Dorin

Package leaflet: Information for the patient

Warning! Keep the leaflet – information on the immediate packaging is in a foreign language!
Dorin (Dienovel)
0.03 mg + 2 mg, coated tablets
Ethinylestradiolum + Dienogestum
Dorin and Dienovel are different brand names for the same medicine.
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 following an interval of 4 weeks or longer.
• Be vigilant and consult a doctor if you suspect symptoms of blood clot formation (see section 2 "Blood clots").

Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. It may harm someone else even if their symptoms are similar.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Dorin is and what it is used for
2. Important information before taking Dorin
3. How to take Dorin
4. Possible side effects
5. How to store Dorin
6. Contents of the pack and other information

1. What Dorin is and what it is used for

Dorin is used:

• for prevention of pregnancy,
• for the treatment of women with moderate acne who have decided to use oral contraceptives and in whom adequate topical treatment or systemic antibiotic therapy has failed.

Each of the 21 coated tablets contains a small amount of two different female hormones called
ethinylestradiol and dienogest.
Contraceptives containing two hormones are known as "combined oral contraceptives" or "combined
hormonal contraceptives".
Clinical studies show that medicines containing ethinylestradiol and dienogest alleviate acne symptoms in women in whom acne results from elevated levels of male hormones (called androgens).

2. Important information before using Dorin

General notes
Before starting to take Dorin, you should read the information about blood clots in section 2. It is particularly important to be aware of the symptoms of blood clots (see section 2 "Blood clots").
Before you can start taking Dorin, 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 situation, may carry out some other tests.
This leaflet describes several situations in which you should stop taking Dorin or when the effectiveness of Dorin may be reduced. In such cases, you should either avoid sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other mechanical methods. Do not use fertility awareness-based methods or temperature monitoring methods. These methods may be unreliable because Dorin alters the monthly changes in body temperature and cervical mucus.
Dorin, like other hormonal contraceptives, does not protect against infection with HIV (AIDS) or other sexually transmitted diseases.
Improvement in acne symptoms usually occurs after three to six months of treatment, but skin condition may continue to improve even after six months of treatment. You should discuss with your doctor the need to continue treatment after three to six months, and then at regular intervals.

When not to use Dorin
Do not use Dorin if you have any of the conditions listed below. If you have any of the conditions listed below, inform your doctor. Your doctor will discuss with you which alternative method of contraception would be more suitable.
Do not use Dorin:

• if you are allergic to ethinylestradiol, dienogest, or any of the other ingredients of this medicine (listed in section 6);
• if you currently have (or have ever had) a blood clot in the deep veins of the legs (deep vein thrombosis), in the lungs (pulmonary embolism), or in other organs;
• if you know you have a clotting disorder—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you are undergoing surgery or will be immobile for a long time (see section "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have had in the past) 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 diseases 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 hyperhomocysteinaemia;
• if you currently have (or have had in the past) a type of migraine called "migraine with aura";
• if you currently have (or have had in the past) pancreatitis (inflammation of the pancreas) in combination with elevated triglyceride levels in the blood (hypertriglyceridaemia);
• if you currently have (or have had in the past) severe liver disease and liver function remains abnormal;
• if you currently have (or have had in the past) a benign or malignant liver tumour;
• if you currently have or have had in the past a suspicion or diagnosis of a hormone-dependent tumour (e.g. breast or endometrial cancer);
• if you have unexplained vaginal bleeding;
• if you have hepatitis C and are taking antiviral medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir (see section "Dorin and other medicines").

If any of the above conditions occur while you are taking Dorin, stop taking the medicine immediately and consult your doctor. During this time, use non-hormonal methods of contraception (see section "Warnings and precautions").

Warnings and precautions
Before starting to take Dorin, discuss this with your doctor or pharmacist.

When to 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 the leg (deep vein thrombosis), in the lungs (pulmonary embolism), a heart attack, or a stroke—see section below "Blood clots". For a description of the symptoms of these serious side effects, see "How to recognize blood clots".

