Prospect: information for the user

Drospil 0.02 mg/3 mg film-coated tablets EFG

etinilestradiol/drospirenona

Important things you should know about combined hormonal contraceptives (CHCs):

(CHCs):

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of suffering a blood clot in the veins and arteries, especially in the first year or when restarting use of a combined hormonal contraceptive after a pause of 4 weeks or more.
• Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).

Read this prospect thoroughly before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may have to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospect. See section 4.

• Drospil is a contraceptive used to prevent pregnancy.
• Each of the 24 pink tablets contains a small amount of two different female hormones, known as ethinyl estradiol and drospirenone.
• The 4 white tablets do not contain active ingredients and are called placebo tablets.
• Contraceptives that contain two hormones are called combined contraceptives.

General Considerations

Do Not Take Drospil

You should not use Drospil if you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you what other form of contraception would be more suitable.

• If you have (or have ever had) a blood clot in a leg vein (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE), or in other organs.
• If you know that you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.
• If you need surgery or if you spend a lot of time without standing up (see section “Blood Clots”).
• If you have ever had a heart attack or a stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, symptoms of a stroke).
• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:
• • Severe diabetes with vascular damage.
  • Very high blood pressure.
  • Very high levels of fat in the blood (cholesterol or triglycerides).
  • A condition called hyperhomocysteinemia.
• If you have (or have ever had) a type of migraine called “migraine with aura”.
• If you have (or have ever had) a liver disease and your liver function has not normalized yet.
• If your kidneys do not function well (renal insufficiency).
• If you have (or have ever had) a tumor in the liver.
• If you have (or have ever had), or if you suspect that you have breast cancer or cancer of the reproductive organs.
• If you have vaginal bleeding, whose cause is unknown.
• If you are allergic to ethinylestradiol or drospirenone, or to any of the other components of this medication (including in section 6). This may manifest as itching, rash, or inflammation.

You should not take Drospil if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section “Other Medications and Drospil”).

Additional Information on Special Populations

Children and Adolescents

Drospil is not indicated for use in women who have not yet had their first menstrual period.

Women of Advanced Age

Drospil is not indicated for useafter menopause.

Women with Liver Insufficiency

You should not take Drospil if you suffer from liver disease. See sections “Do Not Take Drospil” and “Warnings and Precautions”.

Women with Renal Insufficiency

You should not take Drospil if you are suffering from kidney dysfunction or acute renal failure. See sections “Do Not Take Drospil” and “Warnings and Precautions”.

Warnings and Precautions

Inform Your Doctor If You Suffer from Any of the Following Conditions

In some situations, you should take special care while using Drospil or any other combined hormonal contraceptive, and your doctor may need to examine you periodically. If the condition develops or worsens while you are using Drospil, you should also inform your doctor.

• if a close relative has or has ever had breast cancer
• if you have any liver or gallbladder disease
• if you have diabetes
• if you have depression
• if you have inflammatory bowel disease (Crohn's disease or ulcerative colitis).
• if you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
• if you have hemolytic uremic syndrome (HUS, a disorder of blood clotting that causes kidney insufficiency).
• if you have sickle cell anemia (a hereditary disease of red blood cells).
• if you have high levels of fat in the blood (hypertriglyceridemia) or known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
• if you need surgery or spend a lot of time without standing up (see section 2 “Blood Clots”).
• if you are at greater risk of blood clots after giving birth. You should ask your doctor when you can start taking Drospil after delivery.
• if you have superficial thrombophlebitis.
• if you have varicose veins.
• if you have epilepsy (see “Other Medications and Drospil”).
• if you have any disease that appeared for the first time during pregnancy or during a previous use of sex hormones (for example, hearing loss, a blood disorder called porphyria, skin rash with vesicles during pregnancy [herpes gestational], a nervous disorder characterized by involuntary movements [Sydenham's chorea]).
• if you have or have ever had brownish-yellow patches (chloasma), also called “pregnancy patches”, especially on the face. In this case,avoid direct exposure to the sunor ultraviolet rays.
• Seek immediate medical attention if you experience symptoms of angioedema, such as facial swelling, tongue, and/or throat swelling, difficulty swallowing, or potentially life-threatening urticaria. Medications containing estrogens can cause or worsen symptoms of hereditary and acquired angioedema.

