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SYNPHASE

Active substance(s): ETHINYLOESTRADIOL / NORETHISTERONE / ETHINYLOESTRADIOL / NORETHISTERONE / 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.
4

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

6

- 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
- If you have hepatitis C and are taking the medicinal products
containing ombitasvir/paritaprevir/ritonavir and/or dasabuvir (see
also in section ‘Other medicines and Synphase’).
7

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)
8

- 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
9

- 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.
11

12

• If blood clots form in veins they can often be treated, with no longterm 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 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.
13

• 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.
15

16

• 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 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.

17

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

18

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.

19

• 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.
20

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).
21

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.
23

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)
24

- 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)
Do not use Synphase if you have Hepatitis C and are taking the
medicinal products containing ombitasvir/paritaprevir/ritonavir
and/or dasabuvir as this may cause increases in liver function blood
test results (increase in ALT liver enzyme).
Your doctor will prescribe another type of contraceptive prior to start
of the treatment with these medicinal products.
25

Synphase can be restarted approximately 2 weeks after completion of
this treatment. See section ‘Do not take Synphase’.
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.
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.
26

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.
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
27

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.
Driving and using machines
No effects on the ability to drive or use machines have been seen with
Synphase.

28

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.

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.

29

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. 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.
30

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.
31

• 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.
32

• 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

34

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 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.

36

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.
• If you do have a break, ask your doctor, pharmacist or nurse whether
you need an extra contraceptive method, such as a condom.

37

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 this, you may not be protected
until you have taken the tablets for seven days.
38

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)
• 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

41

• 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
• Changes in appetite
• Changes in the way your body breaks down sugars, fats or vitamins
42 • 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
44 last day of that month.

- 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 and come in cartons containing either 21 or
63 tablets. Not all pack sizes may be marketed.

46

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
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 05/2017
Ref: SY 5_0
47

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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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