Regulon

Patient Information Leaflet

Warning! Keep this leaflet. Information on the immediate packaging is in a foreign language.
Regulon (Desorelle 30)
0.03 mg + 0.15 mg, coated tablets
Ethinylestradiolum + Desogestrelum
Regulon and Desorelle 30 are different brand names for the same medicine.
Important information about combined hormonal contraceptives

• When used correctly, they are one of the most reliable reversible methods of contraception.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or after restarting use following a break of 4 weeks or more.
• Be vigilant and consult a doctor if you suspect symptoms of blood clot formation (see section 2 “BLOOD CLOTS”).

Please read this leaflet carefully before taking the medicine, as it contains
important information for you

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What Regulon is and what it is used for

Regulon is a combined oral contraceptive containing ethinylestradiol
(an estrogen) and desogestrel (a progestogen) in low doses.
The mechanism of action of Regulon involves inhibition of ovulation and changes in the consistency of cervical mucus. When used correctly, Regulon provides an effective and reversible method of contraception. However, in certain situations, its contraceptive effectiveness may be reduced or discontinuation of the medicine may be necessary (see section 2). In such cases, either sexual intercourse should be avoided or, to ensure effective contraception, other contraceptive methods should be used, such as condoms or spermicides.
Please remember that combined oral contraceptives, such as Regulon, do not protect against
sexually transmitted infections (such as AIDS). Only the use of condoms provides protective effect.

2. Important information before using Regulon

General notes
Before starting to take Regulon, you should read the information about blood clots (thrombosis) in section 2. It is particularly important to be aware of the symptoms of blood clots (see section 2 “BLOOD CLOTS”).
Regulon must not be used to delay the onset of bleeding.
In exceptional cases, if there is a need to delay the start of bleeding, consult your doctor.
Before starting Regulon, your doctor will ask you several questions about your health and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out other examinations.

When not to use Regulon
Do not use Regulon if you have any of the conditions listed below. If you have any of these conditions, inform your doctor. Your doctor will discuss with you which alternative method of contraception would be more suitable.

• If you are allergic to ethinylestradiol or desogestrel or any of the other ingredients of this medicine (listed in section 6). Symptoms of hypersensitivity may include: itching, rash or swelling;
• If you currently have (or have ever had) a blood clot in the blood vessels of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• If you know you have blood clotting disorders – for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• If you require surgery or will be immobile for a prolonged period (see section “BLOOD CLOTS”);
• If you have had a heart attack or stroke;
• If you have (or have previously had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• If you have any of the following conditions that may increase the risk of arterial blood clots:
  • severe diabetes with blood vessel damage,
  • very high blood pressure,
  • very high levels of fats in the blood (cholesterol or triglycerides),
  • a condition called hyperhomocysteinemia.
• If you currently have (or have previously had) a type of migraine called “migraine with aura”;
• If you currently have or have previously had pancreatitis;
• If you currently have or have previously had severe liver disease and liver function tests have not returned to normal;
• If you currently have or have previously had liver tumours;
• If you currently have, have previously had, or are suspected of having breast cancer or cancer of the genital organs;
• If you have unexplained vaginal bleeding;
• If you have an enlarged endometrium (abnormal growth of the uterine lining);
• If you are or may be pregnant.

Do not use Regulon in patients with hepatitis C who are taking medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also section “Regulon and other medicines”).

Warnings and precautions
Before starting Regulon, discuss this with your doctor or pharmacist.

When to contact your doctor
Seek immediate medical advice if:

• You notice possible symptoms of a blood clot, which may indicate that you have a blood clot in the leg (deep vein thrombosis), in the lungs (pulmonary embolism), a heart attack, or a stroke (see section below “BLOOD CLOTS”).

For a description of the symptoms of these serious adverse events, see “HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS”.

In certain situations, special caution is required when using Regulon or any other combined oral contraceptive. Regular check-ups by your doctor may also be necessary.

Tell your doctor if you have any of the following conditions.
If any of these conditions develop or worsen during treatment with Regulon, inform your doctor.

