TRIQUILAR® ED

Three-phase hormonal preparation:

6 tablets each containing 0.05 mg levonorgestrel + 0.03 mg ethinylestradiol

5 tablets each containing 0.075 mg levonorgestrel + 0.04 mg ethinylestradiol

10 tablets each containing 0.125 mg levonorgestrel + 0.03 mg ethinylestradiol

What is in this leaflet

Please read this leaflet carefully before you start using TRIQUILAR ED. It
will advise you about how to take TRIQUILAR ED properly and when to tell your
doctor about health-related conditions. If you have any questions or need more
advice, ask your doctor, professional health care provider or pharmacist.

What is TRIQUILAR ED used for and how does it work

TRIQUILAR ED is a combined oral contraceptive (often called "the Pill")
consisting of 21 small hormonal tablets which contain a small amount of two
different female hormones. These are levonorgestrel (a progestogen) and
ethinylestradiol (an estrogen). Because of the small amount of hormones,
TRIQUILAR ED is considered a low-dose combined oral contraceptive preparation.
The TRIQUILAR ED blister pack contains 3 different kinds of active tablets, each
kind featuring different amounts of two hormones. These tablets emulate the
natural cycle by generating three distinct hormonal stages. This is why
TRIQUILAR ED is called a triphasic combined oral contraceptive.

TRIQUILAR ED also contains 7 large white non-hormonal tablets that do not
contain any active ingredients.

How does TRIQUILAR ED work?

Combined oral contraceptive Pills, such as TRIQUILAR ED, provide one of the
most effective reversible methods of contraception known. Usually, when
TRIQUILAR ED is taken according to the instructions, the egg cells (normally
released by the ovary each month) are prevented from maturing to the point where
they can be fertilised. In addition, the cervical mucus remains thick, so it is
more difficult for a man's sperm to enter the womb. Also, the lining of the womb
is not prepared sufficiently for a fertilised egg to grow in.

What is TRIQUILAR ED used for?

TRIQUILAR ED is used to prevent pregnancy. Combined oral contraceptives are a
very effective method of birth control. When taken correctly (without missing
tablets) the chance of becoming pregnant is very low (approximately 1% per
year). The failure rate may increase when tablets are missed or taken
incorrectly.

Before you use TRIQUILAR ED

Do not use TRIQUILAR ED if you have any of the conditions listed below. If
any of these apply to you, tell your doctor before starting to use TRIQUILAR ED.
Your doctor may advise you to use a different type of Pill or an entirely
different (non-hormonal) method of birth control.

You must not use TRIQUILAR ED if:

• you have, or have ever had a disorder affecting the blood circulation, in
  particular those conditions relating to thrombosis. Thrombosis is the
  formation of a blood clot. This may occur in the blood vessels of the legs
  (deep vein thrombosis), the lungs (pulmonary embolism), the heart (heart
  attack), the brain (stroke), or other parts of the body. (See also the section
  later in this leaflet called "TRIQUILAR ED and thrombosis".
• you have or have ever had a stroke (caused by a rupture of a blood vessel
  in the brain).
• you have or have ever had a condition that may be a first sign of a heart
  attack (such as angina pectoris or chest pain) or stroke (such as transient
  ischemic attack or small reversible stroke).
• you have diabetes mellitus with blood vessel damage.
• you have or have had pancreatitis (an inflammation of the pancreas)
  associated with high levels of fatty substances in your blood.
• you or someone in your immediate family have or have had high blood levels
  of cholesterol or triglycerides (fatty substances).
• you have or have had jaundice (yellowing of the skin) or severe liver
  disease as long as liver function values have not returned to normal.
• you have or have had a cancer that may grow under the influence of sex
  hormones (e.g. of the breast or the genital organs).
• you have or have had a benign or malignant liver tumor.
• you have a history of migraine accompanied by visual symptoms or speech
  disability or weakness or numbness in any part of your body.
• you have any unexplained vaginal bleeding.
• you are pregnant or think you might be pregnant.
• you are hypersensitive (allergic) to any of the ingredients of TRIQUILAR
  ED.

