantime.

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 very 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 Ovranette.

See your doctor as soon as possible as you may
need to stop using Ovranette if:
• You develop migraine for the first time or suffer
worsening of existing migraine or headaches
• You experience any sudden unexplained changes in
your vision
• You have symptoms such as unusual pains in or
swelling of the legs, stabbing pains on breathing,
persistent cough or coughing blood, pain or tightness
in the chest
• Your blood pressure rises significantly
• You develop jaundice (yellowing of skin and/or white
of eyes).
Other medicines and Ovranette

Laboratory tests
If you are scheduled for any laboratory tests, tell your
doctor you are taking the Pill. Certain blood tests may
be affected by the Pill.
Pregnancy, breast-feeding and fertility
Do not use Ovranette if you are pregnant. If you think
you might be pregnant, do a pregnancy test to confirm
that you are before you stop taking Ovranette.
If you are breast-feeding, your doctor or family
planning nurse may advise you not to take Ovranette.
Talk to them about alternative contraception. Breastfeeding will not stop you getting pregnant.
Driving and using machines
Ovranette has no known effect on the ability to drive or
use machines.
Ovranette contains lactose and sucrose
Ovranette contains the sugars, lactose and sucrose.
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
using Ovranette.

Tell your doctor, pharmacist or family planning nurse if
you are taking, have recently taken or might take any
other medicines, including medicines obtained without
a prescription. Also check the leaflets that come with
all your medicines to see if they can be taken with
hormonal contraceptives.
Some medicines can stop Ovranette from working
properly and may cause unexpected bleeding and
irregular periods, for example:
• some medicines used to treat epilepsy
• some medicines used to treat tuberculosis
• some medicines used to treat HIV or AIDS
• some medicines used to treat fungal infections
• some medicines used to treat sleep disorders
• some medicines used to treat inflammatory
conditions such as gout
• some antibiotics used to treat bacterial infections
• St John’s wort (a herbal remedy).
If you do need to take one of these medicines,
Ovranette may not be suitable for you or you may need
to use extra contraception during and for 7 to 28 days
after treatment with the other medicines. Your doctor,
pharmacist or family planning nurse can tell you if this is
necessary and for how long.

2 0 1 7 - 0 0 0 5 3 7 6 A . Code FPO

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 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.

4. Possible side effects

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 Ovranette,
about 15 will have a blood clot in a year
• Of 100,000 women who are pregnant, around 60 will
have a blood clot in a year.

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 is 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 110 will have breast
cancer by the time they are 45 years old.

Do not take Ovranette if any of the following apply to
you. Taking Ovranette would put your health at risk.
• If you are pregnant, think you might be pregnant or
breast-feeding
• If you have cancer affected by sex hormones – such
as some cancers of the breast or ovary
• If you have vaginal bleeding that has not been
explained by your doctor
• If you or anyone in your close family has ever had a
problem with their 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 very high or uncontrolled blood
pressure
• If you have any condition which makes you more at
risk of a blood clot (thrombosis – see section 2.1,
The Pill and blood clots)
• If you have an irregular heartbeat (atrial fibrillation)
or a heart valve disorder
• If you have migraine with visual disturbances
• If you have diabetes which has affected your
circulation
• If you are 35 years old or over and smoke 15 or more
cigarettes per day
• If you have the disease systemic lupus
erythematosus (SLE)
• If you have ever had liver tumours or severe liver
disease and been told by your doctor that your
liver function tests are not yet back to normal
• If you are allergic (hypersensitive) to the active
substances, levonorgestrel and ethinylestradiol or
any of the other ingredients of this medicine (listed in
section 6).
➜ If you suffer from any of these, or get them for the
first time while taking Ovranette, contact your doctor as
soon as possible. You should not take Ovranette.

Ovranette®

Five important things to know about
the Pill
• The Pill is a reliable contraceptive and may
reduce your risk of cancer of the ovary and
womb if used in the long term.
• 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 Ovranette is right for you.
• To prevent pregnancy it is important to
take Ovranette as instructed and start each
pack on time. Please make sure that you
understand what to do if you miss a pill or
if you think you are pregnant.

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.

150 micrograms/30 micrograms coated tablets

Your doctor may also prescribe Ovranette for some
other conditions such as:

• painful menstruation (dysmenorrhea) or premenstrual tension

• endometriosis

• heavy or irregular bleeding from the womb
(uterus).

