Cemisiana

Package leaflet: Information for the user

Cemisiana 0.030 mg/2 mg film-coated tablets

Ethinylestradiol/dienogest
Equivalent 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Important things to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible methods of contraception when 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 contact your doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

Contents of this leaflet:

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

1. What Cemisiana is and what it is used for

Cemisiana is a medicine used
• to prevent pregnancy (a “pill” contraceptive)
• for the treatment of moderate acne in women who agree to take a contraceptive pill
after failure of appropriate topical treatments or oral antibiotics.

• Each of the 21 white coated tablets contains a small amount of the female hormones ethinylestradiol and dienogest
• The 7 green coated tablets do not contain active ingredients and are also called placebo tablets
• Contraceptive pills containing two hormones are called “combined” pills or “combined hormonal contraceptives”

In women in whom a pronounced effect of male hormones (the so-called “androgens”) causes acne,
clinical trials have shown that Cemisiana improves this condition.

2. What you should know before taking Cemisiana

General information
Before starting to use Cemisiana, 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 Cemisiana, your doctor will ask you some questions about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out additional tests.
This leaflet describes various conditions that require discontinuation of Cemisiana, or situations in which the safety of Cemisiana may be reduced. In such cases, you must abstain from sexual intercourse or use additional non-hormonal contraceptive measures, for example, use a condom or another barrier method. Do not use rhythm or basal body temperature methods. These methods may be unreliable because Cemisiana alters the monthly variations in body temperature and cervical mucus.
Cemisiana, like other hormonal contraceptives, provides no protection against HIV (AIDS) or other sexually transmitted infections.
Acne usually improves after 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 three to six months after starting therapy and periodically thereafter.

When not to take Cemisiana
Do not use Cemisiana 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 may be more suitable for your case.
Do not take Cemisiana:

• If you have (or have ever had) a blood clot in a blood vessel of the leg (deep vein thrombosis, DVT), lung (pulmonary embolism, PE), or other organs;
• if you know you have a blood clotting disorder, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies;
• if you are undergoing surgery or will be bedridden for a prolonged period (see section "Blood clots");
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain that may be an early sign of heart attack) or a transient ischemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following diseases, which may increase the risk of forming clots in the arteries:
• severe diabetes with blood vessel damage
• very high blood pressure
• very high levels of fats (cholesterol or triglycerides) in the blood
• a condition known as hyperhomocysteinemia
• if you have (or have ever had) a type of migraine called "migraine with aura"
• if you have (or have ever had) inflammation of the pancreas (pancreatitis) associated with high levels of fats (lipids) in the blood (hypertriglyceridemia)
• if you have (or have ever had) severe liver disease and liver function is still abnormal
• if you have (or have ever had) benign or malignant liver tumors
• if you have (or have ever had) or are suspected of having hormone-sensitive cancers of the genital organs or breast (e.g., breast cancer or cancer of the lining of the uterus)
• if you have unexplained vaginal bleeding
• if you are allergic (hypersensitive) to ethinylestradiol, dienogest, or any of the other ingredients of this medicine (listed in section 6).
• Do not use Cemisiana if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir (also see section "Other medicines and Cemisiana").

If any of the above conditions occur while you are taking Cemisiana, you must stop taking the medicine immediately and consult your doctor. In the meantime, you must use a different non-hormonal method of contraception. For further information, see also the section "Warnings and precautions".

Warnings and precautions
When to be especially careful with Cemisiana
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"). For a description of the symptoms of these serious side effects, go to the section "How to recognize a blood clot".

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

• if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE, a disease affecting the body's natural defense system);
• if you have hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure);
• if you have sickle cell anemia (an inherited red blood cell disorder);
• if 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);
• if you are undergoing surgery or will be bedridden for a prolonged period (see section 2 "Blood clots");
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking Cemisiana;
• if you have inflammation of veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have heart valve defects or heart rhythm disorders;
• if there are cases of breast cancer in close relatives;
• if you have liver or gallbladder diseases, gallstones;
• if you have jaundice or itching due to bile congestion;
• if 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;
• if you have problems with hemoglobin formation (porphyria);
• if you suffer from depression;
• if you suffer from epilepsy;
• if you have Sydenham's chorea;
• if you had blistering skin rashes during a previous pregnancy (herpes gestationis);
• if you have hearing loss in the inner ear (hearing loss due to otosclerosis);
• if you were born with angioedema, estrogen-containing products may trigger or worsen symptoms. You must contact your doctor immediately if symptoms of angioedema occur, such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives with breathing difficulties.

