KATYA 30/75 COATED TABLETS

Katya 30/75 Coated Tablets
ETHINYLESTRADIOL / GESTODENE

PACKAGE LEAFLET: INFORMATION FOR THE USER
Katya 30/75 coated tablets
Ethinylestradiol / Gestodene
Important things to know about combined hormonal
contraceptives (CHCs):
• They are one of the most reliable reversible methods of contraception
if used correctly
• They slightly increase the risk of having a blood clot in the veins and
arteries, especially in the first year or when restarting a combined
hormonal contraceptive following a break of 4 or more weeks
• Please be alert and see your doctor if you think you may have
symptoms of a blood clot (see section 2 “Blood clots”)
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 pharmacist.
• This medicine has been prescribed for you only, do not pass it on to
others. It may harm them.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet
1 WHAT KATYA 30/75 COATED TABLETS ARE AND WHAT THEY
ARE USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE KATYA 30/75
COATED TABLETS
3 HOW TO TAKE KATYA 30/75 COATED TABLETS
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE KATYA 30/75 COATED TABLETS
6 CONTENTS OF THE PACK AND OTHER INFORMATION
1 WHAT KATYA 30/75 COATED TABLETS ARE AND WHAT THEY
ARE USED FOR?
• Katya 30/75 coated tablets is a contraceptive pill and is used to
prevent pregnancy.
• Each tablet contains a small amount of two different female
hormones, namely ethinylestradiol and gestodene.
• Contraceptive pills as Katya 30/75 coated tablets that contain two
hormones are called “combination” pills.
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE KATYA 30/75
COATED TABLETS
General notes
Before you start using Katya 30/75 coated tablets you should read the
information on blood clots (thrombosis) in section 2. It is particularly
important to read the symptoms of a blood clot – see Section 2 “Blood
clots”).
Before you can begin taking Katya 30/75 coated tablets, your doctor
will ask you some questions about your personal health history and
that of your close relatives. The doctor will also measure your blood
pressure, and depending upon your personal situation, may also carry
out some other tests.
In this leaflet, several situations are described where you should stop
using Katya 30/75 coated tablets, or where the reliability of Katya
30/75 coated tablets may be decreased. In such situations you should
either not have intercourse or you should take extra non-hormonal
contraceptive precautions, e.g., a condom or another barrier method.
Do not use rhythm or temperature methods. These methods can be
unreliable because Katya 30/75 coated tablets alters the monthly
changes of the body temperature and of the cervical mucus.
Katya 30/75 coated tablets, like other hormonal contraceptives,
do not protect against HIV infection (AIDS) or any other
sexually transmitted disease.
Do not use Katya 30/75 coated tablets
You should not use Katya 30/75 coated tablets if you have any of the
conditions listed below. If you do have any of the conditions listed below,
you must tell your doctor. Your doctor will discuss with you what other
form of birth control would be more appropriate.
• if you have (or have ever had) a blood clot in a blood vessel of your
legs (deep vein thrombosis, DVT), your lungs (pulmonary embolus,
PE) or other organs;
• if you know you have a disorder affecting your blood clotting –
for instance, protein C deficiency, protein S deficiency,
antithrombin-III deficiency, Factor V Leiden or antiphospholipid
antibodies;
• if you need an operation or if you are off your feet for a long time
(see section ‘Blood clots (thrombosis and embolus)’
• if you have ever had a heart attack or a stroke;
• if you have (or have ever had) angina pectoris (a condition that
causes severe chest pain and may be a first sign of a heart attack)
or transient ischaemic attack [TIA – temporary stroke symptoms]);
• if you have any of the following diseases that may increase your risk
of a clot in the arteries:
- severe diabetes with blood vessel damage
- very high blood pressure
- a very high level of fat in the blood (cholesterol or triglycerides)
- a condition known as hyperhomocysteinaemia
• if you have (or have ever had) a type of migraine called ‘migraine
with aura’;
