Dienestra

Package leaflet: Information for the user

Dienestra 0.03 mg/2 mg film-coated tablets

ethinylestradiol/dienogest
Generic Medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Important information about combined hormonal contraceptives (CHCs):

• They are among the most reliable reversible methods of contraception, if used correctly.
• They slightly increase the risk of developing blood clots in veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks.
• Be alert and consult your doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of this leaflet:

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

1. What Dienestra is and what it is used for

• Ethinylestradiol/dienogest is a medicine used either to prevent pregnancy (a "pill" contraceptive) or for the treatment of moderate acne in women who are willing to use a contraceptive pill after failure of appropriate topical treatments or oral antibiotics.
• Each of the 21 film-coated tablets contains a small amount of the female hormones ethinylestradiol and dienogest.
• Tablets containing two hormones are called "combined tablets".
• In clinical studies, this medicine has been shown to improve acne in women in whom increased effects of male hormones (the so-called "androgens") lead to the development of acne.

2. What you should know before taking Dienestra

Talk to your doctor or pharmacist before taking Dienestra.
General information
Before starting to use Dienestra, you must read the information about blood clots in section 2.
It is particularly important that you read about the symptoms of a blood clot – see section 2
"Blood clots".
Before taking ethinylestradiol/dienogest, your doctor will ask you questions about your personal
medical history and that of your family members. Your doctor will also measure your blood pressure
and, depending on your individual situation, may carry out additional examinations.
This leaflet describes various situations that require discontinuation of this medicine,
or in which the safety of this medicine may be reduced. In such cases, you must abstain from sexual intercourse or use additional non-hormonal contraceptive methods, for example,
use a condom or another barrier method. Do not use the rhythm method or basal body temperature method. These methods may be unreliable because ethinylestradiol/dienogest alters the monthly fluctuations in body temperature and cervical mucus.
This medicine, like other hormonal contraceptives, does not protect against
HIV infection (AIDS) or other sexually transmitted diseases.
Acne usually improves within three to six months of treatment and may continue to improve even after
six months of treatment. Discuss with your doctor the need to continue treatment for three to six months
after starting therapy and thereafter on a regular basis.
When not to take Dienestra
Do not use ethinylestradiol/dienogest if you have any of the conditions listed below. If you have any
of the conditions listed below, consult your doctor. Your doctor will discuss with you other
birth control methods that might be more suitable for your case.
Do not take Dienestra if:

• you are allergic to ethinylestradiol or dienogest, or to any of the other ingredients of this medicine (listed in section 6);
• you have (or have ever had) a blood clot in a vein of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs;
• you know you have a disorder affecting blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
• you are scheduled for surgery or will be bedridden for a prolonged period (see section 2 “Blood clots”);
• you have ever had a heart attack or stroke;
• you have (or have ever had) angina pectoris (a condition causing severe chest pain that may be an early sign of a heart attack) or transient ischemic attack (TIA – temporary stroke-like symptoms);
• you have one of the following conditions, which could increase the risk of forming clots in the arteries:
  o severe diabetes with blood vessel damage, or very high blood pressure, or very high levels of fats (cholesterol or triglycerides) in the blood, or a condition known as hyperhomocysteinemia;
• you have (or have ever had) a type of migraine called “migraine with aura”;
• you have (or have ever had) inflammation of the pancreas (pancreatitis) associated with high levels of fats (lipids) in the blood (hypertriglyceridemia);
• you have (or have ever had) severe liver disease and liver function is still abnormal;
• you have (or have ever had) benign or malignant liver tumors;
• you have (or have ever had) or suspect you have a hormone-sensitive cancer (e.g., breast or endometrial cancer);
• you have unexplained vaginal bleeding;
• you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (also see section 2 “Other medicines and Dienestra”).

