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SYNPHASE

Active substance(s): ETHINYLOESTRADIOL / NORETHISTERONE

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Package leaflet:
Information for the user

Synphase®

500 microgram / 35 microgram tablets
and 1 milligram / 35 microgram tablets
norethisterone / ethinylestradiol

1

Important things that you SHOULD know about your
medicine:
• Synphase is an oral contraceptive medicine for use by
women.
• You should take Synphase regularly as instructed by
your doctor or nurse, in order for it to be effective. When
taken as instructed, it is a very effective contraceptive.
See section 3, ‘ If you forget to take Synphase’.
• Taking some other medicines may stop Synphase from
working properly. See section 2 for details. Check
with your doctor, nurse or pharmacist before taking any
other medicines while you are taking Synphase.
2

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,
pharmacist or nurse.
- 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, pharmacist
or nurse. This includes any possible side effects not
listed in this leaflet. See section 4.
3

What is in this leaflet








1. What Synphase is and what it is used for
2. What you need to know before you take Synphase
3. How to take Synphase
4. Possible side effects
5. How to store Synphase
6. Contents of the pack and other information

1. What Synphase is and what it is
used for
Synphase is one of a group of medicines called combined
oral contraceptives or “the Pill” for short.
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Synphase contains two hormones, a progestogen hormone
called norethisterone and an oestrogen hormone called
ethinylestradiol. These two hormones act together to
prevent a pregnancy from occurring.

2. What you need to know before you
take Synphase
Do not take Synphase:
- If you are allergic to norethisterone or ethinylestradiol, or any
of the other ingredients of this medicine (listed in section 6)
- If you have a family history of clotting problems
5

- If you have had blood clots in the legs, blood clots in
veins, the lungs, the brain or elsewhere (coronary and
cerebral thrombotic disorders)
- If you have had a heart attack or stroke, or have had angina
- If you have or have had high levels of fats in your blood
(hyperlipidaemia) or other disorders of body fats
- If you have or have had cancer of the breast, cervix,
vagina or womb
- If you have had any of the following during a previous
pregnancy: pruritus (itching of the whole body) or
jaundice (yellowing of the skin or eyes), for which
your doctor could not find the cause; or pemphigoid
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gestationis (a rash previously known as herpes
gestationis typically with blistering of the palms of the
hands and the soles of the feet)
- If you have or have had severe chronic liver disease
(liver tumours, Dubin-Johnson or Rotor syndrome)
- If you have or have had vaginal bleeding (not a period),
for which your doctor could not find the cause
- If you have or have had bad migraines
- If you are pregnant or think you could be pregnant

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Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking
Synphase if you have or have had any of the following
conditions:
- Migraine
- Headaches
- Slow or sudden development of visual disturbances such
as complete or partial loss of vision
- Asthma
- Epilepsy (a condition where you suffer from fits)
- Diseases of the heart and blood vessels (cardiovascular
disease)
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- High blood pressure (hypertension)
- Kidney disease
- Diabetes
- Multiple sclerosis (a problem of the nervous system)
- Tetany (muscle twitches)
- Breast problems of any sort
- Varicose veins (widened or twisted vein usually in the
leg)
- Liver dysfunction
- Severe depression
- Fibroids in your uterus
- Irregular periods
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- Sharp pain in your abdomen
- Gallstones
- Sickle-cell anaemia
- Otosclerosis (an inherited form of deafness)
- Porphyria (a metabolic disease)
- Chloasma (brown patches on your skin which can
happen during pregnancy but may not fade completely)
- Any disease that is likely to get worse during pregnancy

10

Possible risk of thrombosis (blood clot)
• Some evidence suggests that women who take the pill
are more likely to develop various blood circulation
disorders than women who don’t take the pill.
• A thrombosis is a blood clot. A thrombosis can
develop in veins or in arteries and can cause a
blockage. The chance of a thrombosis forming in
women taking the pill and women not taking the pill
is rare. When blood clots form in the arteries they
can cause chest pain (angina), strokes (blood clots in
or bleeding from the blood vessels in the brain) and
heart attacks.
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• If blood clots form in veins they can often be treated,
with no long-term danger. On rare occasions a piece of
thrombosis may break off. It can travel to the lungs to
cause a condition called pulmonary embolism. Therefore
in rare cases a thrombosis can cause serious permanent
disability or could even be fatal.
• I t is important to note that a thrombosis can form in
people who are not taking the pill as well as those
who are taking it. The risk is higher in women who
take the pill than in women who don’t take the pill,
but is not as high as the risk during pregnancy.
The extra risk of thrombosis is highest during the
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first year that a woman ever uses a combined oral
contraceptive pill.
• For healthy non-pregnant women: the chance of having a
blood clot is about 5 in 100,000 each year.
• For women taking the Pill containing either levonorgestrel
or norethisterone (a second generation Pill): the chance of
having a blood clot is about 15 in 100,000 each year.
• For women taking the Pill containing desogestrel or
gestodene (a third generation pill): the chance of having
a blood clot is about 25 in 100,000 each year.
• For women who are pregnant: the chance of having a
blood clot is about 60 in 100,000 pregnancies.
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• T he risk of heart attacks and strokes for women who use
the combined Pill increases with age and smoking. Other
conditions also increase the risk of blood clots in the
arteries. These include being greatly overweight, having
diseased arteries (atherosclerosis), high blood pressure
during pregnancy (pre-eclamptic toxaemia), high blood
levels of cholesterol, and diabetes. If you have any of
these conditions, you should check with your doctor,
pharmacist or nurse to see if the pill is suitable for you.
Smokers over 35 are usually told to stop taking these
pills.

