Regulon

Leaflet accompanying the packaging: patient information

REGULON, 0.03 mg + 0.15 mg, coated tablets
Ethinylestradiol + Desogestrel

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 taking the medicine, 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 medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person.
• 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 Regulon is and what it is used for
• 2. Important information before taking Regulon
• 3. How to take Regulon
• 4. Possible side effects
• 5. How to store Regulon
• 6. Contents of the pack and other information

1. What Regulon is and what it is used for

Regulon is a combined oral contraceptive containing ethinylestradiol (estrogen) and desogestrel (progestogen) in low 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 medicine (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 sexually transmitted diseases (such as AIDS). Only the use of condoms has a protective effect.

2. Important information before taking Regulon

General notes

Before starting to take Regulon, you should read the information about blood clots (thrombosis) in section 2. It is especially important to read about 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 take 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 perform some other tests.

When not to take Regulon

Regulon should not be taken if the patient has any of the conditions listed below. If the patient has any of the conditions listed below, she should inform her 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 medicine (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 she has 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 suffers from (or has suffered in the past) from 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 suffers from any of the following diseases, which may increase the risk of arterial thrombosis:
• severe diabetes with blood vessel 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 she has 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, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section "Regulon and other medicines").

Warnings and precautions

Before starting to take Regulon, you should discuss it with your doctor or pharmacist.
In certain situations, you should be particularly careful when taking Regulon or any other combined oral contraceptive. Regular medical check-ups may also be necessary.

Tell your doctor if you have any of the following conditions.

If these symptoms occur or worsen while taking Regulon, you should also tell your doctor.

• if you have symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives, potentially with difficulty breathing, you should contact your doctor immediately. Products containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema
• if you smoke;
• if you are overweight;
• if you have high blood pressure;
• if you have heart valve problems or heart rhythm disorders;
• if you have superficial thrombophlebitis (inflammation of the 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 that affects the body's natural defense system);
• if you have hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (a hereditary disease of red blood cells);
• if you have been diagnosed with high levels of fats in the blood (hypertriglyceridemia) or have a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if you will be undergoing surgery or will be immobilized for a long time (see section "Blood clots".
• if you are immediately postpartum, you are at an increased risk of blood clots. You should consult your doctor to find out how soon you can start taking Regulon after giving birth;
• if you have varicose veins;
• if any of your close relatives have 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 disease that first appeared during pregnancy or while taking sex hormones (e.g., hearing loss, a blood disease called porphyria, herpes gestationis (a skin rash that occurs during pregnancy)),

When to contact a doctor?

You should contact your doctor immediately

• if you notice any of the following symptoms, which could be signs of a blood clot: swelling of the leg or along a vein in the leg or foot, especially if it is accompanied by pain or tenderness in the leg, increased warmth in the affected leg, change in the color of the leg, such as pale or blue-tinged skin, or swelling of the veins in the leg.

Chorea (a disease of the nervous system characterized by involuntary movements of the body);

• if you have or have had chloasma (melasma), especially on the face. In this case, you should avoid direct exposure to sunlight or ultraviolet radiation;

BLOOD CLOTS

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

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

How to recognize a blood clot

You should contact your doctor immediately if you notice any of the following symptoms.
Do you experience any of these symptoms?
Why is the patient likely to be suffering from

• swelling of the leg or along a vein in the leg or foot, especially if it is accompanied by pain or tenderness in the leg, increased warmth in the affected leg, change in the color of the leg, such as pale or blue-tinged skin.

BLOOD CLOTS IN VEINS

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

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

The risk of blood clots in veins is highest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be higher when resuming combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, although it is always higher compared to not taking combined hormonal contraceptives.
If the patient stops taking 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 of blood clots associated with taking Regulon is small, but some factors can increase this risk. The risk is higher:

• if the patient is severely overweight (body mass index (BMI) over 30 kg/m2);
• if any of the patient's close relatives have 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 a hereditary blood clotting disorder;
• 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 taking Regulon for a few weeks before surgery or immobilization. If the patient needs to stop taking Regulon, they should ask their doctor when they can resume taking it;
• 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 flights (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to tell the doctor if any of these risk factors are present, even if the patient is not sure. The doctor may decide to stop Regulon.
If any of the above conditions change while taking Regulon, e.g., the patient starts smoking, a close relative is diagnosed with a blood clot without a known cause, or the patient gains significant weight, the doctor should be informed.