If any of the above situations occur while you are taking this medicine,
you must stop taking it immediately and consult your doctor. In the meantime, you must
use a different, non-hormonal method of contraception. For further information, see also section 2 "Warnings and precautions".
Warnings and precautions
When to be especially careful with Dienestra
When should you contact a doctor?
Contact a doctor urgently

• if you notice possible signs of a blood clot that may indicate you have a blood clot in the leg (deep vein thrombosis), in the lung (pulmonary embolism), a heart attack, or a stroke (see the following section “Blood clots” [thrombosis]).

For a description of the symptoms of these serious side effects, go to section 2 “How to recognize
a blood clot”.
You must stop taking Dienestra immediately if:

• you suspect or know you are pregnant;
• you experience signs of phlebitis or blood clots (also see “Blood clots”);
• your blood pressure continues to rise above 140/90 mmHg;
• surgery is planned (at least 4 weeks beforehand) or if you are immobilized for a prolonged period (also see “Blood clots”);
• migraine occurs for the first time or worsens;
• you experience unusually frequent, persistent, or severe headaches;
• you feel severe pain in the upper abdomen (also see “Dienestra and cancer”);
• your skin and the whites of your eyes turn yellow, your urine becomes brown, and your stools become very pale (called jaundice), or if your skin itches all over;
• you are diabetic (diabetes mellitus) and your blood sugar levels suddenly become high;
• you suffer from a certain metabolic disorder (porphyria).

Inform your doctor if any of the following conditions apply to you.
In some cases, special care is required when taking this medicine or any other combined pill, and your doctor may ask you to have regular check-ups.
If any of these conditions appear or worsen while you are using Dienestra, inform your doctor if:

• you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• you have systemic lupus erythematosus (SLE, a disease affecting the body’s natural defense system);
• you have hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure);
• you have sickle cell anemia (an inherited red blood cell disorder);
• you have high levels of fats in the blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• you are scheduled for surgery or will be bedridden for a prolonged period (see section 2 “Blood clots”);
• you have recently given birth; your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking Dienestra;
• you have inflammation of veins near the skin surface (superficial thrombophlebitis);
• you have varicose veins;
• you have heart valve defects or heart rhythm disorders;
• there is a history of breast cancer in close relatives;
• you have liver or gallbladder disease, or gallstones;
• you have jaundice or itching due to bile congestion;
• you have patches, yellow-brown skin discoloration, especially on the face (chloasma), or if these occurred during a previous pregnancy; in this case, avoid exposure to strong sunlight and UV radiation;
• you have problems with hemoglobin formation (porphyria);
• you suffer from depression;
• you suffer from epilepsy;
• you have Sydenham’s chorea;
• you had a blistering rash during a previous pregnancy (herpes gestationis);
• you have hearing loss in the inner ear (hearing loss due to otosclerosis);
• symptoms of angioedema occur, such as swelling of the face, tongue, and/or throat and/or difficulty swallowing, or hives, possibly with breathing difficulties – contact a doctor immediately. Estrogen-containing products may cause or worsen hereditary or acquired symptoms.

BLOOD CLOTS
Using a combined hormonal contraceptive such as ethinylestradiol/dienogest increases the
risk of developing a blood clot compared to not using one. In rare cases, a blood clot
can block blood vessels and cause serious problems.
Blood clots can develop

• in veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
• in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, and very rarely, such effects may be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with
Dienestra is low.
HOW TO RECOGNIZE A BLOOD CLOT
Contact a doctor immediately if you notice any of the following signs or symptoms.
Do you have one of these signs? What might you be suffering from?

