Regulon

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Regulon (Desorelle 30)

0.03 mg + 0.15 mg, coated tablets

Ethinylestradiol+ Desogestrel
Regulon and Desorelle 30 are different trade names for the same drug.
Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• To a small extent, they 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.
• One should be vigilant and consult a doctor if the patient suspects that symptoms of blood clots have occurred (see section 2 "BLOOD CLOTS").

One should carefully read the contents of the leaflet before using the drug, as it contains important information for the patient

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, one should consult a doctor or pharmacist.
• This drug has been prescribed to a specific person. It should not be given to others. The drug may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Regulon and what is it used for
• 2. Important information before using Regulon
• 3. How to use Regulon
• 4. Possible side effects
• 5. How to store Regulon
• 6. Package contents and other information

1. What is Regulon and what is it used for

Regulon is a combined oral contraceptive containing ethinylestradiol (estrogen) and desogestrel (progestogen) in small doses.
The mechanism of action of Regulon involves inhibiting ovulation and causing 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 it may be necessary to discontinue the drug (see section 2). In such cases, it is recommended to either abstain from sexual intercourse or use other contraceptive methods, such as condoms or spermicides.

One should remember that combined oral contraceptives, such as Regulon, do not protect

against infection with sexually transmitted diseases (such as AIDS).Only the use of condoms has a protective effect.

2. Important information before using Regulon

General notes

Before starting to take Regulon, one should familiarize themselves with the information about blood clots (thrombosis) in section 2. It is especially important to familiarize oneself with the symptoms of blood clots (see section 2 "BLOOD CLOTS").
Regulon should not be used to delay the start of bleeding.
In exceptional situations, when there is a need to delay the start of bleeding, one should consult a doctor.
Before starting to use Regulon, the doctor will ask the patient a few questions about their health and the health of their close relatives. The doctor will also measure blood pressure and, depending on the individual case, may also perform some other tests.

When not to use Regulon

Regulon should not be used if the patient has any of the following conditions. If the patient has any of the following conditions, they should inform their doctor. The doctor will discuss with the patient which other contraceptive method will be more suitable.

• If the patient is allergic to ethinylestradiol or desogestrel or any of the other ingredients of this drug (listed in section 6). Symptoms of hypersensitivity may include: itching, rash, or swelling;
• If the patient currently has (or has ever had) a blood clot in the blood vessels of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• If the patient knows they have disorders that affect blood clotting - such as protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies;
• If the patient requires surgery or will be immobilized for a long time (see section "BLOOD CLOTS");
• If the patient has had a heart attack or stroke;
• If the patient has (or has had in the past) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or transient ischemic attack (temporary symptoms of stroke);
• If the patient has any of the following diseases, which may increase the risk of a blood clot in an artery:
• severe diabetes with vascular damage,
• very high blood pressure,
• very high levels of fats in the blood (cholesterol or triglycerides),
• a disease called hyperhomocysteinemia.
• If the patient has (or has had in the past) a type of migraine called "migraine with aura";
• If the patient has (or has had in the past) pancreatitis;
• If the patient has (or has had in the past) severe liver diseases, and liver function tests have not returned to normal;
• If the patient has (or has had in the past) liver tumors;
• If the patient has, has had, or suspects they have breast cancer or cancer of the genital organs;
• If the patient has unexplained vaginal bleeding;
• If the patient has an enlarged endometrium (abnormal growth of the uterine lining);
• If the patient is pregnant or breastfeeding.

Regulon should not be used in patients with hepatitis C and taking medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentaswir (see also section "Regulon and other drugs").

Warnings and precautions

Before starting to use Regulon, one should discuss it with their doctor or pharmacist.
When should one contact their doctor?
One should immediately contact their doctor

• if the patient notices possible symptoms of blood clots, which may indicate that the patient has blood clots in the leg (deep vein thrombosis), blood clots in the lungs (pulmonary embolism), a heart attack, or a stroke (see below "BLOOD CLOTS").

In order to obtain a description of the symptoms of these serious side effects, see "HOW TO RECOGNIZE BLOOD CLOTS".
In certain situations, one should be particularly careful when using Regulon or any other combined oral contraceptives. Regular medical check-ups may also be necessary.

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

If these symptoms occur or worsen during the use of Regulon, one should also tell their doctor.

