Dorin

Leaflet accompanying the packaging: information for the user

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

Dorin (Dienovel), 0.03 mg + 2 mg, coated tablets

Ethinylestradiol + Dienogest
Dorin and Dienovel are different trade names for the same medicine.

Important information about combined hormonal contraceptives

• If used correctly, they are one of the most reliable, reversible methods of contraception.
• To a small extent, they increase the risk of blood clots in veins and arteries, especially in the first year of use or after resuming use after a break of 4 weeks or longer.
• One should be vigilant and consult a doctor if the patient suspects that symptoms of blood clots have occurred (see section 2 "Blood clots").

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

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

Table of contents of the leaflet

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

1. What is Dorin and what is it used for

Dorin is used:

• to prevent pregnancy,
• to treat women with moderate acne who have decided to use oral contraceptives and who have not responded to appropriate local treatment or oral antibiotic treatment.

Each of the 21 coated tablets contains a small amount of two different female hormones called ethinylestradiol and dienogest.
Contraceptives that contain two hormones are called "combined tablets" or "combined hormonal contraceptives".
Clinical trials have shown that medicines containing ethinylestradiol and dienogest alleviate symptoms of acne in women who have it as a result of increased levels of male hormones (androgens).

2. Important information before using Dorin

General notes

Before starting to take Dorin, one should read the information about blood clots in section 2. It is especially important to read about the symptoms of blood clots (see section 2 "Blood clots").
Before Dorin can be started, the doctor will ask the patient a few questions about their health and the health of their close relatives. The doctor will also measure blood pressure and, depending on the individual case, may also perform some other tests.
This leaflet describes several situations in which Dorin should not be used or in which the effectiveness of Dorin may be reduced. In such situations, one should either not have sexual intercourse or use additional non-hormonal contraceptives, e.g. condoms or other mechanical methods. One should not use the observation method or the temperature measurement method. These methods may be unreliable, as Dorin modifies the monthly changes in body temperature and cervical mucus.

Dorin, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

Improvement of acne symptoms usually occurs after three to six months of treatment, but skin condition may continue to improve even after six months of treatment. The patient should discuss with their doctor the need to continue treatment after three to six months of treatment, and then at regular intervals.

When not to use Dorin

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

• if the patient is allergic to ethinylestradiol, dienogest or any of the other ingredients of this medicine (listed in section 6).
• if the patient currently has (or has 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 the patient knows they have a blood clotting disorder - for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, the presence of factor V Leiden mutation or antiphospholipid antibodies;
• if the patient needs to have surgery or will be immobilized for a long time (see section "Blood clots");
• if the patient has had a heart attack or stroke;
• if the patient has (or has ever had) angina pectoris (a disease that causes severe chest pain and may be the first symptom of a heart attack) or a transient ischemic attack (transient stroke symptoms);
• if the patient has any of the following diseases, which may increase the risk of a blood clot in an artery:
• severe diabetes with blood vessel damage;
• very high blood pressure;
• very high levels of fats in the blood (cholesterol or triglycerides);
• hyperhomocysteinemia;
• if the patient has (or has ever had) a type of migraine called "migraine with aura";
• if the patient has (or has ever had) pancreatitis (inflammation of the pancreas) in combination with high levels of triglycerides in the blood (hypertriglyceridemia);
• if the patient currently has (or has ever had) severe liver disease, and liver function is still abnormal;
• if the patient has (or has ever had) a benign or malignant liver tumor;
• if the patient has (or has ever had) a suspicion or diagnosis of a hormone-dependent tumor (e.g. breast cancer or endometrial cancer);
• if the patient has unexplained vaginal bleeding;
• 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 (see section "Dorin and other medicines").

If any of the above symptoms occur while taking Dorin, the medicine should be stopped immediately and a doctor consulted. During this time, non-hormonal methods of contraception should be used (see section "Warnings and precautions").

Warnings and precautions

Before starting to take Dorin, one should discuss it with their doctor or pharmacist.
When should one contact a doctor?
One should contact a doctor immediately

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

In order to get a description of the serious side effects listed, see "How to recognize blood clots".

One should tell the doctor if the patient has any of the following conditions.

