Synphasic® 28 Day Tablets
35mcg Ethinyloestradiol and 500mcg Norethisterone + 35mcg Ethinyloestradiol
and 1mg Norethisterone
What is in this leaflet
This leaflet answers some common questions about Synphasic 28 day tablets. It
does not contain all the available information. It does not take the place of
talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of
you taking Synphasic against the benefits it is expected to have for you. Use
Synphasic as directed by your doctor and follow advice given in this leaflet.
If you have any concerns about taking this medicine, ask your doctor or
pharmacist.
Remember: This medicine is prescribed for you and should not be given to
others.
What Synphasic is used for
Synphasic is a birth control pill commonly known as a "Combined Oral
Contraceptive", that contains both an oestrogen (ethinyloestradiol) and
progestogen (norethisterone) hormone.
Oral contraceptives belonging to this group produce their birth control (or
contraceptive) effect by preventing ovulation (or the release of an egg from the
ovary) during each menstrual cycle. Combined Oral Contraceptives also cause
changes to the mucus of the cervix and the lining of the womb which contribute
to the contraceptive action.
If taken according to directions the combined oral contraceptives are very
effective in preventing pregnancy. The failure rate of this type of
contraceptive is such that for every 1,000 women using the pill for one year,
two will become pregnant.
Synphasic 28 day is only available on a prescription from your doctor.
Before you start to take Synphasic
When you must not take it
Synphasic 28 Day tablets are not suitable for some women. You must not take
Synphasic if:
- you have or have had high blood pressure, stroke, heart attack or a clot
in the lung. - you have or have had inflammation, infection or clotting in any blood
vessel(s). - you have liver disease (including tumours of any type), a history of
jaundice or cholestatic jaundice of pregnancy, or severe generalised itch in
the body during pregnancy; Dubin-Johnson Syndrome or Rotor Syndrome. - you have abnormal vaginal bleeding, the cause of which is unknown.
- you are pregnant or suspect that you may be pregnant.
- you are breast feeding.
- you have cancer or suspected cancer of the breast or sex organs (e.g.
cervix, ovaries, endometrium, womb) and known or suspected oestrogen -
dependent tumours. - you have sickle cell anaemia.
- you have a lipid metabolism disorder.
- you have a history of herpes during pregnancy.
- you have otosclerosis (an ear disorder) which worsened in past
pregnancies. - you suffer for partial paralysis during migraine attacks (hemiplegic
migraine).
It is important to tell your doctor about any existing medical condition
as this may be affected by taking the birth control pill.
Also if you have any special sensitivities or allergies, including
sensitivity to any of the ingredients listed under "Ingredients", you should
tell your doctor.
Do not take Synphasic after the expiry date (EXP) printed on the pack has
passed. Do not take Synphasic if the packaging is torn or shows signs of
tampering.
Before you start to take it
Before taking Synphasic tell you doctor if:
- you smoke
- you have uterine fibroids
- you have gall bladder disease
- you have diabetes
- you have high blood pressure
- you suffer from epilepsy, and which medicines you take to control it
- you suffer from migraine headaches
- you have asthma
- you have heart or kidney disease
- you have or have had any form of depression
- you have a disorder of calcium or phosphorus metabolism
- any member of your family has suffered from blood clots, a stroke, or
heart attack.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines,
including any that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with the effectiveness of Synphasic. This is
particularly important if you need to take antibiotics or medicines for
epilepsy.
How to take Synphasic
- To begin Synphasic 28 Day, take your first tablet on the first day of your
next period, that is, the day your bleeding starts. - From the first row of the green section of the strip (i.e. the row which
contains all the blue tablets) take the tablet which corresponds to the
appropriate day of the week. For example, if your first day of bleeding is on
TUESDAY, you should take the tablet marked "TUE" from the first row of the
green section of the strip. (Please note that the green section contains blue
and white active tablets. Be sure to take a blue tablet corresponding to the
day of the week from the first row of the green section). - Continue to take one tablet every day, following the arrows around the
strip until all 21 tablets in this green section are finished. - You should then take one orange tablet daily for the next 7 days,
following the arrows. - You should take your tablet at approximately the same hour each day.
- When you have finished your first strip of tablets start the next strip
the following day and continue taking the tablets even when you are having a
period. - Remember to start every new strip from the first row of the green section.
- This sequence of tablet taking is repeated for as long as birth control is
required. This product is effective from the first day if taken as directed
above.
