EFFIMIA 0.250 MG/0.035 MG Coated tablet

Содержание инструкции

1. Effimia 0.250/0.035 mg 28 tablets
   1. What is Effimia and what is it used for
   2. Cosa deve sapere prima di prendere Effimia
   3. How to take Effimia
   4. Possible side effects
   5. How to store Effimia
   6. Package Contents and Other Information

Effimia 0.250/0.035 mg 28 tablets

norgestimate/ethinylestradiol

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

• If used correctly, they constitute one of the most reliable reversible contraceptive methods.
• CHCs slightly increase the risk of blood clots forming in veins and arteries, particularly in the first year of use or when restarting a combined hormonal contraceptive after an interruption of 4 or more weeks.
• Be careful and consult your doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask 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, as it could be dangerous.
• If you experience any side effects, including those not listed in this leaflet, tell 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 you take 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 is Effimia and what is it 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 called placebo tablets.
Effimia prevents the ovaries from producing an egg, thus preventing pregnancy. In addition, Effimia
makes the fluid (mucus) in the cervix thicker, making it more difficult for sperm to
enter the uterus.

2. Cosa deve sapere prima di prendere Effimia

Note generali
Before starting to use Effimia, read the information on blood clots in section 2.
It is particularly important that you read 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 medical history
and that of your close relatives. The doctor will also measure your blood pressure and,
based on your personal situation, may also perform other tests.
This leaflet describes various situations in which you must stop taking Effimia, or where
the reliability of Effimia may be reduced. In these situations, you should not have sexual intercourse
or you must use additional non-hormonal contraceptive precautions, for example using a
condom or another barrier method. Do not use methods like the 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 from
other sexually transmitted diseases.

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. The doctor will discuss with you other methods of
birth control that may be more suitable for your case.

• If you have (or have ever had) a blood clot in a blood vessel in the leg (deep vein thrombosis, DVT), the lungs (pulmonary embolism, PE) or other organs;
• if you know you have a disorderaffecting blood coagulation, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies;
• if you are going to have surgery or remain bedridden for a long 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 that causes severe chest pain and may be a first sign of a heart attack) or a transient ischemic attack (TIA - symptoms of a temporary stroke);
• if you have one of the following diseases, which may increase the risk of clots forming in the arteries: severe diabeteswith damage to blood vessels, very high blood pressure, very high levels of fats(cholesterol or triglycerides) in the blood, or a condition known as hyperhomocysteinemia;
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you are allergicto norgestimate, ethinylestradiol or any of the other ingredients of this medicine (listed in section 6);
• if you have severe liver diseaseand liver function values have not yet returned to normal;
• if you have liver tumors(benign or malignant);
• if you have or suspect you have a tumor of the breast or genital organs;
• if you have vaginal bleeding of unknown cause;
• If you have jaundice (a condition that causes the skin to turn yellowish) associated with pregnancy or a 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 (see also the section “Other medicines and Effimia”);
• if you have a heart valve disease that has caused complications;
• if you have an abnormal thickening of the lining of the uterus (endometrial hyperplasia);
• if you are or think you might be pregnant. When you need to be particularly careful with Effimia

When should you contact a doctor?
Contact your doctor urgently

• if you notice potential signs of a blood clot that may indicate the presence of 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 the section “How to recognize a blood clot”.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Effimia.

Tell your doctor if any of the following conditions apply to you.
If any of these conditions appear or worsen while you are taking Effimia, tell 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 that affects the body's defense system);
• if you have hemolytic-uremic syndrome (HUS, a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (an inherited red blood cell disease);
• 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 going to have surgery or remain bedridden for a long period (see section 2 “Blood clots”);
• if you have just given birth, the risk of developing blood clots is higher. Ask your doctor how long after childbirth you can start taking Effimia;
• if you have inflammation of the veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have otosclerosis (hearing loss);
• if you have or have ever had chloasma (a skin discoloration, especially on the face or neck, known as “pregnancy spots”). If so, avoid direct sunlight or ultraviolet light;
• if you have a condition called gestational herpes that occurred for the first time during pregnancy;
• if you have (or have ever had) gallstones or inflammation of the gallbladder;
• if you have a blood disease called porphyria;
• if you have a nervous system disease that causes sudden movements of the body (Sydenham's chorea);
• if a close relative of yours has or has ever had breast cancer;
• if you have depression. Some women using hormonal contraceptives, including Effimia, have reported depression or depressed mood. Depression can be severe and sometimes can lead to suicidal thoughts. If you notice mood swings and symptoms of depression, contact your doctor as soon as possible for further professional advice;
• if you have a 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 potentially with difficulty breathing. In this case, contact a doctor immediately. Medicines containing estrogens can cause or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS
The use of a combined hormonal contraceptive like 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 the veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE);
• in the arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, there may be serious long-term effects or, very rarely, such 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 your 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 in the veins (venous thrombosis). However, these side effects are rare. In most cases, they occur in the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• Very rarely, a clot can form in a vein in another organ, such as the eye (retinal vein thrombosis).

