KIPLING 0.075 mg/0.030 mg Tabletka powlekana

Treść ulotki

1. Kipling 75 micrograms/30 micrograms coated tablets
   1. What is Kipling and what is it for?
   2. How to take Kipling
   3. Possible side effects
   4. How to store Kipling
   5. Contents of the pack and other information

Kipling 75 micrograms/30 micrograms coated tablets

gestodene/ethinylestradiol
Generic Medicine

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 blood clots forming in veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks
• Pay attention and consult a doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”)

Read this leaflet carefully before taking this medicinebecause it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Kipling is and what it is used for
• 2. What you need to know before you use Kipling
• 3. How to take Kipling
• 4. Possible side effects
• 5. How to store Kipling
• 6. Contents of the pack and other information

1. What is Kipling and what is it for?

Kipling is a combined oral contraceptive pill and belongs to a group of medicines often called
Pills. Kipling contains two types of hormones: an estrogen, ethinylestradiol, and a progestin, gestodene. These
hormones prevent the ovaries from producing an egg each month (ovulation). In addition, they thicken the fluid (mucus) in
the cervix (cervix), making it more difficult for sperm and eggs to come into contact, and alter the lining
of the uterus to make it more difficult for a fertilized egg to implant. Medical research and extensive experience
have shown that, if taken correctly, the Pill is an effective and reversible method of contraception.
Remember that combined oral contraceptive pills like Kipling do not protect against sexually transmitted diseases (such as AIDS). Only the condom can help protect you.

YOU AND THE PILL
How your body prepares for pregnancy(the menstrual cycle).
Usually you can get pregnant (i.e. conceive) from when you start having periods (this normally happens
during adolescence), until you stop having periods (i.e. when you reach menopause).
Each menstrual cycle lasts about 28 days, and approximately halfway through this cycle one of the ovaries produces an
egg, which passes into one of the two fallopian tubes. This procedure is called ovulation.
The egg descends inside the fallopian tube towards the uterus. When you have sexual intercourse, millions of sperm are released from the
penis of your partner. From the vagina, these sperm pass through the uterus into the
fallopian tubes, and if one of the tubes contains an egg and a sperm reaches it, you may become pregnant.
This process is called ‘conception’.
Once fertilized, the egg implants in the lining of the uterus and grows into a
baby within nine months. Because eggs can live for up to two days, while sperm survive
for up to five days, you can get pregnant by having intercourse up to five days before
ovulation, and for some time after ovulation. If the egg is not fertilized by a
sperm, at the end of the menstrual cycle the body eliminates it together with the lining of the uterus, with
‘menstruation’.

How do natural hormones work?
Your menstrual cycle is controlled by two sex hormones produced by the ovaries: estrogen and progesterone (a
progestin). Estrogen levels rise in the first half of the menstrual cycle and cause the uterus to produce
a thick lining, ready to receive the egg if conception occurs. Progesterone acts later during the menstrual cycle and changes the lining of the uterus to prepare it for pregnancy.
If you do not become pregnant, you will produce less of these hormones and the lining of the uterus will break down. As mentioned
above, the lining of the uterus is eliminated from the body with menstruation. If, on the other hand, you become pregnant, the
ovaries and the placenta (which keeps the fetus connected to the uterus and nourishes it) continue to produce progesterone and
estrogen to prevent the ovaries from secreting other eggs. This means that while you are pregnant you will not be able to
ovulate or have periods.

How does the pill work?
Combined contraceptive pills, like Kipling, contain hormones similar to those produced by your
body (estrogen and progestin). These hormones help you not to get pregnant, just as your natural hormones
prevent you from conceiving again when you are already pregnant.
The combined contraceptive pill protects you from possible pregnancy in three ways.

• 1. There will be no egg available for sperm to fertilize.
• 2. The fluid inside the cervix thickens, making it more difficult for sperm to penetrate.
• 3. The lining of the uterus does not thicken enough to allow the egg to grow.

