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ZYNTHIA 75 MICROGRAM FILM-COATED TABLETS

Active substance(s): DESOGESTREL

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Package leaflet: Information for the user
ZYNTHIA75 microgram film-coated tablet
Desogestrel
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.
What is in this leaflet
1. What ZYNTHIA is and what it is used for
2. What you need to know before you take ZYNTHIA
3. How to take ZYNTHIA
4. Possible side effects
5. How to store ZYNTHIA
6. Contents of the pack and other information
1. What ZYNTHIA is and what it is used for









ZYNTHIA is used to prevent pregnancy.
There are 2 main kinds of hormone contraceptive.
- The combined pill, "The Pill", which contains 2 types of female sex hormone,
an oestrogen and a progestogen
- The progestogen-only pill, POP or mini-pill, which doesn't contain an
oestrogen.
ZYNTHIA is a progestogen-only-pill (POP).
ZYNTHIA contains a small amount of one type of female sex hormone, the
progestogen desogestrel.
Most POPs work primarily by preventing the sperm cells from entering the womb but
they do not always prevent the egg cell from ripening, which is the main way that
combined pills work.
ZYNTHIA is different from most POPs in having a dose that in most cases prevents
the egg cell from ripening. As a result, ZYNTHIA is a highly effective contraceptive.
In contrast to the combined pill, ZYNTHIA can be used by women who do not
tolerate oestrogens and by women who are breast feeding.

A disadvantage is that vaginal bleeding may occur at irregular intervals during the use of
. On the other hand you may not have any bleeding at all.
2. What you need to know before you take
ZYNTHIA, like other hormonal contraceptives, does not protect against HIV infection
(AIDS) or any other sexually transmitted disease.
Do not take ZYNTHIA:
 if you are allergic to desogestrel or any of the other ingredients of this medicine
(listed in section 6).
 if you have a thrombosis. Thrombosis is the formation of a blood clot in a blood
vessel (e.g. of the legs (deep venous thrombosis) or the lungs (pulmonary embolism)).





if you have or have had jaundice (yellowing of the skin) or severe liver disease and
your liver is still not working normally.
if you have or if you are suspected of having a cancer that grows under the influence
of sex-steroids, such as certain types of breast cancer.
if you have any unexplained vaginal bleeding.

If any of these conditions apply to you, tell your doctor before you start to use ZYNTHIA.
Your doctor may advise you to use a non-hormonal method of birth control. If any of these
conditions appear for the first time while using ZYNTHIA, consult your doctor immediately.
Warnings and precautions
Talk to your doctor or pharmacist before taking ZYNTHIA, if
 you have ever had breast cancer.
 you have liver cancer, since a possible effect of ZYNTHIA cannot be excluded.
 you have ever had a thrombosis.
 you have diabetes.
 you suffer from epilepsy (See section ‘Taking other medicines’).
 you have tuberculosis (See section ‘Taking other medicines’).
 you have high blood pressure.
 you have or have had chloasma (yellowish-brown pigmentation patches on the skin,
particularly of the face); if so avoid too much exposure to the sun or ultraviolet
radiation.
When ZYNTHIA is used in the presence of any of these conditions, you may need to be kept
under close observation. Your doctor can explain what to do.
Breast cancer
 It is important to regularly check your breasts and you should contact your doctor as
soon as possible if you feel any lump in your breasts.
 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 is the same as for
women who have never taken the Pill.
Breast cancer is rare under 40 years of age but the risk increases as the woman gets older.
Therefore, the extra number of breast cancers diagnosed is higher if a woman continues to
take the Pill when she is older. How long she takes the Pill is less important.
 In every 10 000 women who take the Pill for up to 5 years but stop taking it by the
age of 20, there would be less than 1 extra case of breast cancer found up to 10 years
after stopping, in addition to the 4 cases normally diagnosed in this age group.
 In 10 000 women who take the Pill for up to 5 years but stop taking it by the age of
30, there would be 5 extra cases in addition to the 44 cases normally diagnosed.
 In 10 000 women who take the Pill for up to 5 years but stop taking it by the age of
40, there would be 20 extra cases in addition to the 160 cases normally diagnosed.
The risk of breast cancer in users of progestogen-only pills like ZYNTHIA is believed to be
similar to that in women who use the Pill, but the evidence is less conclusive.
Breast cancers found in women who take the Pill, seem less likely to have spread than breast
cancers found 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 the
women were examined more often, so that the breast cancer is noticed earlier.

Thrombosis
See your doctor immediately if you notice possible signs of a thrombosis (see also ‘Regular
check-ups’).
Thrombosis is the formation of a blood clot, which may block a blood vessel. A thrombosis
sometimes occurs in the deep veins of the legs (deep venous thrombosis). If this clot breaks
away from the veins where it is formed, it may reach and block the arteries of the lungs,
causing a so-called “pulmonary embolism”. A pulmonary embolism can cause chest pain,
breathlessness, collapse or even death.


Deep venous thrombosis is a rare occurrence. It can develop whether or not you are
taking the Pill. It can also happen if you become pregnant.

