Kelsee

Package leaflet: Information for the user

KELSEE 2 mg/0.02 mg prolonged-release tablets

dienogest / ethinylestradiol
Please 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Important information 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 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”).

Contents of this leaflet

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

1. What KELSEE is and what it is used for

KELSEE is a combined oral contraceptive pill and is used to prevent pregnancy.
Each of the 24 pale white tablets contains a small amount of two different female hormones, called dienogest and ethinylestradiol. The 4 green tablets do not contain any active substances and are called placebo tablets.
Oral contraceptives containing two hormones are known as "combined pills".

2. What you should know before taking KELSEE

General information
Before starting to use KELSEE, you must read the information about blood clots in paragraph 2. It is particularly important that you read about the symptoms of a blood clot – see paragraph 2 “Blood clots”.
Before you can start taking KELSEE, your doctor will ask you some questions about your personal medical history and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your personal situation, may carry out other examinations.
This patient leaflet describes certain situations in which you will need to stop taking KELSEE or in which the effectiveness of KELSEE may be reduced. In these cases, you must not have sexual intercourse or you must use additional non-hormonal contraceptive precautions such as condoms or another barrier method. Do not use the calendar method or temperature measurement method. These methods may be unreliable because KELSEE alters the monthly changes in body temperature and cervical mucus.
KELSEE, like other hormonal contraceptives, does not protect against HIV (AIDS) infections or other sexually transmitted diseases.
If you take the pill, your doctor will ask you to undergo regular check-ups. Normally, you should consult your doctor at least once a year.
Do not take KELSEE
Do not take KELSEE 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 might be more suitable.
Do not take KELSEE if you:

• are allergic to ethinylestradiol, dienogest or any of the other ingredients of this medicine (listed in section 6);
• 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;
• 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;
• need to undergo surgery or will be bedridden for a prolonged period (see section 2 “Blood clots”);
• have ever had a heart attack or stroke;
• have (or have ever had) angina pectoris (a condition causing severe chest pain that may be an early sign of heart attack) or transient ischaemic attack (TIA – temporary stroke-like symptoms);
• have one of the following diseases, which could increase the risk of developing clots 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
• have (or have ever had) a type of migraine called “migraine with aura”;
• have (or have ever had) severe liver disease, unless your liver function tests have returned to normal;
• have (or have ever had) a benign or malignant liver tumour;
• have (or have ever had) or suspect you have a hormone-dependent cancer (e.g. of the breast or endometrium);
• experience unexplained vaginal bleeding;
• have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (see section 2 “Other medicines and KELSEE”).

If you develop any of these conditions while taking KELSEE, you must stop taking it immediately and contact your doctor. In the meantime, you must use another non-hormonal method of contraception. For further information, see also the section “Warnings and precautions”.
Warnings and precautions
Talk to your doctor or pharmacist before taking KELSEE.
When to be especially careful with KELSEE
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” [thrombosis]).

For a description of the symptoms of these serious side effects, go to the section "How to recognize a blood clot”.
Inform your doctor if any of the following conditions apply to you.
In certain situations, special care is needed when taking KELSEE or any other combined pill, and you may need to be regularly monitored by your doctor.
If any of these conditions appear or worsen while you are using KELSEE, you must also inform your doctor if you:

• have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• have systemic lupus erythematosus (SLE, a disease affecting the body’s natural defence system);
• have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);
• have sickle cell anaemia (an inherited red blood cell disorder);
• 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);
• need to undergo surgery or will be bedridden for a prolonged period (see section 2 “Blood clots”);
• have recently given birth; your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking KELSEE;
• have inflammation of the veins just under the skin (superficial thrombophlebitis);
• have varicose veins;
• have heart valve defects or heart rhythm disorders;
• have cases of breast cancer in close relatives;
• have liver or gallbladder disease or gallstones;
• have jaundice or itching due to bile stasis;
• have patchy, yellowish-brown skin discoloration, especially on the face (chloasma), or if you experienced this during a previous pregnancy; in this case, avoid strong sunlight and UV rays;
• have certain disorders affecting haemoglobin formation (porphyria);
• suffer from depression;
• suffer from epilepsy;
• have Sydenham’s chorea;
• had a blistering skin rash during a previous pregnancy (herpes gestationis);
• have hearing loss in the inner ear (hearing loss associated with otosclerosis);
• experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives with potential breathing difficulties, contact your doctor immediately. Medicinal products containing oestrogens may cause or worsen symptoms of hereditary and acquired angioedema.

