Kelzi Pr

Leaflet attached to the packaging: information for the user

Kelzy PR, 2 mg + 0.02 mg, prolonged-release tablets

Dienogest + Ethinylestradiol

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Important information about combined hormonal contraceptives:

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more.
• You should be vigilant and consult a doctor if the patient suspects that blood clot symptoms have occurred (see section 2 "Blood clots").

Table of contents of the leaflet

• 1. What is Kelzy PR and what is it used for
• 2. Important information before taking Kelzy PR
• 3. How to take Kelzy PR
• 4. Possible side effects
• 5. How to store Kelzy PR
• 6. Contents of the pack and other information

1. What is Kelzy PR and what is it used for

Kelzy PR is a combined oral contraceptive used to prevent pregnancy.
Each of the 24 white tablets contains a small amount of two different female hormones, called dienogest and ethinylestradiol. The 4 green tablets do not contain active substances and are called "placebo tablets".
Contraceptive tablets containing two hormones are called "combined tablets".

2. Important information before taking Kelzy PR

General notes

Before starting to take Kelzy PR, you should read the information about blood clots in section 2. It is especially important to read about the symptoms of blood clots - see section 2 "Blood clots").
Before the patient starts taking Kelzy PR, the doctor will ask the patient some questions about their health and that of their close relatives. The doctor will also measure the patient's blood pressure and, depending on the patient's individual condition, may order other tests.
The leaflet describes several situations in which the patient should stop taking Kelzy PR or in which the effectiveness of Kelzy PR may be reduced. In these situations, the patient should not have sexual intercourse or should use additional non-hormonal methods of contraception, such as condoms or other mechanical methods of contraception. The patient should not use the so-called calendar method or the temperature method. These methods may be ineffective because Kelzy PR affects the monthly changes in body temperature and the properties of cervical mucus.

Kelzy PR, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

The doctor will recommend that the patient comes for regular check-ups while taking these tablets. Usually, the patient should see a doctor at least once a year.

When not to take Kelzy PR:

Kelzy PR should not be taken if the patient has any of the conditions listed below. If the patient has any of the conditions listed below, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.

Do not take Kelzy PR if:

• the patient is allergic to ethinylestradiol or dienogest or any of the other ingredients of this medicine (listed in section 6);
• the patient has (or has ever had) a blood clot in the veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• the patient knows they have a blood clotting disorder - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• the patient needs to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• the patient has ever had a heart attack or stroke;
• the patient has (or has had) angina pectoris (a disease that causes severe chest pain and may be a sign of a heart attack) or a transient ischaemic attack (a temporary stroke-like condition);
• the patient has any of the following diseases, which may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage
• very high blood pressure
• very high levels of fats in the blood (cholesterol or triglycerides)
• a disease called hyperhomocysteinaemia;
• the patient has (or has ever had) a type of migraine called migraine with aura;
• the patient has (or has ever had) severe liver disease, unless liver function tests have returned to normal;
• the patient has (or has ever had) benign or malignant liver tumours;
• the patient has (or has ever had) a hormone-dependent cancer (such as breast cancer or cancer of the genital organs) or there is a suspicion of such a cancer;
• the patient has unexplained vaginal bleeding;
• the patient has liver disease and is taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section 2 "Kelzy PR and other medicines").
  If any of the above conditions occur during treatment with Kelzy PR, the patient should stop taking the medicine and consult a doctor. During this time, the patient should use another non-hormonal method of contraception. For further information, see the section "Warnings and precautions".

  Warnings and precautions

  The patient should discuss this with their doctor or pharmacist before starting to take Kelzy PR.

  When to be careful when taking Kelzy PR

  When should the patient contact their doctor?
  The patient should see their doctor immediately

  • if they notice any of the symptoms of a blood clot, which may indicate that they have a blood clot in their leg (deep vein thrombosis), lung (pulmonary embolism), heart attack, or stroke (see below "Blood clots").

