Drosurelle diario 0.02 mg/3 mg comprimidos recubiertos con pelicula efg
Introduction
Package Insert: Information for the User
Drosurelle Daily 0.02 mg/3 mg Film-Coated Tablets EFG
ethinylestradiol/drospirenone
Read this package insert carefully before starting to take this medicine, as it contains important information for you.
- Keep this package insert, as you may need to read it again.
- If you have any doubts, consult your doctor or pharmacist.
- This medicine has been prescribed only for you, and you should not give it 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 things you should know about combined hormonal contraceptives (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”).
1. What is Drosurelle Diario and what is it used for
- Drosurelle Diario is a contraceptive and is used to prevent pregnancy.
- Each of the 21 active tablets, of pink color, contains a small amount of two different female hormones, called ethinylestradiol and drospirenone.
- The 7 white tablets, which do not contain active principles, are called placebo tablets.
- Contraceptives that contain two hormones are called combined contraceptives.
2. What you need to know before starting Drosurelle Diario
General Considerations
Before starting to use Drosurelle Diario, 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 to take Drosurelle Diario, your doctor will ask you some questions about your personal and family medical history. Your doctor will also measure your blood pressure and, depending on your health status, perform other tests.
In this prospectus, several situations are described in which you should interrupt the use of Drosurelle Diario, or in which the effect of Drosurelle Diario may decrease. In these situations, you should not have sexual intercourse or take additional non-hormonal contraceptive precautions, for example, the use of a condom or another barrier method. Do not use the rhythm or basal body temperature method. These methods may not be reliable because Drosurelle Diario alters the monthly changes in body temperature and cervical mucus.
Drosurelle Diario, like other hormonal contraceptives, does not protect against HIV (AIDS) or any other sexually transmitted disease.
Do not take Drosurelle Diario
You should not use Drosurelle Diario 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 2 “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, temporary 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 yet normalized.
- If your kidneys do not function well (renal insufficiency).
- If you have (or have ever had) a liver tumor.
- 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, the cause of which 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 cause itching, rash, or inflammation.
- Do not take Drosurelle Diario 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 Drosurelle Diario”).
Additional Information on Special Populations
Children and Adolescents
Drosurelle Diario is not indicated for use in women who have not yet had their first menstrual period.
Women of Advanced Age
Drosurelle Diario is not indicated for use after menopause.
Women with Liver Insufficiency
Do not take Drosurelle Diario if you suffer from liver disease. See sections “Do not take Drosurelle Diario” and “Warnings and Precautions”.
Women with Renal Insufficiency
Do not take Drosurelle Diario if you are suffering from kidney dysfunction or acute renal failure. See sections “Do not take Drosurelle Diario” and “Warnings and Precautions”.
Warnings and Precautions
When should you consult your doctor?
Seek urgent medical assistance
- If you notice possible signs of a blood clot that may indicate that you are suffering from a blood clot in the leg (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”.
Inform your doctor if you suffer from any of the following conditions
In some situations, you should take special care while using Drosurelle Diario or any other combined hormonal contraceptive, and you may need to have regular check-ups with your doctor.If the condition develops or worsens while you are using Drosurelle Diario, you should also inform your doctor.
- If a close relative has or has had breast cancer.
- If you have any liver or gallbladder disease.
- If you have diabetes.
- If you have depression. Some women who use hormonal contraceptives like Drosurelle Diario 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, contact your doctor for additional medical advice as soon as possible.
- 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 blood clotting disorder 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 a 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 have recently given birth, you are at higher risk of blood clots. Ask your doctor when you can start taking Drosurelle Diario after childbirth.
- If you have superficial thrombophlebitis (inflammation of the veins under the skin).
- If you have varicose veins.
- If you have epilepsy (see “Other Medications and Drosurelle Diario”).
- If you have any disease that may have 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 blisters during pregnancy (herpes gestationalis), a nervous disorder characterized by involuntary movements (Sydenham's chorea)).
- If you have or have had melasma (a skin discoloration, especially on the face and neck, known as “pregnancy mask”). In that case, you should avoid direct exposure to the sun or ultraviolet rays.