Do not hesitate to ask your doctor or pharmacist for advice if you have any doubts about using KELSEE.
BLOOD CLOTS
Using a combined hormonal contraceptive such as KELSEE 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 or, very rarely, these effects may be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with KELSEE is low.
HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical attention if you notice any of the following signs or symptoms.
Do you have any of these signs? What might you be suffering from?

• swelling in one leg or along a vein in the leg or foot, especially if accompanied by:
• pain or tenderness in the leg, which may only be felt when standing or walking
• increased warmth in the affected leg
• change in skin colour of the leg, such as paleness, redness or blueness
• sudden, unexplained shortness of breath; Pulmonary embolism
• sudden cough without an obvious cause, possibly with coughing up of blood;
• sharp chest pain that may worsen when breathing deeply;
• severe dizziness;
• rapid heartbeat;
• severe stomach pain. If you are unsure, inform your doctor, as some of these symptoms such as cough or shortness of breath may be mistaken for a milder condition such as a respiratory tract infection (e.g. a "common cold").

Symptoms occurring more frequently in the eye: Retinal vein thrombosis

• sudden loss of vision or (blood clot in the eye)
• painless blurring of vision that may progress to vision loss
• pain, discomfort, pressure or heaviness in the chest Heart attack
• crushing or fullness sensation in the chest, one arm or under the breastbone;
• feeling of fullness, indigestion or suffocation;
• discomfort in the upper body spreading to the back, jaw, throat, arms and stomach;
• sweating, nausea, vomiting or dizziness;
• extreme weakness, anxiety or shortness of breath;
• rapid or irregular heartbeat
• sudden numbness or weakness of the face, arm or leg, especially on one side of the body; Stroke
• sudden confusion, difficulty speaking or understanding;

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 the 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 if you restart taking a combined hormonal contraceptive (the same medication or a different one) 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 KELSEE, 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 venous thromboembolism (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 KELSEE 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 dienogest and ethinylestradiol, such as KELSEE, approximately 8 to 11 women will develop a VTE in one year.

The risk 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 KELSEE is low, but certain conditions can increase it. 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 may have an inherited blood clotting disorder;
• if you are scheduled for surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a leg in plaster. You may need to stop taking KELSEE several weeks before surgery or during periods of reduced mobility. If you need to stop taking KELSEE, ask your doctor when you can restart it.
• as you get older (especially over 35 years of age);
• if you have recently given birth (within the last few weeks).

The risk of developing a blood clot increases if you have more than one of these conditions.
Air travel (lasting > 4 hours) may temporarily increase the risk of developing a blood clot, particularly if some of the other listed factors are present.
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 KELSEE.
If any of the above conditions change while you are using KELSEE—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 lead to 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 KELSEE is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as KELSEE, it is advisable to stop smoking. If you cannot stop smoking and 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 KELSEE—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.

KELSEE and cancer
Breast cancer has been detected slightly more frequently in women using combined oral contraceptives, but it has not been established whether this is due to the pill. It is possible that these women have simply been examined more thoroughly and more frequently, meaning breast cancer was diagnosed earlier. The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important that you regularly check your breasts and contact your doctor if you feel any lumps.
In women who have used combined oral contraceptives for a relatively long time, studies have reported cases of cervical cancer. It is currently unknown whether this is caused by the pill or is related to sexual behavior (e.g., more frequent partner changes) and other factors.
Rarely, benign liver tumors and even more rarely malignant liver tumors have been reported in women taking the pill. Consult your doctor if you experience unusual, severe abdominal pain.

