Dorin

Patient Information Leaflet

Caution! Please keep this leaflet. The 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 about combined hormonal contraceptives

• When used correctly, they are one of the most reliable reversible methods of contraception.
• They slightly increase the risk of blood clots in veins and arteries, especially during the first year of use or after restarting following a break of 4 weeks or longer.
• Be vigilant and consult your doctor if you suspect symptoms of a blood clot (see section 2 "Blood clots").

Please read this leaflet carefully before using 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 the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Dorin is and what it is used for
2. What you need to know 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 the 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 oral antibiotic therapy has failed.

Each of the 21 coated tablets contains a small amount of two different female hormones,
ethinylestradiol and dienogest.
Contraceptives containing two hormones are known as "combined oral contraceptives" or "combined hormonal contraceptives".
Clinical studies have shown that medicines containing ethinylestradiol and dienogest reduce acne symptoms in women whose acne is due to elevated levels of male hormones (called androgens).

2. Important information before using Dorin

General notes
Before starting treatment with 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 starting 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 perform additional tests.
This leaflet describes several situations in which you should stop using Dorin or in which the effectiveness of Dorin may be reduced. In such cases, you should either abstain from sexual intercourse or use additional non-hormonal contraceptive methods, such as condoms or other barrier 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 HIV (AIDS) infection or other sexually transmitted infections.
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 any of these conditions apply to you, inform your doctor. Your doctor will discuss with you which alternative method of contraception may 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 veins of your legs (deep vein thrombosis), in your lungs (pulmonary embolism), or in other organs;
• if you know you have blood clotting disorders—for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden mutation, or antiphospholipid antibodies;
• if you require surgery or will be immobile for a prolonged period (see section "Blood clots");
• if you have had a heart attack or stroke;
• if you have (or have previously had) angina pectoris (a condition causing severe chest pain and may be the first sign of a heart attack) or transient ischaemic attack (temporary stroke-like symptoms);
• if you have any of the following conditions that may increase the risk of arterial blood clots:
• severe diabetes with blood vessel damage;
• very high blood pressure;
• very high levels of fats in the blood (cholesterol or triglycerides);
• a condition called hyperhomocysteinemia;
• if you currently have (or have previously had) a type of migraine called "migraine with aura";
• if you currently have (or have previously had) pancreatitis (inflammation of the pancreas) associated with high levels of triglycerides in the blood (hypertriglyceridemia);
• if you currently have (or have previously had) severe liver disease and liver function remains abnormal;
• if you currently have (or have previously had) a benign or malignant liver tumour;
• if you currently have or have previously had suspicion or diagnosis of a hormone-dependent cancer (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 contact your doctor. During this time, use non-hormonal methods of contraception (see section "Warnings and precautions").

Warnings and precautions
Before starting Dorin, discuss this with your doctor or pharmacist.
When should you contact your doctor?
Seek immediate medical attention:

• if you notice symptoms suggesting a blood clot, which may indicate a blood clot in your leg (deep vein thrombosis), in your lungs (pulmonary embolism), a heart attack, or a stroke—see section below "Blood clots".

For a description of the symptoms of these serious adverse events, 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 medical check-ups may also be necessary.
If any of these symptoms 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 immune system);
• if you have haemolytic uraemic syndrome (a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited disorder of red blood cells);
• 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 require surgery or will be immobile for a prolonged period (see section 2 "Blood clots");
• if you have recently given birth, as you are at increased risk of blood clots. Consult your doctor about when it is safe to start taking Dorin after delivery;
• if you have phlebitis (inflammation of superficial veins under the skin);
• if you have varicose veins;
• if you have heart valve disorders or heart rhythm abnormalities;
• if 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 cholestasis;
• if you developed brownish patches on the skin during pregnancy, especially on the face. In such cases, avoid direct exposure to sunlight or ultraviolet radiation;
• if you have disorders affecting haemoglobin synthesis (porphyria);
• if you suffer from depression;
• if you have epilepsy;
• if you have Sydenham's chorea (St. Vitus' dance);
• if you developed blistering rash during a previous pregnancy (pemphigoid 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 depressed mood. Depression can be severe and may, in some cases, 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 hormonal contraception. In rare cases, a blood clot may block a blood vessel and cause serious complications.
Blood clots may occur:

• in veins (referred to as "venous thrombosis" or "venous thromboembolic disease");
• in arteries (referred to as "arterial thrombosis" or "arterial thromboembolic events").

