Qlaira is a hormonal medication which helps to prevent pregnancy when taken daily. The drug contains different dosages of 2 female hormones, dienogest and estradiol valerate.
Indications for use
- Oral contraception;
- Treatment of profuse and / or prolonged menstrual bleeding without organic pathology.
Mechanism of action
The contraceptive effect of Qlaira is based on the suppression of ovulation and changes in the density of cervical mucus. In addition to preventing unwanted pregnancy, tablets have a number of other positive properties:
- reduce the sensitivity of the endometrium of the uterus to the blastocyst (the first stage of embryo development);
- reduce the duration and intensity of menstrual bleeding;
- improve the metabolism of iron in the blood serum;
- relieve symptoms of premenstrual syndrome;
- reduce pain during menstruation;
- reduce the risk of ovarian and endometrial cancer.
Estradiol valerate is the natural estrogen, which has a less negative effect on the liver. After oral administration of tablets, the valerate is quickly and completely absorbed in the body. When passing through the gastrointestinal mucosa, the substance breaks down into valeric acid and estradiol. The maximum amount of the active component in the blood plasma is recorded 1.5-12 hours after a single dose.
The second active ingredient, dienogest, is a progestogen, which has additional antiandrogenic effects when administered orally: improves the condition of the hair and nails, reduces the growth of facial, pubic, axillary hair, normalizes the period and sensitiveness of the endometrium. The maximum amount of dienogest in the composition of the blood is reached 1 hour after oral administration.
Dosage and mode of application
Each Qlaira pack contains 28 tablets that are taken in the following order:
- 2 dark yellow tablets (3 mg estradiol valerate);
- 5 medium red tablets (2 mg estradiol valerate and 2 mg dienogest);
- 17 light yellow tablets (2 mg estradiol valerate and 3 mg dienogest);
- 2 dark red tablets (1 mg estradiol valerate);
- 2 white tablets (no hormones).
Tablets should be taken daily in the order indicated on the packaging, regardless of foods, approximately at the same time, with water. Take 1 tablet a day for 28 days. Begin each new package after taking the last tablet from the previous package. Menstruation-like bleeding usually occurs when you take the last tablets of the pack and may not finish before taking the tablets from the next pack.
Preparation of a cot-book:
In order to control the order of taking the tablets, 7 labels are attached to the package with the names of 7 days of the week.
It is necessary to choose a sticker that starts from the day of the week in which you starts taking the tablets. For example, if the intake starts on Wednesday, you should use a “Wed” sticker.
The sticker is applied to the top of the unfolding pack so that the name of the first day is above the tablet with the number “1”.
Now you have the name of the corresponding day of the week above each tablet, and it is clear whether the tablet has already been taken on a current day or not.
The next packing begins without interruption, i.e. the day after the current packaging is finished, even if the bleeding has not stopped. This means that the next package should be started on the same day of the week as the current one, and that menstrual bleeding should occur every month on the same days of the week.
If you use Qlaira drug as indicated in the instructions, you are protected from unwanted pregnancy even during those 2 days when you take inactive tablets.
How to start taking tablets from the first package:
If you did not use hormonal contraceptives last month:
Begin taking tablets on the 1st day of the period, i.e. in the 1st day of menstrual bleeding.
If you switch to Qlaira from a contraceptive vaginal ring or patch:
Begin taking birth control pills the day after the last active tablet from the current package was taken. If in the package of the previous contraceptive contain inactive tablets, they must be discarded. If you previously used a contraceptive vaginal ring or plaster, start taking the tablets on the day of removal of the ring / patch.
When switching from only-progestogen contraceptive preparations (“mini-pills”, injections, implants or intrauterine systems):
It is possible to switch to Qlaira medication any day (from the implant or the IUD – on the day of their removal, from the injection method – on the day the next injection is prescribed), but in all cases during the first 9 days of taking this contraceptive, additional non-hormonal contraceptive measures should be used.
After an abortion in the first trimester of pregnancy:
You can start taking birth control pills immediately. In this case, you do not need to use additional contraceptive measures.
After childbirth or abortion in the second trimester of pregnancy:
You should start taking pills on days 21-28 after delivery (if you do not breastfeed) or abortion in the second trimester of pregnancy. If you start taking pills later, you are recommended to use a barrier method of contraception during the first 9 days of taking the pills. However, if you have had sexual intercourse before taking birth control pills, you need to exclude pregnancy or wait for the first menstrual period before taking the preparation.
