Drospil

Package leaflet: Information for the user

Drospil 0,02 mg/3 mg film-coated tablets

Ethinylestradiol/Drospirenone
Equivalent Medicine
Important things to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods 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 taking this medicine because it contains important information for you.

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

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

1. What Drospil is and what it is used for

• Drospil is a contraceptive pill and is used to prevent pregnancy.
• Each of the 24 pink tablets contains a small amount of two different female hormones, drospirenone and ethinylestradiol.
• The 4 white tablets do not contain active ingredients and are also called placebo tablets.
• Contraceptive pills containing two hormones are called “combined” pills.

2. What you should know before using Drospil

General information
Before starting to use Drospil, 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 you start taking Drospil, your doctor will ask you 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 decide to carry out further examinations.
This patient leaflet describes various situations in which you should stop using
Drospil or in which the effectiveness of Drospil may be reduced. In these situations, you should avoid
sexual intercourse or use additional non-hormonal contraceptive precautions, such as a
condom or another barrier method. Do not use methods based on natural rhythms or body temperature, as these methods may be unreliable since Drospil alters the normal changes in body temperature and cervical mucus that occur during the menstrual cycle.
Drospil, like other hormonal contraceptives, does not protect against HIV (AIDS) infection or
other sexually transmitted diseases.
Do not use Drospil
Do not use Drospil 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 situation.

• if you have (or have ever had) a blood clot in a blood vessel in your leg (deep vein thrombosis, DVT), in your lung (pulmonary embolism, PE), or in another organ;
• 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 scheduled for surgery or will be confined to bed for a prolonged period (see section “Blood clots”);
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition causing severe chest pain that may be an early sign of heart attack) or a transient 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 hyperhomocysteinaemia
  • if you have (or have ever had) a type of migraine called “migraine with aura”;
  • if you have (or have had in the past) inflammation of the pancreas (pancreatitis)
  • if you have (or have had in the past) a liver disease and your liver is not functioning properly
  • if you have kidney problems (renal failure)
  • if you have (or have had in the past) a liver tumour
  • if you have (or have had in the past) or are suspected to have a tumour of the breast or genital organs
  • if you have unexplained vaginal bleeding
  • if you are allergic to ethinylestradiol or drospirenone, or to any of the other ingredients of this medicine (listed in section 6). In this case, you may experience itching, rash or swelling.

Do not use Drospil if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and
dasabuvir (see also section “Other medicines and Drospil”).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Drospil.
When should you contact a doctor?
Contact a doctor immediately

• if you notice possible signs of a 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 section "Blood clot (thrombosis)"). For a description of the symptoms of these serious side effects, go to the section “How to recognize a blood clot”.

In certain situations, you must take special care when using Drospil or any other combined pill, and your doctor may need to examine you regularly.
Inform your doctor if any of the following conditions apply to you.
If any of these conditions develop or worsen while you are using Drospil, inform your doctor.

• if a close relative has or has had breast cancer
• if you have liver or gallbladder disease
• if you have diabetes
• if you suffer from depression
• 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 scheduled for surgery or will be confined to bed for a prolonged period (see section 2 “Blood clots”);
• if you have recently given birth, your risk of developing blood clots is higher. Ask your doctor how long after delivery you can start taking Drospil;
• if you have inflammation of veins near the skin surface (superficial thrombophlebitis);
• if you have varicose veins;
• if you have epilepsy (see section “Other medicines and Drospil”)
• if you have a condition that first appeared during pregnancy or during previous use of sex hormones (e.g. hearing loss, a blood disorder called porphyria, blistering rash during pregnancy (herpes gestationis), a nerve disorder causing sudden involuntary movements (Sydenham's chorea))
• if you have or have had brownish-yellow patches (chloasma), often called “pregnancy mask”, especially on the face. In this case, you must avoid exposure to direct sunlight or ultraviolet light.
• if you have hereditary angioedema, products containing oestrogens may cause or worsen symptoms. You must therefore contact your doctor immediately if you experience symptoms of angioedema such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or hives with breathing difficulties.

