Serisima

Patient Information Leaflet: Information for the User

Serisima 0.03 mg/2.0 mg film-coated tablets

Ethinylestradiol and dienogest
Generic medicine

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 blood clots forming 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”).

Read 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, consult 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, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Serisima is and what it is used for

Serisima is a hormonal oral contraceptive for women (a combined oral contraceptive, also known as the "pill").

• Each of the 21 white tablets contains a small amount of two different female hormones: a progestin (dienogest) and an oestrogen (ethinylestradiol);
• The 7 green tablets do not contain any active substances and are also called placebo tablets.

In women in whom a pronounced effect of male hormones (so-called "androgens") causes acne, clinical trials have shown that Serisima alleviates this condition.
Serisima is used

• to prevent pregnancy;
• for the treatment of women with moderate acne who agree to receive a contraceptive pill after appropriate topical treatments or oral antibiotics have not been effective.

2. What you should know before taking Serisima

General notes
Before starting to use Serisima, you should read the information about blood clots in
paragraph 2. It is particularly important that you read about the symptoms of a blood clot – see
paragraph 2 “Blood clots”).
Your acne will usually improve within three to six months of treatment and may continue to improve
even after six months. You should discuss with your doctor the need to continue treatment after three
or six months from the start, and subsequently on a regular basis.
Do not take Serisima:
Do not take Serisima 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 methods of
birth control that might be more suitable for your case.

• If you are allergic to ethinylestradiol, dienogest, or any of the other ingredients of this medicine (listed in paragraph 6).
• 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 disorder affecting blood clotting – such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you are due to have surgery or if you will be bedridden for a prolonged period (see paragraph “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 and which may be an early sign of heart attack) or transient ischaemic attack (TIA – temporary stroke-like symptoms).
• If you have any of the following conditions, which may increase the risk of developing 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 smoke (see paragraph 2 “Blood clots”);
• If you have - or have ever had - inflammation of the pancreas associated with increased triglycerides in the blood (lipid metabolism disorders (fats)).
• If you have or have ever had - liver dysfunction and your liver blood tests have not yet returned to normal (including Dubin-Johnson syndrome and Rotor syndrome).
• If you have - or have ever had - a liver tumour (benign or malignant).
• If you have, have ever had, or suspect you may have a hormone-dependent cancer (e.g. of the breast or endometrium).
• If you experience vaginal bleeding without any identifiable cause.
• If withdrawal bleeding does not occur and no cause has been established;
• If you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also paragraph “Other medicines and Serisima”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Serisima.
You must stop taking Serisima and speak to your doctor immediately if any of the
diseases or conditions mentioned in the section “Do not take Serisima” occur for the first time
while you are taking Serisima.
When should you contact a doctor?
Seek urgent medical advice

• if you notice signs of a possible blood clot which may indicate that 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 paragraph "Blood clots"). For a description of the symptoms of these serious side effects, go to the paragraph "How to recognize a blood clot".

Inform your doctor if any of the following conditions apply to you.
If any of these conditions develop or worsen while you are using Serisima, you should 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 defence system);
• if you have haemolytic uraemic syndrome (HUS, a blood clotting disorder causing kidney failure);
• if you have sickle cell anaemia (an inherited red blood cell disorder);
• if you have high levels of fats in the blood (hypertriglyceridaemia) or a family history of this condition. Hypertriglyceridaemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are due to have surgery or if you will be bedridden for a prolonged period (see paragraph 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 Serisima;
• if you have inflammation of the veins just under the skin (superficial thrombophlebitis);
• if you have varicose veins.

BLOOD CLOTS
Using a combined hormonal contraceptive such as Serisima 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, or very rarely, such effects may be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with
Serisima is low.
HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical advice if you notice any of the following signs or symptoms.
Do you have any of these signs? What might you be suffering from?

