Drosure diario 0.03 mg/3 mg comprimidos recubiertos con pelicula efg
Introduction
Package Insert: Information for the User
Drosure Daily 0.03 mg/3 mg Film-Coated Tablets EFG
etinilestradiol/drospirenona
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 should not be given to others, even if they have the same symptoms as you, as it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
Important 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”).
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1. What is Drosure Diario and what is it used for
- Drosure Diario is a contraceptive and is used to prevent pregnancy.
- Each of the 21 yellow-colored tablets contains a small amount of two different female hormones, known as ethinyl estradiol and drospirenone.
- The 7 white-colored tablets do not contain active ingredients and are called placebo tablets.
- Contraceptives that contain two hormones are called "combined contraceptives".
2. What you need to know before starting Drosure Daily
Before starting to use Drosure Diario, 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 Diario, your doctor will ask you some questions about your personal and family medical history. The doctor will also measure your blood pressure and, depending on your personal situation, may perform some other tests.
In this prospectus, several situations are described in which you should interrupt the use of Drosure Diario, or in which the effect of Drosure Diario may decrease. In these situations, you should not have sexual intercourse or should take additional non-hormonal contraceptive precautions, for example, 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 Drosure Diario alters the monthly changes in body temperature and cervical mucus.
Drosure Diario, like other hormonal contraceptives, does not protect against HIV (AIDS) or any other sexually transmitted disease.
Do not take Drosure Diario
You should not use Drosure 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, 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) 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 well (renal insufficiency).
- If you have (or have ever had) a tumor in the liver.
- If you have (or have ever had), or if you suspect that you have breast cancer or cancer of the reproductive organs.
- If you have vaginal bleeding, 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 Drosure 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 Drosure Diario”).
Additional information for special populations
Drosure Diario is not indicated for use in women who have not yet had their first menstrual period.
Women of advanced age
Drosure Diario is not indicated for use after menopause.
Women with liver insufficiency
Do not take Drosure Diario if you suffer from liver disease. See sections “Do not take Drosure Diario” and “Warnings and precautions”.
Women with renal insufficiency
Do not take Drosure Diario if you are suffering from kidney dysfunction or acute renal failure. See sections “Do not take Drosure Diario” and “Warnings and precautions”.
Warnings and precautions
Consult your doctor or pharmacist before starting to take this medication.
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 lung (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 Drosure Diario or any other combined hormonal contraceptive, and you may need to have a periodic examination by your doctor.If the condition develops or worsens while you are using Drosure 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 any kidney problems and have to take medications that increase the levels of potassium in the blood.
- If you have diabetes.
- If you have depression. Some women who use hormonal contraceptives like Drosure 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 (LES: a disease that affects your natural defense system).
- If you have hemolytic-uremic syndrome (HUS: a disorder of blood clotting that causes kidney insufficiency).
- If you have sickle cell anemia (a hereditary disease of red blood cells).
- If you have high levels of fat in the blood (hypertriglyceridemia) or 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 greater risk of developing blood clots. Ask your doctor when you can start taking Drosure Diario 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 Drosure Diario”).
- If you have a disease that appeared for the first time during pregnancy or during a previous use of sex hormones (for example, hearing loss, a blood disorder called porphyria, skin rash with 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 or neck, known as “pregnancy mask”). In this case, you should avoid direct exposure to the sun.
- If you have hereditary angioedema, products containing estrogens may cause or worsen symptoms. You should contact your doctor immediately if you experience symptoms of angioedema such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria, along with difficulty breathing.
BLOOD CLOTS
The use of a combined hormonal contraceptive like Drosure Diario 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.
What can happen if a blood clot forms in a vein?
- The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in veins (venous thromboembolism, VTE). However, these adverse effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
- If a blood clot forms in a vein in the leg or foot, it may cause deep vein thrombosis (DVT).
- If a blood clot breaks loose from the leg and lodges in the 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 developing a blood clot in a vein greater?
The risk of developing a blood clot in a vein is greater during the first year in which you start taking a combined hormonal contraceptive for the first time. The risk may be greater if you restart taking a combined hormonal contraceptive (the same medication or a different medication) after a break of 4 weeks or more.
After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive.