Consult your doctor before taking Drospil.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Drospil increases your risk of suffering ablood clotcompared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• in veins (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE).
• in arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or TEA).

The recovery of blood clots is not always complete. In rare cases, there may be long-lasting or even fatal effects.

It is essential to remember that the overall risk of a harmful blood clot due to Drospil is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek Emergency Medical Assistanceif 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 veins (venous thromboembolism, VTE). However, these adverse effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from the leg and lodges in the lungs, it may cause a pulmonary embolism (PE).

• In very rare cases, a blood clot can form in a vein in another organ, such as the eye (retinal vein thrombosis).

When Is the Risk of a Blood Clot in a Vein Greater?

The risk of a blood clot in a vein is greater during the first year in which you take a combined hormonal contraceptive for the first time. The risk may be greater if you restart taking a combined hormonal contraceptive (the same medication or a different medication) after a break of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop taking Drospil, your risk of a blood clot returns to normal in a few weeks.

What Is the Risk of a Blood Clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of a blood clot in the leg or lung (DVT or PE) with Drospil is small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, 2 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone, or norgestimato, 5-7 will develop a blood clot in a year.
• Of every 10,000 women who use Drospil, 9-12 will develop a blood clot in a year.
• The risk of a blood clot will depend on your personal history (see “Factors That Increase Your Risk of a Blood Clot” below).

Factors That Increase Your Risk of a Blood Clot in a Vein

The risk of a blood clot with Drospil is small, but some conditions increase the risk. Your risk is greater:

• If you are overweight (body mass index (BMI) greater than 30 kg/m2).
• If a close relative has had a blood clot in the leg, lung, or other organ at a young age (i.e., before the age of 50). In this case, you may have an inherited disorder of blood clotting.
• If you need surgery or spend a lot of time without standing up due to an injury or illness or if you have your leg immobilized. You may need to interrupt the use of Drospil for several weeks before surgery or while you have less mobility. If you need to interrupt the use of Drospil, ask your doctor when you can start using it again.
• As you get older (especially over the age of 35).
• If you have given birth recently.

The risk of a blood clot increases the more conditions you have.

Long flights (over 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you have any of the conditions listed above, even if you are unsure. Your doctor may decide that you should interrupt the use of Drospil.

If any of the conditions listed above change while you are using Drospil, for example, a close relative experiences a blood clot without a known cause or you gain a lot of weight, inform your doctor.

BLOOD CLOTS IN AN ARTERY

What Can Happen If a Blood Clot Forms in an Artery?

Like a blood clot in a vein, a blood clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

Factors That Increase Your Risk of a Blood Clot in an Artery

It is essential to note that the risk of a heart attack or stroke due to Drospil is very small, but it may increase:

• With age (over the age of 35).
• If you smoke. When using a combined hormonal contraceptive like Drospil, you are advised to quit smoking. If you are unable to quit smoking and are over 35, 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 (less than 50). In this case, you may also be at greater risk of a heart attack or stroke.
• If you or a close relative has high levels of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart condition (valve disorder, arrhythmia called atrial fibrillation).
• If you have diabetes.

If you have more than one of these conditions or if any of them are particularly severe, the risk of a blood clot may be increased even further.

If any of the conditions listed above change while you are using Drospil, for example, you start smoking, a close relative experiences a blood clot without a known cause, or you gain a lot of weight, inform your doctor.

Drospil and Cancer

Cancer of the breast has been observed slightly more frequently in women using combined hormonal contraceptives, but it is not known whether this is due to the treatment. For example, it may be that more tumors are detected in women taking combined hormonal contraceptives because they are examined by their doctor more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential to undergo regular breast examinations, and you should consult your doctor if you notice any lumps.