14

Possible risk of breast cancer
• Every woman is at risk of breast cancer whether or not
she takes the pill. Breast cancer is rare under the age of
40 years, but the risk increases as a woman gets older.
• Breast cancer has been found slightly more often in
women who take the pill than in women of the same age
who do not take the pill. If women stop taking the pill,
this reduces the risk so that 10 years after stopping the
pill, the risk of finding breast cancer is the same as for
women who have never taken the pill. Breast cancer
seems less likely to have spread when found in women
who take the pill than in women who do not take the pill.
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• It is not certain whether the pill causes the increased
risk of breast cancer. It may be that women taking the
pill are examined more often, so that breast cancer is
noticed earlier. The risk of finding breast cancer is not
affected by how long a woman takes the pill but by the
age at which she stops. This is because the risk of breast
cancer strongly increases as a woman gets older.
• T he chart below shows the background chances of breast
cancer at various ages for 10,000 women who have never
taken the pill (black bars) and for 10,000 women whilst
taking the pill and during the 10 years after stopping it
(grey bars). The small extra risk of finding breast cancer
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can be seen for each age group. This small possible
additional risk in women who take the pill has to be
balanced against the fact that the pill is a very effective
contraceptive and it helps prevent cancer of the womb or
ovary.

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Estimated number of breast cancers found in 10,000 women who
took the Pill for 5 years then stopped, or who never took the Pill.

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Estimated number of breast cancers found in 10,000 women who
took the Pill for 5 years then stopped, or who never took the Pill.

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• T here have been some reports on the risk of liver tumors
and cervical cancer associated with the use of oral
contraceptives.
• T here is evidence to suggest that the use of combined
oral contraceptives offer protection against both ovarian
and endometrial cancer.
Cervical cancer
Some research suggests an increased risk of getting
cancer of the cervix (neck of the uterus or womb) in
women who take combined oral contraceptives for a long
time. However, this may be due to other causes, such as
sexual behaviour.
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Liver cancer
• Very rarely, tumours of the liver have been seen in
women taking combined oral contraceptives, especially if
they have been taken for a long time.
• If you are worried about any of these things or if you have
had cancer in the past, talk to your doctor, pharmacist
or nurse to see if you should take the combined oral
contraceptive pill.
Endometrial and ovarian cancer
Research shows that combined oral contraceptives protect
against cancer of the ovary and cancer of the endometrium
(lining of the womb).
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If you are going to have a major operation
Make sure your doctor knows about it. You may need to
stop taking Synphase about 4 weeks before the operation
until at least 2 weeks after the operation and until you are
fully mobile. Alternatively, your doctor may prescribe an
oestrogen-free hormonal contraceptive.
Patients undergoing injection treatment for varicose veins
should not resume taking Synphase until 3 months after the
last injection.
Your doctor, pharmacist or nurse will advise you whether
you can still take Synphase.
22

Medical check-ups while taking Synphase
Your doctor or nurse will give you regular check-ups
while you are taking Synphase. Your blood pressure
will be checked before you start Synphase and then at
regular intervals whilst you are on Synphase. You may
be required to have an examination of your breasts,
abdomen and pelvis including taking a cervical smear
test at regular intervals, if this is considered necessary
by the doctor.
Other medicines and Synphase
Tell your doctor, pharmacist or nurse if you are taking, have
recently taken or might take any other medicines.
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The following medicines may stop Synphase from working
properly (the condition they treat being shown in brackets):
- The herbal remedy St John’s wort – Latin name
Hypericum perforatum (depression)
- Carbamazepine (epilepsy)
- Oxacarbazepine (epilepsy)
- Phenytoin (epilepsy)
- Phenobarbital (sleeplessness, anxiety, epilepsy)
- Primidone (epilepsy)
- Topiramate (epilepsy)
- Nelfinavir (HIV – Human Immunodeficiency Virus infection)
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- Nevirapine (HIV infection and AIDS)
- Ritonavir (HIV infection and AIDS)
- Rifabutin (bacterial infection)
- Rifampicin (bacterial infection)
- Griseofulvin (fungal infection)
- Modafinil (narcolepsy i.e. daytime sleepiness)
If you do need to take any of the medicines listed above,
Synphase may not be suitable for you. Your doctor,
pharmacist or nurse will advise you whether to stop taking
these medicines or to use another contraceptive method,
such as a condom while you are taking these medicines.
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Tell your doctor, pharmacist or nurse if you are taking or
have recently taken any other medicines, including those
bought without a prescription, because they might interact
with Synphase.
Laboratory tests
Synphase may interfere with some tests, tell your doctor,
pharmacist or nurse if you need to give samples for
laboratory assessment.
Synphase with food and drink
Please refer to section 3.

