Kipling

Package leaflet: Information for the user

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 when used correctly.
• They slightly increase the risk of developing blood clots 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.
• Be alert and contact your doctor if you think you have symptoms of a blood clot (see section 2 "Blood clots").

Read all of this leaflet carefully before taking this medicine
because 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 give it to others; it could be harmful to them.
• If you experience any side effect, including those not listed in this leaflet, talk to 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 using 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 Kipling is and what it is used for

Kipling is a combined oral contraceptive pill and belongs to a group of medicines commonly referred to as
"the Pill". Kipling contains two types of hormones: an oestrogen, ethinylestradiol, and a progestogen, gestodene. These
hormones prevent the ovaries from releasing an egg each month (ovulation). In addition, they thicken the fluid (mucus) in
the neck of the womb (cervix), making it more difficult for sperm to reach the egg, and they alter the lining
of the uterus to make it harder for a fertilised egg to implant. Medical research and extensive experience
have shown that, when taken correctly, the Pill is an effective and reversible method of contraception.
Please remember that combined oral contraceptive pills such as Kipling do not protect against sexually transmitted
diseases (such as AIDS). Only a condom can help protect you.
YOU AND THE PILL
How your body prepares for pregnancy (the menstrual cycle).
Typically, you can become pregnant (i.e. conceive) from the time you begin having menstrual periods (which normally occurs
during adolescence), until you no longer have periods (i.e. when you enter menopause).
Each menstrual cycle lasts approximately 28 days, and roughly halfway through this cycle, one of the ovaries releases an
egg, which passes into one of the two fallopian tubes. This process is called ovulation.
The egg travels down the fallopian tube towards the uterus. When you have sexual intercourse, millions of sperm are released from
your partner's penis. 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 can become pregnant.
This process is known as 'conception'.
Once fertilised, the egg implants into the lining of the uterus and over the course of nine months develops into a
baby. Since eggs can survive up to a maximum of two days, while sperm can survive up to five days, you can become pregnant from sexual intercourse up to five days before
ovulation, and for a short time after ovulation. If the egg is not fertilised by a
sperm, at the end of the menstrual cycle your body sheds it along with the lining of the uterus, resulting in
your 'period'.
How do natural hormones work?
Your menstrual cycle is regulated by two sex hormones produced by the ovaries: oestrogen and progesterone (a
progestogen). Oestrogen levels rise during the first half of the menstrual cycle and cause the uterus to develop
a thick lining, ready to receive the egg in case of conception. Progesterone acts later in the menstrual cycle and changes the lining of the uterus to prepare it for pregnancy.
If you do not become pregnant, your body produces less of these hormones and the uterine lining breaks down. As mentioned
above, the uterine lining is expelled from the body during menstruation. If, however, you become pregnant, the
ovaries and the placenta (which connects the foetus to the uterus and nourishes it) continue to produce progesterone and
oestrogen to prevent the ovaries from releasing further eggs. This means that while you are pregnant, you will not
ovulate or have menstrual periods.
How does the Pill work?
Combined oral contraceptives, such as Kipling, contain hormones similar to those naturally produced in your
body (oestrogen and progestogen). These hormones help prevent pregnancy, just as your natural hormones
prevent you from conceiving again while you are already pregnant.
The combined oral contraceptive protects you from pregnancy in three ways:

1. There will be no egg available for fertilisation by sperm.
2. The fluid in the neck of the womb thickens, making it harder for sperm to penetrate.
3. The lining of the uterus does not thicken sufficiently to allow the fertilised egg to grow.

2.
General Notes
Before starting to use Kipling, you must read the information about blood clots (thrombosis) in section 2.
It is particularly important that you read about the symptoms of a blood clot (see section 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. Your doctor will discuss with you other birth control methods that may be more suitable for you.

• if you have (or have ever had) a blood clot in a blood vessel of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs;
• if you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are due to undergo surgery or will be bedridden for a prolonged period (see section “Blood clots”);
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain and which may be an early sign of a heart attack) or a transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you have (or have ever had) any of the following conditions, which may increase the risk of blood clots forming in the arteries:
  • severe diabetes with blood vessel damage
  • very high blood pressure
  • very high levels of fats (cholesterol or triglycerides) in the blood
  • a condition known as hyperhomocysteinaemia
• if you have (or have ever had) inflammation of the pancreas (pancreatitis) associated with high lipid levels 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 tumour;
• if you have (or have ever had) a hormone-sensitive tumour (e.g. breast cancer or reproductive organ cancer);
• if you have unusual vaginal bleeding;
• if you are allergic to gestodene or ethinylestradiol or to any of the other ingredients of this medicine (listed in section 6).