When is the risk of a blood clot forming in a vein highest?
The risk of a blood clot forming in a vein is highest during the first year you
first take a combined hormonal contraceptive. The risk may also be higher
if you restart 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 it is still slightly higher than that of
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 a blood clot forming?
The risk depends on your natural risk of TEV 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.

• Out of 10,000 women who do not use any combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
• Out of 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone or norgestimato, like Effimia, about 5-7 will develop a blood clot in a

year.

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

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

• if you are strongly overweight (body mass index or BMI greater than 30 kg/m²);
• if a close relative of yours has had a blood clot in a leg, lung or other organ at a young age (e.g. before the age of about 50). In this case, you may have an inherited blood clotting disorder;
• if you need to undergo surgery or remain bedridden for a long period due to an injury or illness, or if you have a leg in plaster. You may need to stop taking Effimia a few weeks before surgery or during the period when you are less mobile. If you need to stop taking Effimia, ask your doctor when you can start taking it again;
• with increasing age (especially after about 35 years of age);
• if you have given birth less than a few weeks ago. The risk of a blood clot forming increases with the number of conditions you have.

Air travel (lasting more than 4 hours) can temporarily increase the risk of a blood clot forming, especially if you have some of the other risk factors listed.
It is important that you inform your doctor if any of these conditions apply to you, even if you are
not sure. Your doctor may decide to stop you from taking Effimia.
If any of the above conditions change while you are using Effimia, for example if a
close relative has a thrombosis without an obvious cause or if you gain a lot of weight,
tell your doctor.

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

Factors that increase the risk of a blood clot forming 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 can increase:

• with increasing age (over 35 years of age);
• if you smoke.When you use a combined hormonal contraceptive like Effimia, it is advisable to quit smoking. If you cannot quit smoking and you 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 of yours has had a heart attack or stroke at a young age (before the age of about 50). In this case, you may also be at high risk of heart attack or stroke;
• if you or a close relative of yours 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 defect of the heart valves, 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 a clot forming may be even greater.
If any of the above conditions change while you are using Effimia, for example if you start
to smoke, if a close relative has a thrombosis without an obvious cause or if you gain
a lot of weight, tell your doctor.

The pill and cancer
The risk of breast cancer generally increases with age. The risk of breast cancer is slightly
higher when you take oral contraceptives. Compared to the risk of breast cancer at a
specific time in life, the increased risk associated with the use of oral contraceptives is low. The
additional risk decreases gradually over the 10 years after stopping the use of
oral contraceptives.
Breast cancers diagnosed in women who use oral contraceptives were not as advanced
as in women who do not use them.
Rare cases of benign liver tumors and even rarer cases of malignant tumors have been reported in people using oral contraceptives. These tumors can cause internal bleeding with
life-threatening danger. Contact your doctor if you have unusually severe stomach pain.
Cervical cancer has been observed to occur slightly more frequently
when oral contraceptives are used for a long time. This data is not necessarily due to the use
of oral contraceptives and may be related to sexual behavior or other factors.

Bleeding between periods
During the first few months of taking Effimia, you may experience unexpected bleeding on the days of
withdrawal (i.e. the days of the week when you take the placebo tablets). If the bleeding
occurs for more than a few months or if it starts to occur after a few months, your doctor will need to
investigate the cause.

What to do if you do not have a withdrawal bleed
If you have taken all the blue tablets correctly, you have not vomited or had severe diarrhea and you have not taken
any other medicines, it is very unlikely that you are pregnant.
If the expected bleeding does not occur for two consecutive times, you may be pregnant. Contact your doctor immediately. Do not start the next strip until you are sure you
are not pregnant.
Blood levels of a nutrient called folate may be lower in women who use
oral contraceptives. This data may be important for women who become pregnant shortly after
stopping oral contraceptives.

