Qlaira. 28 tablets

What is Qlaira and what it is used
Qlaira pill is to be used for contraception.
Qlaira used to treat heavy menstrual bleeding (not caused by disease of the uterus) in women who wish to use oral contraception.
Each colored active tablet contains a small amount of female hormones - estradiol valerate or estradiol valerate combined with dienogest.
The two white tablets contain no active substances and are called inactive tablets.
Contraceptive pills that contain two hormones are called "combined pills".

2. What you need to know before taking Qlaira
General comments
Before you can start taking Qlaira Your doctor will ask you some questions about your health and that of your close relatives. The doctor will also measure your blood pressure and, depending on your condition, you may also do some additional tests.
In this leaflet describes several situations where you need to stop taking Qlaira or where the reliability of Qlaira can be reduced. In these situations you should refrain from sexual intercourse or you should take extra non-hormonal contraceptive measures, eg. to use a condom or other barrier method. Do not use rhythm or temperature methods. These methods may be unreliable, as amended Qlaira typical monthly changes in body temperature and in the mucus in the cervix.
Qlaira, like other hormonal contraceptives, does not protect against HTV infection (AIDS) or other sexually transmitted diseases.

When you should not take Qlaira
Do not take Qlaira:
if you have (or have had) a blood clot in a blood vessel in the legs (thrombosis), lung (pulmonary embolism) or other organs;
if you have (or have had) a heart attack or stroke;
if you have (or have had) a disease that can be (1) indicative of future heart attack (eg, angina pectoris with severe chest pain) or (2) for stroke (eg, mild stroke with no residual effects);
if you have (or have had) a certain kind of migraine (with so-called focal neurological symptoms);
if you have a condition that may increase the risk of a clot in the arteries. This applies to the following diseases:
diabetes with damage to blood vessels;
very high blood pressure;
very high levels of blood fats (cholesterol or triglycerides);
if you have a bleeding disorder (eg, failure of protein);
if you have (or have had) inflammation of the pancreas (pancreatitis);
if you have (or have had) liver disease and liver function tests continue to be outside the norm;
if you have (or have ever had) a tumor in the liver;
if you have (or have had) cancer or suspected carcinoma of the breast or genital organs;
if you have any unexplained bleeding from the vagina;
if you are allergic (hypersensitive) to estradiol valerate, dienogest or any of the other ingredients of this medicine (listed in section 6). This may cause itching, rash or swelling.
Warnings and Precautions
In some situations you should pay particular attention to the use of Qlaira or other combined pills, but may need your doctor regularly to check you. Consult your doctor before you start taking Qlaira if any of the following conditions applies to you or has appeared or worsened while taking Qlaira:
If your close relative has or ever had breast cancer;
if you have liver disease and gall bladder;
if you have jaundice;
if you have diabetes;
if you suffer from depression;
if you have Crohn's disease or inflammatory bowel disease (ulcerative colitis);
if you have a blood disease called hemolytic uremic syndrome (HUS), in which the kidneys are damaged;
if you have sickle cell anemia;
if you have epilepsy (see "Other medicines and Qlaira");
if you have an immune system disease called systemic lupus erythematosus (SLE);
if you have a disease that appeared for the first time during pregnancy or previous use of sex hormones, for example, hearing loss, porphyria (a disease of the blood), gestational herpes (skin rash with blisters during pregnancy), Sydenham's chorea (nerve disease causing sudden movements of the body);
if you have (or have had) golden brown pigment patches, so called "pregnancy patches", especially on the face (chloasma). In this case, avoid direct contact with sunlight or ultraviolet light;
if you have hereditary angioedema. Immediately consult your doctor if you have symptoms of angioedema such as swollen face, tongue and / or throat and / or difficulty swallowing or hives together with difficulty breathing. Products containing estrogen may cause or worsen symptoms of angioedema;
if you suffer from heart or kidney failure.
Talk to your doctor before taking Qlaira.

Qlaira and venous / arterial blood clots
The following warnings and precautions are based on information from studies with combined pills containing ethinylestradiol. It is not yet known whether they apply to Qlaira:
The use of any combined pill (including Qlaira) increase the risk of the formation of venous blood clots (venous thrombosis) compared with women who did not take any contraceptive pill.

Very rarely, blood clots can cause serious permanent damage or even be fatal. The primary localization of coagulation, for example in the veins of the lower extremities (vein thrombosis) in the arteries of the heart (heart attack), the lungs (pulmonary embolism) or the brain (stroke).