• swelling in one leg or along a vein in the leg or foot, Deep vein thrombosis, 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
  • change in skin colour of the leg, such as paleness, redness or bluish discolouration
• sudden and unexplained shortness of breath or rapid breathing; Pulmonary embolism
• 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;

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").
Symptoms occurring more frequently in an eye: Retinal vein thrombosis

• sudden loss of vision or (blood clot in the eye)
• painless blurring of vision that may progress to vision loss
• pain, discomfort, pressure or heaviness in the chest Heart attack
• crushing or fullness sensation in the chest, arm, or under the breastbone;
• feeling of fullness, indigestion or choking;
• discomfort in the upper body spreading to the back, jaw, throat, arms, or stomach;
• sweating, nausea, vomiting or dizziness;
• extreme weakness, anxiety or shortness of breath;
• rapid or irregular heartbeat

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 can cause deep vein thrombosis (DVT).
• If a blood clot breaks away from the leg and travels to the lung, it can cause a pulmonary embolism.
• Very rarely, the 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 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 Serisima, 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 Serisima 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.
• Among 10,000 women who use a combined hormonal contraceptive containing dienogest and ethinylestradiol, such as Serisima, between 8 and 11 women will develop a VTE in one year.
  The likelihood of a blood clot forming depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).

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

• if you are significantly overweight (body mass index or BMI above 30 kg/m²);
• if 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;
• 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 Serisima several weeks before surgery or during periods of reduced mobility. If you stop taking Serisima, ask your doctor when you can start taking it again.
• as you get older (especially over 35 years of age);
• if you gave birth less than a few weeks ago.

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 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 have you stop taking Serisima.
If any of the above conditions change while you are using Serisima—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 Serisima is very low, but it may increase:

• with increasing age (over 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Serisima, 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 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 above conditions change while you are using Serisima—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.

Stop taking Serisima immediately:

• If you are pregnant or think you might be pregnant.
• If you have signs of phlebitis or blood clots (see section 2 “Blood clots”).
• If your blood pressure consistently rises above 140/90 mmHg (your doctor may advise you to restart taking the 'pill' once your blood pressure has normalized with treatment for high blood pressure).
• If surgery is planned (you should stop taking the 'pill' at least 4 weeks before surgery) or in case of prolonged immobilization (see section 2 “Blood clots”).
• If migraine occurs for the first time or worsens.
• If you experience unusually frequent, severe, or persistent headaches that start suddenly with symptoms of so-called aura (sensory disturbances, perception issues, and/or movement problems).
• If you have severe pain in the upper abdomen (see also “The 'pill' and cancer”).
• If your skin and the whites of your eyes turn yellow, your urine becomes brown, and your stools are very pale (jaundice), or if your skin itches all over.
• If you are diabetic (diabetes mellitus) and blood sugar levels increase suddenly.
• If you have a disorder in blood pigment formation (porphyria), and this recurs during use of Serisima.

Your doctor will monitor you carefully:

• if you have heart or kidney disease,
• if you are prone to vein inflammation (phlebitis) or marked varicose veins,
• if you have circulation problems in hands/feet,
• if your blood pressure is above 140/90 mmHg,
• if you have had problems with how your body processes fats (lipid metabolism disorders),
• if you have had sickle cell anemia (an inherited red blood cell disorder),
• if you have had liver disease,
• if you have had gallbladder disease,
• if you have migraine,
• if you suffer from depression,
• if you are diabetic (diabetes mellitus) or have limited ability to metabolize glucose (impaired glucose tolerance). The dose of medication needed to treat diabetes may vary if you are taking Serisima concurrently,
• if you smoke (see section 2 “Blood clots”).
• if you have epilepsy. If epileptic seizures increase during use of Serisima, you should consider using other contraceptive methods,
• if you suffer from movement disorders with rapid jerky movements, especially affecting the face, feet, and hands, also known as ‘Sydenham's chorea’,
• if you suffer from chronic inflammatory bowel disease (Crohn’s disease, ulcerative colitis),
• if you suffer from a blood disorder causing kidney damage (hemolytic uremic syndrome),
• if you suffer from a benign tumor in the uterine muscle layer (uterine fibroid),
• if you suffer from a certain form of hearing loss (otosclerosis),
• in case of prolonged immobilization (see section 2 “Blood clots”),
• if you are overweight,
• if you suffer from a certain autoimmune disease (systemic lupus erythematosus),
• if you are 40 years of age or older.