• If you smoke;
• If you are obese;
• If you have high blood pressure;
• If you have heart valve disorders or heart rhythm abnormalities;
• If you have superficial thrombophlebitis (inflammation of veins under the skin);
• If you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel diseases);
• If you have systemic lupus erythematosus (a disease affecting the body’s natural immune system);
• If you have haemolytic uraemic syndrome (a blood clotting disorder leading to kidney failure);
• If you have sickle cell anaemia (an inherited disorder of red blood cells);
• If you have been diagnosed with high levels of fats in the blood (hypertriglyceridaemia) or have a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• If you require surgery or will be immobile for a prolonged period (see section 2 “BLOOD CLOTS”);
• If you are in the immediate postpartum period, as you are at increased risk of blood clots. Consult your doctor for advice on how soon after delivery you can start taking Regulon;
• If you have varicose veins;
• If your close relatives currently have or have previously had breast cancer;
• If you have liver or gallbladder disease;
• If you have diabetes;
• If you have depression or mood changes;
• If you have epilepsy (see “Regulon and other medicines”);
• If you have a condition that first occurred during pregnancy or previous use of sex hormones (e.g. hearing loss, porphyria (a blood disorder), herpes gestationis (skin rash with blisters during pregnancy), Sydenham’s chorea (a nervous system disorder causing involuntary body movements));
• If you currently have or have ever had brownish patches (chloasma), also known as pregnancy mask, especially on the face. In such cases, avoid direct exposure to sunlight or ultraviolet radiation;
• If you have hereditary angioedema, products containing estrogens may trigger or worsen symptoms. You should contact your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with breathing difficulties.

BLOOD CLOTS
Using combined hormonal contraceptives such as Regulon increases the risk of blood clots compared to not using hormonal contraception. In rare cases, a blood clot can block a blood vessel and cause serious complications.

Blood clots can occur:

• in veins (called “venous thrombosis” or “venous thromboembolic disease”),
• in arteries (called “arterial thrombosis” or “arterial thromboembolic events”).

Recovery after a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.

Remember that the overall risk of harmful blood clots associated with the use of Regulon is low.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if you notice any of the following symptoms.

Do you experience any of these symptoms? What is the likely cause?

• Swelling of the leg or swelling along a vein in the leg or foot, Deep vein thrombosis especially if accompanied by:
  • pain or tenderness in the leg, which may occur only when standing or walking,
  • increased warmth in the affected leg,
  • change in skin colour of the leg, such as pallor, redness or blueness.
• Sudden onset of unexplained shortness of breath or rapid breathing; Pulmonary embolism
• Sudden cough without obvious cause, which may be associated with coughing up blood;
• Sharp chest pain, which may worsen on deep breathing;
• Severe dizziness or vertigo;
• Rapid or irregular heartbeat;
• Severe abdominal pain.

If you are unsure, consult your doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for milder conditions such as respiratory tract infections (e.g. cold).

Symptoms usually occur in one eye: Retinal vein thrombosis (blood clot in the eye)

• sudden loss of vision, or

• painless visual disturbances, which may progress to vision loss.

• Chest pain, discomfort, pressure, heaviness; Myocardial infarction

BLOOD CLOTS IN VEINS
What can happen if blood clots form in a vein?

• The use of combined hormonal contraceptives is associated with an increased risk of developing blood clots in veins (venous thrombosis). Although these adverse events are rare, they most commonly occur during the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, this may lead to the development of deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of developing blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher when restarting combined hormonal contraceptives (the same or another product) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher than in women who do not use combined hormonal contraceptives.
If a patient stops taking Regulon, the risk of blood clots returns to normal within a few weeks.

What does the risk of developing blood clots in veins depend on?
The risk depends on the natural risk of developing venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs associated with using Regulon is low.