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

Bleeding between menstrual periods
During the first months of using KELSEE, you may experience unexpected bleeding (bleeding not coinciding with the days of taking placebo tablets). If this bleeding persists for more than a few months, or if it starts after several months, your doctor should investigate the cause.

What to do if no bleeding occurs during the placebo tablet days
If you have correctly taken all the active white tablets, have not vomited or had severe diarrhea, and have not taken other medications, it is highly unlikely that you are pregnant.
If you have missed two consecutive cycles, you may be pregnant. Contact your doctor immediately. Do not start the next blister pack until you are certain you are not pregnant.

Other medicines and KELSEE
Always tell your doctor what medicines or herbal products you are currently using, including any medicines obtained without a prescription. Inform any doctor or dentist prescribing other medicines (or your pharmacist) that you are taking KELSEE. They can advise you whether you need to take additional contraceptive precautions (e.g., use of a condom) and, if so, for how long.
Some medicines:

• can affect KELSEE levels in the blood;
• can make it less effective in preventing pregnancy;
• can cause unexpected bleeding.

These include:

• medicines used to treat:
• HIV infections and hepatitis C virus (called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz);
• epilepsy (e.g., phenobarbital, phenytoin, primidone, carbamazepine, oxcarbazepine, topiramate, or felbamate);
• tuberculosis (e.g., rifampicin);
• fungal infections (griseofulvin, imidazole antifungals, e.g., itraconazole, voriconazole, fluconazole);
• bacterial infections (macrolide antibiotics, e.g., clarithromycin, erythromycin);
• certain heart conditions, high blood pressure (calcium channel blockers, e.g., verapamil, diltiazem);
• arthritis, osteoarthritis (etoricoxib);
• the herbal remedy St. John’s wort, used to treat certain types of depression.

KELSEE can affect the effect of other medicines, for example:

• lamotrigine;
• cyclosporine;
• theophylline;
• tizanidine.

Do not use KELSEE if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or
sofosbuvir/velpatasvir/voxilaprevir, because these medicines can cause increased values in blood tests assessing liver function (elevated liver enzyme ALT levels). Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines. KELSEE may be restarted approximately 2 weeks after completion of this treatment. See section “Do not use KELSEE”.
Ask your doctor or pharmacist for advice before taking any medicine.

Interactions with laboratory tests
The use of KELSEE may influence the results of certain laboratory tests, including liver, adrenal cortex, kidney, and thyroid function values, as well as the levels of certain blood proteins, such as those affecting lipid (fat) and carbohydrate metabolism, blood coagulation, and fibrinolysis. However, such variations generally remain within the normal range.

Pregnancy and breastfeeding
Pregnancy
KELSEE must not be taken during pregnancy. You must not be pregnant before starting KELSEE. If you become pregnant while taking KELSEE, stop taking it immediately and contact your doctor.

Breastfeeding
It is not recommended to take KELSEE while breastfeeding.
If you wish to breastfeed, your doctor will advise you on an appropriate contraceptive method.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and use of machines
No effects on the ability to drive or use machines have been observed.

KELSEE contains lactose
Each active white tablet of KELSEE contains 19 mg of lactose (as lactose monohydrate). Each green placebo tablet contains 56 mg of lactose (as lactose monohydrate).
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take KELSEE

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Each blister contains 28 tablets. Take one KELSEE tablet every day at the same time for 28 consecutive days, following strictly the direction indicated by the arrows as follows: take one white active tablet each day for the first 24 days, followed by one green placebo tablet each day for the last 4 days.
After taking the last tablet, continue taking KELSEE the next day by starting a new blister without any break between blisters. You will always start a new blister on the same day of the week. Since there is no interruption in taking the medicine, it is important to have the next blister ready before finishing the current one.
To help you keep track, there are 7 stickers indicating the 7 days of the week for each KELSEE blister. Choose the weekly sticker that starts with the day on which you begin taking the tablets. For example, if you start on Wednesday, use the sticker starting with “WED”. Apply the weekly sticker to the KELSEE blister where it says “Apply sticker here”. In this way, each tablet will have a day marked above it, allowing you to see whether you have taken a particular tablet. The arrows indicate the order in which you must take the tablets.
During the 4 days when you take the green placebo tablets (the placebo days), you should experience bleeding (the so-called withdrawal bleed). This usually starts on the second or third day after taking the last white active tablet of KELSEE. After taking the last green placebo tablet, you must start the next blister, whether or not the bleeding has stopped. This means you must start each new blister on the same day of the week, and the withdrawal bleed should begin on the same day each month.
If you use KELSEE in this way, you will be protected against pregnancy even during the 4 days when you take the placebo tablets.
Please note the instructions in section 3 “If you forget to take KELSEE” to maintain contraceptive effectiveness.

