film-coated tablets
estradiol valerate / dienogest
What Qlaira is and what it is used for
- Qlaira is a birth control pill and is used to prevent pregnancy.
- Qlaira is used to treat heavy menstrual bleeding (which is not due to any disease of the uterus) in women who want to use oral contraceptives ( oral contraception).
- Each colored, active tablet contains a small number of female hormones, either estradiol valerate or estradiol valerate in combination with dienogest.
- The two white tablets do not contain any active substances and are also called inactive tablets.
- Birth control pills that contain two hormones are called combination birth control pills.
What you need to know before using Qlaira
Do not use Qlaira
| General notesBefore using Qlaira, read the information on blood clots in section 2. You must read the symptoms of blood clots – see section 2, “Blood clots”. Before you can start taking Qlaira, the midwife / doctor will ask you some questions about your own and your immediate relatives’ medical history. The midwife / doctor will also measure your blood pressure and it is possible that the midwife/doctor, depending on your situation, will also take other samples. This leaflet describes several situations in which you need to stop taking Qlaira or when Qlaira’s reliability may be impaired. In such situations, you should either refrain from having intercourse or use other non-hormonal contraceptives, e.g. condom or any other barrier method. Do not use the rhythm method (safe periods) or the temperature method. These methods can be unreliable, as Qlaira affects the monthly changes in body temperature and cervical secretions. Qlaira, like other birth control pills, does not protect against HIV infection ( AIDS ) or other sexually transmitted diseases. |
Do not use Qlaira if you have any of the conditions listed below. If you have any of these conditions, you need to tell your doctor. The doctor will discuss what other type of contraception may be more appropriate.
Do not use Qlaira:
- if you have (or have had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs ( pulmonary embolism ), or any other organ
- if you know you have a disease that affects blood coagulation – e.g. protein C deficiency, protein S deficiency, antithrombin III deficiency, Factor V Leiden or antiphospholipid antibodies
- if you need to have an operation or if you stay in bed for a longer period (see section “Blood clots”)
- if you have (or have had) a heart attack or a stroke (stroke)
- if you have (or have had) angina (a condition that causes severe chest pain and maybe the first sign of a heart attack) or transient ischemic attack ( TIA – transient stroke symptoms)
- if you have any of the following conditions that may increase the risk of a blood clot in your arteries:
- severe diabetes with damaged blood vessels
- very high blood pressure
- a very high level of fat in the blood ( cholesterol or triglycerides )
- a condition called hyperhomocysteinemia
- if you have (or have had) a type of migraine called “migraine with aura”
- if you have (or have had) liver disease and your liver function is not yet normal
- if you have (or have had) a tumor in your liver
- if you have (or have had) cancer or are suspected of having breast or genital cancer
- if you have unexplained vaginal bleeding
- if you are allergic (hypersensitive) to estradiol valerate or dienogest, or any of the other ingredients of this medicine (listed in section 6). This can cause itching, rash, or swelling
Warnings and cautions
| When should you contact a doctor? Seek medical attention immediatelyif you notice any possible signs of a blood clot that may indicate a blood clot in your leg (ie deep vein thrombosis ), a blood clot in your lung (ie pulmonary embolism ), a heart attack, or a stroke (see section “Blood clots” below). For a description of the symptoms of these serious side effects, go to “How to recognize a blood clot”. |
Tell your doctor if any of the following conditions apply to you.
In some situations, you need to be especially careful when taking Qlaira or other combined birth control pills, and you may need to be checked regularly by your midwife/doctor. If the condition occurs or worsens when you use Qlaira, you should also consult a doctor.