Ovranette can also affect how well other medicines
work:
• certain medicines used to prevent rejection after
an organ transplant
• certain drugs for asthma
• certain medicines used to treat epilepsy.
➜ Remind your doctor that you are taking the Pill if
you take any of the above medicines.

levonorgestrel and ethinylestradiol

150 micrograms/
30 micrograms coated
tablets
levonorgestrel and
ethinylestradiol

before you take Ovranette

K

what it is used for

Ovranette

®

K

Package leaflet:
Information for the patient

K

Ovranette®
150 micrograms/30 micrograms
coated tablets
levonorgestrel and ethinylestradiol

K

3. How to take Ovranette

4. Possible side effects

Always take this medicine exactly as your doctor,
pharmacist or family planning nurse has told you.
Check with your doctor or pharmacist if you are not
sure.

As long as you take Ovranette correctly, you will always
start each new strip on the same day of the week.

3.1 How to take it

As a new user or starting the Pill again after a break
Either take your first Ovranette pill on the first day of
your next period. By starting in this way, you will have
contraceptive protection with your first pill.

To prevent pregnancy, always take Ovranette as
described below. Check with your doctor or family
planning nurse if you are not sure.
Take Ovranette every day for 21 days
Ovranette comes in strips 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, until you have finished all
21 pills.
• 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.

3.2 Starting Ovranette

Or start taking Ovranette on any other day of your
period. You must also use extra contraception, such
as condoms, until you have taken the first seven pills
correctly.
Changing to Ovranette from another contraceptive
Pill
• If you are currently on a 21-day Pill: start Ovranette
the next day after the end of the previous strip. You
will have contraceptive protection with your first pill.
You will not have a bleed until after your first strip of
Ovranette.
• If you are currently on a 28-day Pill: start taking
Ovranette the day after your last active pill. You will
have contraceptive protection with your first pill.
You will not have a bleed until after your first strip of
Ovranette.
• If you are taking a progestogen-only Pill (POP
or “mini Pill”): start Ovranette on the first day
of bleeding, even if you have already taken the
progestogen-only Pill for that day. You will have
contraceptive cover straight away.

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.

Starting Ovranette after a miscarriage or abortion
If you have had a miscarriage or an abortion during the
first three months of pregnancy, your doctor may tell
you to start taking Ovranette straight away. This means
that you will have contraceptive protection with your
first pill.

Then start your next strip
Start taking your next strip of Ovranette after the
seven pill-free days – even if you are still bleeding.
Always start the new strip on time.

If you have had a miscarriage or an abortion after the
third month of pregnancy, ask your doctor for advice.
You may need to use extra contraception, such as
condoms, for a short time.
Contraception after having a baby
You can start using Ovranette after 21 days if you are
not breast-feeding and had a vaginal delivery with no
complications and you are fully mobile.
If the pill is started later than 21 days after delivery, then
alternative contraception, such as condoms, should
be used until oral contraception is started and for the
first 7 days of pill taking. If unprotected intercourse
has taken place after 21 days of delivery, then oral
contraception should not be started until the first period
after childbirth.
Your doctor or family planning clinic can provide further
advice about contraception.

3.3 If you take more Ovranette than you should
Taking too many tablets may cause nausea (feeling
sick), vomiting (being sick), breast tenderness,
dizziness, tummy pain, and drowsiness/fatigue.
Withdrawal bleeding may occur in some females. In
case of overdose, contact your doctor or pharmacist.
3.4 If you forget to take Ovranette
If you miss a pill, follow these instructions:
Start here

When were you due
to take the missed pill?

Less than 12 hours ago

• Take the delayed pill
straight away, and
further pills as usual.
This may mean taking
two pills in one day.
• Don’t worry, your
contraceptive protection
should not be reduced.

More than 12 hours ago,
or you’ve missed more
than one pill
• Take the most recently
missed pill straight away.
• Leave any earlier missed
pills in the strip.
• Take your further pills as
usual. This may mean
taking two pills in one day.
• 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 pills left in
the pack

Fewer than 7 pills left in
the pack

• Don’t forget to 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
one or more pills from
the first week of your
strip (days 1 to 7) 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.

• Don’t forget to use extra
precautions for the next
7 days.
• When you finish the strip
of pills, 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 before
starting another strip.
• If you missed one or
more pills in the first
week of your strip (days
1 to 7) 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.

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 seven 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.

Date: 28 Aug 2017 Time: 11:39
New Component Nº 2017-0005376A
OLD Component Nº n/a

