Drosurelle 0.02 mg/3 mg comprimidos recubiertos con pelicula efg
Introduction
Prospect: information for the user
Drosurelle 0.02 mg/3 mg film-coated tablets
etinilestradiol/drospirenona
Read this prospect carefully before starting to take this medicine, as it contains important information for you.
- Keep this prospect, 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 other people, even if they have the same symptoms as you, as it may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. 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 and what is it used for
- Drosurelle is a contraceptive and is used to prevent pregnancy.
- Each coated tablet contains a small amount of two different female hormones, known as drospirenone and ethinylestradiol.
- Contraceptives that contain two hormones are known as combined contraceptives.
2. What you need to know before starting to take Drosurelle
General Considerations
Before starting to use Drosurelle, 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, 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 health status, perform other tests.
This leaflet describes several situations in which you should interrupt the use of Drosurelle, or in which the effect of Drosurelle may be reduced.
In these situations, you should not have sexual intercourse or should take additional non-hormonal contraceptive precautions, such as the use of a condom or other barrier method.
Do not use the rhythm or basal body temperature method. These methods may not be reliable because Drosurelle alters the monthly changes in body temperature and cervical mucus.
Drosurelle, like other hormonal contraceptives, does not protect against HIV (AIDS) or any other sexually transmitted disease.
Do not take Drosurelle
You should not use Drosurelle 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 homocysteineemia.
- 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 failure).
- If you have (or have ever had) a liver tumor.
- If you have (or have ever had), or are suspected to 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 (see section 6). This may cause itching, rash, or inflammation.
- Do not take Drosurelle 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”).
Additional Information on Special Populations
Children and Adolescents
Drosurelle is not indicated for use in women who have not yet had their first menstrual period.
Women of Advanced Age
Drosurelle is not indicated for use after menopause.
Women with Liver Disease
Do not take Drosurelle if you suffer from liver disease. See sections “Do not take Drosurelle” and “Warnings and Precautions”.
Women with Renal Disease
Do not take Drosurelle if you are suffering from kidney disease or acute renal failure. See sections “Do not take Drosurelle” and “Warnings and Precautions”.
Warnings and Precautions
When to Consult a Doctor
Seek immediate medical attention
- If you notice any of the following possible signs of a blood clot that may indicate that you are suffering from a blood clot in a leg vein (DVT), a blood clot in the lungs (PE), 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 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 Drosurelle, you should also inform your doctor.
- If a close relative has had or has breast cancer.
- If you have any liver or gallbladder disease (such as gallstones).
- If you have diabetes.
- If you have depression. Some women who use hormonal contraceptives like Drosurelle 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 disorder of blood clotting that causes kidney failure).
- If you have sickle cell anemia (a hereditary disorder of red blood cells).
- 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 standing up (see section 2 “Blood Clots”).
- If you have recently given birth, you are at increased risk of blood clots. Ask your doctor when you can start taking Drosurelle after delivery.
- 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”).
- If you have any disease that may have appeared for the first time during pregnancy or during a previous use of sex hormones (such as hearing loss, a blood disorder called porphyria, skin rash with blisters during pregnancy (herpes gestationalis), or 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 this case, you should avoid direct exposure to the sun or ultraviolet rays while taking this medication.
- Consult your doctor immediately if you experience symptoms of angioedema, such as facial swelling, tongue, and/or throat swelling, difficulty swallowing, or potentially difficulty breathing. Medications containing estrogens can cause or worsen symptoms of hereditary and acquired angioedema.
BLOOD CLOTS
The use of a combined hormonal contraceptive like Drosurelle 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 (known as “deep vein thrombosis”, “venous thromboembolism”, or VTE).
- In arteries (known as “arterial thrombosis”, “arterial thromboembolism”, or ATE).
The recovery from 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 that can cause harm due to Drosurelle is small.
HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical attentionif you notice any of the following signs or symptoms.
Do you experience any of these symptoms? | What might 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 attention 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 (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 Drosurelle, 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 Drosurelle 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, 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 in a vein” 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 Drosurelle | 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 with Drosurelle is small, but some conditions increase the risk. Your risk is higher:
- If you are overweight (body mass index (BMI) greater than 30 kg/m2).
- If any of your close relatives have had a blood clot in a leg, lung, or other organ at a young age (i.e., before about 50 years). 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 Drosurelle for several weeks before surgery or while you have reduced mobility. If you need to interrupt the use of Drosurelle, ask your doctor when you can start taking it again.
- With increasing age (especially above 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.
If any of the conditions listed above change while you are using Drosurelle, 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 the 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 is very small, but it may increase:
- With age (above about 35 years).
- If you smoke. When using a combined hormonal contraceptive like Drosurelle, you are advised to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may advise you to use a different type of contraceptive.
- If you are overweight.
- If you have high blood pressure.