- if a close relative has or has had breast cancer
- if you have any liver or bile disease
- if you have jaundice
- if you have diabetes
- if you suffer from depression
- if you have Crohn’s disease or ulcerative colitis ( chronic inflammatory bowel disease)
- if you have systemic lupus erythematosus ( SLE – a disease that affects your natural immune system)
- if you have hemolytic uremic syndrome (HUS – a disorder of blood coagulation that leads to kidney failure )
- if you have sickle cell anemia (a hereditary disease of the red blood cells )
- if you have high blood fats ( hypertriglyceridemia ) or a hereditary condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas)
- if you need to have an operation or stay in bed for a longer period (see section 2 “Blood clots)
- if you have just given birth, you are at increased risk of getting blood clots. Ask your doctor how soon after giving birth you can start using Qlaira
- if you have an inflammation of the veins under the skin (superficial thrombophlebitis )
- if you have varicose veins
- if you have epilepsy (see ” Other medicines and Qlaira “)
- if you have a disease that first appeared during pregnancy or previous use of sex hormones, e.g. hearing loss, a blood disease called porphyria, skin rash with blisters during pregnancy (pregnancy herpes), a nerve disease that causes sudden twitching in the body (Sydenhams Korea)
- if you have (or have had) golden brown pigment spots (chloasma), so-called “pregnancy spots”, especially on the face. In this case, avoid exposure to sunlight or ultraviolet light
- if you have hereditary or acquired angioedema. Stop taking Qlaira and see a doctor immediately if you experience symptoms such as swelling of the face, tongue, and/or throat and/or difficulty swallowing or hives along with breathing difficulties that may indicate angioedema. Products that contain estrogen can cause or worsen the symptoms of angioedema
- if you have heart or kidney failure
Talk to your doctor before taking Qlaira.
Special patient groups
Children and young people
Qlaira is not intended for use before the first menstrual period.
BLOOD CLOTS
Using combined hormonal contraceptives such as Qlaira increases the risk of blood clots compared to not using these drugs. In rare cases, a blood clot can block the blood vessels and cause serious problems.
Blood clots can form
- in veins (called venous thrombosis , venous thromboembolism, or VTE)
- in arteries (called arterial thrombosis , arterial thromboembolism, or ATE)
It is not always possible to fully recover from blood clots. In rare cases, they can have serious lasting effects and, in very rare cases, be fatal.
It is important to remember that the overall risk of a dangerous blood clot due to Qlaira is small.
HOW TO FEEL A BLOOD CLOTH AGAIN
Seek medical attention immediately if you notice any of the following signs or symptoms:
| Do you experience any of these signs? | What can you possibly suffer from? |
|---|---|
| • swelling of a leg or along a vein in the leg or foot, especially if you also get:• pain or tenderness in the leg that is only felt when you stand or walk• increased heat in the affected leg• discoloration of the skin on the leg, e.g. pale, red or blue | Deep vein thrombosis |
| • sudden unexplained shortness of breath or rapid breathing• sudden cough for no apparent reason that could cause you to cough up blood• severe chest pain that may increase with deep breathing• strong instability or dizziness• fast or irregular heartbeat• severe pain in the abdomen If you are not sure, talk to a doctor as some of these symptoms, such as cough and shortness of breath, can be mistaken for a mild condition such as a respiratory infection (such as a common cold). | Pulmonary embolism |
| Symptoms that usually occur in one eye: Immediate vision loss or• blurred vision without pain that can lead to vision loss | Retinal venous thrombosis (blood clot in the eye) |
| • chest pain, discomfort, pressure, heaviness• pressure or feeling of fullness in the chest, arm, or below the sternum• feeling full, indigestion or suffocation• discomfort in the upper body that radiates to the back, jaw, neck, arm and abdomen• sweating, nausea, vomiting or dizziness• extreme weakness, anxiety or shortness of breath• fast or irregular heartbeat | Myocardial infarction |
| • sudden weakness or numbness in the face, arms or legs, especially on one side of the body• sudden confusion, difficulty speaking or understanding• sudden vision problems in one or both eyes• sudden difficulty walking, dizziness, loss of balance or coordination• sudden, severe or prolonged headache without a known cause• unconsciousness or fainting with or without seizures Sometimes the symptoms of a stroke can be short-lived with almost immediate or complete recovery, but you should still seek medical attention immediately because you are at risk of having a new stroke . | Stroke |
| • swelling and slight blue discoloration of an arm or leg• severe pain in the abdomen ( acute abdomen) | Blood clots that block other blood vessels |
BLOOD CLOTS IN A FRIEND
What can happen if a blood clot forms in a vein?
- The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in the vein (venous thrombosis ). However, these side effects are rare. They usually occur during the first year of using a combined hormonal contraceptive.
- If a blood clot forms in a vein in the leg or foot, it can lead to deep vein thrombosis (DVT).
- If a blood clot moves from the bone and stays in the lung, it can lead to a pulmonary embolism .
- In very rare cases, a blood clot can form in a vein in another organ such as the eye ( retinal venous thrombosis ).
When is the risk of developing a blood clot in a vein greatest?