• if the patient smokes;
• if the patient is overweight;
• if the patient has high blood pressure;
• if the patient has heart valve defects or heart rhythm disorders;
• if the patient has superficial thrombophlebitis (inflammation of the veins under the skin);
• if the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if the patient has systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if the patient has hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if the patient has sickle cell anemia (a genetic disorder of red blood cells);
• if the patient has been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or has a family history of this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if the patient is about to undergo surgery or will be immobilized for a long time (see section "BLOOD CLOTS");
• if the patient has recently given birth, as they are at increased risk of blood clots. The doctor should be consulted to determine how soon Regulon can be started after giving birth;
• if the patient has varicose veins;
• if any of the patient's close relatives have had breast cancer;
• if the patient has liver or gallbladder disease;
• if the patient has diabetes;
• if the patient has depression or mood changes;
• if the patient has epilepsy (see "Regulon and other drugs");
• if the patient has a disease that first appeared during pregnancy or while using hormonal contraceptives (e.g., hearing loss, a blood disease called porphyria, herpes gestationis (a skin rash that occurs during pregnancy), Sydenham's chorea (a neurological disorder characterized by involuntary movements of the body));
• if the patient has or has ever had chloasma (melasma), especially on the face. In such cases, one should avoid direct exposure to sunlight or ultraviolet radiation;
• if the patient has hereditary angioedema, estrogen-containing products may cause or worsen its symptoms. The patient should immediately contact their doctor if they experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or breathing.

If one experiences any of these symptoms, they should immediately contact their doctor.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Regulon, is associated with an increased risk of blood clots, compared to when no therapy is used. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can occur

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

Not everyone recovers fully from a blood clot. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

One should remember that the overall risk of serious blood clots caused by Regulon is small.

HOW TO RECOGNIZE BLOOD CLOTS

One should immediately contact their doctor 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

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by: Deep vein thrombosis
• pain or tenderness in the leg, which may only be felt when standing or walking,
• increased temperature in the affected leg,
• change in skin color in the affected leg, such as pallor, redness, or discoloration.
• sudden unexplained shortness of breath or rapid breathing;
• sudden unexplained cough, 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 abdominal pain.

If the patient is unsure, they should contact their doctor, as some of these symptoms, such as coughing or shortness of breath, may be mistaken for less serious conditions, such as a respiratory infection (e.g., a cold).
Pulmonary embolism
Symptoms usually occur in one eye:
Retinal vein thrombosis
(blood clot in the eye)

• sudden loss of vision or,
• painless vision disturbances, which may lead to loss of vision.
• chest pain, discomfort, or pressure; Heart attack

BLOOD CLOTS IN VEINS

What can happen if blood clots form in veins?

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in veins (venous thromboembolism). Although these side effects are rare, they can occur. Most often, they occur in the first year of using combined hormonal contraceptives.
• If blood clots form in the veins of the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot breaks loose from the leg and lodges in the lungs, it 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 veins the highest?

The risk of forming blood clots in veins is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of combined hormonal contraceptives (the same or a different drug) after a break of 4 weeks or more.
After the first year, the risk decreases, although it is always higher compared to when not using combined hormonal contraceptives.
If the patient stops using Regulon, the risk of blood clots returns to normal within a few weeks.

What factors increase the risk of blood clots in veins?

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

• During a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• During a year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestrel will develop blood clots.
• During a year, about 9-12 out of 10,000 women who use combined hormonal contraceptives containing desogestrel, such as Regulon, 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 in veins", below).

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with the use of Regulon is small, but some factors can increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) over 30 kg/m);
• if someone in the patient's immediate family has had blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years old). In this case, the patient may have inherited blood clotting disorders;
• if the patient needs to undergo surgery, is immobilized for a long time due to injury or illness, or has a leg in a cast. It may be necessary to temporarily stop using Regulon for a few weeks before surgery or immobilization. If the patient needs to stop using Regulon, they should ask their doctor when they can resume using the drug;
• with 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.
Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to inform the doctor if any of these risk factors are present, even if the patient is unsure. The doctor may decide to stop the use of Regulon.
One should inform the doctor if any of the above conditions change during the use of Regulon, e.g., if someone in the patient's immediate family is diagnosed with a blood clot without a known cause or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in arteries?