- If any 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 increased risk of a heart attack or stroke.
- If you or any 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, 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, your risk of a blood clot may be increased even further.
If any of the conditions listed above change while you are using Drosurelle, 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 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 the 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 lump.
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 unusual abdominal pain.
Menstrual Bleeding
During the first few months of taking Drosurelle, you may experience unexpected bleeding (bleeding outside the menstrual period). If these bleeding persist beyond a few months or start after a few months, your doctor will investigate what is wrong.
What to Do if You Do Not Have a Menstrual Period During the Menstrual Period
If you have taken all the tablets correctly, have not had severe vomiting or diarrhea, and have not taken other medications, it is very unlikely that you are pregnant.
If your expected menstrual 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
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. They may advise you to take additional contraceptive precautions (e.g., condoms) and, if so, for how long or whether you need to modify the use of another medication that you need.
Some medications:
- may affect the levels of Drosurelle in the blood
- may makeit less effective in preventing pregnancy
- may cause unexpected bleeding.
This may occur with:
- medications used in the treatment of:
- epilepsy (phenytoin, carbamazepine, barbiturates, primidone, and 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, and efavirenz),
- infections with fungi (e.g., griseofulvin or ketoconazole),
- arthritis, osteoarthritis (etoricoxib),
- high blood pressure in the blood vessels of the lungs (bosentan).
- herbal preparations of St. John's Wort
Drosurelle 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 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 an increase in liver function test results (elevated ALT levels).
Your doctor will prescribe another type of contraceptive before starting treatment with these medications.
Drosurelle can be taken again approximately 2 weeks after the end of this treatment. See the section “Do not take Drosurelle”.
Consult your doctor or pharmacist before using any medication.
Taking Drosurelle with Food and Drink
Drosurellecan 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
If you are pregnant, do not take Drosurelle. If you become pregnant during treatment with Drosurelle, stop treatment immediately and consult your doctor. If you want to become pregnant, you can stop taking Drosurelle at any time (see “Stopping Treatment with Drosurelle”).
Consult your doctor or pharmacist before using any medication.
Lactation
Generally, it is not recommended to take Drosurelle 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 Machinery
There is no information to suggest that the use of Drosurelle has any effect on your ability to drive or operate machinery.
Drosurelle 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, or is essentially “sodium-free”.
3. How to take Drosurelle
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.
Take one Drosurelle tablet every day, with a little water if necessary. You can take the tablets with or without food, but at approximately the same time every day.
The packaging (blister) contains 21 tablets. Next to each tablet, the day of the week is printed on which it should be taken. If, for example, you start on a Wednesday, take a tablet with "MIE" next to it. Follow the direction of the arrow on the packaging until you have taken all 21 tablets.
After that, you should not take any tablets for 7 days. During those 7 days when no tablets are taken (a period called the withdrawal week), menstruation should occur. Menstruation, also known as "withdrawal bleeding," usually starts on the 2nd or 3rd day of the withdrawal week.
By the 8th day of taking the last Drosurelle tablet (i.e., after the 7-day withdrawal period), you should start the next package, even if the period has not ended. This means that you should start each package on the same day of the week, and menstruation should occur on the same days every month.
If you use Drosurelle in this way, you will also be protected against pregnancy during the 7 days when no tablets are taken.
When can you start with the first package?
- If you have not used any hormonal contraceptives in the past month
Start taking Drosurelle on the first day of your usual cycle (i.e., the first day of your period). If you start taking Drosurelle 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 a combined hormonal contraceptive, vaginal combined contraceptive ring, or patch
You can start taking Drosurelle preferably the day after taking the last active tablet (the last tablet containing active ingredients) of your previous contraceptive, but no later than the day after the withdrawal week 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 (progestin-only pills, injection, implant, or intrauterine device releasing progestin)
You can switch from progestin-only pills, an implant, or an intrauterine device releasing progestin on any day (if it's an implant or an intrauterine device, on the day of its removal; if it's 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
Follow your doctor's recommendations.
- After giving birth
You can start taking Drosurelle between 21 and 28 days after giving birth. If you start later, use one of the so-called barrier contraceptive methods (e.g., a condom) during the first 7 days of taking Drosurelle.
If, after giving birth, you have already had sex before starting to take Drosurelle (again), you should be sure you are not pregnant or wait for your next menstrual period.
- If you are breastfeeding and want to start taking Drosurelle again after giving birth
Read the section "Breastfeeding."
Ask your doctor if you are unsure when to start.
What if you take more Drosurelle than you should?
No serious cases of overdose have been reported.
The symptoms that may appear if you take many tablets at once are 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 tablets, or if 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used.
What if you forget to take Drosurelle?
- If you are lateless than 12 hoursin taking a tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and the following tablets at the usual time.