Blood clots
Using a combined hormonal contraceptive such as Drospil 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)
or in arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE).
Recovery from blood clots is not always complete. Rarely, long-term serious effects may occur, or, very rarely, these effects may be fatal.
It is important to remember that the overall risk of a harmful blood clot associated with Drospil 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 developing blood clots in veins (venous thrombosis). However, these side effects are rare. In most cases, they occur during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may form in another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of first-time use of a combined hormonal contraceptive. The risk may also be higher when restarting a combined hormonal contraceptive (the same or a different product) after a break of 4 or more weeks.
After the first year, the risk decreases but remains slightly higher than in women not using a combined hormonal contraceptive.
When you stop taking Drospil, 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 the type of combined hormonal contraceptive you are using.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Drospil is low.

• Among 10,000 women who do not use any combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in a year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in a year.
• Among 10,000 women who use a combined hormonal contraceptive containing drospirenone, such as Drospil, about 9–12 will develop a blood clot in a year.
• The likelihood of developing a blood clot depends on your medical history (see below “Factors that increase the risk of developing a blood clot”).

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

• if you are overweight (body mass index or BMI above 30 kg/m²);
• if a close relative has had a blood clot in a leg, lung, or another organ at a young age (under approximately 50 years). In this case, you might have an inherited blood clotting disorder;
• if you need to undergo surgery or if you have to remain bedridden for a long period due to injury or illness, or if you have a leg in a cast. You may need to stop taking Drospil several weeks before surgery or during periods of reduced mobility. If you need to stop taking Drospil, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years of age);
• if you have given 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 some of the other risk factors listed above.
It is important that you inform your doctor if any of these conditions apply to you, even if you are uncertain. Your doctor may decide to have you stop taking Drospil.
If any of the above conditions change while you are using Drospil—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 can lead to a heart attack or stroke.

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

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

If any of the above conditions change while you are using Drospil—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.

Drospil and cancer
Breast cancer has been observed slightly more frequently in women using combined oral contraceptives compared to those who do not, but it is not known whether this is due to the treatment. For example, the higher number of breast cancer diagnoses in women using the pill might be due to more frequent medical check-ups they undergo. The incidence of breast cancer gradually decreases after stopping combined hormonal contraceptives.
It is important to examine your breasts regularly and contact your doctor if you notice any lumps.

In rare cases, benign liver tumors have been reported in users of the pill, and in an even smaller number of cases, malignant liver tumors. Contact your doctor if you experience unusual and severe abdominal pain.

Intermenstrual bleeding
During the first few months of taking Drospil, you may experience unexpected bleeding (outside the days when taking placebo tablets). If this bleeding occurs for more than a few months or starts after several months, your doctor should evaluate its cause.

What to do if you do not have a menstrual period during the days you take the placebo tablets
If you have taken all the active pink tablets correctly, have not vomited or had severe diarrhea, and have not taken any other medicines, it is highly unlikely that you are pregnant.
If the expected bleeding does not occur for two consecutive cycles, pregnancy may have occurred. Contact your doctor immediately. Do not start a new pack of medication until you are certain you are not pregnant.

Other medicines and Drospil
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Always tell your doctor which medicines or herbal products you are currently using. Also inform other doctors or your dentist who prescribe medicines for you (or the pharmacist who dispenses them) that you are using Drospil. They will advise you whether you need to use additional contraceptive measures (for example, a condom) and, if so, for how long.

• Some medicines can affect Drospil levels in the blood and make Drospil less effective in preventing pregnancy, or may cause unexpected bleeding. These include medicines used to treat:
  o epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
  o tuberculosis (e.g., rifampicin)
  o HIV and Hepatitis C virus infections (known as protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)
  o other infections (antibiotics such as griseofulvin)
  o high blood pressure in the pulmonary vessels (bosentan)
  o the herbal preparation St. John's wort (Hypericum perforatum)

Drospil can affect the action of other medicines, for example:
o medicines containing cyclosporine
o the antiepileptic lamotrigine (this may cause an increase in the frequency of epileptic seizures)

Ask your doctor or pharmacist for advice before taking any medicine.
Do not use Drospil if you have hepatitis C and are taking medicinal products containing ombitasvir/paritaprevir/ritonavir and dasabuvir, as this may cause increases in blood test results indicating liver function abnormalities (increase in liver enzyme ALT).
Your doctor will prescribe a different type of contraceptive before starting treatment with these medicines.
Drospil can be restarted approximately 2 weeks after completion of this treatment. See section "Do not take Drospil".

