Summer ®

Read all of this leaflet carefully before you start taking this medicine, it contains
important information for you.
• 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 only for you, Do not pass it on to others even if they have the same symptoms you, as yours.
• If you experience side effects , Consult your doctor or pharmacist, even if it is side effects not listed in this leaflet.

1. What is YAZ and what it is used

Yaz is a contraceptive used to prevent pregnancy.
Each 24 pale pink tablets containing a small amount of two different female hormones, called drospirenone and ethinylestradiol. The,es 4 white tablets containing no active and placebo tablets are called.
Contraceptives containing two hormones are called combined contraceptive.

2. What to know before you start taking YAZ

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

When not to use YAZ
Do not take YAZ:
• if you have (or have had in the past) a blood clot (thrombosis) in a blood vessel of the leg, of the lung (pulmonary 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, that causes severe chest pain) or stroke (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
– 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 had in the past) a certain kind of migraine (with focal neurological symptoms called)
• if you have (or have had in the past) Pancreatic inflammation (pancreatitis)
• if you have (or have had in the past) 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 in the past) a tumor in the liver
• if you have (or have had in the past), 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 components of this drug (In section 6, page 14). This can manifest with itching, eruption of the inflammation.

Warnings and Precautions
In some situations, You should be especially careful while using YAZ or other combined hormonal contraceptive, and may require that your doctor check periodically.
If any of these conditions apply to you, you should tell your doctor before you start taking YAZ. You should also consult your doctor if the following conditions arise or worsen while using YAZ:
• 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 "Other drugs and YAZ”, page 6)
• if you have SLE (lupus erythematosus; a disease of the immune system)
• if you have some diseases that first appeared during pregnancy or a 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 golden-brown spots (cloasma), also called "pregnancy patches", especially in the face. In this case,es, 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.
Consult your doctor before taking YAZ.

Yaz and blood clots in veins and arteries
The use of any combined contraceptive, including YAZ, increases the risk that a woman will suffer the formation of a blood clot in the veins (venous thrombosis), 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 in the leg, lungs or any other organ at a young age
• If you are going to have surgery, has suffered a serious accident or will have to be immobilized for a prolonged period. It is important to tell your doctor in advance that you are taking YAZ since treatment may have to be stopped. Your doctor will tell you when to start again YAZ. 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 like YAZ, 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 in 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 blood clots in the arteries (arterial thrombosis), 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: you are strongly advised to stop smoking while using YAZ, especially if you are over 35 años
• if you have high 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 migraine
• if you have heart problems (valve disorders, cardiac rhythm disturbance).

Stop taking YAZ and contact your doctor immediately if you notice possible signs of 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 cause
• unusual headache, intense or 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

YAZ 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, can be detected more tumors in women using 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 more rarely malignant, in contraceptive users. See your doctor if you have abdominal pain unusually strong.

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

What to do if you do not have the rule during the days of placebo
If you have taken all tablets correctly pale pink assets, 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 the next blister pack until you are sure you are not pregnant.

Other drugs and YAZ
Tell the doctor has prescribed YAZ at all times on drugs or herbal preparations you are taking. Also tell any other doctor or dentist who prescribes another medicine (or on a farmacéutico) that uses YAZ. They can tell you if you need to take additional contraceptive precautions (por ejemplo, condoms) and, if so, how long.
• Some medications can cause lost YAZ contraceptive effect, or can cause unexpected bleeding. This can occur with drugs used in the treatment of:
– Epilepsy (p. not. primidona, phenytoin, barbiturates, carbamazepine, oxcarbazepina)
– TB (p. not. rifampin)
-HIV infection (ritonavir, nevirapina) 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

YAZ may influence the effect of other drugs, por ejemplo:
– medication containing cyclosporin
– the antiepileptic lamotrigine (can lead to an increase in seizure frequency)

Consult your doctor or pharmacist before taking any medicine.