- Consult your doctor immediately 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 the symptoms of hereditary and acquired angioedema.
Blood Clots
The use of a combined hormonal contraceptive like Drosurelle Diario increases your risk of blood clots 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 overall risk of a blood clot due to Drosurelle Diario is small.
How to Recognize a Blood Clot
Seek urgent medical assistance if you notice any of the following signs or symptoms.
Do you experience any of these signs? | What could you be suffering from? |
| Deep vein thrombosis |
If you are unsure, consult a doctor, as some of these symptoms, such as coughing or shortness of breath, can be confused with a milder condition like a common cold. | Pulmonary embolism |
Symptoms that occur more frequently in one eye:
| Retinal vein thrombosis (blood clot in the eye) |
| Heart attack |
Sometimes, the symptoms of a stroke may be brief, with almost immediate and complete recovery, but you should still seek medical assistance as you may be at risk of another stroke. | Stroke |
| 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 thrombosis). 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 lung, it may cause a pulmonary embolism.
- 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 Drosurelle Diario, 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 Drosurelle Diario 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 drospirenone like Drosurelle Diario, 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 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 Drosurelle Diario | 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) 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 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 standing up due to an injury or illness or if you have a leg cast. You may need to interrupt the use of Drosurelle Diario for several weeks before the surgical procedure or while you have reduced mobility. If you need to interrupt the use of Drosurelle Diario, ask your doctor when you can start using 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 (more than 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 listed above, even if you are unsure. Your doctor may decide that you should interrupt the use of Drosurelle Diario.
If any of the conditions listed above change while you are using Drosurelle Diario, 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 Drosurelle Diario 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 (less than about 50 years). In this case, you may also be at higher risk of a heart attack or stroke.
- If you have 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 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 listed above change while you are using Drosurelle Diario, 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.
Drosurelle Diario and Cancer
Cancer of the breast has been observed slightly more frequently in women who use 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 who take 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 you should consult your doctor if you notice any lump.
In rare cases, benign tumors in the liver and, more rarely, malignant tumors have been reported in users of contraceptives. Consult your doctor if you experience severe abdominal pain.
Spotting
During the first few months of taking Drosurelle Diario, you may experience unexpected bleeding (bleeding outside the week when you take the white pills). If this bleeding persists beyond a few months or starts after a few months, your doctor will investigate what is wrong.
What to do if you do not have your period during the placebo days
If you have taken all the active pills correctly, are not experiencing vomiting or severe diarrhea, and have not taken other medications, it is very 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 sure you are not pregnant.
Other Medications and Drosurelle Diario
Inform your doctor if you are taking, have taken recently, or may need to take any other medication or herbal preparations. You should also inform any other doctor or dentist who prescribes another medication (or your pharmacist) that you are taking Drosurelle Diario. They may advise you to take additional contraceptive precautions (for example, condoms) and, if so, for how long, or to modify the use of another medication that you need.
Some medications:
- may affect the levels of Drosurelle Diario in the blood,
- may make it less effective in preventing pregnancy,
- may cause unexpected bleeding.
This may occur with:
- medications used in the treatment of:
- epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine),
- tuberculosis (e.g., rifampicin),
- infection with HIV and hepatitis C (the so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz),
- infections with fungi (e.g., griseofulvin, ketoconazole),
- arthritis, osteoarthritis (etoricoxib),
- high blood pressure in the blood vessels of the lungs (bosentan).
- herbal preparations containing St. John's Wort.
Drosurelle Diario may affect the effect of 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).
Do not take Drosurelle Diario 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 enzyme levels (elevated ALT). Your doctor will prescribe another type of contraceptive before starting treatment with these medications. Drosurelle Diario can be taken again approximately 2 weeks after completing this treatment. See the section “Do not take Drosurelle Diario”
Consult your doctor or pharmacist before using any medication.
Taking Drosurelle Diario with Food and Drinks
Drosurelle Diario 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 may affect the results of some tests.
