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 Do not pass it on to others, 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.
1. Qlaira WHAT IS AND WHAT IT IS USED
Qlaira is a contraceptive used to prevent pregnancy.
Qlaira used in treating excessive menstrual bleeding (not caused by any disease of the uterus) in women who wish to use oral contraception.
Each color active tablet contains a small amount of female hormones: estradiol valerate, or estradiol valerate combined with dienogest. The,es 2 white tablets contain no active ingredients and are called inactive tablets.
Contraceptives containing two hormones are called "combination pills".
2. BEFORE Qlaira
Before you start taking Qlaira, 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 use interumpir
of Qlaira, or in which reliability may decrease Qlaira. 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 Qlaira alters the monthly changes in body temperature and cervical mucus.
Qlaira, like other hormonal contraceptives, not protect against HIV infection (PAGE) or any other sexually transmitted disease.
When not to take Qlaira
Do not take Qlaira:
- 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) to suspect a disease that (in) a future heart attack (por ejemplo, angina, that causes severe chest pain) O (ii) stroke (por ejemplo, mild stroke with no residual effects)
- if you have (or have had in the past) a certain kind of migraine (with focal neurological symptoms called)
- if you have a disease that may increase the risk of 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 had in the past) Pancreatic inflammation (pancreatitis)
- i you have (or have had in the past) liver disease and liver function has not been standardized yet
- if you have (or have had in the past) a tumor in the liver
- if you have (or have had in the past) or suspected to have cancer of the breast or sex organs
- if you have vaginal bleeding of unknown cause.
- if you are allergic (hypersensitive) to estradiol valerate or dienogest, or any of the other components of Qlaira. This can manifest with itching, eruption of the inflammation.
When to take special care with Qlaira
In some situations, You should be especially careful while taking Qlaira or other combined hormonal contraceptive, and may require that your doctor check periodically. Consult your doctor before you start using Qlaira if any of the following conditions applies to you or if they arise or worsen while you take Qlaira:
- if a close relative has or has had breast cancer
- if you have liver disease or gallbladder
- if you have jaundice
- 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 hemolytic uremic syndrome (SHU), that causes kidney damage
- if you have sickle cell disease
- if you have epilepsy (see "Taking other medicines")
- if you have an immune system disease called systemic lupus erythematosus (THE).
- if you have a disease 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 had in the past) golden brown spots, also called "pregnancy patches", especially in the face (cloasma). Then, avoid direct exposure to the sun or ultraviolet radiation
- if you have hereditary angioedema. See your doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue and / or throat and / or difficulty swallowing, or urticaria, along with difficulty breathing. Products containing estrogens may induce or exacerbate symptoms of angioedema
- If you have heart or kidney failure
Qlaira and blood clots in veins and arteries
The following warnings and cautions are derived from studies with combined contraceptives containing ethinylestradiol. It is still unknown whether or not to apply Qlaira.
The use of any combined contraceptive (Included Qlaira) 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 developing a blood clot in the veins is highest during the first year a woman takes the pill. Very occasionally, Blood clots can cause permanent disability and can be serious or even fatal. The main locations are blood clots, por ejemplo, veins of the legs (venous thrombosis), heart arteries (heart attack), lungs (pulmonary embolism) or the,es
The risk of blood clots in the veins 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 (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 Qlaira since treatment may have to be stopped. Your doctor will tell you when to start again Qlaira. This usually occurs two
weeks after recover mobility.
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 risk of blood clots in the arteries increases in contraceptive users
– with age
– if you smoke. You are strongly advised to stop smoking while taking the pill, 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 Qlaira and immediately seek your doctor if you notice possible signs of blood clot or stroke, 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
– weakness, abnormal sensations or numbness in any part of the body
– sudden severe stomach pain
Directly after giving birth, Women are at greater risk of blood clots, so you should ask your doctor when you can start taking a combined contraceptive after pregnancy.
Qlaira 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 even more rarely malignant, in contraceptive users. In isolated cases, these tumors have caused internal bleeding that endangers the life of the patient. See your doctor if you have abdominal pain unusually strong.
Some studies suggest that prolonged use of the pill increases the risk of developing cervical cancer. However, it is unclear to what extent sexual behavior or other factors such as human papilloma virus (HPV) increase this risk.
Bleeding between periods
During the first few months that you are taking Qlaira, can have unexpected bleeding. Generally, the bleeding starts on 26 th day, the day taking the second tablet dark red, or the following day. According to information propocionada by women in their journals during a clinical study of Qlaira, it is not unusual
experience unexpected bleeding in a given cycle (10-18% of the users). If bleeding occurs during unexpected over 3 consecutive months or starts after several months, your doctor should investigate the cause.