If any of these conditions appear for the first time while using TRIQUILAR
ED, stop taking it at once and consult your doctor. In the meantime, use
non-hormonal contraceptive measures.

Tell your doctor if:

If TRIQUILAR ED is used in the presence of any of the conditions listed below
or they appear for the first time or recur or worsen during treatment, you may
need to be kept under close observation. Your doctor can explain this to you.
You should tell your doctor if:

• you smoke
• you have diabetes
• you are overweight
• you have high blood pressure
• you have a heart valve disorder or a certain heart rhythm disorder
• you have an inflammation of your veins (superficial phlebitis)
• you have varicose veins
• anyone in your immediate family has had thrombosis, a heart attack or a
  stroke
• you suffer from headaches
• you suffer from epilepsy
• anyone in your immediate family has had breast cancer
• you have liver, kidney or gallbladder disease
• you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel
  disease)
• you have systemic lupus erythematosus (SLE; a disease affecting the skin
  all over the body)
• you have hemolytic uremic syndrome (HUS; a disorder of blood clotting
  causing failure of the kidneys)
• you have sickle cell disease
• you have a condition that occurred for the first time or worsened during
  pregnancy or previous use of sex hormones (e.g. hearing loss, a metabolic
  disease called porphyria, a skin disease called herpes gestationis, a
  neurological disease called Sydenham's chorea);
• 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
• you have hereditary angioedema; exogenous estrogens may induce or
  exacerbate symptoms of angioedema. You should see your doctor immediately if
  you experience symptoms of angioedema such as swollen face, tongue and/or
  pharynx and/or difficulty swallowing or hives together with difficulty
  breathing.

What else you should know

TRIQUILAR ED does not protect against HIV infection (AIDS) or any other
sexually transmitted disease.

In this leaflet, several situations are described where you should stop
taking TRIQUILAR ED, or where the reliability of TRIQUILAR ED may be decreased.
In such situations you should not have sex or you should take extra non-hormonal
contraceptive precautions, e.g., use a condom or another barrier method. Do not
use rhythm or temperature methods. These methods can be unreliable because
TRIQUILAR ED alters the usual changes in temperature and cervical mucus that
occur during the menstrual cycle.

TRIQUILAR ED and thrombosis

Thrombosis is the formation of a blood clot which may block a blood vessel.

Thrombosis sometimes occurs in the deep veins of the legs (deep venous
thrombosis). If this blood 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". Deep venous thrombosis is a rare occurrence. The risk is highest
during the first year a woman ever uses the Pill.

Venous thrombosis can develop whether or not you are using the Pill. It can
also happen if you become pregnant. The risk is higher in Pill users than in
non-users but not as high as the risk during pregnancy.

Blood clots can also occur very rarely in the blood vessels of the heart
(causing a heart attack) or the brain (causing a stroke). Extremely rarely,
blood clots can occur in the liver, gut, kidney or eye.

Very occasionally a thrombosis may cause serious permanent disabilities or
may even be fatal.

The risk of having a heart attack or stroke increases as you get older. It
also increases the more you smoke.

When using TRIQUILAR ED you should stop smoking, especially if you are
older than about 35 years of age.

If you develop high blood pressure while using TRIQUILAR ED, you may be told
to stop using it.

The risk of having deep venous thrombosis is temporarily increased as a
result of an operation or immobilization (for example, when you have your leg or
legs in plaster or splints). In women who use the Pill (such as TRIQUILAR ED)
the risk may be even higher. Tell your doctor you are using TRIQUILAR ED well in
advance of any expected hospitalization or surgery. Your doctor may tell you to
stop taking TRIQUILAR ED several weeks before surgery or at the time of
immobilization. Your doctor will also tell you when you can start taking
TRIQUILAR ED again after you are back on your feet.

