Qlaira tabs #84

Qlaira instruction

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Composition

The composition of tablets includes estradiol valerate as an active substance and a number of auxiliary components:
    lactose monohydrate;
    corn starch;
    magnesium stearate;
    starch corn pregelatinized.
The shell consists of:
    talc;
    dye;
    hypromellose;
    titanium dioxide;
    macrogol-6000.

Form of issue

Tablets with thin film coating, round, biconvex. In total, five types of tablets are produced:
    With the marking "DD". The package contains 2 tablets. The shell is yellow, the core is white.
    With the label "DJ". The package contains 5 tablets. The shell is pink, the core is white.
    With the marking "DH". The package contains 17 tablets. The shell is pale yellow, the core is white.
    With the marking "DN". The package contains 2 tablets. The shell is red, the core is white.
    With the marking "DT". The package contains 2 tablets. The shell is white, the core is white.
Each Qlaira pack contains four types of active tablets, each type containing several different doses of hormones. Two dark yellow tablets contain 3 mg of estradiol, five medium red tablets contain 2 mg of estradiol and 2 mg of dienogest, 17 light-yellow tablets contain 2 mg of estradiol and 3 mg of dienogest, and two dark red tablets contain 1 mg of estradiol. There are also two inactive white tablets in the package.

pharmachologic effect

Qlaira is a combined contraceptive, low-dose, intended for oral use. The preparation contains both estrogenic and progestational components, so that the tablets are well tolerated by patients in 99% of cases. In addition to active tablets, the package contains 2 more inactive tablets, which makes it possible to continuously take the drug. The effect of the contraceptive is achieved due to the oppression of ovulation, increasing the density of cervical mucus, as well as reducing the sensitivity of the endometrium of the uterus to the blastocyst (the initial stage of development of the embryo).
In addition to the main effect, this drug stimulates a decrease in the intensity and duration of the menstrual cycle, relieves the symptoms of PMS and minimizes pain symptoms.

Pharmacodynamics and Pharmacokinetics

Estrogen in Qlaira is estradiol valerate - ester of human 17β-estradiol (1 mg of estradiol valerate corresponds to 0.76 mg of 17β-estradiol). This estrogen differs from ethinylestradiol or its precursor to mestranol used in other COCs and containing the ethyl group 17a, which causes more stable metabolic activity, but also affects the liver.
Dienogest (DNG) is a progestogen with previous clinical trials. It has a pronounced effect on the endometrium. Structurally comes from nortestosterone, has the characteristics of nortestosterone and progestogen derivatives. DNG does not have androgenic activity, but has anti-androgenic activity.

Pharmacokinetics

Estradiol valerate
Absorption: After oral administration of estradiol, the valerate is completely absorbed by the intestinal mucosa. After initial absorption, E2V is hydrolyzed to produce E2 and valeric acid by a metabolic process in the mucosa of the gastrointestinal tract and liver.
Metabolism: metabolism occurs in the mucosa of the gastrointestinal tract and liver. Estradiol valerate is undergoing extensive changes in the first passage of metabolism, which leads to an increase in the concentration of estradiol and its metabolites in the blood serum. In the metabolism, approximately 95% of the oral dose of estradiol valerate is involved before it enters the systemic circulation, so the bioavailability of E2V is about 3-5%. Metabolism E2 in the intestinal mucosa and liver leads to conversion to estrone (E1) and estriol (E3). Both E1 and E3 are metabolized in sulfate and glucuronide forms. These forms of limited cell penetration partly explain their low effectiveness. Estrone (E1) is converted to estrone sulfate (E1-S) by the estrogen sulfotransefare and both can be converted back to E2. Since most of the absorbed E2 is converted to E1 and E1-S, E2 levels are stabilized. Estrogens undergo further oxidation with the help of liver cytochrome P450, affecting the pathways of CYP3A4 and 1A2 until complete elimination.
Distribution: 5% of the oral dose of E2V achieve systematic circulation. E2 is associated with 38% of the mandatory sex hormone globulin (SHBG), 60% albumin and - 3% circulates in free form. The approximate volume of the distribution is ~ 1.2 l / kg. The serum concentration of E2 remains stable during the 28-day treatment period in the range of 0.0336-0.0647 ng / ml due to the stable state between E2-E1-E1-S. Recirculation includes E1-S and estrone glucuronide. The half-life of estradiol is 1.5 hours, the final half-life of estradiol after oral administration is 13-20 hours and depends on the recycling of estrogen sulfate.
Excretion: Estradiol and its metabolites are mainly excreted in the urine. 10% is excreted with feces.
Dienogest
Absorption: DNG is almost completely absorbed after oral administration and has a high bioavailability (91%). There is no clinically established effect on the rate and extent of absorption of DNG concomitant food intake.
Distribution: DNG has a distribution volume of 46L. It circulates in serum with serum albumin (90%) and 9% in the form of free and bioavailable elements. Concentration in serum of DNG in steady state is: min 11.8ng / ml; max 82.9ng / ml.
Metabolism: The half-life of plasma is 12 hours. The substance is almost completely metabolized by cytochrome P450, isoforms of CYP3A4 in pharmacologically inactive metabolites.
Excretion: DNG and its metabolites are excreted mainly by the kidneys. 86% of the hormone and its metabolites are excreted after 6 days.