• In the course of one year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• In the course of one year, about 5–7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• In the course of one year, about 9 to 12 out of 10,000 women who use combined hormonal contraceptives containing desogestrel, such as Regulon, will develop blood clots.
• The risk of developing blood clots depends on the individual's medical history (see "Factors increasing the risk of developing blood clots in veins" below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Regulon is small, but certain factors may increase this risk. The risk is higher:

• if the patient is overweight (body mass index (BMI) above 30 kg/m²);
• if a close relative of the patient has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years of age). In such cases, the patient may have an inherited clotting disorder;
• if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to temporarily discontinue Regulon a few weeks before surgery or during immobilization. If the patient must stop taking Regulon, consult the doctor about when it is safe to resume;
• with increasing age (especially over 35 years);
• if the patient has recently given birth (within the past few weeks).

The risk of venous blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is important to inform the doctor if any of these risk factors apply, even if uncertain. The doctor may decide to discontinue Regulon.
Inform the doctor if any of the above conditions change during treatment with Regulon, for example, if a close relative develops unexplained thrombosis or if the patient gains significant weight.

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries?
Similar to venous clots, arterial clots can lead to serious consequences, such as myocardial infarction (heart attack) or stroke.

Factors increasing the risk of arterial blood clots
It is important to emphasize that the risk of heart attack or stroke associated with Regulon is very small, but it may increase:

• with age (over approximately 35 years);
• if the patient smokes. While using hormonal contraceptives such as Regulon, smoking should be discontinued. 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 a close relative has had a heart attack or stroke at a young age (under 50 years). In such cases, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close relative has high levels of blood lipids (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valvular heart disease, arrhythmia such as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any condition is particularly severe, the risk of arterial blood clots may be further increased.
Inform the doctor if any of the above conditions change during treatment with Regulon, for example, if the patient starts smoking, a close relative develops unexplained thrombosis, or if the patient gains significant weight.

The pill and cancer
Breast cancer is diagnosed slightly more frequently in women using oral contraceptives than in women of the same age who do not use them. This small increase in incidence gradually disappears within 10 years after stopping oral contraceptives. It is not known whether this difference is caused by the use of oral contraceptives. It may be related to the fact that women using oral contraceptives undergo more frequent medical examinations, leading to earlier detection of breast cancer.
Benign liver tumors have been reported in rare cases, and malignant liver tumors in even rarer cases, in women using oral contraceptives. If the patient experiences an unusual, severe abdominal pain, she should contact her doctor.

Psychiatric disorders
Some women using hormonal contraceptives, including Regulon, have reported depression or mood changes. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact the doctor as soon as possible for further medical advice.

Intermenstrual bleeding
During the first few months of taking Regulon, unexpected bleeding (bleeding outside the withdrawal week) may occur. If such bleeding persists for longer than a few months or starts after several months, the doctor should investigate the cause.

What to do if withdrawal bleeding does not occur during the pill-free week
If all tablets have been taken correctly, there have been no vomiting or severe diarrhea, and no other medications have been taken, the likelihood of pregnancy is very low.
If the expected withdrawal bleeding does not occur twice in a row, pregnancy may be possible. The patient should contact the doctor immediately. The next pack of Regulon should only be started once pregnancy has been ruled out.

Children and adolescents
The safety and efficacy of desogestrel in adolescents under 18 years of age have not been established. No data are available.

Regulon and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use. Also inform any other doctor, dentist, or pharmacist prescribing another medicine about the use of Regulon. They may advise whether additional contraceptive methods (e.g., condoms) are needed and for how long.
Regulon should not be used in patients with hepatitis C who are taking medicinal products containing ombitasvir or paritaprevir or ritonavir and dasabuvir or glecaprevir/pibrentasvir, as this may lead to abnormal liver function test results (increased liver enzyme ALT activity). Before starting these medications, the doctor will prescribe a different contraceptive method. Regulon may be restarted approximately 2 weeks after stopping the above-mentioned treatment. See section "When not to use Regulon".
Some medicines may affect blood levels of Regulon, leading to reduced contraceptive effectiveness and unexpected bleeding. These include medicines used to treat:

• epilepsy (e.g., phenytoin, phenobarbital, primidone, carbamazepine, felbamate, oxcarbazepine, topiramate);
• tuberculosis (e.g., rifampicin, rifabutin);
• HIV infection (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz, nelfinavir);
• hepatitis C virus infection (boceprevir, telaprevir);
• fungal infections (griseofulvin);
• pulmonary hypertension (bosentan);
• herbal products containing St. John's wort (Hypericum perforatum). If the patient wishes to use herbal products containing St. John's wort while taking Regulon, she should consult her doctor first.