BLOOD CLOTS
Using a combined hormonal contraceptive such as Cemisiana 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, serious long-term effects may occur, and very rarely, these effects can be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with Cemisiana is low.

HOW TO RECOGNIZE A BLOOD CLOT
Contact a doctor immediately if you notice any of the following signs or symptoms.

What condition do you have?
Do you have any of these signs?
Possibly?

• swelling in one leg or along a vein in the leg or foot, especially if accompanied by:
  o pain or tenderness in the leg, which may only be felt when standing or walking
  o increased warmth in the affected leg
  o skin discoloration of the leg, such as paleness, reddish or bluish coloration
  Deep vein thrombosis

• 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
  Pulmonary embolism

If you are unsure, inform your doctor, as some of these symptoms, such as cough or shortness of breath, may be mistaken for a milder condition such as a respiratory tract infection (e.g., a "common cold").

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 blood clots forming in 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 when restarting a combined hormonal contraceptive (the same or a different medicine) 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 taking Cemisiana, 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 VTE (venous thromboembolism) and 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 Cemisiana 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 one 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 one year.
• It is not yet known how the risk of developing a blood clot with Cemisiana compares to the risk associated with a combined hormonal contraceptive containing levonorgestrel.
• The likelihood of a blood clot forming 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 Cemisiana 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);
• if a close relative has had a blood clot in a leg, lung, or another organ at a young age (under approximately 50 years). In this case, you might have an inherited blood clotting disorder;
• if you are scheduled for surgery or need to remain bedridden for a prolonged period due to injury or illness, or if you have a leg in a cast. You may need to stop taking Cemisiana several weeks before surgery or during periods of reduced mobility. If you need to stop taking Cemisiana, ask your doctor when you can start taking it again;
• with increasing age (especially over 35 years);
• if you have given birth within the last few weeks.

The risk of developing a blood clot increases when 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 some 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 have you stop taking Cemisiana.
If any of the conditions listed above change while you are using Cemisiana—for example, if a close relative develops thrombosis without a known 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 may 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 Cemisiana is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Cemisiana, it is advisable to stop smoking. If you are unable to quit 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 fats 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 Cemisiana—for example, if you start smoking, if a close relative develops thrombosis without a known cause, or if you gain significant weight—contact your doctor.

Cemisiana and cancer
Breast cancer is diagnosed slightly more frequently in women taking the pill, but it is not known whether this is due to the treatment. For example, more cancers may be detected in women taking combined pills 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 and contact your doctor if you notice a lump.
In rare cases, benign liver tumors have been diagnosed in users of the pill, and even more rarely, malignant liver tumors. In isolated cases, these tumors 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 this risk is influenced by sexual behavior (e.g., frequent partner changes) and other factors such as human papillomavirus (HPV).

When should you consult your doctor?
Regular check-ups:
If you are taking the pill, your doctor will recommend periodic check-ups. Normally, you should consult your doctor at least once a year.
Additionally, consult your doctor immediately if:

• you notice any change in your health, particularly those mentioned in the section “Do not take Cemisiana.” Do not forget illnesses affecting your family members;
• you feel a lump in your breast;
• you are taking other medicines (see also section “Other medicines and Cemisiana”);
• you are confined to bed for a prolonged period or are about to undergo surgery (contact your doctor at least four weeks in advance);
• you have unusual, heavy vaginal bleeding between periods;
• you forgot to take the white tablets in 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 tablets and suspect you might be pregnant.

If you experience unexpected bleeding between periods:
During the first months of treatment with Cemisiana, you may experience unexpected bleeding. Irregular vaginal bleeding usually stops once your body has adapted to taking the pill (usually after about 3 tablet cycles). If you experience vaginal bleeding heavier than a normal menstrual period or light vaginal bleeding lasting several days, consult your doctor.