Although spotting and break-through bleeding may occur in some women,
these tend to disappear in the majority of patients after the first three to
four cycles.
Always ensure that you have a new strip of tablets available, so that
you can continue to take the tablets without interruption.
If you are switching to Synphasic 28 Day from another 21 or 28 Day oral
contraceptive, please see your doctor or pharmacist for directions.
When to use it
You should take your tablet at approximately the same hour each day.
If you forget to take a tablet
Tablets should be taken at about the same hour each day. If you are less than
12 hours late in taking your tablet, you should take that tablet at once and
then take the next one at your usual time.
If you are more than 12 hours late in taking your tablet you should continue
to take your tablets as usual, but ignore the missed tablet or tablets and take
extra contraceptive precautions (other than the rhythm or temperature method)
for the next seven days.
If these seven days extend into the inactive orange tablet section, start a
new pack on the next day after having taken the last active tablet of the
current pack, that is, skip the orange inactive tablets. This will mean that you
will not have a period until the end of two packs.
If you miss an orange (inactive) tablet, take it as soon as you
remember and continue on as before. An additional birth control method is not
necessary in this case.
If your doctor has prescribed the taking of Synphasic any differently, or you
are unclear about the above directions, then you should discuss this with him or
her.
If you have trouble remembering to take Synphasic, ask your pharmacist for
some hints.
If you miss a period
If you have missed a period you may be pregnant and should contact your
doctor immediately.
If you take too much (overdose)
Overdosage may cause nausea. This may be followed by vaginal bleeding in some
women.
Serious ill effects have not been reported in young children who have
taken large doses of birth control pills. However, in the case of overdosage or
accidental ingestion, immediately telephone your doctor or pharmacist or the
National Poisons Centre (telephone 
03 474 7000
) or go to Accident and Emergency
at your nearest hospital. Do this even if there are no signs of discomfort or
poisoning.
While you are using Synphasic
Women who use oral contraceptives should not smoke. Cigarette smoking
increases the risk of blood clotting and damage to the heart and blood vessels
from birth control pills. The risk increases with age and with heavy smoking (15
or more cigarettes per day) and is quite marked in women over 35 years of age.
If you develop unexplained or persistent pains in the head, chest, stomach
or legs, you should stop taking the tablets and see your doctor. In the
meantime, use another method of birth control. If you are in any doubt, see your
doctor.
Stop taking Synphasic Tablets if you develop gradual or sudden, partial or
complete loss of vision; double vision or symptoms of severe vision impairment,
eye protrusion, swelling of the eye or eye lesions, aggravation of migraine or
development of severe headache of a new pattern. See your doctor immediately
and use another birth control method in the meantime.
Slight breast tenderness or a feeling of sickness may occur in the first few
months of use. This usually improves or stops with continued use.
If a full monthly period or slight spotting starts before all tablets have
been taken, do not stop taking your tablets. Slight spotting during tablet
taking is normally of no significance. However, if such bleeding persists, or
if heavier bleeding occurs, you should see your doctor.
If vaginal irritation or discharge occurs, it may be an indication of a yeast
infection for which treatment is available from your doctor.
If you suffer from a stomach upset which results in vomiting or diarrhoea,
the effectiveness of Synphasic may be reduced. Tablet taking should continue as
normal, and a non-hormonal method of contraception (other than the rhythm or
temperature method) should be used during the period of vomiting or diarrhoea
and continued for seven days following the episode of vomiting or diarrhoea. If
these seven days extend into the inactive orange tablet section you should start
a new pack on the next day after having taken the last active tablet from the
green section of the current pack (i.e. skip the orange inactive tablets).
If you need to have an operation, or go to hospital in an
emergency, you should tell the hospital doctor that you are taking Synphasic
birth control pills. Surgery and prolonged periods of bed rest increase the risk
of developing blood clots.
Delays in becoming pregnant may occur after Synphasic therapy is stopped.
This is more likely to occur in women whose periods were irregular before using
birth control pills. If you continue to experience difficulties in falling
pregnant, see your doctor.
Synphasic may affect the amount and quality of breast milk as the components
of Synphasic are found in breast milk. If you are breast-feeding you should talk
to your doctor.
Tell your doctor if you feel depressed, think you are retaining water or your
eyes are uncomfortable whilst wearing contact lenses. Your doctor will make an
assessment of your condition and advise whether or not you should continue to
take Synphasic.
