SYNPHASE

Active substance: 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

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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
“What if I forget to take a tablet?”
 Most people do not have serious problems when taking 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.
 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.
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 or 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.
If you experience any side effects, talk to your doctor or healthcare professional. This
includes any possible side effects not listed in this leaflet. See section 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

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.

2.

What you need to know before you take Synphase

Do not take Synphase
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If you are allergic to either of the actives substances, 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
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 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.

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
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
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

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

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Other medicines and Synphase
Tell your doctor or healthcare professional if you are taking, have recently taken or might
take any other medicines.
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)
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 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.
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

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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.
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.
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.

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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.

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.
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.
How to start the treatment

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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 or
healthcare professional 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.

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.

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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.

Then, 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.

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 healthcare professional at your next check-up.
If you forget to take a tablet

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 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.
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.

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If you wish to become pregnant, you should contact your 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.
If you have any further questions on the use of this product, ask your doctor or
healthcare professional.

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.

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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.

If you do have a break, ask your doctor or healthcare professional 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 or
healthcare professional 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 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.

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).
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
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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)
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

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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
 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 or 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)

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.

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.

It 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
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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.
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.
The 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 or healthcare professional to see if the pill is suitable for
you. Smokers over 35 are usually told to stop taking these pills.

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.

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.

The 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 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
.

300

262
230

250
Number of breast
200
cancers

181

Never took the Pill Used Pill for 5 years

160

150
100

111

100
44 48.7

50
4 4.5

16 17.5

0
Took the pill at these ages

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Cancers found up to
the age of:




Under 20

30

20-24

35

25-29

40

30-34

45

35-39

40-44

50

55

There have been some reports on the risk of liver tumors and cervical cancer associated
with the use of oral contraceptives.
There 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.
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 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).
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.

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5. How to store Synphase.
-

6.

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.
Do not store above 25°C.
Store in a dry place away from direct sunlight.
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.

Contents of the pack and other information

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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’.
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.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharmacia 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 04/2013

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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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