Recovery from a blood clot may not always be 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 low.

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

Are you experiencing any of these symptoms? What might be the likely cause?

• swelling of the leg or swelling along a vein in the leg or foot, especially if accompanied by:
  • pain or tenderness in the leg, felt only when standing or walking;
  • increased warmth in the affected leg;
  • change in skin colour of the leg, such as pallor, redness, or blueness.
• sudden unexplained shortness of breath or rapid breathing;
  • chest pain, possibly radiating to the arm, neck, or jaw;
  • coughing (sometimes with blood);
  • dizziness or fainting.
• sudden severe headache, possibly different from previous headaches;
• sudden vision problems (blurred vision, partial or complete loss of vision);
• sudden difficulty speaking or understanding speech;
• sudden weakness or numbness, especially on one side of the body;
• sudden severe abdominal pain.

These symptoms may indicate a deep vein thrombosis, pulmonary embolism, heart attack, or stroke. Seek immediate medical help.

Blood clots in veins
What can happen if blood clots form in a vein?

• Use of combined hormonal contraceptives is associated with an increased risk of venous blood clots (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 the development of deep vein thrombosis.
• If a blood clot travels from the leg and lodges in the lungs, it may cause pulmonary embolism.
• In very rare cases, a clot may form in another organ, such as the eye (retinal vein thrombosis).

When is the risk of venous blood clots highest?
The risk of developing venous blood clots is greatest during the first year of taking combined hormonal contraceptives for the first time. The risk may also be increased when restarting combined hormonal contraceptives (the same or a different medicine) after a break of 4 weeks or more.
After the first year, the risk decreases, although it remains higher than if you were not using combined hormonal contraceptives.
If you stop taking Dorin, the risk of blood clots returns to normal within a few weeks.

What factors influence the risk of venous blood clots?
The risk depends on your natural risk of venous thromboembolic disease and the type of combined hormonal contraceptive you are using.
The overall risk of developing blood clots in the legs or lungs while using Dorin is small.

• In 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 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 one 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.
• To date, it has not 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 your individual medical history (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 small, but certain factors may increase this risk. The risk is higher:

• if the patient is significantly overweight (body mass index (BMI) above 30 kg/m²);
• if a close family member has had 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, will be immobilized for a prolonged period due to injury or illness, or has a leg in a cast. It may be necessary to discontinue Dorin 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 recently given birth (within the past few weeks).

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

Arterial blood clots
What can happen if blood clots form in arteries?
As with venous clots, arterial clots can lead to 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 is very low, but may increase:

• with age (particularly over about 35 years);
• if the patient smokes. When 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 is overweight;
• if the patient has high blood pressure;
• if a close family member has had a heart attack or stroke at a young age (under 50 years). In this case, the patient may also be at increased risk of heart attack or stroke;
• if the patient or a close family member has high levels of blood fats (cholesterol or triglycerides);
• if the patient suffers from migraines, especially migraines with aura;
• if the patient has heart disease (valve problems, heart rhythm disorders such as atrial fibrillation);
• if the patient has diabetes.

If the patient has more than one of the above conditions, or if any of them are particularly severe, the risk of blood clots may be further increased.
Inform the doctor if any of these conditions change during treatment with Dorin, for example, if the patient starts smoking, a family member develops 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 undergo more frequent medical examinations.
The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives. It is important to examine the breasts regularly and contact a doctor if any lump is detected.
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 a 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 rather to sexual behavior or other factors, such as human papillomavirus (HPV) infection.

When to contact a doctor
Regular check-ups:
While using hormonal contraception, regular contact with a doctor is essential. Usually, an annual check-up is recommended.
Additionally, contact a doctor immediately if:

• any concerning health changes occur, especially any of the symptoms listed in this leaflet under “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 surgery is expected (inform the doctor at least 4 weeks in advance);
• there is heavy vaginal bleeding 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 the bleeding is heavy and persists for more than a few days, the doctor should investigate the cause.