Tell your doctor if you have any of the following conditions.
In certain cases, special caution is required when using Dorin or any other combined oral contraceptive. Regular check-ups by your doctor may also be necessary.
If any of these conditions appear or worsen during treatment with Dorin, inform your doctor.
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 red blood cell disorder);
if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
if you are undergoing surgery or will be immobile for a long time (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 Dorin;
if you have phlebitis (inflammation of veins under the skin);
if you have varicose veins;
if you have heart valve disorders or heart rhythm disorders;
if your close relatives currently have or have previously had breast cancer;
if you have liver disease, gallbladder disease, or gallstones;
if you have jaundice or itching caused by bile stasis;
if you have developed chloasma (brownish pigmentation), especially on the face, during pregnancy. In such cases, avoid direct exposure to sunlight or ultraviolet radiation;
if you have disorders affecting haemoglobin synthesis (porphyria);
if you have depression;
if you have epilepsy;
if you have Sydenham's chorea (St. Vitus' dance);
if you previously developed a blistering rash during pregnancy (herpes gestationis);
if you have hearing loss caused by middle ear disease (otosclerosis);
if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat and/or difficulty swallowing, or hives potentially with breathing difficulties, seek immediate medical attention. Medicines containing estrogens may cause or worsen symptoms of hereditary or acquired angioedema.

Psychiatric disorders
Some women using hormonal contraceptives, including Dorin, have reported depression or low mood. Depression can be severe and may sometimes lead to suicidal thoughts. If you experience mood changes or symptoms of depression, contact your doctor as soon as possible for further medical advice.

Blood clots
Using combined hormonal contraceptives such as Dorin 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 complications.
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").
Recovery from a blood clot is not always complete. In rare cases, the consequences of a blood clot may be permanent or, very rarely, fatal.
Remember that the overall risk of harmful blood clots caused by using Dorin is small.

How to recognize blood clots
Seek immediate medical advice if you notice any of the following symptoms.

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 veins (venous thromboembolism), although these adverse events are rare. They most commonly occur during the first year of using combined hormonal contraceptives.
If blood clots form in the veins of the leg or foot, this may lead to 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 first-time use of combined hormonal contraceptives. The risk may also be increased when restarting combined hormonal contraceptives (the same or a different product) after a break of 4 weeks or longer.
After the first year, the risk decreases, but it remains higher than in women who do not use combined hormonal contraceptives.
If a patient stops taking Dorin, the risk of 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 individual's natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive used.
The overall risk of developing blood clots in the legs or lungs with the use of Dorin is low.

• 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 8–11 out of 10,000 women who use combined contraceptives containing dienogest and ethinylestradiol, such as Dorin, will develop blood clots.
• It has not yet been established how the risk of blood clots with Dorin compares to the risk with combined hormonal contraceptives containing levonorgestrel.
• The risk of developing blood clots depends on the individual medical history of the patient (see "Factors that increase the risk of blood clots" below).

Factors increasing the risk of venous blood clots
The risk of blood clots associated with the use of Dorin is low, 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 someone in the patient's immediate family has experienced blood clots in the legs, lungs, or other organs at a young age (e.g., under 50 years). In this case, the patient may have an inherited clotting disorder;
if the patient requires surgery, is immobilized for a prolonged period due to injury or illness, or has a leg in plaster. It may be necessary to discontinue Dorin for several weeks before surgery or immobilization. If Dorin must be stopped, ask the doctor when it is safe to restart;
with increasing age (especially 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 risk factors apply to the patient, even if uncertain. The doctor may decide to discontinue Dorin.
Inform the doctor if any of the above conditions change during treatment with Dorin, e.g., if a family member is diagnosed with unexplained thrombosis or if the patient gains significant weight.

Arterial blood clots
What can happen if blood clots form in arteries?
As with venous blood clots, arterial clots may cause serious consequences, such as 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 Dorin use is very low, but it may increase:
with age (over approximately 35 years);
if the patient smokes. While using a hormonal contraceptive such as Dorin, smoking should be discontinued. If the patient cannot stop smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
if the patient has overweight;
if the patient has high blood pressure;
if someone in the immediate family has experienced 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 someone in her immediate family has high levels of blood fats (cholesterol or triglycerides);
if the patient suffers from migraines, especially migraines with aura;
if the patient has heart disease (valve disorder, heart rhythm disorder called atrial fibrillation);
if the patient has diabetes.