See your doctor if you notice any unusual physical changes or discomfort
while using oral contraceptives. Women who use oral contraceptives should visit
their doctor regularly for medical check-ups, which may include blood tests.
Your doctor will advise you of the type and frequency of any tests required.
Synphasic (like all oral contraceptives) is intended to prevent pregnancy. It
does not protect against HIV infection (AIDS) and other sexually transmitted
diseases.
Tell any other doctors, dentists, and pharmacists who are treating you
that you are taking Synphasic. If you are about to be started on any new
medicine, tell your doctor, dentist or pharmacist that you are taking Synphasic.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well
while you are taking Synphasic.
All medicines can have side effects. Sometimes they are serious, most of the
time they are not. You may need medical treatment if you get some of the side
effects. Ask your doctor or pharmacist to answer any questions you may have.
Side effects most commonly reported in early cycles of therapy include
break-through bleeding, spotting, nausea, vomiting and other gastric or stomach
discomforts. These often decrease with continued use.
Other common side effects include: change in menstrual flow, change in
weight, dark discolouration of the skin, blotchy discolouration on the face
(which may persist after the tablets have been stopped), absence of periods, and
breast changes (tenderness, enlargement and secretion).
In addition to the above, the following side effects have also been
reported in some women using Synphasic tablets: headache, migraine, drowsiness,
mental depression, fatigue or tiredness, change in appetite, hair growth, loss
of scalp hair, acne, rashes, itching, eye lesions, dizziness, vaginal thrush,
change in cervical secretions, suppression of milk production and intolerance to
contact lenses.
The most serious known side effect with Combined Oral Contraceptive use is
abnormal blood clotting which may have serious consequences. Deaths have
occurred in some women as a result of blood clots carried by the blood stream
causing obstruction of blood vessels in the lungs or in the brain. The risk
of developing blood clotting disorders and other blood vessel diseases in oral
contraceptive users increases with age from 30 years onwards. Cigarette
smoking also increases the risk. These problems may persist after a woman
has stopped taking the birth control pill.
The use of a Combined Oral Contraceptive can increase the risk of a woman
having a heart attack. Other risk factors for a heart attack include
cigarette smoking; high blood pressure; high cholesterol; obesity; diabetes; a
history of pre-eclamptic toxaemia in pregnancy and age over 40 years.
Some women may experience a rise in blood pressure whilst using oral
contraceptives.
The association between the use of Combined Oral Contraceptives and the
development of breast cancer has not been firmly established to date. Breast
cancer has been diagnosed slightly more often in women taking the pill. This
increased risk seems to be related to use at a young age, and duration of use.
Rarer side effects associated with the use of combined oral
contraceptives are not listed here. You may wish to discuss these, or any of the
side effects listed above, with your doctor if you are concerned.
Side effects not previously reported with Synphasic may also occur. If
you notice anything unusual while you are taking Synphasic, see your doctor.
Do not be alarmed by this list of possible side effects. You may not
experience any of them.
After taking Synphasic
Storage
Keep your Synphasic Tablets in a safe place away from the sight and reach of
children. Keep your Synphasic tablets in a dry place, at a temperature below
25°C. Do not keep your tablets in the refrigerator.
Do not take any tablets past the expiry date shown on the label.
Do not store Synphasic or any other medicine in the bathroom or near a sink.
Do not leave it in the car on hot days or on window sills. Heat and dampness can
destroy some medicines.
Disposal
If your doctor tells you to stop taking Synphasic or if the tablets have
passed their expiry date, ask your pharmacist what to do with any that are
left over.
Product description
What it looks like
Synphasic 28 Day is available in calendar packs consisting of three strips of
tablets (3 months' supply) each with 12 blue active tablets marked "SEARLE" on
one side and "BX" on the other, and 9 white active tablets marked "SEARLE" on
one side and "BX" on the other and 7 orange inactive tablets.
Ingredients
Each blue tablet contains the hormones "norethisterone" 500 micrograms (mcg)
and "ethinyloestradiol" 35 micrograms (mcg). These blue tablets also contain
magnesium stearate, povidone, maize starch, lactose and indigo carmine CI 73015.
Each white tablet contains the hormones "norethisterone" 1.0 milligram (mg) and
"ethinyloestradiol" 35 micrograms (mcg). These white tablets also contain
magnesium stearate, povidone, maize starch and lactose. The orange inactive
tablets contain magnesium stearate, cellulose microcrystalline, lactose & sunset yellow FCF (CI No. 15985).