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Pregnancy and breast-feeding
Do not take Synphase if you are pregnant or breast-feeding,
think you may be pregnant or are planning to have a baby.
If you miss a period while you are taking Synphase, tell
your doctor, pharmacist or nurse. Your doctor, pharmacist
or nurse will inform you about the increased risk to the
foetus if you have become pregnant while taking Synphase.
You will need to have a pregnancy test before you continue
to take Synphase.
Sexually transmitted diseases
Synphase helps to prevent pregnancy. It will not protect
against sexually transmitted diseases including AIDS.
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For safer sex, use a condom as well as your usual
contraceptive.
Driving and using machines
No effects on the ability to drive or use machines have been
seen with Synphase.
Synphase contains lactose
Lactose is a type of sugar. If you have diabetes or you have
been told by your doctor that you
have an intolerance to some sugars, contact your doctor or
pharmacist before taking this medicine.

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3. How to take Synphase
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
A pack of Synphase contains different coloured tablets.
• Seven blue ones.
• Nine white ones.
• Five more blue ones.
The different coloured tablets contain different amounts of
hormones. When you take them in the correct order they
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imitate the natural rise and fall of your body’s hormone
levels during your monthly cycle.
Take one tablet every day, in the right order. Synphase can
be taken with or without food.
Each blister strip has a row of bubbles marked with the
days of the week. When you take your first tablet, press
the bubble for the day of the week you have started taking
the tablets, for example, if you take your first tablet on a
Tuesday, press the bubble marked ‘Tue’. This will help you
to remember the day of the week you started the pack. Each
new pack after this will also start on the same day of the
week.
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How to start the treatment
Starting your first blister strip:
• Take tablet number one, marked ‘start here’ on your first
day of bleeding. This is the day when your period starts. If
you are not having periods, ask your doctor, pharmacist or
nurse when you should start taking your tablets.
• You will be protected at once as long as you take a tablet
every day.
• You can take the tablet at a time that suits you, but you
must take it at about the same time every day.
• Take a tablet every day until you finish a blister strip.
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• If you cannot start taking the tablets on the first day of
your period you may start to take it on any day up to the
fifth day. However, if you do this, you may not be protected
for the first seven days, so you should use another method
of contraception such as a condom during those days.
Starting the next blister strip:
• Once you have finished all 21 tablets, stop for seven
days. You will probably bleed during some or all of
these seven days.
• T hen, start the next blister strip. Do this whether or not
you are still bleeding. You will always start the next
blister strip on the same day of the week.
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• You are protected during the seven day break, but only if
you start the next blister strip on time.
The first tablet in your next blister strip is the worst pill of
all to miss or take late.
If you notice a change in your periods
It is normal that your periods may become irregular and you
may notice some bleeding between periods. Your periods
may become lighter and you may occasionally have no
bleeding during the tablet free days. Make a note of what
happens so that you can tell your doctor or nurse at your
next check-up.
33

If you forget to take Synphase
• If you forget to take a tablet take it as soon as you
remember and take the next one at your normal time.
This may mean taking two tablets on the same day.
• If you are 12 or more hours late in taking one or more
tablets, it may not work. As soon as you remember,
take your last missed tablet and carry on taking them
normally. However, you may not be protected for the next
seven days, so either avoid sexual intercourse or use an
extra contraceptive method, such as a condom.
• If you have fewer than seven tablets in your blister
strip after you have missed taking a dose, you should
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complete the blister strip and start the next blister strip
without a break. This will give you protection from when
you took the last missed tablet. You may not have a
period until the end of two blister strips, but this will not
harm you. You may also have some bleeding on days
when you take the tablets.
If you take more Synphase than you should
Taking too many tablets at once may make you sick,
cause vaginal bleeding or breast swelling. Contact your
doctor or go to your nearest hospital casualty department
immediately.
35