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

Dorin and cancer
Breast cancer is observed slightly more frequently in women using combined oral contraceptives, but it is not known whether this is caused by the pills. For example, more cancers may be detected in women using combined oral contraceptives because they are examined more frequently by doctors.
The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important to examine breasts regularly and contact the doctor if any lump is felt.

Rare cases of benign and, even more rarely, malignant liver tumors have been reported in women using combined oral contraceptives, which led to life-threatening intra-abdominal bleeding. If severe upper abdominal pain occurs, contact the doctor immediately.

There are reports of increased incidence of cervical cancer in women who have used oral contraceptives for a long time. However, this association may not be due to the pills themselves but to sexual behavior or other factors, such as infection with human papillomavirus (HPV).

When to contact the doctor
Regular check-ups:
While using hormonal contraception, it is important to maintain regular contact with the doctor. Usually, an annual check-up is recommended.

Additionally, contact the doctor immediately if:

• any concerning health changes occur, especially any of the symptoms listed in this leaflet under the section "When not to use Dorin". Remember to consider family medical history;
• a breast lump is detected;
• the patient is taking other medicines (see also "Dorin and other medicines");
• immobilization or planned surgical procedure is expected (inform the doctor at least 4 weeks in advance);
• heavy vaginal bleeding occurs between withdrawal bleeds;
• tablets are missed in the first week of the cycle (each first week of consecutive months of Dorin use), and intercourse occurred in the previous 7 days;
• withdrawal bleeding does not occur for two consecutive months, or pregnancy is suspected.

Intermenstrual bleeding
During the first few months of taking Dorin, unexpected bleeding (bleeding outside the tablet-free period) may occur. This should resolve as the body adjusts to the tablets (usually after about 3 packs). If such bleeding is heavy and lasts longer than a few days, the doctor should investigate the cause.

Absence of withdrawal bleeding
If all tablets were taken correctly, without vomiting, severe diarrhoea, or concomitant use of other medicines, it is very unlikely that the woman is pregnant. Continue taking Dorin as directed.
If withdrawal bleeding does not occur for two consecutive cycles, or if the patient did not follow the instructions before the missed bleeding, pregnancy may be possible. Contact the doctor immediately. Do not take Dorin until the doctor has ruled out pregnancy.

Children and adolescents
Dorin is indicated only after the onset of menstruation.

Dorin and other medicines
Inform the doctor or pharmacist about all medicines currently or recently used, including those planned for future use.

Do not use Dorin if the patient has hepatitis C and is taking antiviral medicines containing ombitasvir with paritaprevir and ritonavir, dasabuvir, glecaprevir with pibrentasvir, or sofosbuvir with velpatasvir and voxilaprevir, as these medicines may cause abnormal liver function test results (increased liver enzyme AlAT activity).
The doctor will recommend another form of contraception before starting these antiviral treatments. Dorin may be restarted approximately 2 weeks after completing the antiviral treatment. See section "When not to use Dorin".

Some medicines may cause intermenstrual bleeding and/or reduce contraceptive effectiveness.

Effect of other medicines on Dorin
Always inform the doctor about all medicines or herbal products being used. Also inform any other doctor or dentist (or pharmacist) prescribing medicines about Dorin use. They will advise whether additional contraception (e.g., condoms) is needed, how long it should be used, and whether the dosing of other medicines should be adjusted.

The following medicines may:

• affect Dorin blood levels,
• reduce Dorin's contraceptive effect,
• cause unexpected bleeding.

These include medicines used to treat:

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g., rifampicin);
• HIV and hepatitis C virus infections (protease inhibitors and non-nucleoside reverse transcriptase inhibitors);
• fungal infections (e.g., griseofulvin, ketoconazole);
• arthritis, osteoarthritis (etoricoxib);
• herbal products containing St John’s wort (Hypericum perforatum).

While taking any of the above medicines, use an additional barrier method of contraception (e.g., condom) alongside Dorin, or choose another form of contraception.
Additional contraceptive methods should be used not only during co-administration with other medicines but also for 28 days after stopping them.
If the Dorin pack runs out during treatment, start the next pack without the 7-day break.