When you stop taking Drosure Diario, your risk of developing a blood clot returns to normal in a few weeks.
What is the risk of developing 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 developing a blood clot in the leg or lung (DVT or PE) with Drosure Diario is small.
- Of every 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 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, about 5-7 will develop a blood clot in a year.
- Of every 10,000 women who use a combined hormonal contraceptive containing drospirenone like Drosure Diario, between 9 and 12 women will develop a blood clot in a year.
- The risk of developing a blood clot will depend on your personal history (see “Factors that increase your risk of a blood clot” below).
Risk of developing a blood clot in a year | |
Women whodo not usea combined hormonal contraceptive and who are not pregnant | About 2 of every 10,000 women |
Women who use a combined hormonal contraceptive containinglevonorgestrel, noretisterone, or norgestimato | About 5-7 of every 10,000 women |
Women who use Drosure Diario | About 9-12 of every 10,000 women |
Factors that increase your risk of a blood clot in a vein
The risk of developing a blood clot is small, but some conditions increase the risk. Your risk is greater:
- If you are overweight (body mass index (BMI) greater than 30 kg/m2).
- If any of your close relatives have 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 a hereditary disorder of blood clotting.
- If you need surgery or spend a lot of time without standing up due to an injury or disease, or if you have a leg cast. You may need to interrupt the use of Drosure Diario for several weeks before the surgical procedure or while you have less mobility. If you need to interrupt the use of Drosure Diario, ask your doctor when you can start using it again.
- As you get older (especially over about 35 years).
- If you have recently given birth.
The risk of developing a blood clot increases the more conditions you have.
Long flights (more than 4 hours) may temporarily increase the risk of a blood clot, especially if you have any of the other risk factors listed.
It is essential to inform your doctor if you have any of the conditions mentioned above, even if you are unsure. Your doctor may decide that you should interrupt the use of Drosure Diario.
If any of the conditions mentioned above change while you are using Drosure 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 the use of Drosure Diario is very small, but it may increase:
- With age (over about 35 years).
- If you smoke. When using a combined hormonal contraceptive like Drosure Diario, 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 of your close relatives have had a heart attack or stroke at a young age (less than about 50 years). In this case, you may also have a higher risk of developing a heart attack or stroke.
- If you or any of your close relatives have 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 any of the conditions mentioned above or if any of them are particularly severe, your risk of developing a blood clot may be increased even further.
If any of the conditions mentioned above change while you are using Drosure 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.
Drosure Diario and cancer
Cancer of the breast has been observed slightly more frequently in women using combined hormonal contraceptives, but it is not known whether this is due to the treatment. For example, it may be that more tumors are detected in women taking combined hormonal contraceptives because they are examined by their doctor more frequently. The incidence of breast tumors decreases gradually after stopping combined hormonal contraceptives. It is essential to have regular breast examinations, and you should contact 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. Contact your doctor if you experience severe abdominal pain.
Spotting between periods
During the first few months of using Drosure Diario, you may experience unexpected bleeding (bleeding outside the week when you are taking the white pills). If this bleeding persists beyond a few months or starts after a few months, your doctor should investigate what is wrong.
What to do if you do not have a period during the placebo days
If you have taken all the active pills correctly, have not had vomiting or diarrhea, and have not taken any other medications, it is very unlikely that you are pregnant.
If your expected period does not come in two consecutive occasions, you may be pregnant. Contact your doctor immediately. Do not start the next pack until you are sure you are not pregnant.
Other medications and Drosure Diario
Inform your doctor or pharmacist 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 Diario. They may advise you to take additional contraceptive precautions (for example, condoms) and, if so, for how long, or if you need to modify the use of another medication that you need.
Some medications:
- may affect the levels of Drosure 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),
- 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, ketoconazole)
- arthritis, osteoarthritis (etoricoxib)
- high blood pressure in the pulmonary vessels (bosentan)
- herbal preparations of St. John's Wort.
If you are taking these medications mentioned above at the same time as Drosure Diario, you should take additional contraceptive precautions (e.g., condoms) for at least 28 days after completing the treatment.
Drosure 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),
Your doctor will prescribe another type of contraceptive before starting treatment with these medications.