In some cases, one should be particularly careful when using Dorin or any other combined oral contraceptive. Regular medical check-ups may also be necessary.
If these symptoms occur or worsen while taking Dorin, one should also tell their doctor.

• If the patient has Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if the patient has systemic lupus erythematosus (a disease that affects the body's natural defense system);
• if the patient has hemolytic uremic syndrome (a blood clotting disorder that causes kidney failure);
• if the patient has sickle cell anemia (a hereditary disease of red blood cells);
• if the patient has high levels of fats in the blood (hypertriglyceridemia) or a positive family history for this disease. Hypertriglyceridemia is associated with an increased risk of developing pancreatitis;
• if the patient needs to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if the patient has recently given birth, as they are at increased risk of blood clots. One should consult a doctor to find out how soon they can start taking Dorin after giving birth;
• if the patient has superficial thrombophlebitis (inflammation of the veins under the skin);
• if the patient has varicose veins;
• if the patient has heart valve defects or heart rhythm disorders;
• if there is a history of breast cancer in the patient's close relatives;
• if the patient has liver disease, gallbladder disease, or gallstones;
• if the patient has jaundice or itching caused by bile duct obstruction;
• if the patient has or has had chloasma (melasma) during pregnancy, especially on the face. In such a case, one should avoid direct exposure to sunlight or ultraviolet radiation;
• if the patient has problems with hemoglobin synthesis (porphyria);
• if the patient has depression;
• if the patient has epilepsy;
• if the patient has Sydenham's chorea (Saint Vitus' dance);
• if the patient had a rash during pregnancy (pregnancy rash);
• if the patient has hearing loss caused by middle ear disease (hearing loss caused by otosclerosis);
• if the patient experiences symptoms of angioedema, such as facial, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria with potential breathing difficulties, one should contact a doctor immediately. Estrogen-containing medicines may cause or worsen symptoms of hereditary and acquired angioedema.

Psychiatric disorders

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

Blood clots

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

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

Not all patients who have had a blood clot will recover completely. In rare cases, the effects of a blood clot can be permanent or, very rarely, fatal.

It should be remembered that the total risk of having a harmful blood clot due to Dorin is small.

How to recognize blood clots

One should contact a doctor immediately if they notice any of the following symptoms.

Is the patient experiencing any of these symptoms?

Why is the patient likely to be suffering?

• swelling of the leg or swelling along a vein in the leg or foot, especially if it is accompanied by:
• pain or tenderness in the leg, which can be felt only when standing or walking; this is deep vein thrombosis

that can be felt only when standing or walking;

• increased temperature in the affected leg;
• change in the color of the skin of the leg, e.g. pallor, redness, or cyanosis.
• sudden onset of unexplained shortness of breath or rapid breathing; pulmonary embolism

Blood clots in a vein

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

• The use of combined hormonal contraceptives is associated with an increased risk of blood clots in the veins (venous thromboembolism), although these side effects are rare. They most often occur in the first year of using combined hormonal contraceptives.
• If blood clots form in the veins in the leg or foot, it can lead to the development of deep vein thrombosis.
• If a blood clot moves from the leg and settles in the lungs, it can cause a pulmonary embolism.
• In very rare cases, a blood clot can form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of blood clots in a vein the highest?

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

What affects the risk of blood clots in veins?

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

• During a year, about 2 out of 10,000 women who do not use combined hormonal contraceptives and are not pregnant will develop blood clots.
• During a year, about 5-7 out of 10,000 women who use combined hormonal contraceptives containing levonorgestrel, norethisterone, or norgestimate will develop blood clots.
• During a year, about 8-11 out of 10,000 women who use combined hormonal contraceptives containing dienogest and ethinylestradiol, such as Dorin, will develop blood clots.
• So far, it has not been established how the risk of blood clots associated with Dorin compares to the risk associated with combined hormonal contraceptives containing levonorgestrel.
• The risk of blood clots depends on the patient's individual medical history (see "Factors that increase the risk of blood clots" below).