  For a description of the symptoms of these serious side effects, see section 2 "How to recognize a blood clot".

  The patient should tell their doctor if they have any of the following conditions.

  In certain situations, the patient should be careful when taking Kelzy PR or any other combined hormonal contraceptive and may need to have regular medical check-ups.
  If any of the conditions listed below occur or worsen while taking Kelzy PR, the patient should consult their doctor if:

  • the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
  • the patient has systemic lupus erythematosus (a disease that affects the body's natural defence system);
  • the patient has haemolytic uraemic syndrome (a blood clotting disorder that causes kidney failure);
  • the patient has sickle-cell disease (a genetic disorder of the red blood cells);
  • the patient has elevated levels of fats in the blood (hypertriglyceridaemia) or has a positive family history for this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
  • the patient needs to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
  • the patient is immediately after childbirth, in which case they are at increased risk of blood clots. The patient should consult their doctor for advice on how soon after childbirth they can start taking Kelzy PR;
  • the patient has superficial thrombophlebitis (inflammation of veins just under the skin);
  • the patient has varicose veins;
  • the patient has heart valve problems or irregular heart rhythm;
  • a close relative has had breast cancer;
  • the patient has liver or gallbladder disease or gallstones;
  • the patient has jaundice or itching caused by bile obstruction;
  • the patient has patchy brown skin markings, especially on the face (chloasma) or if these markings occurred during a previous pregnancy. In this case, the patient should avoid excessive exposure to sunlight and ultraviolet radiation;
  • the patient has certain blood disorders (porphyria);
  • the patient has depression;
  • the patient has epilepsy;
  • the patient has a condition called "Sydenham's chorea" (a movement disorder);
  • the patient had a skin rash with blistering during a previous pregnancy (pregnancy herpes);
  • the patient has hearing loss in the inner ear (hearing loss associated with otosclerosis);
  • the patient has symptoms of angio-oedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or breathing, and should contact their doctor immediately. Medicines containing oestrogens may cause or worsen the symptoms of angio-oedema.

  If the patient has any further doubts about taking Kelzy PR, they should consult their doctor or pharmacist.

  BLOOD CLOTS

  Taking combined hormonal contraceptives, such as Kelzy PR, is associated with an increased risk of blood clots compared to not taking them. In rare cases, a blood clot can block a blood vessel and cause serious complications.
  Blood clots can occur:

  • in the veins (also known as "venous thromboembolism" or "deep vein thrombosis");
  • in the arteries (also known as "arterial thromboembolism").

  Not everyone who gets a blood clot will recover fully. In rare cases, the effects of a blood clot can be long-term or, very rarely, fatal.

  It is important to remember that the overall risk of having a harmful blood clot due to taking Kelzy PR is small.

  HOW TO RECOGNIZE A BLOOD CLOT

  The patient should see their doctor immediately if they notice any of the following symptoms.
  Is the patient experiencing any of these symptoms?
  Why is the patient likely to be suffering from
  this symptom?

  • swelling of the leg or swelling along a vein in the leg or foot, deep vein thrombosis, especially if it is accompanied by:
  • pain or tenderness in the leg, which may only be felt when standing or walking;
  • increased temperature in the affected leg;
  • change in the colour of the leg, such as paleness, redness, or blue discoloration.
  • sudden unexplained shortness of breath or rapid breathing;
  • sudden cough without an obvious cause, which may be accompanied by coughing up blood;
  • sharp chest pain, which may worsen with deep breathing;
  • severe dizziness or fainting;
  • rapid or irregular heartbeat;
  • severe stomach pain.

  If the patient is unsure, they should see their doctor,
  as some of these symptoms, such as coughing or shortness of breath, can be mistaken for less serious conditions, such as a respiratory infection (e.g. a cold).