General Notes
Before starting to use Kipling, you must read the information on blood clots (thrombosis) in paragraph 2.
It is particularly important that you read the symptoms of a blood clot (see paragraph 2 “Blood clots”).

Do not use Kipling
Do not use Kipling if you have any of the conditions listed below. If you have any of the conditions listed below, consult your doctor. The doctor will discuss with you other methods of birth control that may be more
suitable for your case.

• if you have (or have ever had) a blood clot in a leg vein (deep vein thrombosis, DVT), in the lung (pulmonary embolism, PE) or in other organs;
• if you know you have a disorder that affects blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies;
• if you need to undergo surgery or if you will be bedridden for a long period (see paragraph “Blood clots”);
• if you have ever had a heart attack or 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 a transient ischemic attack (TIA - symptoms of a temporary stroke);
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you have one of the following diseases, which may increase the risk of blood clots forming in the arteries:
• severe diabetes with damage to blood vessels
• very high blood pressure
• very high levels of fats (cholesterol or triglycerides) in the blood
• a disease known as hyperhomocysteinemia
• if you have (or have ever had) inflammation of the pancreas (pancreatitis) associated with high levels of lipids in the blood;
• if you have (or have ever had) liver disease and liver function tests have not yet returned to normal;
• if you have or have ever had a liver tumor;
• if you have (or have ever had) a hormone-sensitive tumor (e.g. breast cancer or cancer of the reproductive organs)
• if you have unusual bleeding from the vagina;
• if you are allergic to gestodene or ethinylestradiol or any of the other ingredients of this medicine (listed in paragraph 6)

Do not use Kipling if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and
dasabuvir (see also the paragraph “Other medicines and Kipling”).
If you suffer from any of these conditions while taking Kipling, stop taking the pills and contact your doctor immediately.
In the meantime, use another method of contraception, such as a condom or diaphragm with a spermicide.

Warnings and Precautions
When should you see a doctor?
Seek urgent medical attention

• if you notice possible signs of a blood clot that may indicate you have a blood clot in the leg (deep vein thrombosis), a blood clot in the lung (pulmonary embolism), a heart attack or a stroke (see the following section "Blood clots").

For a description of the symptoms of these serious side effects, go to the paragraph “How to recognize a blood
clot”.

Regular Checks
Before starting to take Kipling, your doctor will need to ask you about your medical history, asking you some questions
about you and other members of your family. In addition, the doctor will measure your blood pressure and rule out that you are
pregnant. The doctor may also give you a check-up. Once you have started taking Kipling, you will need to see
your doctor again for regular check-ups, which will take place when you visit the doctor to request further
packs of pills.

Tell your doctor if any of the following conditions apply to you.
If this condition appears or worsens while you are using Kipling, you should tell your doctor.
The doctor may ask you to stop using Kipling and advise you on another method of contraception.

• if you have high levels of fats in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you have systemic lupus erythematosus (SLE, a disease that affects the body's defense system);
• if you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure);
• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have sickle cell anemia (an inherited red blood cell disease);
• if you need to undergo surgery or if you will be bedridden for a long period (see paragraph 2 “Blood clots”);
• if you have just given birth, your risk of developing blood clots is higher. Ask your doctor how long after childbirth you can start taking Kipling;
• if you have inflammation of the veins in the skin (superficial thrombophlebitis);
• if you have varicose veins.

If you suffer from:

• high blood pressure (hypertension);
• jaundice (yellowing of the skin);
• itching all over the body;
• gallstones;
• an inherited disease called porphyria;
• a movement disorder called Sydenham's chorea;
• the skin rash called herpes gestationis;
• an inherited form of deafness called otosclerosis;
• liver dysfunction;
• diabetes;
• depression or mood changes;
• dark spots on the face and body (chloasma), which can be alleviated by not exposing yourself to the sun and not using sunbeds or sun lamps.

BLOOD CLOTS
The use of a combined hormonal contraceptive like Kipling causes an increased risk of developing a
blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause
serious problems.
Blood clots can develop

• in the veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE);
• in the arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, there may be serious long-term effects or, very rarely, such effects may be fatal.

