Regulon

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Warning! Keep this leaflet. The 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 treatment following a break of 4 weeks or more.
• Be vigilant and consult your doctor if you suspect symptoms of blood clots (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 you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm someone else.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

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 package 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 circumstances, its contraceptive effectiveness may be reduced or discontinuation of the medicine may be necessary (see section 2). In such cases, either abstain from sexual intercourse or use other contraceptive methods (e.g. condoms or spermicides) to ensure effective contraception.
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 action.

2. Important information before using Regulon

General information
Before starting to take Regulon, you should read the information about blood clots (thrombosis) in section 2. It is especially important to be aware of the symptoms of blood clots (see section 2, "Blood clots").
Regulon should not be used to delay the onset of bleeding.
In exceptional circumstances, when there is a need to delay the start of bleeding, you should 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 case, may carry out some other examinations.

When not to use Regulon
Do not use Regulon if any of the following conditions apply to you. If any of these conditions apply, inform your doctor. Your doctor will discuss with you which alternative method of contraception may 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 your legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• If you know you have disorders affecting blood clotting – 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 cancer of the breast or 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, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Regulon and other medicines").

Warnings and precautions
Before starting Regulon, discuss this with your doctor or pharmacist.
When should you contact your doctor?
Seek immediate medical advice if:

• You notice possible symptoms of blood clots, which may indicate that you have a blood clot in your leg (deep vein thrombosis), in your lungs (pulmonary embolism), a heart attack, or a stroke (see section below, "Blood clots").

For a description of the symptoms of these serious adverse effects, see "How to recognize blood clots".
Special caution may be required when using Regulon or any other combined oral contraceptive, particularly in certain situations. 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 symptoms develop or worsen during treatment with Regulon, inform your doctor.

• If you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives, potentially with breathing difficulties, seek immediate medical attention. Medicinal products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.
• 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 hemolytic uremic syndrome (a blood clotting disorder causing kidney failure);
• If you have sickle cell anemia (a hereditary disorder of red blood cells);
• If you have high blood fat levels (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia 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 have recently given birth, as you are at increased risk of blood clots. Consult your doctor to find out 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 appeared 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 movements));
• If you currently have or have ever had brownish pigmentation (chloasma), particularly on the face. In such cases, avoid direct exposure to sunlight or ultraviolet radiation.

BLOOD CLOTS
Using combined hormonal contraceptives such as Regulon is associated with an increased risk of blood clots compared to not using such therapy. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur:

• in veins (referred to as "venous thrombosis" or "venous thromboembolic disease");
• in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic events").

Complete recovery after a blood clot is not always possible. 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 caused by using Regulon is low.

HOW TO RECOGNIZE BLOOD CLOTS
Seek immediate medical advice if you notice any of the following symptoms.
Are you experiencing any of these symptoms? What might be 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 unexplained shortness of breath or rapid breathing – Pulmonary embolism;
• Sudden coughing without an obvious cause, possibly accompanied by 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 infection (e.g., cold).
Symptoms most commonly affecting one eye: Retinal vein thrombosis

• sudden loss of vision or (blood clot in the eye)
• painless visual disturbances, which may progress to

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 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 blood clots in veins the highest?
The risk of developing blood clots in veins is greatest during the first year of first-time use of combined hormonal contraceptives. The risk may also be higher when restarting combined hormonal contraceptives (the same or a different 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 developing blood clots returns to normal within a few weeks.

What factors influence the risk of blood clots in veins?
The risk depends on the individual's natural risk of 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 who 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 patient's individual medical history (see "Factors increasing the risk of 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, however,
some factors may increase this risk. The risk is higher:

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

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

ARTERIAL BLOOD CLOTS
What can happen if blood clots form in arteries?
As with venous blood 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 the use of Regulon is very low, but may increase:

• with age (over approximately 35 years);
• if the patient smokes. When using a hormonal contraceptive such as Regulon, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using 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 this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close relative has been diagnosed with high blood lipid levels (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly migraines with aura;
• if the patient has heart disease (valve disorder, cardiac arrhythmia known as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them are 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, e.g., if the patient starts smoking, a close relative is diagnosed with unexplained thrombosis, or if the patient gains significant weight.