  Objectives of the study became apparent after the completion of the study and the analysis of the results
  Symptoms usually occur in one eye: sudden loss of vision or painless vision disturbances, which can progress to loss of vision.	Retinal vein thrombosis (blood clot in the eye)
  chest pain, discomfort, feeling of pressure, heaviness; feeling of squeezing or fullness in the chest, arm, or below the breastbone; feeling of fullness, indigestion, or choking; discomfort in the upper body radiating to the back, jaw, throat, arm, and stomach; sweating, nausea, vomiting, or fainting; extreme weakness, anxiety, or shortness of breath; rapid or irregular heartbeat.	Heart attack
  sudden weakness or numbness of the face, arms, or legs, especially on one side of the body; sudden confusion, difficulty speaking or understanding; sudden vision disturbances in one or both eyes; sudden difficulty walking, dizziness, loss of balance or coordination; sudden severe or prolonged headache without a known cause; loss of consciousness or fainting with or without seizures. In some cases, the symptoms of a stroke can be transient, with almost immediate and complete recovery, but the patient should see their doctor immediately, as they may be at risk of having another stroke.	Stroke
  swelling and slight blue discoloration of the skin of the legs or arms; severe stomach pain (so-called acute abdomen).	Blood clots blocking other blood vessels

  BLOOD CLOTS IN VEINS

  What can happen if a blood clot forms in a vein?

  • Taking combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism). Although these side effects are rare, they can occur. They are most likely to occur in the first year of taking combined hormonal contraceptives.
  • If blood clots form in the veins in the leg or foot, this can lead to deep vein thrombosis.
  • If a blood clot moves from the leg and lodges in the lungs, this can cause a pulmonary embolism.
  • In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

  When is the risk of blood clots in a vein highest?

  The risk of forming a blood clot in a vein is highest during the first year of taking combined hormonal contraceptives. The risk may also be higher when restarting combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.
  After the first year, the risk decreases, although it is always higher than when not taking combined hormonal contraceptives.
  If the patient stops taking Kelzy PR, the risk of blood clots returns to normal within a few weeks.

  What factors can increase the risk of blood clots in veins?

  The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
  The overall risk of blood clots in the legs or lungs associated with taking Kelzy PR is small.

  • During a year, about 2 in 10,000 women who do not take combined hormonal contraceptives and are not pregnant will develop blood clots.
  • During a year, about 5-7 in 10,000 women who take combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
  • During a year, about 8-11 in 10,000 women who take combined hormonal contraceptives containing dienogest and ethinylestradiol, such as Kelzy PR, will develop blood clots.

  The risk of blood clots depends on the patient's individual medical history (see "Factors that increase the risk of blood clots", below).

  	Risk of blood clots in a year
  Women who do not take combined hormonal pills and are not pregnant	About 2 in 10,000 women
  Women taking combined hormonal contraceptive pills containing levonorgestrel, norethisterone, or norgestimate	About 5-7 in 10,000 women
  Women taking dienogest and ethinylestradiol in a dose of 2 mg + 0.03 mg, with a different dosage and higher dose of ethinylestradiol than Kelzy PR	About 8-11 in 10,000 women

  Factors that increase the risk of blood clots in veins

  The risk of blood clots associated with taking Kelzy PR is small, but some factors can increase this risk. The risk is higher:

  • if the patient is overweight (body mass index (BMI) over 30 kg/m2);
  • if someone in the patient's close family has had a blood clot in their leg, lung, or other organ at a young age (e.g. under 50 years old). In this case, the patient may have an inherited blood clotting disorder;
  • if the patient needs to have surgery or will be immobilized for a long time due to injury or illness or has a leg in a cast. It may be necessary to stop taking Kelzy PR for a few weeks before surgery or immobilization. If the patient needs to stop taking Kelzy PR, they should ask their doctor when they can start taking it again;
  • with increasing age (especially over 35 years old);
  • if the patient has recently given birth.