Packaging Site Haupt Munster

Smallest

Market United Kingdom
Proof Nº 03
Component Leaflet

Barcode Nº N/A

Pharma Code FPO

BODY TEXT Size 8 pt

Drawing Nº N/A

Dimensions 665 x 300 mm
Notes N/A
PAR Number PAR-2017-0005376

Colours
Printing

Non-Printing

Black

Profile

3.5 If you are sick or have diarrhoea
If you are sick (vomit) or have very bad diarrhoea within
4 hours after taking your Ovranette, your body may
not get its usual dose of hormones from that pill. Take
another pill as soon as you are able to and continue to
take your next pills at your usual time. If you are still sick
or have diarrhoea for more than 24 hours after taking
Ovranette, follow the instructions in section 3.4, If you
forget to take Ovranette.
➜ Talk to your doctor if your stomach upset carries
on or gets worse. They 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. If you think
that you might have put yourself at risk of pregnancy
(for example, by missing pills or taking other medicines)
you should do a pregnancy test before you start your
next pack. You can buy these from the chemist or get
a free test at your family planning clinic or doctors
surgery. If you are pregnant, stop taking Ovranette and
see your doctor.
3.7 If you take more Ovranette than you should
It is unlikely that taking more than one pill will do you
any harm, but you may feel sick or vomit; have breast
tenderness or abdominal pain; feel dizzy, drowsy or
tired; or you may have some vaginal bleeding. You
should talk to your doctor as soon as possible if you
have any of these symptoms.
3.8 Taking Ovranette for something other than
contraception
Your doctor may have prescribed Ovranette for
something other than contraception and at a different
daily dose. The usual doses are:
• Painful menstruation (dysmenorrhea) or
premenstrual tension: The same dose is used as for
oral contraception (see 3.1, How to take it). You take
a pill every day for 21 days, then have a seven day
break (when you take no pills) before starting your
next pack.
• Endometriosis: You take two pills every day
continuously without any breaks.
• Bleeding of the womb (uterus): You take two pills
every day for 21 days, then have a 7 day break. For
the first month or two, your doctor may ask you to
take 4 or 5 pills a day. However, if the bleeding from
your womb is more serious, your doctor may ask you
to take 4 pills immediately, then 4-8 pills daily until
the bleeding is controlled.
If you have any further questions on the use of this
medicine, ask your doctor, family planning nurse or
pharmacist.

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If any of the side effects gets serious, talk to your
doctor, pharmacist or family planning nurse. This
includes any possible side effects not listed in this
leaflet.
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.
Signs of heart attack or stroke include:
• a migraine for the first time, or a migraine that is
worse than normal
• any sudden changes to your eyesight (such as loss
of vision or blurred vision)
• problems with speech (such as slurred speech or
difficulty talking)
• sudden weakness or numbness in one side or part
of your body
• sudden sharp pains in your chest which may reach
your left arm
• dizziness, fainting or seizures
• sharp pains in your stomach.
Signs of a severe allergic reaction to Ovranette:
• swelling of the face, lips, mouth, tongue or throat.
Signs of breast cancer include:
• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel.
Signs of cancer of the cervix include:
• vaginal discharge that smells and contains blood
• unusual vaginal bleeding
• pelvic pain
• painful sex.
Signs of severe liver problems include:
• severe pain in your upper abdomen
• yellow skin or eyes (jaundice).
➜ If you think you may have any of these, see a
doctor straight away. You may need to stop taking
Ovranette.
Other possible side effects
Very common: may affect more than 1 in 10 women
• Headaches including migraines (but if it is severe, or
the headache is unusual or long lasting, see a doctor
as soon as possible)
• Breakthrough bleeding or spotting.
Common: may affect up to 1 in 10 women
• Infections of the vagina including thrush
• Feeling sick (nausea) or being sick (vomiting)
• Stomach pain or cramps
• Changes in weight
• Change in mood including depression or low mood
• Dizziness
• Nervousness
• Change in sex drive
• Acne
• Sore, painful or tender breasts
• Changes in the secretion from the breast,
enlargement of breasts.

Uncommon: may affect up to 1 in 100 women
• Diarrhoea
• Changes in appetite
• Change in menstrual flow
• Rash
• Brown patches on your face or body (chloasma)
• Hives (urticaria)
• Fluid retention resulting in swollen ankles, hands or
feet
• Increase in blood pressure
• Changes in the fat levels in your blood (e.g. high
triglyceride levels).
Rare: may affect up to 1 in 1000 women
• Change in glucose tolerance
• Contact lenses may feel uncomfortable
• Painful red lumps on skin (erythema nodosum)
• Pink-red blotches on skin (erythema multiforme)
• Period pain (dysmenorrhea), lack/absence of periods
(amenorrhea)
• Vaginal discharge.
Very rare: may affect up to 1 in 10,000 women
• Inflammation of the pancreas (pancreatitis)
• New gallbladder disease and worsening of existing
gallbladder disease
• Worsening of chorea (a nerve disease causing
sudden movements of the body)
• Worsening of systemic lupus erythematosus
• Problems at the back of your eye which may
cause partial or complete loss of vision (retinal vein
thrombosis)
• Worsening of porphyria (a rare disease of the blood
pigments)
• Liver tumour.
Not known: frequency cannot be estimated from the
available data
• Worsening of varicose veins
• Crohn’s disease, ulcerative colitis (Inflammatory
bowel disease)
• Bloating
• Herpes gestationis (skin rash with fluid-filled blisters
during pregnancy).
Bleeding between periods should not last long
A few women have a little unexpected bleeding or
spotting while they are taking Ovranette, especially
during the first few months. Normally, this bleeding is
nothing to worry about and will stop after a day or two.
Keep taking Ovranette 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 Ovranette for a while
• carries on even after you’ve stopped taking
Ovranette.
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.

