Effimia

Patient Information Leaflet

Effimia 0.250/0.035 mg 28 tablets

norgestimate/ethinylestradiol
Important information about combined hormonal contraceptives (CHCs):

• When used correctly, they are among the most reliable reversible methods of contraception.
• CHCs slightly increase the risk of blood clots forming in veins and arteries, particularly 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").

Please read this leaflet carefully before 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, pharmacist, or nurse.
• 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 effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Effimia is and what it is used for

Effimia is a low-dose combined oral hormonal contraceptive pill and is used to
prevent pregnancy.
Each blue tablet contains two types of female hormones, norgestimate and ethinylestradiol.
The white tablets do not contain active ingredients and are referred to as placebo tablets.
Effimia prevents the ovaries from releasing an egg, thereby preventing pregnancy. In addition, Effimia thickens the fluid (mucus) in the cervix, making it more difficult for sperm to enter the uterus.

2. What you should know before taking Effimia

General information
Before starting to use Effimia, 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 starting to take Effimia, your doctor will ask you some questions about your personal medical history and that of your close relatives. Your doctor will also measure your blood pressure and, depending on your individual situation, may carry out other examinations.
This leaflet describes various situations in which you must stop taking Effimia, or where the effectiveness of Effimia may be reduced. In these situations, you must avoid sexual intercourse or use additional non-hormonal contraceptive precautions, such as using a condom or another barrier method. Do not use methods such as rhythm or basal body temperature. These methods may be unreliable because Effimia alters the monthly changes in body temperature and cervical mucus.
Effimia, like other hormonal contraceptives, does not protect against HIV (AIDS) and other sexually transmitted infections.

Do not take Effimia
Do not take Effimia 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 situation.

• If you have (or have ever had) a blood clot in a blood vessel in your leg (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in another organ;
• 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 due to undergo surgery or need to remain bedridden for a prolonged period (see section 2 “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 a heart attack) or transient ischaemic attack (TIA – temporary stroke-like symptoms);
• if you have any of the following conditions, which could increase the risk of developing clots in the arteries:
  o severe diabetes with blood vessel damage,
  o very high blood pressure,
  o very high levels of fats (cholesterol or triglycerides) in the blood,
  o a condition known as hyperhomocysteinaemia;
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you are allergic to norgestimate, ethinylestradiol, or any of the other ingredients of this medicine (listed in section 6);
• if you have a severe liver disease and liver function test results have not yet returned to normal;
• if you have liver tumours (benign or malignant);
• if you have or suspect you have a breast or genital organ tumour;
• if you have vaginal bleeding without an obvious cause;
• if you have jaundice (a condition causing yellowing of the skin) associated with pregnancy or previous use of hormonal contraceptives;
• if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir (also see section “Other medicines and Effimia”);
• if you have a heart valve disease that has caused complications;
• if you have abnormal thickening of the inner lining of the uterus (endometrial hyperplasia);
• if you are or think you may be pregnant.

When to exercise particular caution with Effimia

When should you contact a doctor?
Contact a doctor urgently

• if you notice possible signs of a blood clot, which may indicate a blood clot in the leg (deep vein thrombosis), a blood clot in the lung (pulmonary embolism), a heart attack, or a stroke (see section 2 “Blood clots”). For a description of the symptoms of these serious side effects, see section “How to recognize a blood clot”.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Effimia.
Inform your doctor if any of the following conditions apply to you.
If any of these conditions appear or worsen while you are taking Effimia, inform your doctor.
In some situations, you need to be particularly careful when using Effimia, and your doctor may need to examine you regularly.

• 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 undergo surgery or need to remain bedridden for a prolonged period (see section 2 “Blood clots”);
• if you have recently given birth, the risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking Effimia;
• if you have inflammation of veins near the skin surface (superficial thrombophlebitis);
• if you have varicose veins;
• if you have otosclerosis (hearing loss);
• if you have or have ever had chloasma (skin discolouration, particularly on the face or neck, also known as “pregnancy mask”). If so, avoid direct sunlight or ultraviolet light;
• if you have a condition called gestational herpes that first occurred during pregnancy;
• if you have (or have ever had) gallstones or inflammation of the gallbladder;
• if you have a blood disorder called porphyria;
• if you have a nervous system disorder causing sudden body movements (Sydenham’s chorea);
• if a close relative has or has ever had breast cancer;
• if you have depression. Some women using hormonal contraceptives, including Effimia, have reported depression or low mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood swings or symptoms of depression, contact your doctor as soon as possible for further professional advice;
• if you have liver disease;
• if you have diabetes;
• if you have epilepsy (see section “Other medicines and Effimia”);
• if you have symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives possibly with breathing difficulties. In such cases, contact a doctor immediately. Medicines containing oestrogens can cause or worsen symptoms of hereditary or acquired angioedema.