  The risk of blood clots increases with the number of risk factors present in the patient.
  Taking a long-haul flight (more than 4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
  It is essential to tell the doctor if any of these risk factors are present, even if the patient is not sure. The doctor may decide to stop the patient taking Kelzy PR.
  The patient should tell their doctor if any of the above conditions change while taking Kelzy PR, e.g. if someone in their close family is found to have a blood clot without a known cause or if the patient puts on a lot of weight.

  BLOOD CLOTS IN ARTERIES

  What can happen if a blood clot forms in an artery?

  As with blood clots in veins, blood clots in arteries can cause serious complications, such as a heart attack or stroke.

  Factors that increase the risk of blood clots in arteries

  It is essential to note that the risk of a heart attack or stroke associated with taking Kelzy PR is very small, but it may increase:

  • with age (over about 35 years old);
  • if the patient smokes. While taking a combined hormonal contraceptive like Kelzy PR, the patient is advised to stop smoking. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend a different type of contraception;
  • if the patient is overweight;
  • if the patient has high blood pressure;
  • if someone in the patient's close family has had a heart attack or stroke at a young age (under 50 years old). In this case, the patient may also be at increased risk of having a heart attack or stroke;
  • if the patient or someone in their close family has high levels of fats in the blood (cholesterol or triglycerides);
  • if the patient has migraines, especially migraines with aura;
  • if the patient has heart valve problems or irregular heart rhythm;
  • if the patient has diabetes.

  If the patient has more than one of these conditions or if any of them are particularly severe, the risk of a blood clot may be even higher.
  The patient should tell their doctor if any of the above conditions change while taking Kelzy PR, e.g. if they start smoking, someone in their close family is found to have a blood clot without a known cause, or if they put on a lot of weight.

  Kelzy PR and cancer

  Women taking combined hormonal contraceptives have a slightly higher risk of being diagnosed with breast cancer than those who do not take them. However, it is not known whether this is caused by the medicines or other factors.
  It is possible that more breast cancers are detected in women taking combined hormonal contraceptives because they are more likely to have regular medical check-ups.
  The risk of breast cancer decreases gradually after stopping combined hormonal contraceptives.
  It is essential to regularly check the breasts and consult a doctor if any lumps are found.
  Some studies have found an increased risk of cervical cancer in women taking combined hormonal contraceptives for an extended period. However, it is not known whether this is caused by the medicines or other factors, such as sexual behaviour (e.g. frequent changes of partner) or other factors.
  Women taking combined hormonal contraceptives have a rare increased risk of benign liver tumours and, even more rarely, liver cancer.
  The patient should consult their doctor if they experience severe stomach pain.

  Psychiatric disorders

  Some women taking hormonal contraceptives, including Kelzy PR, have reported depression or mood swings. Depression can be severe and, in some cases, may lead to suicidal thoughts. If mood changes and symptoms of depression occur, the patient should consult their doctor as soon as possible for further medical advice.

  Irregular bleeding

  During the first few months of taking Kelzy PR, the patient may experience unexpected bleeding (outside of the week without taking the active tablets). If bleeding occurs for longer than a few months or if it occurs after a few months, the patient should see their doctor, who will determine the cause.

  What to do if bleeding does not occur during the placebo period

  If the patient has taken all the active tablets correctly, has not vomited, and has not had severe diarrhoea, and has not taken any other medicines, it is unlikely that they are pregnant.
  If two consecutive periods are missed, the patient may be pregnant. In this case, they should see their doctor immediately. Before starting the next pack, the patient should make sure they are not pregnant.

  Kelzy PR and other medicines

  The patient should always tell their doctor or pharmacist about all medicines or herbal products they are currently taking, including those available without a prescription. The patient should also inform any other doctor, including their dentist, who prescribes another medicine (or pharmacist) that they are taking Kelzy PR. They may tell the patient whether they need to use additional contraception (e.g. condoms) and for how long.
  Certain medicines

  • may affect the levels of Kelzy PR in the blood;
  • may reduce its effectiveness in preventing pregnancy;
  • may cause unexpected bleeding.