The risk of venous blood clots in users of combined pills increases:
with age;
if you are overweight;
if someone in your immediate family has had a blood clot in the legs, lungs (pulmonary embolism) or other organs at a young age;
if you need surgery if you have had a serious accident or have a prolonged period of immobilisation. It is important to tell your doctor that you are using Qlaira as may be necessary to discontinue treatment. Your doctor will tell you when to restart taking Qlaira. This usually happens about two weeks after you have recovered.
The use of combination pills are associated with an increased risk of blood clot formation in the arteries (arterial thrombosis), for example, in the blood vessels of the heart (heart attack) or the brain (stroke).

The risk of arterial blood clots in women using combined pills increases:
with age;
if you smoke. Our advice is to stop smoking while taking the pills, especially if you are older than 35 years;
if you have high cholesterol or triglycerides in the blood;
if you are overweight;
if someone in your immediate family has had a heart attack or stroke at a young age;
if you have high blood pressure;
if you suffer from migraine;
if you have heart problems (valvulopathy, abnormal heart rhythm).
Stop taking Qlaira and tell your doctor immediately if you notice possible signs of a blood clot or stroke as:
pain and / or swelling in one of the legs;
sudden severe pain in the chest with possible spread to the left arm;
sudden shortness of breath;
sudden coughing for no apparent reason;
any unusual, severe or long-lasting headache or worsening of migraine;
partial or complete blindness or double vision;
difficulty in speaking or inability to speak;
dizziness or loss of consciousness;
weakness, strange feeling or numbness in any part of the body;
sudden severe pain in the stomach.
Immediately after birth, women are at increased risk of developing blood clots ma, so you should consult with your doctor how long after birth can start taking a combined pill.

Qlaira and cancer
Breast cancer occurs slightly more often in women using combined pills, but it is not known whether the cause of this is in the treatment phase. For example, the opening can more tumors in women on combined pills take place due to the fact that they are tested more frequently. The risk of breast cancer becomes gradually less after stopping the combination hormonal contraceptives. It is important to regularly check your breasts and you tell your doctor if you feel with your fingers any lump.
In rare cases in women using combined pills observed benign liver tumors, and even more rare and malignant liver tumors. In isolated cases, these tumors have caused life-threatening internal bleeding. Tell your doctor if you have unusual severe abdominal pain.
Some studies have shown that prolonged use of the pill may result in an increased risk of cancer of the cervix. It is not clear to what extent sexual behavior or other factors such as human papilloma virus (Human Papilloma Virus, HPV), increase that risk.

Bleeding between menstrual periods
In the first months of taking Qlaira may have unexpected bleeding. Usually bleeding starts on the 26th day - the day on which you take the second dark red tablet, or in the next few days. Information provided by women in the diaries, which are occupied during the trial of Qlaira shows that it is not unusual to appear unexpected bleeding in a given cycle (10-18% of patients). If unexpected bleeding occurs within the more than 3 consecutive months, or start in a few months, your doctor should investigate the cause.

What to do if bleeding occurs 2b of the third or next (s) day (s)
Information provided by women in the diaries, which are occupied during the trial of Qlaira shows that it is not unusual to not show the expected bleeding after the 26th day (observed in about 15% of the cycles).
If you've taken all the tablets correctly, have not had vomiting or severe diarrhea and you have not taken any other medicines, it is unlikely that you are pregnant.
If the expected bleeding does not appear in two consecutive months or you have not taken the tablets correctly, you may be pregnant. Tell your doctor immediately. Do not start the next metal until you are sure you are not pregnant.

Other medicines and Qlaira
Tell your doctor if you are taking, have recently taken or might take any other medicines. Furthermore inform any other doctor or dentist who prescribes another medicine (or the pharmacist from whom you are buying drugs) that take Qlaira. They can tell if you need to take additional measures against contraception (eg condoms) and if so, for what period of time.

Some medicines may cause Qlaira be less effective in preventing pregnancy or cause unexpected bleeding. These are:
drugs used for the treatment of:
epilepsy (e. primidone, phenytoin, barbiturates, karbazepin, oxcarbazepine, topiramate, felbamate);
tuberculosis (eg. rifampicin);
HIV infections (eg. Ritonavir, nevirapine);
other infections (antibiotics such as penicillins, tetracyclines, griseofulvin);
the herb St. John's Wort.
Some medicines can increase the levels of active substances Qlaira blood. Tell your doctor if you use:
antifungal medicines containing ketoconazole;
antibiotics comprising erythromycin.
Qlaira may influence the effect of other drugs, eg .:
medicines containing cyclosporine;
antiepileptic lamotrigine product (this can lead to more frequent relapses).
Ask your doctor or pharmacist before taking any medicine. They will know what additional precautions to take while you are taking other medicines with Qlaira.