You can start taking Drosure Diario again about 2 weeks after completing this treatment. See the section “Do not take Drosure Diario”.
Consult your doctor or pharmacist before taking any medication.
Taking Drosure Diario with food and drinks
Drosure 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 hormonal contraceptive, as hormonal contraceptives may affect the results of some tests.
Pregnancy
If you are pregnant, you should not take Drosure Diario. If you become pregnant while taking Drosure Diario, stop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking Drosure Diario at any time (see “If you want to interrupt treatment with Drosure Diario”).
Consult your doctor or pharmacist before taking any medication.
Lactation
Generally, it is not recommended to take Drosure Diario during the lactation period (when you are breastfeeding). If you want to take the contraceptive while breastfeeding, you should consult your doctor.
Consult your doctor or pharmacist before taking any medication.
Driving and operating machinery
There is no information to suggest that the use of Drosure Diario has any effect on your ability to drive or operate machinery.
Drosure Diario contains lactose
If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.
3. How to Take Drosure Daily
Each blister contains 21 active yellow tablets and 7 white placebo tablets.
The two different colored tablets of Drosure Diario are arranged in order. A package contains 28 tablets.
Take one Drosure Diario tablet every day, with water if necessary. You can take the tablets with or without food, but at approximately the same time every day.
Do not confuse the tablets: take a yellow tablet for the first 21 days, and then a white tablet for the last 7 days. You must then start taking a new package (21 yellow tablets and 7 white tablets). In this way, there is no week of rest between packages.
Due to the different composition of the tablets, you must start with the first tablet located in the upper 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, the Drosure Diario package contains 7 adhesive strips with the days of the week.
Choose the adhesive strip that starts with the day you take the first tablet. For example, if you start on Wednesday, stick the one that indicates “WED”.
Stick the weekly adhesive strip on the top left of the Drosure Diario blister, with the first day 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 specific tablet. The arrows show the order in which the tablets should be taken.
During the 7 days when you take 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 yellow tablet of Drosure Diario. Once you have taken the last white tablet, you must start the next package, even if you have not finished bleeding. 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 Drosure Diario as indicated, you will also be protected against pregnancy during the 7 days when you are taking placebo tablets.
When can you start with the first package?
- If you have not used any hormonal contraceptive in the previous month.
Start taking Drosure Diario on the first day of your cycle (i.e., the first day of your period). If you start Drosure Diario 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.
- Switching from another combined hormonal contraceptive, vaginal combined contraceptive ring, or patch.
You can start taking Drosure Diario 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 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 (progestin-only pills, injection, implant, or progestin-releasing intrauterine system SLI).
You can switch from progestin-only pills on any day (if it's an implant or SLI, on the day of its removal; if it's an injectable, on the next scheduled 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 Drosure 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 Drosure Diario.
If, after giving birth, you have already had sex before starting to take Drosure 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 Drosure Diario (again) after giving birth.
Read the “Breastfeeding” section.
Ask your doctor if you are unsure when to start.
If you take more Drosure Diario than you should
No serious cases of overdose of Drosure Diario have been reported.
If you have taken too many Drosure Diario tablets, or if you discover that a child has taken them, consult your doctor or pharmacist.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20 indicating the medication and the amount used.
If you forget to take Drosure 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 reliability of Drosure Diario. Discard the forgotten placebo tablet.
If you forget to take an active yellow tablet from the1st, 2nd, or 3rdrow, do the following:
- 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 subsequent 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 greater the risk of pregnancy.
The risk of incomplete protection against pregnancy is maximum if you forget to take a yellow tablet at the beginning or end of the package. Therefore, you must 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 a condom, for 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 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, possibly during the taking of the second package. Finalize this second package by taking the 7 white placebo tablets from the 4th row. Then start with the new package.
- You can also interrupt the taking of active yellow tablets and pass directly to the 7 white placebo tablets, including the day you forgot to take the tablet(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 bleeding during the placebo days, you may be pregnant. Contact your doctor before starting the next package.
What to do in case of vomiting or intense diarrhea
If you have vomiting in the 3-4 hours after taking an active yellow 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. The situation is almost equivalent to forgetting a tablet. After vomiting or diarrhea, take another active yellow tablet from a reserve package as soon as possible. If possible, take itwithin 12 hoursafter the usual time 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 Diario”.
Delay of your menstrual period: what you should know
Although not recommended, you can delay your period if you do not take the placebo tablets, start taking a new package of Drosure Diario, and finish it. You may experience bleeding during the use of the second package, possibly during the taking of the second package. Finalize this second package by taking the 7 white placebo tablets from the 4th row. Then start with the new package.
You should ask your doctor for advice before deciding to delay your menstrual period.
Change of the first day of your menstrual period: what you should know
If you take the tablets as indicated, your period will start duringthe placebo week. If you need to change that day, reduce the number of placebo days (but never increase – 7 at most!) when you take the white placebo tablets. For example, if you usually start taking the placebo tablets on Friday, and you want to change it to Tuesday (3 days earlier), start a 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 or a menstrual-like bleeding.
If you are unsure how to proceed, consult your doctor.
If you interrupt the treatment with Drosure Diario
You can stop taking Drosure Diario 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 Diario and wait until your period before trying to get 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 Drosure 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 Drosure Diario”.
The following list of side effects has been associated with the use of Drosure Diario.
Frequent side effects(may affect up to 1 in 10 people):
- headache, depressive mood,
- migraine,
- nausea,
- menstrual disorders, intermenstrual bleeding, breast pain, breast tenderness
- thick, white vaginal discharge and vaginal yeast infection.
Infrequent side effects(may affect up to 1 in 100 people):
- breast enlargement, changes in sex drive,
- high blood pressure, low blood pressure,
- vomiting, diarrhea,
- acne, skin rash, intense itching, hair loss (alopecia),
- vaginal infection,
- fluid retention and changes in body weight.
Rare side effects(may affect up to 1 in 1,000 people):
- allergic reactions (hypersensitivity), asthma,
- breast secretion,
- hearing problems,
- blockage of a blood vessel by a clot formed in some part of the body,
- skin disorders such as erythema nodosum (characterized by painful red nodules on the skin) or erythema multiforme (characterized by skin rash with red spots or ulcers),
- harmful blood clots in a vein or artery, for example:
- in a leg or foot (i.e., DVT),
- in a lung (i.e., PE),
- heart attack,
- stroke,
- mild stroke or temporary symptoms similar to a stroke, known as transient ischemic attack (TIA),
- 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: facial swelling, tongue and/or throat swelling and/or difficulty swallowing or potentially life-threatening urticaria (see also the section “Warnings and precautions”).
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
5. Daily Storage of Drosure
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.Deposit empty packaging and unused medications at the SIGRE Pointat the pharmacy. In case of doubt, ask your pharmacist how to dispose of empty packaging and unused medications. By doing so, you will help protect the environment.
6. Contents of the packaging and additional information
Composition of Drosure Daily
Each blister of Drosure Daily contains 21 active yellow tablets in the 1st, 2nd, and 3rd rows of the blister, and 7 white placebo tablets in the 4th row.
Active Tablets
The active principles are 0.03 mg of etinilestradiol and 3 mg of drospirenona.
The other components are:
Tablet core: lactose monohydrate, cornstarch, pregelatinized cornstarch, crospovidone, povidone, polisorbate 80, magnesium stearate.
Coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, and yellow 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, yellow 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.
Drosure Daily is available in boxes of 1, 2, 3, 6, and 13 blisters, 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. C/ La Vallina s/n
24008 - Villaquilambre, León.
Spain
Or
ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.
Production Branch in Nowa Deba, Ul. Metalowca 2
39-460 Nowa Deba
Poland
This medication is authorized in the member states of the European Economic Area with the following names:
Czech Republic | Jangee |
Greece | Eronileight 0.03 mg/3 mg |
Spain | Drosure 0.03 mg/3 mg film-coated tablets EFG |
Ireland | Ethinylestradiol/Drospirenone Leon Farma & placebo 0.03 mg/3 mg film-coated tablets |
Poland | Vibin |
Romania | Jangee 0.03 mg/3 mg 28 film-coated tablets |
Slovakia | KarHleight |
Last review date of this leaflet: November 2022
For detailed and updated information on this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es.
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