The risk of developing a blood clot in a vein is greatest during the first year that you use combined hormonal contraceptives for the first time. The risk can also be higher if you start again with a combined hormonal contraceptive (same product or another product) after a break of 4 weeks or longer.
After the first year, the risk decreases, but it is always slightly higher than if you did not use a combined hormonal contraceptive.
When you stop using Qlaira, the risk of a blood clot returns to normal within a few weeks.
How big is the risk of developing a blood clot?
The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.
The total risk of a blood clot in the leg or lungs with Qlaira is small.
- Of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 develop a blood clot in one year.
- Of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel or norethisterone or norgestimate, about 5-7 develop a blood clot in a year.
- The risk of blood clots during treatment with Qlaira is about the same as for a combined hormonal contraceptive or a combined hormonal contraceptive containing levonorgestrel.
- The risk of blood clots varies depending on your medical history (see “Factors that may increase the risk of a blood clot” below).
| Risk of developing a blood clot during a year | |
|---|---|
| Women who do not use the combined hormonal contraceptive pill and who are not pregnant | About 2 out of 10,000 women |
| Women using a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate | About 5-7 out of 10,000 women |
| Women using Qlaira | Approximately the same as for a combined hormonal contraceptive or a combined hormonal contraceptive containing levonorgestrel |
Factors that may increase the risk of a blood clot in a vein
The risk of a blood clot with Qlaira is small but some conditions increase the risk. The risk is higher:
- if you are overweight (body mass index or BMI over 30 kg / m 2 )
- if someone in your family has had a blood clot in the bones, lungs, or another organ at a young age (eg under 50 years) In this case you may have a hereditary blood clotting disease
- if you need to undergo surgery or stay in bed for an extended period due to injury or illness, or if your leg is plastered. The use of Qlaira may need to be stopped for several weeks before an operation or while you are less mobile. If you have to stop taking Qlaira, ask your doctor when you can start taking it again
- with increasing age (especially if you are over 35 years old)
- if you gave birth a few weeks ago
The more conditions you have, the greater the risk of developing a blood clot.
Air travel (over 4 hours) can temporarily increase the risk of a blood clot, especially if you have any of the other factors listed here.
It is important that you tell your doctor if any of these conditions apply to you, even if you are unsure. Your doctor may decide that you need to stop taking Qlaira.
If any of the above conditions change when you use Qlaira, such as close relative suffering from a blood clot for an unknown reason, or you gain a lot of weight, talk to your doctor.
BLOOD CLOTS IN AN ART
What can happen if a blood clot forms in an artery ?
In the same way as a blood clot in a vein, a clot in an artery can lead to serious problems. It can e.g. cause a heart attack or stroke.
Factors that may increase the risk of a blood clot in an artery
It is important to know that the risk of a heart attack or stroke due to the use of Qlaira is very small but may increase:
| with increasing age (after about 35 years of age)if you smoke. When you use combined hormonal contraceptives like Qlaira, you should stop smoking. If you can not stop smoking and are over 35 years old, your doctor may advise you to use another type of contraceptive if you are overweight if you have high blood pressureif a close relative has had a heart attack or stroke at a young age (younger than 50 years). In this case, you may also be at greater risk for a heart attack or stroke if you or a close relative have high blood fats ( cholesterol or triglycerides )if you get migraines, especially migraines with an aura if you have heart problems (valve disease, a heart rhythm disorder called atrial fibrillation )if you have diabetes |
If you have more than one of these conditions or if any of them are particularly serious, the risk of developing a blood clot can be even greater.
If any of the above conditions change when you use Qlaira, e.g. If you start smoking, a close relative suffers from thrombosis of unknown cause, or you gain a lot of weight, talk to your doctor.
Qlaira and cancer
Breast cancer has been observed slightly more often in women using combined oral contraceptives , but it is not known if this is caused by the treatment. It can e.g. be that more tumors are detected in women who use combined contraceptive pills because they are more often examined by doctors. The risk of breast tumors gradually decreases after stopping treatment with combined hormonal contraceptives. It is important that you examine your breasts regularly, and you should consult your doctor if you feel any lumps.
In rare cases, benign liver tumors, and in even fewer cases malignant liver tumors, have been reported in birth control pill users. In rare cases, these tumors have led to life-threatening internal bleeding. Contact your doctor if you experience unusually severe abdominal pain.