YAZ with food and drink
YAZ 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
If you are pregnant, should not take YAZ. If you become pregnant while taking YAZ should be discontinued immediately and contact your doctor. If you want to get pregnant, can stop taking YAZ anytime (see "If you stop taking YAZ”, page 12).
Consult your doctor or pharmacist before taking any medicine.

Breastfeeding
Overall, YAZ is not advised 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 YAZ has any effect on ability to drive and use machines.

Information about Yaz components

YAZ contains lactose If your doctor has told you have an intolerance to some sugars, contact your doctor before taking YAZ.

3. Taking YAZ

Each blister contains 24 active tablets pale pink, and 4 white placebo tablets.
YAZ tablets of different colors are ordered. A blister contains 28 tablets. Take one tablet daily YAZ, with some water if necessary. You can take the tablets with or without food, but every day at about the same time. Do not confuse the tablets: take a pale pink compressed during the first 24 days and then a white compressed during recent 4 days. After another blister should begin immediately (24 pale pink tablets and then 4 white tablets). Therefore, no interval between two blisters.
Since the composition of the tablets is different, have to start the tablet blister the upper left corner and take the tablets every day. Follow the direction of the arrows on the pack to take the tablets in the correct order.

Preparation of Blister
To help you follow the order making, Each container contains YAZ 7 with self-adhesive strips 7 weekdays. Choose strip the week starting with the day you take the first tablet. Por ejemplo, if you take your first pill on a Wednesday, use the strip that starts with "MIE". Stick the adhesive strip of the week at the top of the blister YAZ, where it says "Place the adhesive strip here!”, so that the first day is positioned above the tablet marked with "1". Now you have a day marked above each tablet and can visually check if you have taken your tablets. The arrows indicate the order of making tablets.
Throughout the 4 days taken placebo tablets (placebo day), menstruation should occur (the so-called withdrawal bleeding). Usually starts the 2nd or 3rd day after taking the last active tablet of pale pink YAZ. After taking the last white tablet, start the next blister, 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 the withdrawal period should occur during the same days every month.
If you use YAZ thus, also protected against pregnancy during the 4 days taking placebo tablet.

When can you start with the first blister
If you have not used a hormonal contraceptive in the past month
Start taking YAZ the first day of the cycle (ie, the first day of your period). If YAZ begins the first day of your period, is immediately protected against pregnancy. You can also start on days 2-5 of cycle, but in that case you should use additional contraception (por ejemplo, a condom) during 7 early days.

Changing from a combined hormonal contraceptive, combined contraceptive vaginal ring or patch
You can start taking YAZ 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 the tablet-free days (or after the last inactive tablet) of its preceding contraceptive. 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, implant releasing intrauterine system (SLI) progestin)
You can change from the progestogen-only pill any day. If it is an implant or SLI, the day of his retirement; if it is an injectable, when the next injection. In all cases you should use additional contraceptive measures (por ejemplo, a condom) during 7 early days of tablet-.

After abortion
Follow your doctor's recommendations.

After having a child
After having a baby, can start taking YAZ 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 YAZ.
Yes, after having a child, you have already had sex, before you start taking YAZ, You must be sure of not being pregnant or wait for her next menstrual period.

If you are breastfeeding and want to start taking YAZ
Read "Breastfeeding”, page 7.
Consult your doctor if you have questions about when to start.

If you take more than you should YAZ
There are no reported cases in which the ingestion of an overdose of YAZ has caused serious damages.
If you take several tablets at once, may have symptoms of nausea or vomiting. Adolescent women may experience vaginal bleeding. If you have taken too many tablets of YAZ, or discovers that a child has taken, check with your doctor or pharmacist.