Recommendations for gastrointestinal disorders:
If you have vomiting or severe diarrhea after taking any of the 26 active tablets of Qlaira, the absorption of the active substances may be incomplete. If vomiting occurred 3-4 hours after taking the active pill, it is equivalent to missing a tablet. Therefore, in this case, you need to read the information given in the “What if I miss a pill” section. If you do not want to change your usual intake scheme, you should take an additional tablet of the same color from another package. Vomiting or diarrhea on the days of taking the last 2 inactive tablets does not have any effect on the effectiveness of contraception.
How to stop taking Qlaira pills:
You can stop taking the drug at any time. If you are not planning a pregnancy, you should switch to other methods of contraception. If you are planning a pregnancy, you should just stop taking birth control pills.
- Symptoms: no serious negative effects were reported with an overdose of Qlaira. Symptoms that can occur when an active pill is overdosed: nausea, vomiting, spotting, metrorrhagia;
- Treatment: symptomatic.
- Infections and invasions: fungal infection, vaginal candidiasis, vaginal infection, unspecified, herpes, syndrome of suspected eye histoplasmosis, multicolored lichen, urinary tract infection, bacterial vaginosis, vulvovaginal fungal infection;
- Metabolism and alimentary disorders: increased appetite, fluid retention, hypertriglyceridemia;
- Nervous system: a headache (including a headache “tension”), depression / mood reduction, decreased libido, mental disorders, mood changes, dizziness, affective lability, aggressiveness, anxiety, dysphoria, increased libido, nervousness, anxiety, sleep disturbance, stress, attention disorder, paresthesia, vertigo;
- Vision: intolerance to contact lenses;
- Cardiovascular system: increased blood pressure, migraine, bleeding from varicose veins, “hot flushes”, lowering blood pressure, pain along the veins;
- Digestive system: abdominal pain, bloating, diarrhea, nausea, vomiting, constipation, dyspepsia, gastroesophageal reflux;
- Skin and subcutaneous tissue: acne, alopecia, itching, rash, allergic skin reactions, including allergic dermatitis and hives, chloasma, hirsutism, hypertrichosis, neurodermatitis, pigmentation disorders, seborrhea, skin lesion;
- Musculoskeletal: back pain, muscle spasms, a feeling of heaviness.
- Reproductive system and mammary glands: amenorrhea, discomfort in the mammary glands, pains in the mammary glands, disorders in the nipple, pain in the nipples, dysmenorrhea, metrorrhagia, enlargement of the mammary glands, diffuse mammary gland thickening, dysplasia of the cervical epithelium, dysfunctional uterine bleeding, dyspareunia, fibrocystic mastopathy, cysts in the ovaries, pelvic pain, PMS, uterine leiomyoma, spasms of the uterus, vaginal discharge, dryness in the vulvovaginal area, benign neoplasm in the breast milk, breast cyst, bleeding during sexual intercourse, galactorrhea, gipomenoreya, menstrual-like delayed bleeding, ovarian cysts break, burning sensation in the vagina, uterine / vaginal bleeding, including sputum discharge, vaginal odor, vulvovaginal discomfort;
- Common symptoms: weight gain, irritability, swelling, chest pain, fatigue, malaise.
The following undesirable phenomena occurred with very low frequency:
- Tumors: The incidence of breast cancer has been slightly increased in women using combined oral contraceptives. Since breast cancer is rare in women younger than 40 years, an excess of frequency is insignificant in relation to the general risk of occurrence of a mammary gland cancer. The causal relationship of breast cancer with the use of Qlaira is not established;
- Other conditions: arterial and venous thromboses and thromboembolic complications, erythema nodosum, erythema multiforme; discharge from the mammary glands, increased risk of developing pancreatitis, increased blood pressure, the onset or deterioration of conditions in which communication with the use of combined oral contraceptives is not undeniable: jaundice and / or pruritus associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; Sydenham’s chorea; herpes during pregnancy; hearing loss associated with otosclerosis.
In women with hereditary angioedema, estrogen-containing contraceptives can cause or exacerbate symptoms of angioedema.