Similarly to blood clots in veins, blood clots in arteries can have serious consequences, 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 the use of Regulon is very small, but it may increase:

• with age (over approximately 35 years old);
• if the patient smokes. While using a hormonal contraceptive like Regulon, it is recommended to quit smoking. If the patient is unable to quit 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 someone in the patient's immediate 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 immediate 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 disease (valve damage, heart rhythm disorder called 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 blood clots may be even higher.
One should inform the doctor if any of the above conditions change during the use of Regulon, e.g., if the patient starts smoking, someone in their immediate family is diagnosed with a blood clot without a known cause, or if the patient gains significant weight.

Cancer and Regulon

In women using oral contraceptives, breast cancer is diagnosed slightly more often than in women of the same age who do not use them. This small increase in the frequency of breast cancer diagnosis gradually disappears within 10 years after stopping the use of 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 are more frequently examined by doctors and breast cancer is diagnosed earlier in them.
In women using oral contraceptives, benign liver tumors have been reported in rare cases, and in even rarer cases, malignant liver tumors. If the patient experiences unusual, severe abdominal pain, they should contact their doctor.

Psychiatric disorders

Some women using hormonal contraceptives, including Regulon, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, one should contact their doctor as soon as possible to receive further medical advice.

Irregular bleeding

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

What to do if withdrawal bleeding does not occur during the withdrawal week

If all tablets were taken correctly, there was no vomiting or severe diarrhea, and no other drugs were taken, it is very unlikely that the woman is pregnant.
If the expected withdrawal bleeding does not occur for two consecutive times, it may indicate pregnancy. One should immediately contact their doctor. One should only start the next pack of Regulon when they are sure they are not pregnant.

Children and adolescents

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

Regulon and other drugs

One should tell their doctor or pharmacist about all the drugs they are currently taking or have recently taken, as well as any drugs they plan to take. One should also inform any other doctor or dentist who prescribes any other drug (or pharmacist) about the use of Regulon. Doctors may say whether additional contraceptive methods should be used (e.g., condoms) and for how long.
Regulon should not be used in patients with hepatitis C and taking medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentaswir, as this may cause abnormal liver function test results in the blood (increased liver enzyme activity ALT). Before starting these drugs, the doctor will prescribe a different type of contraception. The use of Regulon can be resumed 2 weeks after the end of the above-mentioned treatment. See section "When not to use Regulon".
Certain drugs may affect the level of Regulon in the blood, leading to a decrease in its contraceptive effectivenessand unexpected bleeding. These include:

• drugs used to treat epilepsy (e.g., phenytoin, phenobarbital, primidone, carbamazepine, felbamate, oxcarbazepine, topiramate),
• drugs used to treat tuberculosis (e.g., rifampicin, rifabutin),
• drugs used to treat HIV infection (protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz, nelfinavir),
• drugs used to treat hepatitis C (boceprevir, telaprevir),
• drugs used to treat fungal infections (griseofulvin),
• drugs used to treat high blood pressure in the blood vessels of the lungs (bosentan),
• herbal products containing St. John's Wort (Hypericum perforatum). If the patient wants to use herbal products containing St. John's Wort while using Regulon, they should first consult their doctor.

The following drugs may reduce the tolerance of Regulon:

• ketokonazole, 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 diseases and high blood pressure);
• etoricoxib (used to treat arthritis, osteoarthritis).

Regulon may affect the action of other drugs, such as:

• cyclosporin (a drug used to prevent organ rejection after transplants),
• the antiepileptic drug lamotrigine (which may lead to an increased frequency of seizures),
• tizanidine (a drug used to treat muscle spasticity),
• levothyroxine (a drug used to treat hypothyroidism),
• theophylline (a drug used to treat asthma).

Before using any drug, one should consult their doctor or pharmacist.

Before performing laboratory tests

One should inform their doctor or laboratory staff about the use of oral contraceptives, as oral contraceptives may affect the results of some laboratory tests.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this drug.
Regulon should not be used when the patient is pregnant. If the patient is pregnant or suspects they are pregnant, they should stop using Regulon immediately and inform their doctor without delay.
The use of Regulon is not recommended during breastfeeding. If the patient is breastfeeding and wants to use oral contraceptives during this time, they should contact their doctor.

Driving and operating machinery

While using Regulon, one can drive vehicles and operate machinery.

Regulon contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking Regulon.