If long-term treatment with any of the above medicines is required, use non-hormonal contraception.

Effect of Dorin on other medicines
Dorin may affect the action of other medicines, for example:

• the antiepileptic lamotrigine (Dorin's effect may lead to increased frequency of seizures);
• cyclosporine;
• theophylline (used to treat respiratory diseases);
• tizanidine (used to treat muscle pain and spasms).

Read the package leaflets of all prescribed medicines.
Inform the doctor or pharmacist about all medicines currently or recently used, including those planned for future use, even those available without a prescription.

Effect of Dorin on laboratory test results
Taking Dorin may affect the results of certain laboratory tests, including liver, adrenal gland, kidney, and thyroid function parameters, as well as levels of certain blood proteins, e.g., proteins affecting fat metabolism (fat digestion), carbohydrate metabolism, or blood clotting and fibrinolysis. However, these changes usually remain within normal ranges. Inform the doctor or laboratory staff about Dorin use before undergoing any tests.

Taking Dorin with food and drink
Dorin may be taken with or without food. If needed, take it with a small amount of water.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Dorin must not be used during pregnancy.
If the patient becomes pregnant while taking Dorin, stop immediately and contact the doctor.
If the patient wishes to become pregnant, she may stop taking Dorin at any time (see section: "Discontinuing Dorin").

Breastfeeding
Dorin is generally not recommended during breastfeeding, as it may reduce milk production and the active substance passes into breast milk in small amounts.

Driving and operating machinery
There is no information suggesting that Dorin affects the ability to drive or operate machinery.

Dorin contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult the doctor before taking this medicine.
Dorin contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Dorin

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
To effectively prevent pregnancy and treat acne in women, Dorin must be taken according
to the instructions for use. To maintain the contraceptive effect of Dorin, refer to the section
of the leaflet entitled “Missed dose of Dorin”.
Take one Dorin tablet every day, whole, with a small amount of water if necessary. Tablets
may be taken regardless of meals, but at approximately the same time each day.
The blister pack contains 21 coated tablets. Each tablet is marked on the packaging with the
symbol of the day of the week on which it should be taken (translations of the day-of-week symbols
adjacent to each tablet on the immediate packaging are located at the end of this leaflet and on the
carton included with the package). Tablets should be taken daily.
Take one tablet marked with the day of the week. For example, if starting on Friday, take the tablet
marked “Fr”. Take one tablet daily in the order indicated on the packaging.
The time of day is not critical, but it is important to take the tablet at the same time each day. Continue
taking tablets in the direction of the arrows until all 21 tablets have been taken. Then, do not take any
tablets for 7 days. During this 7-day break, withdrawal bleeding (menstrual-like bleeding) should occur
2–3 days after taking the last tablet. On the 8th day after the last tablet of Dorin (i.e. after the 7-day
break), start a new blister pack regardless of whether bleeding has stopped or not. This means that
each blister pack starts on the same day of the week, and bleeding should occur on approximately
the same day of the month.
Dorin prevents pregnancy during the 7-day break as long as the medicine is taken according to
instructions.

Starting the first blister pack
If the patient has not taken any contraceptive tablets in the previous month:
Start taking Dorin on the first day of the cycle, i.e. on the first day of menstrual bleeding.
Switching from another combined oral contraceptive:
It is recommended to start taking Dorin on the first day after taking the last active tablet of the previous
combined oral contraceptive, but no later than the first day after the usual break from active or placebo
tablets in the previous combined oral contraceptive regimen.
Switching from a vaginal ring or patch (transdermal system):
It is recommended to start taking Dorin on the same day the ring or patch is removed, but no later than
the day the next ring or patch would have been applied.
If previously using a progestogen-only hormonal contraceptive method (mini-pill, implant, injections)
or an intrauterine system releasing progestogen:
The mini-pill may be discontinued on any day, and Dorin may be started instead at the same time. If
sexual intercourse occurs during the first 7 days of taking Dorin, an additional non-hormonal
contraceptive method (barrier method) should be used simultaneously.
After a first-trimester abortion:
Consult a doctor. In most cases, Dorin may be started immediately.
After childbirth or second-trimester abortion:
The doctor should advise that tablet intake should begin between 21 and 28 days after childbirth or
second-trimester abortion. If starting later, the doctor should advise using additional mechanical
contraception for the first 7 days of tablet intake. If intercourse occurred before starting the combined
oral contraceptive, ensure that pregnancy has not occurred or wait until the first menstrual bleeding
occurs.
Breastfeeding women:
See section “Breastfeeding”.

