Read this entire package insert carefully before starting to take this medication, as it contains important information for you
Keep this package insert, as you may need to refer to it again.
If you have any questions, consult your doctor, pharmacist, or nurse.
This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
Important Information About Combined Hormonal Contraceptives (CHCs):
They are one of the most reliable reversible contraceptive methods if used correctly.
They slightly increase the risk of blood clots in veins and arteries, especially in the first year or when restarting use of a CHC after a pause of 4 weeks or more.
Be aware and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood Clots”).
Do not take Ethinylestradiol/Drospirenone Exeltis
Warnings and Precautions
Blood Clots
Ethinylestradiol/Drospirenone Exeltis and Cancer
Spotting Between Periods
What to Do If You Do Not Have Your Period During the Placebo Days
Other Medications and Ethinylestradiol/Drospirenone Exeltis
What to Do If You Take More Ethinylestradiol/Drospirenone Exeltis Than You Should
What to Do If You Forget to Take Ethinylestradiol/Drospirenone Exeltis
What to Do in Case of Severe Vomiting or Diarrhea
Delayed Menstrual Period: What You Should Know
Change in the First Day of Your Menstrual Period: What You Should Know
What to Do If You Stop Taking Ethinylestradiol/Drospirenone Exeltis
Possible Adverse Effects
Storage of Ethinylestradiol/Drospirenone Exeltis
Contents of the Package and Additional Information
1. What is Etinilestradiol/Drospirenona Exeltis and what is it used for
Ethinylestradiol/drospirenona is a contraceptive pill used to prevent pregnancy.
Each of the 24 pink tablets contains a small amount of two different female hormones, called drospirenona and ethinylestradiol.
The 4 white tablets do not contain active ingredients and are also known as placebo tablets.
Contraceptives that contain two hormones are known as combined contraceptives.
2. What you need to know before starting Etinilestradiol/Drospirenona Exeltis
General Considerations
Before starting etinilestradiol/drospirenona, read the information about 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 etinilestradiol/drospirenona, your doctor will ask you some questions about your personal and family medical history. The doctor will also measure your blood pressure and, depending on your personal situation, may perform some other tests.
In this prospectus, several situations are described in which you should interrupt the use of etinilestradiol/drospirenona or in which the reliability of etinilestradiol/drospirenona may decrease. In these situations, you should not have sexual intercourse or should take additional non-hormonal contraceptive precautions, for example, use a condom or another barrier method. Do not use the rhythm or temperature method. These methods may not be reliable since etinilestradiol/drospirenona alters the monthly changes in body temperature and cervical mucus.
Ethinylestradiol/Drospirenona, like other hormonal contraceptives, does not protect against HIV (AIDS) or any other sexually transmitted disease.
Do Not Take Etinilestradiol/DrospirenonaExeltis
You should not take etinilestradiol/drospirenona 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 had at any time) a blood clot in a leg vein (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs.
If you have ever had a heart attack or a stroke.
If you have (or have had at any time) 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 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 have (or have had at any time) a type of migraine called “migraine with aura”.
If you have (or have had at any time) a liver disease and your liver function has not normalized yet.
If your kidneys do not function properly (renal failure).
If you have (or have had in the past) a liver tumor.
If you have (or have had in the past) or are suspected of having breast cancer or cancer of the reproductive organs.
If you have vaginal bleeding of unknown cause.
If you need surgery or if you spend a lot of time without getting up (see section 2 “Blood Clots”).
If you are allergic to etinilestradiol or drospirenona, or any of the other components of this medication (including in section 6). This may manifest as itching, rash, or inflammation.
Do not take etinilestradiol/drospirenona if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section “Other Medications and Etinilestradiol/Drospirenona Exeltis”).
Children and Adolescents
This medication is not indicated for use in women who have not yet had their first menstrual period.
Women of Advanced Age
This medication is not indicated for use after menopause.
Women with Liver Insufficiency
Do not take this medication if you have liver disease. See sections “Do Not Take Etinilestradiol/Drospirenona Exeltis” and “Warnings and Precautions”.