The following medicines may impair tolerance to Regulon:

• ketoconazole, itraconazole, fluconazole (used to treat fungal infections);
• macrolide antibiotics such as clarithromycin, erythromycin (used to treat bacterial infections);
• calcium channel blockers such as diltiazem (used to treat certain heart conditions and high blood pressure);
• etoricoxib (used to treat arthritis and osteoarthritis).

Regulon may affect the action of other medicines, for example:

• cyclosporine (a medicine used to prevent organ transplant rejection);
• the antiepileptic lamotrigine (which may lead to increased seizure frequency);
• tizanidine (used to treat muscle spasticity);
• levothyroxine (used to treat hormone deficiency);
• theophylline (used to treat asthma).
  Before taking any medicine, consult a doctor or pharmacist.

Before laboratory tests
Inform the doctor or laboratory staff about the use of oral contraceptives, as they may affect the results of certain laboratory tests.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Regulon must not be used during pregnancy. If the patient is pregnant or suspects pregnancy, she should stop taking Regulon immediately and inform her doctor without delay.
Regulon is not recommended during breastfeeding. If the patient is breastfeeding and wishes to use Regulon, she should consult her doctor.

Driving and operating machinery
Regulon does not affect the ability to drive or operate machinery.

Regulon contains monohydrate lactose
If the patient has been previously diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.

3. How to use Regulon

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Each Regulon pack contains 1 blister of 21 coated tablets or 3 blisters of 21 coated tablets each. Special markings on the blisters with symbols for the days of the week (see "Translation of symbols for days of the week located next to each tablet in the immediate packaging" section 6 of the leaflet) help ensure regular use of the contraceptive tablets.
Each tablet in the pack is marked with the symbol of the day of the week on which it should be taken. Take 1 tablet daily for 21 consecutive days, following the direction of the arrow on the blister, until the blister is completely empty.
After taking all 21 tablets from the blister, a 7-day tablet-free interval follows. During the 2nd or 3rd day of this interval, withdrawal bleeding resembling menstrual bleeding should occur.
Start taking tablets from the next blister on the 8th day (after the 7-day tablet-free interval), even if bleeding has not yet stopped. With regular use of Regulon, the start of tablets from the next pack will always fall on the same day of the week, and bleeding will occur on the same day of the month.
Tablets should always be taken at the same time of day.
Taking the tablets in the morning (first activity of the day) or late in the evening (last activity before sleep) may help ensure regular use.
Swallow the tablets whole, with water if necessary.

How to start using Regulon
If no hormonal contraceptives have been used in the previous month
Begin taking tablets on the first day of the woman's natural menstrual cycle (i.e., the first day of menstruation). Starting between the 2nd and 5th day is also acceptable, but during the first cycle, additional mechanical contraceptive methods (e.g., condoms) should be used for the first 7 days of tablet intake.

Switching from another combined contraceptive (pill, vaginal ring, transdermal patch)
The woman should start taking Regulon the day after taking the last active tablet of the previous oral contraceptive, or at the latest on the first day of the usual tablet-free interval or after taking the last placebo tablet of the previous oral contraceptive. Additional contraceptive methods are not required.
If the patient previously used a vaginal ring or transdermal system, she should start taking Regulon on the day of removal of the system, or at the latest on the day the next application would normally occur. Additional contraceptive methods are not required.

Switching from progestogen-only contraceptives (mini-pills, injections, implants)
The woman may switch to Regulon at any time from a progestogen-only pill (from an implant on the day of removal, or from an injectable form on the day of the next scheduled injection), but additional barrier methods must be used for the first 7 days of tablet intake.

Use after first-trimester abortion
Begin taking tablets immediately. Additional contraceptive methods are not required.