  These medicines include:

  • Medicines used to treat:
  • HIV and hepatitis C infections (such as protease inhibitors and non-nucleoside reverse transcriptase inhibitors, e.g. ritonavir, nevirapine, efavirenz);
  • epilepsy (e.g. phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, or felbamate);
  • tuberculosis (e.g. rifampicin);
  • fungal infections (e.g. griseofulvin, azole antifungals, e.g. itraconazole, voriconazole, fluconazole);
  • bacterial infections (macrolide antibiotics, e.g. clarithromycin, erythromycin);
  • certain heart conditions and high blood pressure (calcium channel blockers, e.g. verapamil, diltiazem);
  • arthritis or arthrosis (etoricoxib);
  • depression (St. John's Wort (Hypericum perforatum)).

  Kelzy PR may affect the actionof other medicines, such as:

  • lamotrigine,
  • cyclosporin,
  • theophylline,
  • tiagabine.

  Kelzy PR should not be taken by patients with hepatitis C who are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as this may cause abnormal liver function test results in the blood (elevated liver enzyme alanine aminotransferase (ALT)). Before starting these medicines, the doctor will prescribe a different contraceptive. The patient can start taking Kelzy PR again about 2 weeks after finishing the above treatment. See the section "When not to take Kelzy PR".
  Before taking any medicine, the patient should consult their doctor or pharmacist.
  Effect on laboratory tests
  Taking Kelzy PR may affect the results of some laboratory tests, including liver, adrenal, kidney, and thyroid function tests, as well as the levels of certain blood proteins, e.g. proteins involved in lipid metabolism, proteins involved in carbohydrate metabolism, and proteins involved in blood clotting and fibrinolysis. However, these changes are usually within normal limits.

  Pregnancy and breastfeeding

  Pregnancy
  Kelzy PR should not be taken during pregnancy. The patient should not be pregnant before starting to take Kelzy PR. If the patient becomes pregnant while taking Kelzy PR, they should stop taking it immediately and consult their doctor.
  Breastfeeding
  Kelzy PR should not be taken during breastfeeding.
  If the patient wants to breastfeed, the doctor will recommend a suitable contraceptive method.
  Before taking any medicine, the patient should consult their doctor or pharmacist.

  Driving and using machines

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

  Kelzy PR contains lactose

  Each white active tablet of Kelzy PR contains 19 mg of lactose (in the form of lactose monohydrate).
  Each green placebo tablet contains 56 mg of lactose (in the form of lactose monohydrate).
  If the patient has been diagnosed with an intolerance to some sugars, they should consult their doctor before taking Kelzy PR.

  3. How to take Kelzy PR

  This medicine should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
  Each pack contains 28 tablets. The patient should take one Kelzy PR tablet every day for 28 consecutive days, following the direction of the arrows, as follows: for the first 24 days, they should take one white active tablet per day, and then for the last 4 days, they should take one green placebo tablet.
  After taking the last tablet from the previous pack, the patient should continue taking Kelzy PR the next day, starting the next pack without a break between packs. A new pack will always be started on the same day of the week. Since there is no break in taking the medicine, it is essential to have the next pack ready before finishing the previous one.
  To help the patient remember to take the tablets, each pack of Kelzy PR contains 7 self-adhesive strips with the names of the days of the week. The patient should choose a strip that starts with the day of the week they want to start taking the tablets. For example, if the patient starts taking the tablets on a Wednesday, they should choose a strip that starts with "Wed". The strip should be stuck to the Kelzy PR pack in the section marked "Place the day-of-the-week sticker here".
  Then, each tablet will have a symbol for the day of the week, indicating the day on which the patient should take the tablet. The arrows show the order in which the tablets should be taken.
  During the 4 days when the patient takes the green placebo tablets (placebo days), they should experience bleeding (so-called withdrawal bleeding). This bleeding usually starts 2 or 3 days after taking the last white active tablet of Kelzy PR. After taking the last green tablet from the pack, the patient should start the next pack, regardless of whether the bleeding has stopped or not. This means that the patient will start new packs on the same day of the week and that the bleeding will occur at about the same time every month.
  If the patient takes Kelzy PR in this way, they will be protected against pregnancy during the 4 days of placebo tablets.