It is important to remember that the overall risk of a harmful blood clot associated with KIPLING is low.
HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical attention if you notice any of the following signs or symptoms.

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been linked to an increased risk of blood clots in the veins (venous thrombosis). However, these side effects are rare. In most cases, they occur in the first year of using a combined hormonal contraceptive.

If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).

• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• Very rarely, the clot can form 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 first-time use of a combined hormonal contraceptive. The risk may also be higher if you restart a combined hormonal contraceptive (the same medicine or a different medicine) after a break of 4 or more weeks.
After the first year, the risk decreases but is still slightly higher than the risk if you were not using a combined hormonal contraceptive.
When you stop taking Kipling, the risk of developing a blood clot returns to normal levels 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 developing a blood clot in the leg or lung (DVT or PE) with KIPLING is low.

• Out of 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone or norgestimate, about 5-7 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive containing gestodene, such as KIPLING, about 9-12 will develop a blood clot in a year.
• The risk of a blood clot forming depends on your medical history (see below “Factors that increase the risk of a blood clot”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with Kipling is low but some conditions increase it. Your risk is higher:

• if you are strongly overweight (body mass index or BMI greater than 30 kg/m2);
• if a close relative has had a blood clot in a leg, lung or other organ at a young age (under about 50 years). In this case you may have an inherited blood clotting disorder;
• if you are going to have surgery or if you have to lie down for a long period due to an injury or illness or if you have a leg in plaster. You may need to stop taking Kipling a few weeks before surgery or during the time you are less mobile. If you need to stop taking Kipling, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years);
• if you have given birth less than a few weeks ago. The risk of developing a blood clot increases when you have more than one of these conditions. Air travel (duration >4 hours) can temporarily increase the risk of a blood clot forming, especially if you have some of the other risk factors listed.

It is important that you tell your doctor if any of these conditions apply to you, even if you are not sure. Your doctor may decide to stop you from taking Kipling
If any of the above conditions change while you are using Kipling, for example if a close relative develops a thrombosis for no known reason or if you gain a lot of weight, contact your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like blood clots in a vein, clots in an artery can cause serious problems, for example, they can cause a heart attack or stroke.

Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of Kipling is very low but can increase:

• as you get older (over 35 years);
• if you smoke.When you use a combined hormonal contraceptive like Kipling, it is advisable to quit smoking. If you cannot quit smoking and you are over 35 years old, your doctor may advise you to use a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under about 50 years). In this case you may also be at high risk of heart attack or stroke;
• if you, or a close relative, have high levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valve defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions or if one of them is particularly severe, the risk of developing a blood clot may be even higher.
If any of the above conditions change while you are using Kipling, for example if you start smoking, if a close relative develops a thrombosis for no known reason or if you gain a lot of weight, contact your doctor.

The pill and cancer
Some studies have found a possible increased risk of cervical cancer with long-term use of the pill. This increased risk may not be due to the pill, but rather to the effects of sexual behavior and other circumstances. The most important risk factor for cervical cancer is infection with the human papillomavirus (HPV).
All women are at risk of breast cancer, even if they do not take the pill. This cancer rarely affects women under 40 years of age, and has been found to a slightly greater extent in women who take the pill compared to their peers who do not use the pill. If you stop the pill this risk decreases, and after 10 years of stopping the pill the incidence of breast cancer is the same among women who took the pill and those who never took it. Because breast cancer is rare in women under 40 years of age, the increase in the number of cases diagnosed of breast cancer in women who take the pill and who have taken it in the past is low compared to the risk of developing breast cancer over a lifetime.
In rare cases, the use of the pill has led to liver diseases, such as jaundice and benign liver tumors. In very rare cases, the pill has been associated with some forms of malignant liver tumors (cancer) in women who use it for a long time. Liver tumors can cause bleeding into the abdomen (bleeding in the abdomen) potentially fatal. If you experience pain in the upper abdomen that does not improve quickly, tell your doctor. Also see a doctor if you notice yellowing of the skin (jaundice).