Method and route of administration
Swallow each tablet whole, with a small amount of water if necessary. It does not matter whether you take the tablets with or without food.

When you can start taking KELSEE

If you have not used any hormonal contraceptive in the previous month
Start taking KELSEE on the first day of your cycle (i.e. the first day of menstruation). If you start taking KELSEE on the first day of your period, contraceptive protection begins immediately. You may also start between the second and fifth day of the cycle, but in this case you must use additional contraceptive precautions (e.g. a condom) for the first 7 days.

If switching from a combined hormonal contraceptive or from a combined contraceptive vaginal ring or patch
You may start KELSEE preferably the day after the last active tablet (the last tablet containing active ingredients) of your previous pill, but no later than the day after the end of the tablet-free interval of your previous pill (or after the last inactive tablet of your previous pill).
If switching to KELSEE from a vaginal ring or patch, you should preferably start on the day of removal of the last ring or patch of the cycle pack, but no later than the day when the next application would have occurred.

If you were using a progestogen-only method (progestogen-only pill, injection, implant, or progestogen-releasing intrauterine device - IUD)
You may switch at any time from the progestogen-only pill (from an implant or IUD on the day of removal, from an injectable when the next injection would have been due), but in all these cases you must use additional contraceptive precautions (e.g. a condom) for the first 7 days of tablet intake.

If starting KELSEE after an early pregnancy termination (first trimester)
You can usually start immediately, but you should follow your doctor’s advice before doing so.

If starting KELSEE after childbirth or after a second-trimester pregnancy termination
You may start KELSEE between 21 and 28 days after childbirth or after the termination of pregnancy. If you start later, you must use an additional barrier contraceptive method during the first seven days of tablet intake. If you have had sexual intercourse before starting KELSEE, make sure you are not pregnant or wait until your next menstrual cycle.

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Duration of use
Your doctor will advise you on how long to take this medicine.

If you take more KELSEE than you should
No serious harmful effects have been reported after taking too many KELSEE tablets. If you take several tablets at once, symptoms that may occur include nausea, vomiting, and slight vaginal bleeding.

If you forget to take KELSEE
If you forget to take a white active tablet (tablets 1–24 of your blister), follow these instructions:

• If you remember you missed a white tablet within 24 hours of your usual intake time, contraceptive protection is not reduced. Take the missed tablet as soon as you remember and continue taking the following tablets at your usual time.
• If you remember you missed a white tablet more than 24 hours after your usual intake time, contraceptive protection may be reduced. The more tablets you miss, the higher the risk of pregnancy.

The risk of incomplete contraceptive protection is greater if you miss a white tablet at the beginning or end of the blister. Therefore, follow these rules:

• More than one tablet missed in this blister: Contact your doctor.
• One tablet missed on days 1–7 (first row): Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time and use additional contraceptive precautions (e.g. a condom) for the next 7 days. If you had sexual intercourse in the previous week, consider the possibility of pregnancy. In this case, consult your doctor.
• One tablet missed on days 8–14 (second row): Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. If you took the tablets correctly in the 7 days before the missed tablet, contraceptive protection is not reduced and no additional precautions are needed.
• One tablet missed on days 15–24 (third or fourth row): You may choose between the following options without needing additional contraception, provided you took the tablets correctly in the 7 days before the missed tablet. Otherwise, follow the first option and use additional contraceptive precautions for 7 days.
  1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Then continue taking the tablets at your usual time. Instead of taking the green placebo tablets of this blister, discard them and start the next blister immediately (your starting day will change). You will most likely have a menstrual period at the end of the second blister—during the green placebo tablets—but you may experience light bleeding or spotting during the second blister.
  2. Alternatively, you may stop taking the white active tablets and immediately start taking the 4 green placebo tablets (before taking the placebo tablets, note the day on which you missed the tablet). If you wish to start a new blister on your usual starting day, take fewer than 4 placebo tablets.

