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SYNPHASE

Active substance: NORETHISTERONE

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Transcript
24 Jan 2014

REASON FOR REVISION:
change of owner name, text and Pharmacia to Pfizer logo
- affects Carton, Foil and Pil. MHRA submission due end
of January mocks up require by 24th January. Estimated
MHRA approval expected end of March - with implementation
6 months - no further Pharmacia stock can be sold after
implementation date.

Description SYNPHASE
Market United Kingdom
Supplier No 20715604
Perigord No 223429
Barcode No N/A
Pages 48

Proof No 01
Component Booklet
Colour Bar Positions N/A
Drawing No N/A
Laetus Code 5257

Dimensions 84 x 52 mm - Image Prints @ 100%
Notes N/A
Colours 02
Supplier Piramal
Smallest Font Used 8 pt
PAR Number PAR-2014-0000458

PMS 183

11:04

Black
20% Black

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:
•  ynphase is an oral contraceptive medicine for use by
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women.
•  ou should take Synphase regularly as instructed by your
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doctor or nurse, in order for it to be effective. When taken
as instructed, it is a very effective contraceptive. See
Section 3 “What if I forget to take a tablet?”
•  ost people do not have serious problems when taking
M
Synphase but side effects can occur – see Section 4
for details. If any of the side effects gets serious, or
if you notice any side effects not listed in this leaflet,
please tell your doctor, nurse or pharmacist.
2

•  aking some other medicines may stop Synphase from
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working properly. See Section 2 for details. Check with
your doctor, nurse or pharmacist before taking any other
medicines while you are taking Synphase.

3

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.
-  you have any further questions, ask your doctor or
If
healthcare professional.
- 
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.
-  you experience any side effects, talk to your doctor or
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healthcare professional. This includes any possible side
effects not listed in this leaflet. See section 4.
4

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

5

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.
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 occuring.

6

2. What you need to know before you
take Synphase
Do not take Synphase
-  you are allergic to either of the actives substances,
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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
-  you have had blood clots in the legs, blood clots in
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veins, the lungs, the brain or elsewhere (coronary and
cerebral thrombotic disorders).
-  you have had a heart attack or stroke, or have had
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angina.
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-  you have or have had high levels of fats in your blood
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(hyperlipidaemia) or other disorders of body fats.
-  you have or have had cancer of the breast, cervix,
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vagina or womb.
-  you have had any of the following during a previous
If
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 gestationis (a rash
previously known as herpes gestationis typically with
blistering of the palms of the hands and the soles of the feet).
-  you have or have had severe chronic liver disease
If
(liver tumours, Dubin-Johnson or Rotor syndrome).
8

-  you have or have had vaginal bleeding (not a period),
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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.
Warnings and precautions
Talk to your doctor or healthcare professional, 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
9

- Asthma
- Epilepsy (a condition where you suffer from fits)
- 
Diseases of the heart and blood vessels (cardiovascular
disease)
- 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
10

- Severe depression
- Fibroids in your uterus
- Irregular periods
- 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
11

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 or healthcare professional will advise you
whether you can still take Synphase.
12

Medical check-ups while taking Synphase
Your doctor or healthcare professional 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 or healthcare professional if you are taking,
have recently taken or might take any other medicines.
13

The following medicines may stop Synphase from working
properly (the condition they treat being shown in brackets):
-  herbal remedy St John’s wort – Latin name
The
Hypericum perforatum (depression)
- Carbamazepine (epilepsy)
- Oxacarbazepine (epilepsy)
- Phenytoin (epilepsy)
- Phenobarbital (sleeplessness, anxiety, epilepsy)
- Primidone (epilepsy)
- Topiramate (epilepsy)
- Nelfinavir (HIV – Human Immunodeficiency Virus - infection)
- Nevirapine (HIV infection and AIDS)
14

-
-
-
-
-

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 or
healthcare professional 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.

15

Tell your doctor or healthcare professional 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
or healthcare professional if you need to give samples for
laboratory assessment.
Taking Synphase with food and drink
Synphase can be taken with or without food.
16

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 or healthcare professional. Your doctor or
healthcare professional 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.

17

Sexually transmitted diseases
Synphase helps to prevent pregnancy. It will not protect
against sexually transmitted diseases including AIDS. 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 healthcare
professional before taking this medicine.
18

3. How to take Synphase
You should always take this medicine exactly as your
doctor or healthcare professional has told you. Check with
your doctor or healthcare professional 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
imitate the natural rise and fall of your body’s hormone
levels during your monthly cycle.
19

Take one tablet every day, in the right order.
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.

20

How to start the treatment
Starting your first blister strip:
•  ake tablet number one, marked ‘start here’ on your first
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day of bleeding. This is the day when your period starts. If
you are not having periods, ask your doctor or healthcare
professional when you should start taking your tablets.
•  ou will be protected at once as long as you take a tablet
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every day.
•  ou can take the tablet at a time that suits you, but you
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must take it at about the same time every day.
•  ake a tablet every day until you finish a blister strip.
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21

• f you cannot start taking the tablets on the first day of
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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:
•  nce you have finished all 21 tablets, stop for seven
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days. You will probably bleed during some or all of
these seven days.
•  hen, start the next blister strip. Do this whether or not
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you are still bleeding. You will always start the next
blister strip on the same day of the week.
22

•  ou are protected during the seven day break, but only if
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you start the next blister strip on time.
 first tablet in your next blister strip is the worst pill
The
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 healthcare
professional at your next check-up.
23

If you forget to take a tablet
• f you forget to take a tablet take it as soon as you
I
remember and take the next one at your normal time.
This may mean taking two tablets on the same day.
• f you are 12 or more hours late in taking one or more
I
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.
• f you have fewer than seven tablets in your blister
I
strip after you have missed taking a dose, you should
24

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 tablets 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.
25

If you want to stop taking Synphase or want to
have a baby
• f you stop taking Synphase, this will result in the loss of
I
contraceptive protection and the risk of pregnancy.
• f you wish to become pregnant, you should contact your
I
doctor or healthcare professional about stopping the
tablets. It is advisable to stop taking Synphase
three (3) months before you want to start trying to
have a baby.
• f you have any further questions on the use of this
I
product, ask your doctor or healthcare professional.