Psychiatric disorders
Some women who use hormonal contraceptives including Kipling have reported depression or depressed mood. Depression can be severe and sometimes can lead to suicidal thoughts. If you experience changes in mood and depressive symptoms, see your doctor as soon as possible for further medical advice.

Migraine/headache
Tell your doctor immediately if your migraine worsens or is recurrent, persistent, or if you develop a severe headache (see also section 2 “Blood clots”).

Immune system disorders
Kipling may induce or worsen symptoms of angioedema (sudden swelling of the face, tongue and trachea which can cause difficulty breathing and swallowing). The risk is higher if you or your close relatives have had angioedema.

Other medicines and Kipling
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Also tell your doctor or dentist, who prescribes you other medicines, that you are taking Kipling. They may tell you if you need to use additional contraceptive precautions (for example condoms) and if so, for how long, or if you need to change the use of other medicines.
Do not use Kipling if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, as this may cause an increase in laboratory test results concerning liver function (increased ALT).
Your doctor will prescribe you another type of contraceptive before starting treatment with these medicines.
Kipling can be restarted about 2 weeks after the end of treatment with these medicines.
See the section “Do not use Kipling”.
Some medicines can affect the levels of Kipling in the blood and can make Kipling less effective in preventing pregnancy, or can cause unexpected bleeding. These include medicines used for the treatment of:

• epilepsy (e.g. barbiturates, carbamazepine, phenytoin, primidone, felbamate, oxcarbazepine, topiramate);
• tuberculosis (e.g. rifampicin);
• HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz);
• fungal infections (e.g. griseofulvin);
• medicines used for the treatment of pulmonary hypertension (bosentan) arthritis, osteoarthritis (etoricoxib) The herbal remedy St John's Wort. If you want to use herbal products containing St John's Wort while already using Kipling, consult your doctor first.

Kipling can affect the effectiveness of other medicines, e.g.:

• cyclosporine (a medicine used for the treatment of rejection suppression following transplantation);
• theophylline (a medicine for the treatment of asthma);
• lamotrigine (a medicine for the treatment of epilepsy - this can lead to an increase in the frequency of seizures);
• tizanidine (a medicine used for the treatment of pain and/or muscle cramps);

Ask your doctor or pharmacist before taking any medicine.

Before undergoing any laboratory tests
Tell your doctor or laboratory personnel that you are taking an oral contraceptive, because oral contraceptives can affect the results of some tests.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
If you suspect you are pregnant, stop taking Kipling and see your doctor immediately. Until you talk to your doctor, use a different method of contraception, such as a condom or diaphragm plus a spermicide. Ask your doctor or pharmacist for advice before taking any medicine.

Breastfeeding
Ask your doctor or pharmacist before taking Kipling. Do not take Kipling while breastfeeding your baby.

Driving and using machines
The effects of Kipling on the ability to drive or operate machinery have not been studied.

Kipling contains lactose and sucrose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Kipling

Take this medicine following the doctor's instructions exactly. If you have any doubts, consult your doctor.
This pack is designed to help you remember to take the pills.

How to start the first pack
Take the first pill on the first day of your period. This is the first day of your menstrual period, i.e. when
bleeding begins. If you start taking the pill between the 2nd and 5th day of your cycle, also use another
contraceptive method, such as a condom, for the first 7 days of using the pill. However, this only applies to the first
pack. You can take the pill at any time, but you should do so at more or less the same time each
day. It may be easier to take it before going to bed, or when you wake up in the morning. Take one
pill every day, following the order indicated on the pack, until you have finished the entire pack of 21 pills.
After taking all 21 pills, stop for seven days. You will probably have some bleeding during some of these seven days.
You do not need to use other contraceptive methods during the 7 days when you are not taking the pill, as long as
the 21 pills have been taken correctly and you start the next pack without delay.

Switching to the next pack
After seven days without taking any pills, start the next pack. Do this even if the
bleeding has not yet ended. You should always start a new pack on the same day of the
week.