Do not use Kipling if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir,
dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (also see section “Other
medicines and Kipling”).
If you develop any of these conditions while taking Kipling, stop taking the pills immediately and contact your doctor
without delay. In the meantime, use another contraceptive method, such as a condom or diaphragm plus a
spermicide.
Warnings and Precautions
When should you contact a doctor?
Contact a doctor urgently

• if you notice possible signs of a blood clot, which may indicate that you have a blood clot in the leg (deep vein thrombosis), 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, refer to the section “How to recognise a blood clot”.
Regular checks
Before starting Kipling, your doctor will need to take your medical history, asking you some questions about yourself and other members of your family. In addition, your doctor will measure your blood pressure and rule out pregnancy. Your doctor may also perform a physical examination. Once you have started taking Kipling, you should return to your doctor for regular check-ups, which can be scheduled when you visit for further supplies of pills.
Inform your doctor if any of the following conditions apply to you.
If any of these conditions develop or worsen while you are using Kipling, inform your doctor.
Your doctor may advise you to stop using Kipling and recommend another contraceptive method.

• If you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with possible breathing difficulties, contact your doctor immediately. Medicinal products containing oestrogens may cause or worsen symptoms of hereditary and acquired angioedema.
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you have systemic lupus erythematosus (SLE, a disease affecting the body's natural defence system);
• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have sickle cell anaemia (a hereditary red blood cell disorder);
• if you are due to undergo surgery or will be bedridden for a prolonged period (see section 2 “Blood clots”);
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking Kipling;
• if you have inflammation of veins near the skin surface (superficial thrombophlebitis);
• if you have varicose veins.

If you suffer from:

• high blood pressure (hypertension);
• yellowing of the skin (jaundice);
• itching all over the body;
• gallstones;
• a hereditary condition called porphyria;
• a movement disorder called Sydenham’s chorea;
• a skin rash called herpes gestationis;
• hereditary hearing loss called otosclerosis;
• disorders of liver function;
• diabetes;
• depression or mood changes;
• dark patches on the face and body (chloasma), which may be reduced by avoiding sun exposure and not using sunbeds or sunlamps.

BLOOD CLOTS
Using a combined hormonal contraceptive such as Kipling increases the risk of developing a
blood clot compared to not using one. In rare cases, a blood clot can block blood vessels and cause
serious problems.
Blood clots can develop

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

Recovery from blood clots is not always complete. Rarely, serious long-term effects may occur, and 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 RECOGNISE A BLOOD CLOT
Contact a doctor immediately 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 associated with an increased risk of developing blood clots in veins (venous thrombosis). However, these side effects are rare. In most cases, they occur during the first year of using a combined hormonal contraceptive. If a blood clot forms in a vein of the leg or foot, it can cause 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 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 when restarting a combined hormonal contraceptive (the same or a different drug) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than 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 individual baseline risk of venous thromboembolism (VTE) and the type of combined hormonal contraceptive you are using.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with KIPLING is low.

• Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing gestodene, such as KIPLING, about 9–12 will develop a blood clot in one year.
• The likelihood of developing a blood clot depends on your medical history (see below “Factors that increase the risk of developing 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 certain conditions can increase this risk. Your risk is higher:

• if you are very overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in a leg, lung, or another organ at a young age (under approximately 50 years). In this case, you might have an inherited blood clotting disorder;
• if you are due to have surgery or need to remain bedridden for a long time due to injury or illness, or if you have a leg in plaster. You may need to stop taking Kipling several weeks before surgery or during periods of reduced mobility. 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 (lasting >4 hours) may temporarily increase the risk of blood clots forming, especially if you have some of the other risk factors listed.

It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide to stop your use of Kipling.
If any of the above conditions change while you are using Kipling—for example, if a close relative develops thrombosis without a known cause or if you gain significant 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 may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Kipling, it is advisable to stop smoking. If you cannot stop smoking and you are over 35 years old, your doctor may recommend using 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 approximately 50 years). In this case, you may also have an increased 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 (valvular 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 thrombosis without a known cause, or if you gain significant 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 itself, but rather to the effects of sexual behavior and other circumstances. The most important risk factor for cervical cancer is infection with 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 occur slightly more frequently in women who take the pill compared to those of the same age who do not use the pill. If you stop taking the pill, this risk decreases, and after 10 years from stopping the pill, the incidence of breast cancer is the same among women who took the pill and those who never used it. Since breast cancer is rare in women under 40 years, the increase in the number of diagnosed cases of breast cancer among women who take or have taken the pill is low compared to the lifetime risk of developing breast cancer.