The risk is higher in Pill-users than in non-users. The risk with progestogen-only pills like
ZYNTHIA is believed to be lower than in users of Pills that also contain oestrogens
(combined Pills).
Children and adolescents
No clinical data on efficacy and safety are available in adolescents below 18 years.
Other medicines and ZYNTHIA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Some medicines may stop ZYNTHIA from working properly. These include medicines used
for the treatment of
 epilepsy (e.g. primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate and
phenobarbital)
 tuberculosis (e.g. rifampicin)
 HIV infections (e.g. ritonavir), or other infectious diseases (e.g. griseofulvin)
 stomach upset (medical charcoal)
 depressive moods (the herbal remedy St. John’s Wort).
Your doctor can tell you if you need to take additional contraceptive precautions and if so, for
how long.
ZYNTHIA may also interfere with how certain medicines work, causing either an increase in
effect (e.g. medicines containing cyclosporine) or a decrease in effect.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not use ZYNTHIA if you are pregnant, or think you may be pregnant.
Breast-feeding
ZYNTHIA may be used while you are breast-feeding. Desogestrel does not influence the
production or the quality of breast milk. However, a small amount of the active substance of
ZYNTHIA passes over into the milk.
The health of children who were breast-fed for 7 months while their mothers were using
desogestrel has been studied up until they were 2½ years of age. No effects on the growth and
development of the children were observed.

If you are breast-feeding and want to use ZYNTHIA, please contact your doctor.
Driving and using machines
ZYNTHIA has no known effect on the ability to drive or use machines.
ZYNTHIA contains lactose
ZYNTHIA contains lactose (milk sugar). Please contact your doctor before taking ZYNTHIA
if you have been told by your doctor that you are intolerant to some sugars.
Regular Check-ups
When you are using , your doctor will tell you to return for regular checkups. In general, the frequency and nature of these check-ups will depend on your personal
situation.
Contact your doctor as soon as possible if:
 you notice possible signs of a blood clot (e.g. severe pain or swelling in either of your
legs); unexplained pains in the chest, breathlessness, an unusual cough, especially when
you cough up blood);
 you have a sudden, severe stomach ache or jaundice (you may notice yellowing of the
skin, the whites of the eyes, or dark urine, possibly a sign of liver problems);
 you feel a lump in your breast (possibly a sign of breast cancer);
 you have a sudden or severe pain in the lower abdomen or stomach area (possibly a sign of
an ectopic pregnancy - a pregnancy outside the womb);
 you are to be immobilised or are to have surgery (consult your doctor at least four weeks
in advance);
 you have unusual, heavy vaginal bleeding
 you suspect that you are pregnant.

3.

How to take ZYNTHIA

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
When and how to take the tablets?
Each strip of ZYNTHIA contains 28 tablets – 4 weeks supply.
 Take your tablet each day at about the same time. Swallow the tablet whole,
with water.
 Arrows are printed on the front of the strip, between the tablets. The days of the week
are printed on the back of the strip. Each day corresponds with one tablet.
 Every time you start a new strip of ZYNTHIA, take a tablet from the top row. Don’t
start with just any tablet. For example if you start on a Wednesday, you must take the
tablet from the top row marked (on the back) with WED.
 Continue to take one tablet at every day until the pack is empty, always following the
direction indicated by the arrows. By looking at the back of your pack you can easily
check if you have already taken your tablet on a particular day.
 You may have some bleeding during the use of ZYNTHIA, (See Section 4 - Side
Effects) but you must continue to take your tablets as normal.
 When a strip is empty, you must start with a new strip of ZYNTHIA on the next day without interruption and without waiting for a bleed.
Starting your first pack of ZYNTHIA
If you are not using hormonal contraception at present (or in the past month)

Wait for your period to begin. On the first day of your period take the first ZYNTHIA tablet.
Additional contraceptive precautions are not necessary.
If you take your first tablet on days 2 to 5 of your period use an additional barrier method of
contraception for the first 7 days of tablet-taking.
When you change from a combined pill (COC), vaginal ring, or transdermal patch.
If you have a tablet-, ring- or patch-free break
 You can also start at the latest the day following the tablet-, ring-or patch-free break,
or when you have taken all the inactive (placebo) tablets, of your present
contraceptive.
 If you follow these instructions, make sure you use an additional barrier method
of contraception for the first 7 days of tablet-taking.
If you don’t have a tablet-, ring- or patch-free break
 Start taking ZYNTHIA on the day after you take the last tablet from the present Pill
pack, or on the day of removal of your vaginal ring or patch (this means no tablet-,
ring- or patch-free break).
 If your present Pill pack also contains inactive (placebo) tablets you can start
ZYNTHIA on the day after taking the last active tablet (if you are not sure which this
is, ask your doctor or pharmacist).
 If you follow these instructions, additional contraceptive precautions are not
necessary.
When changing from another progestogen-only pill
Switch on any day from another mini pill. Additional contraceptive precautions are not
necessary.
When changing from an injection, implant or a hormonal IUS
Start using ZYNTHIA when your next injection is due or on the day that your implant or you
IUS is removed. Additional contraceptive precautions are not necessary.
After you have a baby
You can start ZYNTHIA, between 21 to 28 days after the birth of your baby.
If you start later, make sure that you use an additional barrier method of contraception until
you have completed the first 7 days of tablet-taking. However, if you have already had sex,
check that you are not pregnant before starting ZYNTHIA. Information for breast-feeding
women can be found in section 2 “Before you take ZYNTHIA” in the paragraph “Pregnancy
and breast-feeding”. Your doctor can also advise you.
After a miscarriage or an abortion
Your doctor will advise you.
If you take more ZYNTHIA than you should
There have been no reports of serious harmful effects from taking too many ZYNTHIA
tablets at one time. Symptoms that may occur are nausea, vomiting and in young girls, slight
vaginal bleeding.
For more information ask your doctor for advice.
If you forget to take ZYNTHIA
If you are less than 12 hours late:
 Take the missed tablet as soon as you remember and take the next one at the usual
time. ZYNTHIA will still protect you from pregnancy.