Women with Renal Insufficiency
Do not take this medication if you are suffering from kidney dysfunction or acute renal failure. See sections “Do Not Take Etinilestradiol/Drospirenona Exeltis” and “Warnings and Precautions”.
Warnings and Precautions
When to Consult Your Doctor?
Seek Urgent Medical Assistance
If you notice possible signs of a blood clot that may indicate you are suffering from a blood clot in a leg vein (deep vein thrombosis), a blood clot in the lungs (pulmonary embolism), a heart attack, or a stroke (see section “Blood Clots” below).
For a description of the symptoms of these serious adverse effects, see “How to Recognize a Blood Clot”.
In some situations, you should be particularly careful while using etinilestradiol/drospirenona or any other combined hormonal contraceptive and may need to have regular check-ups with your doctor.
Consult Your Doctor if Any of the Following Conditions Develop or Worsen While You Are Using Etinilestradiol/Drospirenona.
Consult your doctor before taking etinilestradiol/drospirenona:
If a close relative has had breast cancer.
If you have cancer.
If you have any liver or gallbladder disease.
If you have other kidney problems and are taking medications that increase blood potassium levels.
If you have diabetes.
If you have depression.
If you have inflammatory bowel disease (Crohn's disease or ulcerative colitis).
If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).
If you have sickle cell anemia (a genetic disorder of red blood cells).
If you have epilepsy (see “Other Medications and Etinilestradiol/Drospirenona Exeltis”).
If you have systemic lupus erythematosus (SLE, a disease that affects your natural defense system).
If you have high levels of fat in the blood (hypertriglyceridemia) or a 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 getting up (see section 2 “Blood Clots”).
If you recently gave birth, you are at higher risk of blood clots. Ask your doctor when you can start taking etinilestradiol/drospirenona after childbirth.
If you have superficial thrombophlebitis (inflammation of veins under the skin).
If you have varicose veins.
If you have diseases that appeared for the first time during pregnancy or in a previous use of sex hormones (for example, hearing loss), a blood disorder called porphyria, skin rash with blisters during pregnancy (herpes gestationalis), a nervous disorder characterized by involuntary movements (Sydenham's chorea).
If you have high blood pressure during treatment, which is not controlled with medications.
If you have or have had melasma (brownish patches on the skin, especially on the face). In this case,avoid direct exposureto the sun or ultraviolet rays while taking this medication.
If you have hereditary angioedema. If you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat, and/or difficulty swallowing or urticaria, with possible difficulty breathing,contact a doctor immediately. Products containing estrogens can induce or worsen the symptoms of hereditary or acquired angioedema.
Blood Clots
The use of a combined hormonal contraceptive like etinilestradiol/drospirenona increases your risk of suffering a blood clot compared 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 ATE).
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 global risk of a harmful blood clot due to etinilestradiol/drospirenona is small.
How to Recognize a Blood Clot
Seek Urgent Medical Assistanceif you notice any of the following signs or symptoms.
Do you experience any of these signs?
What could you be suffering from?
Swelling of a leg or foot or along a vein in the leg or foot, especially when accompanied by:
Pain or sensitivity in the leg, which may only be noticeable when standing up or walking.
Increased temperature in the affected leg.
Change in skin color of the leg, for example, if it becomes pale, red, or blue.
Deep vein thrombosis
Sudden shortness of breath without a known cause or rapid breathing.
Sudden coughing without a clear cause, which may bring up blood.
Sudden chest pain, which may worsen with deep breathing.
Intense dizziness or fainting.
Irregular or rapid heartbeat.
Severe stomach pain.
Pulmonary embolism
Symptoms that occur more frequently in one eye:
Sudden loss of vision or
Blurred vision without pain, which may progress to loss of vision.
Retinal vein thrombosis (blood clot in the eye)
Chest pain, discomfort, pressure, or heaviness.
Sensation of oppression or fullness in the chest, arm, or under the sternum.
Sensation of fullness, indigestion, or choking.
Upper body discomfort that radiates to the back, jaw, throat, arm, and stomach.