Other medicines and Effimia
Always tell your doctor if you are taking any other medicines or herbal products. Also tell any other doctor or dentist who may prescribe you other medicines (or the pharmacist) that
you are taking Effimia. They can tell you if you need to use additional contraceptive
precautions (e.g. condoms) and, if so, for how long, or if it is necessary to change
the use of other medicines.
Some medicines

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

These medicines include those used to treat:

• epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine);
• tuberculosis (e.g. rifampicin);
• HIV and hepatitis C 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);
• herbal remedy called “St John's wort”.

Effimia can affect the effect of other medicines, e.g.

• medicines containing cyclosporine;
• antiepileptic “lamotrigine” (this can lead to a higher frequency of seizures);
• theophylline (used to treat breathing 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
can cause increases in blood values related to liver function (increased liver enzymes
called ALT).
Do not use Effimia if you are taking tranexamic acid, as it may increase the risk of a blood clot forming or a heart attack or stroke.
Your doctor will prescribe you a different type of contraceptive before starting treatment with these
medicines.
You can resume taking Effimia about 2 weeks after the end of treatment. See
paragraph “Do not take Effimia”.

Laboratory tests
If you are going to have a blood test, tell your doctor or the people working in the laboratory that you
are taking a contraceptive pill, because oral contraceptives can affect the results
of some tests.

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

Pregnancy, breastfeeding and fertility
Ask your doctor or pharmacist for advice before taking any medicine.

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

Breastfeeding
The use of Effimia during breastfeeding may have effects on the baby. Therefore, do
not use Effimia during breastfeeding unless your doctor has specifically
prescribed it. Mothers who are breastfeeding should monitor milk volume, as Effimia may reduce
the amount of milk produced.

Fertility
Effimia is used to prevent pregnancy.

Driving and using machines
Effimia has no known effects on the ability to drive and operate machines.

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

3. How to take Effimia

How to take it
Take this medicine always exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.
After taking the 21 blue tablets, continue taking the 7 placebo tablets (white); in this way you will never have to stop taking the medicine to take a break but for one week you will take the placebo (the week in which you will take the placebo tablets present in row 4 of the strip).
The tablets of two colors in the 28-tablet pack of Effimia are arranged in sequence.
Each strip contains 28 tablets.
The contraceptive effect begins with the first tablet taken. Each strip with a calendar contains 28 tablets.

• Take the tablet every day at the same time.
• Start with the first tablet at the top left (near the “Start” writing).
• Follow the direction of the arrows on the strip. Take one tablet a day, until you finish all 28 tablets.
• Swallow each tablet whole, if necessary with some water. Do not chew the tablet.

Do not exchange the tablets:the strip contains 28 tablets. Following the direction of the arrow on the strip, take one blue tablet once a day for the first 21 days and, subsequently, one white tablet a day for the last 7 days. Once the strip is finished, start a new one immediately: there is no break between the two strips in which you do not take the medicine. The strip contains 28 tablets.
Preparation of the strip:
To help you remember to take the tablet, each pack of Effimia provides a label with stickers for the 7 days of the week for each strip. Choose the sticker with the day of the week corresponding to the one in which you start taking the tablets. For example, if you start on Wednesday, use the sticker with the day of the week that says “Wednesday”.
Place the sticker on the strip above the writing “Affix the day of the week sticker here”.
The arrows show the order in which you must take the tablets from “Start” to “End”.
During the 7 days in which you take the white placebo tablets, you should start withdrawal bleeding. It usually starts on the second or third day after the last active blue tablet of Effimia. Once you have taken the last white tablet, you must start a new strip, even if the bleeding is still in progress. This means that you must start each strip on the same day of the week and the withdrawal bleeding should always occur on the same days of the month.
If you use Effimia in this way, you are protected from the risk of pregnancy even during the 7 days in which you take the placebo tablets.

When to start the first strip

• If you have not used any hormonal contraception during the previous monthStart taking Effimia on the first day of your cycle (i.e. the first day of your period). If you start taking Effimia on the first day of your cycle, protection against pregnancy starts immediately. You can also start between the 2nd and 5th day 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 contraceptive

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

• Switching from a progestin-only method (progestin-only pill, injection, implant or progestin-releasing intrauterine system [IUS])You can switch on any day from the progestin pill (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 is 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 an abortion, spontaneous or inducedIf you have had a spontaneous or induced abortion during the first three months of pregnancy, your doctor may tell you to start taking Effimia immediately. In this case you will have contraceptive protection from the first tablet.
• After giving birthYou can start taking Effimia between 21 and 28 days after giving birth. If you start using the medicine more than 28 days after delivery, use a barrier contraceptive method (e.g. a condom) for the first seven days while taking Effimia. If you have had sexual intercourse after giving birth before starting or restarting taking Effimia, make sure you are not pregnant or wait until your next menstrual period.
• If you are breastfeeding and want to start taking EFFIMIA after having a babyRead the “Breastfeeding” section of paragraph 2.