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

The 'pill' and cancer
A slight increase in the risk of breast cancer has been observed in women using the 'pill' compared to women of the same age who do not use it. The risk gradually decreases after stopping the 'pill', and after 10 years, there is no difference between former 'pill' users and other women of the same age.
Since breast cancer is rare in women under 40 years of age, the number of additional breast cancer cases is small among women who currently use or have previously used the 'pill', compared to the overall risk of breast cancer.
Some studies suggest that long-term use of hormonal contraceptives represents a risk factor for cervical cancer in women whose cervix is infected with a sexually transmitted virus (human papillomavirus). However, the extent to which this result is influenced by other factors (e.g., differences in number of sexual partners or use of mechanical contraceptive methods) has not yet been fully established.
Very rarely, benign but dangerous liver tumors may occur, which can cause potentially fatal internal bleeding. Seek immediate medical treatment if you experience sudden, severe abdominal pain. Studies have shown an increased risk of developing liver cell cancer with long-term use of the 'pill'; however, this is extremely rare.

Other conditions
High blood pressure
An increase in blood pressure has been reported in women taking the 'pill'. This occurs more frequently in older users and with continued use. The incidence of high blood pressure increases with higher levels of progesterone. Use a different contraceptive method if you have ever had a condition caused by high blood pressure, or if you suffer from certain kidney diseases (for more information, consult your doctor; see also section 2 “Stop taking Serisima immediately” and “Special medical monitoring required”).

Pigmentation spots
Brownish-yellow pigmentation spots (chloasma) may occasionally appear on the skin, particularly in women with a history of this condition during pregnancy. Therefore, women prone to this condition should avoid direct exposure to sunlight or ultraviolet light (e.g., in a tanning bed) during the period of taking the 'pill'.

Hereditary angioedema (swelling)
If you suffer from hereditary angioedema, medicines containing estrogens may trigger or worsen angioedema symptoms. Speak immediately with your doctor if you notice symptoms of angioedema, such as swelling of the face, tongue, and/or throat and/or difficulty swallowing, or rash together with breathing problems.

Irregular bleeding (bleeding between periods)
During the first months of using the 'pill', irregular bleeding (spotting or breakthrough bleeding) may occur. Consult your doctor if irregular bleeding continues for more than 3 months or if bleeding reappears after a regular cycle has resumed.
It is possible to have days without withdrawal bleeding during the placebo period. If you have taken Serisima correctly, pregnancy is unlikely. However, if you did not take the 'pill' correctly before the first missed withdrawal bleed or if withdrawal bleeding does not occur for a second consecutive time, you may be pregnant. Pregnancy must be definitively ruled out before continuing to take Serisima.
After stopping treatment with the 'pill', it may take some time before menstrual cycles return to normal.

Reduced effectiveness
The effectiveness of the 'pill' may be reduced if you forget to take it, if you vomit, if you have intestinal disease, severe diarrhea, or if you take other medicines at the same time.
If Serisima and preparations containing St. John's wort are taken together, use of an alternative barrier contraceptive method (e.g., condom) is recommended (see “Other medicines and Serisima”).

Medical advice/examinations
Before using Serisima, your doctor will ask you questions about your medical history and that of your close relatives. You will undergo a general and gynecological examination, including a breast exam and cervical smear. Pregnancy must be excluded. If you are taking the 'pill', these examinations should be repeated regularly. Inform your doctor if you smoke or are taking other medicines.
Serisima does not protect against HIV infection or other sexually transmitted diseases.

Other medicines and Serisima
Do not use Serisima if you have Hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, as this may cause elevated liver function test results (increased ALT enzyme levels).
Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
Serisima may be restarted approximately 2 weeks after completion of treatment. See section “Do not use Serisima”.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, including those obtained without a prescription.
Some medicines may cause Serisima to lose its contraceptive effectiveness and/or cause breakthrough bleeding.

The following medicines may interfere with the effect of Serisima:

• medicines that increase intestinal motility (e.g., metoclopramide);
• medicines used to treat epilepsy such as phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, and felbamate;
• medicines used to treat high blood pressure in the pulmonary blood vessels (bosentan);
• certain antibiotics used to treat tuberculosis (e.g., rifampicin) or fungal infections (e.g., griseofulvin);
• certain medicines used to treat HIV infection and Hepatitis C infection (called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz);
• herbal preparations containing St. John's wort (Hypericum perforatum).

If you are taking any of the medicines listed above, you must use a barrier contraceptive method (e.g., condom) in addition to Serisima. With some of the listed medicines, additional contraception must be used not only during concomitant use but also for an additional 7 to 28 days afterward, depending on the medicine. If you are unsure, consult your doctor or pharmacist. If the barrier method must be used for longer than the number of 'pills' in the blister pack, start taking 'pills' from the next Serisima blister pack without taking the 7 green placebo tablets. If prolonged treatment with any of the listed medicines is required, talk to your doctor about switching to a non-hormonal contraceptive method.