If your normal monthly period does not occur:
If you have taken the tablets correctly, have not experienced vomiting or severe diarrhea, and have not taken any other medicines, the likelihood that you are pregnant is extremely low. Continue taking Cemisiana as usual.
If two consecutive periods do not occur, or if you did not take Cemisiana as prescribed in the period before the missed period, you may be pregnant. Consult your doctor immediately. Do not take Cemisiana until your doctor has ruled out pregnancy.

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

Other medicines and Cemisiana
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may cause breakthrough bleeding and/or reduce the contraceptive effectiveness of Cemisiana.

Effect of other medicines on Cemisiana
Always inform your doctor if you are taking other medicines or herbal products. Also inform any other doctor or dentist who prescribes you medicines (or your pharmacist) that you are taking Cemisiana. 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 required medication.
Some medicines:

• may affect Cemisiana levels in the blood;
• may make Cemisiana less effective in preventing pregnancy;
• may cause unexpected bleeding.

These medicines include:
o Medicines used to treat:

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
• high blood pressure in the pulmonary blood vessels (bosentan);
• tuberculosis (e.g., rifampicin);
• HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz);
• 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 Cemisiana and also for 28 days after stopping treatment with the other medicines.
If treatment lasts longer than the duration of one Cemisiana blister pack, start the next blister pack immediately without taking the green tablets.
If long-term treatment with any of the medicines listed above is required, you should choose another reliable non-hormonal contraceptive method.

Effect of Cemisiana on other medicines
Cemisiana may affect the effect of other medicines, such as:

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

Also read the Patient Information Leaflet of any other prescribed medicines.
Do not take Cemisiana if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, 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.
Cemisiana may be resumed approximately 2 weeks after completing this treatment. See the section “Do not take Cemisiana.”

Interaction with laboratory tests
The use of Cemisiana 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. Inform your doctor or laboratory staff that you are taking the pill.

Cemisiana with food and drink
Cemisiana 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
If you are pregnant, you must not use Cemisiana. If pregnancy occurs while taking Cemisiana, stop taking the medicine immediately and consult your doctor. If you wish to become pregnant, you may stop taking Cemisiana at any time (see also “If you wish to stop taking Cemisiana”).

Breastfeeding
In general, you should not take Cemisiana while breastfeeding, as it may reduce milk production and small amounts of the active substance may pass into breast milk.

Driving and using machines
There is no indication that the use of Cemisiana affects the ability to drive vehicles or operate machinery.

Cemisiana contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Cemisiana

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take one Cemisiana tablet daily, if necessary, with a small amount of water and swallow it whole. You may take the tablets with or without food, but you must take them at approximately the same time each day. The time of day does not matter, but once you have chosen a time, you must stick to this schedule.

Blister with arrows
Follow the direction of the black arrows on the blister until you have taken all 21 white tablets.
Then follow the direction of the red arrows and take one green tablet daily for 7 days.

Blister with weekly adhesive labels
To help you follow the correct sequence, there are 7 adhesive labels, each showing the 7 days of the week, provided for each Cemisiana blister. Choose the weekly adhesive label that starts with the day of the week on which you begin taking the tablets. For example, if you start on Wednesday, use the weekly adhesive label starting with “WED”.
Apply the weekly adhesive label along the top of the Cemisiana blister where it says “Apply weekly label here”, so that the first day is above the tablet marked “Start”.
This way, each tablet will have a day marked above it, allowing you to check whether you have taken the tablet on any given day. The arrows indicate the order in which to take the tablets.

During the 7 days when you take the green tablets, menstrual bleeding (withdrawal bleeding) should begin 2–3 days after taking the last white tablet.
On the 8th day after taking the last white tablet of Cemisiana (i.e., after the 7 days of taking the green tablets), you must start the next blister, regardless of whether bleeding has stopped or not. This means you must start each blister on the same day of the week, and withdrawal bleeding should begin on the same day each month.
If you use Cemisiana in this way, you will be protected against pregnancy even during the 7 days when you take the placebo tablets.