5. How to store Ovranette

6. Contents of the pack and

Keep this medicine out of the sight and reach of
children.

What Ovranette contains
Each tablet contains 150 micrograms of the
progestogen levonorgestrel, and 30 micrograms of the
estrogen ethinylestradiol.

Do not use this medicine after the expiry date which
is stated after EXP on the blister strip and the carton.
The expiry date refers to the last day of the month.
Do not store above 25°C.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help protect the environment.

other information

The other ingredients are: lactose monohydrate, maize
starch, povidone 25, magnesium stearate, talc, purified
water, sucrose, polyethylene glycol 6000, calcium
carbonate, white wax and wax carnauba (see section 2
Ovranette contains lactose and sucrose).
What Ovranette looks like and contents of the pack
Each carton of Ovranette contains three blister strips
of 21 white tablets. Ovranette tablets are packed in
aluminium foil/pvc blister strips.
Each blister strip is packed inside an aluminium foil
pouch together with a silica gel desiccant sachet. The
silica gel desiccant should be thrown away on opening
the pouch.
Ovranette is available in pack sizes of 1, 3 and 50 blister
strips.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom
Manufacturer:
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
D-48159 Münster
Germany
This leaflet was last revised in 09/2017.

Company Contact Address: For further information
on your medicine, please contact Medical Information
at the following address: Pfizer Limited, Walton
Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS;
Tel 01304 616161.
Ref: OT 11_1

Package leaflet:
Information for the patient

Ovranette®

150 micrograms/
30 micrograms coated
tablets
levonorgestrel and
ethinylestradiol
Five important things to know about
the Pill
• The Pill is a reliable contraceptive and
may reduce your risk of cancer of the
ovary and womb if used in the long term.
• 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 Ovranette is right for you.
• To prevent pregnancy it is important
to take Ovranette as instructed and
start each pack on time. 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 because it
contains important information for you.
• 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 only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
• 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.

1. What Ovranette is and

2. What you need to know

Ovranette is a combined oral contraceptive
pill (‘the Pill’). You take it to stop you getting
pregnant.

Do not take Ovranette:

2.1 The Pill and blood clots

2.2 The Pill and cancer

• If you are pregnant, think you might be
pregnant or breast-feeding
• If you or anyone in your close family has ever
had a problem with their 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 any condition which makes you
more at risk of a blood clot (thrombosis –
see The Pill and blood clots under Warnings
and precautions)
• If you are 35 years old or over and smoke
15 or more cigarettes per day
• If you have very high or uncontrolled blood
pressure
• If you have an irregular heartbeat (atrial
fibrillation) or a heart valve disorder
• If you have migraine with visual
disturbances
• If you have diabetes which has affected your
circulation
• If you have the disease systemic lupus
erythematosus (SLE)
• If you have ever had liver tumours or severe
liver disease and been told by your doctor
that your liver function tests are not yet
back to normal
• If you have cancer affected by sex hormones –
such as some cancers of the breast or
ovary
• If you have vaginal bleeding that has not
been explained by your doctor
• If you are allergic to levonorgestrel or
ethinylestradiol or any of the other ingredients
of this medicine (listed in section 6).

The Pill may slightly increase your risk of
having a blood clot (called a thrombosis),
especially in the first year of taking it.

The Pill reduces your risk of cancer of the ovary
and womb if used in the long term. 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.

what it is used for

Your doctor may also prescribe Ovranette for
some other conditions such as:

• painful menstruation (dysmenorrhea) or
pre-menstrual tension

• endometriosis

• heavy or irregular bleeding from the womb
(uterus).
This contraceptive contains two types of female
sex hormones, estrogen and progestogen.
These hormones prevent an egg being released
from your ovaries so you can’t get pregnant.
Also, Ovranette makes the fluid (mucus) in your
cervix thicker which makes it more difficult for
sperm to enter the womb.
Ovranette 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.
Ovranette will not protect you against sexually
transmitted infections, such as Chlamydia or
HIV. Only condoms can help to do this.
Ovranette needs to be taken as directed to
prevent pregnancy.

3. How to take Ovranette

before you take
Ovranette

Warnings and precautions
Talk to your doctor, pharmacist or family
planning nurse before taking Ovranette.
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.