Ask your doctor what to do if you are not sure when to start.

If you take more Effimia than you should
There are no reports of serious harmful effects due to taking too many Effimia tablets.
If you take several tablets at the same time, 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 have this bleeding.
If you have taken too many Effimia tablets or have discovered that a child has taken some, ask your doctor or pharmacist for advice.

If you forget to take Effimia
The tablets in the fourthrow of the pack are placebo tablets. If you forget to take one of these tablets, the reliability of Effimia remains the same. Throw away the forgotten placebo tablet.
If you forget to take an active blue tablet (tablets in the first, second and third rows), proceed as follows:
Do not take a double dose to make up for forgetting a single dose.

• If the delay in taking a tablet is less than 12 hours, the contraceptive effect of Effimia is not reduced. Take the forgotten tablet as soon as you remember and take the next tablets at the usual time.
• If the delay in taking a tablet is more than 12 hours, the contraceptive effect may be reduced. The more tablets you forget, the greater the risk that the contraceptive effect is reduced.

The risk of pregnancy is particularly high if you forget to take a tablet during week 1 or 3. In this case, follow these rules:

If you have forgotten more than 1 active tablet from a strip
Ask your doctor for advice.

If you have forgotten a tablet during week 1
Take the forgotten tablet as soon as possible, even if this means taking two tablets at the same time. Continue taking the tablets at the usual time and use an additional contraceptive method (e.g. a condom) for the next 7 days. If you have had sexual intercourse in the week before forgetting to take the tablet, you may be pregnant. In this case, contact your doctor immediately.

If you have forgotten a tablet during week 2
Take the forgotten tablet as soon as possible, even if this means taking two tablets at the same time. Take the next tablets at the usual time. If you have taken Effimia correctly for the 7 days before the forgotten tablet, the contraceptive effect of the tablets is not reduced and you do not need to use additional contraceptive methods.

If you have forgotten a tablet during week 3
You can choose between these two options:

• 1. Take the forgotten tablet as soon as possible, even if this means taking two tablets at the same time. Take the next tablets at the usual time. Instead of taking the white placebo tablets of this strip, throw them away and start the next strip (in this case the day to start the strip changes). It is very likely that you will have bleeding at the end of the second strip, during the taking of the placebo tablets, but you may have light bleeding or similar to a period even while taking the active tablets of the second strip.
• 2. You can also stop taking the active blue tablets and go directly to the 7 white placebo tablets (before taking the placebo tablets, note the day you forgot the tablet). Then continue with the next strip. If you want to start a new strip on your usual day of the week, take the placebo tablets for a period of less than 7 days.

If you have forgotten to take one or more active tablets from the strip and you do not have withdrawal bleeding during the week of taking the placebo tablets, you may be pregnant. See your doctor before continuing to take the tablets from a new strip.

What to do in case of severe vomiting or diarrhea
If you vomit within 3-4 hours of taking an active tablet or if you have severe diarrhea, there is a risk that the active ingredients present in the tablet have not been completely absorbed by the body. The situation is almost the same as when you forget a tablet. After the episode of vomiting or diarrhea, take another tablet from a reserve strip as soon as possible. If possible, take it within 12 hours of the time you usually take the tablets. If this is not possible or 12 hours have passed, you must follow the instructions given in the section “If you forget to take Effimia”.

Delaying your period: what you need to know
Although not recommended, you can postpone your period by skipping the white placebo tablets and going directly to a new strip of Effimia until you finish it. You may experience light bleeding or similar to a period while taking the tablets of 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 period, you can ask your doctor for advice.
Changing the first day of your period: what you need to know
If you take the tablets following the instructions, your period will start during the days in which you take the placebo tablets. If you need to change the day of the start, reduce the number of days in which you take the placebo tablets (but never increase the days in which you take these tablets: 7 days is the maximum number). For example, if you start taking the placebo tablets on Friday and want to start taking them on Tuesday (3 days earlier) start the new strip 3 days earlier than usual. During this period of time you may not have any bleeding. It is possible that you will subsequently have light bleeding or similar to a period.

If you are not sure how to proceed, see your doctor.

If you stop taking Effimia
You can stop taking Effimia at any time. If you do not want to become pregnant, ask your doctor to advise you on other reliable contraceptive methods.
If you want to become pregnant, stop taking Effimia and wait for a period before trying to conceive. This will allow you to calculate the expected date of delivery more easily.