Taking more Dorin than recommended
There are no reports of serious harmful effects from taking too many Dorin tablets. If several tablets
are taken at once, symptoms such as nausea, vomiting, or vaginal bleeding may occur. Such bleeding
may even occur in girls who have not yet started menstruating but accidentally took the medicine.

Missed dose of Dorin

• If the delay in taking the tablet does not exceed 12 hours, the contraceptive effect of Dorin is still maintained. Take the missed tablet as soon as possible, and continue taking the next tablets at the usual time.
• If the delay in taking the tablet exceeds 12 hours, the contraceptive effect is not fully ensured. The more consecutive tablets missed, the greater the risk of reduced contraceptive effectiveness.

The risk of pregnancy is particularly high when tablets are missed at the beginning or end of the pack. In such cases, follow the rules below.

• More than 1 tablet missed from the pack – Consult your doctor.
• 1 tablet missed in the first week – Take the missed tablet as soon as possible (even if this means taking two tablets at the same time), and continue taking the next tablets at the usual time. Use additional contraceptive methods (e.g. condoms) for the next 7 days. If sexual intercourse occurred in the week before the missed tablet, pregnancy is possible. Inform your doctor immediately.
• 1 tablet missed in the second week – Take the missed tablet as soon as possible (even if this means taking two tablets at the same time), and continue taking the next tablets at the usual time. If Dorin was taken regularly in the 7 days before the missed tablet, the contraceptive effect is maintained and no additional contraceptive methods are needed. However, if there were previous dosing errors or more than one tablet was missed, use an additional contraceptive method for 7 days.
• 1 tablet missed in the third week – One of the following options may be chosen without the need for additional contraceptive methods, provided correct dosing was maintained in the 7 days before the missed dose:
  1. Take the missed tablet as soon as possible (even if this means taking two tablets at the same time), and continue taking the next tablets at the usual time. Omit the tablet-free interval and immediately start taking tablets from the next blister pack. Withdrawal bleeding will likely not occur until the end of the second blister pack, but breakthrough bleeding or spotting may occur during the second pack. Or:
  2. Alternatively, stop taking tablets from the current blister pack and immediately take a 7-day break (including the day the tablet was missed). If the patient wishes to start the new blister pack on the usual day of the week, the tablet-free interval may be shortened accordingly. If the patient forgot to take tablets and withdrawal bleeding does not occur during the first tablet-free interval, pregnancy may be possible. Consult a doctor before starting the next pack.

What to do if vomiting or diarrhoea occurs
In severe gastrointestinal disturbances (e.g. vomiting or severe diarrhoea), active ingredients may not be completely absorbed. Protection against pregnancy may be reduced, similar to a missed tablet. Additional contraceptive protection should be used.
If vomiting occurs within 3 to 4 hours after taking the tablet, take another tablet from a spare blister pack as soon as possible. If possible, take it within 12 hours of the usual tablet-taking time. If this is not possible or if more than 12 hours have passed, follow the recommendations for a missed tablet. If the patient wishes to maintain her tablet-taking cycle, she may take an additional tablet from another blister pack and use that pack later as a spare.

What to know if a patient wishes to delay withdrawal bleeding
Although not recommended, a patient may delay withdrawal bleeding by immediately starting the next blister pack of Dorin as soon as the current one is finished, without observing the tablet-free interval. Withdrawal bleeding may be delayed as long as desired, but not longer than until the end of the second blister pack. The likelihood of breakthrough bleeding or spotting during this time is increased. After the next 7-day tablet-free interval, Dorin may be continued as usual.
Before deciding to delay bleeding, consult a doctor.