What is in this leaflet
1. What Ovranette is and what it is used
for

Before you start taking the Pill
• Your doctor will check/confirm that you are
not pregnant then ask about you and your
family’s medical problems and check your
blood pressure. You may also need other
checks, such as a breast, abdomen or pelvic
examination but only if these examinations are
necessary for you, or if you have any special
concerns.

2. What you need to know before you
take Ovranette
3. How to take Ovranette
4. Possible side effects
5. How to store Ovranette
6. Contents of the pack and other
information

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
Ovranette, about 15 will have a blood clot in a
year
• Of 100,000 women who are pregnant, around
60 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 or any of your close family have had
blood clots
• if you have certain rare medical conditions
such as systemic lupus erythematosus
(SLE)
• 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 Ovranette may not be suitable for you.
Signs of a blood clot include:
• painful swelling in your leg
• sudden chest pain
• difficulty breathing.
➜ See a doctor as soon as possible. Do not
take any more Ovranette 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
• if you have a disease affecting your heart
valves or an irregular heartbeat (atrial
fibrillation)
• if you have certain rare medical conditions
such as systemic lupus erythematosus
(SLE)
• 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.
➜ Tell your doctor if any of these risk factors
apply to you. Taking the Pill may add to this risk
so Ovranette may not be suitable for you.
Signs of a heart attack or stroke include:
• sudden sharp pains in your chest which may
reach your left arm
• sudden weakness or numbness in one side
or part of your body
• if you have a migraine for the first time or any
migraine that is worse than normal
• any sudden changes to your eyesight (such
as loss of vision or blurred vision)
• problems with speech (such as slurred
speech or difficulty talking)
• dizziness, fainting, collapse or seizures.
➜ See a doctor as soon as possible. Do not
take any more Ovranette until your doctor says
you can. Use another method of contraception,
such as condoms, in the meantime.

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 is 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 110 will
have breast cancer by the time they are
45 years old.
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 very 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
Ovranette.
2.3 Ovranette 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 Ovranette if any of the following
apply to you. Taking Ovranette would put your
health at risk.
• If you are pregnant, think you might be
pregnant or breast-feeding
• If you have cancer affected by sex hormones –
such as some cancers of the breast or ovary
• If you have vaginal bleeding that has not been
explained by your doctor
• If you or anyone in your close family has ever
had a problem with their 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 very high or uncontrolled blood
pressure
• If you have any condition which makes you
more at risk of a blood clot (thrombosis – see
section 2.1, The Pill and blood clots)
• If you have an irregular heartbeat (atrial
fibrillation) or a heart valve disorder
• If you have migraine with visual
disturbances
• If you have diabetes which has affected your
circulation
• If you are 35 years old or over and smoke
15 or more cigarettes per day
• If you have the disease systemic lupus
erythematosus (SLE)
• If you have ever had liver tumours or severe
liver disease and been told by your doctor
that your liver function tests are not yet
back to normal
• If you are allergic (hypersensitive) to the active
substances, levonorgestrel and ethinylestradiol
or any of the other ingredients of this medicine
(listed in section 6).
➜ If you suffer from any of these, or get them
for the first time while taking Ovranette, contact
your doctor as soon as possible. You should not
take Ovranette.

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 Ovranette but you need to take special care
and have check-ups more often.
• If you have problems with your heart,
circulation or blood clotting, such as:
◦ heart disease
◦ high blood pressure for which you take
medicines
◦ diabetes
• If you have ever had liver problems, or have
had gallstones in the past
• If you have high levels of cholesterol or lipids
(fats) in the blood (hyperlipidaemia)
• If you have had migraines
• If you have had any illness that worsened
during pregnancy or previous use of the
Pill.
➜ 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
Ovranette.
See your doctor as soon as possible as you
may need to stop using Ovranette if:
• You develop migraine for the first time or
suffer worsening of existing migraine or
headaches
• You experience any sudden unexplained
changes in your vision
• You have symptoms such as unusual pains
in or swelling of the legs, stabbing pains
on breathing, persistent cough or coughing
blood, pain or tightness in the chest
• Your blood pressure rises significantly
• You develop jaundice (yellowing of skin and/or
white of eyes).
Other medicines and Ovranette
Tell your doctor, pharmacist or family planning
nurse if you are taking, have recently taken
or might take any other medicines, including
medicines obtained without a prescription.
Also check the leaflets that come with all your
medicines to see if they can be taken with
hormonal contraceptives.
Some medicines can stop Ovranette from
working properly and may cause unexpected
bleeding and irregular periods, for example:
• some medicines used to treat epilepsy
• some medicines used to treat tuberculosis
• some medicines used to treat HIV or AIDS
• some medicines used to treat fungal
infections
• some medicines used to treat sleep
disorders
• some medicines used to treat inflammatory
conditions such as gout
• some antibiotics used to treat bacterial
infections
• St John’s wort (a herbal remedy).
If you do need to take one of these medicines,
Ovranette may not be suitable for you or you
may need to use extra contraception during and
for 7 to 28 days after treatment with the other
medicines. Your doctor, pharmacist or family
planning nurse can tell you if this is necessary
and for how long.
Ovranette can also affect how well other
medicines work:
• certain medicines used to prevent rejection
after an organ transplant
• certain drugs for asthma
• certain medicines used to treat epilepsy.
➜ Remind your doctor that you are taking the
Pill if you take any of the above medicines.
Laboratory tests
If you are scheduled for any laboratory tests, tell
your doctor you are taking the Pill. Certain blood
tests may be affected by the Pill.
Pregnancy, breast-feeding and fertility
Do not use Ovranette if you are pregnant. If you
think you might be pregnant, do a pregnancy
test to confirm that you are before you stop
taking Ovranette.
If you are breast-feeding, your doctor or
family planning nurse may advise you not to
take Ovranette. Talk to them about alternative
contraception. Breast-feeding will not stop you
getting pregnant.
Driving and using machines
Ovranette has no known effect on the ability to
drive or use machines.
Ovranette contains lactose and sucrose
Ovranette contains the sugars, lactose and
sucrose. If you have been told by your doctor
that you have an intolerance to some sugars,
contact your doctor before using Ovranette.