Factors that increase the risk of blood clots in veins

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

• if the patient is significantly overweight (body mass index (BMI) over 30 kg/m);
• if someone in the patient's close family has had blood clots in the legs, lungs, or other organs at a young age (e.g. under 50 years old). In this case, the patient may have a hereditary blood clotting disorder;
• if the patient needs to have surgery or will be immobilized for a long time (see section "Blood clots");
• with age (especially over 35 years old);
• if the patient has recently given birth.

The risk of blood clots increases with the number of risk factors present in the patient.
Air travel (>4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to tell the doctor if any of the above factors apply to the patient, even if they are not sure. The doctor may decide to stop Dorin.
One should tell the doctor if any of the above conditions change while taking Dorin, e.g. if someone in the patient's close family is diagnosed with a blood clot without a known cause or if the patient gains weight significantly.

Blood clots in an artery

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

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

Factors that increase the risk of blood clots in arteries

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

• with age (over about 35 years old);
• if the patient smokes.When using a hormonal contraceptive like Dorin, it is recommended to quit smoking. If the patient is unable to quit smoking and is over 35 years old, the doctor may recommend a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if someone in the patient's close family has had a heart attack or stroke at a young age (under 50 years old). In this case, the patient may also be at increased risk of having a heart attack or stroke;
• if the patient or someone in their close family has high levels of fats in the blood (cholesterol or triglycerides);
• if the patient has migraines, especially migraines with aura;
• if the patient has heart disease (valve damage, heart rhythm disorder called atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions or if any of them are particularly severe, the risk of blood clots may be even higher.
One should tell the doctor if any of the above conditions change while taking Dorin, e.g. if the patient starts smoking, someone in their close family is diagnosed with a blood clot without a known cause, or if the patient gains weight significantly.

Dorin and cancer

Women using combined oral contraceptives have a slightly higher incidence of breast cancer, but it is not known if this is caused by the use of the tablets. For example, it may be that more tumors are detected in women using combined oral contraceptives because they are examined by doctors more often.
The incidence of breast tumors gradually decreases after stopping the use of combined hormonal contraceptives. It is essential to examine the breasts regularly and contact a doctor if a lump is found.
Rarely, cases of benign or, even more rarely, malignant liver tumors have been reported in women using combined oral contraceptives, which can cause life-threatening bleeding into the abdominal cavity. If severe abdominal pain occurs, one should contact a doctor immediately.
There are reports of a higher incidence of cervical cancer in women who have used oral contraceptives for a long time. This relationship may not be related to the use of the tablets but to sexual behavior or other factors, such as human papillomavirus (HPV) infection.
When to contact a doctor
Regular check-ups:
While using hormonal contraception, one should remain in regular contact with their doctor.
Usually, one should visit the doctor once a year for a check-up.
Additionally, one should contact a doctor immediately if:

• they notice any worrying changes in their health, especially any of the symptoms listed in this leaflet in the section "When not to use Dorin". One should remember to mention any family history of diseases;
• a breast lump is found;
• the patient is using other medicines (see also "Dorin and other medicines");
• immobilization or surgery is planned (the doctor should be informed at least 4 weeks in advance);
• there is heavy vaginal bleeding between periods;
• the patient misses a period or suspects they may be pregnant.

Vaginal bleeding between periods

During the first few months of taking Dorin, unexpected bleeding (bleeding outside of the period when tablets are not taken) may occur. This bleeding should stop when the body gets used to taking the tablets (usually after about 3 blisters). If such bleeding is very heavy and lasts longer than a few days, the doctor should investigate the cause.

No vaginal bleeding between periods

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.
One should continue taking Dorin.
If the expected bleeding does not occur twice in a row, or the patient did not follow the instructions for taking Dorin before the missed bleeding, it may mean that the patient is pregnant. One should contact a doctor immediately. One should 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

One should tell the doctor or pharmacist about all the medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
One should 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 activity).
The doctor will recommend a different type of contraception before starting these medicines.
One can start taking Dorin again about 2 weeks after finishing the treatment with these medicines.
See section "When not to use Dorin".
Some medicines may cause vaginal bleeding between periods and/or reduce the effectiveness of Dorin.