Pregnancy
If you are pregnant, do not take Drosurelle Diario. If you become pregnant during treatment with Drosurelle Diario, stop treatment immediately and consult your doctor. If you want to become pregnant, you can stop taking Drosurelle Diario at any time (see “Stopping Treatment with Drosurelle Diario”).
Consult your doctor or pharmacist before using any medication.
Breastfeeding
Generally, it is not recommended to take Drosurelle Diario during the breastfeeding period. 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 Drosurelle Diario has any effect on your ability to drive or operate machinery.
Drosurelle Diario 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 23 mg of sodium (1 mmol) per tablet, which is essentially “sodium-free”.
3. How to Take Drosurelle Daily
Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
Each blister contains 21 active pink tablets and 7 white placebo tablets.
The two different colored tablets of Drosurelle Diario are placed in order. A package contains 28 tablets.
Take one Drosurelle Diario tablet every day, with some 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 21 days, followed by a white tablet for the last 7 days. Then you should start taking a new package (21 pink tablets and 7 white tablets). In this way, there is no break between two packages.
Due to the different composition of the tablets, you must start with the first tablet located in the top left corner and then take one tablet every day. To maintain the order, follow the direction of the arrows on the package.
Preparation of the package
To help you follow the order of taking, each package of Drosurelle Diario includes seven adhesive strips with the 7 days of the week.
Choose the adhesive strip that starts with the day you take the first tablet. For example, if you take your first tablet on a Wednesday, use the adhesive strip that starts with "WED".
Stick the adhesive strip of the week on the top left corner of the package, in the "Start" position.
In this way, there is a day of the week indicated above each tablet and you can see if you have taken a particular tablet. The arrows show the order in which the tablets should be taken.
During the 7 days when you take white placebo tablets (the placebo days), you usually start your period (also called withdrawal bleeding). Normally, your period starts the second or third day after taking the last active tablet, which is pink, of Drosurelle Diario. Once you have taken the last white tablet, you should start the next package, even if you have not finished your period. This means that you should start each packageon the same day of the weekthat you started the previous one, and your period should occur on the same days every month.
If you take Drosurelle Diario as indicated, you will also be protected against pregnancy during the 7 days when you are taking the placebo tablets.
When can you start with the first package?
- If you have not used any hormonal contraceptive in the previous month.
Start taking Drosurelle Diario on the first day of your cycle (i.e., the first day of your period). If you start Drosurelle Diario on the first day of your period, you are immediately protected against pregnancy. You can also start on days 2-5 of your cycle, but you should use additional contraceptive methods (e.g., a condom) during the first 7 days.
- Switching from another combined hormonal contraceptive, vaginal combined contraceptive ring, or patch.
You can start taking Drosurelle Diario 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 break days of your previous contraceptive (or after taking the last inactive tablet of your previous contraceptive). When switching from a vaginal combined contraceptive ring or patch, follow your doctor's recommendations.
- Switching from a progestin-only method (pill, injection, implant, or progestin-releasing intrauterine device (IUD)).
You can switch from the progestin-only pill at any time (if it is an implant or IUD, on the day of its removal; if it is an injection, on the day of the next injection), but in all cases, use additional contraceptive methods (e.g., a condom) during the first 7 days of taking tablets.
- After an abortion or miscarriage.
Follow your doctor's recommendations.
- After giving birth.
You can start taking Drosurelle Diario between 21 and 28 days after giving birth. If you start later, use one of the barrier methods (e.g., a condom) during the first 7 days of using Drosurelle Diario.
If, after giving birth, you have already had sex before starting to take Drosurelle Diario (again), you must be sure you are not pregnant or wait for your next menstrual period.
- If you are breastfeeding and want to start taking Drosurelle Diario (again) after giving birth.
Read the section "Breastfeeding".
Ask your doctor if you are unsure when to start.
If you take more Drosurelle Diario than you should
No serious cases of overdose of Drosurelle Diario have been reported.
The symptoms that may appear if you take many tablets can be feeling unwell, vomiting, or 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 Drosurelle Diario tablets, or if you discover that a child has taken them, consult your doctor or pharmacist immediately.