BLOOD CLOTS
Using a combined hormonal contraceptive such as Effimia 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 may be fatal.
It is important to remember that the overall risk of developing a harmful blood clot associated with Effimia is low.

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

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 the veins (venous thrombosis). However, these side effects are rare. Most cases 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 travels from the leg and lodges in the lung, it can cause a pulmonary embolism.
• Very rarely, a clot may form in a vein of another organ, such as the eye (retinal vein thrombosis).

When is the risk of forming a blood clot in a vein highest?
The risk of forming a blood clot in a vein is highest during the first year of first-time use of a combined hormonal contraceptive. 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 taking Effimia, the risk of developing a blood clot returns to normal levels within a few weeks.

What is the risk of forming 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 Effimia 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, such as Effimia, about 5–7 will develop a blood clot in one year.

• The risk of forming a blood clot depends on your medical history (see the section below “Factors that increase the risk of forming a blood clot”).

Factors that increase the risk of blood clot formation in a vein
The risk of developing a blood clot with Effimia is low, but it increases in the presence of certain conditions. The risk is higher:

• if you are significantly overweight (body mass index or BMI greater than 30 kg/m²);
• if a close relative has had a blood clot in the leg, lung, or another organ at a young age (e.g., before approximately 50 years). In this case, you may have an inherited blood clotting disorder;
• if you are scheduled for surgery or must 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 Effimia several weeks before surgery or during periods of reduced mobility. If you must stop taking Effimia, ask your doctor when you can start taking it again;
• with increasing age (especially after about 35 years);
• if you have given birth within the past few weeks. The risk of developing a blood clot increases with the number of risk factors you have.

Air travel (lasting more than 4 hours) may temporarily increase the risk of blood clot formation, particularly if you have any of the other listed risk factors.
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 discontinue your use of Effimia.
If any of the above conditions change while you are using Effimia—for example, if a close relative develops thrombosis without an obvious cause or if you gain significant weight—inform your doctor.

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

Factors that increase the risk of blood clot formation in an artery
It is important to emphasize that the risk of heart attack or stroke associated with the use of Effimia is very low, but it may increase:

• with increasing age (after about 35 years);
• if you smoke. When using a combined hormonal contraceptive such as Effimia, you should stop smoking. If you are unable to quit smoking and are over 35 years old, your doctor may advise you to use 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 (before about 50 years). In this case, you may also be at 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 (a heart valve defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

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

Oral contraceptives and tumors
The risk of breast cancer generally increases with age. The risk of breast cancer is slightly higher when taking oral contraceptives. Compared to the baseline risk of breast cancer at a specific point in life, the additional risk associated with the use of oral contraceptives is low. This additional risk gradually decreases over the 10 years following discontinuation of oral contraceptives.
Breast cancers diagnosed in women using oral contraceptives were not more advanced than those in women who did not use them.
Rare cases of benign liver tumors and even rarer cases of malignant liver tumors have been reported in users of oral contraceptives. These tumors may cause life-threatening internal bleeding. Contact your doctor if you experience unusually severe stomach pain.
A slightly increased incidence of cervical cancer has been observed with long-term use of oral contraceptives. This finding is not necessarily due to oral contraceptive use and may be related to sexual behavior or other factors.

Bleeding between menstrual periods
During the first few months of taking Effimia, you may experience unexpected bleeding during the tablet-free interval (i.e., the days of the week when you take placebo tablets). If bleeding occurs for more than a few months or begins after several months of use, your doctor should investigate the cause.

What to do if no bleeding occurs during the tablet-free interval
If you have taken all blue tablets correctly, have not vomited or had severe diarrhea, and have not taken other medications, it is very unlikely that you are pregnant.
If the expected bleeding does not occur for two consecutive cycles, you may be pregnant. Consult your doctor immediately. Do not start the next strip until you are certain you are not pregnant.