• if you have (had) an inflammation of the pancreas (pancreatitis)
• if you have or have had a liver disease and your liver function is still
not normal.
• if you have or have had a tumour in the liver.
• if your kidneys are not working well (renal failure).
• if you have (had) or if you are suspected to having breast cancer or
cancer of the genital organs.
• if you have any unexplained bleeding from the vagina.
• if you are allergic to ethinylestradiol or gestodene, or any of the
other ingredients of this medicine (listed in section 6). This can be
recognised by itching, rash or swelling.
Warnings and precautions
When should you contact your doctor?
Seek urgent medical attention
- if you notice possible signs of a blood clot that may mean you are
suffering from a blood clot in the leg (i.e. deep vein thrombosis), a
blood clot in the lung (i.e. pulmonary embolism), a heart attack or a
stroke (see ‘Blood clot’ (thrombosis) section below.
For a description of the symptoms of these serious side effects please
go to “How to recognise a blood clot”.
Tell your doctor if any of the following conditions apply to you.
If the condition develops, or gets worse while you are using Katya 30/75
coated tablets, you should also tell your doctor.
In some situations you need to take special care while using Katya 30/75
coated tablets or any other combined hormonal contraceptive, and it may
be necessary that you are regularly checked by your doctor. If any of the
following conditions applies to you, you must inform your doctor before
starting to use Katya 30/75 coated tablets:
• if you have Crohn’s disease or ulcerative colitis
(chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE –; a disease
affecting your natural defence system);
• if you have haemolytic uraemic syndrome (HUS - a disorder of blood
clotting causing failure of the kidneys);
• if you have sickle cell anaemia (an inherited disease of the red blood
cells);
• if you have elevated levels of fat in the blood (hypertriglyceridaemia)
or a positive family history for this condition. Hypertriglyceridaemia
has been associated with an increased risk of developing
pancreatitis (inflammation of the pancreas);
• if you need an operation, or you are off your feet for a long time
(see in section 2 ‘Blood clots (thrombosis)’).
• if you have just given birth you are at an increased risk of blood
clots. You should ask your doctor how soon after delivery you can
start taking Katya 30/75 coated tablets.
• if you have an inflammation in the veins under the skin (superficial
thrombophlebitis).
• if you have varicose veins.
• if a close relative has (had) breast cancer or breast cancer was
diagnosed
• if you have a disease of the liver or the gallbladder
• if you have diabetes
• if you have depression
• if you have epilepsy (see section “Katya 30/75 coated tablets and
other medicines”)
• if you have a disease that first appeared during pregnancy or earlier
use of sex hormones (for example, hearing loss, porphyria (a disease
of the blood), gestational herpes (skin rash with vesicles during
pregnancy), Sydenham’s chorea (a disease of the nerves in which
sudden movements of the body occur)
• if you have (had) chloasma (golden brown pigment patches, so
called “pregnancy patches”, especially on the face). If this is the
case, avoid direct exposure to sunlight or ultraviolet light.
• If you have hereditary angioedema (severe allergic reaction),
products containing estrogens may induce or worsen 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.
Katya 30/75 coated tablets and thrombosis
BLOOD CLOTS
Using a combined hormonal contraceptive such as Katya 30/75 coated
tablets increases your risk of developing a blood clot compared with not
using one. In rare cases a blood clot can block blood vessels and cause
serious problems.
Blood clots can develop
• in veins (referred to as a ‘venous thrombosis’, ‘venous
thromboembolism’ or VTE)
• in the arteries (referred to as an ‘arterial thrombosis’, ‘arterial
thromboembolism’ or ATE).
Recovery from blood clots is not always complete. Rarely, there may be
serious lasting effects or, very rarely, they may be fatal.
It is important to remember that the overall risk of a harmful blood
clot due to Katya 30/75 coated tablets is small.