In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount taken.
If you forgot to take Drosurelle Diario
The tablets in thefourthrow of the package are placebo tablets. If you forget to take one of these tablets, it will have no effect on the effect of Drosurelle Diario. Discard the forgotten placebo tablet.
If you forget to take an active pink tablet from the1st, 2nd, or 3rdrow, do the following:
- If you are lateless than 12 hoursin taking a tablet, 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 12 hoursin taking a tablet, 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 the pink tablet at the beginning or end of the package. Therefore, you should follow the following recommendations (see the diagram below):
- Forgetting more than one tablet from the package
Consult your doctor.
- Forgetting a tablet in week 1
Take the forgotten tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the tablets at the usual time and useadditional precautions, such as condoms, during the next 7 days. If you have had sex in the week before forgetting the tablet, you may be pregnant. In that case, consult your doctor.
- Forgetting a tablet in week 2
Take the forgotten tablet as soon as you remember, even if this means taking two tablets at once. Continue taking the tablets at the usual time. The protection against pregnancy does not decrease and you do not need to take additional precautions.
- Forgetting a tablet in week 3
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 tablets at the usual time. Instead of taking the white placebo tablets from this package, discard them and start the next package.
You may experience bleeding during the use of the second package, which may be light or similar to your period. Finish this second package by taking the 7 white placebo tablets from the 4th row. Then start the new package.
- You can also interrupt the active pink tablets and go directly to the 7 white placebo tablets (before taking the placebo tablets, you must note the day you forgot to take the tablet). If you want to start a new package on the day you always start, take the placebo tabletsless than 7 days.
If you follow one of these two recommendations, you will remain protected against pregnancy.
- If you have forgotten to take a tablet and do not have a period during the placebo days, you may be pregnant. Contact your doctor before starting the next package.
The following diagram indicates what to do if you have forgotten 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 contraceptive will not be fully absorbed by the body, in which case you may need to use additional protection (such as a condom). The situation is almost equivalent to forgetting a tablet. After vomiting or diarrhea, take another active pink tablet from a reserve package as soon as possible. If possible,take it within 12 hours after the usual time you take your contraceptive. If this is not possible or more than 12 hours have passed, follow the instructions in the section "If you forgot to take Drosurelle Diario".
Delay of your menstrual period: what you should know
Although it is not recommended, you can delay your menstrual period if you do not take the placebo tablets, start taking a new package of Drosurelle Diario, and finish it. You may experience bleeding during the use of the second package, which may be light or similar to your period. Finish this second package by taking the 7 white placebo tablets from the 4th row. Then start the new package.
You should ask your doctor for advice before deciding to delay your menstrual period.
Change of the first day of your period: what you should know
If you take the tablets as indicated, your period will start duringthe placebo week. If you want to change that day, reduce the number of days with placebo tablets – when you take the white placebo tablets-(but never increase it- 7 at most!). For example, if you normally start taking the placebo tablets on Fridays and want to change it to Tuesdays (3 days earlier), start a new package 3 days earlier than usual. If you make the interval between taking placebo tablets very short (e.g., 3 days or less), you may not experience bleeding during these days. Then you may experience bleeding that is light or similar to your period.
If you are unsure how to proceed, consult your doctor.
If you interrupt the treatment with Drosurelle Diario
You can stop taking Drosurelle Diario when you want. If you do not want to become pregnant, consult your doctor about other effective birth control methods. If you want to become pregnant, stop taking Drosurelle Diario and wait until your menstrual period before trying to become pregnant. This way, you can calculate your estimated due date more easily.
If you have any doubts about the use of this medication, ask your doctor or pharmacist.
4. Possible Adverse Effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them. If you experience any side effect, especially if it is severe and persistent, or if you have any health changes that you think may be due to Drosurelle Diario, 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 Drosurelle Diario”.
The following list of side effects has been associated with the use of Drosurelle Diario.
Side effectsfrequent(may affect up to 1 in 10 people):
- Changes in mood,
- Headache,
- Abdominal pain (stomach pain),
- Acne,
- Breast pain, breast enlargement, breast tenderness, painful or irregular periods,
- Weight gain.