If you want to stop taking Synphase or want to
have a baby
• If you stop taking Synphase, this will result in the loss of
contraceptive protection and the risk of pregnancy.
• If you wish to become pregnant, you should contact
your doctor or nurse about stopping the tablets. It is
advisable to stop taking Synphase three (3) months
before you want to start trying to have a baby.
• If you have any further questions on the use of this
product, ask your doctor, pharmacist or nurse.
If you are changing brands of oral contraceptive (pill)
Take the first tablet of your new blister strip on the day
immediately after you have finished your old blister strip.
36

Your period will usually be delayed until the new blister
strip is finished, but you may have some breakthrough
bleeding during the first few days of the new blister strip.
This is quite normal and you will still be protected against
pregnancy.
If you have a stomach upset or you are sick
• Synphase may not work if you are sick or have severe
diarrhoea. You should carry on taking the tablets as
normal, but use a condom while you are ill and for the
next seven days. If these seven days run beyond the end
of the blister strip, start the next pack without a break.

37

• If you do have a break, ask your doctor, pharmacist or
nurse whether you need an extra contraceptive method,
such as a condom.
If you have just had a baby
• If you are breast-feeding, you should not take the combined
oral contraceptive. This is because the oestrogen in the
tablets may reduce the amount of milk you produce. You
should be able to take another type of contraceptive instead.
Ask your doctor, pharmacist or nurse for advice.
• If you are not breast-feeding, you may start taking
Synphase twenty one (21) days after your baby is born.
This will protect you immediately. If you start later than
38

this, you may not be protected until you have taken the
tablets for seven days.
If you have just had a miscarriage or abortion
You may be able to start taking Synphase immediately.
If you can, you will be protected straight away. Ask your
doctor, pharmacist or nurse if you should do so.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.

39

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Tell your doctor or call an ambulance immediately
if you experience any of the following symptoms of an
allergic reaction after taking this medicine. Although they
are rare, the symptoms can be severe and you may need
urgent medical attention or hospitalisation.
• Sudden wheeziness, difficulty in breathing, chest pain,
fever, sudden swellings, rash or itching (especially
affecting the whole body).
40

Stop taking Synphase and contact your doctor
straight away if you notice any of the following
serious side effects. These may be signs of
thrombosis (a blood clot):
• You are coughing up blood
• You have swelling or tenderness in your stomach
• You have a sudden sharp or severe pain in your chest
• You suddenly become short of breath or find breathing is
painful
• You have painful or inflamed veins in your legs
• You have a first attack of migraine (a bad headache with
sickness)
41

• You have migraines which get worse, especially if your sight is
affected, you see flashing lights, your limbs feel weak, you lose the
sensation or feel a different sensation in your limbs, or you have a fit
• You have sudden and unusual severe headaches
• You experience dizziness or you faint
• You develop a problem with your sight or speech
For more information on this possible side effect, see also
‘Possible risk of thrombosis (blood clot)’ section further below.
Other side effects that you might have include:
• Feeling sick
• Stomach upsets
• Weight gain
42

• Changes in appetite
• Changes in the way your body breaks down sugars, fats or vitamins
• Headaches
• High blood pressure
• Depression
• Swollen or sore breasts
• Change in sex drive
• Worsening of womb disorders
• Irregular vaginal bleeding.
Taking any medicine carries some risk. You can use the information
in this leaflet, and the advice your doctor, pharmacist or nurse has
given you to weigh up the risks and benefits of taking the pill. Don’t
be embarrassed, and ask as many questions as you need to.
43

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 Yellow Card Scheme, website:
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 Synphase
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the
carton or blister strip after EXP. The expiry date refers to the last day
of that month.
44

- Do not store above 25°C.
- Store in the original package to protect from light and moisture.
- Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away any medicines you
no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Synphase contains
- The active substances are norethisterone and ethinylestradiol.
- The other ingredients in each tablet are maize starch, polyvidone,
lactose, magnesium stearate and colouring E132 (in the blue pills
only). Please also refer to section 2, ‘Synphase contains lactose’.
45

What Synphase looks like and contents of the pack
Synphase tablets are blue or white, and are marked ‘SEARLE’ on
one side and ‘BX’ on the other side. They are packed in blister strips
containing 21 tablets.
Each foil strip contains:
- Seven blue tablets containing 500 micrograms of norethisterone
and 35 micrograms ethinylestradiol
- Nine white tablets containing 1 milligram of norethisterone and
35 micrograms ethinylestradiol
- Five blue tablets containing 500 micrograms of norethisterone and
35 micrograms ethinylestradiol

46

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent, CT13 9NJ.

Manufacturer
Piramal Healthcare UK Limited
Whalton Road
Morpeth
Northumberland
NE61 3YA
United Kingdom.

This leaflet was last revised in 04/2016
Ref: SY 4_0

20160316C
47

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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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