Sweating, nausea, vomiting, or dizziness.
Extreme weakness, anxiety, or shortness of breath.
Irregular or rapid heartbeat.
Heart attack
Sudden weakness or numbness in one side of the face, arm, or leg, especially on one side of the body.
Sudden confusion, difficulty speaking, or understanding.
Sudden difficulty seeing in one eye or both eyes.
Sudden difficulty walking, dizziness, loss of balance, or coordination.
Sudden severe headache, intense or prolonged without a known cause.
Sudden loss of consciousness or fainting, with or without convulsions.
Stroke
Swelling and slight blue discoloration of an extremity.
Severe stomach pain (abdominal pain).
Blood clots that block other blood vessels.
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). 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 Higher?
The risk of a blood clot in a vein is higher during the first year of taking a combined hormonal contraceptive for the first time. The risk may be higher if you restart taking a combined hormonal contraceptive (the same medication or a different one) 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 etinilestradiol/drospirenona, 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 global risk of a blood clot in the leg or lung (DVT or PE) with etinilestradiol/drospirenona 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 a combined hormonal contraceptive containing drospirenona like etinilestradiol/drospirenona, 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).
Risk of Developing a Blood Clot in a Year
Women whodo not usea combined hormonal contraceptive and are not pregnant
2 out of every 10,000 women
Women who use a combined hormonal contraceptive containinglevonorgestrel, noretisterone, or norgestimato
5-7 out of every 10,000 women
Women who use etinilestradiol/drospirenona
9-12 out of every 10,000 women
Factors That Increase Your Risk of a Blood Clot in a Vein
Your risk of a blood clot is small, but some conditions increase your risk. Your risk is higher:
If you are overweight (body mass index (BMI) of 30 kg/m2 or higher).
If a close relative has had a blood clot in a leg, lung, or other organ at a young age (before about 50 years). In this case, you may have an inherited blood clotting disorder.
If you need surgery or spend a lot of time without getting up due to an injury or disease, or if you have a leg cast. You may need to stop taking etinilestradiol/drospirenona for several weeks before surgery or while you have limited mobility. If you need to stop taking etinilestradiol/drospirenona, ask your doctor when you can start taking it again.
As you get older (especially over about 35 years).
If you have given birth recently.
Your risk of a blood clot increases the more conditions you have.
Long flights (over 4 hours) may temporarily increase your 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 mentioned above, even if you are unsure. Your doctor may decide that you should stop taking etinilestradiol/drospirenona.
If any of the conditions mentioned above change while you are using etinilestradiol/drospirenona, 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 etinilestradiol/drospirenona is very small, but it may increase:
With age (over about 35 years).
If you smoke.
If you are overweight.
If you have high blood pressure.
If a close relative has had a heart attack or stroke at a young age (before about 50 years). In this case, you may also be at higher 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 problem (valve disorder, irregular heart rhythm called atrial fibrillation).
If you have diabetes.
If you have one or more of these conditions or if any of them are particularly severe, your risk of a blood clot may be increased even further.
If any of the conditions mentioned above change while you are using etinilestradiol/drospirenona, 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.
Ethinylestradiol/Drospirenona Exeltis 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 using 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 have regular breast examinations and to see 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. See your doctor if you experience unusual abdominal pain or swelling (which may be due to liver enlargement).
Bleeding Between Periods
During the first few months of taking etinilestradiol/drospirenona, you may experience unexpected bleeding (bleeding outside of the days of placebo pill use). If this bleeding persists beyond a few months or starts after a few months, your doctor should investigate the cause.
What to Do If You Do Not Have Your Period During Placebo Days
If you have taken all the active pink pills correctly, have not had severe vomiting or diarrhea, and have not taken other medications, it is unlikely that you are pregnant. If your expected period does not arrive in two consecutive instances, you may be pregnant. See your doctor immediately. Do not start the next pack until you are sure you are not pregnant.
Mental Health Disorders
Some women who use combined hormonal contraceptives like etinilestradiol/drospirenona have reported depression or a depressed mood. Depression can be severe and, in some cases, may induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.