If you notice possible signs of a thrombosis, stop taking the Pill and
consult your doctor immediately (See also the section called "Tell your
doctor if:")

TRIQUILAR ED and cancer

Breast cancer has been diagnosed slightly more often in women who use the
Pill than in women of the same age who do not use the Pill. This slight increase
in the numbers of breast cancer diagnoses gradually disappears during the course
of the ten years after stopping use of the Pill. It is not known whether the
difference is caused by the Pill. It may be that the women were examined more
often, so that the breast cancer was noticed earlier.

In rare cases, benign, and even more rarely, malignant liver tumors have been
reported in users of the Pill. These tumors may lead to internal bleeding.
Contact your doctor immediately if you have severe pain in your abdomen.

The most important risk factor for cervical cancer is persistent human
papilloma virus infection. Some studies have indicated that long-term use of the
Pill may further contribute to this increased risk but there continues to be
controversy about the extent to which this finding is attributable to other
factors, e.g., cervical screening and sexual behaviour including use of barrier
contraceptives.

TRIQUILAR ED and other medicines

Some oral medicines may stop TRIQUILAR ED from working properly. These
include medicines used for the treatment of epilepsy (e.g. primidone, phenytoin,
barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate) and
tuberculosis (e.g. rifampicin, rifabutin); HIV infections (e.g. ritonavir,
nevirapine); antibiotics (e.g. ampicillin, tetracyclines, griseofulvin) for some
other infectious diseases; and the herbal remedy St. John's wort (primarily used
for the treatment of depressive moods).

The Pill may also interfere with the working of other medicines, e.g.
medicines containing cyclosporin, or the anti-epileptic lamotrigine.

Please inform your doctor or pharmacist if you are taking or have recently
taken any other medicines or herbal products, even those not prescribed.

Always tell the doctor who prescribes TRIQUILAR ED which medicines you are
already using. Also tell any other doctor or dentist who prescribes another
medicine (or the dispensing pharmacist) that you use TRIQUILAR ED. They can tell
you if you need to take additional contraceptive precautions and if so, for how
long.

TRIQUILAR ED and breast-feeding

TRIQUILAR ED is generally not recommended for use during breast-feeding. If
you wish to take the Pill while breast-feeding, please seek the advice of your
doctor.

TRIQUILAR ED and pregnancy

TRIQUILAR ED must not be used by women who are pregnant, or who think they
may be pregnant. If you suspect that you are pregnant while you are already
using TRIQUILAR ED, you should consult your doctor as soon as possible.

TRIQUILAR ED and ability to drive and use machines

There are no observed effects.

How to use TRIQUILAR ED properly

When you follow the starting instructions and continue to take TRIQUILAR ED
correctly, the contraceptive protection provided by TRIQUILAR ED is continuous.
This includes the week when you take the non-hormonal tablets.

Additional contraceptive precautions are only required when special
circumstances (e.g. forgetting tablets) reduce the reliability of the
preparation.

Remember that TRIQUILAR ED has been prescribed for you personally. Do not
share it with others.

When and how to take the tablets

Take your tablet at about the same time each day, with some water if
necessary. Follow the direction of the arrows until all the tablets have been
taken (you will find detailed instructions on the preparation of the blister
pack in the section "How to prepare the blister pack of TRIQUILAR ED - Day of
the week stickers"). A period (the withdrawal bleed) should begin during the
7 days of taking the larger white non-hormonal tablets. Start taking your next
pack on the very next day after you have completed your last pack. This means
that you will always start new packs on the same day of the week, and also that
you will have your withdrawal bleed on about the same day each month.

How to prepare the blister pack of TRIQUILAR ED - Day of the week stickers

The TRIQUILAR ED pack holds 3 memo-packs, each containing 21 small, round
hormonal tablets (i.e. 6 light-brown, 5 small white and 10 ochre tablets) and 7
large white non-hormonal tablets.

In addition to the memo-packs, the outer carton contains a sheet of stickers
divided, by perforated lines, into three sections. Separate each section along
the perforated lines to give you 3 single sheets of stickers. Each of the 3
sticker sheets hold 7 self-adhesive strips showing the days of the week.