Changing the day of the week on which bleeding occurs
If the patient takes tablets as directed, bleeding occurs approximately every 4 weeks on the same day. To change the bleeding day to another day of the week than indicated by the dosing schedule, shorten (never extend) the next tablet-free interval. For example, if bleeding usually starts on Fridays but should start on Tuesdays (3 days earlier), start the new pack 3 days earlier than usual. If the tablet-free interval is very short (e.g. 3 days or less), withdrawal bleeding may not occur during the break, but slight bleeding may occur.

If you have any further doubts about using this medicine, consult your doctor.

Stopping Dorin
Dorin may be discontinued at any time. If the patient does not wish to become pregnant, consult a doctor about other effective methods of birth control.
If the patient wishes to become pregnant, she should stop taking Dorin and wait for the first natural menstrual period before trying to conceive. This makes it easier to calculate the expected delivery date. After stopping Dorin, it may take some time before a normal menstrual cycle returns.

Additional information for specific patient groups

Children and adolescents
Dorin is indicated only after the onset of menstruation.

Elderly patients
Not applicable. Dorin is not indicated for postmenopausal women.

Patients with hepatic impairment
Dorin is contraindicated in women with severe liver disease. See also section 2 “When not to use Dorin”.

Patients with renal impairment
No specific studies have been conducted with Dorin in patients with renal impairment. Available data do not indicate a need to modify treatment in this patient group.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Dorin may cause adverse effects, although not everyone will experience them.
If any adverse effects occur, particularly severe or persistent ones, or changes in health which the patient considers to be related to the use of Dorin, medical advice should be sought.
All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolic disease) or blood clots in the arteries (arterial thromboembolic disorders). For detailed information on the various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before taking Dorin".
Serious adverse effects related to the use of Dorin are listed in the section "Warnings and precautions", which contains detailed information. If any adverse effects occur, immediate contact with a doctor is recommended.
The following are adverse effects associated with Dorin, listed according to their frequency of occurrence.

Common adverse effects (may affect up to 1 in 10 users)

• Headache
• Breast pain, including discomfort and breast tenderness

Uncommon adverse effects (may affect up to 1 in 100 users)

• Vaginitis and/or vulvitis (inflammatory conditions of the genital organs), vaginal candidiasis (yeast infection) or other fungal infections of the vagina
• Increased appetite
• Depressed mood
• Migraine, dizziness
• High or low blood pressure
• Abdominal pain (including bloating), nausea, vomiting, diarrhoea
• Acne, hair loss (alopecia), rash, itching
• Changes in bleeding patterns such as heavy, light, infrequent or absent menstrual periods
• Intermenstrual vaginal bleeding, uterine haemorrhage (irregular bleeding between periods), painful menstruation
• Vaginal discharge
• Ovarian cysts
• Pelvic pain
• Breast enlargement, breast swelling
• Feeling of fatigue, malaise
• Weight gain

Rare adverse effects (may affect up to 1 in 1,000 users)

• Oophoritis and salpingitis, urinary tract infections, cystitis, mastitis, cervicitis (inflammatory condition of the cervix), fungal infections (e.g. candidiasis), viral infections (e.g. herpes), influenza, bronchitis, sinusitis, upper respiratory tract infections

• Uterine leiomyoma

• Breast fibroadenoma

• Anaemia

• Hypersensitivity (allergic reaction)

• Masculinization in women (development of male secondary sexual characteristics)

• Loss of appetite (anorexia)

• Depression, psychiatric disorders, insomnia, sleep disturbances, aggression

• Circulatory disorders in the brain or heart

• Dystonia (persistent muscle contractions causing, for example, twisting or abnormal postures)

• Dry or irritated eyes

• Sudden hearing loss, tinnitus, dizziness, hearing disturbances

• Phlebitis, elevated diastolic pressure, dizziness or fainting upon standing from sitting or lying positions (orthostatic hypotension), hot flushes, varicose veins, venous dysfunction, vein pain

• Asthma, rapid and deep breathing (hyperventilation)

• Gastritis, enteritis, dyspepsia

• Skin reactions, skin disorders including allergic dermatitis, neurodermatitis and/or atopic dermatitis, rash, psoriasis, excessive sweating, pigmentary skin disorders (e.g. melasma), seborrhoea, dandruff, skin changes, "orange peel" skin appearance (cellulite), spider angioma