Use after childbirth or second-trimester abortion
Breastfeeding women – see section: "Pregnancy and breastfeeding".
The doctor will advise the patient to start taking tablets between the 21st and 28th day after childbirth or second-trimester abortion. If tablet intake begins later, additional mechanical contraceptive methods (e.g., condoms) should be used for the first 7 days of tablet intake. However, if the woman has already had sexual intercourse, she should either confirm she is not pregnant before starting tablets or wait for the onset of the first menstrual period.

Use of a higher than recommended dose of Regulon
If an overdose of Regulon occurs, there is no risk of serious health problems, although nausea, vomiting, or slight vaginal bleeding may occur in young girls. If such symptoms occur, contact a doctor, who will provide appropriate treatment if necessary.

Missed dose of Regulon
If a dose of Regulon is missed, follow the rules below.
If tablet intake is delayed by less than 12 hours, contraceptive protection is not reduced. The woman should take the missed tablet as soon as she remembers, and continue taking subsequent tablets at the usual time.
If tablet intake is delayed by more than 12 hours, contraceptive protection may be reduced. The more tablets missed, the greater the risk of reduced contraceptive effectiveness. The risk of pregnancy is higher if a tablet is missed at the beginning or end of the cycle. Please review the information below (see also the diagram).

More than one missed tablet in a pack
Consult a doctor.
In case of missed tablets, follow these two basic principles:

1. The continuous tablet-free interval should never exceed 7 days.
2. Continuous intake of tablets for 7 days is necessary to adequately suppress the hypothalamic-pituitary-ovarian axis.

According to this, in daily practice, the doctor may give the following advice:
Week 1
The patient should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. Then continue taking tablets at the usual time. Use additional mechanical contraceptive methods (e.g., condoms) for the next 7 days. If sexual intercourse occurred in the 7 days before the missed tablet, consider the possibility of pregnancy. The more tablets missed and the closer to the tablet-free interval, the higher the risk of pregnancy.

Week 2
The patient should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. Then continue taking tablets at the usual time. If tablets were taken correctly for the 7 days preceding the missed tablet, additional contraceptive methods are not required. However, if this was not the case or if more than one tablet was missed, use additional contraception for 7 days.

Week 3
The risk of reduced contraceptive protection is inevitable due to the approaching tablet-free interval. However, this can be prevented by adjusting the way tablets are taken. Thus, additional contraceptive methods are not necessary if one of the two alternative approaches below is followed, provided all tablets were taken correctly during the 7 days preceding the missed tablet. Otherwise, follow the first of the two alternative approaches and use additional contraception for the next 7 days.

1. The patient should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. Then continue taking tablets at the usual time. Start the next pack immediately after the last tablet of the current pack, i.e., without a tablet-free interval between packs. Withdrawal bleeding will probably not occur until the end of the next pack, but breakthrough bleeding or spotting may occur during tablet intake.
2. The doctor may advise the patient to stop taking tablets from the current pack. In this case, the patient should have a tablet-free interval of up to 7 days (including the days when tablets were missed), then continue taking tablets from the next pack.

If a woman missed tablets and no withdrawal bleeding occurred during the first tablet-free interval, consider the possibility of pregnancy.

Missed more than one tablet in a cycle → Consult a doctor
Yes
Sexual intercourse in the week preceding the missed tablet
Week 1
No

• Take the missed tablet
• Use additional contraception for 7 days
• Finish the pack

Missed only one tablet (tablet-free interval longer than 12 hours)
Week 2

• Take the missed tablet
• Finish the pack

Week 3

• Take the missed tablet
• Do not take a 7-day break
• Continue with tablets from the next pack
  or
• Discard the remaining tablets in the pack
• Take a break (no more than 7 days total, including the day of the missed tablet)
• Continue with tablets from the next pack

Use of Regulon in case of vomiting or severe diarrhoea
If vomiting or severe diarrhoea occurs within 3 to 4 hours after taking a tablet, the tablet may not be fully absorbed. In this case, follow the recommendations for missed tablets described above. If the patient does not wish to change her usual way of taking tablets, she should take an additional tablet (tablets) from another pack.