Qlaira with food and drink
Qlaira can be taken with or without food, if necessary with a small amount of water.

laboratory tests
If you need to have blood tests or other laboratory tests, tell your doctor or laboratory personnel that you are taking the pill, because oral contraceptives can affect the results of some research.

Pregnancy and lactation
Qlaira not take if you are pregnant. If you become pregnant while taking Qlaira immediately stop taking and contact your doctor. If you want to become pregnant, you should stop taking Qlaira at any time (see also "If you stop taking Qlaira").
In general, you should not take Qlaira while breastfeeding. If you want to take the pill while breastfeeding, you should consult your doctor.

Ask your doctor or pharmacist before taking any medicine during pregnancy or lactation.

Driving and using machines
There is nothing to suggest a possible effect of Qlaira when driving or operating machinery.

Qlaira contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this product.

3. How to take Qlaira
Each plaque contains 26 colored active tablets and 2 white inactive tablets.
Take one tablet Qlaira every day, if necessary with a small amount of water.
You can take the tablet with or without food, but you should take it at about the same time each day.

Preparing plaketata
For you it is easier to keep track of the sequence of adoption, there are 7 stickers with 7 days of the week.
Select the sticker that starts with the day of the week when you start taking the tablets. For example, if you start on Wednesday, use the week sticker labeled "Mon".
Attach sticker in the upper plaketata Qlaira, which says "Place week sticker here", so that the first day is above the tablet marked "1".
Now over each tablet has written day and you can track whether you've taken your tablet for the day. Following the direction of the arrows on plaketata continue until all take 28 tablets.
Usually the so-called withdrawal bleeding starts when you take the second dark red tablet or the white tablets and may not be stopped when you start the next metal. Some women continue to have bleeding after taking the first tablets of the new metal.
Start the next metal without interruption, in other words the day after you have finished with this metal, even if the bleeding has not stopped. This means that you need to start your next metal in the same day of the week, and this metal, in which case the waste bleeding should begin the same day each month.
If you use Qlaira thus, have provided birth control even during the two days when you take inactive tablets.

When can you start with the first metal?
If you have not used contraception with hormones in the previous month.
Taking Qlaira the first day of the cycle (ie the first day of your period).

Changing from another combined pill or combined contraceptive vaginal ring or patch.
Qlaira start the day after taking the last active tablet (the last tablet containing the active substance) of your previous pill. When changing from a combined contraceptive vaginal ring or patch, start taking Qlaira the day of downloading them or as directed by your doctor.

Switching from a progestogen only method (progestogen-only pill, injection or implant or a progestogen-releasing Navy IUS).
You can switch from progestogen-only pill, in any day (from an implant or the Navy on the day of removal, from an injectable on the day when you have to put another injection), but in all these cases you must use extra protection contraception (such as a condom) during the first 9 days of use of Qlaira.

After miscarriage.
Follow your doctor's instructions.

After birth.
You can start Qlaira between 21st and 28th day after birth. If you start later than day 28, use a barrier method (eg, condom) during the first nine days of using Qlaira.
If after birth you had intercourse before you start taking Qlaira, you must be sure you are not pregnant or wait until the next menstrual period. If you want to start with Qlaira after birth and while breastfeeding, read the section "Pregnancy and lactation".

Ask your doctor what you should do if you are not sure when to start.

If you take more dose Qlaira
No severe side effects from taking more than the required amount Qlaira tablets.
If you take several active tablets at the same time, you may be sick and vomit. Young girls may experience vaginal bleeding.
If you take too many tablets Qlaira or discover that a child has taken tablets, seek advice from your doctor or pharmacist.

If you forget to take Qlaira
Inactive tablets: If you miss a white tablet (2 tablets at the end of plaketata) should not take it later, since these tablets do not contain active substance. It is important to discard missed (s) white (s) tablet (s) to make sure that the number of days you take inactive tablets is not increased, as in this situation increases the risk of pregnancy. Continue with the next tablet as usual.

Active tablets: Depending on the day of the cycle, which has been omitted an active tablet, you may need to take extra precautions against pregnancy, for example, a barrier method such as condom. Take the tablets by following principles.