Drosure 0.03 mg/3 mg comprimidos recubiertos con pelicula efg
Introduction
Prospect: information for the user
Drosure 0.03 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 to 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 or pharmacist, 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 aware and consult your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”).
1. What is Drosure and how is it used
- Drosure is a contraceptive and is used to prevent pregnancy.
- Each tablet contains a small amount of two different female hormones, known as ethinylestradiol and drospirenone.
- Contraceptives that contain two hormones are called "combined" contraceptives.
2. What you need to know before starting to use Drosure
Before starting to use Drosure, you should 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 Drosure, 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 personal situation, may perform some other tests.
This leaflet describes several situations in which you should interrupt the use of Drosure or in which the effect of Drosure may be reduced. In these situations, you should not have sexual intercourse or should take additional non-hormonal contraceptive precautions, for example, use a condom or other barrier method. Do not use the rhythm or basal body temperature method. These methods may not be reliable because Drosure alters the monthly changes in body temperature and cervical mucus.
Drosure, like other hormonal contraceptives, does not protect against HIV (AIDS) or any other sexually transmitted disease.
Do not take Drosure
You should not use Drosure 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 vein in your leg (deep vein thrombosis, DVT), in your 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 your arteries:
- Severe diabetes with vascular damage.
- Very high blood pressure.
- Very high levels of fat in your 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) pancreatitis (inflammation of the pancreas).
- If you have (or have ever had) liver disease and your liver function has not yet normalized.
- If your kidneys do not function properly (renal insufficiency).
- If you have (or have ever had) a tumor in the liver.
- If you have (or have ever had), or if you suspect that you have breast cancer or cancer of the reproductive organs.
- If you have vaginal bleeding, 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 those listed in section 6). This may cause itching, rash, or inflammation.
- Do not take Drosure 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 Drosure").
Additional information on additional populations
Drosure is not indicated for use in women who have not yet had their first menstrual period.
Women of advanced age
Drosure is not indicated for use after menopause.
Women with liver insufficiency
Do not take Drosure if you are suffering from liver disease. See sections "Do not take Drosure" and "Warnings and precautions".
Women with renal insufficiency
Do not take Drosure if you are suffering from kidney dysfunction or acute renal failure. See sections "Do not take Drosure" and "Warnings and precautions".
Warnings and precautions
When should you consult your doctor?
Seek immediate medical attention
- If you notice possible signs of a blood clot that may indicate that you are suffering from a blood clot in your leg (deep vein thrombosis), a blood clot in your 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
If the condition develops or worsens while you are using Drosure, you should inform your doctor. In some situations, you should take special care while using Drosure or any other combined hormonal contraceptive, and your doctor may need to examine you periodically.
Talk to your doctor or pharmacist before taking Drosure:
- If a close relative has had or has cancer of the breast.
- If you have any liver disease (such as a bile duct obstruction that may cause jaundice or pruritus) or gallbladder disease (such as gallstones).
- If you have other kidney problems and are taking medications that increase potassium levels in the blood.
- If you have diabetes.
- If you have depression. Some women who use hormonal contraceptives like Drosure 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 your 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 recently gave birth, you are at greater risk of developing blood clots. Ask your doctor when you can start taking Drosure 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 Drosure").
- If you have a disease that 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 gestational), a nervous disorder characterized by involuntary movements (Sydenham's chorea)).
- If you have high blood pressure during treatment and it is not controlled with medication.
- If you have or have had melasma (a skin discoloration, especially on the face or 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, tongue, or throat swelling, difficulty swallowing, or potentially life-threatening urticaria. Medications containing estrogens can cause or worsen symptoms of hereditary and acquired angioedema.
BLOOD CLOTS
The use of a combined hormonal contraceptive like Drosure increases your risk of developing 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 TEA).
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 harmful blood clot due to Drosure is small.
HOW TO RECOGNIZE A BLOOD CLOT
Seek immediate medical attention
If you notice any of the following signs or symptoms, seek immediate medical attention.
| Do you experience any of these symptoms? | What might you be suffering from? |
| Deep vein thrombosis |
If you are unsure, consult your doctor, as some of these symptoms, such as coughing or shortness of breath, can be confused with a less severe 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 thromboembolism, VTE). However, these adverse effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
- If a blood clot forms in a vein in your leg or foot, it may cause deep vein thrombosis (DVT).