• swelling in one leg or along a vein in the leg or foot, especially if accompanied by:
  • pain or tenderness in the leg, which may only be felt when standing or walking
  • increased warmth in the affected leg
  • skin discoloration of the leg, such as paleness, redness, or bluish color
• sudden and unexplained shortness of breath or rapid breathing
• sudden cough without an obvious cause, possibly with coughing up blood
• sharp chest pain that may worsen when breathing deeply
• severe dizziness or lightheadedness
• rapid or irregular heartbeat
• severe stomach pain

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of developing blood clots in the veins (venous thrombosis). However, these side effects are rare. In most cases, they occur during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may form in another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking a combined hormonal contraceptive for the first time. The risk may also be higher if you restart taking a combined hormonal contraceptive (the same medicine or a different one) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than if you were not using a combined hormonal contraceptive.
When you stop treatment, the risk of developing a blood clot returns to normal levels within a few weeks.

What is the risk of developing a blood clot?
The risk depends on your natural risk of venous thromboembolism (VTE) and on the type of combined hormonal contraceptive you are taking.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with ethinylestradiol/dienogest is low.

• Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in a year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in a year.
• Among 10,000 women who use a combined hormonal contraceptive containing dienogest and ethinylestradiol, such as this medicine, about 8 to 11 will experience a blood clot during one year.

The likelihood of developing a blood clot depends on your medical history (see below “Factors that increase the risk of developing a blood clot in a vein”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with ethinylestradiol/dienogest is low, but certain conditions can increase it. Your risk is higher if:

• you are very overweight (body mass index or BMI above 30 kg/m²);

• a close relative has had a blood clot in the leg, lung, or another organ at a young age (under approximately 50 years). In this case, you may have an inherited blood clotting disorder;

• you are scheduled for surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a plaster cast on your leg. You may need to stop taking this medicine several weeks before surgery or during periods of reduced mobility. If you need to stop taking this medicine, ask your doctor when you can start again.

• as you get older (especially over 35 years of age);

• you have given birth less than a few weeks ago.

The risk of developing a blood clot increases if you have more than one of these conditions.
Air travel (lasting >4 hours) may temporarily increase the risk of blood clot formation, especially if you have one or more of the other risk factors listed above.
It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide to stop your treatment with ethinylestradiol/dienogest.
If any of the conditions listed above change while you are using this medicine—for example, if a close relative develops thrombosis without an obvious cause, or if you gain significant weight—contact your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like blood clots in a vein, clots in an artery can cause serious problems. For example, they can lead to a heart attack or stroke.

Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of ethinylestradiol/dienogest is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive like this medicine, it is advisable to stop smoking. If you are unable to stop smoking and are over 35 years old, your doctor may recommend using a different type of contraceptive;
• if you are overweight;
• if you have high blood pressure;
• if a close relative has had a heart attack or stroke at a young age (under approximately 50 years). In this case, you may also have an increased risk of heart attack or stroke;
• if you or a close relative have high levels of fat in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have heart problems (valvular defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions, or if one of them is particularly severe, the risk of developing a blood clot may be even higher.
If any of the conditions listed above change while you are using Dienestra—for example, if you start smoking, if a close relative develops thrombosis without an obvious cause, or if you gain significant weight—contact your doctor.

Dienestra and cancer
Breast cancer is diagnosed slightly more frequently in women taking "combined pills," but it is not known whether this is due to the treatment. For example, more cancers may be detected in women taking "the pill" because they undergo medical check-ups more frequently. The risk of breast cancer gradually decreases after stopping the combined hormonal contraceptive. It is important that you regularly examine your breasts. Contact your doctor if you feel a lump.

In rare cases, benign liver tumours have been diagnosed in users of the pill, and even more rarely, malignant liver tumours. In isolated cases, these tumours have caused potentially fatal internal bleeding. Contact your doctor if you have severe abdominal pain.

Some studies suggest that long-term use of the pill increases a woman's risk of developing cervical cancer. However, it is unclear to what extent sexual behaviour (e.g. frequent partner change) and other factors such as human papillomavirus (HPV) contribute to this risk.

When to consult your doctor?
Periodic check-ups
If you are taking the pill, your doctor will recommend periodic check-ups. Normally, you should see your doctor at least once a year.