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

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

Laboratory tests
If you need to have a blood test, inform your doctor or laboratory staff that you are taking the pill, as oral contraceptives can alter the results of certain tests.

Pregnancy, breastfeeding and fertility
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
If you are pregnant, you must not take Drospil. If you become pregnant while taking Drospil, stop taking the tablets immediately and contact your doctor. If you discover you are pregnant, you may stop taking Drospil at any time (see also “If you stop taking Drospil”).

Consult your doctor or pharmacist before taking any medicine.

Breastfeeding
Generally, the use of Drospil is not recommended during breastfeeding. If you wish to take the pill while breastfeeding, contact your doctor.

Consult your doctor or pharmacist before taking any medicine.

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

Drospil contains lactose
If you have an intolerance to certain sugars, contact your doctor before taking Drospil.

3. How to take Drospil

Each blister contains 24 pink active tablets and 4 white placebo tablets.
The tablets of different colours are arranged in a specific order. One strip contains 28 tablets.
Take one Drospil tablet every day, if necessary with a small amount of water. You may take the tablets with or without food, but they should be taken at approximately the same time each day.
Do not confuse the tablets: take one pink tablet for the first 24 days, followed by one white tablet for the last 4 days. Then immediately start a new strip of tablets (24 pink tablets followed by 4 white tablets). There is therefore no break between two strips.
Due to the different composition of the tablets, you must start with the first tablet in the top left corner of the strip, and continue taking the tablets in the correct order each day. To ensure the correct sequence, follow the direction of the arrows on the strip.

Preparing the strip
To help you remember, each Drospil strip is supplied with 7 adhesive labels indicating the 7 days of the week. Choose the label corresponding to the day of the week on which you start taking the tablets. For example, if you start taking the tablets on Wednesday, use the label marked “WED”.
Stick the weekly day label along the top edge of the blister, where it says “Stick label here”, so that the first day is positioned above the tablet marked “1”. Each tablet is labelled with a day, allowing you to check whether you have taken a specific tablet. The arrows indicate the order in which to take the tablets.

During the 4 days when you take the white placebo tablets (the placebo days), you should experience a withdrawal bleed (also known as a withdrawal bleed). This usually occurs on the 2nd or 3rd day after taking the last active pink tablet of Drospil. After taking the last white tablet, you must immediately start a new strip, regardless of whether bleeding is still ongoing. This means that each strip of tablets must be started on the same day of the week, and the withdrawal bleed should occur on the same days every month.

If you use Drospil according to this regimen, you will be protected against pregnancy even during the 4 days when you take the placebo tablets.

When can you start the first strip?

• If you have not used a hormonal contraceptive in the previous month Start taking Drospil on the first day of your cycle (i.e. the first day of natural menstruation). If you start taking Drospil on the first day of your cycle, you will be immediately protected against unintended pregnancy. 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 hormonal contraceptive, combined pill, vaginal ring, or transdermal patch You may start taking Drospil preferably the day after taking the last active tablet (the last tablet containing active ingredients) of your previous contraceptive, or at the latest the day after the tablet-free interval of your previous contraceptive (or after the last inactive tablet of your previous contraceptive). For switching from a vaginal ring or transdermal patch, follow your doctor’s advice.
• Switching from a progestogen-only contraceptive (progestogen-only pill, injection, implant, or intrauterine device releasing progestogen (IUD)) If you have previously used a progestogen-only pill, you may switch to Drospil at any time. If you have used an implant or IUD, you may start on the day of removal. If you have used an injectable, start on the day the next injection would have been due. However, in all these cases, you must use additional contraceptive protection (e.g. a condom) for the first 7 days of tablet intake.
• After an abortion Follow your doctor’s advice.
• After childbirth

You may start taking Drospil between 21 and 28 days after giving birth. If you start after day 28, you must also use a barrier method of contraception (e.g. a condom) during the first seven days of using Drospil.
If, after childbirth, you have had sexual intercourse before starting (or restarting) Drospil, make sure you are not pregnant, or wait for the onset of the next menstrual period.

• If you are breastfeeding and wish to start (or restart) taking Drospil after childbirth Read the section "Breastfeeding". Consult your doctor if you are unsure about when to start.