Taking the following medicines together with Serisima may increase your risk of side effects:

• Paracetamol (used for pain and fever),
• Ascorbic acid (vitamin C),
• Atorvastatin (used to lower blood fats),
• Troleandomycin (an antibiotic),
• Imidazole antifungals (used against fungal infections) such as fluconazole,
• Indinavir (used to treat HIV infection).

Taking Serisima together with other medicines may affect how these other medicines work:

• Cyclosporine (used to suppress the immune system),
• Theophylline (used to treat asthma),
• Glucocorticoids (e.g., cortisone),
• Some benzodiazepines (tranquilizers) such as diazepam, lorazepam,
• Clofibrate (used to lower blood fats),
• Paracetamol (used for pain and fever),
• Morphine (a very strong painkiller),
• Lamotrigine (used to treat epilepsy).

Also read the leaflet of any other medicines you are using.

Diabetes
If you are diabetic, your need for blood sugar-lowering medicines (e.g., insulin) may vary.

Laboratory tests
If you need to have a blood test, inform your doctor or laboratory staff that you are taking an oral contraceptive, as this medicine may affect the results of certain tests, including liver function, adrenal cortex, kidney and thyroid function, and also the levels of certain blood proteins involved in lipid (fat) and carbohydrate metabolism, blood clotting, and fibrinolysis. However, such changes are generally within the normal range.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not use Serisima during pregnancy. Before starting Serisima, you must be sure you are not pregnant. If you become pregnant while using this medicine, stop taking Serisima immediately and consult your doctor.

Breastfeeding
Do not use Serisima while breastfeeding, as it may reduce milk production and small amounts of the active substance may pass into breast milk. During breastfeeding, a non-hormonal contraceptive method should be used.

Driving and use of machines
Serisima has no effect on the ability to drive vehicles or operate machinery.

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

3. How to take Serisima

Take Serisima exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
If your doctor has not instructed otherwise, the usual dose is 1 tablet of Serisima daily.

How to take Serisima
Each blister contains 28 tablets: 21 active white tablets and 7 placebo green tablets.
The Serisima tablets in the two different colours are arranged in order.
Swallow one tablet whole daily, with water if necessary. You must take the tablets every day at approximately the same time.

Do not confuse the tablets: take one white tablet once daily for the first 21 days, followed by one green tablet once daily for the next 7 days. You must then immediately start a new blister (21 white tablets followed by 7 green tablets). In this way, there is no tablet-free interval (no break) between two blisters.

Due to the different composition of the tablets, you must start taking them with the first tablet located in the upper left corner (next to the label “Start”) and take one tablet each day. Follow the direction of the arrows on the blister for the correct order.

Preparing the blister
To help you remember to take your tablet, each package of Serisima includes, for each blister, a self-adhesive strip containing 7 weekly labels with the days of the week printed on them. Choose the weekly label that starts with the day on which you begin taking the tablets. For example, if you start on Wednesday, use the weekly label starting with “WED”.

Apply the weekly label along the top edge of the blister where it says “Apply weekly label here”.

This way, each tablet will have a day marked above it, allowing you to check whether you have taken a particular tablet. The arrows indicate the order in which you should take the tablets.

During the 7 days when you are taking the green placebo tablets (the placebo days), you should experience bleeding (called withdrawal bleeding). This usually starts 2 or 3 days after taking the last active white tablet. After taking the last green tablet, start the next blister immediately, regardless of whether the bleeding has stopped or is still ongoing. This means you should start each new blister on the same day of the week, so that withdrawal bleeding occurs on the same days each month.

If you use Serisima in this way, you will be protected against pregnancy even during the 7 days when you are taking the green placebo tablets.

When to start taking Serisima

If you have not taken any ‘pill’ in the previous month:
Start taking Serisima on the first day of your cycle, i.e. the first day of your menstrual period. If used correctly, contraceptive protection begins on the first day of intake. If you start taking Serisima between the second and fifth day of your cycle, you must also use a barrier contraceptive method during the first 7 days of ‘pill’ intake.

