YASMINELLE ®

Please read this leaflet carefully before taking this medicine.
• Keep this leaflet. You may have to read it again.
• If you have any questions, Consult your doctor or pharmacist.
• This medicine has been prescribed for you personally and you should not pass on to others. Yours.
• If you notice any side effects not listed in this leaflet, or if you have one of the side effects become serious, tell your doctor or pharmacist.

1. YASMINELLE WHAT IS AND WHAT IT IS USED?

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

2. BEFORE TAKING YASMINELLE

Considerations
Before you start taking Yasminelle, your doctor will ask you questions about your personal and family medical history. The doctor will also measure your blood pressure and, depending on your personal situation, may carry out some other tests. In this leaflet describes several situations in which you should discontinue using Yasminelle, or in that the effect may decrease Yasminelle. In such situations you should not have sex or you should take extra non-hormonal contraceptive precautions, por ejemplo, use of condoms or other
barrier method. Do not use the rhythm method or the temperature. These methods can be unreliable because Yasminelle alters the monthly changes in body temperature and cervical mucus.
Yasminelle, like other hormonal contraceptives, not protect against HIV infection (PAGE) or any other sexually transmitted disease.

When you must not use Yasminelle?
• if you have (or have had in the past) blood clots (thrombosis) in a blood vessel of the leg, of the lung (embolism) or other organs
• if you have (or have had in the past) a heart attack al a stroke
• if you have (or have had in the past) any conditions that may lead to suspicion that can occur after a heart attack (por ejemplo, angina, which causes severe pain in the chest) or accident
cerebrovascular (por ejemplo, passenger stroke and mild with no residual effects). • if you have a disease that may increase the risk of thrombosis in arteries. This refers to the following diseases: diabetes with damaged blood vessels, very high blood pressure and 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 had) a certain kind of migraine (with focal neurological symptoms called)
• if you have (or had) Pancreatic inflammation (pancreatitis)
• if you have or have had in the past a liver disease and liver function has not been standardized yet.
• if your kidneys are not working well (renal failure).
• if you have or have had a liver tumor.
• if you have (or had), or is suspected breast cancer or cancer of sexual organs.
• if you have vaginal bleeding, unknown cause.
• if you are allergic to ethinylestradiol or drospirenone, or any of the other ingredients of Yasminelle. This can manifest with itching, eruption of the inflammation.

When should be especially careful with Yasminelle?
In some situations, You should be especially careful while using Yasminelle or other combined hormonal contraceptive, and may require that your doctor may perform regular checks. If any of these conditions affect you, you should tell your doctor before you start using Yasminelle. It should also
talking to your doctor if the following conditions arise or worsen while using Yasminelle:
• if a close relative has or has 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 ulcerative colitis (inflammatory bowel disease)
• if you have SHU (Hemolytic uremic syndrome; a disease of the blood that causes kidney damage)
• if you have sickle cell disease (an inherited disease of red blood cells)
• if you have epilepsy (see "Yasminelle and use of other drugs”)
• if you have SLE (lupus erythematosus; a disease of the immune system)
• if you have some diseases that first appeared during pregnancy or during previous use of sex hormones; por ejemplo, hearing loss, porphyria (a blood disease), herpes gestationis (rash with blisters during pregnancy), Sydenham chorea (nerve disease in which there are involuntary movements)
• if you have or have ever had chloasma (golden brown spots, also called "pregnancy patches", especially in the face). Then, must avoid direct exposure to the sun or ultraviolet radiation.
• if you have hereditary angioedema, products containing estrogens may induce or exacerbate symptoms of angioedema. You should see your doctor immediately if you experience symptoms of angioedema such as swelling of the face, lengua y / o faringe, and / or difficulty swallowing or hives, along with difficulty breathing.

Potentially serious diseases

Venous thrombosis
The use of any combined contraceptive, Included Yasminelle, increases the risk that a woman will suffer a venous thrombosis (formation of a blood clot in blood vessels), compared with a woman who does not take any contraceptive.
The risk of venous thrombosis in users of combined pills increases:
• with age
• if you are overweight,
• If any of your close relatives has had a blood clot (thrombosis) in the leg, lungs or any other organ at a young age,
• If you are going to have surgery, will have to be immobilized for a prolonged period or have had a serious accident. It is important to tell your doctor in advance that you are taking Yasminelle since treatment may have to be stopped. Your doctor will tell you when
Yasminelle start again. This usually occurs after two weeks to recover mobility.

