Regulon

Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
REGULON (Desorelle 30), 0.03 mg + 0.15 mg, coated tablets
Ethinylestradiolum + Desogestrelum
REGULON and Desorelle 30 are different brand names of the same medicinal product.
Important information regarding combined hormonal contraceptives

• When used correctly, they are one of the most reliable, reversible methods of contraception.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or after restarting treatment following a break of 4 weeks or more.
• Be vigilant and consult a doctor if the patient suspects symptoms of blood clot formation (see section 2 "BLOOD CLOTS"). Please read this leaflet carefully before using the medicine, as it contains important information for the patient.
• Keep the leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. Do not give it to others. This medicine may harm someone else, even if their symptoms are the same.
• If any adverse effects occur, including any not listed in this leaflet, inform your 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 (an estrogen) and desogestrel (a progestogen) in low doses.
The mechanism of action of Regulon involves inhibition of ovulation and changes in the consistency of cervical mucus. When used correctly, Regulon provides an effective and reversible method of contraception. However, in certain situations, contraceptive effectiveness may be reduced or discontinuation of the medicine may be necessary (see section 2). In such cases, either sexual intercourse should be avoided or, to ensure effective contraception, other contraceptive methods should be used, such as condoms or spermicides.
Please remember that combined oral contraceptives, such as Regulon, do not protect against sexually transmitted infections (such as AIDS). Only the use of condoms provides protective action.

2. Important information before using Regulon

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

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

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

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

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

When should you contact your doctor?
Seek immediate medical advice if:

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

For a description of the symptoms of these serious adverse effects, see "How to recognize the occurrence of blood clots".
Special caution may be required when using Regulon or any other combined oral contraceptive, and regular check-ups by a doctor may be necessary.

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

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

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

• in veins (referred to below as "venous thrombosis" or "venous thromboembolic disease"),
• in arteries (referred to below as "arterial thrombosis" or "arterial thromboembolic events").
  Complete recovery after a blood clot is not always possible. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal. Remember that the overall risk of harmful blood clots caused by taking Regulon is small.

HOW TO RECOGNIZE THE OCCURRENCE OF BLOOD CLOTS
Seek immediate medical advice if you experience any of the following symptoms.
Are you experiencing any of these symptoms? What might be the likely cause?

• Swelling of the leg or swelling along a vein in the leg or foot, especially if accompanied by:
  Deep vein thrombosis

  • Pain or tenderness in the leg, which may occur only when standing or walking;
  • Increased warmth in the affected leg;
  • Change in skin colour of the leg, such as pallor, redness, or blueness.

• Sudden onset of unexplained shortness of breath or rapid breathing;
  Pulmonary embolism

• Sudden cough without obvious cause, possibly accompanied by coughing up blood;

• Sharp chest pain, which may worsen on deep breathing;

• Severe dizziness or vertigo;

• Rapid or irregular heartbeat;

• Severe stomach pain.

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

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

• Sudden loss of vision or partial vision loss

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

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

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

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

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

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

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

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

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

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

• with age (over approximately 35 years);
• if the patient smokes. While using a hormonal contraceptive such as Regulon, smoking should be discontinued. If the patient is unable to stop smoking and is over 35 years of age, the doctor may recommend using another type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of blood lipids (cholesterol or triglycerides);
• if the patient suffers from migraines, particularly migraines with aura;
• if the patient has heart disease (valve disorders, heart rhythm disorders such as atrial fibrillation);
• if the patient has diabetes.

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

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

Psychiatric disorders
Some women using hormonal contraceptives, including Regulon, have reported depression or depressed mood. Depression can be severe and may 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.

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

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

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

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

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

The following medicines may reduce tolerance to Regulon:

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

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

• cyclosporine (a medicine used to prevent organ transplant rejection),
• the antiepileptic drug lamotrigine (this may lead to increased seizure frequency),
• tizanidine (a medicine used to treat muscle spasticity),
• levothyroxine (a medicine used to treat hormone deficiency),
• theophyllines (a medicine used to treat asthma).

Before taking any medicine, consult a doctor or pharmacist.
Before laboratory tests
Inform the doctor or laboratory staff about the use of oral contraceptives, as they may affect the results of certain laboratory tests.

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

Driving and operating machinery
Patients may drive and operate machinery while taking Regulon.

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

3. How to use Regulon

This medicine must always be used as directed by your doctor. If in doubt, consult your doctor or pharmacist.

Each pack of Regulon contains 1 blister strip of 21 coated tablets or 3 blister strips of 21 coated tablets. The special marking of blisters with symbols of the days of the week facilitates control over regular use of oral contraceptive tablets. 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 completely empty.

After taking all 21 tablets, a 7-day break without taking tablets follows. During the 2nd or 3rd day of this break, withdrawal bleeding resembling menstrual bleeding should occur.