Some studies suggest that long-term use of birth control pills increases a woman’s risk of developing cervical cancer . However, it is not clear to what extent sexual habits or other factors such as human papillomavirus (HPV) increase the risk.
Mental disorders
Some women who use hormonal contraceptives, including Qlaira, have reported depression or depression. Depression can be severe and can sometimes lead to suicidal thoughts. If you experience mood swings and symptoms of depression, you should contact a doctor as soon as possible for advice.
Intermittent bleeding
During the first months of using Qlaira, you may experience unexpected bleeding. The bleeding usually starts on day 26, the day you take the second dark red tablet or the following days. Information obtained from women through diaries they have written during a clinical study with Qlaira shows that it is not uncommon to have unexpected bleeding in a given menstrual cycle (10-18% of women). If unexpected bleeding occurs for more than three consecutive months, or if it occurs after a few months, your midwife/doctor should investigate the cause.
What to do if you do not experience any bleeding on day 26 or the following day (s)
Information obtained from women through diaries they have written during a clinical study with Qlaira shows that it is not uncommon for menstruation to occur after day 26 (observed in approximately 15% of menstrual cycles).
If you have taken all the tablets correctly, have not had vomiting or severe diarrhea and you have not taken any other medicines, it is very unlikely that you are pregnant.
If you have taken the tablets incorrectly or if the expected bleeding does not occur twice in a row, you may be pregnant. Contact your midwife/doctor immediately. Do not start on the next tablet card until you are sure you are not pregnant.
Other medicines and Qlaira
| Always tell your midwife/doctor which medicines or herbal remedies you are already using. Also, tell other doctors or dentists who prescribe other medicines (or the pharmacy staff from whom you are taking the medicine) that you are using Qlaira. They can tell you if you need to use additional contraceptives (eg condoms), and if so, for how long. |
Some medicines
- may affect the level of Qlaira in the blood
- can make it less effective in preventing pregnancy
- may cause unexpected bleeding
This applies to:
- drugs used to treat:
- epilepsy (eg primidone, phenytoin , barbiturates , carbamazepine, oxcarbamazepine, topiramate, felbamate)
- tuberculosis (eg rifampicin)
- HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz
- Hepatitis C virus ( HCV ) (such as the combination treatment ombitasvir/paritaprevir/ritonavir with or without dasabuvir as well as the treatment glekaprevir / pibrentasvir) may cause elevated liver function values in blood test results (increase in ALT liver enzyme) in women using combined hormonal contraceptives containing ethine. Qlaira contains estradiol instead of Ethinylestradiol. It is not known whether an increase in ALT liver enzyme may occur with the use of Qlaira in combination with this HCV combination therapy. Your doctor will advise you
- fungal infections (eg griseofulvin, ketoconazole )
- the herbal medicine St. John’s wort
Qlaira may affect the effectiveness of other medicines, e.g.
- medicines containing ciclosporin
- the antiepileptic drug lamotrigine (this may lead to an increase in the number of seizures).
Ask your doctor or pharmacist for advice before taking any medicine. Your doctor or pharmacist may advise you on additional contraceptives when using other medicines with Qlaira.
Qlaira with food and drink
Qlaira can be taken with or without food and if necessary with a small amount of water.
Laboratory samples
If you need to take a blood sample or other laboratory samples, tell your doctor or laboratory staff that you are taking birth control pills, as birth control pills can affect the results of certain tests.
Pregnancy and breastfeeding
Do not use Qlaira if you are pregnant. If you become pregnant while taking Qlaira, you must stop taking Qlaira immediately and contact your midwife / doctor. If you want to get pregnant, you can stop taking Qlaira at any time (see also ” If you stop using Qlaira “).
You should generally not use Qlaira while breast-feeding. If you want to use birth control pills while breastfeeding, contact your midwife/doctor.
Consult a midwife/doctor or pharmacist before taking any medicine while you are pregnant or breast-feeding.
Driving and using machines
There is no information to suggest that the use of Qlaira affects the ability to drive or use machines.
Qlaira contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your midwife/doctor before taking this medicine.
How to use Qlaira
Each tablet map contains 26 colored active tablets and 2 white inactive tablets.
Take one tablet of Qlaira daily, with a little water if needed. You can take the tablets with or without food, but you should take the tablets at about the same time each day.
Preparation for the start of a new tablet map
To help you keep track of the tablets, each tablet card comes with 7 memory strips with 7 days a week.