What should you do if you have no rule in the 26th day or on the following days?
According to information propocionada by women in their journals during a clinical study of Qlaira, not unusual that no regular bleeding occurs after the 26th day (this was observed in approximately 15% cycles).
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 or taken incorrectly tablets, you may be pregnant. See your doctor immediately. Do not start the next pack calendar until you are sure you are not pregnant.
Taking other medicines
Tell your doctor all the time about drugs or herbal preparations you are taking. Also tell any other doctor or dentist who prescribes another medicine (or farmacéutico this the pantry and medicine) of taking Qlaira.
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 Qlaira contraceptive effect, or can cause unexpected bleeding. These can occur with the following medications:
- Medications used to treat:
– Epilepsy (p. not. primidona, phenytoin, barbiturates, carbamazepine, oxcarbazepina, topiramate, felbamato)
– TB (p.ej. rifampin)
– HIV infection (p. not. ritonavir, nevirapina) or other infections (antibiotics such as penicillins, tetracyclines, griseofulvina).
- the preparations of St. John's wort
Some medications can increase the levels of active ingredients in the blood Qlaira. Tell your doctor if you take:
– containing antifungal ketoconazole
– containing antibiotic erythromycin
Qlaira may influence the effect of other drugs, por ejemplo:
– medicines containing cyclosporine
– the antiepileptic lamotrigine (can lead to an increase in seizure frequency).
Consult your doctor or pharmacist before taking any medicine. Your doctor or pharmacist can advise you to use additional protective measures while you take other medicines with Qlaira.
If you need a blood test or other laboratory tests, tell your doctor and the laboratory personnel that you are taking the pill, because oral contraceptives can affect the results of some tests.
Pregnancy and lactation
Do not take if pregnant Qlaira. If you become pregnant while taking Qlaira should be discontinued immediately and contact your doctor. If you want to get pregnant, Qlaira may stop at any time (see also "If you want to stop taking Qlaira”).
Overall, Qlaira is not recommended during breast-feeding. If you want to take birth control while breastfeeding, should consult with your doctor.
Consult your doctor or pharmacist before taking any medicine if you are pregnant or breast-feeding.
Driving and using machines
There is no information to suggest that the use of Qlaira have any effect on ability to drive and use machines.
Important information about some of the components of Qlaira
Qlaira contains lactose. If your doctor has told you have an intolerance to some sugars, contact your doctor before taking Qlaira.
3. HOW Qlaira
Each package contains calendar 26 color active tablets, and two white inactive tablets.
Take one tablet daily Qlaira, with some water if necessary. You can take the tablets with or without food, but every day more or less at the same time.
Preparation of the pack calendar
To help you follow the order making, provided 7 with self-adhesive strips 7 weekdays.
Choose the adhesive strip of the week starting with the day you take the first tablet. Por ejemplo, if you take your first pill on a Wednesday, use the adhesive strip that starts with "MIE". Stick the adhesive strip of the week at the top of the pack calendar Qlaira, 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 you can check if you have taken visulamente the tablet on a given day. Follow the direction of the arrow on the calendar packaging until you have taken the 28 tablets.
Generally, the call begins withdrawal bleeding when you are taking the second tablet of dark red or white tablets and may not have finished when you start the next pack calendar. Some women continue to have bleeding after taking the first tablet of the new wallet.
Start the next pack without interruption calendar, ie the day after finishing the current calendar package, although the bleeding has not ended. This means that you should start the next pack on the same calendar day of the week that the current calendar container and withdrawal bleeding that should occur during the same days of the week every month. If you use Qlaira thus, is protected against pregnancy even during 2 days inactive tablets taking.
When can you start with the first container calendar?
If you have not used a hormonal contraceptive in the past month.
Start taking Qlaira the first day of the cycle (ie, the first day of your period).
Changing from another combined hormonal contraceptive pill, combined contraceptive vaginal ring or patch.
Start Qlaira the day after taking the last active tablet (the last tablet containing the active) of its preceding pill. When changing from a combined contraceptive vaginal ring or patch, Qlaira start using the day of his retirement or follow the recommendations of your doctor.
Changing from a progestogen method based exclusively on (progestogen only contraceptive, injection, implant releasing intrauterine system (SLI) progestin).
You can change from the progestogen-only pill any day. If it is an implant or an 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 9 making first days Qlaira.
After an abortion.
Follow your doctor's recommendations.
After having a baby.
You can start taking Qlaira between 21 and 28 days after having a baby. If you start later than the 28th day, use a barrier method (por ejemplo, a condom) during 9 first days of using Qlaira.