If you take more Drospil than you should
There are no reports of harmful effects following an overdose of Drospil tablets.
If you have taken several tablets at once, you may experience symptoms such as nausea or vomiting. Younger girls may experience vaginal bleeding.
If you have taken too many Drospil tablets, or if you notice that a child has taken some, consult your doctor or pharmacist.

If you forget to take Drospil
The last 4 tablets in the 4th row of the strip are placebo tablets. If you forget to take one of these tablets, there will be no effect on the reliability of Drospil. Discard the forgotten placebo tablet.
If you forget to take an active pink tablet (tablets numbered 1 to 24 on the blister strip), follow the instructions below:

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

The risk of incomplete contraceptive protection is higher if you missed a pink tablet at the beginning or end of the strip. Therefore, follow the instructions below (see also the diagram below):

• More than 1 tablet missed in the current strip Contact your doctor.
• One tablet missed between days 1–7 (first row)

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time on the same day. Then continue taking the following tablets at your usual time and use additional contraceptive methods for the next 7 days, for example a condom. If you had sexual intercourse during the week before missing the tablet, there is a possibility of pregnancy. In this case, contact your doctor.

• One tablet missed between days 8–14 (second row)

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time on the same day. Then continue taking the following tablets at your usual time. Protection against pregnancy is not reduced, and you do not need to take additional precautions.

• One tablet missed between days 15–24 (third or fourth row)

You have two options:

1. Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time on the same day. Then continue taking the following tablets at your usual time. Instead of taking the white placebo tablets from the current pack, discard them and immediately start a new strip (the day you start the new strip does not matter).

It is very likely that you will have a menstrual bleed at the end of the second pack – during the intake of the white placebo tablets – but you may experience light bleeding or spotting during the intake of the tablets from the second pack.

2. You may also stop taking the active pink tablets and directly take the 4 white placebo tablets (before taking the placebo tablets, note down the day on which you missed the tablet). If you wish to start a new pack on the same day of the week as usual, take the placebo tablets for fewer than 4 days.

If you follow either of the two recommendations above, you will remain protected against pregnancy.

• If you have missed several tablets from the current pack and do not experience bleeding during the placebo tablet days, you may be pregnant. Contact your doctor before starting a new pack.

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

Delaying menstruation: what you need to know
Although not a recommended practice, it is possible to delay menstruation by not taking the white placebo tablets in the 4th row, and instead immediately starting a new strip of Drospil, continuing until the end of that strip. You may experience light bleeding or spotting during the use of the second strip. After finishing the second strip, take the 4 white tablets in the 4th row. Then start a new strip.
You may wish to consult your doctor before deciding to delay your menstrual period.

Changing the first day of menstruation: what you need to know
If you take the tablets as instructed, your menstrual period will begin during the days when you take the placebo tablets. If you wish to change the day your period starts, reduce the number of placebo days – i.e. the days when you take the white placebo tablets – (but never increase them – 4 days is the maximum!). For example, if you usually start taking the placebo tablets on Friday, and you wish to shift it to Tuesday (3 days earlier), start the new pack 3 days earlier than usual. During this time, you may not experience any bleeding. Subsequently, you may notice light bleeding or spotting.
If you are unsure about what to do, contact your doctor for advice.

If you stop treatment with Drospil
You may stop taking Drospil at any time. If you do not wish to become pregnant, consult your doctor about other reliable methods of birth control. If you wish to become pregnant, stop taking Drospil and wait until you have a natural menstrual period before trying to conceive. This will make it easier to calculate the expected date of delivery.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Drospil may cause side effects, although not all women will experience them.
If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think could be due to Drospil, inform your doctor.
An increased risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)) exists in all women taking combined hormonal contraceptives. For more detailed information on the different risks associated with taking combined hormonal contraceptives, see section 2 “What you should know before using Drospil”.