Absence of withdrawal bleeding
If all tablets have been taken correctly, without vomiting, severe diarrhea, or concomitant use of other medicines, the likelihood of pregnancy is very low. Continue taking Dorin as prescribed.
If withdrawal bleeding does not occur for two consecutive cycles, or if the patient has not followed the dosing instructions before the missed bleeding, pregnancy may be possible. Contact a 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, as well as any medicines planned for 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 an alternative contraceptive method before starting these antiviral treatments. Dorin may be restarted approximately 2 weeks after completing antiviral therapy.
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 any medicines or herbal products being used. Also inform any other doctor, dentist, or pharmacist prescribing medicines (or a pharmacist) that Dorin is being used. 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 the contraceptive effect of Dorin,
• 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 and osteoarthritis (etoricoxib);
• herbal products containing St. John’s wort (Hypericum perforatum).

When taking any of the above medicines, use an additional barrier method of contraception (e.g., condom) alongside Dorin, or choose a different contraceptive method.
Additional contraceptive methods should be used not only during concomitant treatment with other medicines but also for 28 days after stopping them.
If the Dorin pack is finished during treatment, start the next pack without a 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 may increase seizure frequency);
• 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 use and those available without a prescription.

Effect of Dorin on laboratory test results
Dorin may affect the results of certain laboratory tests, including liver, adrenal gland, kidney, and thyroid function, as well as levels of certain blood proteins, such as those involved in fat metabolism (fat digestion), carbohydrate metabolism, blood clotting, and fibrinolysis. However, these changes usually remain within normal ranges. Inform the doctor or laboratory staff that Dorin is being taken before 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 pregnancy occurs while taking Dorin, stop immediately and contact a doctor.
If the patient wishes to become pregnant, she may stop 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 monohydrate lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, i.e., the medicine is considered “sodium-free”.

3. How to use Dorin

This medicine should always be used 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 used according to
the instructions for use. To maintain the contraceptive effect of Dorin, refer to the section
in the leaflet entitled “Missed dose of Dorin”.
Take one Dorin tablet daily, 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 pack with the symbol of the
day of the week on which it should be taken (see “Translation of the day-of-the-week symbols
located next to each tablet on the immediate packaging” – section 6. at the end of the leaflet).
Tablets should be taken daily.
Take one tablet marked with the day-of-the-week symbol. If starting to take tablets on, for example,
Friday, take the tablet marked “Fr”. Take one tablet daily in the order indicated on the pack.
The time of day is not critical, but it is important to take the tablet at approximately the same time
every day. Continue taking the 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 to 3 days after the last tablet.

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

Dorin prevents pregnancy also during the 7-day break, provided the medicine is taken according to
instructions.
Starting the first blister pack
If the patient has not used any oral contraceptives in the previous month:
Begin taking Dorin on the first day of the menstrual 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 transdermal 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 used.
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 at any time, and Dorin may be started instead at the same time of day. If sexual intercourse occurs during the first 7 days of taking Dorin, use an additional contraceptive method (barrier method) simultaneously.
After 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 during 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 than the recommended dose of Dorin
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 this medicine.
Missed dose of Dorin
˗ If the tablet is taken less than 12 hours late, the contraceptive effect of Dorin is still maintained.
Take the missed tablet as soon as possible, and continue taking the following tablets at the usual
time.
˗ If the tablet is taken more than 12 hours late, the contraceptive effect may not be fully ensured.
The more tablets missed consecutively, the greater the risk of reduced contraceptive effectiveness.
The risk of pregnancy is particularly high if 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 following 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 may have occurred. 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 following tablets at the usual time. If Dorin has been taken regularly during the 7 days preceding the missed tablet, contraceptive protection is maintained, and no additional contraceptive methods are needed. However, if previous dosing errors occurred 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 during the 7 days preceding 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 following tablets at the usual time. Skip the tablet-free interval and immediately start the next blister pack. Withdrawal bleeding will likely not occur until the end of the second pack, but breakthrough bleeding or spotting may occur during the second pack.

Or:

2. Alternatively, stop taking tablets from the current pack and immediately begin a 7-day break (including the day the tablet was missed). If the patient wishes to start a new pack on the same day of the week as usual, the tablet-free interval may be shortened accordingly. If a patient forgets to take tablets and withdrawal bleeding does not occur during the first tablet-free interval, pregnancy may have occurred. Consult a doctor before starting the next pack.