Yes, After having a baby, you have already had sex before retaking Qlaira, You must be sure of not being pregnant or wait for her next menstrual period.
If you start taking Qlaira after having a baby and is nursing, read "Pregnancy and lactation”.
Consult your doctor if you have questions about when to start.
If you take more than you should Qlaira
There are no reported cases in which the ingestion of an overdose has caused serious damages Qlaira.
If you take many simultaneously active tablets, may have nausea or vomiting. Young girls may experience vaginal bleeding.
If you have taken too many tablets of Qlaira, or discovers that a child has taken, Consult your doctor or pharmacist.
If you forget to take Qlaira
Inactive tablets: If you forget to take a white tablet (2 final packaging tablets calendar), not have to take it later and do not contain any active. Nevertheless, is important that you put the white tablets have forgotten to take, to ensure that the number of days of taking the inactive tablets not increase, as this would increase the risk of pregnancy. Continue with the next tablet at the time
Active tablets: Depending on the day of the cycle you have forgotten to take a tablet active, you may need to take additional contraceptive precautions, por ejemplo, a barrier method such as a condom. Take the tablets according to the principles described below:
- If you are delayed 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. Depending on the day of the cycle when you forget to take your tablet, take additional contraceptive precautions, por ejemplo, a barrier method such as a condom.
- If you have missed more than one tablet of calendar: Consult your doctor.
Do not take more than 2 active tablets in a given day.
- If you forget to start a new wallet or if you forget to take tablets between the 3rd and 9th day of calendar packaging, There is a risk of being pregnant (if you have had sex in the 7 days before forgetting the tablet). Then, seek medical. The more tablets have forgotten (especially between the 3rd and 24th day) and the closer the placebo tablet phase, greater the risk of reduced protection against pregnancy.
- If you have missed any active tablet of a calendar packing rule and not the end of the calendar pack, you may be pregnant. See your doctor before continuing with the next pack calendar.
Use in children
No data are available in adolescents under 18 años.
What to do in case of vomiting or severe diarrhea
If you have vomiting in 3-4 hours of taking an active tablet 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, to take the next tablet 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 Qlaira”. If you do not want to change their normal pattern making compressed, take the corresponding tablet
other container calendar.
If you want to stop taking Qlaira
You can stop taking Qlaira whenever you want. If you do not want to get pregnant, ask your doctor about other effective methods of birth control. If you want to get pregnant, it is advisable to stop taking Qlaira 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 medicine, Consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Qlaira can cause side effects, although not everybody gets them.
– Serious side effects:
Serious reactions associated with the use of the pill, and related symptoms, are described in the following sections "Qlaira and blood clots in veins and arteries"And"Qlaira and cancer”. Read these sections and consult your doctor when appropriate.
– Other possible side effects:
The following side effects have been associated with the use of Qlaira:
- Common adverse effects (affect between 1 and 10 each 100 women): – headache, abdominal pain, nausea
– no periods, breast discomfort, painful periods, irregular bleeding (Heavy and irregular bleeding)
– weight gain
- Uncommon side effects (affect between 1 and 10 each 1.000 women): – Fungal Infections, fungal infection of the vulva and vagina, vaginal infection
– increased appetite
– depression, depressed mood, emotional disturbances, Sleep disorder, loss of interest in sex, trastorno mental, mood swings
– dizziness, migraine
– flushing, Hypertension
– diarrhea, vomiting
– increased liver enzymes
– hair loss, excessive sweating (Hyperhidrosis), itching and rash
– muscle cramps
– increase in breast size, breast lumps, Abnormal growth of cells in the cervix (cervical dysplasia), Sangrado genital uterine, painful intercourse, fibrocystic breast disease, heavy periods, menstrual disorders, ovarian cyst, pelvic pain, premenstrual syndrome, growth in utero, uterine contractions, Sangrado uterine / vaginal incl. stained, vaginal discharge, vulvovaginal dryness
– fatigue, irritability, inflammation of body parts, p.ej. ankles (edema)
– weight loss, Changes in blood pressure.