26

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.
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.
27

• f you do have a break, ask your doctor or healthcare
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professional whether you need an extra contraceptive
method, such as a condom.
If you have just had a baby
• f you are breast-feeding, you should not take the
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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 or healthcare
professional for advice.

28

• f you are not breast-feeding, you may start taking
I
Synphase twenty one (21) days after your baby is born.
This will protect you immediately. If you start later than
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 or healthcare professional if you should do so.
If you have any further questions on the use of this
medicine, ask your doctor or healthcare professional.
29

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.
•  udden wheeziness, difficulty in breathing, chest pain,
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fever, sudden swellings, rash or itching (especially
affecting the whole body).
30

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):
•  ou are coughing up blood
Y
•  ou have swelling or tenderness in your stomach
Y
•  ou have a sudden sharp or severe pain in your chest
Y
•  ou suddenly become short of breath or find breathing is
Y
painful
•  ou have painful or inflamed veins in your legs
Y
•  ou have a first attack of migraine (a bad headache with
Y
sickness)
31

•  ou have migraines which get worse, especially if your
Y
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
•  ou have sudden and unusual severe headaches
Y
•  ou experience dizziness or you faint
Y
•  ou develop a problem with your sight or speech
Y
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:
•  eeling sick
F
•  tomach upsets
S
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•  eight gain
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•  hanges in appetite
C
•  hanges in the way your body breaks down sugars, fats
C
or vitamins
•  eadaches
H
•  igh blood pressure
H
•  epression
D
•  wollen or sore breasts
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•  hange in sex drive
C
•  orsening of womb disorders
W
• rregular vaginal bleeding.
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Taking any medicine carries some risk. You can use the
information in this leaflet, and the advice your doctor or
33

healthcare professional 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.
If you get any side effects talk to your doctor or healthcare
professional. This includes any possible side effects not
listed in this leaflet.
Possible risk of thrombosis (blood clot)
•  ome evidence suggests that women who take the pill
S
are more likely to develop various blood circulation
disorders than women who don’t take the pill.
•  thrombosis is a blood clot. A thrombosis can develop
A
in veins or in arteries and can cause a blockage. The
34

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.
• f blood clots form in veins they can often be treated,
I
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.
• t is important to note that a thrombosis can form in
I
people who are not taking the pill as well as those who
35

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 first year that a woman
ever uses a combined oral contraceptive pill.
•  or healthy non-pregnant women: the chance of having a
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blood clot is about 5 in 100,000 each year.
•  or women taking the Pill containing either
F
levonorgestrel or norethisterone (a second generation
Pill): the chance of having a blood clot is about 15 in
100,000 each year.
•  or women taking the Pill containing desogestrel or
F
gestodene (a third generation pill): the chance of having
a blood clot is about 25 in 100,000 each year.
36

•  or women who are pregnant: the chance of having a
F
blood clot is about 60 in 100,000 pregnancies.
•  he risk of heart attacks and strokes for women who use
T
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 or
healthcare professional to see if the pill is suitable for
you. Smokers over 35 are usually told to stop taking
these pills.
37

Possible risk of breast cancer
•  very woman is at risk of breast cancer whether or not
E
she takes the pill. Breast cancer is rare under the age of
40 years, but the risk increases as a woman gets older.
•  reast cancer has been found slightly more often in
B
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.
• t is not certain whether the pill causes the increased risk
I
of breast cancer. It may be that women taking the pill are
38

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.
•  he chart below shows the background chances of breast
T
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 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.
39

Estimated number of breast cancers found
took the Pill for 5 years then stopped, or w

40

breast cancers found in 10,000 women who
rs then stopped, or who never took the Pill.

41

•  here have been some reports on the risk of liver tumors and
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cervical cancer associated with the use of oral contraceptives.
•  here is evidence to suggest that the use of combined oral
T
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.

42

Liver cancer
•  ery rarely, tumours of the liver have been seen in women
V
taking combined oral contraceptives, especially if they have
been taken for a long time.
• f you are worried about any of these things or if you have had
I
cancer in the past, talk to your doctor or healthcare professional
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).
43

Reporting of side effects
Also you can help to make sure that medicines remain as safe as
possible by reporting any unwanted side effects via the internet at
www.mhra.gov.uk/yellowcard
Alternatively you can call Freephone 0808 100 3352 (available from
10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available
from your local pharmacy.

5. How to store Synphase
- Keep this medicine out of the sight and reach of children.
-  not use this medicine after the expiry date which is stated on the
Do
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 a dry place away from direct sunlight.
-  not throw away any medicines via wastewater or household
Do
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.
-  other ingredients in each tablet are maize starch,
The
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 and 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 03/2014
Ref: SY 3_0

20715604
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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