Effect of other medicines on Dorin

One should always tell the doctor which medicines or herbal products the patient is using.
One should also inform any other doctor or dentist who prescribes medicines (or pharmacist) about the use of Dorin. They will inform the patient whether it is necessary to use additional contraception (e.g. condoms) and for how long, and whether it is necessary to change the way other medicines are taken.
Some medicines may:

• affect the level of Dorin in the blood,
• reduce the effectiveness of Dorin,
• cause vaginal bleeding between periods.

This applies to medicines used to treat:

• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate),
• tuberculosis (e.g. rifampicin),
• HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors),
• fungal infections (e.g. griseofulvin, ketoconazole),
• arthritis, degenerative joint disease (etoricoxib),
• herbal medicines containing St. John's Wort (Hypericum perforatum).

While taking any of the above medicines with Dorin, one should also use a barrier method of contraception (e.g. condoms) or choose another form of contraception.
Additional methods of contraception should be used not only while taking other medicines with Dorin but also for 28 days after finishing the treatment with these medicines.
If the blisters of Dorin are finished during treatment with any of the above medicines, one should start the next blister without taking a 7-day break.
If it is necessary to take any of the above medicines for a long time, one should use non-hormonal methods of contraception.

Effect of Dorin on other medicines

Dorin may affect the action of other medicines, e.g.:

• the antiepileptic medicine lamotrigine (the effect of Dorin may lead to an increased frequency of seizures),
• cyclosporin,
• theophylline (used to treat respiratory diseases),
• tizanidine (used to treat muscle pain and muscle spasms).

One should read the leaflets of all prescribed medicines.
One should tell the doctor or pharmacist about all the medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those that are available without a prescription.
Effect of Dorin on laboratory test results
Taking Dorin may affect the results of some laboratory tests, including parameters of liver, adrenal, kidney, and thyroid function, as well as the levels of some proteins in the blood, e.g. proteins that affect fat metabolism (lipid metabolism), carbohydrate metabolism, or blood clotting and fibrinolysis. However, these changes usually remain within the normal range. Before undergoing tests, one should inform the doctor or laboratory staff that they are taking Dorin.

Using Dorin with food and drink

Dorin can be taken with or without food. If necessary, it can be taken with a small amount of water.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
Pregnancy
Women who are pregnant should not take Dorin.
If the patient becomes pregnant while taking Dorin, they should stop taking it immediately and contact a doctor.
If the patient wants to become pregnant, they can stop taking Dorin at any time (see section "Stopping Dorin").
Breastfeeding
Generally, Dorin is not recommended when breastfeeding, as it may reduce the amount of milk produced, and the active substance passes into breast milk in small amounts.

Driving and using machines

There is no information to suggest that taking Dorin affects the ability to drive or use machines.

Dorin contains lactose monohydrate and sodium

If the patient has been diagnosed with an intolerance to some sugars, they should contact their doctor before taking Dorin.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means that the medicine is considered "sodium-free".

3. How to use Dorin

This medicine should always be used as directed by the doctor or pharmacist. If one is unsure, they should contact their doctor or pharmacist.
To effectively prevent pregnancy and treat acne in women, Dorin must be used according to the instructions. To maintain the contraceptive effect of Dorin, one should read the section of the leaflet "If you miss a dose of Dorin".
One should take one Dorin tablet every day, whole, with a small amount of water if necessary. The tablets can be taken with or without food, but it is recommended to take them at the same time every day.
The blister pack contains 21 coated tablets. On the packaging, each tablet is marked with a symbol of the day of the week on which it should be taken (see "Translation of the day of the week symbols on the packaging" - section 6 at the end of the leaflet).
The tablets should be taken daily.
One should take the tablet marked with the symbol of the day of the week. If one starts taking the tablets, for example, on a Friday, they should take the tablet marked "Fr". One should take one tablet daily, in the order indicated on the packaging.
The time of taking the tablets does not matter, but one should stick to the chosen time. The next tablets should be taken according to the direction of the arrows, until all 21 tablets have been taken.
Then, one should not take any tablets for 7 days. During this 7-day break, menstrual bleeding (withdrawal bleeding) should occur within 2-3 days after taking the last tablet.

• On the 8th day after taking the last Dorin tablet (i.e. after the 7-day break), one should start the next blister, regardless of whether the bleeding has stopped or not. This means that each blister starts on the same day of the week, and the bleeding should occur on the same day of the month.