HOW TO RECOGNISE A BLOOD CLOT
Seek urgent medical attention if you notice any of the following signs or
symptoms.
Are you experiencing
any of these signs?

What are you possibly
suffering from?

• swelling of one leg or along a vein
in the leg or foot
especially when accompanied by:
- pain or tenderness in the leg which
may be felt only when standing or
walking
- increased warmth in the affected leg
- change in colour of the skin on the leg
e.g. turning pale, red or blue

Deep vein thrombosis

• sudden unexplained breathlessness or
rapid breathing;
• sudden cough without an obvious cause,
which may bring up blood;
• sharp chest pain which may increase
with deep breathing;
• severe light headedness or dizziness;
• rapid or irregular heartbeat
• severe pain in your stomach;
If you are unsure, talk to a doctor as some
of these symptoms such as coughing or
being short of breath may be mistaken for
a milder condition such as a respiratory
tract infection (e.g. a ‘common cold’).

Pulmonary embolism

Symptoms most commonly occur in
one eye:
• immediate loss of vision or
• painless blurring of vision which can
progress to loss of vision

Retinal vein thrombosis
(blood clot in the eye)

• chest pain, discomfort, pressure,
heaviness
• sensation of squeezing or fullness in
the chest, arm or below the breastbone;
• fullness, indigestion or choking feeling;
• upper body discomfort radiating to
the back, jaw, throat, arm and stomach;
• sweating, nausea, vomiting or dizziness;
• extreme weakness, anxiety, or shortness
of breath;
• rapid or irregular heartbeats

Heart attack

• sudden weakness or numbness of the
face, arm or leg, especially on one side
of the body;
• sudden confusion, trouble speaking or
understanding;
• sudden trouble seeing in one or both
eyes;
• sudden trouble walking, dizziness, loss
of balance or coordination;
• sudden, severe or prolonged headache
with no known cause;
• loss of consciousness or fainting with or
without seizure.
Sometimes the symptoms of stroke can be
brief with an almost immediate and full
recovery, but you should still seek urgent
medical attention as you may be at risk of
another stroke.

Stroke

• swelling and slight blue discolouration
of an extremity;
• severe pain in your stomach (acute
abdomen)

Blood clots blocking other
blood vessels

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?
• The use of combined hormonal contraceptives has been connected
with an increase in the risk of blood clots in the vein (venous
thrombosis). However, these side effects are rare. Most frequently,
they occur in the first year of use of a combined hormonal
contraceptive.
• If a blood clot forms in a vein in the leg or foot it can cause a deep
vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung it can
cause a pulmonary embolism.
• Very rarely a clot may form in a vein in another organ such as the
eye (retinal vein thrombosis).
When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year
of taking a combined hormonal contraceptive for the first time.
The risk may also be higher if you restart taking a combined hormonal
contraceptive (the same product or a different product) after a break of 4
weeks or more
After the first year, the risk gets smaller but is always slightly higher than
if you were not using a combined hormonal contraceptive.
When you stop taking Katya 30/75 coated tablets your risk of a blood clot
returns to normal within a few weeks.
What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE and the type of combined
hormonal contraceptive you are taking.
The overall risk of a blood clot in the leg or lung (DVT or PE) with Katya
30/75 coated tablets is small.
• Out of 10,000 women who are not using any combined hormonal
contraceptive and are not pregnant, about 2 will develop a blood clot
in a year.
• Out of 10,000 women who are using a combined hormonal
contraceptive that contains levonorgestrel, norethisterone, or
norgestimate about 5-7 will develop a blood clot in a year.
• Out of 10,000 women who are using a combined hormonal
contraceptive that contains gestodene such as Katya 30/75 coated
tablets between about 9 and 12 women will develop a blood clot in
a year.
• The risk of having a blood clot will vary according to your personal
medical history (see “Factors that increase your risk of a blood clot”
below)
Risk of developing a blood
clot in a year
Women who are not using a combined About 2 out of 10,000 women
hormonal pill/patch/ring and are not
pregnant
Women using a combined hormonal
About 5-7 out of 10,000
contraceptive pill containing
women
levonorgestrel, norethisterone
or norgestimate
Women using Katya 30/75
About 9-12 out of 10,000
coated tablets
women
Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with Katya 30/75 coated tablets is small but some
conditions will increase the risk. Your risk is higher:
• if you are very overweight (body mass index or BMI over 30kg/m2);
• if one of your immediate family has had a blood clot in the leg, lung or
other organ at a young age (e.g. below the age of about 50). In this
case you could have a hereditary blood clotting disorder;
• if you need to have an operation, or if you are off your feet for a long
time because of an injury or illness, or you have your leg in a cast. The
use of Katya 30/75 coated tablets may need to be stopped several
weeks before surgery or while you are less mobile. If you need to stop
Katya 30/75 coated tablets ask your doctor when you can start using it
again.
• as you get older (particularly above about 35 years);
• if you gave birth less than a few weeks ago
The risk of developing a blood clot increases the more conditions you
have.
Air travel (>4 hours) may temporarily increase your risk of a blood clot,
particularly if you have some of the other factors listed.
It is important to tell your doctor if any of these conditions apply to you,
even if you are unsure. Your doctor may decide that Katya 30/75 coated
tablets needs to be stopped.
If any of the above conditions change while you are using Katya 30/75
coated tablets, for example a close family member experiences a
thrombosis for no known reason; or you gain a lot of weight, tell your
doctor.
BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like a blood clot in a vein, a clot in an artery can cause serious problems.
For example, it can cause a heart attack or a stroke.
Factors that increase your risk of a blood clot in an artery
It is important to note that the risk of a heart attack or stroke from using
Katya 30/75 coated tablets is very small but can increase:
• with increasing age (beyond about 35 years);
• if you smoke. When using a combined hormonal contraceptive like
Katya 30/75 coated tablets you are advised to stop smoking.
If you are unable to stop smoking and are older than 35 your doctor
may advise you to use a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a member of your immediate family has had a heart attack or stroke
at a young age (less than about 50). In this case you could also have a
higher risk of having a heart attack or stroke;
• if you, or someone in your immediate family, have a high level of fat
in the blood (cholesterol or triglycerides);
• if you get migraines, especially migraines with aura;
• if you have a problem with your heart (valve disorder, disturbance of
the rhythm called atrial fibrillation)
• if you have diabetes.
If you have more than one of these conditions or if any of them are
particularly severe the risk of developing a blood clot may be increased
even more.