When can you start the first Cemisiana blister?

• If you have not used a hormonal contraceptive in the previous month Start taking Cemisiana on the first day of your cycle, i.e., the first day of menstruation.
• Switching from another combined hormonal contraceptive pill Start taking Cemisiana preferably the day after the last active tablet of the previous pill, or at the latest the day after the pill-free interval or after the last inactive tablet of the previous pill.
• Switching from a vaginal ring or transdermal patch to Cemisiana Start taking Cemisiana preferably on the day of removal of the last vaginal ring or patch as scheduled in the treatment cycle, or at the latest on the day 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 coil) to Cemisiana You may switch on any day from the progestogen-only pill (from an implant or IUS on the day of removal, from an injectable when the next injection would have been due), but in all these cases you must use additional contraceptive measures for the first 7 days of taking Cemisiana.
• If you wish to start Cemisiana after a first-trimester abortion Speak with your doctor. In principle, you may start taking Cemisiana immediately.
• If you wish to start Cemisiana after a second-trimester abortion or after childbirth If you wish to take Cemisiana, your doctor will advise you to start between the 21st and 28th day after delivery or second-trimester abortion. If you start later, you must use a barrier method (e.g., condom) during the first 7 days of taking Cemisiana.

However, if you have already had sexual intercourse, you must ensure you are not pregnant before starting Cemisiana, or wait until your next menstrual period.

• If you are breastfeeding and wish to start taking Cemisiana after childbirth See section “Breast-feeding”.

If you take more Cemisiana than you should
There have been no reports of serious harmful effects after taking too many Cemisiana tablets.
If you have taken several tablets at once, you may experience symptoms such as nausea, vomiting, or vaginal bleeding. Even girls who have not yet had their first menstruation and have taken the tablets by mistake may experience such bleeding. If a child has taken Cemisiana, consult your doctor.
If you have taken too many Cemisiana tablets, or if you find out that a child has taken some tablets, seek advice from your doctor or pharmacist.

If you forget to take Cemisiana
The green tablets in the fourth row of the blister are placebo tablets. If you forget to take one of these green tablets, this does not affect the reliability of this medicine. Discard the forgotten placebo tablet.

• If you are less than 12 hours late in taking a white tablet, the contraceptive effect is not reduced. Take the missed tablet as soon as you remember, then continue taking the following tablets at your usual time.
• If you are more than 12 hours late in taking a white tablet, the contraceptive effect may be reduced. The greater the number of tablets missed, the higher the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is greater if you miss a white tablet at the beginning or end of the pack. In this case, follow the rules below:
More than one white tablet missed in this pack:
Contact your doctor.
One white 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 and use additional contraceptive methods for the next 7 days, for example, a condom. If you had sexual intercourse in the week before missing the tablet, there is a possibility you may be pregnant. In this case, contact your doctor.
One white 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. Continue taking the following tablets at your usual time. If you have taken Cemisiana correctly in the 7 days before missing the tablet, the contraceptive effect is not reduced. There is no need to use additional barrier contraceptive methods.
However, if you missed more than one tablet, use additional contraceptive methods for 7 days.
One white tablet missed in week 3:
You may choose either of the following two options without needing to use additional contraceptive measures, provided you have taken Cemisiana correctly in the 7 days before missing the tablet.

1. Take the missed white tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the following tablets at your usual time. Instead of taking the green tablets, start the next blister. It is unlikely you will have a menstrual period at the end of the second blister; however, you may experience spotting or breakthrough bleeding during the days you take the white tablets of the second blister. OR
2. You may immediately stop taking the white tablets from the current blister and start taking the green tablets (note the day you missed the tablet). If you wish to start a new blister on your usual day of the week, make the period of taking the green tablets shorter than 7 days. If you missed any tablet in the blister and do not have bleeding during the first period of taking the green tablets, you may be pregnant. Consult your doctor before starting the next blister.