What to remember if vomiting or diarrhoea occurs
In severe gastrointestinal disturbances (e.g. vomiting or severe diarrhoea), the active substances may
not be completely absorbed. Protection against pregnancy may be reduced, as with a missed tablet.
Additional contraceptive protection should therefore be used.
If vomiting occurs within 3 to 4 hours after taking a tablet, take another tablet from a reserve blister
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 instructions 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 reserve.
What to know if the patient wishes to delay withdrawal bleeding
Although not recommended, the patient may delay withdrawal bleeding by immediately starting the
next Dorin blister pack as soon as the current one is finished, without observing the tablet-free
interval. Withdrawal bleeding may be delayed for as long as the patient wishes, 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, continue taking Dorin as usual.
Before deciding to delay bleeding, consult a doctor.
Changing the day of bleeding to another day of the week.
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 (but never extend) the next tablet-free interval. If bleeding usually starts on Fridays and the
patient wants it to 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
this interval. Light bleeding may occur instead.
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 with Dorin have been conducted in patients with renal impairment. Available
data do not indicate a need to modify treatment in this patient group.
If in any doubt about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Dorin may cause adverse effects, although not everyone experiences them.
If any adverse effects occur, particularly severe or persistent ones, or changes in health which the user considers to be related to the use of Dorin, medical advice should be sought immediately.
All women using combined hormonal contraceptives have an increased risk of developing venous blood clots (venous thromboembolic disease) or arterial blood clots (arterial thromboembolic disorders). For detailed information on various risk factors associated with the use of combined hormonal contraceptives, please refer to section 2, "Important information before using Dorin".
Serious adverse effects associated with the use of Dorin are listed in the section "Warnings and precautions", which contains detailed information. In case of any adverse effects, contact your doctor without delay.
The adverse effects of Dorin are listed below according to their frequency of occurrence.

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

• Headache
• Breast pain, including discomfort and breast tenderness

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

• Vaginitis and (or) vulvitis (inflammation 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 completely 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 1000 women)

• Inflammation of the ovaries and fallopian tubes, urinary tract infections, cystitis (bladder inflammation), mastitis (breast inflammation), cervicitis (inflammation of the cervix), fungal infections (e.g. candidiasis), viral infections (e.g. herpes), influenza, bronchitis, sinusitis, upper respiratory tract infections
• Uterine leiomyoma (fibroids)
• Breast fibroadenoma
• Anaemia
• Hypersensitivity (allergic reaction)
• Masculinisation 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 (sustained muscle contractions causing 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 a sitting or lying position (orthostatic hypotension), hot flushes, varicose veins, venous insufficiency, 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. chloasma), 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, dyspareunia (painful intercourse), galactorrhoea (milk discharge), menstrual disorders
• Chest pain, swelling of legs and arms, flu-like illnesses, fever, irritability
• Increased blood cholesterol and triglyceride levels, weight loss, weight fluctuations
• Discovery of accessory breast tissue
• Potentially serious venous and arterial thromboembolic events, e.g.:
  • in the leg or foot (deep vein thrombosis),
  • in the lungs (pulmonary embolism),
  • heart attack,
  • stroke,
  • mini-stroke or transient ischaemic attack (TIA),
  • blood clots in the liver, stomach and intestines, kidney or eye.
    The risk of blood clots increases if the user has other risk factors (see section 2).

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

Neoplasms
˗ A slightly increased number of breast cancer cases has been observed in women using combined oral contraceptives. However, since breast cancer is rare in women under 40 years of age, the number of diagnosed cases remains small relative 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 fat 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 is not established: jaundice and (or) pruritus associated with cholestasis (impaired 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 skin condition 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
˗ Chloasma

Interactions
Intermenstrual bleeding and (or) reduced contraceptive effectiveness may result from interactions with other medicinal products affecting oral contraceptives (e.g. St John's wort (Hypericum perforatum), antiepileptic drugs, tuberculosis medications, HIV and other antiviral drugs). See section "Interactions with other medicines".

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

Serious adverse effects
Seek immediate medical attention if any of the following symptoms of angioedema occur: swelling of the face, tongue and (or) throat and (or) difficulty in 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 any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Dorin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines should 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 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 a white coated tablet. Pack sizes:
21 tablets – 1 blister containing 21 tablets
63 tablets – 3 blisters containing 21 tablets each
Blister packs made of PVC/PE/PVDC/Aluminium 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, 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, Poland

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

German Marketing Authorisation Number (country of export): 81073.00.00
Parallel Import Authorisation Number: 145/24

Translation of the day-of-the-week symbols printed next to each tablet on the immediate packaging:
Mo – Monday
Di – Tuesday
Mi – Wednesday
Do – Thursday
Fr – Friday
Sa – Saturday
So – Sunday