If any of the above conditions change while you are using Katya 30/75
coated tablets, for example you start smoking, a close family member
experiences a thrombosis for no known reason; or you gain a lot of
weight, tell your doctor.
Katya 30/75 coated tablets and cancer
Breast cancer has been observed slightly more often in women using
combined pills, but it is not known whether this is caused by the
treatment. For example it may be that more tumours are detected in
women on combined pills because they are examined by their doctor more
often. The occurrence of breast tumours becomes gradually less after
stopping the combination hormonal contraceptives. It is important to
regularly check your breasts and you should contact your doctor if you feel
any lump.
In rare cases, benign liver tumours, and in even fewer cases malignant
liver tumours have been reported in pill users. Contact your doctor if you
have unusual severe abdominal pain.
Bleeding between periods
During the first few months that you are taking Katya 30/75 coated
tablets, you may have unexpected bleeding (bleeding outside the gap
week). If this bleeding continues longer than a few months, or if it begins
after some months, your doctor must investigate the cause.
What you must do if no bleeding occurs in the gap week
If you have taken all the tablets correctly, have not had vomiting or severe
diarrhoea and you have not taken any other medicines, it is highly unlikely
that you are pregnant.
If the expected bleeding does not happen twice in succession, you may be
pregnant. Contact your doctor immediately. Do not start the next strip until
you are sure that you are not pregnant.
Other medicines and Katya 30/75 coated tablets

If you follow either of these two recommendations, you will remain
protected against pregnancy.
• If you have forgotten any of the tablets in a strip, and you do not have
bleeding in the first tablet-free period, this may mean that you are
pregnant. You must contact your doctor before you go on to the next
strip.
Several tablets
forgotten in
1 strip

Ask your doctor for advice

YES
in week 1

NO

Only 1 tablet
forgotten
(taken more
than 12 hours
late)

• Take the forgotten tablet
• Use a barrier method
(condom) for the following
7 days
• And finish strip
in week 2

Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that you are
taking the pill, because oral contraceptives can affect the results of some
tests.
Pregnancy and breast-feeding
If you are pregnant, you must not take Katya 30/75 coated tablets. If you
become pregnant while taking Katya 30/75 coated tablets you must stop
immediately and contact you doctor.
Breast-feeding
Use of Katya 30/75 coated tablets is generally not advisable when a
woman is breast-feeding. If you want to take the pill while you are
breast-feeding you should contact your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
There is no information suggesting that use of Katya 30/75 coated tablets
affects driving or use of machines.
Katya 30/75 coated tablets contain lactose and sucrose.
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE KATYA 30/75 COATED TABLETS
Take one tablet of Katya 30/75 coated tablets every day, if necessary with
a small amount of water. You may take the tablets with or without food,
but you should take the tablets every day around the same time.
The strip contains 21 tablets. Next to each tablet the day of the week is
printed. If, for example you start on a Wednesday, take a tablet with
“WED” next to it. Follow the direction of the arrow on the strip until all 21
tablets have been taken.
Then take no tablets for 7 days. In the course of these 7 tablet-free days
(otherwise called a stop or gap week) bleeding should begin. This
so-called “withdrawal bleeding” usually starts on the 2nd or 3rd day of
the gap week.
On the 8th day after the last Katya 30/75 coated tablets (that is, after the
7-day gap week), start the following strip, even if the bleeding has not
stopped. This means that you should start the following strip on the same
day of the week and that the withdrawal bleed should occur during this time.
If you use Katya 30/75 coated tablets in this manner, you are also
protected against pregnancy during the 7 days that you are not taking a
tablet.
When can you start with the first strip
• If you have not used a contraceptive with hormones in the previous
month.
Begin with Katya 30/75 coated tablets on the first day of the cycle
(that is the first day of your menstruation). If you start Katya 30/75
coated tablets on the first day of your menstruation you are
immediately protected against pregnancy. You may also begin on
day 2-5 of the cycle, but then you must use extra protective
measures (for example, a condom) for the first 7 days.
• Changing from another combined hormonal contraceptive, or
combined contraceptive vaginal ring or patch.
You can start Katya 30/75 coated tablets on the day after the
tablet-free period of your previous pill finishes (or after the last
inactive tablet of your previous pill). When changing from a
combined contraceptive vaginal ring or patch, follow the advice
of your doctor.
• Changing from a preparation containing only a progestogen
(progestogen-only pill, injection, implant or a progestogen-releasing
IUD).
You may switch any day from an injectable when the next injection
would be due from the progestogen-only pill and from an implant or
the IUD on the day of its removal.) But in all of these cases you must
use extra protective measures (for example, a condom) for the first
7 days of tablet-taking.
• After a miscarriage.
Follow the advice of your doctor.
• After having a baby.
After having a baby, you can start with Katya 30/75 coated tablets
between 21 and 28 days later. If you start later than day 28,
you must use a so-called barrier method (for example, a condom)
during the first seven days of Katya 30/75 coated tablets use.
If, after having a baby, you have had intercourse before starting
Katya 30/75 coated tablets (again), you must first be sure that you
are not pregnant otherwise you must wait until the next menstrual
bleed.
Let your doctor advice you in case you are not sure when to start.
• If you are breastfeeding and want to start Katya 30/75 coated
tablets (again) after having a baby.
Katya 30/75 coated tablets should not be used during breast
feeding. Read the section on “Breast feeding”.
If you take more Katya 30/75 coated tablets than you should
There are no reports of serious harmful results of taking too many Katya
30/75 coated tablets.
If you take several tablets at once then you may have symptoms of nausea
or vomiting. Young girls may have bleeding from the vagina.
If you have taken too many Katya 30/75 coated tablets, or you discover
that a child has taken some, ask your doctor or pharmacist for advice.
If you forget to take Katya 30/75 coated tablets
• If you are less than 12 hours late taking a tablet, the protection from
pregnancy is not reduced. Take the tablet as soon as you remember
and then take the following tablets again at the usual time.
• If you are more than 12 hours late taking a tablet, the protection
from pregnancy may be reduced. The greater the number of tablets
that you have forgotten, the greater is the risk that the protection from
pregnancy is reduced.
The risk of incomplete protection against pregnancy is greatest if you
forget a tablet at the beginning or the end of the strip. Therefore, you
should adhere to the following rules (see also the diagram below):
• More than one tablet forgotten in this strip
Contact your doctor.
• One tablet forgotten in week 1
Take the forgotten tablet as soon as you remember, even if that
means that you have to take two tablets at the same time. Take the
tablets again at the usual time and use extra precautions for the
next 7 days, for example, a condom. If you have had intercourse in the
week before the oversight or you have forgotten to start a new strip
after the tablet-free period, you must realize that there is a risk of
pregnancy. In that case, contact your doctor.
• One tablet forgotten in week 2
Take the forgotten tablet as soon as you remember, even if that
means that you have to take two tablets at the same time. Take the
tablets again at the usual time. The protection from pregnancy is not
reduced, and you do not need to take extra precautions.
• One tablet forgotten in week 3
You can choose between two possibilities:
1. Take the forgotten tablet as soon as you remember, even if that
means that you have to take two tablets at the same time. Take the
tablets again at the usual time. Instead of the tablet-free period go
straight on to the next strip.
Most likely, you will have a period (withdrawal bleed) at the end of
the second strip but you may also have spotting or breakthrough
bleeding during the second strip.
2. You can also stop the strip and go directly to the tablet-free period
of 7 days (record the day on which you forgot your tablet). If
you want to start a new strip on your fixed start day, make the
tablet-free period less than 7 days.