What you should know if you have diarrhoea or severe vomiting
If you vomit within 3 or 4 hours after taking a tablet or have severe diarrhoea, there is a risk that the active ingredients in the tablet may not be fully absorbed by your body. The situation is similar to missing a tablet. After vomiting or severe diarrhoea, take another tablet from a spare blister as soon as possible. If possible, take the tablet within 12 hours of your usual time of intake. If this is not possible or if more than 12 hours have passed, you must follow the instructions described under “If you forget to take Cemisiana”.

Postponing menstrual periods: what you should know
Although not recommended, you may delay your monthly period by starting a new blister of Cemisiana immediately instead of taking the green tablets. You may continue taking tablets for as long as you wish to delay menstruation. However, stop taking the pill no later than the end of the second blister. Light bleeding or menstruation-like bleeding may occur during the intake of this second blister. After the usual 7-day period of taking the green tablets, start the next blister.
Consult your doctor before deciding to delay your period

Changing the day of the week on which menstruation starts: what you should know
If you take the tablets as directed, you will have your menstrual period every 4 weeks, approximately on the same day. If you wish to change this day, simply shorten (never lengthen) the interval during which you take the green tablets. For example, if your period usually starts on Friday and you wish it to start on Tuesday (3 days earlier), start the first tablet of the new blister 3 days earlier than usual. If you make the interval of taking green tablets very short (e.g., 3 days or less), you may not have any bleeding during these days. Light bleeding or menstruation-like bleeding may then occur.
If you are unsure what to do, consult your doctor.

If you wish to stop taking Cemisiana
You may stop taking Cemisiana 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 Cemisiana and wait for menstrual bleeding before trying to conceive. This will allow you to calculate the possible date of delivery more easily.
After stopping treatment, it may take some time before a normal menstrual cycle resumes.

Additional information for specific patient groups
Use in children and adolescents
Cemisiana may only be used after the first menstrual period (menarche).
Elderly patients
Cemisiana may only be used in women before menopause.
Patients with hepatic impairment
Cemisiana must not be used in women with severe liver disorders (see section 2 “Do not take Cemisiana”).
Patients with renal impairment
The use of Cemisiana in women with impaired renal function has not been studied. Available data do not suggest any change in treatment for this patient group.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think may be due to Cemisiana, 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. For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2, “What you need to know before taking Cemisiana”.

Serious side effects associated with the use of Cemisiana are described in the section “What you need to know before taking Cemisiana”. Please read this section carefully and contact your doctor immediately if necessary.

The following side effects have been observed in clinical studies with ethinylestradiol/dienogest:

Common side effects (may affect up to 1 in 10 people):

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

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

• inflammation of the vagina and/or external genitalia (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 or 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 consisting of vaginal haemorrhage and irregular bleeding between periods (metrorrhagia), painful menstruation (dysmenorrhoea)
• genital/vaginal discharge, fluid-filled structures (cysts) in the ovaries, pain in internal genital organs, breast enlargement, breast swelling
• fatigue, weakness, and general feeling of malaise
• weight gain

Rare side effects (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 (fibroids), benign fatty tissue growths in the breast (lipomas)
• reduced number of red blood cells in the blood (anaemia)
• allergic reactions
• masculinization (virilism)
• loss of appetite (anorexia)
• depression, psychiatric disorders, insomnia, sleep disorders, aggression
• blood circulation problems in the brain or heart, muscle disorders which, for example, may cause abnormal posture (dystonia)
• dry or irritated eyes, visual disturbances, blurred vision
• sudden hearing loss, ringing or other noise in the ears (tinnitus), dizziness, hearing impairment
• rapid heartbeat
• vein inflammation, elevated diastolic pressure, dizziness or fainting when rising from a sitting or lying position (orthostatic hypotension), hot flushes, varicose veins (varices), vein disorders, vein pain
• harmful blood clots in a vein or artery, for example:
  o in a leg or foot (DVT) or in a lung (PE) or heart attack or stroke
  o mini-stroke or temporary symptoms similar to stroke, known as transient ischaemic attack (TIA)
  o 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).
• asthma, rapid or deep breathing (hyperventilation)
• inflammation of the stomach lining (gastritis), intestinal inflammation (enteritis), stomach disorders (dyspepsia)
• allergic skin inflammation (dermatitis), skin rash (e.g. neurodermatitis), itching, redness, rash (eczema), skin disease with thickened red patches (psoriasis), excessive sweating (hyperhidrosis), changes or disturbances in skin colour (e.g. chloasma), overproduction of oil by sebaceous glands (seborrhoea), dandruff, excess body and facial hair (hirsutism), skin lesions, orange-peel skin (cellulite), presence of spider-like blood vessels with a central red spot on the skin (spider nevi)
• back pain, pain in bones, joints and muscles (e.g. myalgia), pain in arms and legs
• abnormal cell growth on the surface of the cervix (cervical dysplasia), pain or fluid-filled structures in the fallopian tubes and ovaries, fluid-filled structures in the breast, pain/spasms during sexual intercourse (dyspareunia), milk-like secretion from mammary glands (galactorrhoea), menstrual disorders
• chest pain, swelling of hands, ankles or feet (peripheral oedema), flu-like symptoms, inflammation, fever, irritability
• increased levels of fats in the blood (elevated triglyceride and cholesterol levels), weight loss, weight changes
• swelling of congenital accessory mammary glands outside the breast area (accessory breasts)