If you forget to take YAZ

The,es 4 tablets past the 4th row of the blister are placebo tablets. If you missed one of these tablets, not lost YAZ contraceptive effect. You must dispose the placebo tablet forgotten.
If you forgot an active tablet pale pink (1-24 tablets blister), should follow the following tips:
• If you are late less than 12 hours in taking a 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 than 12 hours in taking a tablet, protection against pregnancy can be reduced. The more forgotten tablets, greater the risk of having a pregnancy.
The risk of incomplete protection against pregnancy is greatest if you forget to take a tablet pale pink at the beginning or end of the pack. The following are recommendations to follow in this situation (see also the diagram on page 11):

  • Forgetting over a tablet from the blister: Check with your doctor.
  • One tablet forgotten during days 1-7 (ringside): 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 such, condoms, during 7 days. If you have had sex in the week before forgetting the tablet should know that there is a risk of pregnancy. Then, Tell your doctor.
  • One tablet forgotten during days 8-14 (second row): 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. Protection against pregnancy decreases and you do not need to take extra precautions.
  • One tablet forgotten between days 15 and 24 (third or fourth row): 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 white placebo tablets, discard and start taking the next pack (the day taking the first tablet will be different). Probably, will rule at the end of the second pack, while taking placebo tablets-though white may experience spotting or bleeding during the taking of the second pack. 2. You can also stop taking active tablets pale pink and go directly to the 4 white placebo tablets (before taking the placebo tablets, note the day you forget to take your tablet). If you want to start a new pack on the day fixed home, taking placebo tablets for less than 4 days. If you follow one of these two recommendations, remain protected against pregnancy.

If you forgot to take one tablet of a blister and not the rule during the days of placebo, this may mean that you are pregnant. In this case,es, you should see your doctor before continuing with the next pack.

What to do in case of vomiting or severe diarrhea
If you vomit within 3-4 hours of taking an active tablet pale pink or if you have severe diarrhea, no risk that the tablet 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 pale pink 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 forget to take YAZ”, page 9.

Retraso of the menstrual period: What you should know
Although not recommended, can delay your period if you take the white tablets of placebo in the 4th row and start taking the tablets directly to a new pack of YAZ to finalize this new blister. You may experience spotting (drops or spotting) or bleeding during the use of the second pack. After completing this second pack taking 4 white tablets of the 4th row, start the next pack.
Before deciding to delay your period, ask your doctor.

Change the first day of the menstrual period: What you should know
If you take the tablets as directed, your period will start during the days of placebo. If you have to change this day, can do to reduce the days of placebo (the days taking white tablets) But never stretching - 4 day is the maximum! Por ejemplo, If you start on a Friday and placebo want to change to Tuesday (3 days before), should start a new pack 3 days earlier than usual. It is possible that no bleeding occurs during these days of placebo. Then you may experience spotting or bleeding. If you are unsure of how to proceed, Tell your doctor.

If you stop taking YAZ
You can stop taking YAZ whenever you want. If you do not want to get pregnant, talk to your doctor about other effective methods of birth control. If you want to get pregnant, it is advisable to stop taking YAZ and wait until your period before trying to conceive. You can then calculate the expected delivery date more easily. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, YAZ may cause side effects, although not everybody gets them.
The following describes adverse effects associated with the use of YAZ:
– Common adverse effects: may affect up 1 each 10 people

  • changes in mood
  • headache
  • nausea
  • breast pain, problems with irregular periods as periods, no periods

– Uncommon side effects: may affect up 1 each 100 people

  • depression, nervousness, sleepiness
  • dizziness, pins and needles
  • migraine, Varicose veins, increased arterial pressure
  • stomach ache, vomiting, indigestion, flatulence, inflammation of the stomach, diarrhea
  • acne, itching, rash
  • Pains, as back pain, pain in extremity, muscle cramps
  • vaginal yeast infection, pain in the lower abdomen (pelvic), increase in breast size, benign breast lumps, bleeding uterine / vaginal (often refer throughout treatment), vaginal discharge, flushing, inflammation of the vagina (vaginitis), Problems with the rules, painful periods, shorter rules, heavy periods, vaginal dryness, frotis cervical anormal, loss of interest in sex
  • lack of energy, increased sweating, fluid retention
  • weight gain