Select the memory strip that starts with the day of the week when you start taking the tablets. An example: if you start on a Wednesday, use the memory strip that starts with “ONS”.
Paste the memory strip at the top of the tablet map where it says “attach the memory strip here” so that the first day is above the tablet marked “1”.
A day of the week is now indicated above each tablet, so that you can see if you have taken the contraceptive pill on a particular day. Follow the direction of the arrow on the tablet map until all 28 tablets have been taken.
Normally, a so-called dropout bleeding starts when you take the other dark red tablet or tablets, and the bleeding may not have stopped when you start on the next tablet chart. Some women still bleed after taking the first tablets on the new tablet chart.
Start on the next tablet chart without interruption, in other words, the day after you finish the current tablet chart, even if the bleeding is still ongoing. This means that you should start the following tablet chart on the same day of the week as the current tablet chart, and that dropout bleeding should occur during the same days of the week in each month.
If you use Qlaira in this way, you are protected against pregnancy even during the two days when you take inactive tablets.
When can you start with the first tablet map?
- If you have not used a hormonal contraceptive in the previous month
Start taking Qlaira on the first day of your menstrual cycle (ie the first day of your period). - Changing from another hormonal oral contraceptive pill or combination preparation in the form of a vaginal ring or contraceptive patch
Start with Qlaira the day after you take the last active tablet (the last tablet containing the active substances) of your previous oral contraceptive pill. When changing from a combination preparation in the form of a vaginal ring or contraceptive patch , start with Qlaira on the day it is removed or follow your midwife’s / doctor’s advice. - Switching from the progestogen -only method ( mini-pills, injection, IUD, or IUD)
You can change from IUDs (from an IUD or IUD on the day they are removed, from an injectable contraceptive the day after the next injection ). ), but in all these cases you must use extra protection (eg condoms) during the first 9 days of using Qlaira. - After a miscarriage
Follow the midwife’s / doctor’s advice. - After delivery
You can start with Qlaira between 21 and 28 days after delivery. If you start later than day 28, you must use a so-called barrier method (eg condom) for the first 9 days of using Qlaira.
If you have had intercourse before using Qlaira again after giving birth, you must first check that you are not pregnant or wait until the next period.
If you are breastfeeding and want to start taking Qlaira again after having children, read the section “Pregnancy and breast-feeding”.
Ask your midwife/doctor what to do if you are unsure when to start.
If you take more Qlaira than you should
There are no reports of serious adverse effects due to taking too many Qlaira tablets.
If you take several active tablets at the same time, you may feel sick or vomit. Young girls may experience vaginal bleeding.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to take Qlaira
Inactive tablets: If you forget to take a white tablet (the two tablets last on the tablet map), you do not need to take them later as they do not contain any active substances. However, you must discard the white tablet (s) you forgot to take so that the number of days you take inactive tablets does not increase, as this would increase the risk of pregnancy. Take the next tablet at the usual time.
Active tablets: Depending on the day of the cycle that you forgot to take an active tablet, you may need to use extra protection, e.g. a barrier method such as a condom. Take the tablets according to the following principles: See also the diagram “forgotten tablets” for more information.
- If less than 12 hours have passed since the tablet was taken, pregnancy protection is not reduced. Take the tablet as soon as you remember and then continue to take the tablets again at the usual time.
- If it has been more than 12 hours since the tablet was taken, the pregnancy protection may be reduced. Depending on the day on the bike you forgot a tablet use extra protection, e.g. a barrier method such as a condom. See also the diagram “forgotten tablets” for more information.
- More than one tablet forgotten in the tablet map
Contact your midwife/doctor.
Do not take more than two active tablets in one day.
If you have forgotten to start a new tablet chart or if you have forgotten one or more tablets during days 3-9 in the tablet chart, there is a risk that you are already pregnant (if you have had intercourse during the 7 days before you forgot the tablet) . In this case, contact your midwife/doctor. The more tablets you have forgotten (especially days 3-24 ) and the closer they are to the inactive tablet phase (the two white tablets), the greater the risk that the protection against pregnancy is reduced. See also the diagram “forgotten tablets” for more information.
If you have forgotten any of the active tablets in a tablet chart and you do not experience any bleeding at the end of the tablet chart, you may be pregnant. You must then contact the midwife/doctor before starting on the next tablet chart.