Additionally, consult your doctor immediately if:

• you notice any change in your health, particularly those mentioned in section 2 “Do not take Dienestra” and “When to be cautious with Dienestra”. Do not forget to mention illnesses affecting your family members;
• you feel a lump in your breast;
• you are taking other medicines (see also section 2 “Other medicines and Dienestra”);
• you are confined to bed for a prolonged period or are scheduled for surgery (contact your doctor at least four weeks in advance);
• you have unusual, heavy vaginal bleeding between periods;
• you missed taking the white coated tablets during the first week of pill intake and had sexual intercourse in the previous 7 days;
• you have missed two consecutive menstrual periods despite regular intake of the white coated tablets and suspect you may be pregnant.

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

If you have unexpected bleeding between periods
With all pills, unexpected bleeding (breakthrough bleeding) may occur, especially during the first few months of pill use. You may need to use sanitary pads or tampons, but you do not need to stop taking Dienestra. Light bleeding between periods usually stops once your body has adjusted to the pill, typically within 3 months. If you experience heavier vaginal bleeding similar to a normal menstrual period, or light vaginal bleeding lasting for several days, consult your doctor.

If your regular monthly period does not occur
If you have taken the tablets correctly, have not experienced vomiting or severe diarrhoea, and have not taken any other medicines, the likelihood that you are pregnant is extremely low. Continue taking this medicine as usual.

If two consecutive periods do not occur, or if you did not take this medicine as prescribed in the cycle preceding the missed period, you may be pregnant. Consult your doctor immediately. Do not take this medicine until your doctor has ruled out pregnancy.

Children and adolescents
This medicine may only be used after the first menstrual period (menarche).

Other medicines and Dienestra
Effect of other medicines on Dienestra
Always inform your doctor if you are taking other medicines or herbal products. Also inform any other doctor or dentist who prescribes medicines for you (or your pharmacist) that you are taking ethinylestradiol/dienogest. They will advise you whether you need to use additional contraceptive measures (e.g. condom), and if so, for how long, or whether you need to change your medication.

Some medicines:

• may affect ethinylestradiol/dienogest blood levels;
• may reduce contraceptive effectiveness;
• may cause unexpected bleeding.

These medicines include:

• medicines for the treatment of:
  • 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 (griseofulvin, ketoconazole);
  • arthritis, osteoarthritis (etoricoxib);
• the herbal remedy St. John’s wort.

If you are taking any of the medicines listed above, you must temporarily use a barrier contraceptive method (e.g. condom) or choose another contraceptive method. Use additional local contraceptives while taking other medicines together with ethinylestradiol/dienogest and for 28 days after stopping the other medicines.

If the treatment lasts longer than the duration of the Dienestra blister pack, start the next blister pack immediately without the usual tablet-free interval.

If long-term treatment with any of the medicines listed above is required, you must choose another reliable non-hormonal contraceptive method.

Effect of Dienestra on other medicines
Ethinylestradiol/dienogest may affect the action of other medicines, such as:

• the antiepileptic lamotrigine (this could lead to an increased frequency of epileptic seizures);
• medicines containing cyclosporine;
• theophylline (used to treat respiratory problems);
• tizanidine (used to treat muscle pain or muscle cramps).

Do not take ethinylestradiol/dienogest if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as this may cause increases in liver function blood test results (elevated liver enzyme ALT).
Your doctor will prescribe another type of contraceptive before starting treatment with these medicines. This medicine may be restarted approximately 2 weeks after completing this treatment. See section 2 “Do not take Dienestra”.
Also read the package leaflet of any other prescribed medicines.

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Interaction with laboratory tests
The use of this medicine may affect the results of certain laboratory tests, including liver function, adrenal cortex, kidney and thyroid function values, as well as the levels of certain blood proteins involved in fat digestion, carbohydrate metabolism, blood clotting, and fibrinolysis. However, such variations generally remain within the normal range.