Component

Leaflet

Pfizer Drawing No.

xxxxxxx

Date

06/07/16

Version

01

Date: 31 Aug(front)
2017
Item Code PAA088304
Job Nº 307697
Packaging Plant Newbridge
Barcode Nº N/A
Smallest BODY TEXT Size

9 pt

Time: 08:48
Market United Kingdom

Pass Nº 03
Component MFB (Front)
Laetus Code 532 (Mini)
Smallest TEXT Size

Colours

Unwind Instructions

Printing

Non-Printing

Black

Profile

Foil/Pouch Unwind: N/A

PXXX

8 pt

Foil/Pouch Unwind: N/A

Dimensions 670 x 440mm folded to 75 x 45mm
MRP Description MFB OVRANETTE 150/30MCG 3X21 GB
PAR Number PAR-2017-0003628
Telephone: +353 (0)1 440 3222
info@perigord-as.com - www.perigord-as.com

Always take this medicine exactly as your
doctor, pharmacist or family planning nurse has
told you. Check with your doctor or pharmacist if
you are not sure.
3.1 How to take it
To prevent pregnancy, always take Ovranette
as described below. Check with your doctor or
family planning nurse if you are not sure.
Take Ovranette every day for 21 days
Ovranette comes in strips 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, until you have finished
all 21 pills.
• 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.

drowsiness/fatigue. Withdrawal bleeding may
occur in some females. In case of overdose,
contact your doctor or pharmacist.
3.4 If you forget to take Ovranette
If you miss a pill, follow these instructions:
Start here

When were you due
to take the missed pill?

Less than 12 hours
ago

More than 12 hours
ago, or you’ve missed
more than one pill

• Take the delayed pill
straight away, and
further pills as usual.
This may mean taking
two pills in one day.
• 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 further pills
as usual. This may
mean taking two pills
in one day.
• 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 pills left in
the pack

Fewer than 7 pills left
in the pack

• Don’t forget to 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
one or more pills
from
the first week of
your strip (days 1 to
7) 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.

• Don’t forget to use
extra precautions for
the next
7 days.
• When you finish the
strip of pills, 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 before
starting another strip.
• If you missed one or
more pills in the first
week of your strip
(days 1 to 7) 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.

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 Ovranette after
the seven pill-free days – even if you are still
bleeding. Always start the new strip on time.
As long as you take Ovranette correctly, you will
always start each new strip on the same day of
the week.
3.2 Starting Ovranette
As a new user or starting the Pill again after
a break
Either take your first Ovranette pill on the first
day of your next period. By starting in this way,
you will have contraceptive protection with your
first pill.
Or start taking Ovranette on any other day
of your period. You must also use extra
contraception, such as condoms, until you have
taken the first seven pills correctly.
Changing to Ovranette from another
contraceptive Pill
• If you are currently on a 21-day Pill: start
Ovranette the next day after the end of the
previous strip. You will have contraceptive
protection with your first pill. You will not have
a bleed until after your first strip of Ovranette.
• If you are currently on a 28-day Pill: start
taking Ovranette the day after your last active
pill. You will have contraceptive protection
with your first pill. You will not have a bleed
until after your first strip of Ovranette.
• If you are taking a progestogen-only Pill
(POP or “mini Pill”): start Ovranette on the
first day of bleeding, even if you have already
taken the progestogen-only Pill for that day.
You will have contraceptive cover straight
away.
Starting Ovranette after a miscarriage or
abortion
If you have had a miscarriage or an abortion
during the first three months of pregnancy,
your doctor may tell you to start taking
Ovranette straight away. This means that you will
have contraceptive protection with your first pill.
If you have had a miscarriage or an abortion
after the third month of pregnancy, ask your
doctor for advice. You may need to use extra
contraception, such as condoms, for a short
time.
Contraception after having a baby
You can start using Ovranette after 21 days if
you are not breast-feeding and had a vaginal
delivery with no complications and you are fully
mobile.
If the pill is started later than 21 days after
delivery, then alternative contraception,
such as condoms, should be used until oral
contraception is started and for the first 7 days
of pill taking. If unprotected intercourse has
taken place after 21 days of delivery, then oral
contraception should not be started until the first
period after childbirth.
Your doctor or family planning clinic can provide
further advice about contraception.
3.3 If you take more Ovranette than you
should
Taking too many tablets may cause nausea
(feeling sick), vomiting (being sick), breast
tenderness, dizziness, tummy pain, and