Indications for use

Qlaira is used to prevent pregnancy. Also, the drug is prescribed for the treatment of severe and prolonged menstrual bleeding (not related to the course of the underlying disease).

Contraindications

The contraceptive preparation of Qlaira should not be taken:
    women who are breastfeeding (combined birth control pills should not be taken until weaning the baby or within six months of birth);
    women with venous thromboembolism, for example, with deep vein thrombosis or thrombi in the lung (pulmonary embolism);
    women with blood diseases, because the substances included in the preparation, as well as their effect on the body, increase the risk of blood clots in the veins;
    women who undergo a course of sclerosing treatment for varicose veins;
    women with two or more risk factors for thrombus formation in the vein, for example, in a family history, there is deep vein thrombosis or pulmonary embolism under the age of 45 (parent, brother or sister);
    women with obesity, smoking, long-term immobility;
    women who have ever had a heart attack, a stroke or a mini-stroke caused by thrombosis in the artery;
    women with angina, heart valve diseases or irregular heartbeats - ciliary arrhythmia;
    women with unstable blood pressure;
    women who smoke more than 40 cigarettes a day;
    women over 50;
    women with severe diabetes;
    women with diabetes, high blood pressure, high cholesterol, migraine;
    women with breast cancer;
    women with abnormal vaginal bleeding, the cause of which is not established;
    women with excess urea in the blood, resulting in damaged blood cells (hemolytic uremic syndrome);
    women with active liver disease, such as liver cancer, hepatitis;
    women with impaired bile excretion, which causes jaundice;
    women with gallstones;
    hereditary blood diseases, known as porphyria.

Side Effects of Qlaira

    nausea and the urge to vomit;
    pain in the abdomen;
    migraine or attacks of severe headaches;
    increased mammary glands and pain in this area;
    weight changes;
    preservation of water in the tissues of the body (fluid retention);
    vaginal thrush (candidiasis);
    change in menstrual bleeding;
    bloody discharge or breakthrough bleeding;
    depression;
    lack of sexual desire;
    unstable blood pressure;
    skin reactions;
    irregular brown spots on the skin, usually on the face (chloasma);
    abnormal liver function;
    stones in the gallbladder.

Qlaira tablets, instructions for use (Method and dosage)

In accordance with the instructions for the use of Qlaira, tablets are consumed every day at about the same time for one piece. Take the drug should be every day, no matter how often you have sex. Swallow tablets need not chewing, squeezed a lot of liquid. The intake of food for the action of active substances is not affected.
Each package contains active tablets in an amount of 26 pieces and 2 inactive white tablets.
Usually the period of use begins with the reception of the second dark red or white and does not end before the opening of the next package. Some women begin bleeding after taking the first pill of a new package, which is considered quite natural and in most cases does not require specialist intervention.
Tablets should be taken continuously, even if the bleeding did not stop. This means that you must start a new packing of tablets on the same day of the week as the current one.

Application of the drug

Provided that previously no contraceptives were taken, you should start to drink Qlaira pills on the first day of the menstrual cycle. The reception of the first tablet is guaranteed to protect against pregnancy. After the birth of a child or abortion before taking the drug should consult with a doctor.
Qlaira's admission after the use of other oral contraceptives is carried out on the day after the last active tablet of the previous package was taken.

