Dorin

Leaflet accompanying the packaging: information for the user

Dorin

0.03 mg + 2 mg, coated tablets

Ethinylestradiol + Dienogest

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").

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

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for one 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 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.
Hormonal contraceptives that contain two hormones are called "combined tablets" or "combined hormonal contraceptives".
Clinical trials have shown that drugs 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, you 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 her health and the health of her close relatives. The doctor will also measure blood pressure and, depending on the individual case, may also perform some other tests.
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, either no sexual intercourse should be maintained, or additional non-hormonal contraceptive methods should be used, e.g. condoms or other mechanical methods. The observational method or temperature measurement method should not be used. These methods may be unreliable because Dorin modifies the monthly changes in body temperature and cervical mucus.

Dorin, like other hormonal contraceptives, does not protect against 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. The patient should discuss with her doctor the need to continue treatment after three to six months of treatment, and then at regular intervals.
The doctor will advise how to proceed in order to minimize the risk of blood clots.

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 veins of the legs (deep vein thrombosis), lungs (pulmonary embolism), or other organs;
• if the patient knows that she has a blood clotting disorder - for example, deficiency of protein C, protein S, antithrombin III, 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 transient ischaemic attack (temporary stroke-like symptoms);
• if the patient has any of the following diseases that 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); a disease called hyperhomocysteinaemia; 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) associated with high levels of triglycerides in the blood (hypertriglyceridaemia);
• if the patient has (or has ever had) severe liver disease, and liver function is still not normal;

If any of the above conditions occur during treatment with 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 use Dorin, you should discuss it with your doctor or pharmacist.
When should you contact your doctor?
You should contact your doctor immediately

• if you notice any of the following symptoms that could indicate a blood clot: deep vein thrombosis, pulmonary embolism, heart attack, or stroke - see below under "Blood clots". For a description of these serious side effects, see "How to recognize a blood clot".

You should tell your doctor if you have any of the following conditions.

In some cases, you should be particularly careful when using Dorin or any other combined oral contraceptive. Regular medical examination may also be necessary.
If these symptoms occur or worsen while using Dorin, you should also tell your doctor.

• If you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel diseases);
• if you have systemic lupus erythematosus (a disease that affects the body's natural defence system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder that causes kidney failure);
• if you have sickle-cell anaemia (a hereditary disease of red blood cells);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this disease. Hypertriglyceridaemia is associated with an increased risk of developing pancreatitis;
• if you need to have surgery or will be immobilized for a long time (see section 2 "Blood clots");
• if you have just given birth, as you are at a higher risk of blood clots. You should consult your doctor to find out how soon you can start using Dorin after giving birth;
• if you have superficial thrombophlebitis (blood clots in the veins under the skin);
• if you have varicose veins;
• if you have heart valve problems or irregular heart rhythm;
• if any of your close relatives have had breast cancer;
• if you have liver disease, gallbladder disease, or gallstones;
• if you have jaundice or itching caused by bile duct obstruction;
• if you have had chloasma (patchy skin discoloration) during pregnancy, especially on the face. In this case, you should avoid direct exposure to sunlight or ultraviolet radiation;
• if you have problems with haemoglobin synthesis (porphyria);
• if you have depression;
• if you have epilepsy;
• if you have Sydenham's chorea (a disease that affects movement);
• if you have had a rash during pregnancy (pregnancy rash);
• if you have hearing loss caused by middle ear disease (hearing loss caused by otosclerosis);
• if you experience symptoms of angioedema, such as facial swelling, tongue and/or pharyngeal swelling, and/or difficulty swallowing or breathing, you should contact your doctor immediately. Oestrogen-containing medicines may cause or worsen the 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 sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, you should contact your doctor as soon as possible for 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 treatment is used.
Blood clots can occur

• in veins (deep vein thrombosis),
• in arteries (arterial thrombosis).

Blood clots can cause serious complications.

How to recognize a blood clot

You should contact your doctor immediately if you notice any of the following symptoms.

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 highest?

The risk of blood clots in a vein is highest during the first year of using combined hormonal contraceptives for the first time. The risk may also be higher when resuming the use of combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or longer.
After the first year, the risk decreases, although 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 factors increase the risk of blood clots in a vein?