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 seven 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.
3.5 If you are sick or have diarrhoea
If you are sick (vomit) or have very bad diarrhoea
within 4 hours after taking your Ovranette, your
body may not get its usual dose of hormones
from that pill. Take another pill as soon as you
are able to and continue to take your next pills
at your usual time. If you are still sick or have
diarrhoea for more than 24 hours after taking
Ovranette, follow the instructions in section 3.4, If
you forget to take Ovranette.
➜ Talk to your doctor if your stomach upset
carries on or gets worse. They 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. If you think that you might have put
yourself at risk of pregnancy (for example, by
missing pills or taking other medicines) you
should do a pregnancy test before you start your
next pack. You can buy these from the chemist
or get a free test at your family planning clinic or
doctors surgery. If you are pregnant, stop taking
Ovranette and see your doctor.

3.7 If you take more Ovranette than you
should
It is unlikely that taking more than one pill
will do you any harm, but you may feel
sick or vomit; have breast tenderness or
abdominal pain; feel dizzy, drowsy or tired;
or you may have some vaginal bleeding.
You should talk to your doctor as soon as
possible if you have any of these symptoms.
3.8 Taking Ovranette for something other
than contraception
Your doctor may have prescribed Ovranette
for something other than contraception and
at a different daily dose. The usual doses
are:
• Painful menstruation (dysmenorrhea)
or premenstrual tension: The same
dose is used as for oral contraception
(see 3.1, How to take it). You take a pill
every day for 21 days, then have a seven
day break (when you take no pills) before
starting your next pack.
• Endometriosis: You take two pills every
day continuously without any breaks.
• Bleeding of the womb (uterus): You
take two pills every day for 21 days, then
have a 7 day break. For the first month
or two, your doctor may ask you to take
4 or 5 pills a day. However, if the bleeding
from your womb is more serious, your
doctor may ask you to take 4 pills
immediately, then 4-8 pills daily until the
bleeding is controlled.
If you have any further questions on the use
of this medicine, ask your doctor, family
planning nurse or pharmacist.

PAA088304

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
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.

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.

2.4 Ovranette can make some illnesses
worse

Ovranette®
150 micrograms/30 micrograms
coated tablets
levonorgestrel and ethinylestradiol

4. Possible side effects
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.

• Worsening of porphyria (a rare disease of the
blood pigments)
• Liver tumour.

If any of the side effects gets serious, talk to
your doctor, pharmacist or family planning
nurse. This includes any possible side
effects not listed in this leaflet.

Not known: frequency cannot be estimated
from the available data
• Worsening of varicose veins
• Crohn’s disease, ulcerative colitis
(Inflammatory bowel disease)
• Bloating
• Herpes gestationis (skin rash with fluid-filled
blisters during pregnancy).

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.
Signs of heart attack or stroke include:
• a migraine for the first time, or a migraine
that is worse than normal
• any sudden changes to your eyesight
(such as loss of vision or blurred vision)
• problems with speech (such as slurred
speech or difficulty talking)
• sudden weakness or numbness in one
side or part of your body
• sudden sharp pains in your chest which
may reach your left arm
• dizziness, fainting or seizures
• sharp pains in your stomach.
Signs of a severe allergic reaction to
Ovranette:
• swelling of the face, lips, mouth,
tongue or throat.
Signs of breast cancer include:
• dimpling of the skin
• changes in the nipple
• any lumps you can see or feel.
Signs of cancer of the cervix include:
• vaginal discharge that smells and
contains blood
• unusual vaginal bleeding
• pelvic pain
• painful sex.

Bleeding between periods should not last long
A few women have a little unexpected bleeding
or spotting while they are taking Ovranette,
especially during the first few months. Normally,
this bleeding is nothing to worry about and will
stop after a day or two. Keep taking Ovranette
as usual. The problem should disappear after the
first few strips.