- If you are latemore than 12 hoursin taking a tablet, the protection against pregnancy may be reduced. The more tablets you have forgotten, the higher the risk of becoming pregnant.
The risk of incomplete protection against pregnancy is maximum if you forget to take a tablet at the beginning or end of the package. Therefore, you should follow the following recommendations (see also 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 is not reduced, 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 starting the withdrawal period, start the next package.
You may experience bleeding during the second package, which may be light or similar to menstruation. After finishing the second package, follow the usual withdrawal period andstartthe next package.
- You can also interrupt taking tablets and go directly to the withdrawal period (noting the day you forgot to take the tablet). If you want to start a new package where you always start, your withdrawal period should lastless 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 menstruation during the first withdrawal period, you may be pregnant. Contact your doctor before starting the next package.
The following diagram will indicate what to do if you have forgotten to take a tablet:
What should you do in case of vomiting or intense diarrhea?
If you have vomiting within 3-4 hours after taking a tablet or have intense diarrhea, there is a risk that the active ingredients of the contraceptive will not be fully absorbed by the body. The situation is almost equivalent to forgetting a tablet. After vomiting or diarrhea, take a tablet from a spare package as soon as possible. If possible, take itwithin 12 hoursafter the usual time when you take your contraceptive. If this is not possible or more than 12 hours have passed, follow the advice in the section "If you forgot to take Drosurelle."
Delaying your menstrual period: what you should know
Although not recommended, you can delay your menstrual period if you start taking a new package of Drosurelle instead of continuing with the withdrawal period and finish it. You may experience bleeding during the second package, which may be light or similar to menstruation. After finishing the second package, follow the usual withdrawal period andstartthe next package.
You should ask your doctor for advice before deciding to delay your menstrual period.
Changing the first day of your period: what you should know
If you take the tablets according to the instructions, your menstrual period will startduring the withdrawal period. If you need to change the day, reduce the number of withdrawal days (but never increase – 7 at most!). For example, if your withdrawal days usually start on Fridays and you want to change to Tuesdays (3 days earlier), start a new package 3 days earlier than usual. If you make the withdrawal period very short (e.g., 3 days or less), you may not experience bleeding during these days. Then you may experience light bleeding or similar to menstruation.
If you are unsure how to proceed, consult your doctor.
What if you interrupt treatment with Drosurelle?
You can stop taking Drosurelle whenever 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 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 additional questions about using 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 change that you think may be due to Drosurelle, 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 use Drosurelle”.
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 potentially difficulty breathing (also see the section “Warnings and precautions”).
The following list of side effects has been associated with the use of Drosurelle.
Frequent side effects(may affect up to 1 in 10 people):
- Mood changes,
- Headache,
- Abdominal pain (stomach pain),
- Acne,
- Breast pain, breast enlargement, breast tenderness, painful or irregular periods,
- Weight gain.
Infrequent side effects(may affect up to 1 in 100 people):
- Candidiasis (a fungal infection),
- Herpes labialis (simple herpes),
- Allergic reactions
- Increased appetite,
- Depression, nervousness, sleep disorders
- Tickling and pins and needles,Vertigo,
- 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 with difficulty breathing (angioedema),
- Hair loss (alopecia), eczema, itching, skin rash, 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, absence of menstruation, heavy periods, vaginal discharge, vaginal dryness, lower abdominal pain (pelvic pain), abnormal cervical smears (Papanicolau or Papanicolau staining), decreased interest in sex,
- Fluid retention, lack of energy, excessive thirst, increased sweating,
- Weight loss.
Rare side effects(may affect up to 1 in 1,000 people):
- Asthma
- Auditory problems
- Erythema nodosum (characterized by painful red nodules on the skin)
- 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).
Reporting 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 theSpanish 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
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:” 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 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.
6. Contents of the packaging and additional information
Composition of Drosurelle
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, sodium croscarmellose, 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).
Appearance of the product and contents of the packaging
The tablets are film-coated, round, pink, approximately 5.7 mm in diameter.
Drosurelle is available in boxes of 1, 2, 3, 6, and 13 blisters, each containing 21 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.
C/ La Vallina, s/n,
Navatejera Industrial Estate,
Villaquilambre
24193 León, Spain
This medication is authorized in the member states of the European Economic Area with the following names:
Bulgaria:Jangee 0.02 mg/3 mg ????????? ????????
Greece:Estrofix 0.02 mg/3 mg επικαλυμμ?νο με λεπτ? υμ?νιο δισκ?ο
Spain:Drosurelle 0,02 mg/3 mg film-coated tablets EFG
Ireland:Ethinylestradiol/Drospirenone Leon Farma 0.02 mg/3 mg film-coated tablets
Portugal:Drospirenona + Etinilestradiol Generis 3 mg + 0.02 mg film-coated tablets
Last review date of this leaflet: November 2022
Updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/
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