Blood levels of a nutrient called folate may be lower in women using oral contraceptives. This may be important for women who become pregnant shortly after stopping oral contraceptives.

Other medicines and Effimia
Always inform your doctor if you are taking any other medicines or herbal products. Also inform any other doctor or dentist who may prescribe medicines (or your pharmacist) that you are taking Effimia. They can advise whether you need to use additional contraceptive precautions (e.g., condoms), and if so, for how long, or whether adjustments to other medicines are necessary.

Some medicines:

• May affect blood levels of Effimia.
• May make it less effective in preventing pregnancy.
• May cause unexpected bleeding.

These include medicines used to treat:

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine);
• 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 (e.g., griseofulvin);
• arthritis, osteoarthritis (etoricoxib);
• high blood pressure in the blood vessels of the lungs (bosentan);
• the herbal remedy known as "St. John's wort".

Effimia may affect the action of other medicines, for example:

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

Do not use Effimia if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, as these products may cause increases in blood markers of liver function (elevated liver enzymes called ALT).
Do not use Effimia if you are taking tranexamic acid, as it may increase the risk of blood clot formation or of heart attack or stroke.
Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
You may resume taking Effimia approximately 2 weeks after completing treatment. See section "Do not take Effimia".

Laboratory tests
If you are scheduled for a blood test, inform your doctor or laboratory personnel that you are taking an oral contraceptive, as oral contraceptives may influence the results of certain tests.

Effimia with food and drink
Effimia may be taken with or without food, if necessary accompanied by a small amount of water.

Pregnancy, breastfeeding, and fertility
Consult your doctor or pharmacist before taking any medicine.

Pregnancy
Do not use Effimia during pregnancy. If you become pregnant, stop using contraceptives and consult your doctor. If you have taken Effimia tablets during pregnancy, inform your doctor.

Breastfeeding
The use of Effimia during breastfeeding may affect the infant. Therefore, you should not use Effimia during breastfeeding unless specifically prescribed by your doctor. Breastfeeding mothers should monitor milk volume, as Effimia may reduce the amount of milk produced.

Fertility
Effimia is used to prevent pregnancy.

Driving and use of machines
Effimia has no known effects on the ability to drive vehicles or operate machinery.

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

3. How to take Effimia

How to take it
Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
After taking the 21 blue tablets, continue with the 7 placebo tablets (white); this way you will never need to interrupt treatment, but instead will take the placebo for one week (the week during which you take the white tablets in row 4 of the strip).
The two-coloured tablets in the 28-tablet Effimia pack are arranged in sequence. Each strip contains 28 tablets.
The contraceptive effect begins with the first tablet taken. Each calendar strip contains 28 tablets.

• Take one tablet every day at the same time.
• Start with the first tablet in the top left corner (next to the word “Start”).
• Follow the direction of the arrows on the strip. Take one tablet daily until you have taken all 28 tablets.
• Swallow each tablet whole, with water if needed. Do not chew the tablet.

Do not switch the tablets: the strip contains 28 tablets. Following the direction of the arrow on the strip, take one blue tablet once daily for the first 21 days, followed by one white tablet daily for the last 7 days. Once the strip is finished, immediately start a new one: there is no break between strips during which you stop taking the medicine.
The strip contains 28 tablets.
Strip preparation:
To help you remember to take your tablet, each Effimia pack includes a label with adhesive stickers showing the days of the week for each strip. Choose the sticker corresponding to the day of the week on which you start taking the tablets. For example, if you start on Wednesday, use the sticker indicating “Wednesday”.
Place the sticker on the strip above the text “Apply the day-of-the-week sticker here”.
The arrows indicate the order in which you should take the tablets, from “Start” to “End”.
During the 7 days when you take the white placebo tablets, you should experience withdrawal bleeding. This usually starts on the second or third day after the last active blue tablet of Effimia. Once you have taken the last white tablet, start a new strip immediately, even if bleeding is still ongoing. This means you should start each new strip on the same day of the week, and withdrawal bleeding should occur regularly during the same days each month.
If you use Effimia in this way, you are protected from pregnancy even during the 7 days when you take the placebo tablets.