How to switch to Kipling from another combined hormonal contraceptive
Start taking Kipling the day after the end of the pill-free period of your previous
contraceptive (or after the last inactive pill of your previous contraceptive).

How to switch to Kipling from a progestin-only product (progestin-only pills, injection,

implant)
You can switch from a progestin-only pill at any time, but you must use additional protective measures (for example, a condom) for the first 7 days of taking it.
If you have had an injection, an implant, or a intrauterine device inserted, you can start taking Kipling on the day scheduled for the next injection, or on the day your implant or intrauterine system
is removed, but in all these cases you must use additional contraceptive measures (for example, a
condom) for the first 7 days of taking it.

How to start after childbirth, or after a spontaneous or surgical abortion
After childbirth or after a surgical or spontaneous abortion, your doctor will advise on the suitability of using
the pill.
You can start taking Kipling immediately after a spontaneous or surgical abortion that occurs in the first
trimester of pregnancy. In this case, you do not need to take any further contraceptive measures. In the event of childbirth or
abortion in the second trimester of pregnancy, Kipling can be started 21-28 days after childbirth or abortion.
While breastfeeding, it is not recommended to take a combined pill, as it may reduce milk production. Use
a different contraceptive method (such as a condom) for the first 7 days while taking the pill. If you have
had unprotected intercourse, do not start taking Kipling until the start of your menstrual cycle, or until pregnancy can be ruled out. If you have any doubts about using Kipling after childbirth or after an abortion, consult
your doctor or pharmacist.

If you take more Kipling than you should
If you take more Kipling than you should, it is unlikely to harm you, however you may experience nausea,
vomiting or vaginal bleeding. If you experience any of these symptoms, talk to your doctor, who may
advise you whether anything needs to be done.

If you forget to take Kipling
If you forget to take a pill, follow these instructions.
If you forgot to take the pill at the usual time and less than 12 hourshave passed, take it as soon as you remember. Then continue taking the pills at the usual time.
If you forgot to take the pill at the usual time and more than 12 hourshave passed, or if you forgot to take
more than one pill, the contraceptive protection may be reduced. Take the forgotten pill as soon as you remember, even if this means taking two pills in one day. Then continue
taking the pills at the usual time. In addition, a non-hormonal contraceptive method should be
used for the next 7 days (e.g. condoms or a cervical cap with spermicide).
If you take the last pill from the blister during this 7-day period, you should start taking
pills from a new blister as soon as the current pack is finished; no interval should be left between
the blisters. You are unlikely to have withdrawal bleeding during the second pack, but you may experience spotting or breakthrough bleeding. If you do not have a
withdrawal bleed after the second pack, talk to your doctor. The possibility of
pregnancy must be ruled out before taking Kipling again.

If you stop taking Kipling
If you stop taking Kipling, you may become pregnant. Discuss other contraceptive methods with your doctor to
avoid pregnancy.

What to do in case of vomiting or diarrhea
If you experience vomiting or diarrhea within 3-4 hours of taking the pill, the active ingredients it contains may not
be fully absorbed by the body. In this case, follow the above advice regarding
forgotten pills. In case of vomiting or diarrhea, use additional contraceptive precautions, such as a condom, for all intercourse while you have an upset stomach, and for the next seven days.

What to do if you want to delay or move your periods
If you want to delay or move your menstrual cycle, contact your doctor for advice.