Use in children
There is no experience from children under 18 years.
What to do if you vomit or have severe diarrhea
If you vomit within 3-4 hours after taking an active tablet, or if you have severe diarrhea, there is a risk that the active substances in the contraceptive pill will not be completely absorbed by the body.
It’s almost the same as forgetting a tablet. After vomiting or diarrhea, you must take a new tablet as soon as possible. Take it if possible within 12 hours from the time you normally take your pill. If this is not possible or if 12 hours have already passed, you should follow the advice under ” If you forget to take Qlaira “ .
If you do not want to change your normal tablet intake, take the corresponding tablet from another tablet chart.
If you stop using Qlaira
You can stop taking Qlaira whenever you want. If you do not want to get pregnant, consult your midwife/doctor about other reliable methods of contraception. If you want to get pregnant, stop taking Qlaira and wait for your period before trying to conceive. You will then be able to more easily calculate the expected date of birth.
If you have any further questions on the use of this product, ask your midwife/doctor, or pharmacist.
Possible side effects
Like all medicines, Qlaira can cause side effects, although not everybody gets them. If you get any side effects , especially if they are serious or persistent, or if your health changes and you think it may be due to Qlaira, talk to your doctor.
As with all women taking combined hormonal contraceptives, there is an increased risk of blood clots in your veins (venous thromboembolism , VTE) or blood clots in your arteries ( arterial thrombosis, ATE). For more information on the different risks of taking combined hormonal contraceptives, see section 2 “What you need to know before taking Qlaira”.
Serious side effects are
Serious side effects associated with the use of birth control pills and related symptoms are described in the following sections: ” Blood clots ” and ” Qlaira and cancer “. Read these sections carefully and contact your doctor immediately if necessary.
Other possible side effects are
The following side effects have been linked using Qlaira:
Common side effects ( between 1 and 10 in 100 people may be affected):
- headache
- abdominal pain, nausea
- acne
- missed menstruation, discomfort in the breasts, painful menstruation, irregular bleeding, (abundant irregular bleeding)
- weight gain
Uncommon side effects ( between 1 and 10 users in 1,000 may be affected):
- fungal infections, fungal infection of the abdomen, vaginal infection
- increased appetite
- depression, depression, emotional disturbances, sleep problems, decreased sex drive, mental imbalance, mood swings
- dizziness, migraine
- hot flashes, high blood pressure
- diarrhea, vomiting
- increased liver enzymes
- hair loss, heavy sweating ( hyperhidrosis ), itching, rash
- muscle cramps
- swollen breasts, lumps in the breasts, abnormal cell growth in the cervix (cervical dysplasia), abnormal genital bleeding, pain during intercourse, fibrocystic breast disease, heavy menstruation, menstrual disorders, ovarian cysts, pelvic pain, premenstrual syndrome , uterus / vaginal bleeding incl splashing, vaginal discharge, dryness of the abdomen
- fatigue, irritation, swelling of parts of the body e.g. ankles ( edema )
- weight loss, changes in blood pressure.
Rare side effects ( between 1 and 10 users in 10,000 may be affected):
- candida infection, oral herpes, inflammation of the pelvis, a vascular disease of the eye similar to fungal infection (suspected ocular histoplasmosis ), a fungal infection of the skin ( tinea versicolor), urinary tract infection, bacterial inflammation of the vagina
- fluid accumulation in the body, increase in certain blood fats ( triglycerides )
- aggression, anxiety, feeling unwell, increased interest in sex, nervousness, nightmares, restlessness, difficulty sleeping, stress
- decreased attention, tingling sensation, dizziness
- intolerance to contact lenses, dry eyes, swollen eyes
- heart attack, palpitations
- bleeding varicose veins, low blood pressure, inflammation of superficial veins, pain in the veins
- dangerous blood clots in a vein or artery, eg:
- in one leg or foot (ie DVT)
- in the lungs
- myocardial infarction
- stroke
- mini-stroke or transient stroke-like symptoms, called transient ischemic attack ( TIA )
- blood clots in the liver, stomach/intestines, kidneys, or eyes. The risk of developing a blood clot may be higher if you have other conditions that increase this risk (see section 2 for more information on the conditions that increase the risk of blood clots and the symptoms of a blood clot).