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

• if the patient is severely overweight (body mass index (BMI) over 30 kg/m2);
• if 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 increasing 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 (over 4 hours) may temporarily increase the risk of blood clots, especially if the patient has another risk factor.
It is essential to tell the doctor if any of these risk factors are present, even if you are not sure. The doctor may decide to stop Dorin.
You should tell your doctor if any of the above conditions change while using Dorin, e.g. if you start smoking, if someone in your close family is diagnosed with a blood clot without a known cause, or if you gain 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 complications, such as a heart attack or stroke.

Factors that increase the risk of blood clots in arteries

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

• with increasing age (over approximately 35 years old);
• if the patient smokes. When using a hormonal contraceptive like Dorin, it is recommended to stop smoking. If the patient is unable to stop smoking and is over 35 years old, the doctor may recommend using a different type of contraception;
• if the patient is overweight;
• if the patient has high blood pressure;
• if someone in the patient's 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 a higher 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, irregular heart rhythm);
• if the patient has diabetes.

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

Dorin and cancer

Women using combined oral contraceptives have a slightly higher risk of breast cancer, but it is not known if this is caused by the pills. For example, more breast cancers may be detected in women using combined oral contraceptives because they are examined by doctors more often.
The incidence of breast cancer gradually decreases after stopping the use of combined hormonal contraceptives. It is essential to examine the breasts regularly and consult a doctor if a lump is found.
Women using combined oral contraceptives have rarely reported cases of benign or, even more rarely, malignant liver tumours, which can cause life-threatening bleeding into the abdominal cavity. If severe abdominal pain occurs, you should consult a doctor immediately.
There have been reports of a higher incidence of cervical cancer in women who have used oral contraceptives for a long time. However, this association may not be related to the use of the pills but to sexual behaviour or other factors, such as infection with human papillomavirus (HPV).

When to contact your doctor

Regular check-ups:
While using hormonal contraception, you should remain in regular contact with your doctor.
Usually, you should visit your doctor once a year for a check-up.
In addition, you should contact your doctor immediately if:

• you notice any changes in your health, especially any of the symptoms listed in this leaflet in the section "When not to use Dorin". Remember to mention any family history;
• a breast lump is found;
• you are using other medicines (see also "Dorin and other medicines");
• you are going to have surgery or a surgical procedure is planned (inform your doctor at least 4 weeks in advance);
• you experience heavy vaginal bleeding between periods;
• you miss a period or experience an unusually light period;
• you experience unexpected bleeding or spotting.

Irregular bleeding

During the first few months of using Dorin, you may experience unexpected bleeding (bleeding at times when you are not taking the pills). This should stop once your body has adjusted to the pills (usually after about 3 blisters). If such bleeding is very heavy or lasts longer than a few days, your doctor should investigate the cause.

Missed periods

If all the pills have been taken correctly and no vomiting or severe diarrhoea has occurred, and no other medicines have been taken, it is very unlikely that you are pregnant. You should continue to use Dorin.
If the expected period does not occur twice in a row, or if you did not follow the instructions for using Dorin before the missed period, this may indicate pregnancy. You should contact your doctor immediately. Do not take Dorin until your doctor has ruled out pregnancy.

Children and adolescents

Dorin is indicated only after the onset of menstruation.

Dorin and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not use Dorin if you have hepatitis C and are taking antiviral medicines containing ombitasvir, 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).
Your doctor will recommend a different type of contraception before starting these medicines.
You can start using Dorin again about 2 weeks after stopping treatment. See section "When not to use Dorin".

Effect of other medicines on Dorin

Some medicines may cause irregular bleeding or reduce the effectiveness of Dorin. 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 (e.g. etoricoxib)
• herbal remedies containing St. John's Wort (Hypericum perforatum).

While taking any of the above medicines with Dorin, you should also use a barrier method of contraception, such as a condom, or choose another form of contraception.
Additional contraceptive methods should be used not only while taking other medicines with Dorin but also for 28 days after stopping the other medicine.
If you run out of Dorin tablets, you should start the next blister pack without taking a 7-day break.
If long-term treatment with any of the above medicines is necessary, you should use non-hormonal methods of contraception.