Regulon and cancer
Breast cancer occurs slightly more frequently in women using oral contraceptives than in women of the same age who do not use them. This small increase in breast cancer 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 medical examinations more frequently, leading to earlier detection of breast cancer.
Benign liver tumors have been reported, rarely, in women using oral contraceptives, and malignant liver tumors have been reported even more rarely. 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 disturbances. Depression can be severe and may sometimes lead to suicidal thoughts. If mood changes or symptoms of depression occur, contact the doctor immediately for further medical advice.

Intermenstrual bleeding
During the first few months of taking Regulon, unexpected bleeding (bleeding outside the pill-free week) may occur. If such bleeding persists for longer than a few months, or if it 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, without vomiting, severe diarrhea, or concomitant use of other medications, it is very unlikely that the woman is pregnant.
If the expected withdrawal bleeding does not occur twice in succession, pregnancy may be possible. The patient should contact her 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 Regulon in adolescents under 18 years of age have not been established. No data are available.

Regulon and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take. Also inform any other doctor or dentist (or pharmacist) who prescribes another medicine about the use of Regulon. The doctor may advise whether additional contraceptive methods (e.g., condoms) should be used, and if so, for how long.
Do not use Regulon in patients with hepatitis C who are taking medicinal products containing ombitasvir or paritaprevir or ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these drugs may cause abnormal liver function test results (increased activity of liver enzymes ALT).
Before starting these medications, the doctor will prescribe a different type of contraception.
Regulon may be restarted approximately 2 weeks after completion of the above-mentioned treatment. See section "When not to use Regulon."
Some medicines may affect the 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 infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz, nelfinavir), hepatitis C virus infections (boceprevir, telaprevir), fungal infections (griseofulvin), high blood pressure in the pulmonary blood vessels (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 first consult her doctor.

The following medicines may reduce 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, e.g.:
o cyclosporine (a medicine used to prevent organ transplant rejection),
o the antiepileptic drug lamotrigine (this may lead to increased seizure frequency),
o tizanidine (a medicine used to treat muscle spasticity),
o levothyroxine (a medicine used to treat hormone deficiency),
o theophylline (a medicine used to treat asthma).
Before taking any medicine, consult your doctor or pharmacist.

Before laboratory tests
Inform the doctor or laboratory staff about the use of oral contraceptives, as oral contraceptives 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 her doctor or pharmacist before using this medicine.
Do not use Regulon if the patient is pregnant. If the patient is pregnant or suspects pregnancy, she should immediately stop taking Regulon and inform her doctor without delay.
Regulon is not recommended during breastfeeding. If the patient is breastfeeding and wishes to use Regulon during this period, she should consult her doctor.

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

Regulon contains monohydrate lactose.
If the patient has previously been 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 taken exactly as instructed by your doctor. If in doubt, consult your doctor or pharmacist.
Each pack of Regulon contains 1 blister strip with 21 coated tablets. Special markings on the blister indicating the days of the week 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 (see "Explanation of day-of-the-week symbols on the immediate packaging" at the end of this leaflet). One tablet should be taken 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, a 7-day break from tablets follows. During the 2nd or 3rd day of this break, withdrawal bleeding resembling menstruation should occur.
The next pack should be started on the 8th day (after the 7-day tablet-free interval), even if bleeding has not yet stopped. With regular use of Regulon, starting each new pack will always fall on the same day of the week, and bleeding will occur on the same day each month.
Tablets should always be taken at the same time of day.
Taking the tablets in the morning (as the first activity of the day) or late in the evening (as the last activity before going to sleep) may help ensure regular use.
Tablets should be swallowed whole, with water if necessary.

How to start taking Regulon
If no hormonal contraceptives have been used in the previous month
Tablets should be started 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 in this case, 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 hormonal contraceptive (oral tablet, 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 after 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 patch, 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 have occurred. Additional contraceptive methods are not required.

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

After first-trimester abortion
Tablet intake should be started immediately. Additional contraceptive methods are not required.

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 is started 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 be confirmed not pregnant before starting tablets, or wait for the onset of the first menstrual period.

Taking more than the recommended dose of Regulon
In case of Regulon overdose, there is no risk of serious health problems, although nausea, vomiting, or slight vaginal bleeding in young girls may occur. If such symptoms occur, consult 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 efficacy. The risk of pregnancy is higher if a tablet is missed at the beginning or end of the cycle. Please refer to the information below (see also the chart).