Arterial thrombosis
The use of combination contraceptives has been associated with an increased risk of arterial thrombosis (blockage of an artery), por ejemplo, in blood vessels of the heart (heart attack) or brain (stroke).
The increased risk of arterial thrombosis in users of combined pills:
• if you smoke. If you use Yasminelle, 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 have high blood pressure
• if you have migraine • if you have heart problems (valve disorders, heart rhythm disturbances)

Stop taking Yasminelle and immediately seek your doctor if you notice possible signs of thrombosis, 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 cause
• unusual headache, intense and prolonged or worsening of migraine
• partial vision loss or complete, the double vision
• difficulty or inability to speak
• dizziness
• weakness, abnormal sensations, or numbness in any part of the body

Yasminelle and cancer
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 lumps.
In rare cases have been reported benign liver tumors, and even more rarely malignant, in contraceptive users. See your doctor if you have sudden severe abdominal pain.

Bleeding between periods
During the first few months that you are taking Yasminelle, can have unexpected bleeding (bleeding outside the period of rest). If these bleeding persist beyond a few months, or start after a few months, Your doctor should investigate the cause.

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 very unlikely that you are 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.

Yasminelle and use of other drugs

Tell the doctor has prescribed Yasminelle at all times about medications or herbal preparations you are taking. Also tell any other doctor or dentist who prescribes another medicine (or on a farmacéutico) that uses Yasminelle. They can tell you if you need to take additional contraceptive precautions (por ejemplo, condoms) and, if so, how long.

Some medications can cause loss Yasminelle contraceptive effect, or can cause unexpected bleeding:

  • Drugs used in the treatment of epilepsy (primidona, phenytoin, barbiturates, carbamazepine, oxcarbazepina)
  • Drugs used in the treatment of tuberculosis (por ejemplo; rifampin), or HIV (ritonavir) or other infectious diseases (griseofulvina, ampicillin, tetracycline)
  • Medicinal herbal preparations containing St. John's wort. If you want to use herbal preparations containing St. John's wort while taking Yasminelle, should consult their doctor before.

Yasminelle may decrease the effectiveness of other medications, por ejemplo, those containing cyclosporine or anticonvulsant lamotrigine (this can lead to an increase in seizure frequency).

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
If you are pregnant, stop taking Yasminelle. If you become pregnant while taking Yasminelle should be discontinued immediately and contact your doctor.
Consult your doctor or pharmacist before taking any medicine.

Breastfeeding

Overall, not recommended to take Yasminelle during lactation. 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 Yasminelle have any effect on the ability to drive or operate machinery.

Important information about some of the ingredients of Yasminelle
Yasminelle contains lactose. If you can not tolerate some sugars, consult your doctor before taking Yasminelle.

3. HOW TO TAKE YASMINELLE?

Take one tablet daily Yasminelle, with some water if necessary. You can take the tablets with or without food, but every day at about the same time.
The container (blíster) contains 21 pink tablets stick. 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. Then should not take any pills for 7 days. Throughout these 7 days on which tablets are not taken (week rest period called), menstruation should occur. Menstruation, which may also be called bleeding
deprivation, usually starts the 2nd or 3rd day of the week off. On the 8th day of taking the last tablet Yasminelle (ie, after the rest period 7 days), start the next pack, menstruation but not finalized. This means that you should start the next pack on the same
day of the week that started earlier and that menstruation should occur on the same days every month.
If you use this mode Yasminelle, 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 Yasminelle the first day of the cycle (ie, the first day of your period). If Yasminelle begins the first day of your period, is immediately protected against pregnancy. You can also start the cycle days2-5, 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 Yasminelle the day after their bye week previous contraceptive (or after taking the last inactive tablet). When changing from a combined contraceptive vaginal ring or
patch, follow the recommendations of your doctor.

Changing from a progestogen method based exclusively on (minipíldora, injection, IUD implant or progestogen-releasing IUD)
You can switch any day from the minipill (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 it is recommended that you 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 Yasminelle between 21 and 28 days. If you start later, must use one of the methods known barrier (por ejemplo, a condom) during 7 first days of
Using Yasminelle. Yes, After having a baby, you have already had sex before you start taking Yasminelle (de nuevo), You must first be certain she is not pregnant or wait for her next menstrual period. Let your doctor tells you if you are not sure when to start.

If you are breastfeeding and want to start taking Yasminelle (de nuevo) after having a child
Read "Breastfeeding”.

If you drink more than I should Yasminelle
There are no reported cases in which the ingestion of an overdose has caused serious damages Yasminelle.
Symptoms that may occur if you take many tablets at once are nausea and vomiting. Adolescent women may experience slight vaginal bleeding. If you have taken too many tablets Yasminelle, or discovers that a child has taken, check with your doctor or pharmacist.
In case of overdose accidental ingestion, consult the local poison control. Telephone 915 620 420.