Other Medications and Etinilestradiol/Drospirenona Exeltis
Inform your doctor if you are taking, have taken recently, or may need to take any other medication, including herbal preparations. Also, inform any other doctor or dentist who prescribes another medication (or your pharmacist) that you are taking etinilestradiol/drospirenona. They may advise you to take additional contraceptive precautions (for example, condoms) and, if so, for how long or if you need to change another medication that you need.
Do not take etinilestradiol/drospirenona if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver function test results (elevated ALT enzyme levels).
Your doctor will prescribe another type of contraceptive before starting treatment with these medications.
Etinilestradiol/drospirenona administration can be resumed about 2 weeks after completing this treatment. See section “Do Not Take Etinilestradiol/Drospirenona Exeltis”.
Some medications may affect the blood levels of etinilestradiol/drospirenona and make it less effective as a contraceptive or may cause unexpected bleeding. This may occur with:
Medications used to treat:
Epilepsy (for example, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, felbamate, topiramate).
Tuberculosis (for example, rifampicin).
HIV and Hepatitis C (medications called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz).
Fungal infections (for example, griseofulvin, ketoconazole).
Arthritis, osteoarthritis (etoricoxib).
Pulmonary hypertension (bosentan).
And St. John's Wort.
If you are taking any of the medications mentioned above with etinilestradiol/drospirenona, you should take additional contraceptive precautions (for example, condoms) during and for 28 days after treatment.
Ethinylestradiol/drospirenona may affect the effect of other medications, for example:
Medications containing ciclosporin.
The antiepileptic lamotrigine (may lead to an increase in seizure frequency).
Your doctor may monitor your potassium levels in the blood if you are taking certain medications for heart problems (for example, diuretics).
Laboratory Tests
If you need a blood test, inform your doctor or the laboratory staff that you are taking a contraceptive, as combined oral contraceptives may affect the results of some tests.
Pregnancy and Breastfeeding
Pregnancy
If you are pregnant, do not take etinilestradiol/drospirenona. If you become pregnant during treatment with etinilestradiol/drospirenona, stop treatment immediately and contact your doctor. If you want to become pregnant, you can stop taking etinilestradiol/drospirenona at any time (see also “If You Interrupt Treatment with Etinilestradiol/Drospirenona Exeltis”).
Breastfeeding
Generally, it is not recommended to take etinilestradiol/drospirenona during the breastfeeding period. If you want to take the contraceptive while breastfeeding, consult your doctor.
If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medication.
Driving and Operating Machines
There is no information to suggest that the use of etinilestradiol/drospirenona has any effect on your ability to drive or operate machines.
Ethinylestradiol/Drospirenona Exeltis Contains Lactose and Sodium
If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.
This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.
3. How to Take Etinilestradiol/Drospirenona Exeltis
Follow exactly the administration instructions indicated by your doctor or pharmacist for this medication. If in doubt, consult your doctor or pharmacist again.
Each blister contains 24 active pink tablets and 4 white placebo tablets.
The two-colored etinilestradiol/drospirenona tablets are ordered. A blister contains 28 tablets.
Take one etinilestradiol/drospirenona tablet every day, with water if necessary. You can take the tablets with or without food, but approximately at the same time every day.
Do not confuse the tablets:take a pink tablet for the first 24 days and then a white tablet for the last 4 days. After that, you must start another blister immediately (24 pink tablets and then 4 white tablets). Therefore, there is no interval between two blisters.
Since the composition of the tablets is different, you must start with the tablet from the top left corner and take the tablets every day. Follow the direction of the arrows on the blister to take the tablets in the correct order.
Preparation of the blister
To help you follow the taking order, each etinilestradiol/drospirenona blister contains 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 etinilestradiol/drospirenona blister, where it is indicated "Start". 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 taking order of the tablets.
During the 4 days when you take the placebo tablets (the placebo days), you should have menstruation (the so-called withdrawal bleeding). It usually starts on the 2nd or 3rd day after taking the last active pink etinilestradiol/drospirenona tablet. After taking the last white tablet, start the next blister, even if menstruation has not finished. This means that you must start the next blister on the same day of the week that you started the previous one and menstruation by withdrawal should take place during the same days every month.