- constipation, dry mouth, indigestion, heartburn
- hepatic nodules (focal nodular hyperplasia ), chronic inflammation of the gallbladder
- allergic skin reactions, golden-brown pigment spots (chloasma) and other pigment changes, male hair, increased hair growth, skin conditions such as dermatitis and neurodermatitis, dandruff and oily skin ( seborrhea ) and other skin conditions
- back pain, pain in the jaw, a feeling of heaviness
- pain in the urinary tract
- abnormal ejaculation bleeding benign breast lumps, early stage of breast cancer, breast cysts, secretion from the breasts, a polyp on the cervix, redness of the cervix, bleeding during intercourse, the flow of breast milk in women who are not breastfeeding, bleeding from the abdomen, light menstruation, breastfeeding, delayed menstruation, bad smell from the genitals, burning sensation in the genitals, discomfort in the genitals
- swollen lymph nodes
- asthma, difficulty breathing, nosebleeds
- chest pain, fatigue and general malaise, fever
- abnormal cell sample from the cervix.
Further information (taken from the diaries written by women during a clinical study with Qlaira) on the possible side effects of “irregular bleeding (heavy irregular bleeding)” and “missed periods” can be found in the sections ” Intermittent bleeding ” and ” What to do if you do not may have any bleeding on day 26 or the following day (s) ‘.
Description of selected adverse reactions
Listed below are side effects with very low incidence or with delayed onset of symptoms that are considered to be associated with the group of combined contraceptive pills and may also occur during treatment with Qlaira (see also section “Do not use Qlaira”, “Warnings and precautions”):
- liver tumors (both malignant and benign)
- Erythema nodosum (sore red bumps under the skin), Erythema multiforme (skin rash with red spots or sores)
- hypersensitivity (including symptoms such as rash, urticaria )
- in women with hereditary angioedema (characterized by sudden swelling of eg eyes, mouth, throat, etc.), estrogen in combined contraceptive pills can cause or worsen the symptoms of angioedema
In case of impaired liver function, it may be necessary to temporarily discontinue the use of combined oral contraceptives .
How to store Qlaira
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substances are estradiol valerate or estradiol valerate in combination with dienogest.
Each tablet map (28 film-coated tablets) with Qlaira contains 26 active tablets in four different colors on rows 1, 2, 3 and 4 and two white inactive tablets on rows 4.
Composition of the colored tablets containing one or two active substances:
2 dark yellow tablets each containing 3 mg estradiol valerate
5 red tablets each containing 2 mg estradiol valerate and 2 mg dienogest
17 light yellow tablets each containing 2 mg estradiol valerate and 3 mg dienogest
2 dark red tablets each containing 1 mg estradiol valerate
Composition of the white inactive tablets:
These tablets do not contain any active substances.
The other ingredients in the colored active tablets are:
Tablet core: lactose monohydrate, maize starch, pregelatinized maize starch, povidone K25 (E1201), magnesium stearate (E572)
Tablet 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 in the white inactive tablets are:
Tablet core: lactose monohydrate, corn starch, povidone K25 (E1201), magnesium stearate (E572)
Tablet coating: hypromellose type 2910 (E464), talc (E553b), titanium dioxide (E171)
What Qlaira looks like and the contents of the package
The Qlaira tablets are film-coated; the core of the tablet is covered by an outer layer.
Each tablet (28 film-coated tablets) contains 2 dark yellow tablets on row 1, 5 red tablets on row 1, 17 light yellow tablets on rows 2, 3, and 4, and 2 dark red, and 2 white tablets on row 4.
The dark yellow active tablet is round with biconvex surfaces, on one side marked with the letters DD in an equilateral hexagon.
The red active tablet is round with biconvex surfaces, on one side marked with the letters DJ in an equilateral hexagon.
The light yellow active tablet is round with biconvex surfaces, on one side marked with the letters DH in an equilateral hexagon.
The dark red active tablet is round with biconvex surfaces, on one side marked with the letters DN in an equilateral hexagon.
The white inactive tablet is round with biconvex surfaces, on one side marked with the letters DT in an equilateral hexagon.
Qlaira is available in packs of 1, 3, or 6 tablets, and each tablet contains 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
| Bayer Weimar GmbH and Co. KG99427 Weimar Germany | and | Bayer AG13342 Berlin Germany |
This medicinal product is authorized in the European Economic Area and the United Kingdom (Northern Ireland) under the names:
• Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland): QLAIRA / Qlaira
• Italy: KLAIRA