The next pack should be started on the 8th day (after the 7-day tablet-free interval), even if bleeding has not yet stopped. With regular use of Regulon, the start of tablets from the next pack will always fall on the same day of the week, and bleeding will occur on the same day of the month.

Tablets should always be taken at the same time of day. Taking tablets in the morning (first activity of the day) or late in the evening (last activity before sleep) may help ensure regular use.

Tablets should be swallowed whole, with water if necessary.

How to start using Regulon

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

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

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

Use after first-trimester abortion
Tablet use should be started promptly. Additional contraceptive methods are not necessary.

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

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

Missed dose of Regulon

If a dose of Regulon is missed, follow the rules below.

If tablet intake is delayed by less than 12 hours, contraceptive protection is not reduced. The woman should take the missed tablet as soon as she remembers, and continue taking subsequent tablets at the usual time.

If tablet intake is delayed by more than 12 hours, contraceptive protection may be reduced. The more tablets missed, the greater the risk of reduced contraceptive efficacy. The risk of pregnancy is higher if a tablet is missed at the beginning or end of the cycle. Please review the information below (see also the diagram).

More than one missed tablet in a pack
Consult your doctor.

In case of missed tablets, the following two basic rules should be observed:

1. The break in continuous tablet intake should never exceed 7 days.
2. Continuous tablet intake for 7 days is required to adequately suppress the hypothalamic-pituitary-ovarian axis. Therefore, in daily practice, the doctor may give the following advice:

Week 1
The patient should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. Then she should continue taking tablets at the usual time of day. For the next 7 days, she should additionally use mechanical contraceptive methods, e.g., condoms. If sexual intercourse occurred within the 7 days before the missed tablet, consider the possibility of pregnancy. The greater the number of missed tablets and the closer to the tablet-free interval, the higher the risk of pregnancy.

Week 2
The patient should take the last missed tablet as soon as she remembers, even if this means taking two tablets at the same time. Then she should continue taking tablets at the usual time of day. If tablets were taken correctly for the 7 days preceding the missed tablet, there is no need to use additional contraceptive methods. However, if this was not the case, or if the woman missed more than one tablet, additional contraceptive methods should be used for 7 days.

Week 3
The risk of reduced contraceptive protection is inevitable due to the approaching tablet-free interval. However, this can be prevented by adjusting the way tablets are taken. Thus, additional contraceptive methods are not necessary if one of the two alternative procedures below is followed, provided that all tablets were taken correctly during the 7 days preceding the missed tablet. Otherwise, follow the first of the two alternative procedures 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 this means taking two tablets at the same time. Then she should continue taking tablets at the usual time of day. The next pack should be started immediately after the last tablet of the current pack, i.e., without a break between packs. Withdrawal bleeding will probably not occur until the end of the next pack, but breakthrough bleeding or spotting may occur during tablet intake.

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

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

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

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

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

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

If withdrawal bleeding does not occur in two consecutive cycles, pregnancy is possible. In such a case, contact your doctor immediately. Use of contraceptive tablets may continue only after pregnancy has been excluded, as advised by the doctor.

Discontinuation of Regulon
Regulon may be discontinued on any chosen day. If the reason for stopping contraceptive tablets is planned pregnancy, another contraceptive method should be used until menstrual bleeding occurs. This will help the doctor determine the due date.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any adverse effects occur, especially severe and persistent ones, or changes in health which the patient considers to be related to the use of Regulon, medical advice should be sought from a doctor.
All women using combined hormonal contraceptives have an increased risk of venous blood clots (venous thromboembolic disease) or arterial blood clots (arterial thromboembolic disorders). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before taking Regulon".
Common (may affect up to 1 in 10 people): depression, mood changes, headache, nausea, abdominal pain, breast pain, breast tenderness, weight gain.
Uncommon (may affect up to 1 in 100 people): fluid retention, decreased libido, migraine, vomiting, diarrhoea, rash, urticaria, breast enlargement.
Rare (may affect up to 1 in 1000 people): hypersensitivity, increased libido, eye irritation due to contact lenses, skin disorders (nodular erythema, erythema multiforme), abnormal cervical discharge, galactorrhea, weight loss.

Harmful blood clots in a vein or artery, for example:

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

The likelihood of developing blood clots may be higher if the patient has other risk factors (see section 2 for further information on risk factors increasing the likelihood of blood clots and symptoms of blood clot formation).
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Regulon

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

6. Contents of the pack and other information

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

What Regulon looks like and contents of the pack
White or almost white, round, biconvex tablets, engraved with the codes "RG" on one side and "P8" on the other.
The carton pack contains 1 blister or 3 blisters with 21 coated tablets each. A cardboard pouch is included in the pack, in which the blister should be placed.

For further detailed information, please contact the marketing authorisation holder or the parallel importer.

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

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

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Belgium, country of export: BE339421
Parallel Import Authorisation Number: 355/12

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