Regulon

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

REGULON (Desorelle 30), 0.03 mg + 0.15 mg, film-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.
• They slightly increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or more.
• Caution should be exercised and a doctor should be consulted if the patient suspects that symptoms of blood clots have occurred (see section 2 "BLOOD CLOTS").

You 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 in case it needs to be read again.
• In case of any doubts, a doctor or pharmacist should be consulted.
• 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 or pharmacist. 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. Contents of the packaging 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 effective and reversible 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.

It should be remembered 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, you should familiarize yourself with the information about blood clots (thrombosis) in section 2. It is especially important to familiarize yourself with the symptoms of blood clots (see section 2 "BLOOD CLOTS").
Regulon should not be used to delay the start of bleeding.
In exceptional cases, when there is a need to delay the start of bleeding, you should consult a doctor.
Before starting to use Regulon, the doctor will ask the patient a few questions about her health and the health of her 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, presence of 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 suffers from (or has suffered 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 (transient stroke symptoms);
• If the patient has any of the following diseases, which may increase the risk of arterial thrombosis:
• 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 breast cancer or genital cancer;
• If the patient has unexplained vaginal bleeding;
• If the patient has an enlarged endometrium (abnormal growth of the uterine lining);
• If the patient is or may be pregnant.

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

Warnings and precautions

Before starting to use Regulon, you should discuss it with your doctor or pharmacist.

When to contact a doctor?

A doctor should be contacted immediately

• if the patient notices probable 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), heart attack, or stroke (see below "BLOOD CLOTS").

In order to obtain a description of the serious side effects mentioned, see "How to recognize blood clots".
In certain situations, special caution should be exercised when using Regulon or any other combined oral contraceptives. Regular medical examination may also be necessary.

The doctor should be told if the patient has any of the following conditions.

If these symptoms occur or worsen during the use of Regulon, the doctor should also be informed.

• 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 hereditary disease of red blood cells);
• if the patient has been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or has a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if the patient requires surgery or will be immobilized for a long time (see section 2 "BLOOD CLOTS").
• if the patient has recently given birth, she is at increased risk of blood clots. The doctor should be consulted to determine how soon Regulon can be started after childbirth;
• if the patient has varicose veins;
• if any of the patient's close relatives currently have or 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 sex hormones (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 brown spots (chloasma), especially on the face. In such cases, it is recommended to 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 a doctor if symptoms of angioedema occur, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or breathing with hives.

BLOOD CLOTS

The use of combined hormonal contraceptives, such as Regulon, is associated with an increased risk of blood clots compared to not using them. In rare cases, a blood clot can block a blood vessel and cause serious complications.
Blood clots can form

• in veins (hereinafter referred to as "venous thromboembolism" or "venous thromboembolic disease"),
• in arteries (hereinafter referred to as "arterial thromboembolism" or "arterial thromboembolic disease").

It should be remembered that the total risk of harmful blood clots caused by Regulon is small.

HOW TO RECOGNIZE BLOOD CLOTS

A doctor should be contacted immediately if any of the following symptoms are noticed.
Is the patient experiencing any of these symptoms?
What is the probable cause of the patient's condition?

• 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 only be felt when standing or walking;
• increased temperature in the affected leg;
• change in skin color of the leg, such as pallor, redness, or cyanosis.
• 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 a doctor,
as some of these symptoms, such as cough or shortness of breath, may be mistaken for milder conditions, such as a respiratory infection (e.g., a cold).
Symptoms usually occur in one eye:

• sudden loss of vision or, retinal vein thrombosis (blood clot in the eye)

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 the veins (venous thromboembolism). Although these side effects are rare, they most often 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 settles 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 a vein highest?

The risk of forming blood clots in a vein 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 not using combined hormonal contraceptives.
If the patient stops using Regulon, the risk of blood clots returns to normal within a few weeks.

What affects the risk of blood clots?

The risk depends on the natural risk of venous thromboembolism and the type of combined hormonal contraceptive used.
The total risk of blood clots in the legs or lungs associated with 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 norgestimate 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", below).