In rare cases, 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 certain forms of malignant liver tumors (cancer) in women who use it for a long time. Liver tumors can cause intra-abdominal bleeding (bleeding in the abdomen), which may be fatal. If you experience pain in the upper part of your abdomen that does not improve quickly, inform your doctor. Also consult your doctor if you notice yellowing of the skin (jaundice).

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

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

Children and adolescents
Kipling is not indicated before menarche (the first menstrual bleeding).

Other medicines and Kipling
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Also inform the doctor or dentist who prescribes other medicines that you are taking Kipling. They can advise you whether you need to use additional contraceptive precautions (e.g., condoms) and, if so, for how long, or whether you need to adjust the use of other medicines.

Do not use Kipling if you have hepatitis C and are taking medications containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medicines can cause increases in blood test results related to liver function (increase in liver enzyme ALT). Your doctor will prescribe another type of contraceptive before starting treatment with these medicines.
Kipling can be restarted approximately 2 weeks after completing treatment with these medicines.
See section “Do not use Kipling.”

Some medicines can affect the plasma levels of Kipling and may make Kipling less effective in preventing pregnancy, or may cause unexpected bleeding. These include medicines used to treat:

• 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 to treat pulmonary arterial hypertension (bosentan), arthritis, osteoarthritis (etoricoxib), and the herbal remedy St. John’s wort. If you wish to use herbal products containing St. John’s wort while already using Kipling, consult your doctor first.

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

• cyclosporine (a medicine used to treat tissue transplant rejection);
• theophylline (a medicine used to treat asthma);
• lamotrigine (a medicine used to treat epilepsy—which may lead to an increase in seizure frequency);
• tizanidine (a medicine used to treat pain and/or muscle cramps).

Ask your doctor or pharmacist for advice before taking any medicine.

Before undergoing any laboratory tests
Inform your doctor or laboratory staff that you are taking an oral contraceptive, as oral contraceptives may affect the results of certain tests.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
If you suspect you are pregnant, stop taking Kipling and contact your doctor immediately. Until you speak with your doctor, use a different contraceptive method such as condoms or a diaphragm with spermicide. Consult your doctor or pharmacist before taking any medicine.

Breastfeeding
Consult 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 vehicles or operate machinery have not been studied.

Kipling contains lactose, sucrose, and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free.”

3. How to take Kipling

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.
This pack is designed to help you remember to take your pills.

Starting the first pack
Take the first pill on the first day of your menstrual period. This is the first day of menstruation, i.e. when
bleeding begins. If you start taking the pill between the 2nd and 5th day of your cycle, also use a second method
of contraception, such as a condom, during the first 7 days of pill use. However, this applies only to the first
pack. You may take the pill at any time, but you should do so at approximately 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 finish the entire pack of 21 pills.
After taking all 21 pills, stop for seven days. During some of these seven days, you will likely experience
bleeding. You do not need to use any other contraceptive methods during the 7 days when you are not taking
the pill, provided that all 21 pills have been taken correctly and you start the next pack without delay.

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

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

Switching to Kipling from a progestogen-only product (progestogen-only pills, injection, implant)
You may switch from a progestogen-only pill at any time, but you must use additional contraceptive measures
(e.g. a condom) during the first 7 days of taking Kipling.
If you have received an injection, had an implant, or had an intrauterine device inserted, you may start taking
Kipling on the day when the next injection is due, or on the day when your implant or intrauterine system is
removed. However, in all these cases, you must use additional contraceptive methods (e.g. a condom) during
the first 7 days of taking Kipling.

Starting after childbirth, or after a spontaneous or surgical abortion
After childbirth or after a surgical or spontaneous abortion, your doctor will advise you on whether it is suitable
to use the pill.
You may start taking Kipling immediately after a spontaneous or surgical abortion occurring in the first
trimester of pregnancy. In this case, no additional contraceptive measures are needed. In the case of childbirth or
abortion in the second trimester of pregnancy, Kipling may be started 21–28 days after childbirth or abortion.
Combined oral contraceptives are not recommended during breastfeeding, as they may reduce milk production.
Use a different contraceptive method (such as a condom) during the first 7 days of taking the pill. If you have had
unprotected intercourse, do not start taking Kipling until the beginning 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, but you may experience nausea, vomiting, or
vaginal bleeding. If you have any of these symptoms, speak to your doctor, who may advise you on whether any
action is needed.