• Back pain, bone, muscle and joint pain, pain in arms and legs

• Cervical dysplasia (abnormal cell growth on the surface of the cervix), pain or cysts of the uterine appendages (ovaries and fallopian tubes), breast cysts, painful intercourse, galactorrhoea (milk secretion), menstrual disorders

• Chest pain, swelling of arms and legs, influenza-like illness, fever, irritability

• Increased blood cholesterol and triglyceride levels, weight loss, weight fluctuations

• Discovery of accessory breast tissue

• Potentially life-threatening venous and arterial thromboembolic events, for example:

  • in the leg or foot (deep vein thrombosis)
  • in the lungs (pulmonary embolism)
  • myocardial infarction (heart attack)
  • stroke
  • transient ischaemic attack (mini-stroke) or transient stroke-like symptoms known as transient ischaemic attack
  • blood clots in the liver, stomach and intestines, kidney or eye

The risk of developing blood clots increases if the patient has other risk factors for thrombosis (see section 2).

Frequency not known (cannot be estimated from available data)
Mood changes, decreased or increased libido (sex drive), intolerance to contact lenses, urticaria, skin and/or mucous membrane changes such as: rash, eruptions, blisters or tissue necrosis (erythema multiforme or erythema nodosum), nipple discharge, fluid retention.

Neoplasms

• A slightly increased number of breast cancer cases have been diagnosed in women using combined oral contraceptives. However, since breast cancer is rare in women under 40 years of age, the number of diagnoses is small in relation to the overall risk of breast cancer. A causal relationship between combined oral contraceptives and breast cancer has not been established.
• Liver tumours (benign and malignant)
• Cervical cancer

Other

• Women with hypertriglyceridaemia: increased blood lipid levels, increasing the risk of pancreatitis during use of combined oral contraceptives
• High blood pressure
• Occurrence or worsening of symptoms whose relationship to hormonal contraceptive use has not been established: jaundice and/or pruritus associated with cholestasis (blocked bile flow); gallstones; metabolic disorders such as porphyria; systemic lupus erythematosus (chronic autoimmune disease); haemolytic-uraemic syndrome (a blood clotting disorder); neurological disorders known as Sydenham's chorea; herpes gestationis (a type of skin disease occurring during pregnancy); otosclerosis associated with hearing loss
• Liver function disorders
• Changes in glucose tolerance or effects on peripheral insulin resistance
• Crohn's disease, ulcerative colitis
• Melasma

Interactions
Intermenstrual bleeding and/or reduced contraceptive effectiveness may be caused by the interaction of other medicinal products with oral contraceptives (e.g. St John's wort (Hypericum perforatum), or medicines used for epilepsy, tuberculosis, HIV infection and other infections). See section "Interaction with other medicinal products".

Other serious reactions to Dorin and their symptoms are described in the section "Warnings and precautions".

Serious adverse effects
Seek immediate medical attention if the patient experiences any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, or urticaria potentially associated with breathing difficulties (see also section 2 "Warnings and precautions").

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

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and blister.
The expiry date refers to the last day of the stated month.
No special storage conditions apply.
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 Dorin contains

• The active substances in the medicine are: ethinylestradiol and dienogest. Each coated tablet contains 0.03 mg ethinylestradiol and 2 mg dienogest.
• Other ingredients are:
  Tablet core: Monohydrate lactose, corn starch, maltodextrin, magnesium stearate.
  Coating: Hypromellose 15 cP, titanium dioxide (E 171), monohydrate lactose, macrogol 4000, sodium citrate.

What Dorin looks like and contents of the pack
Dorin is available as white coated tablets.
Pack sizes:
21 coated tablets
2 x 21 coated tablets
3 x 21 coated tablets
PVC/PE/PVDC/Aluminium blisters in a cardboard box. A cardboard pouch is included with the pack, in which the blister should be placed.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Germany, the country of export:
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
Manufacturer:
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
Parallel Importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
German Marketing Authorisation Number (country of export): 81073.00.00
Parallel Import Authorisation Number: 300/25
Translation of weekday symbols printed next to each tablet on the immediate packaging:
Mo - Monday
Di - Tuesday
Mi - Wednesday
Do - Thursday
Fr - Friday
Sa - Saturday
So - Sunday