3. How to use Regulon

This drug should always be used as directed by the doctor. In case of doubts, one should consult their doctor or pharmacist.
Each pack of Regulon contains 1 blister pack of 21 coated tablets or 3 blister packs of 21 coated tablets. The special labeling of the blister packs with symbols of the days of the week (see "Translation of the day symbols on the packaging" section 6 of the leaflet) makes it easier to control the regular use of oral contraceptives.
Each tablet in the pack is marked with a symbol of the day of the week on which it should be taken. One should take 1 tablet per day for 21 consecutive days, following the direction of the arrow on the blister pack, until the pack is empty.
After taking all 21 tablets from the blister pack, there is a 7-day break in taking tablets. During the 2nd or 3rd day of the break, withdrawal bleeding should occur, similar to menstrual bleeding.
One should start taking tablets from the next pack on the 8th day (after the 7-day break), even if the bleeding has not stopped yet. With regular use of Regulon, the start of taking 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 tablets in the morning (the first thing in the morning) or late in the evening (the last thing before bedtime) can make it easier to remember to take them regularly.
Tablets should be swallowed whole, with water if necessary.

How to start using Regulon

In the case of not using hormonal contraceptives (in the previous month)
One should start taking tablets on the first day of the woman's natural menstrual cycle (i.e., on the first day of menstruation). It is allowed to start taking tablets between the 2nd and 5th day, but in this case, during the first cycle, additional mechanical contraceptive methods (e.g., condoms) should be used for the first 7 days of taking tablets.
Changing from another combined contraceptive (tablet, vaginal ring, transdermal patch)
The woman should start using Regulon the next day after taking the last active tablet of the previous oral contraceptive, or at the latest on the first day of the usual break in taking tablets or after taking the last placebo tablet of the previous oral contraceptive. There is no need to use additional contraceptive methods.
If the patient previously used a vaginal ring or transdermal patch, they should start taking Regulon on the day the ring or patch is removed, or at the latest on the day the next ring or patch would have been applied. There is no need to use additional contraceptive methods.
Changing from progestogen-only contraceptives (minipill, injections, implants)
The woman can switch from a progestogen-only pill (from an implant on the day of its removal or from injections on the day of the planned next injection) to Regulon at any time, but in all cases, additional contraceptive methods should be used for the first 7 days of taking tablets.
Use after miscarriage in the first trimester of pregnancy
One should start taking tablets immediately. There is no need to use additional contraceptive methods.
Use after childbirth or miscarriage in the second trimester of pregnancy
For breastfeeding women, see the section "Pregnancy and breastfeeding".
The doctor will advise the patient to start taking tablets between the 21st and 28th day after childbirth or miscarriage in the second trimester. If the patient starts taking tablets later, they should use additional mechanical contraceptive methods (e.g., condoms) for the first 7 days of taking tablets. However, if the woman has had sexual intercourse, before starting to take tablets, she should make sure she is not pregnant or wait for her first menstrual period.

Use of a higher dose of Regulon than recommended

If an overdose of Regulon occurs, there is no risk of serious health disorders, although nausea, vomiting, or slight vaginal bleeding may occur in young girls. If such symptoms occur, one should contact their doctor, who will provide appropriate treatment if necessary.

Missing a dose of Regulon

If a dose of Regulon is missed, one should follow the instructions below.
If the tablet is delayed by less than 12 hours, the contraceptive protection is not reduced. The woman should take the missed tablet as soon as she remembers, even if it means taking 2 tablets at the same time. Then, she should continue taking the tablets at the usual time of day.
If the tablet is delayed by more than 12 hours, the contraceptive protection may be reduced. The more missed tablets, the higher the risk of reduced contraceptive effectiveness. A higher risk of pregnancy exists if a tablet is missed at the beginning or end of the cycle. Please refer to the information below (see also the scheme).

More than one missed tablet in a pack

One should consult their doctor.
In the case of missed tablets, one should follow the two basic rules:

• 1. The break in continuous tablet use should never be longer than 7 days.

• 2. It is necessary to take tablets continuously for 7 days to achieve the appropriate inhibition of the hypothalamic-pituitary-ovarian axis.