Dienestra with food and drink
This medicine may be taken with or without food, if necessary, with a small amount of water.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Ethinylestradiol/dienogest must not be taken during pregnancy. You must not be pregnant before starting this medicine. If pregnancy occurs while taking Dienestra, stop taking the medicine immediately and consult your doctor.

Breastfeeding
Ethinylestradiol/dienogest is not recommended during breastfeeding, as it may reduce milk production and small amounts of the active substance may pass into breast milk. Reliable non-hormonal contraceptives should be used during breastfeeding.

Driving and using machines
No effects on the ability to drive and use machines have been observed.

Dienestra contains lactose
Each film-coated tablet contains 44.57 mg of lactose (as lactose monohydrate).
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Dienestra

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Ethinylestradiol/dienogest must be taken according to the following instructions both for pregnancy
prevention and for the treatment of women with moderate acne. To maintain the contraceptive effect,
follow the instructions provided in section 3 “If you forget to take Dienestra”.
Take one tablet of this medicine every day. Swallow the tablets whole, with or without water if needed.
The tablets must be taken every day at about the same time. It does not matter whether you take the
tablets on an empty stomach or with food.
Each blister contains 21 film-coated tablets. Next to each tablet, the day of the week on which it should
be taken is indicated; take one tablet daily. For example, if you start on Friday, take the first tablet
marked with “Fri” (for Friday) on the packaging, pushing it through the aluminium foil.
The time of day does not matter, but once you have chosen a time, you must stick to this schedule.
Follow the direction of the arrow on the blister until all 21 tablets have been taken. Then do not take
any tablets for 7 days. During these 7 tablet-free days, your menstrual period (withdrawal bleeding)
should occur 2–3 days after taking the last tablet.
On the 8th day, start the next blister pack regardless of whether bleeding has stopped. This means that
each new pack of Dienestra starts on the same day of the week as the first pack, and your periods will
begin approximately on the same day of the week each month.
If you take this medicine as directed, you will be protected against pregnancy even during the 7 days
when you are not taking tablets.

Starting treatment
If you have not used any hormonal contraceptive in the previous month:
Start treatment on the first day of your cycle, i.e. the first day of menstruation.

Switching from another combined hormonal contraceptive to Dienestra:
Start taking Dienestra preferably the day after the last active tablet of your previous oral contraceptive,
but no later than the day after the usual tablet-free interval or after the last inactive tablet of the
previously used oral contraceptive.

Switching from a vaginal ring or transdermal patch to Dienestra:
Dienestra should preferably be started on the same day of removal, but no later than when the next
application would have been due.

Switching from a progestogen-only method (mini-pill, implant, injection) or from a progestogen-releasing intrauterine system (IUS, hormonal IUD) to Dienestra:
You may switch at any time from the progestogen-only pill. From an implant or IUS, switch on the day of removal. From an injectable, switch when the next injection would have been due. However, in all these cases, you must use additional contraceptive measures for the first 7 days of taking Dienestra.

If you wish to start taking Dienestra after a first-trimester abortion:
Talk to your doctor. In principle, you may start taking Dienestra immediately.

If you wish to start taking Dienestra after a second-trimester abortion or after childbirth:
Your doctor will advise you to start taking Dienestra between the 21st and 28th day after childbirth or
second-trimester abortion. If you start Dienestra later, you must use a barrier method (e.g. condom)
during the first 7 days of taking Dienestra.
However, if you have already had sexual intercourse, you must ensure you are not pregnant before
starting Dienestra, or wait until your next menstrual period.

If you are breastfeeding and wish to start taking Dienestra after childbirth:
Read the section “Breast-feeding”.

If you take more Dienestra than you should
No serious harmful effects have been reported after taking too many Dienestra tablets.
If you have taken several tablets at once, you may experience nausea, vomiting, or vaginal bleeding.
Even girls who have not yet had their first period and have accidentally taken this medicine may
experience such bleeding.
If you have taken too many Dienestra tablets, or if you find that a child has taken some tablets, seek
advice from your doctor or pharmacist.