If switching to Serisima from another ‘pill’ (containing two hormonal active ingredients), a vaginal ring, or a contraceptive patch:

• If you previously took a ‘pill’ that required a tablet-free interval after the last active tablet, start taking Serisima the day after this tablet-free interval.
• If you previously took a ‘pill’ whose pack also contained inactive tablets (also known as placebo tablets) in addition to the active tablets, do not take a tablet-free interval. Start taking Serisima the day after taking the last inactive tablet. If you are unsure which tablet was the last inactive one, ask your doctor or pharmacist.
• If you were using a vaginal ring or contraceptive patch, start taking Serisima the day after the usual ring- or patch-free interval.

If switching from a progestogen-only ‘pill’ (also called ‘mini-pill’):
You may stop the ‘mini-pill’ on any day. Start taking Serisima the next day. For the first 7 days, you must use an additional non-hormonal contraceptive method (e.g. condom).

If switching from an injectable contraceptive (also called ‘three-monthly injection’), an implant, or an intrauterine drug delivery system:
Start taking Serisima on the day you would have received your next injection, on the day the implant would have been inserted, or on the day the intrauterine device is removed. For the first 7 days, use an additional non-hormonal contraceptive method (e.g. condom).

After childbirth and if you are not breastfeeding:
Start taking the ‘pill’ no earlier than 21–28 days after childbirth. For the first 7 days, you must also use an additional barrier contraceptive method (e.g. condom). If you have already had sexual intercourse before starting Serisima, you must ensure you are not pregnant, or wait until your first menstrual period before taking this medicine.

During breastfeeding
If you are breastfeeding and wish to start taking Serisima, speak to your doctor (see “Pregnancy and breastfeeding”).

If you have had a miscarriage or an induced abortion:
Speak to your doctor about taking Serisima.

Duration of use
You may take Serisima for as long as you wish to use a hormonal contraceptive method and there are no health risks (see “Do not take Serisima” and “Stop taking Serisima immediately”). Regular medical check-ups are strongly recommended (see “Medical advice/check-ups”).

If you take more Serisima than you should
If you take more tablets than prescribed, speak to your doctor or pharmacist.
Possible signs of overdose include nausea, vomiting (usually 12–24 hours after intake, sometimes persisting for several days), breast tenderness, dizziness, stomach ache, drowsiness/tiredness; in women and girls, vaginal bleeding may occur. You should consult a doctor if you have taken relatively large quantities.

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

If you forget to take an active white tablet (tablets in the first, second or third row), follow these instructions:

• If you are less than 12 hours late in taking a tablet, the contraceptive effect of Serisima is not reduced. Take the missed tablet as soon as possible and continue taking the following tablets at your usual time.
• If you are more than 12 hours late in taking a tablet, contraceptive protection may no longer be guaranteed. If you do not have bleeding during the first days of taking the green placebo tablets (the first placebo days), you may be pregnant. In this case, consult your doctor before starting a new blister.

In general, consider the following two points:

• The intake of active tablets should not be interrupted for more than 7 days.
• For adequate contraceptive protection after missing a tablet, active tablets must be taken continuously for 7 days.

Follow the instructions below if you have forgotten to take a tablet:

If you missed 1 tablet in the first week of intake:
Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Then continue taking the tablets as usual. However, for the next 7 days, you must also use a mechanical contraceptive method (e.g. condom). If you had sexual intercourse in the week before you missed the tablet, there is a possibility you may be pregnant. The closer the missed tablet was to the placebo tablets, the higher the risk of pregnancy.

If you missed 1 tablet in the second week of intake:
Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. You may then take the following tablets at your usual time. If you took Serisima correctly during the 7 days before the missed tablet, the contraceptive effect of the ‘pill’ is not affected and you do not need to use additional contraceptive methods. If this was not the case, or if you missed more than one tablet, use an additional barrier contraceptive method (e.g. condom) for the next 7 days.

If you missed 1 tablet in the third week of intake:
Contraceptive protection is not fully guaranteed. However, by adjusting the 7-day placebo period, you can maintain contraceptive efficacy. If you follow either of the two procedures described below, no additional contraceptive measures are needed, provided you took Serisima correctly during the 7 days before missing the tablet. Otherwise, follow the instructions under point 1 below. Additionally, use an additional barrier contraceptive method (e.g. condom) for the next 7 days.