When to start the first strip

• If you have not used any hormonal contraceptive in the previous month Start taking Effimia on the first day of your cycle (i.e. the first day of menstruation). If you start taking Effimia on the first day of your cycle, contraceptive protection begins immediately. You may also start between day 2 and day 5 of your cycle, but in this case you must use additional contraceptive methods (e.g. a condom) for the first 7 days.
• Switching from another combined oral hormonal contraceptive or from a combined hormonal contraceptive

in the form of a vaginal ring or patch
You may start taking Effimia preferably the day after the last active tablet (i.e. the last tablet containing active ingredients) of the previous contraceptive, but in any case no later than the day after the tablet-free interval (or after the last placebo tablet) of the previous contraceptive. When switching from a combined contraceptive in the form of a vaginal ring or patch, follow your doctor’s advice.

• Switching from a progestogen-only method (progestogen-only tablet, injection, progestogen-only implant, or intrauterine system releasing progestogen [IUS]) You may switch on any day from the progestogen-only tablet (in the case of an implant or IUS, on the day of removal; in the case of an injectable preparation, on the day the next injection would have been due), but in each of these cases you must use an additional contraceptive method (e.g. a condom) for the first 7 days of taking Effimia.
• After a spontaneous or induced abortion If you have had a spontaneous or induced abortion during the first three months of pregnancy, your doctor may advise you to start taking Effimia immediately. In this case, you will be protected from pregnancy starting with the first tablet.
• After childbirth You may start taking Effimia between 21 and 28 days after childbirth. If you start taking the medicine more than 28 days after childbirth, use a barrier contraceptive method (e.g. a condom) during the first seven days of taking Effimia. If you have had sexual intercourse after childbirth and before starting or resuming Effimia, make sure you are not pregnant or wait until your next menstrual period.
• If you are breastfeeding and wish to start taking EFFIMIA after giving birth Read the “Breast-feeding” section in paragraph 2.

Ask your doctor what to do if you are unsure about when to start.
If you take more Effimia than you should
There have been no reports of serious harmful effects from taking too many Effimia tablets.
If you take several tablets at once, you may experience symptoms such as nausea or vomiting, or you may have vaginal bleeding.
Even girls who have not yet had their first period but have accidentally taken this medicine may experience such bleeding.
If you have taken too many Effimia tablets or if you discover that a child has taken some, consult your doctor or pharmacist.

If you forget to take Effimia
The tablets in the fourth row of the pack are placebo tablets. If you forget to take one of these tablets, the reliability of Effimia remains unchanged. Discard the forgotten placebo tablet.
If you forget to take an active blue tablet (tablets in the first, second, and third rows), follow the instructions below:
Do not take a double dose to make up for a missed dose.

• If you are less than 12 hours late in taking a tablet, the contraceptive effect of Effimia is not reduced. Take the missed tablet as soon as you remember, and take the following tablets at your usual time.
• If you are more than 12 hours late in taking a tablet, the contraceptive effect may be reduced. The more tablets you miss, the greater the risk that contraceptive protection will be reduced.

The risk of pregnancy is particularly high if you miss a tablet during week 1 or week 3. In such cases, follow these rules:
If you have missed more than one active tablet in a strip
Consult your doctor.
If you missed a tablet during week 1
Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Continue taking the tablets at your usual time and use an additional contraceptive method (e.g. a condom) for the next 7 days. If you had sexual intercourse in the week before you missed the tablet, you may be pregnant. In this case, contact your doctor immediately.
If you missed a tablet during week 2
Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Take the following tablets at your usual time. If you have taken Effimia correctly in the 7 days before the missed tablet, the contraceptive effect is not reduced and you do not need to use additional contraceptive methods.
If you missed a tablet during week 3
You have two options:

1. Take the missed tablet as soon as possible, even if this means taking two tablets at the same time. Take the following tablets at your usual time. Instead of taking the white placebo tablets in this strip, discard them and immediately start the next strip (in this case, the starting day of the strip will change). You are very likely to experience bleeding at the end of the second strip, during the placebo tablets, but you may also have light bleeding or bleeding similar to menstruation while taking the active tablets of the second strip.
2. You may also stop taking the blue active tablets and go directly to the 7 white placebo tablets (before taking the placebo tablets, note the day on which you missed the tablet). Then continue with the next strip. If you wish to start a new strip on your usual day of the week, take the placebo tablets for fewer than 7 days.