If you forget to take Dienestra
If the delay in taking a tablet is less than 12 hours, contraceptive protection is still ensured. Take the
missed tablet as soon as possible, then continue taking the following tablets at your usual time.
If the delay in taking a tablet is more than 12 hours, contraceptive protection may no longer be
complete. The more tablets you forget, the greater the risk that Dienestra will stop working.
The risk of incomplete contraceptive protection is greater if you miss a tablet at the beginning or end of
the pack. In this case, follow the rules below:

More than one tablet missed in this pack:
Contact your doctor.

One tablet missed in week 1:
Take the missed tablet as soon as you remember – even if this means taking two tablets at the same
time – then continue taking the tablets as usual. For the next 7 days, you must also use a barrier method.
If you had sexual intercourse in the week before missing the tablet, there is a possibility you may be
pregnant. Contact your doctor immediately.

One tablet missed in week 2:
Take the missed tablet as soon as you remember – even if this means taking two tablets at the same
time – then continue taking the tablets as usual. If you have taken the tablets correctly in the 7 days
before missing the tablet, contraceptive protection is not reduced. There is no need to use additional
barrier contraceptive methods.
However, if you have missed more than one tablet, use additional contraceptive methods for 7 days.

One tablet missed in week 3:
You may choose either of the two options below without needing additional contraceptive measures,
provided you have taken the tablets correctly in the 7 days before missing the tablet.

1. Take the missed tablet as soon as you remember – even if this means taking two tablets at the same
   time – then continue taking the tablets as usual. Start the next pack immediately after finishing the
   current one, i.e. without a break. Withdrawal bleeding will not occur; however, spotting may be more
   frequent until the second pack is finished.

OR:

2. You may also stop taking tablets. After a break of no more than 7 days, including the day you missed
   the tablet, resume taking tablets from the next pack. With this method, you may also start taking tablets
   on the day of the week you are used to. If you wish to start a new pack on your usual day of the week,
   make the tablet-free interval shorter than 7 days.

If you have missed any tablet in the pack and do not bleed during the first tablet-free interval, you may
be pregnant. Therefore, consult your doctor before starting the next pack of Dienestra.

What you need to know if you vomit or have severe diarrhoea
In case of severe gastrointestinal disturbances (e.g. vomiting or diarrhoea), the active ingredients in the
tablet may not have been fully absorbed by the body. The effect may therefore be reduced, as if you had
missed a tablet. Additional contraceptive measures are needed. If you vomit within 3 or 4 hours after
taking Dienestra, take another tablet (a replacement tablet) as soon as possible. If possible, take the new
tablet within 12 hours of your usual time of intake. If more than 12 hours have passed, follow the
instructions for missed tablets. However, if you wish to maintain your usual intake schedule, you may
also take a replacement tablet from another pack and use that pack subsequently as a spare.

Postponing menstrual periods: What you need to know
Although not recommended, you may delay your monthly period by starting a new pack immediately
without taking the usual break. You may continue taking tablets until you wish your period to start.
However, stop taking the pill no later than the end of the second pack. Light bleeding may occur during
the intake of this second pack. After the usual 7-day break, start the next pack.
Consult your doctor before deciding to delay your period.

Changing the day of the week when your period starts: What you need to know
If you take the tablets as directed, you will have your period every 4 weeks, approximately on the same
day. If you wish to change this day, simply shorten (never lengthen) the tablet-free interval. For
example, if your period usually starts on Friday and you want it to start on Tuesday (3 days earlier),
start the new pack 3 days earlier than usual. The shorter the interval (e.g. 3 days or less), the greater the
chance that no withdrawal bleeding will occur during this short interval. However, breakthrough
bleeding may occur.
If you are unsure what to do, consult your doctor.

