Please read this leaflet carefully before taking this medicine.
• Keep this leaflet, You may need to read it again.
• If you have any questions, Consult your doctor or pharmacist.
• This medicine has been prescribed for you and you should not give it to others, even if their symptoms,as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist
Table of Contents
1. DROSURELLE WHAT IS AND WHAT IT IS USED
Drosurelle is a contraceptive and is used to prevent pregnancy.
Each active tablet contains a small amount of two different female hormones, called drospirenone and ethinylestradiol.
Contraceptives containing two hormones are called combined contraceptive.
2. ANTES DE TOMAR DROSURELLE
Before you start taking Drosurelle, the doctor will ask you questions about your personal and family medical history. The doctor will also measure your blood pressure and, depending on your health, perform other tests.
In this leaflet describes several situations in which you should discontinue using Drosurelle, or in that the effect may decrease Drosurelle.
In such situations you should not have sex or you should take extra non-hormonal contraceptive precautions, as the use of condoms or other barrier method.
Do not use the rhythm method or the temperature. These methods can be unreliable because Drosurelle alters the monthly changes in body temperature and cervical mucus.
Drosurelle, like other hormonal contraceptives, not protect against HIV infection (PAGE) or any other sexually transmitted disease.
When not to use Drosurelle
No Volume Drosurelle:
• if you have (or have ever had) a blood clot in a blood vessel of the leg (thrombosis), of the lung (pulmonary embolism) or other organs
• if you have (or have ever had) a heart attack al a stroke
• if you have (or have ever had) any disease that could be indicative of a heart attack in the future (por ejemplo, angina, that causes severe chest pain) or stroke (por ejemplo, passenger stroke and mild with no residual effects).
• if you have any conditions that may increase the risk of developing a blood clot in the arteries. This refers to the following diseases: diabetes with the involvement blood vessels, aeterial very high voltage or very high fat levels in the blood (cholesterol or triglycerides)
• if you have a coagulation disorder (por ejemplo, deficiency of protein C).
• if you have (or have ever had) a certain kind of migraine (with focal neurological symptoms called)
• if you have (or have ever had) Pancreatic inflammation (pancreatitis)
• if you have (or have ever had) liver disease and liver function has not been standardized yet. • if your kidneys are not working well (renal failure).
• if you have (or have ever had) a tumor in the liver.
• if you have (or have ever had), or is suspected breast cancer or cancer of the genital organs.
• if you have vaginal bleeding, unknown cause.
• if you are allergic to ethinylestradiol or drospirenone, or any of the other components of Drosurelle. This can cause itching, eruption of the inflammation.
Take special care with Drosurelle
In some situations, You should be especially careful while using Drosurelle or other combined contraceptive, and may require that your doctor check periodically. Consult your doctor before you start using Drosurelle if any of the following disorders affect you or worsen while using Drosurelle:
• if a close relative has or has had in the past breast cancer
• if you have liver disease or gallbladder
• if you have diabetes
• if you have depression
• if you have Crohn's disease or inflammatory bowel disease (ulcerative colitis)
• if you have (blood disease called HUS (Hemolytic uremic syndrome) that produce kidney damage
• if you have a blood disorder called sickle cell disease
• if you have epilepsy (see "Taking other medicines")
• if you have an immune system disease called SLE (lupus erythematosus)
• if you have a disease that could have appeared for the first time during pregnancy or during previous use of sex hormones (por ejemplo, hearing loss, blood disease called porphyria, rash with blisters during pregnancy (herpes gestationis), nerve disease in which there are involuntary movements (Sydenham chorea)
• if you have or have ever had chloasma (discoloration of the skin, especially of the face and neck, known as "pregnancy patches"). Then, must avoid direct exposure to the sun or ultraviolet radiation.
• If you have hereditary angioedema, medications that contain estrogen can cause or worsen symptoms. You should see your doctor immediately if you experience symptoms of angioedema such as swelling of the face, lengua y / o Garganta, and / or difficulty swallowing or hives, along with difficulty breathing.
Drosurelle and blood clots in veins and arteries
The use of any combined contraceptive, Included Drosurelle, e lreisgo increases a woman has to suffer the formation of a blood clot in the veins (venous thrombosis), compared to women not taking any contraceptive.
The risk of blood clots in the veins in users of combined pills increases:
• With age
• If you are overweight • If any of your close relatives has had in the past a blood clot in the leg, lungs (pulmonary embolism) or any other body to early uan.
• If you are going to have surgery, if you have had a serious accident or if you are immobilized for a prolonged period. It is important to tell your doctor that you are taking Drosurelle since treatment may have to be stopped. Your doctor will tell you when to start over. This usually occurs after two weeks to recover mobility-
Your chances of having a blood clot when taking the pill increase.
-Of 100.000 women not taking the pill and not pregnant, some 5-10 can have a blood clot in one year.
-Of 100.000 women taking a pill as Drosurelle, 30-40 can have a blood clot in one year, the exact number is unknown.
-Of 100.000 Women who are pregnant, around 60 can have a blood clot in one year.
A blood clot in the veins can travel to the lungs and block blood vessels (called a pulmonary embolism). The formation of blood clots in the veins can be fatal ele 1-2% cases.
The level of risk may vary depending on the type of pill taking. Check with your doctor the options available.
The combination contraceptive use has been associated with an increased risk of a blood clot in the arteries (arterial thrombosis), por ejemplo, lso blood vessels in the heart (heart attack) or brain (stroke).
The risk of a blood clot in the arteries in users of combined pills increases:
• If you smoke. Si usted usa Drosurelle, you are strongly advised to stop smoking, especially if you are over 35 años.
• If increased levels of blood fats (cholesterol or triglycerides)
• If you are overweight.
• If any of your close relatives have suffered a heart attack or stroke at a young age.
• If you have high blood pressure.
• If you have migraines.
• If you have heart problems (valve disorders, heart rhythm disturbances)
Stop taking and contact Drosurelle your doctor immediately if you notice possible signs of a blood clot, such as:
• Severe pain and / or swelling in one leg
• sudden severe pain in the chest, which may reach the left arm
• Sudden trouble breathing
• sudden cough without a clear cusa
• Headache unusual, intense and prolonged or worsening of migraine
• Loss of partial or complete vision, the double vision.
• Difficulty or inability to speak.
• Dizziness or lightheadedness. • Weakness, abnormal sensations or numbness in any part of the body
And cancer Drosurelle
It has been observed slightly breast cancer in women oftener used combined anticondeptivos, but it is not known whether this is due to treatment. Por ejemplo, may be that more tumors are detected in women taking combined contraceptives because they are examined by the doctor more often. The incidence of breast tumors becomes gradually less after stopping combined hormonal contraceptives.
It is important to have regular breast exams and you should see your doctor if you notice any lump.
In rare cases have been reported benign liver tumors, and even more rarely malignant, in contraceptive users. See your doctor if you have severe abdominal pain unusually strong.
Bleeding between periods
During the first few months that you are taking Drosurelle, can have unexpected bleeding (bleeding out of the bye week). If these bleeding persist beyond a few months, or start after a few months, your doctor will examine what is wrong.
What should you do if you do not have the rule during the bye week?
If you have taken all tablets correctly, not had vomiting or severe diarrhea and has not taken other drugs, is likely to be pregnant.
If the rule is not scheduled on two consecutive occasions, you may be pregnant. See your doctor immediately. Do not start with the next pack until you are sure you are not pregnant.
Drosurelle and use of other drugs
Tell your doctor all the time about drugs or herbal preparations you are taking. Also tell any other doctor or dentist who prescribes another medicine (or on a farmacéutico) of that Drosurelle usa. They can tell you if you need to take additional contraceptive precautions (por ejemplo, condoms) and, if so, how long.
Some medications can cause lose its contraceptive effect Drosurelle, or can cause unexpected bleeding. This may occur with:
Drugs used in the treatment of:
-Epilepsy (primidona, phenytoin, barbiturates, carbamazepine, oxcarbazepina)
-TB (por ejemplo, rifampin),
-HIV infection (ritonavir) or other infections (antibiotics such as griseofulvin, penicillin, tetracycline)
-High pressure in the blood vessels of the lungs (bosentan) -The preparations of St. John's wort-containing medicines cyclosporine or lamotrigine antiepileptic (this can lead to an increase in seizure frequency).
Consult your doctor or pharmacist before taking any medicine.
Taking Drosurelle with food and drink
Drosurelle can be taken with or without food and some water if necessary.
If you need a blood test, Discuss with your doctor or the laboratory staff that you are taking a contraceptive, because oral contraceptives can affect the results of some tests.
Pregnancy and lactation
If you are pregnant, Volume No. Drosurelle. If you become pregnant while taking Drosurelle stop treatment immediately and contact your doctor. If you want to get pregnant, can stop drinking anytime Drosurelle (see "If you want to stop taking Drosurelle")
Consult your doctor or pharmacist before taking any medicine.
Overall, No changes are recommended Drosurelle during breastfeeding. If you want to take birth control while breastfeeding, should consult with your doctor.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
There is no information to suggest that the use of Drosurelle have any effect on the ability to drive or operate machinery.
Important information about some of the components of Drosurelle
Drosurelle contiene lactosa.
If your doctor has told you have an intolerance to some sugars, contact your doctor before taking the medication.
3. TAKING DROSURELLE
Take one tablet daily Drosurelle, with some water if necessary. You can take the tablets with or without food, but every day at about the same time.
The pack contains 21 tablets. Beside each tablet is printed on the day of the week that should be taken. Yes, por ejemplo, You start on a Wednesday, Take one tablet with "WED" next. Follow the direction of the arrow on the container until you have taken the 21 tablets.
Después, should not take any pills for 7 days. Throughout these 7 days not to take tablets (week rest period called), menstruation should occur. Menstruation, also also be called "withdrawal bleeding", habitualrmente starts the 2nd or 3rd day of the week off.
On the 8th day of taking the last tablet Drosurelle (ie, after the rest period 7 days), should start the next pack, without terminating the period. This means you should start each package the same day of the week, and that the period should take place on the same days every month.
If you use thereby Drosurelle, also be protected against pregnancy during the 7 days that takes no tablet.
When can you start with the first container?
If you have not used a hormonal contraceptive in the past month.
Start taking Drosurelle the first day of the cycle (ie, the first day of your period). If Drosurelle begins the first day of your period, immediately be protected against pregnancy. You can also start day 2-5 cycle, but you must use additional contraception (por ejemplo, a condom) during the first 7 days.
Changing from a combined hormonal contraceptive, combined contraceptive vaginal ring or patch.
You can start taking Drosurelle preferably the day after taking the last active tablet (last tablet containing the active principle) of its preceding contraceptive, but no later than the day following its bye week previous contraceptive (or after taking the last inactive tablet of your previous birth control) When changing from a combined contraceptive vaginal ring or patch, follow the recommendations of your doctor.
Changing from a progestogen method based exclusively on (pill, injection, IUD implant or progestogen-releasing IUD).
You can change from the progestogen only pill, any day (if it is an implant or IUD, the day of his retirement; if it is an injectable, when the next injection), but in all cases use additional contraceptive measures (por ejemplo, a condom) during 7 early days of tablet-.
After an abortion.
Follow your doctor's recommendations.
After having a baby.
After having a baby, can start taking Drosurelle between 21 and 28 days. If you start later, use a so-called barrier methods (por ejemplo, a condom) during 7 first days of using Drosurelle.
Yes, After having a baby, you have already had sex before you start taking Drosurelle (de nuevo), You must first be certain she is not pregnant or wait for her next menstrual period.
If you are breastfeeding and want to start taking Drosurelle (de nuevo) after having a child, read "Breastfeeding”.
Ask your doctor if you are unsure of when to start.
If you take more than you should Drosurelle
There are no reported cases in which the ingestion of an overdose has caused serious damages Drosurelle.
Symptoms that may occur if you take many tablets at once are nausea and vomiting. Adolescent women may experience vaginal bleeding.
If you have taken too many tablets Drosurelle, or discovers that a child has taken, immediately consult your doctor or pharmacist or call the local poison control 91 562 04 20 indicating the drug and the amount used.
If you forget to take Drosurelle
If you are late less than 12 hours in taking any tablet, protection against pregnancy decreases. Take the tablet as soon as you remember and the next tablet at the usual time.
If you are late more 12 hours in taking any tablet, protection against pregnancy can be reduced. The more tablets have forgotten, the greater the risk that the protection against pregnancy decrease.
The risk of incomplete protection against pregnancy is greatest if you forget to take your tablet at the beginning or end of the package. Por tanto, should follow the following recommendations (see also the diagram below):
- Forgetting over a tablet of: Check with your doctor.
- One tablet forgotten in week 1: Take the missed tablet as soon as you remember, even if it means having to take two tablets at once. Keep taking the tablets again at the usual time and use extra precautions, por ejemplo, condoms, during 7 days. If you have had sex in the week before forgetting the tablet, may be pregnant. Then, ask your doctor.
- One tablet forgotten in week 2: Take the missed tablet as soon as you remember, even if it means having to take two tablets at once. Keep taking the tablets again at the usual time. The contraceptive protection is not reduced and you do not need to take extra precautions.
- One tablet forgotten in week 3:You can choose between two possibilities:
- Take the missed tablet as soon as you remember, even if it means having to take two tablets at once. Keep taking the tablets again at the usual time. Instead of starting the rest period, start the next pack. Probably will rule at the end of the second pack, although there may be slight bleeding like the rule or during the taking of the second container.
- You can also stop taking tablets and move directly to the bye week (noting the day you missed the tablet). If you want to start a new pack that always begins, rest period should last less than 7 days.
If you follow one of these two recommendations, remain protected against pregnancy.
If you forgot to take some pills and no mentruación during the first cycle of rest, may be pregnant. Contact your doctor before starting the next pack.
What to do in case of vomiting or severe diarrhea?
If you have vomiting in 3-4 hours after taking a tablet or have severe diarrhea, there is a risk that the active substances are not fully absorbed by the organism. The situation is almost equivalent to the forgetfulness of a tablet. After vomiting or diarrhea, should take one tablet of a container reserve as soon as possible. If possible, Take within 12 hours after the usual time you take your birth control. If it is not possible or has been more than 12 hours, follow the advice in "If you miss Drosurelle”.
Delaying your period: What you should know
Although not recommended, can delay your period if you start taking a new pack of Drosurelleen instead of continuing with the bye week and ends. You can experience during the second container or light bleeding similar to the rule. Following the usual bye, Enter the next pack.
You should ask your doctor for advice before deciding to delay your period.
Change the first day of your period: What you should know
If you take the tablets as directed, your period will begin during the corresponding week rest period all. If you have to change the day, reduce the number of days off (but never increase - 7 max!). Por ejemplo, if their rest days usually begin on Friday and want to change to Tuesdays (3 days before), start a new pack 3 days earlier than usual. If you do that the rest period is very short (por ejemplo, 3 days or less), may not occur bleeding during these days. Then you can experience light bleeding or similar to the rule.
If you are unsure of how to proceed, Tell your doctor.
If you stop taking Drosurelle
You can stop when you want to take Drosurelle. If you do not want to get pregnant, talk to your doctor about other methods of birth control effective.
If you want to get pregnant, stop taking Drosurelle and wait until your period before trying to get pregnant. Then you can calculate the date of delivery estimda more easily.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Drosurelle can have adverse effects, although not everybody gets them.
The following listing of adverse effects has been associated with the use of Drosurelle.
– Common adverse effects (affect between 1 and 10 each 100 Users):
• changes in mood,
• abdominal pain (stomach ache),
• breast pain, breast enlargement, painful or irregular periods,
• weight gain.
-Uncommon side effects (affect between 1 and 10 each 1.000 Users):
• Candida (a yeast infection),
• cold sores (herpes simple), • allergic reactions
• increased appetite,
• depression, nervousness, sleep disturbances, decreased interest in sex,
• pins and needles, vertigo,
• vision problems,
• irregular heart rate or unusually fast,
• clots (thrombosis) into a blood vessel in the legs or lungs (pulmonary embolism), increased blood pressure, lowering blood pressure, migraine, Varicose veins,
• sore throat,
• nauseas, vomiting, inflammation of the stomach and / or intestine, , diarrhea, constipation,
• sudden swelling of the skin and / or mucous membranes (por ejemplo, o lengua Garganta), and / or difficulty swallowing or hives together with difficulty breathing (angioedema), Hair loss (alopecia), eczema, itching, rash, dry skin, Oily Skin disorders (dermatitis seborreica),
• neck pain, pain in extremity, muscle cramps,
• bladder infection,
• breast lumps (benign or cancer), milk without being pregnant (galactorrhea), ovarian cysts, flushing, no rule, heavy periods, vaginal discharge, vaginal dryness, pain in the lower abdomen (pelvic), abnormal cervical smears (Pap Pap staining the),
• fluid retention, lack of energy, excessive thirst, increased sweating,
• weight loss.
– Rare side effects (affect between 1 and 10 each 10.000 Users):
• hearing problems
• obstruction of a blood vessel by a clot formed elsewhere in the body
• erythema nodosum (characterized by painful nodules on the skin reddish)
• erythema multiforme (redness rash shaped target or ulcers)
If you notice any side effects not mentioned inthis prospectus or if any of the effects described so serious advesos, conuníqueselo your doctor or pharmacist.
5. Conservacion OF DROSURELLE
Keep out of reach and sight of children.
This medicine does not require special storage conditions.
Do not take Drosurelle after the expiration date on the carton after the phrase "Do not use after:"Or" CAD:”
Medicines should not be disposed of via wastewater or household waste. Place containers and medicines no longer required in the pharmacy SIGRE Point. If in doubt, ask your pharmacist how to dispose of medicines no longer required. Thus, help protect the environment.
6. ADDITIONAL INFORMATION
The active principles are 0,02 mg of ethinyl estradiol and 3 mg the drospirenona.
The other ingredients are:
Tablet core: lactose monohydrate, Pregelatinized corn starch, povidone, croscarmellose sodium, polisorbato 80, magnesium stearate.
Cover: Partially hydrolyzed polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, talc, yellow iron oxide (E-172), red iron oxide (E-172), black iron oxide (E-172).
Drosurelle appearance and contents of container
The tablets are film-coated tablets, round, rose-colored.
Drosurelle is available in boxes 1, 2, 3, 6 and 13 packaging (blisters), each with 21 tablets
Can be marketed pack sizes.
Holder of the marketing authorization
Laboratorios Effik, SA.
C / San Rafael , 3
28108 Alcobendas (Madrid)
Leon Farma Laboratories, SA.
Pole. In. Navatejera;
The Vallina s / n;
This leaflet was last approved in: January 2012