In rare cases, benign tumors in the liver and, more rarely, malignant tumors have been reported in users of combined hormonal contraceptives. Consult your doctor if you experience severe abdominal pain.

Mental Health Disorders

Some women who use combined hormonal contraceptives like Drospil have reported depression or a depressed mood. Depression can be severe and sometimes may induce suicidal thoughts. If you experience mood changes and depressive symptoms, consult your doctor for additional medical advice as soon as possible.

Spotting Between Periods

During the first few months of taking Drospil, you may experience unexpected bleeding (bleeding outside of the days of the placebo pills). If these bleeding persists beyond a few months or starts after a few months, your doctor will investigate the cause.

What to Do If You Do Not Have Your Period During the Placebo Days

If you have taken all the pink pills correctly, have not experienced severe vomiting or diarrhea, and have not taken other medications, it is highly unlikely that you are pregnant.

If your expected period does not arrive in two consecutive instances, you may be pregnant. Consult your doctor immediately. Do not start the next pack until you are certain that you are not pregnant.

Other Medications and Drospil

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Always inform your doctor of any medications or herbal preparations you are taking. Also, inform any other doctor or dentist who prescribes another medication (or your pharmacist) that you are using Drospil. They may advise you to take additional contraceptive precautions (for example, condoms) and, if so, for how long, or if you need to modify the use of another medication that you need.

Some medications

• may affect the levels of Drospil in the blood
• may make itless effective in preventing pregnancy
• may cause unexpected bleeding.

This may occur with

• medications used to treat:

• epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine),
• tuberculosis (e.g., rifampicin),
• HIV and hepatitis C infections (the so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapina, efavirenz),
• fungal infections (e.g., griseofulvin, ketoconazole),
• arthritis, osteoarthritis (etoricoxib),
• high blood pressure in the pulmonary vessels (bosentan),

• herbal preparations containing St. John's Wort.

Drospil mayinfluence the effectof other medications, for example:

• medications containing ciclosporin,
• the antiepileptic lamotrigine (may lead to an increase in seizure frequency),
• theophylline (used to treat respiratory problems),
• tizanidine (used to treat muscle pain and/or cramps).

You should not take Drospil if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver function parameters in the blood (elevated ALT enzyme levels).

Your doctor will prescribe another type of contraceptive before starting treatment with these medications.

Drospil can be restarted approximately 2 weeks after the completion of this treatment. See the section “Do Not Take Drospil”.

Consult your doctor or pharmacist before using any medication.

Taking Drospil with Food and Drinks

Drospil can be taken with or without food, and with a little water if necessary.

Laboratory Tests

If you need a blood test, inform your doctor or the laboratory staff that you are taking a contraceptive, as hormonal contraceptives can affect the results of some tests.

Pregnancy, Lactation, and Fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

Pregnancy

If you are pregnant, you should not take Drospil. If you become pregnant while taking Drospil, you should stop taking it immediately and consult your doctor. If you want to become pregnant, you can stop taking Drospil at any time (see “Stopping Treatment with Drospil”).

Consult your doctor or pharmacist before using any medication.

Lactation

Generally, it is not recommended to take Drospil during lactation. If you want to take the contraceptive while breastfeeding, you should consult your doctor.

Consult your doctor or pharmacist before using any medication.

Driving and Operating Machines

There is no information to suggest that the use of Drospil has any effect on your ability to drive or operate machines.

Drospil Contains Lactose

If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication.

The pink pills of this medication contain less than 1 mmol of sodium (23 mg) per pill; this is, essentially “sodium-free”.

Each blister contains 24 active pink tablets and 4 white placebo tablets.

The two different types of colored tablets of Drospil are placed in order. A blister contains 28 tablets.

Take one tablet of Drospil every day, with water if necessary. You can take the tablets with or without food, but at approximately the same time every day.

Do not confuse the tablets:take a pink tablet every day for the first 24 days, followed by a white tablet for the last 4 days. Then you must start another pack immediately (24 pink tablets and 4 white tablets). Therefore, there is no break between two packs.