Dorin also prevents pregnancy during the 7-day break in use, provided that the medicine is used according to the instructions.

Starting the first blister

If the patient has not used any oral contraceptives in the previous month:
One should start taking Dorin on the first day of their period, i.e. on the first day of menstrual bleeding.
Changing 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 of the usual break in taking active tablets or placebo tablets of the previous combined oral contraceptive.
If the patient is changing from a vaginal ring or patch (transdermal system):
It is recommended to start taking Dorin on the same day that the ring or patch is removed, but no later than the day when the next ring or patch would have been used.
If the patient is changing from a progestogen-only hormonal contraceptive (minipill, implant, injections) or an intrauterine system that releases progestogen:
One can stop taking the minipill on any day and start taking Dorin at the same time. If one has vaginal intercourse during the first 7 days of taking Dorin, they should also use a non-hormonal method of contraception (barrier methods).
After a miscarriage in the first trimester of pregnancy:
One should contact a doctor. Usually, one can start taking Dorin immediately.
After childbirth or miscarriage in the second trimester of pregnancy:
The doctor should inform the patient that they can start taking the tablets 21-28 days after childbirth or miscarriage in the second trimester. If the tablets are started later, the doctor should inform the patient about the need to use additional non-hormonal contraception (barrier methods) for the first 7 days of taking the tablets. If one has had vaginal intercourse before starting the combined oral contraceptive, one should make sure they are not pregnant or wait for the first menstrual period.

Taking more than the recommended dose of Dorin

There are no reports of serious harmful effects from taking too many Dorin tablets at once. If several tablets are taken at the same time, symptoms such as nausea or vomiting or vaginal bleeding may occur. This type of bleeding can occur even in girls who have not yet started menstruating but have taken the medicine by mistake.

4. Possible Side Effects

Like all medicines, Dorin can cause side effects, although not everybody gets them.
If you experience any side effects, especially serious and persistent ones or changes in your health that you consider to be related to the use of Dorin, you should consult your doctor.
In all women using combined hormonal contraceptives, there is an increased risk of blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thrombosis). For detailed information on the different risk factors associated with the use of combined hormonal contraceptives, you should refer to section 2 "Important information before using Dorin".
Severe side effects related to the use of Dorin have been listed in the section "Warnings and precautions", which contains detailed information. In case of side effects, you should contact your doctor immediately.
The following are side effects of Dorin, classified by frequency of occurrence.
Common side effects(may affect up to 1 in 10 women)

• Headache
• Breast pain, including discomfort and breast tenderness

Uncommon side effects(may affect up to 1 in 100 women)

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

Rare side effects(may affect up to 1 in 1000 women)

• Oophoritis and (or) salpingitis, urinary tract infections, cystitis (infection of the bladder), mastitis (infection of the breast), cervicitis (inflammation of the cervix), fungal infections (e.g., candidiasis), viral infections (e.g., herpes), flu, bronchitis, sinusitis, upper respiratory tract infections
• Uterine leiomyoma
• Breast lipoma
• Anemia
• Hypersensitivity (allergic reaction)
• Masculinization in women (development of male secondary sex characteristics)
• Anorexia (loss of appetite)
• Depression, psychiatric disorders, insomnia, sleep disorders, aggression
• Cerebral or cardiac circulatory disorders
• Dystonia (persistent muscle contractions causing, e.g., twisting or abnormal posturing)
• Dry or irritated eyes
• Sudden hearing loss, tinnitus, dizziness, hearing disorders
• Phlebitis, elevated diastolic blood pressure, dizziness or fainting when rising from a sitting or lying position (orthostatic hypotension), hot flashes, varicose veins, venous disorders, vein pain
• Asthma, rapid and deep breathing (hyperventilation)
• Gastritis, enteritis, indigestion
• Skin reactions, skin diseases including allergic dermatitis, neurodermatitis, and (or) atopic dermatitis, rash, urticaria, blisters or skin necrosis (erythema multiforme or Stevens-Johnson syndrome), breast discharge, fluid retention
• Back pain, bone pain, muscle and joint pain, pain in the arms and legs
• Cervical dysplasia (abnormal cell growth on the surface of the cervix), pain or cysts on the adnexa (ovaries and fallopian tubes), breast cysts, painful intercourse, milk secretion, menstrual disorders
• Chest pain, swelling of the feet and hands, flu-like illnesses, fever, irritability
• Increased cholesterol and triglyceride levels in the blood, weight loss, weight fluctuations
• Discovery of an accessory breast
• Life-threatening venous and arterial thromboembolic events, such as:
• deep vein thrombosis (in the leg or foot),
• pulmonary embolism,
• myocardial infarction,
• stroke,
• transient ischemic attack or "mini-stroke",
• blood clots in the liver, stomach, and intestines, kidney, or eye. The risk of blood clots increases if you have other risk factors for blood clots (see section 2).