When you are ready to start a new memo-pack, look below the start arrow on
the left of one of the sticker sheets and choose one strip that starts with the
day that you will begin tablet taking. For example, if you start the tablets on
a Wednesday, use the strip that starts with "Wed".

Peel the required strip off the sheet and stick it onto the area indicated on
the front of the memo-pack so that the first day is above the tablet to which
the arrow marked "Start" is pointing.

Throw the unused portion of this sticker away. Repeat the process above with
the other sticker sheets just before you begin each memo-pack.

Starting your first pack of TRIQUILAR ED

First prepare the blister pack with the day of the week sticker using the
instructions above "How to prepare the blister pack of TRIQUILAR ED - Day of
the week stickers"

START WITH THE TABLET FROM THE GREEN SECTION MARKED WITH THAT DAY OF THE
WEEK, in accordance with one of the following:

When no hormonal contraceptive has been used in the past month

Start taking TRIQUILAR ED on the first day of your menstrual bleeding. Then
follow the days in order. TRIQUILAR ED will work immediately, it is not
necessary to use an additional contraceptive method.

You may also start on days 2 - 3 of your cycle, but in that case make sure
that you also use an additional contraceptive method (barrier method such as
condoms) for the first 7 days of tablet-taking in the first cycle.

When changing from a combined Pill, vaginal ring, or transdermal
(contraceptive) patch

You can start taking TRIQUILAR ED the day after you take the last tablet from
your present Pill pack (this means no tablet-free break). Follow the
instructions as described under "Starting your first pack of TRIQUILAR ED".
If your present Pill pack also contains non-hormonal tablets you can start
TRIQUILAR ED on the day after taking the last hormonal tablet (if you are
not sure which this is, ask your doctor or pharmacist). In case you have used a
vaginal ring or transdermal patch, you should start using TRIQUILAR ED
preferably on the day of removal, but at the latest when the next application
would have been due. If you follow these instructions it is not necessary to use
an additional contraceptive method.

When changing from a progestogen-only Pill (minipill)

You can stop taking the minipill any day and start taking TRIQUILAR ED the
next day, at the usual time. Follow the instructions as described under
"Starting your first pack of TRIQUILAR ED". But make sure you also use an
additional contraceptive method (a barrier method such as condoms) for the first
7 days of tablet taking when having intercourse.

When changing from an injectable, an implant, or a progestogen-releasing
intrauterine device (IUD)

Start using TRIQUILAR ED when your next injection is due or on the day that
your implant or IUD is removed. Follow the instructions as described under
"Starting your first pack of TRIQUILAR ED". But make sure you also use an
additional contraceptive method (a barrier method such as condoms) for the first
7 days of tablet taking when having intercourse.

After having a baby

If you have just had a baby, your doctor may tell you to wait until after
your first normal period before you start taking TRIQUILAR ED. Sometimes it is
possible to start sooner. Your doctor will advise you. If you are breast-feeding
and want to take TRIQUILAR ED, you should discuss this first with your doctor.

After a miscarriage or an abortion

Your doctor will advise you.

Special circumstances

The following describes special circumstances that could alter the way you
take TRIQUILAR ED. In all situations where the reliability of TRIQUILAR ED is
reduced (such as missing tablets) additional contraceptive precautions are
required following the advice given below. This advice should also be followed
in situations where other medicines may stop TRIQUILAR ED from working properly
and in the case of vomiting or severe diarrhea after taking TRIQUILAR ED.

If you forget to take your tablets

If you forget to take your tablets, follow the instructions below. This is
often called the "7 day rule". The more tablets you have missed, the
higher the risk that the contraceptive effect is decreased. There is a
particularly high risk of becoming pregnant if you miss tablets at the beginning
or at the end of the pack.

If you vomit or have severe diarrhea after taking TRIQUILAR ED

If you vomit or have severe diarrhea within 3 to 4 hours after taking your
TRIQUILAR ED hormonal tablets, the active ingredients may not have been
completely absorbed. This is like missing a tablet. Therefore, follow the advice
for missed tablets. If vomiting or diarrhea occurs while taking the non-hormonal
tablets, this does not have an influence on the contraceptive reliability.