  Method and route of administration

  Each tablet should be swallowed with a little water if necessary. It does not matter whether the tablets are taken with or without food.

  When to start taking Kelzy PR

  If the patient has not taken a hormonal contraceptive in the previous month

  The patient should start taking Kelzy PR on the first day of their menstrual cycle (i.e. on the first day of their period). If the patient starts taking Kelzy PR on the first day of their period, they will be protected against pregnancy immediately. The patient can also start taking Kelzy PR on days 2-5 of their menstrual cycle, but in this case, they should use additional methods of contraception (e.g. condoms) for the first 7 days.

  Switching from a combined hormonal contraceptive or a combined hormonal contraceptive vaginal ring or patch

  The patient should start taking Kelzy PR preferably on the day after taking the last active tablet (tablet containing active substances) of their previous contraceptive, but no later than the day after the end of the period without taking tablets from their previous contraceptive (or after the last placebo tablet from their previous contraceptive). If the patient is switching from a vaginal ring or patch, they should start taking Kelzy PR on the day the ring or patch is removed, but no later than the day it would have been replaced.

  If the patient has been taking a progestogen-only contraceptive (progestogen-only pill, injection, implant, or intrauterine device (IUD) releasing progestogen)

  The patient can switch to Kelzy PR at any time, but they should use additional methods of contraception (e.g. condoms) for the first 7 days of taking Kelzy PR.

  If the patient starts taking Kelzy PR after a miscarriage in the first trimester of pregnancy

  The patient can start taking Kelzy PR immediately, but they should discuss this with their doctor first.

  If the patient starts taking Kelzy PR after childbirth or a miscarriage in the second trimester

  The patient can start taking Kelzy PR between 21 and 28 days after childbirth or miscarriage in the second trimester. If they start later than 28 days, they should use additional mechanical methods of contraception for the first 7 days of taking Kelzy PR. If the patient has had sexual intercourse before starting Kelzy PR, they should first make sure they are not pregnant or wait for their next period.
  This medicine should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

  Duration of use

  The doctor will inform the patient how long they should take the tablets.

  Overdose of Kelzy PR

  There are no reports of serious, harmful effects from taking too many Kelzy PR tablets at once. If the patient has taken several tablets at the same time, they may experience nausea, vomiting, and slight vaginal bleeding.

  Forgot to take Kelzy PR

  If the patient has missed a white active tablet(tablets 1-24), they should follow these instructions:

  • If it has been less than 24 hours since the usual time of taking the white active tablet, the contraceptive protection is not reduced. The patient should take the tablet as soon as possible and continue taking the tablets at the usual time.
  • If it has been more than 24 hours since the usual time of taking the white active tablet, the contraceptive protection may be reduced. The more tablets the patient has missed, the higher the risk of pregnancy.

  The risk of reduced contraceptive protection is highest if the patient misses a white active tablet at the beginning or end of the pack. In this situation, the patient should follow these rules:

  • Missed more than one tablet from the packThe patient should consult their doctor.
  • Missed one tablet in days 1-7 (first row of tablets in the pack)The patient should take the missed tablet as soon as they remember, even if it means taking two tablets at the same time. The patient should continue taking the tablets at the usual time and use additional contraception, such as condoms, for the next 7 days. If the patient has had sexual intercourse in the week before missing the tablet, they should consider the possibility of pregnancy. In this case, they should consult their doctor.
  • Missed one tablet in days 8-14 (second row of tablets in the pack)The patient should take the missed tablet as soon as they remember, even if it means taking two tablets at the same time. The patient should continue taking the tablets at the usual time. If the patient took all the tablets correctly in the 7 days before missing the tablet, the contraceptive protection is not reduced, and there is no need to use additional contraception.
  • Missed one tablet in days 15-24 (third or fourth row of tablets in the pack)There are two options, and the patient does not need to use additional contraception, provided they took all the tablets correctly in the 7 days before missing the tablet. If this is not the case, the patient should use the first of the two options and use additional contraception for 7 days.
  • 1. The patient should take the missed tablet as soon as they remember, even if it means taking two tablets at the same time. The patient should then continue taking the tablets at the usual time. However, instead of taking the green placebo tablets from the pack, the patient should skip them (discard them) and start the next pack (the start day will change). It is likely that the patient will experience bleeding towards the end of the second pack - during the placebo days - but they may also experience spotting or breakthrough bleeding during the second pack.
  • 2. The patient can also stop taking the white active tablets and go directly to taking the 4 green placebo tablets (before taking the placebo tablets, the patient should make a note of the day they missed the tablet). If the patient wants to start the next pack on the same day as before, they can take the placebo tablets for less than 4 days.

  If the patient follows one of these instructions, the contraceptive protection will be maintained.

  • If the patient misses any tablets from the current pack and does not experience bleeding during the placebo period, this may mean that they are pregnant. In this case, before starting the next pack, the patient should consult their doctor.

  If the patient misses one or more green placebo tablets, the contraceptive protection is maintained, provided the break between taking the last white active tablet from the current pack and the first white active tablet from the next pack does not exceed 4 days.

  4. Possible side effects

  Like all medicines, this medicine can cause side effects, although not everybody gets them.
  If you experience any side effects, especially severe and persistent ones or changes in your health that you consider related to the use of Kelzy PR, you should consult a doctor.
  In all women using combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, you should read section 2 "Important information before taking Kelzy PR".

  Severe side effects

  Detailed information on severe side effects related to the use of the medicine or related symptoms is described in section 2, "Important information before taking Kelzy PR", "Blood clots" and "Kelzy PR and cancer".
  You should read these sections to obtain additional information and, if necessary, consult a doctor.
  You should immediately consult a doctor 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 difficulty breathing (see also section 2, "Warnings and precautions").

  Other possible side effects

  In clinical trials of Kelzy PR, the following side effects were observed, listed according to their frequency:

  • vaginal infections, including fungal infections of the vulva and vagina and bacterial vaginosis
  • changes in libido, mood changes
  • headache
  • nausea, abdominal pain
  • acne
  • discomfort or pain in the breasts, painful menstruation, irregular bleeding between regular periods
  • weight gain, increased levels of thyroid-stimulating hormone and triglycerides in the blood.

  Uncommon side effects(may occur in less than 1 in 100 people):

  • urinary tract infection, presence of bacteria in the urine (bacteriuria)
  • hypothyroidism
  • changes in appetite, including decreased or increased appetite, high blood sugar levels
  • low mood, depression, anxiety disorders, mental disorders (including mental disorders, borderline personality type, and panic attacks), sleep disorders (such as insomnia or drowsiness)
  • dizziness, migraine
  • high blood pressure (hypertension)
  • harmful blood clots in the veins of the legs or feet (deep vein thrombosis)
  • abdominal distension
  • vomiting, diarrhea, bloating with gas
  • hair loss (alopecia)
  • itching of the skin (pruritus), skin irritation (dermatitis), rash
  • increased sweating (hyperhidrosis)
  • pain in the arms and legs
  • amenorrhea, irregular vaginal bleeding, changes in menstrual bleeding, pelvic pain, ovarian cysts, discharge and discomfort in the vulva and vagina, including itching or dryness, vulvovaginitis, cervical dysplasia (abnormal cell growth on the surface of the cervix), pain and/or cramps during sexual intercourse (dyspareunia)
  • fatigue
  • edema
  • weight loss
  • changes in blood test results: increased levels of creatine phosphokinase, cholesterol, increased activity of liver enzymes in the blood.