Since the composition of the tablets is different, you must start with the tablet from the top left corner and take the tablets every day. Follow the direction of the arrows on the blister to take the tablets in the correct order.
By taking etinilestradiol/drospirenona in this way, you are also protected against pregnancy during the 4 days when you take the placebo tablet.
When to start with the first blister
If you have not taken any hormonal contraceptive in the previous month.
Start taking etinilestradiol/drospirenona on the first day of your cycle (i.e. the first day of your menstruation). If you start etinilestradiol/drospirenona on the first day of your menstruation, you are immediately protected against pregnancy. You can also start on days 2-5 of your 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 must start taking etinilestradiol/drospirenona preferably on the day after taking the last active tablet (the last tablet that contains active ingredients) of your previous contraceptive, but at the latest on the day after the days without tablets (or after the last inactive tablet) of your previous contraceptive. When switching from a combined vaginal contraceptive ring or patch, follow your doctor's instructions.
Switching from a progestin-only method (progestin-only pill, injection, implant or intrauterine system (IUS) of progestins).
You can switch from the progestin-only pill on any day, from an implant or an IUS on the day of its removal; if it is an injection, when the next injection is due. In all cases, it is recommended that you use additional contraceptive methods (e.g. a condom) during the first 7 days of taking tablets.
After an abortion or at the end of your pregnancy.
Follow your doctor's recommendations.
After having a child.
After having a child, you can start taking etinilestradiol/drospirenona between 21 and 28 days after. If you start later, you must use one of the barrier methods (e.g. a condom) during the first 7 days of taking etinilestradiol/drospirenona.
If, after having a child, you have had sexual intercourse, before starting to take etinilestradiol/drospirenona, 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 etinilestradiol/drospirenona (again) after having a baby.
Read the section "Breastfeeding".
Consult your doctor if you have any doubts about when to start.
If you take more Etinilestradiol/Drospirenona Exeltis than you should
No serious cases of overdose of etinilestradiol/drospirenona 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 etinilestradiol/drospirenona tablets, or if you discover that a child has taken them, consult your doctor or pharmacist.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take Etinilestradiol/Drospirenona Exeltis
The last 4 tablets of the 4th row of the blister are placebo tablets. If you forget one of these tablets, there is no loss of contraceptive effect of etinilestradiol/drospirenona. You must discard the forgotten placebo tablet.
If you forget an active pink tablet (tablets 1-24 of the blister), follow these instructions:
If you are lateless than 24 hoursin taking some tablets, there is no reduction in protection against pregnancy. 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, there may be a reduction in protection against pregnancy. The more tablets you have forgotten, the higher the risk of pregnancy.
The risk of incomplete protection against pregnancy is maximum if you forget to take a pink tablet at the beginning or end of the blister. The following recommendations are given in this situation (see also the diagram below):
Forgetting more than one tablet from the blister
Consult your doctor.
Forgetting a tablet during days 1-7 (first row)
Take the forgotten tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the subsequent tablets at the usual time and use additional precautions, such as condoms, 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, even if this means taking two tablets at once. Continue taking the subsequent tablets at the usual time. There is no reduction in protection against pregnancy and you do not need to take additional precautions.
Forgetting a tablet between days 15 and 24 (third or fourth row)
You can choose between two options:
Take the forgotten tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the subsequent tablets at the usual time. Instead of continuing with the white placebo tablets, discard them and start taking the next blister (the day you take the first tablet will be different).
Probably, you will have your period at the end of the second blister – during the taking of the second blister – although you may experience spotting or bleeding during the taking of the second blister.
You can also interrupt the taking of active pink tablets and pass directly to the 4 placebo tablets (including the days you forgot to take the tablets,before taking the placebo tablets, note the day you forgot to take your tablet).If you want to start a new blister on your scheduled start day, take the placebo tablets for less than 4 days.
If you follow one of these two recommendations, you will remain protected against pregnancy.