If you miss Yasminelle

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. The following are recommendations to follow in this situation (see also the diagram):
• Forgetfulness 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 or have forgotten start a new pack after the rest period, should know that there is a risk of pregnancy. Then, Tell your doctor.
• One tablet forgotten in week 2: Take the missed tablet as soon as you remember, although this
means that you have to take two tablets at once. Keep taking the tablets again at the usual time. The effect of Yasminelle not decrease 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 again at the usual time. Instead of continuing with the bye week, start taking the next pack. Probably will rule (withdrawal bleeding) at the end of the second pack, but you may have spotting or bleeding while taking the second pack.
  2. 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 strip inits start date set, your 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 a tablet and not the rule during the first period of rest, this may mean that you are pregnant. Then, you should see 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 ingredients are not fully absorbed by the organism. This is similar to what happens when you forget 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 Yasminelle”.

Retraso of the menstrual period: What you should know?
Although not recommended, can delay your period (withdrawal bleeding) to the end of a new pack if you start taking a second container of Yasminelle instead of continuing with the bye week. You may experience while using the second pack spotted (drops or spotting) or bleeding. Following the usual bye, starts again 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, of menstrual period (withdrawal bleeding) begin during the week for the period of rest. If you have to change the day of the week, I can shorten the bye week (But no longer!). Por ejemplo, if their bye week usually begins on Friday and want to change it to Tuesdays (3 days before), should 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), can not occur through bleeding (rule) during the rest period. Then you can experience
stained (drops or spotting) or bleeding. If you are unsure of how to proceed, Tell your doctor.

If you want to stop taking Yasminelle
You can stop when you want to take Yasminelle. If you do not want to get pregnant, talk to your doctor about other methods of birth control effective. If you have any further questions on the use of this product, Consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Yasminelle may have adverse effects, although not everybody gets them.
• Common side effects (affecting more than 1 each 100, but unless 1 each 10 women): Changes in mood, headache, abdominal pain (stomach ache), acne, breast pain, breast enlargement, painful or irregular periods, weight gain
• Uncommon side effects (affecting more than 1 the 1.000, but unless 1 the 100 women): Candida (a yeast infection), cold sore (herpes simple), allergic reactions which can sometimes be severe
(angioedema) with swelling of the skin and / or mucous membranes, increased appetite, depression, nervousness, sleep disturbances, decreased libido (interest in sex), pins and needles, vertigo, vision problems, irregular heart rate or unusually rapid, clots (thrombosis) in a blood vessel in the leg or lung (pulmonary embolism), increased blood pressure, migraine, Varicose veins, sore throat, inflammation of the stomach and / or intestine, nausea, vomiting, diarrhea, constipation, Hair loss (alopecia), itching, Rashes, dry skin, 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.

If you notice any side effects not listed in this leaflet, or if any of the side effects become serious, Tell your doctor or pharmacist

5. How to keep YASMINELLE?

Yasminelle Keep out of the reach and sight of children.
This medicine does not require any special storage conditions
Yasminelle not use after the expiration date on the carton after the phrase "Do not use after:"Or" CAD:”

6. ADDITIONAL INFORMATION

What contains Yasminelle?
• The active substances are ethinylestradiol (as clathrate betadex) and drospirenone. Each tablet contains 0,020 mg ethinylestradiol (as clathrate betadex) and 3 mg the drospirenona.
• The other ingredients (excipients) are lactose monohydrate, cornstarch, magnesium stearate (E-470b), hipromelosa (E-464), talc (E-553b), titanium dioxide (E-171) and pigment red iron oxide (E-172).

Appearance and contents of container Yasminelle
Yasminelle film-coated tablets containing; The tablet core is coated. The coated tablets are pale pink, rounded, with convex faces, and one side bears the letters "DS" in a regular hexagon marked.
Yasminelle is available in boxes 1, 3, 6 and 13 packaging (blisters) each, with
21 tablets. It may not be marketed all presentations.

Holder of the Marketing Authorisation
SA Schering Spain.
Alvaro Mendez, 55
28045 Madrid – Spain

Responsible for manufacturing
Schering AG Schering GmbH and Co. Production
KG
Berlin, Alemania Weimar, Germany

This product is authorized in the Member States of the Economic
Names with the following European:
• Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finlandia,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Polonia, Slovakia, Slovenia, Spain,
Sweden, United Kingdom: Yasminelle
• France: Jasminelle

This leaflet was approved in August 2006

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