Qlaira tablets should not be used in the presence of any of the conditions listed below. The contraceptive should be immediately canceled if any of these conditions develop against the background of using birth control pills:
- hypersensitivity to dienogest and estradiol valerate or any of the excipients;
- thrombosis (venous and arterial) and thromboembolism (current or in the anamnesis), myocardial infarction, stroke (current or in the anamnesis);
- conditions preceding thrombosis (transient ischemic attacks, angina pectoris) at present or in the anamnesis;
- acquired or hereditary predisposition to venous or arterial thrombosis;
- a high risk of venous or arterial thrombosis;
- a migraine with focal neurological symptoms (current or in the anamnesis);
- diabetes mellitus with vascular complications;
- pancreatitis with severe hypertriglyceridemia (current or in the anamnesis);
- hepatic failure and severe liver disease (before the normalization of liver function);
- liver tumors (benign and malignant) at present or in the anamnesis;
- identified hormone-dependent malignant tumors (including genitals or mammary glands);
- bleeding from the vagina of unknown origin;
- lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
In the presence of any of the diseases / conditions / risk factors listed below, the potential risk and the expected benefit of using Qlaira should be weighted in each individual case:
- risk factors for thrombosis and thromboembolism (smoking, obesity, dyslipoproteinemia, arterial hypertension, migraine, heart valve disease, heart rhythm disturbance, extensive surgery without prolonged immobilization);
- other diseases in which peripheral circulation disorders may occur (diabetes mellitus, systemic lupus erythematosus, hemolytic-uremic syndrome, Crohn’s disease and ulcerative colitis, sickle-cell anemia);
- hereditary angioedema;
- diseases that first appeared or worsened during pregnancy or against the background of using hormonal contraceptives (cholestatic pruritus, cholelithiasis, cholestatic jaundice, otosclerosis with hearing impairment, porphyria, herpes pregnant, Sydenham’s chorea);
- postpartum period.
Always inform your doctor about all medicines or herbal remedies you are already taking before using Qlaira for birth control. You will be given recommendations on additional contraceptive measures (for example, condoms).
Some drugs may reduce the effectiveness of Claira in preventing pregnancy or cause untimely bleeding. Such medicines include:
Drugs used to treat:
- epilepsy (for example, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
- tuberculosis (eg, rifampicin);
- HIV infections (ritonavir, nevirapine) and other infections (antibiotics of penicillin, tetracycline groups, griseofulvin);
- a herbal medicine on the basis of St. John’s wort perfumed.
Some drugs can increase the level of dienogest and estradiol valerate in the blood. Such medicines include:
- antifungal agents containing ketoconazole;
- antibiotics containing erythromycin.
Qlaira can influence the effects of other drugs, for example:
- antiepileptic remedy lamotrigine.
Pregnancy and breastfeeding
The use of Qlaira is contraindicated during pregnancy and lactation. If the pregnancy is detected or suspected during the use of birth control pills, they should be immediately canceled. However, extensive epidemiological studies have not revealed any increased risk of developmental defects in children born to women who took combined oral contraceptives before pregnancy or during early pregnancy.
If you are pregnant or breastfeeding, consult your doctor before taking any medication.
What if I miss a pill?
If the delay in taking any of the tablets is less than 12 hours, the contraceptive effect does not decrease. A woman should take a missed pill right away, as soon as she remembers it, and take the rest of the pills at the usual time.
If the delay in taking any of the tablets is more than 12 hours, the contraceptive effect may decrease. A woman should take the missed pill right away, as soon as she remembers it, even if it means that she will have to take 2 tablets at the same time. Then she needs to continue taking birth control pills at the usual time.
Depending on the day of the period in which the pill was missed, additional contraceptive measures (for example, barrier method of protection, in particular condoms) are required in accordance with the following principles:
Take the missed pill immediately, take the next pill at the usual time (even if it means that you have to take 2 tablets in one day).
Continue taking pills in the usual order, use additional contraceptive methods for 9 consecutive days.
Continue taking pills in the usual order, take additional contraceptive methods for 9 consecutive days.
Discard the current package and immediately start taking tablets from the new package. Continue taking pills in the usual order. Use additional contraceptive methods for 9 consecutive days.
Take the missed pill immediately, the next pill is taken at the usual time (even if it means that you have to take 2 tablets in one day). There is no need for additional contraceptive methods.
Discard the missed tablet and continue taking the tablets in the usual order. There is no need for additional contraceptive measures.
It is not allowed to take more than 2 tablets in one day. If you have forgotten to start a new package or missed one or more tablets in the days 3-9, you may already be pregnant (if you had sexual intercourse in the period of 7 days before missing the tablet). The more active pills are missed and the closer they are to inactive tablets, the higher the probability of pregnancy.
If you missed active tablets and have no menstrual bleeding in this period, you need to consider the probability of pregnancy.
Consider the following warnings relating to the use of Qlaira pills.
Thrombosis is the formation of a blood clot (thrombus) that can clog the blood vessel. When the thrombus is broken off, thromboembolism develops. Sometimes thrombosis develops in the deep veins of the legs (deep vein thrombosis), cardiac vessels (myocardial infarction), the brain (stroke), and in the vessels of other organs (extremely rarely).
