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 personally and not pass it on to other people 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. YIRA WHAT IS AND WHAT IT IS USED
Yira 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 YIRA
Before you start taking Yira, 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 Yira, or in that the effect may decrease Yira. 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 Yira alters the monthly changes in body temperature and cervical mucus.
Yira, like other hormonal contraceptives, not protect against HIV infection (PAGE) or any other sexually transmitted disease.
When not to use Yira
Do not take Yira:
– 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 conditions that may be indicative of a heart attack in the future (por ejemplo, angina, which causes severe pain in the chest) 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, 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 if you suspect you have 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 Yira. This can cause itching, eruption of the inflammation.
Take special care with Yira
In some situations, You should be especially careful while using Yira or other combined contraceptive, and may require that your doctor check periodically.
Consult your doctor before you start using Yira if any of the following conditions applies to you or if they arise or worsen while using Yira:
– 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 called HUS (Hemolytic uremic syndrome), that causes 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 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 together with difficulty breathing.
Yira and blood clots in veins and arteries
The use of any combined contraceptive, Included Yira, increases the risk that a woman will suffer the formation of a blood clot in the veins (venous thrombosis), compared to women not taking 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 organ at a young age
– If you need 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 Yira 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 Yira, 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 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. If you use Yira, 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 migraine
– if you have heart problems (valve disorders, heart rhythm disturbances).
Stop taking Yira and contact 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 cause
- unusual headache, intense prolonged, or worsening of migraine
- partial vision loss or complete, the double vision
- difficulty or inability to speak
- weakness, abnormal sensations, or numbness in any part of the body
Yira 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 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 unusual.
Bleeding between periods
During the first few months that you are taking Yira, 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 should examine what is wrong.
What to 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.
Taking other medicines
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 Yira. 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 Yira contraceptive effect, 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, 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
Yira 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 medication.
Taking Yira with food and drink
Yira can be taken with or without food, and with some water if necessary.
If you need a blood test, Discuss with your doctor the laboratory personnel that you are taking a contraceptive, and hormonal contraceptives may influence the results of some tests.
Pregnancy and lactation If you are pregnant, not take Yira. If you become pregnant while taking Yira stop treatment immediately and contact your doctor. If you want to get pregnant, Yira can stop at any time (see "If you want to stop taking Yira”,).
Consult your doctor or pharmacist before taking any medication.
Overall, Yira not recommended during breast-feeding (when you are breastfeeding). If you want to take birth control while breastfeeding, should consult with your doctor.
Consult your doctor or pharmacist before taking any medication.
Driving and using machines
There is no information to suggest that the use of Yira have any effect on the ability to drive or operate machinery.
Important information about some of the components of Yira
Yira contains lactose. If your doctor has told you have an intolerance to some sugars, Consult your doctor before taking this medicine.
3. TAKING YIRA
Take one tablet each day Yira, 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 tablets. Beside each tablet is printed the day of the week in which detabletsdo. 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 withdrawal bleeding, usually starts the 2nd or 3rd day of the week off. On the 8th day of taking the last compridaysde Yira (ie, after the rest period 7 days),
must start with the next pack, although not yet finished bleeding. This means that you should start each package the same day of the week and that menstruation should occur on the same days every month.
If you use this mode Yira, 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 Yira the first day of the cycle (ie, the first day of your period). If Yira 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 Yira 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 Yira between 21 and 28 days after having a baby. If you start later, use a so-called barrier methods (por ejemplo, a condom) during 7 first days of using Yira.
Yes, After having a baby, you have already had sex before you start taking Yira (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 Yira (de nuevo) after having a child
Ask your doctor if you are unsure of when to start.
If you take more than you should Yira
There are no reported cases in which the ingestion of an overdose has caused serious damages Yira.
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 Yira, or discovers that a child has taken, check with your doctor or pharmacist.
In case of overdose accidental ingestion, immediately consult your doctor or pharmacist or call the local poison control, phone 91 562 04 20 indicating the drug and the amount used.
If you forget to take Yira
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, greater the risk of becoming 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. Protection against pregnancy decreases 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 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 and move directly to the rest period 7 days (noting the day you missed the tablet). If you want to start a new pack on the day always begins, 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 some pills and has no bleeding during the first period 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 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 this is not possible or has been more than 12 hours, follow the advice in "If you forget to take Yira”.
Delaying your period: What you should know
Although not recommended, may delay your period if you start taking a new pack of Yira 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: What you should know
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 want to stop taking Yira
You can stop when you want Yira. 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, Yira stop and wait until your period before trying 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, Yira can cause side effects, although not everybody gets them.
The following listing of adverse effects has been associated with the use of Yira:
– Common adverse effects (affect between 1 and 10 each 100 Users):
- menstrual disorders, hemorragia intermenstrual, breast pain, breast tenderness
- headache, depressed mood
- thick whitish vaginal discharge and vaginal yeast infection
– Uncommon side effects (affect between 1 and 10 each 1.000 Users):
- Increasing the size of the breast, changes in sexual interest
- High Blood Pressure, Lower Blood Pressure
- vomiting, diarrhea
- acne, rash, intense itching, Hair loss (alopecia)
- Vaginal Infection
- fluid retention and body weight changes
– Rare side effects (affect between 1 and 10 each 10.000 Users):
- reacciones alérgicas (hypersensitivity), suspended
- breast secretion
- blockage of a blood vessel by a blood clot formed in a body part
- skin disorders such as erythema nodosum (characterized by painful nodules on the skin reddish) one erythema multiforme (characterized by rash 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. YIRA STORE
Yira Keep out of the reach and sight of children. In keep the temperature above 25 ° C. Store in original container. Yira not use after the expiration date on the carton after the words "No
after use:"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. ADDITIONAL INFORMATION
Composition of Yira
The active substances are drospirenone and ethinylestradiol.
Each active tablet contains 3 mg of drospirenone and 0,03 mg ethinylestradiol.
Other components (excipients) are lactose monohydrate, cornstarch, Pregelatinized corn starch, povidone 25.000, magnesium stearate, hipromelosa, macrogol 6000, talc, titanium dioxide (E-171) and iron oxide yellow (E-172).
Looks like and contents of the pack Yira
Each blister contains Yira 21 Film-coated tablets pale yellow.
The compressed tablets are coated Yira, The tablet core is coated.
The tablets are pale yellow, rounded, with the convex surfaces, one side and bears the letters 'DO' marked in a regular hexagon.
Yira 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 authorization
Bayer Hispania, SL.
By. Baix Llobregat, 3 – 5
08970 Sant Joan Despi – Barcelona
Responsible for manufacturing
JENAPHARM ANDCO GMBH KG
(Jena) – D-7745
BAYER SCHERING PHARMA AG
Mueller cup, 170-178
(Berlin) – 13353
This product is authorized in the Member States of the EEA under the following names:
Netherlands: Ethinylestradiol / Drospirenone 0,03 / 3 mg Berlipharm
Germany, Portugal: Petibelle
This leaflet was last approved in Abril/2012.