5. How to store Ovranette

6. Contents of the pack and

Keep this medicine out of the sight and reach of
children.

What Ovranette contains
Each tablet contains 150 micrograms of the
progestogen levonorgestrel, and 30 micrograms
of the estrogen ethinylestradiol.

other information

Do not use this medicine after the expiry date
which is stated after EXP on the blister strip and
the carton. The expiry date refers to the last day
of the month.

The other ingredients are: lactose monohydrate,
maize starch, povidone 25, magnesium stearate,
talc, purified water, sucrose, polyethylene glycol
6000, calcium carbonate, white wax and wax
carnauba (see section 2 Ovranette contains
lactose and sucrose).

Do not store above 25°C.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help protect
the environment.

What Ovranette looks like and contents of the
pack
Each carton of Ovranette contains three blister
strips of 21 white tablets. Ovranette tablets are
packed in aluminium foil/pvc blister strips.
Each blister strip is packed inside an aluminium
foil pouch together with a silica gel desiccant
sachet. The silica gel desiccant should be
thrown away on opening the pouch.

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.

Ovranette is available in pack sizes of 1, 3 and
50 blister strips.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer

➜ 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 Ovranette for a
while
• carries on even after you’ve stopped taking
Ovranette.

Marketing Authorisation Holder:
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

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.

Manufacturer:
Pfizer Ireland Pharmaceuticals
Little Connell
Newbridge
Co. Kildare
Ireland
This leaflet was last revised in 09/2017

Signs of severe liver problems include:
• severe pain in your upper abdomen
• yellow skin or eyes (jaundice).

Company Contact Address: For further
information on your medicine, please contact
Medical Information at the following address:
Pfizer Limited, Walton Oaks, Dorking Road,
Tadworth, Surrey, KT20 7NS; Tel 01304 616161.

➜ If you think you may have any of these,
see a doctor straight away. You may need
to stop taking Ovranette.

Ref: OT 11_1

Other possible side effects
Very common: may affect more than 1 in
10 women
• Headaches including migraines (but if
it is severe, or the headache is unusual
or long lasting, see a doctor as soon as
possible)
• Breakthrough bleeding or spotting.

PAA088304

Common: may affect up to 1 in 10 women
• Infections of the vagina including thrush
• Feeling sick (nausea) or being sick
(vomiting)
• Stomach pain or cramps
• Changes in weight
• Change in mood including depression or
low mood
• Dizziness
• Nervousness
• Change in sex drive
• Acne
• Sore, painful or tender breasts
• Changes in the secretion from the breast,
enlargement of breasts.
Uncommon: may affect up to 1 in
100 women
• Diarrhoea
• Changes in appetite
• Change in menstrual flow
• Rash
• Brown patches on your face or body
(chloasma)
• Hives (urticaria)
• Fluid retention resulting in swollen ankles,
hands or feet
• Increase in blood pressure
• Changes in the fat levels in your blood
(e.g. high triglyceride levels).
Rare: may affect up to 1 in 1000 women
• Change in glucose tolerance
• Contact lenses may feel uncomfortable
• Painful red lumps on skin (erythema
nodosum)
• Pink-red blotches on skin (erythema
multiforme)
• Period pain (dysmenorrhea), lack/
absence of periods (amenorrhea)
• Vaginal discharge.
Very rare: may affect up to 1 in
10,000 women
• Inflammation of the pancreas
(pancreatitis)
• New gallbladder disease and worsening
of existing gallbladder disease
• Worsening of chorea (a nerve disease
causing sudden movements of the body)
• Worsening of systemic lupus
erythematosus
• Problems at the back of your eye which
may cause partial or complete loss of
vision (retinal vein thrombosis)

Component

Leaflet

Pfizer Drawing No.

xxxxxxx

Date

06/07/16

Version

01

Date: 31 Aug(front)
2017
Item Code PAA088304
Job Nº 307697
Packaging Plant Newbridge
Barcode Nº N/A
Smallest BODY TEXT Size

9 pt

Time: 08:48
Market United Kingdom

Pass Nº 03
Component MFB (Back)
Laetus Code 532 (Mini)
Smallest TEXT Size

Colours

Unwind Instructions

Printing

Non-Printing

Black

Profile

Foil/Pouch Unwind: N/A

PXXX

8 pt

Foil/Pouch Unwind: N/A

Dimensions 670 x 440mm folded to 75 x 45mm
MRP Description MFB OVRANETTE 150/30MCG 3X21 GB
PAR Number PAR-2017-0003628
Telephone: +353 (0)1 440 3222
info@perigord-as.com - www.perigord-as.com

+ Expand Transcript

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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