If you want to delay your periods
Continue with the next pack of Kipling after taking the last pill in the current
pack, without any breaks. You can take as many pills as you want from the next pack, up to the end of the second blister. When using the second pack, you may notice
metrorrhagia or some spotting. At the end of the usual 7-day break, you
restart taking Kipling as usual.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think could be due to KIPLING, inform your doctor.
A higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) is present in all women who take combined hormonal contraceptives. For more detailed information on the different risks associated with taking combined hormonal contraceptives, see paragraph 2 “What you need to know before using Kipling”.
The following side effects are related to the use of Kipling.
Very commonside effects (may affect more than 1 in 10 people):
Headache, irregular bleeding and spotting between periods.
Commonside effects (may affect up to 1 in 10 people):
Vaginitis, fungal infections of the vagina, mood changes including depression and nervousness, dizziness, nausea,
upper abdominal pain, acne, painful menstruation, changes in vaginal secretion, absence of
menstruation, weight gain; breast tension, breast pain, breast secretion.
Uncommonside effects (may affect up to 1 in 100 people):
Migraine, fluid retention, altered appetite (increased or decreased), increased blood
pressure, vomiting, diarrhea, skin rashes, urticaria, chloasma (brownish-yellowish spots on the skin), excessive
hair growth, hair loss, changes in serum lipid levels including hypertriglyceridemia,
change in sexual interest (reduced libido).
Rareside effects (may affect up to 1 in 1,000 people):
Anaphylactic reactions (reactions, with very rare cases of urticaria, swelling of the face and tongue, severe circulatory and respiratory disorders), glucose intolerance, jaundice, eye irritation during the use of contact lenses, ear and labyrinth disorders, various skin diseases (such as erythema multiforme, characterized by
skin rashes, including target-like lesions, and sores), erythema nodosum, characterized by reddish and
painful skin nodules, reduction in blood folate levels, other gastrointestinal tract diseases, change
in sexual interest (increased libido).
Dangerous blood clots in the veins or arteries, for example:

• in a leg or foot (e.g. DVT)
• in a lung (e.g. PE)
• heart attack,
• stroke,
• mini-stroke or temporary stroke-like symptoms, known as a transient ischemic attack (TIA)
• blood clots in the liver, stomach/intestines, kidneys or eyes. The likelihood of having a blood clot may be higher if you have any other condition that increases the risk of blood clots (see paragraph 2 for more information on conditions that increase the risk of blood clots and the associated symptoms of blood clots

Very rareside effects (may affect up to 1 in 10,000 people):
Benign or malignant liver tumors, worsening of varicose veins, exacerbation of systemic lupus erythematosus – SLE (a disorder in which blood clots cause kidney failure), exacerbation of
porphyria, exacerbation of chorea (a condition characterized by involuntary movements), inflammation of the optic
nerve, blood clots in the eye vessels, weight loss, pancreatitis (inflammation of the pancreas), inflammatory bowel diseases (Crohn's disease, ulcerative colitis), gallbladder disorders, gallstones, a blood
condition called hemolytic uremic syndrome HUS (a disorder in which blood clots cause
kidney failure).

Not known( frequency cannot be estimated from available data):
Liver damage (such as hepatitis, abnormal liver function).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or
pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Kipling

Keep Kipling out of sight and reach of children.
Store at a temperature below 25° C. Store in the original packaging in order to protect from light and
humidity
Do not use this medicine after the expiry date which is reported on the pack after the abbreviation Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in the wastewater or household waste. Ask your pharmacist how to eliminate the
medicines that you no longer use. This will help to protect the environment.

6. Contents of the pack and other information

What Kipling contains
The active ingredients are: 75 micrograms of gestodene and 30 micrograms of ethinylestradiol in each film-coated tablet.
The excipients are: Tablet core: Calcium edetate disodium, Magnesium stearate, Colloidal anhydrous silica,
Povidone K-30, Corn starch, Lactose monohydrate Tablet coating: Quinoline Yellow
(E104), Povidone K-90, Titanium dioxide (E171), Macrogol 6000, Talc, Calcium carbonate (E170), Sucrose

Description of Kipling and contents of the pack
Yellow, round, biconvex, sugar-coated tablets, without imprinting. Packaging:
Blisters: PVC/PVDC/aluminium. Blisters: PVC/PVDC/aluminium in PETP/aluminium/PE pouch. Pack sizes:
1 x 21 tablets; 3 x 21 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Gedeon Richter Plc.
Gyömrői út 19-21.
1103 Budapest, Hungary

Manufacturer:
Gedeon Richter Plc. Gyömroi út 19-21. Budapest 1103 Hungary