If you have any further questions on the use of this medicine, ask 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 severe and persistent, or if you notice a change in your
health condition that you believe is related to Effimia, contact your doctor.
The risk of blood clots forming in the veins (venous thromboembolism [VTE]) or blood clots in the arteries
(arterial thromboembolism [ATE]) is greater for 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 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 long-lasting, consult a doctor as soon as possible)
• Stomach problemssuch as nausea, vomiting and diarrhoea
• Bleeding and slight spotting between periodsfor the first few months (this problem will stop

between periods and should not last long

• Painful or unusual periods

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

• Urinary tract infection(pain when urinating)
• Vaginal infectionssuch as thrush
• Depression, mood swings,feeling of nervousness
• Migraine(see a doctor as soon as possible if this is your first migraine or if it is worse than usual)
• Acne, 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 defecating), 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 cellsat the cervix (identifiable through a Pap test [also called a “smear”])
• Feeling of anxietyor weakness, tinglingor numbness
• Changes in skin colour
• Skin problemssuch as rednessand itchingor colour changes
• Thinning of hair(alopecia), excessive hair growth
• Changes in appetite, weight change, weight loss
• Changes in libido
• Dry eyes
• Changes in vision
• Palpitations(awareness of heartbeat)
• Hot flushes
• Muscle pain
• Vaginal dryness
• Ovarian cysts(can cause abdominal pain and bloating and changes in periods)
• High blood pressure
• Shortness of breath or difficulty breathing(subjective feeling of discomfort in breathing)

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

• Breast nodules
• Dizziness
• Increased heart rate
• Pancreatitis(inflammation of the pancreas, causing severe abdominal and back pain)
• Increased sweating
• Sensitivity to light
• Hepatitis(inflammation of the liver, causing severe abdominal and back pain)
• Vaginal discharge(change in vaginal fluids)

Not known(frequency cannot be estimated on the basis of available data):

• Reduced amount of breast milk (if breastfeeding)
• Discomfort when using contact lenses
• Red, painful and swollen lumps similar to blood clotsin the legs
• Changes in blood values related to fats(visible in blood tests)
• Night sweats
• Liver adenomas(benign liver tumors generally due to hormones)
• Breast cancer
• Benign breast tumors
• Focal nodular hyperplasia(benign tumor)
• Fibroadenoma of the breast
• Stroke
• Violent and involuntary abnormal muscle contraction or a series of muscle contractions(convulsions)
• Heart attack
• Angioedema(swelling in the deep layers of the skin)

Serious adverse reactions listed below have been reported slightly more often in women who
use tablets (see section 2 “When you need to pay particular attention to taking Effimia”).

• Increased blood pressure
• Liver tumors or breast cancer
• Impaired 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 those of a stroke, collectively known as “transient ischemic attack” (TIA), or blood clots forming in the liver, stomach/intestines, kidneys or eyes.

The likelihood of a blood clot forming 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 the
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 that
causes abdominal pain and mental disorders), systemic lupus erythematosus (a condition that causes
the body to attack and damage its own organs and tissues), herpes in advanced pregnancy, Sydenham's
chorea (rapid involuntary movements or jerky movements), hemolytic uremic syndrome (a
condition that occurs after diarrhea caused by E. coli), liver problems with symptoms such as
jaundice (yellowing of the skin), gallbladder disorders or gallstone formation.
In women with hereditary angioedema (sudden onset of swelling of the skin, mucous membranes,
internal organs or brain), the estrogens in contraceptive pills may cause or worsen the symptoms of
angioedema.
Contact your doctor immediately if you experience any of the following symptoms of angioedema: face, tongue
and/or throat swelling 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, tell your
doctor, pharmacist or nurse. You can also report side effects directly through 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 at a temperature above 25°C.
Keep the blister in the outer packaging to protect the medicine from light.
Do not use this medicine after the expiry date which is reported on the pack. The expiry date refers to the
last day of that month.
Do not dispose of any medicine in waste water 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 Effimia Contains
The active ingredients are norgestimate 0.250 milligrams and ethinylestradiol 0.035 milligrams.
Effimia includes 2-color tablets:

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

Description of the Appearance of Effimia and Package Contents
Each active tablet is blue, round and biconvex, with the inscription “C 250” imprinted on both sides.
Each placebo tablet is white and round, with the inscription “P” imprinted 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 (blisters) of 28 tablets: 21 active blue tablets and 7 white placebo
tablets.
The packs available are 1, 3, 6 and 13 strips; 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 Member States of the European Economic Area under the
following denominations:
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 .