  Rare side effects(may occur in less than 1 in 1000 people):

  • eardrum inflammation, which can cause hearing loss and ear pain (eardrum inflammation)
  • genital herpes
  • benign breast tumor (breast fibroadenoma)
  • decreased white blood cell count in the blood
  • hyperthyroidism
  • fluid retention, lipid metabolism disorders (dyslipidemia)
  • taste disorders (taste disorders)
  • partial loss of touch sensation (hypoesthesia)
  • burning or tingling sensation, usually on the hands, arms, legs, or feet, but may also occur in other parts of the body (paresthesia)
  • eye itching, vision disorders
  • dizziness
  • rapid heartbeat (palpitations)
  • blood pressure fluctuations
  • hematoma (blood accumulation outside the blood vessels under the skin)
  • hot flashes
  • venous disorders, including spider veins and varicose veins
  • harmful blood clots in a vein or artery, for example:

  in the leg or foot (i.e., deep vein thrombosis)
  in the lungs (i.e., pulmonary embolism)

  • nasal bleeding
  • indigestion (dyspepsia)
  • constipation
  • gastroesophageal reflux
  • tooth sensitivity (dentin hypersensitivity)
  • skin diseases, dry skin, hives, chloasma (brownish skin discoloration)
  • joint pain
  • changes in urine test results: presence of red and white blood cells in the urine
  • irregular thickening of the endometrium
  • discomfort in the genital area
  • general malaise
  • changes in blood test results: increased activity of lactate dehydrogenase, increased levels of potassium, prolactin, D-dimer fibrin in the blood
  • abnormal blood pressure.

  Reporting side effects

  If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
  Side effects can also be reported to the marketing authorization holder.
  By reporting side effects, you can help provide more information on the safety of this medicine.

  5. How to store Kelzy PR

  The medicine should be stored out of sight and reach of children.
  Do not use this medicine after the expiry date stated on the carton and on the blister after "Expiry date (EXP)". The expiry date refers to the last day of the month stated.
  There are no special storage precautions for the medicine.
  Store the blister in the outer packaging to protect from light.
  Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

  6. Package contents and other information

  What Kelzy PR contains

  White tablets:

  • The active substances of the medicine are dienogest and ethinylestradiol.
  • Other ingredients are: Tablet core: lactose monohydrate, hypromellose, povidone K-30, magnesium stearate. Tablet coating: polyvinyl alcohol, partially hydrolyzed, titanium dioxide (E 171), macrogol 3350, talc, polyethylene glycol.

  Green tablets:

  • They do not contain active substances.
  • Other ingredients are: Tablet core: lactose monohydrate, corn starch, povidone K-30, colloidal silica, magnesium stearate. Tablet coating: hypromellose 2910, triacetin, polysorbate 80, titanium dioxide (E 171), indigo carmine, aluminum lake (E 132), yellow iron oxide (E 172).

  What Kelzy PR looks like and what the pack contains

  Kelzy PR is available in the form of prolonged-release tablets.
  Each carton contains 1, 3, 6, or 13 blisters, each blister contains 28 tablets (24 white tablets containing active substances and 4 green inactive tablets).
  In addition, a cardboard case for the blister is attached to the carton.
  Not all pack sizes may be marketed.

  Marketing authorization holder and manufacturer

  Marketing authorization holder

  Exeltis Poland Sp. z o.o.
  ul. Szamocka 8
  01-748 Warsaw
  e-mail: biuro@exeltis.com

  Manufacturer

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

  This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

  Austria
  Kelzy
  Belgium
  Kelsee
  Netherlands
  Kelzyn
  Ireland
  Kelzy
  Luxembourg
  Kelsee
  Poland
  Kelzy PR
  Sweden
  Peigit
  Hungary
  Kelsee

  Date of last revision of the leaflet:

  Other sources of information

  Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, http://www.urpl.gov.pl