BLOOD CLOTS IN ARTERIES

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

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

Factors that increase the risk of blood clots in arteries

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

• with age (over approximately 35 years old);
• if the patient smokes.While taking 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 any of the patient's close relatives have 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 any of their close relatives have had 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);
• 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.
It is essential to inform the doctor if any of the above conditions change while taking Regulon, e.g., the patient starts smoking, a close relative is diagnosed with a blood clot without a known cause, or the patient gains significant weight.

Cancer and Regulon

Women taking oral contraceptives have a slightly higher risk of breast cancer than women of the same age who do not take them. This small increase in the risk of breast cancer disappears gradually within 10 years of stopping oral contraceptives. It is not known whether this difference is caused by the oral contraceptives. It may be that women taking oral contraceptives are more likely to have medical check-ups and breast cancer is detected earlier.
Women taking oral contraceptives have been reported to have, in rare cases, benign liver tumors, and even more rarely, malignant liver tumors. If the patient experiences severe abdominal pain, she should contact her doctor.

Psychological disorders

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

Irregular bleeding

During the first few months of taking 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

If all the tablets have been taken correctly, there has been no vomiting or severe diarrhea, and no other medicines have been taken, it is very unlikely that the woman is pregnant.
If the expected withdrawal bleeding does not occur for two consecutive months, it may indicate pregnancy. The patient should contact her doctor immediately. She should only start the next pack of Regulon when she is sure she is not pregnant.

Children and adolescents

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

Regulon and other medicines

The patient should tell her doctor or pharmacist about all medicines she is currently taking or has recently taken, as well as any medicines she plans to take. She should also inform any other doctor or dentist prescribing any other medicine (or pharmacist) that she is taking 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/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medicines may cause abnormal liver function test results (increased liver enzyme activity).
Before starting to take these medicines, the doctor will prescribe a different contraceptive method.
Regulon can be started again about 2 weeks after the end of the above-mentioned treatment. See section "When not to take Regulon".
Certain medicines may affect the level of Regulon in the blood, leading to reduced contraceptive effectivenessand 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 blood vessels of the lungs (bosentan),
• herbal medicines containing St. John's Wort (Hypericum perforatum). If the patient wants to take herbal products containing St. John's Wort while taking Regulon, she should consult her doctor first.

The following medicines 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 medicines, such as:

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

Before taking any medicine, the patient should consult her doctor or pharmacist.

Before laboratory tests

The patient should inform her doctor or laboratory staff that she is taking oral contraceptives, as they may affect the results of certain laboratory tests.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine.
Regulon should not be taken if the patient is pregnant. If the patient is pregnant or thinks she may be pregnant, she should stop taking Regulon immediately and consult her doctor.
Regulon is not recommended during breastfeeding. If the patient is breastfeeding and wants to take Regulon during this time, she should consult her doctor.

Driving and using machines

Regulon does not affect the ability to drive or use machines.

Regulon contains lactose

If the patient has been diagnosed with an intolerance to some sugars, she should consult her doctor before taking Regulon.

3. How to take Regulon

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the patient should consult her doctor or pharmacist.
Each pack of Regulon contains 1 blister pack of 21 tablets or 3 blister packs of 21 tablets. The special marking of the blister packs with symbols of the days of the week makes it easier to control the regular intake of the tablets.
Each tablet in the pack is marked with a symbol of the day of the week on which it should be taken. The patient should take 1 tablet daily for 21 consecutive days, following the direction of the arrows 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 the tablets. During this time, withdrawal bleeding should occur, similar to menstrual bleeding.
The patient should start taking tablets from the next pack on the 8th day (after the 7-day break), even if the bleeding has not stopped. With regular intake 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 (first thing in the morning) or late in the evening (last thing before bed) can help with regular intake.
Tablets should be swallowed whole, with water if necessary.

How to start taking Regulon

In case the patient has not used hormonal contraceptives in the previous month
The patient should start taking tablets on the first day of her natural menstrual cycle (i.e., the first day of menstruation). It is allowed to start taking tablets between the 2nd and 5th day of the cycle, but during the first cycle, additional mechanical contraceptive methods (e.g., condoms) should be used for the first 7 days of taking tablets.

• 2. a 5. day of the cycle, 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.