How to delay withdrawal bleeding
If Regulon is taken correctly, withdrawal bleeding will always occur on the same day of the month.
To delay withdrawal bleeding, continue taking Regulon from the next blister immediately after finishing one blister, without a tablet-free interval.
Tablet intake can be continued until the second pack is finished. During intake of the second pack, breakthrough bleeding or spotting may occur.
Regular intake of Regulon should resume after a 7-day tablet-free interval.

To shift withdrawal bleeding to a different day of the week than usual, different from the day on which bleeding currently occurs, shorten (but never extend) the upcoming tablet-free interval by any number of days. For example, if bleeding currently starts on Friday, but Tuesday (3 days earlier) is preferred, start taking tablets from the next pack 3 days earlier. The shorter the tablet-free interval, the higher the risk that withdrawal bleeding will not occur and that breakthrough bleeding or spotting will appear during intake of the next pack (similar to delaying withdrawal bleeding).

Absence of withdrawal bleeding
If contraceptive tablets were taken correctly, with no vomiting or severe diarrhoea, and no other medicines were taken concurrently, the likelihood of pregnancy is very low. Continue taking tablets as usual.
If no bleeding occurs in two consecutive cycles, pregnancy is possible. In this case, contact a doctor immediately. Contraceptive tablets may be continued only after pregnancy has been ruled out, as directed by a doctor.

Discontinuation of Regulon
Regulon may be discontinued on any chosen day. If discontinuation of contraceptive tablets is due to planned pregnancy, another contraceptive method should be used until menstrual bleeding occurs. This will assist the doctor in determining the due date.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any adverse effects occur, especially severe or persistent ones, or any changes in health that the patient considers related to the use of Regulon, medical advice should be sought from a doctor.

All women using combined hormonal contraceptives have an increased risk of developing blood clots in veins (venous thromboembolic disease) or blood clots in arteries (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2 "Important information before using Regulon".

Common (may affect up to 1 in 10 people): depression, mood changes, headache, nausea, abdominal pain, breast pain, breast tenderness, weight gain.

Uncommon (may affect up to 1 in 100 people): fluid retention, decreased libido, migraine, vomiting, diarrhoea, rash, urticaria, breast enlargement.

Rare (may affect up to 1 in 1000 people): hypersensitivity, increased libido, eye irritation due to contact lenses, skin disorders (nodular erythema, erythema multiforme), abnormal cervical smear, galactorrhoea, weight loss.

Harmful blood clots in a vein or artery, for example:
• in the leg or foot (e.g. deep vein thrombosis),
• in the lungs (e.g. pulmonary embolism),
• heart attack,
• stroke,
• mini-stroke or transient ischaemic attack (TIA),
• blood clots in the liver, stomach, intestines, kidneys or eye.

The likelihood of developing blood clots may be higher if the patient has other risk factors (see section 2 for further information on factors increasing the risk of blood clots and symptoms of their occurrence).

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Regulon

Keep this medicine out of sight and reach of children.
Store below 30°C. Keep in the original packaging.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Regulon contains
The active substances are ethinylestradiol and desogestrel. One coated tablet contains
30 micrograms of ethinylestradiol and 150 micrograms of desogestrel.
The other components are:
Tablet core: all-rac-α-Tocopherol, magnesium stearate, colloidal anhydrous silica, stearic acid,
povidone K 30, potato starch, lactose monohydrate.
Coating: propylene glycol, macrogol 6000, hypromellose.

What Regulon looks like and contents of the pack
White or almost white, round, biconvex tablets, engraved with the codes: "RG" on one side and "P8" on the other.
The cardboard box contains 1 blister or 3 blisters with 21 coated tablets each. A cardboard pouch is included in the package, intended for storing the blister.

For more detailed information, please contact the marketing authorisation holder or the parallel importer:

Marketing authorisation holder in Belgium, country of export:
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest, Hungary

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

Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland

Belgium, country of export, marketing authorisation number: BE 339421
Parallel import authorisation number: 159/12

Translation of the weekday symbols printed next to each tablet in the immediate packaging:
Lu, Mo, ma - Monday
Ma, Di, di - Tuesday
Me, Mi, woe - Wednesday
Je, Do, don - Thursday
Ve, Fr, vrij - Friday
Sa, zat - Saturday
Di, So, zon - Sunday