More than one tablet missed from the pack
Consult your doctor.
In case of missed tablets, the following two basic rules should be observed:

1. The break in continuous tablet intake should never exceed 7 days.
2. Tablets must be taken continuously for 7 days to ensure adequate suppression of the hypothalamic-pituitary-ovarian axis.

Based on 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 she should continue taking tablets at the usual time of day. For the next 7 days, additional mechanical contraceptive methods (e.g., condoms) should be used. If sexual intercourse occurred in the 7 days before the missed tablet, the possibility of pregnancy should be considered. 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 she should continue taking tablets at the usual time of day. If tablets were taken correctly for the 7 days preceding the missed tablet, no additional contraceptive method is needed. However, if this was not the case, or if more than one tablet was missed, an additional contraceptive method should be used 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. Therefore, additional contraceptive methods are not required if one of the two alternative procedures below is followed, provided that all tablets were taken correctly during the 7 days preceding the missed tablet. Otherwise, the first of the two alternative procedures should be followed, and an additional contraceptive method should be used 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 she should continue taking tablets at the usual time of day. The next pack should be started immediately after taking the last tablet of the current pack, i.e., without a break between packs. Withdrawal bleeding will probably not occur until after finishing the next pack, but spotting or breakthrough bleeding 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 take a break from tablets for up to 7 days, including the days when tablets were missed, and then continue with the next pack.

If a woman missed tablets and no withdrawal bleeding occurred during the first tablet-free interval, pregnancy should be considered.

yes
week 1 sex ratio during the week
preceding the missed tablet
no

• take the missed tablet
• use an additional method of contraception for 7 days
• finish the pack

Only 1 tablet missed week 2

• take the missed tablet (gap longer
• finish the pack than 12 hours)
• take the missed tablet
• finish the pack
• do not take the 7-day break
• continue taking tablets from the next pack week 3 or
• discard the remaining tablets in the pack
• take a break (no longer than 7 days, including the day of the missed tablet)
• continue taking 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 completely 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(s) from another pack.

Delaying 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 pack without a break after finishing the current one.
Tablet intake may be continued until the second pack is finished. Breakthrough bleeding or spotting may occur during use of the second pack.
Regular intake of Regulon should resume after a 7-day break from tablets.

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

Absence of withdrawal bleeding
If contraceptive tablets have been taken correctly, without vomiting or severe diarrhoea, and no other medications have been taken concurrently, the likelihood of pregnancy is very low. Continue taking tablets as usual.

If withdrawal bleeding does not occur in two consecutive cycles, pregnancy is possible. In such a case, contact a doctor immediately. Contraceptive tablets may only be continued after pregnancy has been ruled out, as advised by a doctor.

Discontinuation of Regulon
Regulon may be discontinued on any chosen day. If contraceptive tablets are discontinued due to planned pregnancy, another method of contraception should be used until menstrual bleeding occurs. This will assist the doctor in determining the expected date of delivery.

If you have any further questions concerning 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 and persistent ones, or changes in health status that the patient considers to be related to the use of Regulon, medical advice should be sought.
Patients should contact their doctor immediately if they experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing or urticaria potentially associated with breathing difficulties (see also section "Warnings and precautions").

All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolic disease) or blood clots in the 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 taking 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 eyes.

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 blood clots).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, patients should inform their doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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

Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Regulon

Keep this medicine out of sight and reach of children.
Do not store above 30°C. Store 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. Such measures help protect the environment.

6. Contents of the packaging 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.
Other ingredients are:
Tablet core: potato starch, stearic acid, all-rac-α-tocopherol, lactose monohydrate,
magnesium stearate, colloidal anhydrous silica, povidone K 30.
Coating: hypromellose, macrogol 6000, propylene glycol.

What Regulon looks like and contents of the pack
White or almost white, round, biconvex tablets, with embossed markings: “RG” on one side and “P8” on the other.
The cardboard box contains 1 blister with 21 coated tablets. The blister should be placed in the cardboard sachet provided with the package.
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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation Number in Belgium, country of export: BE339421
Parallel Import Licence Number: 287/19

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