If you follow either of these recommendations, you will remain protected against pregnancy.

• If you missed any tablet in a blister and do not have bleeding during the placebo days, you may be pregnant. You should consult your doctor before starting the next blister.

If you forget one or more green placebo tablets, you are still protected, provided that no more than 4 days pass between the last white active tablet of the current blister and the first white active tablet of the next blister.

What to do in case of vomiting or severe diarrhoea
If you vomit or have severe diarrhoea, there is a risk that the active ingredient in the tablet has not been fully absorbed by your body; the situation is similar to missing a tablet. In such cases, you should use an additional contraceptive method and consult your doctor.
If you vomit or have severe diarrhoea within 3–4 hours after taking a white active KELSEE tablet, take another white tablet from another blister as soon as possible. If possible, take it within 24 hours of your usual tablet-taking time. No additional contraceptive precautions are necessary. If this is not possible or if more than 24 hours have passed, follow the instructions in the previous section “If you forget to take KELSEE”.

Delaying your menstrual period: what you need to know
Although not recommended, you can delay your menstrual period by skipping the green placebo tablets in the fourth row and immediately starting a new blister of KELSEE, taking all tablets in that blister. You may experience light bleeding or spotting during use of the second blister. Complete this second blister by taking the 4 green placebo tablets in the fourth row. Then start the next blister.
You may wish to consult your doctor before deciding to delay your menstrual period.

Changing the day of the week on which your menstrual period starts: what you need to know
If you take the tablets as directed, your menstrual period will start during the days you take the placebo tablets. If you wish to change this day, shorten the number of days you take the placebo tablets—when taking the green placebo tablets—but never extend it (4 is the maximum). For example, if you usually start the placebo tablets on Friday and wish to change to Tuesday (3 days earlier), you should start the new blister 3 days earlier than usual. You may not have any bleeding during these days. You may then experience light bleeding or spotting.
If you are unsure how to proceed, consult your doctor.

If you stop taking KELSEE
You may stop taking KELSEE at any time. From the day you stop, you are no longer protected against pregnancy.
If you have any doubts about using this medicine, consult your doctor, pharmacist, or nurse.

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 it is severe or persistent, or if you notice any change in your health that you think may be due to KELSEE, inform your doctor or pharmacist.

An increased risk of developing blood clots in the veins (venous thromboembolism [VTE]) or blood clots in the arteries (arterial thromboembolism [TEA]) 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 taking KELSEE”.

Serious side effects
Serious reactions related to the use of the pill, along with associated symptoms, are described in the sections: “What you need to know before taking KELSEE”, “Blood clots”, “KELSEE and cancer”.
Please read these sections of the package leaflet for more detailed information and contact your doctor if necessary.

Contact your doctor immediately if you notice any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with possible difficulty breathing (see also section 2 “Warnings and precautions”).

Other possible side effects
The following side effects, listed by frequency, have been observed in clinical studies with KELSEE:

Common side effects (may affect up to 1 in 10 people):

• vaginal infections, including fungal infections of the vulva and vagina and bacterial vaginosis
• changes in sexual desire, mood changes
• headache
• nausea, abdominal pain
• acne
• breast discomfort or pain, painful menstrual periods, abnormal bleeding between regular menstrual cycles
• weight gain, increased levels of thyroid-stimulating hormone and triglycerides in the blood

Uncommon side effects (may affect up to 1 in 100 people):