If you wish to stop taking Dienestra
You may stop taking Dienestra at any time. If you do not wish to become pregnant, consult your doctor
for advice on other reliable methods of birth control.
If you wish to become pregnant, stop taking Dienestra and wait for your menstrual period before trying
to conceive. This will help you estimate the expected date of delivery more easily.

Additional information for specific patient groups
Children and adolescents
This medicine may only be used after the first menstrual period (menarche).

Elderly patients
This medicine may only be used in women before menopause.

Patients with hepatic impairment
This medicine must not be used in women with severe liver disorders (see section 2 “Do not take
Dienestra”).

Patients with renal impairment
The use of this medicine in women with impaired renal function has not been studied.
Available data do not suggest any need to modify treatment for this patient group.
If you have any doubts about using Dienestra, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any side effect, especially if it is severe and persistent, or if you notice any change in your health that you think may be due to this medicine, inform your doctor.
An increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) exists in all women taking combined hormonal contraceptives.
Contact a doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing or hives potentially with breathing difficulties (see also section 2 “Warnings and precautions”).
For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you need to know before taking Dienestra”.
Serious side effects associated with the use of this medicine are described in section 2 “When to be particularly careful with Dienestra”.
The following side effects, listed by frequency, were observed in clinical studies with 0.03 mg ethinylestradiol and 2.0 mg dienogest:
Common: may affect up to 1 in 10 people

• headache
• breast pain, including breast discomfort and breast tenderness

Uncommon: may affect up to 1 in 100 people

• inflammation of the vagina and/or external genitals (vaginitis/vulvovaginitis), vaginal yeast infections (candidiasis, other vulvovaginal infections)

• increased appetite

• depressed mood

• migraine, dizziness

• high or low blood pressure

• abdominal pain (including flatulence)

• nausea, vomiting, diarrhoea

• acne

• hair loss (alopecia), skin rash, itching

• abnormal menstrual bleeding, including heavy bleeding (menorrhagia), scanty bleeding (hypomenorrhoea), irregular bleeding (oligomenorrhoea), and absence of bleeding (amenorrhoea)

• bleeding between periods (vaginal haemorrhage and metrorrhagia), painful menstruation (dysmenorrhoea)

• genital/vaginal discharge, ovarian cyst, pelvic pain, breast enlargement, breast swelling

• fatigue including weakness, tiredness, general feeling of malaise

• weight gain

Rare: may affect up to 1 in 1,000 people

• inflammation of the ovaries or fallopian tubes, urinary tract infection, bladder inflammation (cystitis), breast inflammation (mastitis), inflammation of the cervical lining (cervicitis), fungal infections (e.g. Candida), viral infections (e.g. cold sores), influenza, bronchitis, sinus infection (sinusitis), upper respiratory tract infections
• benign uterine growths (leiomyoma), benign growths in the fatty tissue of the breast (breast lipoma)
• reduction in the number of red blood cells in the blood (anaemia)
• allergic reactions
• masculinization (virilism)
• loss of appetite (anorexia)
• depression, psychiatric disorders, insomnia, sleep disorders, aggression
• circulatory problems in the brain or heart, muscle disorders causing, for example, abnormal posture (dystonia)
• dry or irritated eyes, visual disturbances, blurred vision
• sudden hearing loss, tinnitus, dizziness, hearing disorders
• rapid heartbeat
• vein inflammation, elevated diastolic pressure, dizziness or fainting when standing up from a sitting or lying position (orthostatic hypotension), hot flushes, varicose veins (varices), vein disorders, vein pain
• asthma, rapid or deep breathing (hyperventilation)
• inflammation of the stomach lining (gastritis), intestinal inflammation (enteritis), stomach disorders (dyspepsia)
• allergic dermatitis, neurodermatitis, eczema, psoriasis, excessive sweating (hyperhidrosis), chloasma (golden-brown pigment spots), pigmentation disorders, increased pigmentation, overproduction of oil by sebaceous glands (seborrhoea), dandruff, skin lesions, orange-peel skin, spider nevi (presence of spider-like blood vessels with a central red spot on the skin)
• back pain, bone and muscle pain, muscle pain (e.g. myalgia), pain in arms and legs
• cervical dysplasia (abnormal cell growth on the surface of the cervix), pain or cysts in the adnexa (fallopian tubes and ovaries), breast cysts, pain/spasms during sexual intercourse (dyspareunia), milk-like discharge from mammary glands (galactorrhea), menstrual disorders
• chest pain, peripheral oedema (fluid accumulation in the body), flu-like symptoms, inflammation, fever, irritability
• increased levels of triglycerides and cholesterol in the blood (elevated blood fat levels), weight loss, weight changes
• swelling of congenital accessory mammary glands outside the breast area (accessory breasts)
• harmful blood clots in a vein or artery, for example:
• in a leg or foot (deep vein thrombosis DVT)
• in a lung (pulmonary embolism PE)
• heart attack
• stroke
• mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA)
• blood clots in the liver, stomach/intestine, kidneys or eye.