If you are taking medicines that affect TRIQUILAR ED

Some medicines may stop TRIQUILAR ED from working properly. These medicines
are listed in an earlier section. For the time that you are taking the medicine
and for the next 7 days follow the advice for missed tablets. If you are taking
rifampicin, or you are taking these medicines continuously, your doctor will
advise you on the length of time you need to take extra contraceptive
precautions.

If you want to delay a period

You can delay your period if you continue with the last 10 ochre colored

hormonal tablets of another pack of TRIQUILAR ED immediately after
finishing the ochre colored hormonal tablets of your current pack. (Do not
take the large white non-hormonal tablets from your current pack). Continue with
the second pack until this pack is empty. Your period will start while you are
taking the large white non-hormonal tablets in the second pack. You may have
some breakthrough bleeding or spotting while you are taking the small hormonal
tablets.

The extension can be carried on for a maximum of 10 days until the end of the
ochre colored hormonal tablets of your second pack.

If you want to change the starting day of your period

If you take your tablets as directed, you will have your period on about the
same day every 4 weeks. If you want to change this, just shorten (never
lengthen) the duration of taking the large white non-hormonal tablets. For
example if your period usually starts on a Friday and in future you want to
start on Tuesday (3 days earlier) you should now start your next pack 3 days
sooner than you usually do, discard the 3 remaining large white non-hormonal
tablets of your previous pack and then continue with the next pack without
having a break between the packs. If you make the duration of taking the large
non-hormonal tablets very short (e.g. 3 days or less), you may not have a bleed
during the break. You may have some breakthrough bleeding or spotting during the
use of the next pack.

If you have unexpected bleeding

As with other Pills, for the first few months, you can have irregular vaginal
bleeding (spotting or breakthrough bleeding) with TRIQUILAR ED between your
periods. You may need to use sanitary protection, but continue to take your
tablets as normal. Irregular vaginal bleeding usually stops once your body has
adjusted to TRIQUILAR ED (usually after about 3 tablet-taking cycles). If it
continues, becomes heavy or starts again, tell your doctor.

If you have missed a period

If you have taken all of your tablets at the right time, and you have not
vomited, had severe diarrhea while taking the small hormonal tablets or used
other medicines, then you are very unlikely to be pregnant. Continue to take
TRIQUILAR ED as usual.

If you miss your period twice in a row, you may be pregnant. Tell your doctor
immediately. Do not start the next pack of TRIQUILAR ED until your doctor has
checked you are not pregnant.

When you want to stop taking TRIQUILAR ED

You can stop taking TRIQUILAR ED at any time you want. If you stop because
you want to get pregnant, it is generally recommended that you wait until you
have a natural period before trying to conceive. This helps you to work out when
the baby is due.

If you do not want to become pregnant, ask your doctor about other methods of
birth control.

Overdosage

There have been no reports of serious harmful effects from taking too many
TRIQUILAR ED hormonal tablets at one time. If you have taken several tablets at
a time, you may have nausea, vomiting or vaginal bleeding. If you discover that
a child has taken TRIQUILAR ED, ask your doctor for advice. Taking the large
white non-hormonal tablets is harmless because they do not contain active
ingredients.

When using TRIQUILAR ED

Tell your doctor immediately if:

You should stop treatment and see your doctor immediately if you get a
blood clot, heart attack or stroke while you are taking TRIQUILAR ED. Warning
signs for a blood clot, heart attack or stroke to look out for are:

• an unusual cough;
• severe pain in the chest which may reach the left arm;
• breathlessness;
• any unusual, severe, or prolonged headache or migraine attack;
• partial or complete loss of vision, or double vision;
• slurring or speech disability;
• sudden changes to your hearing, sense of smell, or taste;
• dizziness or fainting;
• weakness or numbness in any part of your body;
• severe pain in your abdomen;
• severe pain or swelling in either of your legs.