Effect of Dorin on other medicines

Dorin may affect the action of other medicines, such as:

• the antiepileptic medicine lamotrigine (the effect of Dorin may lead to an increased frequency of seizures),
• ciclosporin,
• theophylline (used to treat respiratory diseases),
• tizanidine (used to treat muscle pain and muscle spasms). You should read the leaflets of all prescribed medicines. You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.

Effect of Dorin on laboratory tests
Taking Dorin may affect the results of some laboratory tests, including liver function tests, adrenal function tests, kidney function tests, and thyroid function tests, as well as the levels of certain proteins in the blood, such as those involved in fat metabolism, carbohydrate metabolism, blood clotting, or fibrinolysis. However, these changes usually remain within the normal range. Before undergoing any tests, you should inform your doctor or laboratory staff that you are taking Dorin.

Taking Dorin with food and drink

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Women who are pregnant should not take Dorin.
If you become pregnant while taking Dorin, you should stop taking it immediately and contact your doctor.
If you want to become pregnant, you can stop taking Dorin at any time (see section "Stopping Dorin").
Breastfeeding
Generally, Dorin should not be used while breastfeeding because 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 using Dorin affects the ability to drive or use machines.

Dorin contains lactose and sodium

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking Dorin.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means that it is essentially "sodium-free".

3. How to use Dorin

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, you should consult your 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, you should read the section of the leaflet entitled "If you forget to take Dorin".
You should take one Dorin tablet every day, whole, with a small amount of water if necessary. The tablets can be taken at any time of day, with or without food, but you should try to take them at the same time every day.
The blister pack contains 21 coated tablets. Each tablet is marked with the day of the week on which it should be taken. You should take one tablet every day.

• 8. On the 8th day after taking the last tablet of Dorin (i.e. after the 7-day break), you should start the next 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 the same day of the month.

Dorin also prevents pregnancy during the 7-day break from taking the tablets, provided that the tablets have been taken correctly.

Starting the first blister pack

If you have not used any contraceptive pills in the previous month:
You should start taking Dorin on the first day of your period, i.e. the first day of menstrual bleeding.
Switching from another combined oral contraceptive:
You should start taking Dorin on the first day after taking the last active tablet of your previous combined oral contraceptive, but no later than the first day of the usual break in taking the active tablets.

• 1. If you are switching from a combined oral contraceptive that contains a different type of progestogen, you should start taking Dorin on the first day after taking the last active tablet of your previous contraceptive.

Switching from a vaginal ring or transdermal patch (transdermal system):
You should start taking Dorin on the same day that you remove the vaginal ring or patch, but no later than the day when you would normally apply a new ring or patch.
Switching from a progestogen-only contraceptive (minipill, implant, injection) or an intrauterine system that releases progestogen:
You can stop taking the minipill and start taking Dorin on the same day, at the same time. If you are using an implant or intrauterine system, you can start taking Dorin on the day that the implant or system is removed.
After a miscarriage in the first trimester:
You should contact your doctor. Usually, you can start taking Dorin immediately.
After childbirth or miscarriage in the second trimester:
Your doctor will advise you to start taking Dorin 21 to 28 days after childbirth or miscarriage. If you start taking the tablets later, your doctor will advise you to use additional non-hormonal contraception (e.g. condoms) for the first 7 days of taking the tablets. If you have had sex before starting Dorin, you should make sure you are not pregnant or wait for your first period.

Forgetting to take Dorin

˗
If the delay in taking a tablet is less than 12 hours, the contraceptive effect of Dorin is still maintained. You should take the missed tablet as soon as possible and take the next tablets at the usual time.
˗
If the delay in taking a tablet is more than 12 hours, the contraceptive effect is not fully guaranteed. The more tablets you miss, the higher the risk of reduced contraceptive effectiveness.
There is a particularly high risk of pregnancy if you miss tablets at the beginning or end of the pack. In this case, you should follow the instructions below.

Missing more than one tablet from the pack

You should contact your doctor.

Missing one tablet in the first week

You should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and continue taking the tablets at the usual time. For the next 7 days, you should use additional non-hormonal contraceptive methods, such as condoms. If you had sex in the week before missing the tablet, you may be pregnant. You should contact your doctor immediately.