If you have forgotten to take a tablet from a blister and you do not have your period during the placebo days, this may mean that you are pregnant. In this case, you must go to your doctor before continuing with the next blister.
The following diagram describes what to do if you forget to take a tablet:
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, in which case you may need to use additional protection (such as a condom) to avoid pregnancy. This is similar to what happens when you forget a tablet. After vomiting or diarrhea, you must take another active pink tablet from a reserve blister as soon as possible. If possible, take it within 24 hours after the usual time you take your contraceptive. If not possible or more than 24 hours have passed, follow the instructions in the section "If you forgot to take Etinilestradiol/Drospirenona Exeltis".
Delay of menstrual period: what you should know
Although not recommended, it is possible to delay your menstrual period if you do not take the white placebo tablets of the 4th row and start taking the tablets of a new etinilestradiol/drospirenona blister until the end of this new blister. You may experience spotting or bleeding during the use of the second blister. Finish this second blister by taking the 4 white placebo tablets of the 4th row. Then, start the next blister.
Before deciding to delay your menstrual period, you must ask your doctor.
Change of the first day of your menstrual period: what you should know
If you take the tablets as instructed, your menstrual period will startduring the placebo days. If you have to change this day, you can do so by reducingthe placebo days(the days when you take the white placebo tablets)– but never extending– 4 days is the maximum! For example, if you start the placebo days on a Friday and want to change it to a Tuesday (3 days earlier), you must start a new blister 3 days earlier than usual. It is possible that you will not have bleeding during these placebo days. Then, you may experience spotting or bleeding.
If you are unsure of what to do, consult your doctor.
If you interrupt the treatment with Etinilestradiol/Drospirenona Exeltis
You can stop taking etinilestradiol/drospirenona whenever you want. If you do not want to get pregnant, consult your doctor about other effective methods of birth control. If you want to get pregnant, it is recommended that you stop taking etinilestradiol/drospirenona and wait until your menstrual period before trying to get pregnant. This way, you will be able to calculate your estimated due date more easily.
If you have any other doubts about the use of this medication, ask your doctor or pharmacist.
4. Possible Adverse Effects
Like all medicines, this medicine may 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 change that you think may be due to etinilestradiol/drospirenona, 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 Etinilestradiol/Drospirenona Exeltis”.
Contact your doctor immediately if you experience any of the following angioedema symptoms: facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria, with possible difficulty breathing (also see section “Warning and precautions”).
If you experience any of the following side effects, you may need urgent medical attention. Stop taking etinilestradiol/drospirenona and see your doctor or go to the nearest hospital:
Rare(may affect up to 1 in 1,000 people):
Bile duct inflammation.
Hypersensitivity (allergic reactions with signs such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing, or urticaria with difficulty breathing).
Formation of blood clots in a vein or artery, for example:
In a leg or foot (i.e., deep vein thrombosis (DVT)).
In the lungs (i.e., pulmonary embolism (PE)).
Heart attack.
Stroke.
Mini-stroke or symptoms similar to transient ischemic attack (TIA).
Blood clots in the liver, stomach/intestine, kidneys, or eyes.
The likelihood of having a blood clot may be higher if you have other conditions that increase this risk (see section 2 for more information on conditions that increase the risk of blood clots and symptoms of a blood clot).
Conditions that may occur or worsen during pregnancy or previous use of the pill include:
SLE (systemic lupus erythematosus, a disease that affects the immune system).
Inflammation of the colon or other parts of the intestine (with signs such as bloody diarrhea, abdominal pain, or pain when passing stools) (Crohn's disease and ulcerative colitis).
Epilepsy.
Uterine fibroids (non-cancerous tumors that grow inside the uterine muscle).
Blood disorder (porphyria).
Blister-like skin rash (gestational herpes) during pregnancy.
Sydenham's chorea (a nervous system disease that causes sudden body movements).
Certain blood disorders that cause kidney damage (hemolytic uremic syndrome, with signs such as decreased urine output, blood in the urine, low red blood cell count, nausea, vomiting, confusion, and diarrhea).