The following list includes side effects that have been associated with the use of Drospil:

• Common side effects (may occur in between 1 and 10 users out of 100):
  o mood swings, or headache, or nausea, or breast pain, or menstrual cycle disorders, such as menstrual irregularities, absence of menstruation

• Uncommon side effects (may occur in between 1 and 10 users out of 1,000):
  o depression, nervousness, drowsiness or dizziness, tingling sensations or migraine, varicose veins, increased blood pressure or stomach ache, vomiting, indigestion, intestinal gas, stomach inflammation, diarrhoea or acne, itching, skin rash or general malaise and pain, for example back pain, limb pain, muscle cramps
  o fungal vaginal infections, pelvic pain, breast enlargement, benign breast nodules, uterine/vaginal bleeding (which generally decreases during continued treatment), genital discharge, hot flushes, vaginal inflammation (vaginitis), menstrual disorders, painful menstruation, brief menstruation, very heavy menstruation, vaginal dryness, abnormal cervical smear, decreased interest in sex
  o lack of energy, increased sweating, fluid retention
  o weight gain

• Rare side effects (may occur in between 1 and 10 users out of 10,000):
  o candidiasis (a fungal infection)
  o anaemia, increased number of platelets in the blood
  o allergic reaction
  o hormonal disorders (endocrine disorders)
  o increased appetite, loss of appetite, unusually high potassium levels in the blood, unusually low sodium levels in the blood
  o inability to achieve orgasm, insomnia, dizziness, tremor
  o eye disorders, for example eyelid inflammation, dry eyes
  o abnormally rapid heartbeat
  o inflammation of a vein, epistaxis (nosebleed), fainting
  o abdominal swelling, intestinal disorders, feeling of fullness, gastric hernia, fungal infection of the mouth, constipation, dry mouth
  o pain in the bile ducts or gallbladder, gallbladder inflammation
  o yellow-brown skin patches, eczema, hair loss, acne-like skin inflammation, dry skin, skin inflammation with nodules, excessive hair growth, skin disorders, stretch marks, skin inflammation, photosensitive skin inflammation, skin nodules
  o sexual difficulties or pain during sexual intercourse, vaginal inflammation (vulvovaginitis), post-coital bleeding, withdrawal bleeding, breast cysts, increased number of breast cells (hyperplasia), malignant breast nodules, abnormal growth of the mucosal surface of the cervix, thinning or deterioration of the uterine lining, ovarian cysts, uterine enlargement
  o general feeling of malaise
  o weight loss
  o harmful blood clots in a vein or an artery, for example:

  • o in a leg or foot (DVT)
  • o in a lung (PE)
  • o heart attack
  • o stroke
  • o mini-stroke or temporary symptoms similar to stroke, known as transient ischaemic attack (TIA)
  • o blood clots in the liver, stomach/intestines, 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).

The following side effects have also been reported, although their frequency cannot be estimated from the available data: hypersensitivity, erythema multiforme (skin rash with redness or target-shaped ulcers).

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
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 Drospil

Keep this medicine out of the sight and reach of children.
Expiry date
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.
This medicine does not require any special storage conditions.
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 Drospil contains

• The active substances are ethinylestradiol and drospirenone. Each pink film-coated active tablet contains 0.02 mg of ethinylestradiol and 3 mg of drospirenone.

The white film-coated tablets do not contain any active substances.

• Other components are:

Pink film-coated active tablets:
Tablet core: monohydrate lactose, pregelatinized starch (maize), povidone (E1201),
sodium croscarmellose, polysorbate 80, magnesium stearate (E572).
Tablet coating: Polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc,
yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
White film-coated inactive tablets:
Tablet core: anhydrous lactose, povidone (E1201), magnesium stearate (E572).
Tablet coating: Polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

Description of the appearance of Drospil and package contents

• Each Drospil blister pack contains 24 pink film-coated active tablets placed in rows 1, 2, 3 and 4 of the strip, and 4 placebo film-coated tablets placed in row 4.
• Both the pink and white tablets of Drospil are film-coated tablets, meaning the tablet core is coated.
• Drospil is available in boxes containing 1, 3, 6 and 13 blisters, each blister containing 28 (24+4) tablets.

It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
EFFIK Italia S.p.A
Via dei Lavoratori, 54
20092 Cinisello Balsamo, Milano
Manufacturer
Laboratorios León Farma, S.A.
C/La Vallina s/n, Poligono Industrial de Navatejera,
24008 Villaquilambre, León, Spain

Belgium Droseffik 20 0.02 mg/3 mg, film-coated tablets
Spain Drospil 3 mg/0.02 mg film-coated tablets
Italy Drospil 0.02 mg/3 mg film-coated tablets
Luxembourg Drospil 3 mg/0.02 mg film-coated tablets Effik
Portugal Droseffik 3 mg/0.02 mg film-coated tablets