Since the composition of the tablets is different, you must start the pack with the tablet from the top left corner and take the tablets every day. Follow the direction of the arrows on the pack to take the tablets in the correct order.

Preparation of the blister:

To help you follow the taking order, each blister of Drospil includes 7 adhesive strips with the 7 days of the week. Choose the strip of the week that starts with the day you take the first tablet. For example, if you take your first tablet on a Wednesday, use the strip that starts with “WED”.

Stick the adhesive strip of the week on the top of the blister where it is indicated “Stick the adhesive strip here”, so that the first day is placed above the tablet marked with “1”. Now you will have a day marked above each tablet and you will be able to check visually if you have taken your tablet. The arrows indicate the order of taking the tablets.

During the 4 days when you take the white placebo tablets (placebo days), menstruation (menstrual bleeding) should take place. It usually starts on the 2nd or 3rd day after taking the last active pink tablet of Drospil. After taking the last white tablet, start the next pack, even if menstruation has not finished. This means that you must start the next pack on the same day of the week that you started the previous one and that menstrual bleeding should take place during the same days every month.

By taking Drospil in this way, you are also protected against pregnancy during the 4 days when you take placebo tablets.

When can you start with the first pack:

• If you have not taken any hormonal contraceptive in the previous month:

Start taking Drospil on the first day of the cycle (i.e. the first day of your menstruation). If you start taking Drospil on the first day of your menstruation, you are immediately protected against pregnancy. You can also start on days 2-5 of the cycle, but in that case you must use additional contraceptive methods (e.g. a condom) during the first 7 days.

• Switching from a combined hormonal contraceptive, combined vaginal contraceptive ring or patch:

You can start taking Drospil preferably on the day after taking the last active tablet (the last tablet that contains active ingredients) of your previous contraceptive, but no later than the day after the rest days (or after the last inactive tablet) of your previous contraceptive. When switching from a combined vaginal contraceptive ring or patch, follow the recommendations of your doctor.

• Switching from a progestin-only method (progestin-only pill, injection, implant or intrauterine system (IUS) of progestin):

You can switch from the progestin-only pill, any day. If it is an implant or an IUS, on the same day of its removal; if it is an injectable, on the day of the next injection). In all cases, it is recommended to use additional contraceptive methods (e.g. a condom) during the first 7 days of taking tablets.

• After an abortion:

Follow the recommendations of your doctor.

• After giving birth:

You can start taking Drospil between 21 and 28 days after giving birth. If you start later, you must use one of the so-called barrier methods (e.g. a condom) during the first 7 days of taking Drospil.

If, after giving birth, you have already had sexual intercourse, before starting to take Drospil you must be sure that you are not pregnant or wait for your next menstrual period.

• If you are breastfeeding and want to start taking Drospil:

Read the section “Breastfeeding”.

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

If you take more Drospil than you should:

No serious cases of overdose of Drospil have been reported.

If you take many tablets at once, you may feel unwell, vomit or have vaginal bleeding. This bleeding can occur even in girls who have not yet had their first menstrual period, if they accidentally take this medication.

If you have taken too many tablets of Drospil, or if you discover that a child has taken them, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20 indicating the medication and the amount taken.

If you forgot to take Drospil:

The last 4 tablets of the 4th row of the pack are placebo tablets. If you forget to take one of these tablets, you will not lose the contraceptive effect of Drospil. Dispose of the forgotten placebo tablet.

If you forgot to take an active pink tablet (tablets 1-24 of the pack), follow these guidelines:

• If you are lateless than 24 hoursin taking some tablets, the protection against pregnancy does not decrease. Take the tablet as soon as you remember and the subsequent tablets at the usual time.
• If you are latemore than 24 hoursin taking some tablets, the protection against pregnancy may decrease. The more tablets you have forgotten, the greater the risk of becoming pregnant.