If you forget to take Kipling
If you forget to take a pill, follow the instructions below.
If you have forgotten to take the tablet at your usual time and less than 12 hours have passed, take it as soon
as you remember. Then continue taking the tablets at your usual time.
If you have forgotten to take the tablet at your usual time and more than 12 hours have passed, or if you have
forgotten to take more than one tablet, contraceptive protection may be reduced. Take the last missed tablet
as soon as you remember, even if this means taking two tablets in one day. Then continue taking the tablets at
your usual time. In addition, a non-hormonal contraceptive method must be used for the next 7 days (e.g.
condoms or a diaphragm with spermicide).
If you take the last tablet from the blister during this 7-day period, you should start taking tablets from a new
blister immediately after finishing the current pack; no break should be left between blisters. It is unlikely that you
will have a withdrawal bleed during the second pack, but you may experience spotting or breakthrough bleeding.
If you do not have a withdrawal bleed after the second pack, speak to your doctor. Pregnancy must be ruled
out before restarting Kipling.

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 diarrhoea
If you vomit or have diarrhoea within 3–4 hours of taking the pill, the active ingredients may not be fully absorbed
by your body. In this case, follow the above advice regarding missed tablets. In case of vomiting or diarrhoea, use
additional contraceptive precautions, such as condoms, for all sexual intercourse during the illness and for the
following 7 days.

What to do if you wish to delay or shift your menstruation
If you wish to delay or shift your menstrual period, contact your doctor for advice.

If you wish to delay your period
Continue with the next pack of Kipling immediately after taking the last tablet in the current pack, without any
interruption. You may take as many tablets as desired from the next pack, up to the end of the second blister.
While taking the second pack, you may notice breakthrough bleeding or spotting. After completing the usual
7-day tablet-free interval, resume taking Kipling in the normal way.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets 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.
Contact your doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with potential breathing difficulties (see also section “Warnings and precautions”).
An increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) exists in all women taking combined hormonal contraceptives. For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before using Kipling”.

The following side effects are associated with the use of Kipling.

Very common side effects (may affect more than 1 in 10 people):
Headache, irregular bleeding and spotting between periods.

Common side 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 discharge, absence of menstruation, weight gain; breast tenderness, breast pain, breast discharge.

Uncommon side effects (may affect up to 1 in 100 people):
Migraine, fluid retention, changes in appetite (increased or decreased), increased blood pressure, vomiting, diarrhoea, skin rashes, urticaria, chloasma (yellowish-brown patches on the skin), excessive hair growth, hair loss, changes in serum lipid levels including hypertriglyceridaemia, changes in sexual interest (reduced libido).

Rare side 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 problems), glucose intolerance, jaundice, eye irritation during contact lens use, general ear and labyrinth disorders, various skin diseases (such as erythema multiforme, characterised by skin eruptions, including target-like lesions, and sores), erythema nodosum, characterised by red, painful skin nodules, decreased levels of folate in the blood, other gastrointestinal tract disorders, change in sexual interest (increased libido).

Dangerous blood clots in 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 transient ischaemic attack (TIA)
• blood clots in the liver, stomach/intestine, kidneys or eyes.
  The likelihood of developing a blood clot may be higher if you have any other condition that increases the risk of blood clots (see section 2 for more information on conditions that increase the risk of blood clots and associated symptoms).

Very rare side effects (may affect up to 1 in 10,000 people):
Benign or malignant liver tumours, 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 characterised by involuntary movements), optic neuritis, blood clots in ocular blood vessels, weight loss, pancreatitis (inflammation of the pancreas), inflammatory bowel diseases (Crohn’s disease, ulcerative colitis), gallbladder disorders, gallstones, a blood disorder called haemolytic uraemic syndrome (HUS) (a disorder in which blood clots cause kidney failure).

Not known (frequency cannot be estimated from the 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, talk to your doctor or pharmacist. You can also report side effects directly via 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 the sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from light and
moisture.
Do not use this medicine after the expiry date stated on the carton after the abbreviation "Exp".
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Kipling contains
The active substances are: 75 micrograms of gestodene and 30 micrograms of ethinylestradiol in each coated tablet.
The excipients are:
Tablet core: Sodium calcium edetate, magnesium stearate, anhydrous colloidal silica, povidone K-30, maize starch, lactose monohydrate
Tablet coating: Quinoline yellow (E 104), povidone K-90, titanium dioxide (E 171), macrogol 6000, talc, calcium carbonate (E 170), sucrose

Description of the appearance of Kipling and package contents
Yellow, round, biconvex sugar-coated tablets without imprint.
Packaging: Blister: PVC/PVDC/aluminium. Blister: 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 and Manufacturer:
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest, Hungary

Marketing Authorisation Holder and Distributor:
Exeltis Italia s.r.l.
Via Lombardia 2/a
20068 Peschiera Borromeo (MI)
Italy