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).
Other side effects observed in Dienestra users, but whose exact frequency is unknown, are:
Mood changes, increased or decreased sexual desire (libido), contact lens intolerance, hives, skin and/or mucous membrane reactions with rash, nodules, blisters or tissue death (erythema nodosum or multiforme); breast discharge, fluid accumulation in the body (oedema).
Tumours

• The incidence of breast cancer diagnosis is slightly increased with the use of this medicine. Since breast cancer is rare in women under 40 years of age, the overall risk of developing breast cancer in relation to the overall risk is low. For further information, see section 2 “Dienestra and cancer”.
• liver tumours (benign and malignant)
• cervical cancer

Other conditions

• women with hypertriglyceridaemia (increased blood fats leading to an increased risk of pancreatitis during the use of combined oral contraceptives)

• high blood pressure

• onset or worsening of conditions for which an association with combined oral contraceptives is not definitively established: jaundice and/or itching due to blocked bile flow; gallstone formation; a metabolic condition called porphyria; systemic lupus erythematosus (an autoimmune disease); haemolytic uraemic syndrome (a blood clotting disorder); a neurological condition called Sydenham's chorea; herpes gestationis (a type of skin condition occurring during pregnancy); hearing loss due to otosclerosis

• in women with hereditary angioedema (characterized by sudden swelling, e.g. of eyes, mouth, throat, etc.), external estrogens may induce or worsen angioedema symptoms

• alteration of liver function

• changes in glucose tolerance or effect on peripheral insulin resistance

• Crohn’s disease, ulcerative colitis

• chloasma

Interactions
Unexpected bleeding and/or contraceptive failure may result from interactions of other medicines with oral contraceptives (e.g. the herbal remedy St. John’s wort, or medicines for epilepsy, tuberculosis, HIV infections and other infections). See section “Effect of other medicines on Dienestra”.
Other serious reactions following the use of Dienestra, as well as related symptoms, are described in the section “Warnings and precautions”.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Dienestra

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and carton after Exp.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you
no longer use. This will help protect the environment.

6. Package contents and other information

What Dienestra contains
The active substances are 0.03 mg of ethinylestradiol and 2 mg of dienogest.
The other components are:

• tablet core: monohydrate lactose, corn starch, maltodextrins, magnesium stearate
• film coating: hypromellose, macrogol, povidone, titanium dioxide (E 171).

Description of the appearance of Dienestra and contents of the pack
The tablets are white, round, biconvex, film-coated. Each tablet has a thickness of 2.4–2.8 mm and a diameter of 5.5–5.7 mm.
Available in packs of 21, 3 x 21 and 6 x 21 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany
Manufacturer
Pharbil Waltrop GmbH
Im Wirrigen 25
45731 Waltrop
Germany
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Spain Dienogest/Ethinylestradiol Aristo
Czech Republic Lobreza
Germany Aristelle
Italy Dienestra