In accordance with this, in daily practice, the doctor may provide the following advice:
Week 1
The patient should take the last missed tablet as soon as they remember, even if it means taking 2 tablets at the same time. Then, they should continue taking the tablets at the usual time of day. For the next 7 days, they should use additional mechanical contraceptive methods, such as condoms. If there was sexual intercourse during the 7 days preceding the day the tablet was missed, one should consider the possibility of pregnancy. The more tablets that were missed and the closer it was to the break in taking tablets, the higher the risk of pregnancy.
Week 2
The patient should take the last missed tablet as soon as they remember, even if it means taking 2 tablets at the same time. Then, they should continue taking the tablets at the usual time of day. If the tablets were taken correctly during the 7 days preceding the day the tablet was missed, there is no need to use additional contraceptive methods. However, if this was not the case or if the woman missed more than 1 tablet, additional contraceptive methods should be used for 7 days.
Week 3
The risk of reduced contraceptive protection is inevitable due to the upcoming break in taking tablets. However, this can be prevented by adjusting the way tablets are taken. Therefore, there is no need to use additional contraceptive methods if one of the two alternative rules below is followed, provided that all tablets were taken correctly during the 7 days preceding the day the tablet was missed. If this was not the case, one should follow the first of the two alternative rules and use additional contraceptive methods for the next 7 days.

• 1. The patient should take the last missed tablet as soon as they remember, even if it means taking 2 tablets at the same time. Then, they should continue taking the tablets at the usual time of day. The next pack should be started immediately after finishing the current pack, i.e., without a break between packs. Withdrawal bleeding may not occur until the end of the next pack, but spotting or breakthrough bleeding may occur during tablet use.
• 2. The doctor may advise the patient to stop taking tablets from the current pack. In this case, the patient should take a break of up to 7 days, including the days they missed tablets, and then continue taking tablets from the next pack.

If the woman misses tablets and does not experience withdrawal bleeding during the first break in taking tablets, one should consider the possibility of pregnancy.
Missed more than 1 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 contraceptive methods for 7 days
• finish the pack

Missed only 1 tablet (break longer than 12 hours)

• take the missed tablet
• finish the pack

week 2

• take the missed tablet
• finish the pack
• do not take a 7-day break
• continue with the next pack

week 3
or

• stop taking the remaining tablets from the pack
• take a break (no more than 7 days, including the day the tablet was missed)
• continue with the next pack

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If side effects occur, especially severe and persistent ones, or changes in health that the patient considers related to the use of Regulon, consult a doctor.
In all women using combined hormonal contraceptives, there is an increased risk of blood clots in veins (venous thromboembolism) or blood clots in arteries (arterial thrombosis). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, refer to section 2 "Important information before using Regulon".
Frequent (may occur in up to 1 in 10 people): depression, mood changes, headache, nausea, abdominal pain, breast pain, breast tenderness, weight gain.
Uncommon (may occur in up to 1 in 100 people): fluid retention, decreased libido, migraine, vomiting, diarrhea, rash, hives, breast enlargement.
Rare (may occur in up to 1 in 1000 people): hypersensitivity, increased libido, eye irritation due to contact lenses, skin disorders (erythema multiforme, erythema nodosum), abnormal cervical smear, breast discharge, weight loss.
Harmful blood clots in a vein or artery, for example:
o
in the leg or foot (e.g., deep vein thrombosis),
o
in the lungs (e.g., pulmonary embolism),
o
heart attack,
o
stroke,
o
mini-stroke or transient stroke-like symptoms, known as a transient ischemic attack,
o
blood clots in the liver, stomach, intestine, kidney, or eye.
The likelihood of blood clots may be higher if the patient has any other risk-increasing factors (see section 2 for more information on risk-increasing factors and symptoms of blood clots).

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 side effects will help gather more information on the safety of the medication.

5. How to store Regulon

Store the medicine out of sight and reach of children.
Store at a temperature below 30°C. Store in the original package.
Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. 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 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:
Core: all-rac-α-tocopherol, magnesium stearate, anhydrous colloidal silica, stearic acid, povidone K 30, potato starch, lactose monohydrate.
Coating: propylene glycol, macrogol 6000, hypromellose.

What Regulon looks like and what the package contains

White or almost white round tablets, convex on both sides, with engraved text: "RG" on one side and "P8" on the other side.
The cardboard box contains 1 blister or 3 blisters of 21 coated tablets. A cardboard sachet is attached to the package, in which the blister should be placed.
For more detailed information, contact the marketing authorization holder or parallel importer:

Marketing authorization holder in Belgium, the 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

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Belgian marketing authorization number, country of export: BE 339421

Parallel import authorization number: 159/12

Translation of day-of-the-week symbols on the 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

Date of leaflet approval: 11.03.2022
[Information about the trademark]