The risk of deep vein thrombosis in women taking combined oral contraceptives is higher than those who do not use them but not as high as during pregnancy.
The risk of developing thrombosis increases with age, and also increases with an increase in the number of cigarettes smoked. When using Qlaira drug, you should stop smoking, especially if your age exceeds 35 years.
The risk of deep vein thrombosis temporarily increases during surgery or prolonged immobilization (immobility), for example, when applying gypsum on the leg, prolonged bed rest. In the event of a planned operation or hospitalization, tell the doctor in advance that you are taking the hormonal contraceptive. The doctor may recommend that you stop taking the medication and resume taking it after two weeks of immobilization.
If you have high blood pressure, your doctor may also recommend that you stop taking the preparation.
The relationship between combined oral contraceptives and breast cancer has not been proven, although women who take combined oral contraceptives are more likely to have breast cancer than women of the same age who do not use them. Perhaps this difference is due to the fact that when taking the drug, women are examined more often and therefore breast cancer is detected at an early stage.
In rare cases, against the background of using sex hormones, development of benign and malignant (extremely rare) liver tumors that can lead to life-threatening internal bleeding. The link with the use of birth control pills has not been proven. If you have sudden severe pain in the abdomen, consult a doctor immediately.
The most significant risk factor for developing cervical cancer is a persistent papillomavirus infection. Cervical cancer was detected more frequently in women using combined oral contraceptives for a long time. The connection with the intake of birth control pills has not been proved. This may be due to more frequent gynecological examinations to detect cervical disease or with peculiarities of sexual behavior.
The effectiveness of Qlaira tablets can be reduced in the following cases: when missing pills, with vomiting and diarrhea, or as a result of drug interactions.
Women with a tendency to chloasma should avoid prolonged exposure to the sun and exposure to ultraviolet radiation when taking the medication.
Impact on laboratory tests:
The intake of dienogest + estradiol valerate may affect the results of some laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney functions, plasma protein levels, for example, corticosteroid-binding globulin and lipid / lipoprotein fraction, parameters of carbohydrate metabolism and coagulation parameters and fibrinolysis. These changes usually remain within the limits of laboratory norms.
Qlaira is not indicated after menopause.
Patients with impaired renal function:
The drug has not been specifically studied in patients with impaired renal function. The available data do not suggest correction of the dosing regimen in such patients.
Insufficient control of the period:
Irregular bleeding from the vagina (spotting or breakthrough uterine bleeding) can occur during the first few months. Use hygiene products and continue taking birth control pills as usual. Irregular menstrual bleeding usually stops as your body adapts to the drug (usually after 3 months of taking the tablets). If it continues, gets heavy or resumes after stopping, visit a doctor.
The absence of the expected menstruation:
If you took all the pills correctly and you did not have vomiting during taking pills, the probability of pregnancy is small. Continue taking the tablets as usual.
If you have no 2 menstruations in a row, consult a doctor immediately. Do not start using the next package until the doctor excludes the pregnancy. In the period of “no-hormones” days before consulting a doctor, use non-hormonal contraceptives.
Impact on the ability to drive a vehicle and work with machinery:
There was no adverse effect of Qlaira on the ability to drive and work with mechanisms, but patients who have had periods of dizziness and attention spillage during the adaptation period (the first 3 months of taking the drug) should be careful.
When you need to consult a doctor:
If you are taking birth control pills, your doctor will inform you about regular examinations, which are usually prescribed once a year.
Consult your doctor as soon as possible:
- if you have any negative changes in health;
- if you have local compaction in the mammary gland;
- if you intend to use other medications;
- if you expect prolonged immobility or plan surgery (consult a doctor at least 4-6 weeks before it);
- if you have an unusually severe bleeding from the vagina;
- if you forgot to take a pill in the first week (a pill from the first row of the package) and had sexual intercourse 7 or fewer days before it;
- you did not have menstrual bleeding for 2 months or you suspect that you are pregnant (do not start taking the pills from the next package until you consult a doctor).
Stop taking pills and immediately consult a doctor if you notice possible signs of thrombosis, myocardial infarction or stroke: an unusual cough; unexpected shortness of breath; unusual headache or migraine attack; partial or complete loss of vision or double vision; inarticulate speech; sudden changes in hearing, smell, or taste; dizziness or faintness; weakness or loss of sensitivity in any part of the body; severe pain in the abdomen; severe pain in the leg or a sudden swelling in either leg.
The drug does not protect against HIV infection (AIDS) or any other sexually transmitted disease.