Option 1: Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. You may then take the following tablets at your usual time. Instead of taking the green placebo tablets, start taking tablets from the next blister. You are very unlikely to have withdrawal bleeding until you finish this second blister; however, breakthrough bleeding or spotting may occur.

or

Option 2: You may immediately stop taking the white tablets from the current blister and start taking the green placebo tablets (starting from the day you missed the tablet); then continue with the white tablets from the next blister. If you wish to start the new blister on your usual day of the week, take fewer than 7 placebo tablets.

If you missed more than one tablet from the current blister:
If you have missed more than one tablet from the current blister, you are no longer protected against pregnancy.
The risk of pregnancy increases the more tablets you miss and the closer they are to the placebo tablets. Until your next expected withdrawal bleeding, use an additional barrier contraceptive method (e.g. condom). If no bleeding occurs after you finish the current blister, during the normal break, you may be pregnant. In this case, consult your doctor before starting a new blister.

If you vomit or have diarrhoea
If you have gastrointestinal disturbances such as vomiting or diarrhoea within 4 hours of taking a tablet, the active ingredient may not have been completely absorbed by your body. In such cases, follow the instructions for missed tablets, provided you notice within 12 hours. If you do not wish to deviate from your usual schedule, take a replacement tablet from another blister. If gastrointestinal symptoms persist for several days or are recurrent, use a barrier contraceptive method (e.g. condom) and inform your doctor.

If you wish to delay withdrawal bleeding (menstruation)
If you wish to delay withdrawal bleeding, continue directly with tablets from the next Serisima blister without taking the placebo tablets. Withdrawal bleeding can be delayed for as long as desired, but only until the second blister is finished. During this time, you may experience breakthrough bleeding or spotting. After the usual subsequent placebo days, you may continue taking Serisima as usual.

If you stop taking Serisima
You may stop taking Serisima at any time. If you do not wish to become pregnant, consult your doctor for other reliable contraceptive methods.

If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Serisima can cause side effects, although not everyone will experience them. If you experience any side effect, especially if it is severe or persistent, or if you notice any change in your health that you think may be due to Serisima, 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 various risks associated with taking combined hormonal contraceptives, see section 2, "What you need to know before taking Serisima".

Serious side effects associated with the use of the 'pill' are listed in section 2, "What you need to know before taking Serisima", where you can find detailed information. Speak to your doctor immediately if necessary.

The following side effects may occur when taking Serisima:

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

• headache
• chest pain, including breast tenderness and pain

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

• genital inflammation (vaginitis/vulvovaginitis), fungal vaginal infections (candidiasis, vulvovaginal infections)
• increased appetite
• depressed mood
• dizziness
• migraine
• high or low blood pressure; in rare cases, increased diastolic blood pressure (the lower blood pressure value)
• abdominal pain (including upper and lower abdominal pain, discomfort/flatulence)
• nausea, vomiting, or diarrhoea
• acne
• hair loss (alopecia)
• skin rash (including macular rash)
• itching (sometimes affecting the whole body)
• irregular menstrual bleeding, including heavy bleeding (menorrhagia), scanty bleeding (hypomenorrhoea), irregular bleeding (oligomenorrhoea), and absence of bleeding (amenorrhoea)
• vaginal spotting (vaginal haemorrhage and metrorrhagia)
• painful menstruation (dysmenorrhoea), pelvic pain
• breast enlargement, including breast swelling, breast oedema
• vaginal discharge
• ovarian cysts
• fatigue, including weakness, tiredness, and general malaise
• weight changes (increase, decrease, or fluctuations)