Switching from another combined contraceptive (tablet, vaginal ring, transdermal patch)
The patient should start taking Regulon the day after taking the last active tablet of the previous oral contraceptive, or at the latest, on the day she would normally start her next contraceptive method. No additional contraceptive methods are needed.
If the patient has been using a vaginal ring or transdermal patch, she should start taking Regulon on the day the ring or patch is removed, or at the latest, on the day she would normally apply a new ring or patch. No additional contraceptive methods are needed.
Switching from progestogen-only contraceptives (mini-pill, injections, implants)
The patient can switch from a progestogen-only pill at any time (from an implant on the day of its removal or from injections on the day the next injection is scheduled), but in all cases, additional contraceptive methods should be used for the first 7 days of taking Regulon.
Use after miscarriage in the first trimester of pregnancy
The patient should start taking Regulon immediately. No additional contraceptive methods are needed.
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 Regulon between the 21st and 28th day after childbirth or miscarriage in the second trimester. If the patient starts taking Regulon later, she should use additional mechanical contraceptive methods (e.g., condoms) for the first 7 days of taking tablets. However, if the patient has had sexual intercourse, she should make sure she is not pregnant before starting to take Regulon or wait for her first menstrual period.

Overdose of Regulon

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

Missed dose of Regulon

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

More than one missed tablet in a pack

The patient should consult her doctor.
In the case of missed tablets, the patient should follow the two basic rules below:

• 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 adequate suppression of the hypothalamic-pituitary-ovarian axis.

According to this, in daily practice, the doctor may give the following advice:
Week 1
The patient should take the last missed tablet as soon as she remembers, even if it means taking 2 tablets at the same time. Then, she should continue taking the tablets at the usual time of day. For the next 7 days, she should use additional mechanical contraceptive methods, such as condoms. If the patient had sexual intercourse during the 7 days before missing a tablet, she should consider the possibility of pregnancy. The more tablets missed and the closer they are 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 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 tablets have been taken correctly for the 7 days before missing a tablet, there is no need for additional contraceptive methods. However, if this is not the case or if the patient has missed more than 1 tablet, she should use additional contraceptive methods 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 tablet-taking schedule. Therefore, there is no need for additional contraceptive methods if the patient follows one of the two alternative rules below, provided that all tablets have been taken correctly during the 7 days before missing a tablet. If this is not the case, the patient 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 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. The patient can continue taking tablets from the next pack without a break, i.e., without a 7-day break between packs. Withdrawal bleeding may not occur until the end of the next pack, but the patient may experience irregular bleeding or spotting during tablet-taking.
• 2. The doctor may advise the patient to stop taking tablets from the current pack. In this case, the patient should have a break of up to 7 days, including the days she missed tablets, and then continue taking tablets from the next pack.

If the patient misses tablets and does not experience withdrawal bleeding during the first break in tablet-taking, she should consider the possibility of pregnancy.

Use of Regulon in case of vomiting or severe diarrhea

If vomiting or severe diarrhea occur within 3-4 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 (see above). If the patient does not want to change her usual tablet-taking schedule, she can take an additional tablet (tablets) from another pack.

How to delay withdrawal bleeding

If Regulon is taken correctly, withdrawal bleeding will always occur on the same day of the month.
To delay withdrawal bleeding, the patient should continue taking Regulon from the next pack without a break, i.e., without the usual 7-day break between packs.
The patient can continue taking tablets until the end of the second pack. During the second pack, she may experience irregular bleeding or spotting. Regular tablet-taking should be resumed after a 7-day break.
To change the day of withdrawal bleeding to a different day of the week than usual, the patient should shorten (but never extend) the next break in tablet-taking by the desired number of days. For example, if the first day of bleeding is on a Friday and the patient wants it to be on a Tuesday, i.e., 3 days earlier, she 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 the patient may experience irregular bleeding or spotting during the next pack (similar to 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 related to the use of Regulon, a doctor should be consulted.
A doctor should be contacted immediately if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat, and/or difficulty swallowing or hives potentially with difficulty breathing (see also the section "Warnings and Precautions").
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 more detailed information on the various risk factors associated with the use of combined hormonal contraceptives, see 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, diarrhea, rash, hives, breast enlargement.
Rare (may affect up to 1 in 1,000 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:

• 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, kidneys, or eye.

The likelihood of blood clots may be higher if the patient has any other risk factors (see section 2 for more information on risk factors 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 Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
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: α-tocopherol, magnesium stearate, colloidal silicon dioxide, stearic acid, povidone, potato starch, lactose monohydrate.
Coating: propylene glycol, polyethylene glycol 6000, hydroxypropylmethylcellulose.

What Regulon Looks Like and What the Package Contains

White or almost white round tablets, convex on both sides, with engraved "RG" on one side and "P8" on the other side.
A carton box contains 1 blister or 3 blisters of 21 coated tablets.

Marketing Authorization Holder and Manufacturer:

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

For More Detailed Information on This Medication, Please Contact:

GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
lekalert@grodzisk.rgnet.org

Date of Last Revision of the Leaflet: