Drosure ®

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 should not give it to others even if they have the same symptoms you, 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

1. DROSURE WHAT IS AND WHAT IT IS USED

Drosure is a contraceptive and is used to prevent pregnancy.
Each tablet contains a small amount of two different female hormones, ethinylestradiol and drospirenone called.
Contraceptives containing two hormones are called tablets "combined”


2. BEFORE TAKING DROSURE

Considerations
Before you start taking Drosure, 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 Drosure, or in that the effect may decrease Drosure.
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 Drosure alters the monthly changes in body temperature and cervical mucus.
Drosure, like other hormonal contraceptives, not protect against HIV infection (PAGE) or any other sexually transmitted disease.

When not to use Drosure
No tome Drosure:
• if you have (or have ever had) blood clots 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 conditions that may 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 damaged blood vessels
• Very high blood pressure
• very high fat levels in the blood (cholesterol or triglycerides)
• if you have a coagulation disorder (por ejemplo, protein C deficiency).
• 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 if you suspect you have 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 Drosure This can manifest itchy, eruption of the inflammation.

Take special care with Drosure:
In some situations, You should be especially careful while using Drosrue or other combined contraceptive, and may require that your doctor check periodically. Consult your doctor before you start using Drosure if any of the following conditions applies to you or if estossurgen or worsen while using Drosure:
• if a close relative has or has ever had 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 a blood disease llamadaSHU (Hemolytic uremic syndrome); that causes kidney damage
• if you have a disease called sickle cell disease
• if you have epilepsy (see "Taking other medicines")
• if you have an immune system disease llamadaLES (lupus erythematosus)
• if you have a disease that first appeared 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 in the face or neck, known as "pregnancy patches"). Then, must avoid direct exposure to the sun or ultraviolet radiation.
• if you have hereditary angioedema, products 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.

Drosure and clots in venous and arterial
The use of any combined contraceptive, Included Drosure, increases the risk of a woman developing venous blood clots(venous thrombosis)), compared with women who did not take any contraceptive.
The risk of a blood clot in the veins in users of combined pills increases:

• with age
• if you are overweight,
• If any of your close relatives ever had a blood clot in the leg, lungs (pulmonary embolism) or any other body, at an early age,
• If you need surgery, if you have had a serious accident or if you have to be immobilized for a prolonged period. It is important to tell your doctor that you are taking Drosure since treatment may be suspended. Your doctor will tell you when to start. This usually occurs after two weeks to recover mobility.
The odds of having a blood clot is increased when taking the pill.
-Of 100.000 women not taking the pill and not pregnant, some 5-10 can may have a blood clot, per annum.
-Of 100.000 Women taking the pill, some 30-40 can have a blood clot, per annum, 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 can travel to the lungs and block blood vessels (called a pulmonary embolism). The formation of blood clots in the veins can be fatal in a 1-2% cases.
The level of risk is closely related to 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, in blood vessels of 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 Drosure, you are strongly advised to stop smoking, especially if you are over 35 años.
• if you have high levels of blood fats (cholesterol or triglycerides)
• if you are overweight
• if algunode their close relatives has had a heart attack or stroke at a young age
• if you have high blood pressure
• if you have migraine
• if you have heart problems (valve disorders, heart rhythm disturbances)

Stop taking and contact Drosure 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 his chest which may reach the left arm
-sudden trouble breathing
-no clear cause coughing repetina
-unusual headache, intense prolonged, or worsening of migraine
-vision loss of complete or partial, the double vision
-difficulty or inability to speak dizziness
-weakness, abnormal sensations or numbness of a body part

And cancer Drosure
It has been observed breast cancer slightly more often in women using combined contraceptive, 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 months of use Drosure, unexpected bleeding may occur (bleeding out of the rest period). If you experience such bleeding for longer than a few months, or begin after a few months, Your doctor must investigate the cause.

What to do if you do not have the time during the bye week?
If you have taken all tablets correctly, has not vomited or suffered severe diarrhea, and has not taken any other medicines, is unlikely to be pregnant.
If you miss two consecutive menstrual periods, might be pregnant. In this case,es, seek medical advice immediately. Do not start the next pack to make sure she is not pregnant.

Drosure and use of other drugs
Tell your doctor or pharmacist if you are taking or have taken other medications, including medicines obtained without a prescription or herbal preparations you are taking. Also tell any other doctor or dentist who prescribes another medicine (or on a farmacéutico) that you use Drosure. 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 Drosure, or can cause unexpected bleeding. This may occur with:drugs used in the treatment of:
-Epilepsy (p. not. primidona, phenytoin, barbiturates, carbamazepine, oxcarbazepina)
-TB (p. not., rifampin)
-HIV infection (ritonavir) or other infections (antibiotics such as griseofulvin, penicillin, tetracycline)
-high blood pressure in the vessels of the lung (bosentan)
-the preparations of St. John's wort.

Drosure may influence the effect of other drugs, por ejemplo,
omedicamentos containing cyclosporin
oel antiepileptic lamotrigine (can lead to an increase in seizure frequency).
Consult your doctor or pharmacist before taking any medicine.

Taking Drosure with food and drink
Drosure can be taken with or without food, and with some water if necessary

Laboratory Tests
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, not take Drosure If you become pregnant while taking Drosure stop treatment immediately and contact your doctor. If you want to get pregnant, can stop drinking anytime Drosure (see "If you stop taking Drosure")
Consult your doctor or pharmacist before taking any medicine.

Overall, No changes are recommended Drosure 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 Drosure have any effect on the ability to drive or operate machinery.

Important information about some of the components of Drosure
Drosure contains lactose. If your doctor has told you have an intolerance to some sugars, Consult your doctor before taking this medicine.

3. TAKING DROSURE

Take one tablet each day Drosure with some water if necessary. You can take the tablets with or without food, but every day at about the same time.
A container (blíster) contains 21 tablets. Beside each tablet is printed the day of the week in which detabletsdo. Por ejemplo, If you start a Wednesday, Take one tablet with "WED" next. Follow the direction of the arrow on the container until you have taken the 21 tablets.
Then should not take any pills for 7 days. Throughout these 7 days on which tablets are not taken (bye call), menstruation should occur. Menstruation, which may also be called withdrawal bleeding, starts the 2nd or 3rd day of the rest of the week.
On the 8th day of taking the last tablet Drosure (ie, after the rest period 7 days ), must start with the next pack, without terminating the bleeding. This means that you should start the next pack on the day of the week and that menstruation should occur on the same days every month.
If you use thereby Drosure, also 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 Drosure the first day of the cycle (ie, the first day of your period). If Drosure 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 Drosure preferably the day after taking the last active tablet (the last tablet containing the active) 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 (progestogen only 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.
You can start taking Drosure between 21 and 28 days after having a baby. If you start later, must use one of the methods known barrier (por ejemplo, a condom) during 7 first days of using Drosure.
Yes, After having a baby, you have already had sex before you start taking Drosure (de nuevo), must be sure of not being pregnant or wait for her next menstrual period.

If you are breastfeeding and want to start taking Drosure (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 Drosure
There are no reported cases in which the ingestion of an overdose of ethinylestradiol / drospirenone has caused serious damages.
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 Drosure, 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 Drosure
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, may become pregnant.
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:

  • 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 at the usual time and use extra precautions, por ejemplo, condom, 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 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:
  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 at the usual time. Instead of starting the rest period, start taking the next pack. Probably will rule at the end of the second pack, but may also have light bleeding or similar to the rule for making the second pack.
  2. You can also stop taking tablets. You must begin a rest period of 7 days (noting the day you missed the tablet). If you want to start a new pack on the day always begins, deberádurar rest period 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 bleeding during the first period of rest, may be pregnant. Contact your doctor before continuing with 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 principles are not contraceptive fully absorbed by the organism. The situation is almost equivalent to the forgetfulness of a tablet. After vomiting or diarrhea, Take one tablet reserve container 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 Drosure”.

How to delay your period

Although not recommended, can delay your period if you start taking a new pack debDrosure instead of continuing with the bye week and ends. You may experience while using the second container or light bleeding similar to the rule. Following the usual bye 7 days, Start the next pack.
You should ask your doctor for advice before deciding to delay your period.

Change the first day of your period
If you take the tablets as directed, your period will start during the bye week. If you have to change that 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 Drosure
You can stop when you want to take Drosure. If you do not want to become pregnant consult your doctor about other methods of effective birth control. If you want to get pregnant, stop taking Drosure and wait until your period to try to get pregnant. You can then calculate the expected delivery date 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, Drosure can cause side effects, although not everybody gets them.
The following listing of adverse effects has been associated with the use of Drosure:

– Common adverse effects (affect between 1 and 10 each 100 Users):
• menstrual disorders, hemorragia intermenstrual, breast pain,
• headache, depressed mood,
• Migraine,
•náuseas,
• letargo, thick whitish vaginal discharge and vaginal yeast infection.

– Uncommon side effects (affect between 1 and 10 each 1.000 Users):
• changes in sexual interest
• high blood pressure, Lower Blood Pressure
• vomiting
• Acne, rash, intense itching
• vaginal infection
• retention and body weight changes

– Rare side effects (affect between 1 and 10 each 10.000 Users):
• Allergic reactions (hypersensitivity), suspended,
• mammary secretion,
• hearing problems,
• obstruction of a blood vessel by a clot formed elsewhere in the body.
• Skin disorders such as erythema (caraterizado by painful nodules on the skin reddish) one erythema multiforme (erupcióncutánea characterized with redness as target or ulcers)

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.

5. DROSURE STORE

Keep out of reach and sight of children.
This medicine does not require special storage conditions.
Journal Drosure not take 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

Composition Drosure:
The active principles are 0,03 mg of ethinyl estradiol and 3 mg the drospirenona.
The other ingredients are:
Tablet core: lactose monohydrate, cornstarch, Pregelatinized corn starch, croscarmellose sodium, povidone, polisorbato 80, magnesium stearate.

Looks like and contents of container
Film-coated tablets, round, yellow.
Drosure is available in boxes 1,2,3,6 and 13 packaging (blisters), each with 21 tablets.
Not all pack sizes may be marketed

Holder of the marketing authorization
Laboratorios Effik, SA.
C / San Rafael , 3
28108 Alcobendas (Madrid)
Spain

Manufacturer
Leon Farma Laboratories, SA.
Pole. In. Navatejera.
C / La Vallina s / n
24008 – Villaquilambre, Leon.
Spain

This leaflet was last approved in: January 2012

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