• Take the forgotten tablet
and
• Finish the strip
• Take the forgotten tablet
and
• Finish the strip
• Instead of the gap week
• Go straight on to the next
strip

OR

in week 3

• Stop the strip immediately
• Begin the gap week
(not longer than 7 days,
including the forgotten
tablet)
• Then go on to the next
strip

Always tell the doctor, who prescribes Katya 30/75 coated tablets,
which medicines or herbal products you are already using. Also tell any
other doctor or dentist who prescribes another medicine (or the
dispensing pharmacist) that you use Katya 30/75 coated tablets. They
can tell you if you need to take additional contraceptive precautions (for
example condoms) and if so, for how long.
• Some medicines can make Katya 30/75 coated tablets less effective
in preventing pregnancy, or can cause unexpected bleeding.
These include medicines used for the treatment of epilepsy
(e.g. hydantoin, topiramate, felbamate, lamotrigine, primidone,
phenytoin, barbiturates, carbamazepine, oxcarbamazepine) and
tuberculosis (e.g. rifampicin), immunomodulating agents
(ciclosporin), HIV infections (ritonavir) or other infectious diseases
(griseofulvin, ampicillin, tetracycline), and the herbal remedy St.
John’s wort.
• If you want to use herbal products containing St. John’s wort while
you are already using Katya 30/75 coated tablets you should consult
your doctor first.
• Katya 30/75 coated tablets may decrease the efficacy of other
medicines, e.g. medicines containing the immunomodulating agent
ciclosporin, or the anti-epileptic lamotrigine (this could lead to an
increased frequency of seizures).
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.

Had sex in the previous
week before forgetting?