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

• inflammation of the fallopian tubes or ovaries
• cervical inflammation (cervicitis)
• urinary tract infections, bladder inflammation (cystitis)
• breast inflammation (mastitis)
• fungal infections (e.g. Candida), viral infections, facial herpes
• influenza, bronchitis, upper respiratory tract infections, sinus infection (sinusitis)
• asthma
• increased breathing rate (hyperventilation)
• benign uterine growths (fibroids)
• benign fatty tissue growths in the breast (lipoma)
• anaemia
• allergic reactions (hypersensitivity)
• masculinization (virilism)
• loss of appetite (anorexia)
• depression, mood changes, irritability, aggression
• insomnia, sleep disorders
• circulatory problems in the brain or heart, stroke
• dystonia (a muscle disorder that may cause abnormal posture or movements)
• dry or irritated eyes
• visual disturbances
• sudden hearing loss, hearing impairment
• tinnitus
• balance disorders
• rapid heartbeat
• thrombosis, pulmonary embolism
• inflammation of veins (phlebitis, thrombophlebitis)
• varicose veins (varices), vein pain or discomfort
• dizziness or fainting when standing up from a sitting or lying position (orthostatic hypotension)
• hot flushes
• inflammation of the stomach lining (gastritis), intestinal inflammation (enteritis)
• stomach disorders (dyspepsia)
• skin reactions/skin diseases, including skin allergic reactions, neurodermatitis/atopic dermatitis, eczema, skin redness and irritation (psoriasis)
• excessive sweating
• brownish-yellow pigmented spots (so-called pregnancy spots), especially on the face (chloasma), pigmentary disorders/increased pigmentation
• oily skin (seborrhoea)
• dandruff
• growth of male-pattern hair (hirsutism)
• dimpled skin (cellulite)
• cutaneous nevus (reticular blood vessels with a central red spot on the skin)
• back pain, chest pain
• muscle and bone discomfort, muscle pain (myalgia), pain in arms and legs
• cervical dysplasia (abnormal growth of cells on the surface of the cervix)
• pain or cysts in the adnexa (fallopian tubes and ovaries)
• breast cysts, benign breast growths (fibrocystic mastopathy), swelling outside the breast area (accessory breasts)
• painful sexual intercourse
• secretion from mammary glands, nipple discharge
• menstrual irregularities
• peripheral oedema (fluid accumulation)
• flu-like symptoms, inflammation, pyrexia (fever)
• increased levels of triglycerides and cholesterol in the blood (hypertriglyceridaemia, hypercholesterolaemia)
• harmful blood clots in a vein or artery, for example:
  • in a leg or foot (DVT)
  • in a lung (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).

Not known (frequency cannot be estimated from available data):

• Increase or decrease in sexual desire (libido)
• intolerance to contact lenses
• urticaria
• painful red lumps under the skin (erythema nodosum or erythema multiforme)

If you suffer from hereditary angioedema, medicines containing estrogens may trigger or worsen angioedema symptoms (see section 2, "Warnings and precautions").

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Serisima

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep the blister in the outer 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 you no longer use. This will help protect the environment.

6. Package contents and other information

What Serisima contains
A Serisima 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 dienogest and ethinylestradiol. One white active tablet contains 2 mg of dienogest and 0.03 mg of ethinylestradiol.
• The 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, anhydrous colloidal silica, maize starch, povidone K-30. Film coating: hypromellose, triacetin, polysorbate 80, titanium dioxide (E171), FD & C Blue 2 aluminium pigment and iron oxide yellow (E172).

Description of the appearance of Serisima and the contents of the pack
The active tablets are white, round, film-coated tablets. The placebo tablets are green,
round, film-coated tablets.
Serisima is available in packs containing 28, 3x28, 6x28 and 13x28 film-coated tablets
(21 active tablets plus 7 placebo tablets). Not all pack sizes may be marketed.
Each Serisima package includes, for each blister, a set of 7 different adhesive labels displaying the days of the week in a different order depending on the day of treatment initiation.
Marketing Authorization Holder
Exeltis Italia S.r.l.
Via Lombardia, 2/A
20068 Peschiera Borromeo (MI)
Italy
Manufacturer
Laboratorios León Farma SA
La Vallina s/n, Pol. Ind. Navatejera,
Navatejera-24008 León Spain
This medicinal product is authorized in the European Economic Area Member States under the
following names:
Austria Dienorette 0.03 mg / 2 mg 21+7 Filmtabletten
Belgium Serisima Continu 2 mg/0.03 mg comprimé pelliculé, filmomhulde tablet, Filmtablette
Bulgaria Dienorette 2mg/0.03 mg
Czech Republic Diecyclen 2mg/0.03mg potahované tablety
Germany Velafee 21+7 0.03 mg / 2.0 mg Filmtabletten
Spain Ceciliana Diario, 2 mg/0.03 mg comprimidos recubiertos con película EFG
France Dienille Continu 2 mg / 0.03 mg comprimé pelliculé
Hungary Diedita 2 mg/0.03 mg, film-coated tablets
Italy Serisima
Luxembourg Serisima Continu 2 mg/0.03 mg comprimé pelliculé
Poland Atywia Daily
Romania Dienorette 2 mg/0.03mg comprimate filmate
Slovakia Diecyclen 2mg/0.03mg filmom obalené tablety