Factors that increase the risk of blood clots in veins

The risk of blood clots associated with 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/m2);
• 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 hereditary clotting disorders;
• if the patient must 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 must 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.
Long-haul 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 not sure. The doctor may decide to stop using Regulon.
If any of the above conditions change during the use of Regulon, the doctor should be informed, e.g., if someone in the patient's immediate family is diagnosed with thrombosis without a known cause or if the patient gains significant weight.

BLOOD CLOTS IN ARTERIES

What can happen if blood clots form in an artery?

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 emphasize that the risk of heart attack or stroke associated with Regulon is very small, but some factors can increase this risk. The risk is higher:

• with age (over approximately 35 years old);
• if the patient smokes.During the use of a hormonal contraceptive like Regulon, it is recommended to quit smoking. If the patient cannot 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 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 severe, the risk of blood clots may be even higher.
The doctor should be informed 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 thrombosis without a known cause, or if the patient gains significant weight.

Pill and cancer

In women using oral contraceptives, breast cancer is slightly more common than in women of the same age who do not use them. This small increase in the incidence of breast cancer disappears gradually within 10 years of 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 likely to undergo medical examinations and breast cancer is diagnosed earlier in them.
In women using oral contraceptives, benign liver tumors have been reported in rare cases, and malignant liver tumors in even rarer cases. 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, the patient should contact their doctor as soon as possible for further medical advice.

Irregular 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 a few months, the doctor should be consulted to determine the cause.

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

If all the 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 the second consecutive time, it may indicate pregnancy. The doctor should be contacted immediately. The next pack of Regulon should only be started when the patient is 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

The patient 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. They should also inform any other doctor or dentist who prescribes any other drug (or pharmacist) about the use of Regulon. Doctors may advise 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 or paritaprevir or ritonavir and dasabuvir or glecaprevir/pibrentasvir, as this may cause abnormal liver function test results in the blood (elevated liver enzyme activity ALT). Before starting these drugs, the doctor will prescribe a different contraceptive method.
The use of Regulon can be resumed 2 weeks after the end of the above-mentioned treatment. See section "When not to use Regulon".
Some drugs may affect the blood levels of Regulon, 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),
• 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 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 taking Regulon, they should consult their doctor first. 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, degenerative joint disease).

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, the patient should consult their doctor or pharmacist.

Before performing laboratory tests

The doctor or laboratory staff should be informed 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 pregnancy, 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 period, they should contact their doctor.

Driving and using machines

Regulon can be used while driving and operating machines.

Regulon contains lactose

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, the doctor or pharmacist should be consulted.
Each pack of Regulon contains 1 blister pack of 21 film-coated tablets or 3 blister packs of 21 film-coated tablets. The special marking of the blisters with the symbols of the days of the week makes it easier to control the regular use of oral contraceptives.
Each tablet in the pack is marked with the symbol of the day of the week on which it should be taken. One tablet should be taken daily for 21 consecutive days, following the direction of the arrow on the blister, until the blister is empty.
After taking all 21 tablets from the blister, there is a 7-day break in taking the tablets. During the 2nd or 3rd day of the break, withdrawal bleeding should occur, similar to menstrual bleeding.
Taking tablets from the next blister should be started on the 8th day (after a 7-day break in taking the tablets), 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 action of the day) or late in the evening (the last action before bedtime) can facilitate regular use.
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)
Taking tablets should be started 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

• 2nd and 5th day, but during the first cycle, additional mechanical contraceptive methods (e.g., condoms) should be used during the first 7 days of taking tablets. Changing from another combined contraceptive (tablet, vaginal system, transdermal system)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 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 system or transdermal system, they should start taking Regulon on the day the system is removed, or at the latest on the day the next application would be due. Additional contraceptive methods are not required.

Changing from progestogen-only contraceptives (minipills, injections, implants)
The woman can switch to Regulon at any time from using a progestogen-only pill (from an implant on the day of its removal or from injections on the day the next injection is scheduled) to Regulon, 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
Taking tablets should be started 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 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 start of taking tablets is delayed, additional mechanical contraceptive methods (e.g., condoms) should be used during the first 7 days of taking tablets. However, if the woman has had sexual intercourse, she should make sure she is not pregnant before starting to take tablets or wait for her 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 disorders, although nausea, vomiting, or slight vaginal bleeding may occur in young girls. If such symptoms occur, the patient should contact their doctor, who will provide appropriate treatment if necessary.