Yellowing of the skin or white of the eyes due to bile duct obstruction (icteric cholestasis).
Additionally, liver cancer (see section 2 Etinilestradiol/Drospirenona Exeltis and cancer) and benign and malignant liver tumors (with signs such as abdominal swelling, weight loss, abnormal liver function, which may be seen in blood tests) and melasma (brownish-yellow skin patches, particularly on the face, known as "pregnancy spots"), which may be permanent, especially in women who have had melasma during pregnancy.
Vaginal yeast infection, lower abdominal pain (pelvic), breast enlargement, benign breast lumps, menstrual bleeding, vaginal discharge, hot flashes, vaginal inflammation (vaginitis), menstrual irregularities, painful menstruation, short menstrual periods, heavy menstrual periods, vaginal dryness, abnormal cervical smear, loss of interest in sex.
Fatigue, increased sweating, fluid retention (with signs such as facial swelling and extremity swelling).
Weight gain.
Rare(may affect up to 1 in 1,000 people):
Candidiasis (a fungal infection).
Anemia, increased platelet count in blood.
Allergic reaction.
Endocrine disorder.
Increased appetite, loss of appetite, potassium concentration in blood, abnormally high, sodium concentration in blood, abnormally low.
Lack of orgasm, insomnia.
Dizziness, tremors.
Eye disorders such as eyelid inflammation, dry eyes.
Abnormal heart rate.
Vein inflammation, nasal bleeding, fainting.
Abdominal swelling, intestinal disorder, feeling of flatulence, gastric hernia, fungal infection of the mouth, constipation, dry mouth.
Abdominal pain, bile duct pain, or gallbladder inflammation.
Eczema, hair loss, acne-like skin inflammation, dry skin, skin inflammation with swelling, excessive hair growth, skin disorders, skin tension marks, skin inflammation, skin inflammation due to photosensitivity, skin nodules.
Difficult or painful sex, vaginal inflammation (vulvovaginitis), post-coital bleeding, intermenstrual bleeding, breast cysts, breast hyperplasia, abnormal cervical mucosa growth, uterine contractions or atrophy, ovarian cysts, uterine enlargement.
General malaise.
Weight loss.
Unknown frequency(cannot be estimated from available data):
Multi-form erythema (skin rash with rosy patches or ulcers).
Reporting of side effects
If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 Vigilance 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.
5. Conservation of Ethinylestradiol/Drospirenona Exeltis
Keep this medication out of the sight and reach of children.
Store below 30°C.
Do not use this medication after the expiration date that appears on the packaging, after CAD or EXP. The expiration date is the last day of the month indicated.
Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.
6. Contents of the packaging and additional information
Ethinylestradiol/Drospirenona CompositionExeltis
The active principlesare ethinylestradiol and drospirenona.
Each pink-coated tablet contains 0.02 mg of ethinylestradiol and 3 mg of drospirenona.
The white-coated tablets do not contain active principles.
The other components are:
Pink-coated active tablets: lactose monohydrate, pregelatinized cornstarch, povidone (E-1201), croscarmellose sodium, polisorbate 80, magnesium stearate (E-572), polyvinyl alcohol (E-1203), titanium dioxide (E-171), macrogol, talc (E-553b), yellow iron oxide (E-172), red iron oxide (E-172), black iron oxide (E-172).
Each blister pack of Ethinylestradiol/Drospirenona Exeltis contains 24 pink-coated active tablets in the 1st, 2nd, 3rd, and 4th rows of the blister pack and 4 white-coated placebo tablets in the 4th row.
The Ethinylestradiol/Drospirenona Exeltis tablets, both pink and white, are film-coated tablets; the tablet core is coated.
Ethinylestradiol/Drospirenona Exeltis is available in boxes of 1, 3, 6, and 13 blister packs, each containing 28 (24 + 4) tablets.
Only some packaging sizes may be commercially available.
The detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/
Информация носит справочный характер и не является медицинской рекомендацией. Перед приёмом любых препаратов проконсультируйтесь с врачом. Oladoctor не несёт ответственности за медицинские решения, принятые на основе этого контента.
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