If you miss a drug

Inactive tablets:
If the white tablets (the last in the package) were not received on time, they can be taken at any convenient time, since they do not contain any active ingredients. The only rule is to accept them in any case, so as not to get confused in the number of days of taking active pills, since this increases the risk of unwanted pregnancy.
Active tablets:
Depending on the day of the cycle, when one intake of the active pill was missed, it may be necessary to take additional contraceptive precautions. If the time elapsed since the usual intake of Qlaira is less than 12 hours, then protection from pregnancy does not decrease and you can drink a pill without using additional contraceptives. If the time is more than 12 hours, then protection from pregnancy can be reduced. Depending on the day of the cycle, when one tablet was missed, an additional contraceptive method should be used.
In normal cases, the pill should be taken internally in order, which is indicated on the package, every day at the same time. Tablets can not be chewed and washed down with a moderate amount of water.
It should take one tablet a day for 28 days. A new package of tablets is opened after the last inactive tablet from the previous calendar package has been accepted.
Stop taking Qlaira and immediately consult a doctor if there is at least one of the possible signs of a thrombus. They include:
    unusual cough;
    severe pain or heaviness in the chest;
    shortness of breath;
    unusual, severe or prolonged headache or migraine attack;
    partial or complete loss of vision;
    inarticulate speech;
    sudden changes in hearing, smell or taste;
    dizziness or fainting;
    weakness or numbness in any part of the body;
    severe pain in the abdomen;
    severe pain, swelling, or discoloration of the legs.

Overdose

The serious health consequences of drug overdose are currently unknown. Young girls with the intake of several Qlaira tablets may experience nausea, headache and sudden vaginal bleeding. At the first signs of an overdose, see a doctor.

Interaction with other drugs

The following drugs can accelerate the disintegration of the hormones contained in Clayre in the liver, which makes the action of the pills less effective in preventing pregnancy:
    aprepitans;
    Boszentan;
    barbiturates;
    Carbamazepine;
    Modafinil;
    Nevirapine;
    Oxcarbazepine;
    Phenobarbital;
    Phenytoin;
    Primidone;
    Rifampicin;
    Rifabutin;
    Ritonavir;
    Telaprevir;
    Topiramate;
    herbal remedies with St. John's wort.
With regular intake of one of these drugs, Qlaira as a method of contraception is not suitable, since the contraceptive effect of these pills will be minimal and will not provide the proper level of protection against unplanned pregnancy.
If a patient is prescribed Rifampicin or Rifabutin, an alternative method of contraception is always recommended, since these two antibiotics make birth control pills ineffective. Also, an alternative contraceptive method is recommended for use with other antibiotics (for example, Amoxicillin, Erythromycin, Doxycycline).
Antifungal agents, such as Griseofulvin can make tablets less effective. When taking such funds, you need to use an additional method of contraception throughout the course of treatment and within one month after its completion.
Preparations for weight loss (Xenical, Turboslim and others) with simultaneous admission with Qlaira cause in 90% of cases of severe diarrhea.
Qlaira's tablets can trigger an increase in blood sugar levels, as well as a decrease in the effect of drugs to treat diabetes. In diabetes, the use of any oral contraceptive should be accompanied by regular measurement of blood sugar levels.
Admission Qlaira and drugs to reduce high blood pressure provokes a decrease in the effect of the latter.
Qlaira prevents the removal of fluid with loss of exposure to diuretics.
Tablets can increase the levels of blood in the cells of the following drugs, which increases the risk of side effects:
    Cyclosporin;
    Melatonin;
    Ropinirole;
    Selegiline;
    Tacrolimus;
    Theophylline;
    Tizanidine;
    Voriconazole.

Terms of sale

To buy Qlaira you do not need to present a doctor's prescription when buying a contraceptive.

Storage conditions

Keep the Qlaira tablets in a sealed pouch until it's time to print it. If the taking of tablets has already begun, then they should not be kept longer than the calendar plan for admission.
Store the drug in a cool dry place where the temperature does not exceed 30 ° C.
It is not recommended to store tablets or other medicines in the bathroom or next to the sink. You can not leave it on the windowsill or in the car. Heat and dampness destroy some components of the drug.
Keep the drug in a place inaccessible to children.

Shelf life

Store the drug can be for four years from the time of production in a sealed package.

Reviews of Qlaira

The doctors' comments about Clare speak about the high contraceptive effect that the drug has on women. Experts agree that this drug perfectly protects against unplanned pregnancy and thus has a positive effect on the health of the female body as a whole.
About the contraceptive pills Qlaira reviews in general are different. Some women claim that taking the drug had an effective effect without the appearance of side effects of Qlaira, others had side effects, but they were of a short-term nature.
Who took hormonal pills, left feedback on Clare on the forums and most of the reviews are positive or neutral. Especially good about the drug responded to women who used a contraceptive in endometriosis. They argue that the specific symptomatology disappeared after the regular intake of birth control pills. However, the duration of the drug in all cases is different.