Frequency not known(cannot be estimated from the available data)
Mood changes, decreased or increased libido (sex drive), intolerance to contact lenses, hives, skin changes and (or) mucosal changes such as: rash, urticaria, blisters or skin necrosis (erythema multiforme or Stevens-Johnson syndrome), breast discharge, fluid retention.
Cancers
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The number of breast cancer cases diagnosed in women using combined oral contraceptives is slightly increased. Since breast cancer is rare in women under 40 years of age, the number of diagnoses is small compared to the overall risk of breast cancer. The causal relationship between breast cancer and combined oral contraceptives is not known.
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Liver tumors (benign and malignant)
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Cervical cancer
Other
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Women with hypertriglyceridemia: the level of fats in the blood increases, leading to an increased risk of pancreatitis during the use of combined oral contraceptives
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High blood pressure
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Occurrence or worsening of symptoms whose connection to the use of hormonal contraceptives is not established: jaundice and (or) itching associated with cholestasis (obstructed bile flow); cholelithiasis; metabolic disorders such as porphyria; systemic lupus erythematosus (a chronic autoimmune disease); hemolytic-uremic syndrome (a blood clotting disorder); neurological disorders known as Sydenham's chorea; herpes gestationis (a skin condition that occurs during pregnancy); otosclerosis associated with hearing loss
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Liver function disorders
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Changes in glucose tolerance or effects on peripheral insulin resistance
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Crohn's disease, ulcerative colitis
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Chloasma
Interactions
Intermenstrual bleeding and (or) reduced contraceptive effectiveness may be caused by the effect of other medicines on oral contraceptives (e.g., St. John's Wort (Hypericum perforatum) or medications for epilepsy, tuberculosis, HIV, and other infections). See section "Effect of other medicines on Dorin".
Other serious reactions to Dorin and their symptoms are described in the section "Warnings and precautions".
Severe side effects
You should immediately contact your doctor if you experience any of the following symptoms of angioedema: facial swelling, tongue and (or) throat swelling, and (or) difficulty swallowing or urticaria potentially with difficulty breathing (see also section 2 "Warnings and precautions").

Reporting Side Effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to 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
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Dorin

The medicinal product should be stored out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should 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 of Dorin are ethinylestradiol and dienogest. Each film-coated tablet contains 0.03 mg of ethinylestradiol and 2 mg of dienogest.
• The other ingredients are: Tablet core: lactose monohydrate, maize starch, maltodextrin, magnesium stearate.
• Coating: hypromellose 15 cP, titanium dioxide (E 171), lactose monohydrate, macrogol 4000, sodium citrate.

What Dorin Looks Like and Contents of the Pack

Dorin is available in the form of white film-coated tablets. Pack sizes:
21 tablets – 1 blister pack of 21
63 tablets – 3 blister packs of 21
PVC/PE/PVDC/Aluminum blisters in a cardboard box.
A cardboard sachet is included in the packaging, in which the blister should be placed.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing Authorization 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:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
German marketing authorization number: 81073.00.00

Parallel Import Authorization Number: 145/24

Translation of Day of the Week Symbols on the Blister Pack:

Mo

• Monday Di
• Tuesday Mi
• Wednesday Do
• Thursday Fr
• Friday Sa
• Saturday So
• Sunday

Date of Approval of the Leaflet: 09.04.2024

[Information about the trademark]