- If a blood clot breaks loose from your leg and lodges in your 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 in which you start 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 medication) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive.
When you stop taking Drosure, 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 Drosure is small.
| Women who | Risk of a blood clot in a year |
| Do not use a combined hormonal contraceptive and are not pregnant. | About 2 per 10,000 women |
| Use a combined hormonal contraceptive containing levonorgestrel, noretisterone, or norgestimato. | About 5-7 per 10,000 women |
| Use Drosure. | About 9-12 per 10,000 women |
Factors that increase your risk of a blood clot in a vein
Your risk of a blood clot 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 their leg, lung, or other organ at a young age (i.e., before the age of about 50). You may have a hereditary 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 a leg cast. You may need to interrupt the use of Drosure for several weeks before the surgery or while you have less mobility. If you need to interrupt the use of Drosure, ask your doctor when you can start using it again.
- As you get older (especially above the age of about 35).
- If you have recently given birth. You are at greater risk of developing a blood clot. Ask your doctor when you can start taking Drosure after childbirth.
The 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 Drosure.
If any of the conditions listed above change while you are using Drosure, 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 Drosure is very small, but it may increase:
- With age (above the age of about 35).
- If you smoke. When using a combined hormonal contraceptive like Drosure, 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 a close relative has had a heart attack or stroke at a young age (i.e., before the age of about 50). You may also be at greater risk of having a heart attack or stroke.
- If you or a close relative has high levels of fat in your blood (cholesterol or triglycerides).
- If you have migraines, especially migraines with aura.
- If you have a heart condition (valve disorder, rhythm disorder 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 Drosure, 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.
Drosure and cancer
Breast cancer 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 undergo regular breast examinations, and you should consult your doctor if you notice any lump.
Bleeding between periods
During the first few months of taking Drosure, you may experience unexpected bleeding (bleeding outside of the menstrual period). If these bleeding persist beyond a few months or start after a few months, your doctor will examine you to see if anything is malfunctioning.
What to do if you do not have a period during the menstrual period
If you have taken all the pills correctly, have not had severe vomiting or diarrhea, and have not taken other medications, it is highly unlikely that you are pregnant.
If your expected period does not arrive in two consecutive instances, you may be pregnant. Consult your doctor immediately. Do not start the next pack until you are sure you are not pregnant.
Other medications and Drosure
Inform your doctor if you are taking, have taken recently, or may need to take any other medication or herbal preparations. Also, inform any other doctor or dentist who prescribes another medication (or your pharmacist) that you are taking Drosure. They may advise you to take additional contraceptive precautions (e.g., condoms) and, if so, for how long, or modify the use of another medication you need.
Some medications
- may affect the levels of Drosure in your blood,
- may make it less effective in preventing pregnancy ,
- may cause unexpected bleeding.
This can occur with:
- Medications used in the treatment of:
- Epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, felbamate, and topiramate)
- Tuberculosis (e.g., rifampicin)
- HIV and hepatitis C infections (the so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)
- Fungal infections (e.g., griseofulvin or ketoconazole)
- Arthritis and osteoarthritis (etoricoxib)
- High blood pressure in the blood vessels of the lungs (bosentan)
- Herbal preparations containing St. John's Wort.
If you are taking these medications mentioned above at the same time as Drosure, you should take additional contraceptive precautions (e.g., condoms) for at least 28 days after completing the treatment.
Drosure 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 pain and/or muscle cramps).
Do not take Drosure if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver function test results (elevated ALT levels).
Your doctor will prescribe another type of contraceptive before starting treatment with these medications.
Drosure can be restarted approximately 2 weeks after completing this treatment. See the section "Do not take Drosure".
Consult your doctor or pharmacist before taking any medication.