What you must do in the case of vomiting or severe diarrhoea
If you vomit within 3-4 hours of taking a tablet or you have severe
diarrhoea, there is a risk that the active substances in the pill are not fully
absorbed into your body. The situation is similar to if you forget a tablet.
After vomiting or diarrhoea, you must take another tablet from a reserve
strip as soon as possible. If possible take it within 12 hours of when you
normally take your pill. If this is not possible or 12 hours have passed, you
should follow the advice given under “If you forget to take Katya 30/75
coated tablets”.
Delay of menstrual period: what you must know
Even if not recommended, delay of your menstrual period (withdrawal
bleed) is possible. This can be done by going straight on to a new strip of
Katya 30/75 coated tablets instead of the tablet-free period, after the first
strip. You may experience spotting (drops or flecks of blood) or
breakthrough bleeding while using this second strip. After the usual
tablet-free period of 7 days, continue with the following strip.
You might ask your doctor for advice before deciding to delay
your menstrual period.
Change of the first day of your menstrual period: what you must
know
If you take the tablets according to the instructions, then your menstrual
period/withdrawal bleed will begin in the tablet-free week. If you have to
change this day, you do this by making the tablet-free period shorter (but
never longer!). For example, if your tablet-free period begins on a Friday,
and you want to change this to a Tuesday (3 days earlier) you must start a
new strip 3 days earlier than usual. If you make the tablet-free period very
short (for example, for 3 days or less) then it may be that you do not have
any bleeding during this tablet-free period. You may then experience
spotting (droplets or flecks or blood) or breakthrough bleeding.
If you are not sure how to proceed, contact your doctor for advice.
If you want to stop taking Katya 30/75 coated tablets
You can stop taking Katya 30/75 coated tablets whenever you want. If you
do not want to become pregnant, ask your doctor for advice about other
reliable methods of birth control.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Katya 30/75 coated tablets can cause side effects,
although not everybody gets them. If you get any side effect, particularly
if severe and persistent, or have any change to your health that you think
may be due to Katya 30/75 coated tablets, please talk to your doctor.
An increased risk of blood clots in your veins (venous thromboembolism
(VTE)) or blood clots in your arteries (arterial thromboembolism (ATE)) is
present for all women taking combined hormonal contraceptives. For
more detailed information on the different risks from taking combined
hormonal contraceptives please see section 2 “What you need to know
before you use Katya 30/75 coated tablets”.
Common side effects (may affect up to 1 in 10 people):
Headaches, nervousness, poor tolerance of contact lenses, visual
disturbances, nausea, acne, migraine, increase in weight, fluid retentions,
bleeding and spotting between your periods can sometimes occur for the
first few months but this usually stops once your body has adjusted to
Katya 30/75 coated tablets. If it continues, becomes heavy or starts again,
contact your doctor. Absence of or reduced menstruations, sore breasts,
loss of interest in sex, depressive moods, irritability.
Uncommon side effects (may affect up to 1 in 100 people):
Excess of lipids in blood, vomiting, hypertension.
Rare side effects (may affect up to 1 in 1,000 people):
Harmful blood clots in a vein or artery for example:
• in a leg or foot (i.e. DVT), in a lung (i.e. PE), heart attack, stroke,
mini-stroke or temporary stroke-like symptoms, known as a transient
ischaemic attack (TIA), blood clots in the liver, stomach/intestine,
kidneys or eye. The chance of having a blood clot may be higher if you
have any other conditions that increase this risk (See section 2 for
more information on the conditions that increase risk for blood clots
and the symptoms of a blood clot).
Liver disease, skin and subcutaneous tissue disorder (lupus
erythematosus), middle ear disorders, gallstones, pigmentation disorders.
This may happen even if you have been using Katya 30/75 coated tablets
for a number of months. This may be reduced by avoiding too much
sunlight. Changes in vaginal secretion.
Very rare side effects (may affect up to 1 in 10,000 people):
Movement disorders, affection of the pancreas.
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 KATYA 30/75 COATED TABLETS
Do not store above 30 ºC.
Keep out of the reach and sight of children.
Do not use Katya 30/75 coated tablets after the expiry date which is
stated on the blister and carton after EXP.
The expiry date refers to the last day of that month.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Katya 30/75 coated tablets contains
• The active substances:
Katya 30/75 coated tablets: Each tablet contains 30 micrograms
ethinylestradiol and 75 micrograms gestodene
• The other ingredients:
Tablet core: Magnesium stearate, Povidone K-25, Maize starch,
Lactose monohydrate
Tablet coating: Povidone K-90, Macrogol 6000, Talc, Calcium
carbonate, Sucrose, Wax montan glycol
What Katya 30/75 coated tablets looks like and contents of the
pack
Katya 30/75 coated tablets are available as white round, biconvex sugar
coated tablets, and both sides without imprinting.
The pills are supplied in a blister strip - each strip containing 21 tablets.
The blister strips are supplied in a carton box. Each box contains 1, 3 or 6
blister strips.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
STRAGEN UK Ltd
Castle Court
41 London Road
Reigate
Surrey
RH2 9RJ
United Kingdom
Manufacturer
Haupt Pharma Münster GmbH
Scheebrüggenkamp 15
48159 Münster
Germany
This leaflet was last revised in 06/2014