Side effectsless common(may affect up to 1 in 100 people):
- Candida (a fungal infection),
- Herpes labialis (simple herpes),
- Allergic reactions,
- Increased appetite,
- Depression, nervousness, sleep disorders,
- Tickling and pinching, dizziness,
- Visual problems,
- Irregular or unusually fast heart rate,
- Blood clots (thrombosis) in the lungs (pulmonary embolism), high blood pressure, low blood pressure, migraine, varicose veins,
- Sore throat,
- Nausea, vomiting, inflammation of the stomach and/or intestines, diarrhea, constipation,
- Sudden swelling of the skin and/or mucous membranes (e.g. tongue or throat), and/or difficulty swallowing or urticaria, along with difficulty breathing (angioedema),
- Hair loss (alopecia), eczema, itching, skin rashes, dry skin, seborrheic dermatitis,
- Neck pain, limb pain, muscle cramps,
- Urinary tract infection,
- Breast lumps (benign or cancerous), milk production without being pregnant (galactorrhea), ovarian cysts, hot flashes, absent periods, heavy periods, vaginal discharge, vaginal infection or inflammation, vaginal dryness, lower abdominal pain (pelvic), abnormal cervical smears (Papanicolaou or Papanicolaou staining), decreased interest in sex
- Fluid retention, lack of energy, feeling thirsty, increased sweating,
- Weight loss,
- Generalized pain.
Side effectsrare(may affect up to 1 in 1,000 people):
- Asthma,
- Auditory problems,
- Erythema nodosum (characterized by painful nodules on the skin, red in color)
- Erythema multiforme (skin rash with red spots in the shape of a target or ulcers)
- Detrimental 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.
- Transient ischemic attack (TIA) or temporary symptoms similar to a stroke.
- Blood clots in the liver, stomach/intestine, kidneys, or eye.
The chances of having 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).
Contact your doctor immediately if you experience any of the following angioedema symptoms: swelling of the face, tongue, and/or throat and/or difficulty swallowing or urticaria potentially with difficulty breathing (also see the section “Warnings and precautions”).
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 Pharmacovigilance of Medicines 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 Drosurelle Diary
Keep this medication out of the sight and reach of children.
Store below 30°C.
Do not take this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.
Do not dispose of medications through drains or 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
Composition of Drosurelle Diario
The blister pack of Drosurelle Diario contains 21 active pink tablets in the 1st, 2nd, and 3rd rows, and 7 white placebo tablets in the 4th row.
Active Tablets
The active principles are 0.02 mg of ethinylestradiol and 3 mg of drospirenone.
The other components are:
Tablet core: lactose monohydrate, pregelatinized cornstarch, povidone, croscarmellose sodium, polisorbate 80, magnesium stearate.
Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172).
Placebo Tablets
Tablet core: anhydrous lactose, povidone, magnesium stearate.
Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.
Appearance of the Product and Contents of the Package
The active tablets are film-coated, round, pink tablets with an approximate diameter of 5.7 mm.
The placebo tablets are film-coated, round, white tablets with an approximate diameter of 5.7 mm.
Drosurelle Diario is available in boxes of 1, 2, 3, 6, and 13 packs (blister packs), each containing 28 tablets (21 active tablets plus 7 placebo 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;
24008-Villaquilambre, León
Spain
Or
ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.
Production Plant in Nowa Deba, Ul. Metalowca 2
39-460 Nowa Deba
Poland
This Medicinal Product is Authorized in the Member States of the European Economic Area with the Following Names:
Czech Republic | Jangee |
Greece | Pirestrol 0.02 mg/3 mg δiσkio εττikαλνμμ?νo με λεττ? νμ?νio |
Spain | Drosurelle Diario 0,02 mg/3 mg film-coated tablets EFG |
Ireland | Ethinylestradiol/Drospirenone Leon Farma & placebo 0.02 mg/3 mg film-coated tablets |
Poland | Vibin Mini |
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.
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