Taking Drosure with food and drinks
Drosure 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 Take one Drosure tablet every day with a little water if necessary. You can take the tablets with or without food, but approximately at the same time every day. One package contains 21 tablets. Next to each tablet is printed the day of the week when it should be taken. For example, if you start on a Wednesday, take a tablet with "MIE" next to it. Follow the direction of the arrow on the package until you have taken the 21 tablets. Do not take any tablets for 7 days after that. During these 7 days when no tablets are taken (called a rest week), menstruation should occur. Menstruation, also known as withdrawal bleeding, begins on the 2nd or 3rd day of the rest week. By the 8th day of taking the last Drosure tablet (i.e., after a 7-day rest period), you should start with the next package, even if bleeding has not stopped. This means that you should start each package on the same day of the week and that menstruation should occur on the same days every month. If you use Drosure in this way, you are also protected against pregnancy during the 7 days when no tablets are taken. When can you start with the first package Start taking Drosure on the first day of your cycle (i.e., the first day of your period). If you start Drosure on the first day of your period, you will be protected immediately against pregnancy. You can also start on days 2-5 of your cycle, but you must use additional contraceptive methods (e.g., a condom) during the first 7 days. You can start taking Drosure 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 rest 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. You can switch from progestin-only pills on any day (if it's an implant or an IUS, 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 tablet-taking. Follow your doctor's recommendations. You can start taking Drosure 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 Drosure use. If, after giving birth, you have already had sex before starting Drosure (again), make sure you are not pregnant or wait for your next menstrual period. Read the "Breastfeeding" section. Ask your doctor if you are unsure when to start. What if you take more Drosure than you should No serious harm has been reported in cases of Drosure overdose. If you take many tablets at once, you may feel unwell, vomit, or experience 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 Drosure 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 Drosure 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, follow these recommendations (see also the diagram below): Consult your doctor. 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 a condom, 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. 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 contraceptive protection does not decrease, and you do not need to take additional precautions. You can choose between two options: You may experience bleeding during the second package, which may be light or similar to menstruation. After the usual 7-day rest period,startthe next package. If you follow one of these two recommendations, you will remain protected against pregnancy. The following diagram indicates what to do if you have forgotten a tablet: What to do in case of vomiting or intense diarrhea If you have vomiting in the 3-4 hours after taking a tablet or experience 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 Drosure". Delaying your period: what you should know Although not recommended, you can delay your period if you start taking a new Drosure package instead of continuing with the rest week and finish it. You may experience light bleeding or menstruation-like bleeding during the second package. After the usual 7-day rest period,startthe 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 period will start during therest week. If you need to change that day, reduce the number of rest days(but never increase it to 7 or more!). For example, if your rest 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 rest period very short (e.g., 3 days or less), you may not experience bleeding during these days. Then you may experience light bleeding or menstruation-like bleeding. If you are unsure how to proceed, consult your doctor. What if you interrupt the treatment with Drosure You can stop taking Drosure when you want. If you do not want to get pregnant, consult your doctor about other effective birth control methods. If you want to get pregnant, stop taking Drosure and wait until your period before trying to get pregnant. This way, you can estimate your due date more easily. If you have any doubts about using this medication, ask your doctor or pharmacist. All women taking combined hormonal contraceptives are at a higher risk of presenting 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 Drosure”. Immediately contact your doctor if you experience any of the following angioedema symptoms: facial swelling, tongue, and/or throat swelling 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 Drosure: Side effectscommon(may affect up to 1 in 10 people): Side effects uncommon(may affect up to 1 in 100 people): Side effects rare(may affect up to 1 in 1000 people): 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). 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 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. Keep this medication out of the reach and sight 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. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment. Composition of Drosure The active principles are 0.03 mg of ethinylestradiol and 3 mg of drospirenone. The other components are: Core of the tablet: lactose monohydrate, cornstarch, pregelatinized cornstarch, povidone, polisorbate 80, magnesium stearate. Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, iron oxide yellow (E172). Appearance of the product and content of the container Coated tablets, round, yellow in color, approximately 5.7 mm in diameter. Drosure is available in boxes of 1, 2, 3, 6, and 13 containers (blister packs), each containing 21 tablets. Only some container sizes may be marketed. Holder of the marketing authorization 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 0.03 mg/3mg ????????? ????????? Greece: Estrofix 0.03 mg/3 mg επικαλυμμ?νο με λεπτ? υμ?νιο δισκ?ο Spain: Drosure 0,03 mg/3 mg coated tablets EFG Ireland: Ethinylestradiol/Drospirenone Leon Farma 0.03 mg/3 mg film-coated tablets Portugal: Drospirenone + Etinilestradiol Generis 3 mg + 0.03 mg coated tablets Last review date of this leaflet: November 2022 The 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 . 3. How to Take Drosure
4. Possible Adverse Effects
5. Storage of Drosure
6. Content of the container and additional information
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