The risk of incomplete protection against pregnancy is maximum if you forget to take a pink tablet at the beginning or end of the pack. The following recommendations are given in this situation (see the diagram below):

• Forgetting more than one tablet from the pack:

Consult your doctor.

• Forgetting a tablet during days 1-7 (first row):

Take the forgotten tablet as soon as you remember, although this means that you will have to take two tablets at once. Continue taking the subsequent tablets at the usual time and useadditional precautions, for example, a condom, during the next 7 days. If you have had sexual intercourse in the week before forgetting the tablet, you must know that there is a risk of pregnancy. In that case, consult your doctor.

• Forgetting a tablet during days 8-14 (second row):

Take the forgotten tablet as soon as you remember, although this means that you will have to take two tablets at once. Continue taking the subsequent tablets at the usual time. The protection against pregnancy does not decrease and you do not need to take additional precautions.

• Forgetting a tablet between days 15-24 (third or fourth row):

You can choose between two options:

Probably you will have bleeding at the end of the second pack – during the taking of the second pack – although you may experience spotting or bleeding similar to menstruation during the taking of the second pack.

If you follow one of these two recommendations, you will remain protected against pregnancy.

• If you have forgotten to take a tablet from a pack and you do not have menstruation during the placebo days, this may mean that you are pregnant. You must consult your doctor before starting the next pack.

What to do in case of vomiting or intense diarrhea:

If you have vomiting in the 3-4 hours after taking an active pink tablet, or if you have intense diarrhea, there is a risk that the active ingredients of the tablet will not be fully absorbed by your body. This is similar to forgetting a tablet. After vomiting or diarrhea, you must take a pink tablet from a reserve pack as soon as possible. If possible, take it within 24 hours after the usual time you take your contraceptive. If this is not possible or more than 24 hours have passed, follow the guidelines of the section “If you forgot to take Drospil”.

Delay of menstrual period: what you should know:

Although it is not recommended, you can delay your menstrual period if you do not take the white placebo tablets from the fourth row and start taking the tablets from a new pack of Drospil and finish it. You may experience spotting or bleeding similar to menstruation during the use of the second pack. Finish this second pack by taking the 4 white placebo tablets from the 4th row. Then, start the next pack.

Ask your doctor before deciding to delay your menstrual period.

Change of the first day of your period: what you should know:

If you take the tablets according to the instructions, your menstrual period will start duringthe placebo days. If you have to change this day, you can do it by reducing theplacebo days(the days when you take the white tablets) (but never increase them-4 days is the maximum!). For example, if you start taking the placebo tablets on a Friday and want to change it to a Tuesday (3 days earlier) you must start a new pack 3 days earlier than usual. It is possible that you will not have bleeding during these placebo days. After that, you may experience light bleeding or spotting similar to menstruation.

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

If you interrupt the treatment with Drospil:

You can stop taking Drospil whenever you want. If you do not want to become pregnant, consult your doctor about other effective methods of birth control. If you want to become pregnant, stop taking Drospil and wait until your menstrual period before trying to become pregnant. This way you will be able to calculate the estimated date of delivery more easily.

If you have any other questions about the use of thismedication,askyour doctor or pharmacist.

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 and persistent, or if you have any health changes that you think may be related to Drospil, consult your doctor.

All women taking combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section 2 “What you need to know before starting to take Drospil”.

Severe side effects

Immediately contact your doctor if you experience any of the following symptoms of angioedema: swelling of the face, tongue, and/or throat and/or difficulty swallowing or potentially difficulty breathing (also see the section “Warnings and precautions”).

The following side effects have been associated with the use of Drospil.

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

• mood changes,
• headaches,
• nausea,
• breast pain, problems with periods such as irregular periods, absence of periods.