- Rare side effects (affect between 1 and 10 each 10.000 women):
– yeast infection, herpes bucal, pelvic inflammatory disease, vascular disease of the eye that resembles a fungal infection (presumed ocular histoplasmosis syndrome), Skin infection by fungi (Tina versicolor), urinary tract infection, bacterial inflammation of the vagina
– fluid retention, increase of some fats in the blood (trigicéridos)
– aggression, anxiety, feeling of unhappiness, increased interest in sex, nervousness, nightmares, restlessness, sleep disturbances, stress
– decreased attention, pins and needles, vertigo
– intolerance to contact lenses, dry eyes, eye swelling
– heart attack (myocardial infarction), palpitations
– bleeding from varicose veins, low blood pressure, inflammation of superficial veins, painful veins
– constipation, dry mouth, indigestion, Heartburn – liver nodules (Focal nodular hyperplasia), chronic inflammation of the gallbladder
– Allergic skin reactions, golden brown spots (cloasma) and other disorders of pigmentation, hair growth in male pattern, excessive hair growth, skin diseases such as dermatitis and neurodermatitis, dandruff and oily skin (seborrhea) and other skin disorders
– back pain, jaw pain, heaviness
– urinary tract pain
– abnormal withdrawal bleeding, benign lumps in the breast, breast cancer early, cysts in the breasts, mammary secretion, polyp cervix, cervical redness, bleeding during intercourse, spontaneous secretion of milk, genital discharge, less abundant menstruations, delay of menses, ruptured ovarian cyst, olor vaginal, burning sensation in the vulva and vagina, harassment vulvovaginal.
– inflammation of lymph nodes
– suspended, shortness of breath, sangrado nasal
– chest pain, tiredness and generally feeling unwell, fever
– cervical smear abnormal
Provides Additional Info (as diaries kept by women in a clinical trial of Qlaira) about possible adverse effects "irregular bleeding (abundant irregular bleeding)"And"no periods"Sections"Bleeding between periods"And"What to do if no rule in the 26th day or on the following days”.
Besides the above mentioned adverse effects, in women using combined oral contraceptives containing ethinyl estradiol occurred skin disorders such as erythema nodosum, erythema multiforme, and secretion and breast tenderness. Although these symptoms were not reported in clinical studies with Qlaira, The possibility can not be excluded that also occur with treatment.
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. Qlaira STORE
Keep out of reach and sight of children.
It does not require any special storage conditions.
Qlaira not use after the expiration date on the carton after EXP calendar. The expiry date is the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Composition of Qlaira
The active substances are estradiol valerate, or estradiol valerate combined with dienogest.
Each package calendar (28 Film-coated tablets) Qlaira contains 26 active tablets of four different colors in the first, second, third and fourth rows, and two white inactive tablets in the fourth row.
Composition of colored tablets containing one or two active:
2 dark yellow tablets. Each tablet contains 3 mg estradiol valerate.
5 red tablets intermediate. Each tablet contains 2 mg estradiol valerate and 2 mg dienogest the.
17 light yellow tablets. Each tablet contains 2 mg estradiol valerate and 3 mg dienogest the.
2 dark red tablets. Each tablet contains 1 mg estradiol valerate.
Composition of white inactive tablets:
These tablets contain no active.
The other ingredients of the tablets are colored assets:
Tablet core: lactose monohydrate, cornstarch, Pregelatinized corn starch, povidona K25 (E1201), magnesium stearate (E572)
Tablet Film Coating: hypromellose type 2910 (E464), macrogol 6000, talc (E553b), titanium dioxide (E171), yellow iron oxide (E172) and / or red iron oxide (E172).
The other ingredients of the tablets are white inactive:
Tablet core: lactose monohydrate, cornstarch, povidona K25 (E1201), magnesium stearate (E572)
Tablet Film Coating: hypromellose type 2910 (E464), talc (E553b), titanium dioxide (E171)
Looks like and contents of container
Qlaira tablets are film-coated tablets; The tablet core is coated with a film.
Each package calendar (28 Film-coated tablets) contains 2 dark yellow tablets in the row 1, 5 red colored tablets in the row intermediate 1, 17 light yellow tablets in rows 2, 3 and 4, 2 dark red tablets in row 4 and 2 white tablets in row 4.
The active tablet is dark yellow round, biconvex faces engraved on one side with the letters "DD" included in a regular hexagon.
The red active tablet is round intermediate, biconvex faces engraved on one side with the letters "DJ" included in a regular hexagon.
The active tablet is light yellow round, biconvex faces engraved on one side with the letters "DH" in a regular hexagon.
The active tablet is dark red round, biconvex faces engraved on one side with the letters "DN" in a regular hexagon.
The white inactive tablet is round, biconvex faces engraved on one side with the letters "DT" in a regular hexagon.
Qlaira is available in packages 1, 3 ó 6 packaging calendars, each with 28 tablets. Can be marketed pack sizes.
Holder of the marketing authorization
Bayer Pharmaceutical Chemistry, SL.
By. Baix Llobregat, 3 – 5
08970 Sant Joan Despi – Barcelona
Responsible for manufacturing
Bayer Schering Pharma AG
such: +49 30 468 1111
fax: +49 30 468 16111
This leaflet was last approved in October/2010.