If you are more than 12 hours late:
 If you are more than 12 hours late in taking any tablet, you may not be completely
protected against pregnancy. The more consecutive tablets you have missed, the
higher the risk that you might fall pregnant.
 Take a tablet as soon as you remember and take the next one at the usual time. This
may mean taking two in one day. This is not harmful. (If you have forgotten more
than one tablet you don’t need to take the earlier missed ones). Continue to take your
tablets as usual but you must also use an extra method, such as a condom, for the next
7 days.
 If you are more than 12 hours late taking your tablet and have sex it is safe to use
emergency contraception; please consult your pharmacist or doctor.
 If you missed one or more tablets in the very first week of tablet-intake and had
intercourse in the week before missing the tablets, you may fall pregnant. Ask your
doctor for advice.
If you vomit or use medical charcoal
If you vomit, or use medical charcoal within 3 - 4 hours after taking your ZYNTHIA tablet or
have severe diarrhoea, the active ingredient may not have been completely absorbed. Follow
the advice for forgotten tablets in the section above.
If you stop taking ZYNTHIA
You can stop taking ZYNTHIA whenever you want. From the day you stop you are no longer
protected against pregnancy.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor if you notice any unwanted effect, especially if severe or persistent.
Serious side effects associated with the use of ZYNTHIA are described in section 2 “Before
you take ZYNTHIA”. Please read this section for additional information on ‘Breast cancer’
and ‘Thrombosis’, and consult your doctor at once where appropriate.
Vaginal bleeding may occur at irregular intervals while using ZYNTHIA. This may be
just slight staining which may not even require a pad, or heavier bleeding, which looks rather
like a scanty period. You may need to use tampons or sanitary towels. You may also not have
any bleeding at all. Irregular bleeding is not a sign that ZYNTHIA is not working. In general,
you need not take any action; just continue to take ZYNTHIA. If bleeding is heavy or
prolonged you should consult your doctor.
How often are other possible side effects seen?
Common (affecting less than 1 in 10 women): mood changes (mood altered, depressed
mood), decreased sexual drive (libido), headache, nausea, acne, breast pain, irregular or no
periods, weight increase.
Uncommon (affecting less than 1 in 100 women) infection of the vagina, difficulties in
wearing contact lenses, vomiting, hair loss, painful periods, ovarian cysts, tiredness.
Rare (affecting less than 1 in 1,000 women) skin conditions such as: rash, hives, painful bluered skin lumps (erythema nodosum)

Apart from these side effects, breast secretion or leakage may occur.
A pregnancy outside the uterine cavity (ectopic pregnancy) was reported rarely.
You should see your doctor immediately if you experience symptoms of angioedema such as
swollen face, tongue or pharynx; difficulty to swallow; orhives and difficulties to breathe.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 ZYNTHIA
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 after EXP. The
expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment.

6.

Contents of the pack and other information

What ZYNTHIA contains
- The active substance is desogestrel. Each tablet contains 75 microgram of desogestrel.
- The other ingredients are: colloidal anhydrous silica; Alpha-tocopherol; maize starch;
povidone; stearic acid; hypromellose; macrogol 6000; propylene glycol, talc; titanium dioxide
(E171); lactose monohydrate (see also “ZYNTHIA contains lactose” in section 2).
What ZYNTHIA looks like and contents of the pack
White, cylindrical, biconvex film-coated tablet with a diameter of 6.00 mm approximately.
ZYNTHIA is packed in PVC / Aluminium blisters. Each individual blister is placed inside a
foil sachet, which is then packed into a cardboard box.
Packs with
For UK/H/4533/01/DC:
28 film coated tablets
84 film coated tablets
168 film coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Cyndea Pharma, S.L.
Polígono Industrial Emiliano Revilla Sanz
Avenida de Ágreda, 31,
Ólvega, 42110 Soria
Spain
This medicinal product is authorised in the Member States of the EEA under the
following names:
Italy:
ZYNTHIA 0,075mg compresse rivestite con film
Spain:
desogestrel cinfa 75 microgramos comprimidos recubiertos con película EFG
United Kingdom: ZYNTHIA 75 microgram film-coated tablets

This leaflet was last revised in October 2014

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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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