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

• depression, nervousness, drowsiness,
• dizziness,tinglingand pins and needles,
• migraine, varicose veins, increased blood pressure,
• stomach pain, vomiting, indigestion, gas, intestinal inflammation, diarrhea,
• acne, itching, skin rash,
• discomfort and pain, such as back pain, limb pain, muscle cramps,
• vaginal yeast infection, lower abdominal pain (pelvic), breast enlargement, benign breast lumps, uterine/vaginal bleeding (which usually resolves during treatment), vaginal discharge, hot flashes, vaginal inflammation (vaginitis), menstrual problems, painful periods, shorter periods, heavier periods, vaginal dryness, abnormal cervical smear, loss of interest in sex,
• lack of energy, increased sweating, fluid retention,
• weight gain.

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

• candidiasis (a fungal infection),
• anemia, increased platelet count in the blood,
• allergic reaction,
• endocrine disorder,
• increased appetite, loss of appetite, abnormally high potassium levels in the blood, abnormally low sodium levels in the blood,
• absence of orgasm, insomnia,
• dizziness, tremors,
• eye disorders, such as eyelid inflammation, dry eyes,
• unusually rapid heart rate,
• inflammation of a vein, nasal bleeding, fainting,
• abdominal enlargement, intestinal disorder, feeling of flatulence, gastric hernia, fungal infection of the mouth, constipation, dry mouth,
• pain in the bile ducts or gallbladder, inflammation of the gallbladder,
• brownish-yellow skin patches, eczema, hair loss, skin inflammation with acne-like appearance, skin inflammation with swelling, excessive hair growth, skin disorders, skin marks, skin inflammation, skin inflammation due to photosensitivity, skin nodules,
• difficult or painful sex, vaginal inflammation (vulvovaginitis), post-coital bleeding, bleeding due to deprivation, breast cysts, increased number of breast cells (hyperplasia), malignant breast lumps, abnormal growth of the surface mucosa of the cervix, cervical atrophy or loss of the uterine lining, ovarian cysts, uterine enlargement,
• unwellness,
• weight loss,
• harmful blood clots in a vein or artery, for example:

• In a leg or foot (i.e., DVT).
• In a lung (i.e., PE).
• Heart attack.
• Stroke.
• Mild stroke or transient symptoms similar to a stroke, known as a transient ischemic attack (TIA).
• Blood clots in the liver, stomach/intestine, kidneys, or eye.

The following side effects have also been reported, but their frequency cannot be estimated from the available data: hypersensitivity,erythema multiforme(skin rash with circular red patches or ulcers).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and unused medications at the SIGRE Collection Pointat the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Drospil

• The active principles are ethinylestradiol and drospirenone. Each film-coated tablet of color pink contains0.02milligrams of ethinylestradiol and 3 milligrams of drospirenone. The film-coated tablets of color white do not contain active principle.
• The other components are:

Film-coated active tablets of color pink:

Tablet core: lactose monohydrate, pregelatinized cornstarch, povidone (E1201), croscarmellose sodium, polisorbate 80, magnesium stearate (E572).

Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).

Film-coated placebo white tablets:

Tablet core: anhydrous lactose, povidone (E1201), magnesium stearate (E572).

Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

Appearance of the product and contents of the package

• Each blister of Drospil contains 24 film-coated active tablets of color pink, in the 1st, 2nd, 3rd and 4th row of the blister, and 4 film-coated placebo tablets of color white, in the 4th row.
• Drospil tablets (pink and white) are film-coated tablets; the tablet core is coated.
• Drospil is available in boxes containing 1, 3, 6 and 13 blisters, each with 28 (24+4) tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Effik Laboratories, S.A.

C/ San Rafael, 3

28108 Alcobendas, Madrid

Spain

Responsible for manufacturing

León Farma Laboratories, S.A.

Navatejera Industrial Estate

La Vallina s/n

24193 Villaquilambre, León

Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Bélgica:Droseffik 0.02 mg/3 mg filmomhulde tabletten

Spain:Drospil 0.02 mg/3 mg film-coated tablets EFG

Italy:Drospil 0.02 mg/3 mg compresse rivestite con film

Luxemburg:Droseffik 0.02 mg/3 mg comprimés pelliculés

Portugal:Droseffik 3 mg/0.02 mg comprimidos revestidos por película

Last review date of this leaflet: November 2022

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.