Missing a dose of Regulon

If a dose of Regulon is missed, the following rules should be followed.
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, and the next tablets should be taken at the usual time.
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. The higher risk of pregnancy exists if a tablet is missed at the beginning or end of the cycle. Please refer to the information provided below (see also the scheme).

More than one missed tablet from the pack

The doctor should be consulted.
In the case of missed tablets, the following two basic rules should be followed:

• 1. The break in continuous tablet-taking 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 line 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 sexual intercourse occurred during the 7 days preceding the day the tablet was missed, pregnancy should be considered. The more tablets missed and the closer to the break in tablet-taking, 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 tablet-taking. 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 of action 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, the first of the two alternative rules of action should be followed, and additional contraceptive methods should be used for 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 of Regulon 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, and during the use of tablets from the next pack, spotting or breakthrough bleeding may occur.

The doctor may advise the patient to stop taking tablets from the current pack. In this case, the patient should take a break from taking tablets for up to 7 days, including the days they missed tablets, and then continue taking tablets from the next pack.

If the patient missed tablets and did not experience withdrawal bleeding during the first break in tablet-taking, pregnancy should be considered.

Use of Regulon in case of vomiting or severe diarrhea

If vomiting or severe diarrhea occur within 3 to 4 hours after taking a tablet, it may not be fully absorbed. In this case, the patient should follow the same rules as for missed tablets described above. If the patient does not want to change their usual way of taking tablets, they should take an additional tablet (tablets) from another pack.
How to delay the occurrence of withdrawal bleeding
If Regulon is taken correctly, withdrawal bleeding will always occur on the same day of the month.
To delay the occurrence of withdrawal bleeding, after finishing one pack of tablets, the patient should continue taking Regulon from the next pack without a break in tablet-taking.
Tablets can be taken until the end of the second pack. During the use of tablets from the second pack, spotting or breakthrough bleeding may occur.
Regular use of Regulon should be resumed after a 7-day break in tablet-taking.
To shift the occurrence of withdrawal bleeding to a different day of the week than usual, different from the day it currently occurs, the next break in tablet-taking should be shortened (but never extended) by any number of days. For example, if the first day of bleeding falls on a Friday, and it would be more convenient if it fell on a Tuesday, i.e., 3 days earlier, the patient should start taking tablets from the next pack 3 days earlier. The shorter the break in tablet-taking, the higher the risk that withdrawal bleeding will not occur, and spotting or breakthrough bleeding may occur during the use of tablets from the next pack (similar to the case of delaying withdrawal bleeding).

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any side effects occur, especially severe and persistent ones or changes in health that the patient considers to be related to the use of Regulon, a doctor should be consulted.
In all women using combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, see 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 nodosum, erythema multiforme), abnormal cervical smear, breast discharge, 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 stroke-like symptoms, known as a transient ischemic attack,
• blood clots in the liver, stomach, intestine, kidney, or eye. The risk of blood clots may be higher if the patient has any other risk factors (see section 2 for more information on risk factors for blood clots and symptoms of blood clots).

Reporting Side Effects

If any side effects occur, including any side effects not listed in the leaflet, a doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 side effects will help to gather more information on the safety of the medication.

5. How to Store Regulon

The medicine should be stored out of sight and reach of children.
Store at a temperature below 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 specified month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medicines. 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:
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 What the Package Contains

White or almost white round tablets, biconvex, with engraved markings: "RG" on one side and "P8" on the other side.
The carton package contains 1 blister or 3 blisters of 21 coated tablets. A cardboard sleeve is included in the package, in which the blister should be placed.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Belgium, Country of Export, Authorization Number:BE339421
Parallel Import Authorization Number:355/12
Translation of the 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: 12.05.2022
[Information about the trademark]