Missing one tablet in the second week

You should take the missed tablet as soon as possible (even if it means taking two tablets at the same time), and continue taking the tablets at the usual time. If you have taken Dorin correctly in the 7 days before missing the tablet, the contraceptive effect is maintained, and there is no need to use additional contraceptive methods. However, if you made mistakes when taking the tablets before or missed more than one tablet, you should use additional non-hormonal contraceptive methods for 7 days.

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 or persistent ones, or changes in your health that you think may be related to the use of Dorin, you should consult a doctor.
All women using combined hormonal contraceptives have an increased risk of developing blood clots in the veins (venous thromboembolism) or blood clots in the arteries (arterial thromboembolism). To get detailed information on the different risk factors related to the use of combined hormonal contraceptives, you should read section 2 "Important information before using Dorin".
Serious side effects associated with 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 a doctor immediately.
The following are side effects of Dorin, classified by frequency of occurrence.

• Frequent side effects (may affect up to 1 in 10 users)

• Headache
• Breast pain, including discomfort and breast tenderness

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

• 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 menorrhagia, metrorrhagia, oligomenorrhea, or amenorrhea
• Intermenstrual bleeding, menorrhagia (irregular bleeding), painful menstruation
• 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 1,000 users)

• Ovarian and (or) tubal inflammation, urinary tract infections, cystitis (inflammation of the bladder), mastitis (inflammation 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 fibroids
• Breast lump
• Anemia
• Hypersensitivity (allergic reaction)
• Masculinization in women (development of male secondary sex characteristics)
• Anorexia (loss of appetite)
• Depression, psychiatric disorders, insomnia, sleep disorders, aggression
• Circulatory disorders in the brain or heart
• 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 standing up from a sitting or lying position (orthostatic hypotension), hot flashes, varicose veins, venous disorders, vein pain
• Asthma, hyperventilation
• Gastritis, enteritis, indigestion
• Skin reactions, skin diseases including allergic dermatitis, neurodermatitis, and (or) atopic dermatitis, rash, urticaria, blisters, or skin necrosis (erythema multiforme), 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 ovaries and (or) fallopian tubes, breast cysts, painful intercourse, milk secretion, menstrual disorders
• Chest pain, swelling of the feet and hands, flu-like illnesses, fever, irritability
• Increased levels of cholesterol and triglycerides 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 (sexual desire), intolerance to contact lenses, hives, skin changes and (or) mucosal changes such as rash, urticaria, blisters, or skin necrosis (erythema multiforme), breast discharge, fluid retention.
Cancer
˗
The number of breast cancer cases in women using combined oral contraceptives is slightly increased. Since breast cancer is rare in women under the age of 40, the number of cases is small compared to the overall risk of breast cancer. The causal relationship between breast cancer and combined oral contraceptives is not known.
˗
Liver tumors (benign and malignant)
˗
Cervical cancer
Other
˗
Women with hypertriglyceridemia: the level of fats in the blood increases, which can increase the risk of pancreatitis when using combined oral contraceptives
˗
High blood pressure
˗
Occurrence or worsening of symptoms whose connection to the use of hormonal contraceptives has not been established: jaundice and (or) itching associated with cholestasis (obstructed bile flow); gallstones; 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 type of skin disease that occurs during pregnancy); otosclerosis-related hearing loss
˗
Liver function disorders
˗
Changes in glucose tolerance or effects on peripheral insulin resistance
˗
Crohn's disease, ulcerative colitis
˗
Chloasma
Interactions
Breakthrough bleeding and (or) contraceptive failure may be caused by the effect of other medicines on oral contraceptives (e.g., St. John's Wort (Hypericum perforatum) or medicines for epilepsy, tuberculosis, HIV, and other infections). See section "Effect of other medicines on Dorin".
Other serious side effects of Dorin and their symptoms are described in the section "Warnings and precautions".
Serious side effects
You should immediately contact a 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 those not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Dorin

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month.
There are no special precautions for the storage of the medicinal product.
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:

Core of the tablet:
Lactose monohydrate, maize starch, maltodextrin, magnesium stearate.

• Coating: Hypromellose 15 cP, titanium dioxide (E171), 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 tablets
42 tablets – 2 blister packs of 21 tablets
63 tablets – 3 blister packs of 21 tablets
PVC/PE/PVDC/Aluminum blisters in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
Date of last revision of the leaflet:04.2023