Tell your doctor if:

Contact your doctor as soon as possible if:

• you notice any changes in your own health, especially involving any of the
  items mentioned in this leaflet. Do not forget about the items related to your
  immediate family;
• you feel a lump in your breast;
• you are going to use other medications (See also the section called "TRIQUILAR
  ED and other medicines");
• you are to be immobilized or are to have surgery (consult your doctor at
  least four weeks in advance);
• you have unusual, heavy vaginal bleeding;
• you forgot tablets in the first week of the pack and had intercourse in
  the seven days before;
• you have severe diarrhea;
• you have missed your period twice in a row or suspect you are pregnant (do
  not start the next pack until told to by your doctor).

Regular check-ups

When you are using TRIQUILAR ED, your doctor will tell you to return for
regular check-ups. In general, you should have a check-up every year.

Side effects

Tell your doctor if you notice any unwanted effect, especially if severe or
persistent, or if there is a change in your health that you think might be
caused by TRIQUILAR ED.

Serious side effects

Serious reactions associated with the use of combined oral contraceptives
such as TRIQUILAR ED, as well as the related symptoms, are described in the
section "Before you use TRIQUILAR ED". Please read this section carefully
and consult your doctor where appropriate.

Other possible side effects

The following side effects have been reported in users of combined oral
contraceptives such as TRIQUILAR ED, although they may not be caused by the
contraceptive Pill. Such side effects that occur in the first few months that
you are using TRIQUILAR ED will probably lessen with time.

System Organ Class	Common (≥ 1/100)	Uncommon (≥ 1/1000 and < 1/100)	Rare (< 1/1000)
Eye disorders			Contact lens intolerance
Gastrointestinal disorders	Nausea, abdominal pain	Vomiting, diarrhea
Immune system disorders			Hypersensitivity
Investigations	Increased weight		Decreased weight
Metabolism and nutrition disorders		Fluid retention
Nervous system disorders	Headache	Migraine
Psychiatric disorders	Depression, altered mood	Decreased libido	Increased libido
Reproductive system and breast disorders	Breast pain, breast tenderness	Breast enlargement	Vaginal discharge, breast discharge
Skin and subcutaneous tissue disorders		Rash, urticaria	Erythema nodosum, erythema multiforme

If you have hereditary angioedema, taking estrogens may induce or exacerbate
symptoms of angioedema. (See also "Before you use TRIQUILAR ED").

If you notice any side effects not mentioned in this leaflet, please inform
your doctor or pharmacist.

Storage

Do not use after the expiry date stated on the package.

Store all medicines properly and keep them out of reach of children.

Further information

Like other combined oral contraceptive Pills, TRIQUILAR ED may also have
non-contraceptive health benefits.

• Your period may be lighter and shorter. As a result, the risk of anemia
  may be lower. Your period pains may become less severe or may completely
  disappear.
• Some serious disorders have been reported to occur less frequently in
  users of "high-dose" oral contraceptive Pills. These are benign breast
  disease, ovarian cysts, pelvic infections (pelvic inflammatory disease or PID),
  ectopic pregnancy (pregnancy in which the embryo implants outside of the womb)
  and cancer of the endometrium (lining of the womb) and ovaries. This may also
  be the case for "low-dose" Pills such as TRIQUILAR ED, but so far this has
  only been confirmed for endometrial and ovarian cancer.

TRIQUILAR ED tablets contain:

active substances (per tablet):

• levonorgestrel 0.05 mg and ethinylestradiol 0.03 mg (6 light-brown
  tablets)
• levonorgestrel 0.075 mg and ethinylestradiol 0.04 mg (5 small white
  tablets)
• levonorgestrel 0.125 mg and ethinylestradiol 0.03 mg (10 ochre tablets)

other substances:

lactose monohydrate, maize starch, polyvidone 25 000, magnesium stearate,
sucrose, polyvidone 700 000, macrogol 6000, calcium carbonate, talc, glycerol
85%, ferric oxide pigment yellow, ferric oxide pigment red, titanium dioxide,
montanglycol wax.

If you have any further questions please consult your doctor or
pharmacist.