If you have missed one or more active tablets from the strip and do not have withdrawal bleeding during the week of placebo tablets, you may be pregnant. Consult your doctor before continuing with a new strip.

What to do in case of vomiting or severe diarrhoea
If you vomit within 3–4 hours after taking an active tablet or if you have severe diarrhoea, there is a risk that
the active ingredients in the tablet have not been completely absorbed by the body. This situation is similar
to forgetting a tablet. After the episode of vomiting or severe diarrhoea, take another tablet as soon as possible from a reserve strip. If possible, take it within 12 hours of your usual tablet-taking time. If this is not possible or more than 12 hours have passed, follow the instructions given in the section “If you forget to take Effimia”.

Delaying the menstrual cycle: what you need to know
Although not recommended, you can delay your menstrual cycle by skipping the white placebo tablets and starting immediately with a new strip of Effimia until its completion. You may experience light bleeding or spotting similar to menstruation while taking the tablets from the second strip.
Finish the second strip by taking the 7 placebo tablets in the fourth row. Then start the next strip.
Before deciding to delay your menstrual cycle, consult your doctor.

Changing the first day of the menstrual cycle: what you need to know
If you take the tablets as instructed, your menstrual cycle will start during the days you take the placebo tablets. If you wish to change the starting day, reduce the number of days during which you take the placebo tablets (but never extend this period: 7 days is the maximum). For example, if you usually start taking the placebo tablets on Friday and wish to start on Tuesday (3 days earlier), begin the new strip 3 days earlier than usual. During this time, you may not have any bleeding. You may later experience light bleeding or spotting similar to menstruation.
If you are unsure about how to proceed, consult your doctor.

If you stop treatment with Effimia
You may stop treatment with Effimia at any time. If you do not wish to become pregnant, ask your doctor to recommend other reliable contraceptive methods.
If you wish to become pregnant, stop treatment with Effimia and wait for a menstrual period before trying to conceive. This will allow you to calculate the expected date of delivery more easily.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine 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 believe is related to Effimia, consult your doctor.
The risk of developing blood clots in the veins (venous thromboembolism [VTE]) or blood clots in the arteries (arterial thromboembolism [ATE]) is higher in all women who take combined hormonal contraceptives. For more detailed information on the various risks associated with taking combined hormonal contraceptives, see section 2 “What you should know before taking Effimia”.
The following side effects have been reported with the use of Effimia:
Very common (may affect more than 1 in 10 people):

• Headache (if severe, unusual or prolonged, consult a doctor as soon as possible)
• Stomach problems such as nausea, vomiting and diarrhoea
• Bleeding and light spotting between periods during the first months (this usually resolves as the body adjusts to Effimia); episodes of intermenstrual bleeding should not last long
• Painful or unusual periods

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

• Urinary tract infection (pain during urination)
• Vaginal infections such as candidiasis
• Depression, mood swings, feeling of nervousness
• Migraine (consult a doctor as soon as possible if this is your first migraine or if it is worse than usual)
• Acne, skin rash
• Breast pain
• Chest pain
• Muscle spasms; pain in legs, arms and back
• Absence of periods
• Weight gain
• Feeling of weakness
• Stomach ache and bloating, constipation (difficulty passing stools), flatulence
• Swollen hands, ankles or feet
• Difficulty sleeping (insomnia)
• Hypersensitivity (anaphylactic reaction)

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

• Breast problems, such as breast enlargement, nipple discharge
• Abnormal cells in the cervix (detectable by Pap test [also known as “smear”])
• Feeling of anxiety or weakness, feeling of tingling or numbness
• Change in skin colour
• Skin problems such as redness, itching or changes in pigmentation
• Thinning of hair (alopecia), excessive hair growth
• Changes in appetite, weight changes, weight loss
• Changes in sexual desire
• Dry eyes
• Changes in vision
• Palpitations (awareness of heartbeat)
• Hot flushes
• Muscle pain
• Vaginal dryness
• Ovarian cysts (may cause abdominal pain and swelling and changes in menstruation)
• High blood pressure
• Shortness of breath or breathlessness (subjective feeling of breathing discomfort)