– Rare side effects: may affect up 1 each 1.000 people

  • white (a yeast infection)
  • anemia, increased number of blood platelets
  • allergic reaction
  • hormonal disorder (endocrine)
  • increased appetite, loss of appetite, concentration of potassium in the blood abnormally high, sodium concentration in the blood abnormally low
  • absence of orgasm, insomnia
  • vertigo, tremors
  • eye disorders, as inflammation of the eyelids, dry eyes
  • unusually rapid heart rate
  • inflammation of a vein, sangrado nasal, fading
  • enlarged abdomen, trastorno intestinal, sensation of flatulence, hernia gástrica, mouth infection yeast, constipation, dry mouth
  • pain in the bile ducts or gallbladder, inflammation of the gallbladder
  • pardoamarillentas spots in the skin, eczema, Hair loss, inflammation of acne-like skin, skin dryness, skin inflammation swellings, excessive hair growth, Skin Disorder, stress marks on the skin, skin inflammation, inflammation of skin photosensitivity, skin nodules
  • difficult or painful intercourse, inflammation of the vagina (vulvovaginitis), bleeding after intercourse, withdrawal bleeding, cyst in the breast, increasing the number of mammalian cells (hyperplasia), malignant breast lumps, Abnormal growth of the mucosal surface of the cervix, shrinkage or loss of the lining of the uterus, fluid-filled sac-like structures in an ovary, enlarged uterus
  • discomfort
  • weight loss

Also have reported the following side effects, but their frequency can not be estimated from available data: hypersensitivity, erythema multiforme (redness rash shaped target or ulcers).
If you experience side effects, Consult your doctor or pharmacist, even if it is side effects not listed in this leaflet.

5. YAZ Conservation

Keep this medicine out of the sight and reach of children.
This medicine does not require special storage conditions. Do not take this medicine after the expiry date which is stated on the carton after "Do not use after:"Or" CAD:”. The expiry date is the last day of that month.
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. Package contents and additional information

Composition of YAZ
• The active substances are ethinylestradiol (As clathrate betadex) and drospirenone. Each active film-coated tablet contains pale pink 0,020 mg ethinylestradiol (As clathrate betadex) and 3 mg drospirenone.
• The white film-coated tablets contain no active.
• The other ingredients are:
– Active film-coated tablets pale pink:
Tablet core: lactose monohydrate, cornstarch, magnesium stearate (E470b). Tablet Film Coating: hipromelosa (E464), talc (E553b), titanium dioxide (E171) and iron oxide red (E172).
– Film-coated tablet white inactive:
Tablet core: lactose monohydrate, cornstarch, povidona K25, magnesium stearate (E470b).
Tablet Film Coating: hipromelosa (E464), talc (E553b) and titanium dioxide (E171).

Looks like and contents of container
• Each blister contains YAZ 24 active film-coated tablets pale pink in the 1st, 2ª, 3and 4th row of the blister, and 4 white film-coated tablets of placebo in the 4th row.
• YAZ tablets, both pale pink and white, are film-coated tablets; The tablet core is coated.
• The active tablet is pale pink, round convex faces, engraved on one side with the letters "DS" in a regular hexagon including.
• The placebo tablet is white, round convex faces, engraved on one side with the letters "DP" in a regular hexagon including.
• YAZ is available in packages 1, 3, 6 and 13 blisters, each with 28 tablets. Can be marketed pack sizes.

Holder of the marketing authorization
Bayer Hispania, SL.
By. Baix Llobregat, 3 – 5
08970 Sant Joan Despi – Barcelona
Spain

Responsible for manufacturing
Bayer Weimar GmbH and Co. KG
Döbereinerstr. 20, 99427 Weimar, Germany
O
Bayer Pharma AG
13342 Berlin, Germany

This product is authorized in the Member States of the EEA under the
following names:
• Bulgaria, Czech Republic, Estonia, France, Germany, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Polonia, Romania, Slovak Republic, Slovenia, Spain,: SUMMER
• Austria, Belgium, Cyprus, Denmark, Finlandia, Greece, Norway, Portugal, Sweden, United Kingdom: Summer
• Holanda: SUMMER 24+4

This leaflet was prepared in June 2012.

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