• urinary tract infections, presence of bacteria in the urine (bacteriuria)
• hypothyroidism (reduced thyroid function)
• changes in appetite, including increased or decreased appetite, elevated blood glucose levels
• depressed mood, depression, anxiety, mental disorders (including mental impairment, borderline personality disorder, and panic attacks), sleep disorders (such as insomnia or drowsiness)
• dizziness, migraine
• high blood pressure (hypertension)
• harmful blood clots in a leg or in the foot veins (deep vein thrombosis)
• abdominal distension
• vomiting, diarrhoea, flatulence
• hair loss (alopecia)
• itching, skin irritation (dermatitis), rash
• increased sweating (hyperhidrosis)
• pain in arms and legs
• absence of menstruation, abnormal vaginal bleeding, menstrual disorders, pelvic pain, ovarian cysts, vaginal discharge and vulvovaginal discomfort, including itching or dryness, vulvovaginitis, cervical dysplasia (abnormal growth of cells on the surface of the cervix), pain/spasms during sexual intercourse (dyspareunia)
• fatigue (tiredness)
• swelling (oedema)
• weight loss
• abnormal blood test results: increased blood levels of creatine phosphokinase, cholesterol, liver enzymes

Rare side effects (may affect up to 1 in 1,000 people):

• inflammation of the eardrum, which may cause hearing disturbance and ear pain (otitis media)
• genital herpes
• benign breast tumour (breast fibroadenoma)
• low white blood cell count (leukopenia)
• hyperthyroidism (increased thyroid activity)
• fluid retention, imbalance of blood lipids (dyslipidaemia)
• altered sense of taste (dysgeusia)
• partial loss of tactile sensation (hypoesthesia)
• burning or tingling sensation, usually felt in the hands, arms, legs or feet, but may also occur in other parts of the body (paraesthesia)
• eye itching, visual disturbances
• dizziness
• rapid heartbeat (palpitations)
• changes in blood pressure
• bruising (haematoma – a collection of blood outside blood vessels under the skin)
• hot flushes
• venous disorders including spider veins and varicose veins
• painful blood clots in a vein or artery, for example: in a leg or foot (i.e. venous thrombosis) or in a lung (i.e. pulmonary embolism)
• nosebleeds (epistaxis)
• indigestion (dyspepsia)
• constipation
• gastroesophageal reflux
• sensitive teeth (dental hyperesthesia)
• skin disorders, dry skin, hives, chloasma (golden-brown pigmented spots)
• joint pain (arthralgia)
• changes in urine tests: presence of red blood cells and white blood cells in urine
• irregular thickening of the endometrium
• genital discomfort
• general feeling of malaise
• abnormal blood test results: increased blood levels of lactate dehydrogenase, potassium, prolactin, fibrin D-dimer
• abnormal blood pressure

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 KELSEE

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature conditions.
Keep the blister in the outer packaging to protect the medicine from light.
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. Contents of the pack and other information

What KELSEE contains
White tablet:

• The active substances are dienogest and ethinylestradiol.
• The other components are: Tablet core: lactose monohydrate, hypromellose (E 464), povidone, magnesium stearate (E 470b). Film coating: partially hydrolysed polyvinyl alcohol, titanium dioxide (E 171), macrogol (E 1521), talc (E 553b).

Green tablet:

• Does not contain any active substances.
• The other components are: Tablet core: lactose monohydrate, maize starch, povidone, colloidal silica, magnesium stearate (E 470b). Film coating: hypromellose (E 464), triacetin (E 1518), polysorbate 80, titanium dioxide (E 171), indigo carmine aluminium lake, yellow iron oxide.

Description of the appearance of KELSEE and contents of the pack
KELSEE is in the form of prolonged-release tablets.
Each pack contains 1, 3, 6 or 13 blisters, each blister containing 28 tablets (24 white active tablets and 4 green inactive tablets).
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder
Exeltis Italia S.r.l.
Via Lombardia, 2/A
20068 Peschiera Borromeo (MI)
Italy

Manufacturer
Laboratorios León Farma, S.A.
C/ La Vallina s/n
24193 Villaquilambre, León
Spain