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

• Breast lumps
• Dizziness
• Rapid heartbeat
• Pancreatitis (inflammation of the pancreas, causing severe abdominal and back pain)
• Increased sweating
• Light sensitivity
• Hepatitis (liver inflammation, causing severe abdominal and back pain)
• Vaginal discharge (change in vaginal fluids)

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

• Reduced amount of breast milk (if breastfeeding)
• Discomfort when wearing contact lenses
• Painful, red, swollen lumps in the legs
• Changes in blood lipid values (visible in blood tests)
• Night sweats
• Hepatic adenomas (benign liver tumours generally caused by hormones)
• Breast cancer
• Benign breast tumours
• Focal nodular hyperplasia (benign tumour)
• Fibroadenoma of the breast
• Cerebrovascular accident (stroke)
• Sudden, violent, involuntary muscle contraction or series of muscle contractions (seizures)
• Heart attack
• Angioedema (swelling in the deep layers of the skin)

The following serious adverse reactions have been reported slightly more frequently in women using oral contraceptive tablets (see section 2 “When you should pay particular attention when taking Effimia”).

• Increase in blood pressure
• Liver tumours or breast tumours
• Disorders of liver function
• Formation of 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 symptoms similar to stroke, collectively known as “transient ischaemic attack” (TIA), or formation of blood clots in the liver, stomach/intestine, kidneys or eyes.

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).
The following conditions may occur or worsen with the use of combined oral contraceptives:
Crohn’s disease, ulcerative colitis, epilepsy, uterine fibroids, porphyria (a metabolic disorder causing abdominal pain and mental disturbances), systemic lupus erythematosus (a condition causing the body to attack and damage its own organs and tissues), herpes in late pregnancy, Sydenham’s chorea (rapid involuntary movements or jerking movements), haemolytic uraemic syndrome (a condition occurring after diarrhoea caused by E. coli), liver problems with symptoms such as jaundice (yellowish skin), gallbladder disorders or gallstone formation.
In women with hereditary angioedema (sudden swelling of the skin, mucous membranes, internal organs or brain), the oestrogens present in contraceptive tablets may trigger or worsen angioedema symptoms.
Contact a doctor immediately if you experience any of the following angioedema symptoms: swollen face, tongue and/or throat and/or difficulty swallowing, or hives with possible difficulty breathing (see also section “Warnings and precautions”).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. You may also report side effects directly via the national reporting system at: https://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 Effimia

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Keep the blister pack in the outer packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Effimia contains
The active substances are norgestimate 0.250 milligrams and ethinylestradiol 0.035 milligrams.
Effimia includes tablets of 2 colours:

• Each blue tablet contains norgestimate 0.250 milligrams and ethinylestradiol 0.035 milligrams. The other components (excipients) are lactose, magnesium stearate (E470b), pregelatinized starch, crospovidone (E1202), and indigotine (E132) aluminium lake.
• Each white tablet (called an inactive tablet or placebo tablet) contains only excipients (no active substance), namely lactose, magnesium stearate (E470b), pregelatinized starch, and crospovidone (E1202).

Description of the appearance of Effimia and package contents
Each active tablet is blue, round, and biconvex, with the imprint “C 250” on both sides.
Each placebo tablet is white and round, with the imprint “P” on one side.
The tablets have a diameter of 6.35 mm (6.25–6.45 mm) and a thickness of 2.50 mm (2.00–3.00 mm).
Effimia is available in strips (blister packs) of 28 tablets: 21 blue active tablets and 7 white placebo tablets.
Pack sizes of 1, 3, 6 and 13 strips are available; each strip contains 28 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Italfarmaco S.p.A.
Viale F. Testi, 330
20126 Milan
Italy

Manufacturer
Delpharm Lille SAS
Parc d’Activités Roubaix-Est
22 Rue de Toufflers
CS 50070
59452 Lys-Lez-Lannoy
France

EFFIK
Bâtiment “Le Newton”
9–11, rue Jeanne Braconnier
92366 Meudon La Forêt
France

This medicinal product is authorised in the European Economic Area Member States under the following names:
Belgium: Cibel
Italy: Effimia
Portugal: Femi

Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency: www.aifa.gov.it.