Other side effects observed in users of ethinylestradiol/dienogest, but whose exact frequency is unknown, are:
Mood changes, increased or decreased sexual desire (libido), contact lens intolerance, urticaria; skin and/or mucous membrane reactions with rash, nodules, blisters or tissue necrosis (erythema nodosum or erythema multiforme); breast secretion, fluid accumulation in the body (oedema).

Tumours

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

Other conditions

• women with hypertriglyceridaemia (increased blood fats leading to increased risk of pancreatitis during use of combined oral contraceptives)
• high blood pressure
• onset or worsening of conditions for which a link to combined oral contraceptives is not established: jaundice and/or itching due to cholestasis (blocked bile flow); gallstone formation; a metabolic condition called porphyria; systemic lupus erythematosus (a chronic 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 (characterised by sudden swelling, e.g. of eyes, mouth, throat, etc.), external oestrogens 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 between other medicines and 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 Cemisiana”.

Other serious reactions following the use of ethinylestradiol/dienogest, 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 http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cemisiana

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 carton and blister after
Exp. The expiry date refers to the last day of that month.
Do not store above 25°C. Keep in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Cemisiana contains
One Cemisiana blister pack contains 21 white active tablets in the first, second and third rows and 7 green placebo tablets in the fourth row.
Active tablets

• The active substances are ethinylestradiol and dienogest. One white active tablet contains 0.03 mg of ethinylestradiol and 2 mg of dienogest.
• Other components are: Tablet core: monohydrate lactose, magnesium stearate, maize starch, povidone K-30. Film coating: hypromellose 2910, macrogol 400 and titanium dioxide (E171).

Placebo tablets
Tablet core: monohydrate lactose, magnesium stearate, maize starch, povidone K-30, anhydrous colloidal silica.
Film coating: hypromellose 2910, triacetin, polysorbate 80, titanium dioxide (E171), FD & C blue 2 aluminium lake (E132) and yellow iron oxide (E172).
Description of the appearance of Cemisiana and contents of the pack
The active tablets are white, round, film-coated tablets with an approximate diameter of 5.0 mm.
The placebo tablets are green, round, film-coated tablets with an approximate diameter of 5.0 mm.
Cemisiana is available in packs containing 28, 3x28, 4x28 and 6x28 film-coated tablets (21 active tablets plus 7 placebo tablets).
The blister may be placed in an outer pouch.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Sandoz S.p.A.
L.go U. Boccioni 1
21040 Origgio (VA)
Italy
Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, Saxony-Anhalt, 39179 Barleben, Germany
This medicinal product is authorised in the European Economic Area Member States under the following names:
Austria Foxinette 0.03 mg/2 mg 21+7 – Film tablets
Belgium Cemisiana 2 mg/0.03 mg filmomhulde tabletten
Finland Cemisiana 0.03 mg/2 mg tabletti, kalvopäällysteinen
Germany Starletta HEXAL 21+7
Italy Cemisiana
Slovenia Ethinylestradiol/dienogest Sandoz 0.03 mg/2 mg filmsko obložene tablete