Qlaira

Pharmacological properties

Qlaira is a combination oral contraceptive used to prevent pregnancy. each color active tablet contains a small amount of female sex hormones (estradiol valerate in combination with dienogest).

2 white tablets do not contain active substances and are called inactive tablets (placebo). Contraceptives containing 2 hormones are called combined oral contraceptives (CPC).

In addition to the contraceptive effect, CPC have a number of positive effects. With the use of CPC, the intensity and duration of menstrual bleeding decreases. As a result, the risk of anemia is reduced. Menses may become less painful or painless.

It has been established that when using high-dose CPC (50 μg ethinyl estradiol), the risk of developing serious diseases is reduced. These include benign breast diseases, ovarian cysts, infectious and inflammatory diseases of the pelvic organs, ectopic pregnancy, endometrial and ovarian cancer. It is possible that a decrease in the level of these diseases is also observed with the use of low-dose oral contraceptives, however, a similar fact was confirmed only for endometrial and ovarian cancer.

Indications

Oral contraception.

Application

Each pack contains 26 colored active tablets and 2 white inactive tablets.

Take 1 tablet 1 time per day at approximately the same time, with a small amount of water, regardless of the meal.

With the correct use of combined oral contraceptives, the incidence of unwanted pregnancy is approximately 1% per year. The incidence of an unwanted pregnancy may increase if you skip the drug or due to improper use.

Packaging preparation

To facilitate control of taking the tablets, 7 sticker strips with the names of the days of the week are attached to the package.

Choose a strip that starts from the day corresponding to the start of the drug (for example, for the medium use a strip starting with "Cp").

Stick the strip on top of the Klaira package in the place where it says “Stick the strip here,” so that the first day of taking the drug is above the pill number “1”.

If there is a specified day over each tablet, you can control the intake of tablets. Take the tablets in turn, following the direction of the arrows, until the end of all 28 tablets.

Typically, menstrual bleeding begins when you take a second pill of a dark red color or a white pill and may not end before you start taking a pill from a new package. In some women, bleeding continues even after taking the first pills from a new package.

They do not take a break before taking pills from a new package, the use of tablets from the next package is started the day after taking pills from the current package, even if menstrual bleeding continues. Thus, the beginning of taking a new package will be on a certain day of the week, and every month the beginning of menstruation will be approximately on the same day of the week. When taking the drug in the manner described above, the contraceptive effect is also preserved when taking inactive tablets for 2 days.

How to start taking Qlaira

In the previous month, hormonal contraceptives were not used.

Pills should be started on the 1st day of the menstrual cycle (1st day of menstrual bleeding). Transition from another PDA, contraceptive vaginal ring or transdermal patch. The use of Qlaira must be started the day after taking the last active tablet of the previous PDA.Inactive tablets from the packaging of the previous PDA (if any) are not taken, but they start taking Clire tablets without a break. When using a combined contraceptive vaginal ring or transdermal patch, it is advisable that the woman start using Klaira on the day the drug is removed or on the recommendation of a doctor.

Transition from a progestogen-based method (mini-pill, injection, implant) or an intrauterine system with a progestogen

You can start taking Qlaira on any day after you stop taking the mini-pill (in the case of an implant or intrauterine system, on the day they are removed, in the case of an injection, instead of the next injection). Nevertheless, in all cases, it is recommended to additionally use the barrier method of contraception during the first 9 days of taking the tablets.

After a miscarriage. On the recommendation of a doctor.

After childbirth. Acceptance of the drug Qlaira begins after the end of the first physiological menstrual cycle. In some cases, this is possible earlier (on the recommendation of a doctor). However, if sexual intercourse has already taken place, then before starting the use of CPC, it is necessary to exclude the presence of a possible pregnancy or wait for menstruation.

When using the drug during breastfeeding, as well as in the absence of confidence in the timing of the start of the drug, prior medical advice is necessary.

What to do if you miss a pill

Inactive pills. If you skip taking the white pill (2 tablets at the end of the package), there is no need to take it later, since it does not contain active substances, and the contraceptive effect of the drug does not decrease.

It is important to take the next pill at the usual time and remove the forgotten inactive white tablets from the package. The contraceptive effectiveness of the drug may decrease with a random increase in the period during which active tablets are not used.

If you skip taking the last white pill from the package, you must take the first tablet from the next package at the usual time.

Active pills (1–26 tablets per pack). Depending on the day of the menstrual cycle, in which the active pill was missed, there may be a need for additional contraception (using the barrier method of contraception - a condom). Tablets should be taken according to the recommendations given (see also the Principles of use in case of a missed tablet).

If the delay in taking the active pill does not exceed 12 hours, the contraceptive effect of the drug Qlaira does not decrease. A missed pill should be taken as soon as possible. The following tablets from this package should be taken at the usual time.

If the delay in taking the active pill exceeds 12 hours, the contraceptive effect may decrease. Depending on the day of the menstrual cycle, in which the active pill was missed, it may be necessary to use additional contraception (use of the barrier method of contraception - a condom) (see also Principles of use in case of a missed pill).

Principles of use in case of a missed tablet

If you skip taking more than 1 active pill, you need to consult a doctor.

If you skip taking the 1st active pill (being late in taking more than 12 hours) and if there is one week before skipping sex, you must adhere to the following recommendations:

1st – 9th day of the menstrual cycle - additional consultation with a doctor;

On the 10-17th day of the menstrual cycle, they take a forgotten pill, all subsequent pills at the usual time, even if it is necessary to take 2 tablets in 1 day, use additional methods of contraception for the next 9 days (condom);

The 18-24th day of the menstrual cycle does not take a forgotten pill, but begins with the 1st pill of a new package, using additional methods of contraception in the next 9 days;

On the 25-26th day of the menstrual cycle, they take a forgotten pill, all subsequent pills at the usual time, even if it is necessary to take 2 tablets in 1 day, additional methods of contraception are not necessary;

On the 27–28th day of the menstrual cycle, they do not take the missed pill and continue taking the pill at the usual time; there is no need for additional methods of contraception.

If you skip taking another pill, do not take more than 2 active tablets per day.

In the case when the start of taking the tablets from the next package is missed or the reception of ≥1 tablets is missed during the 3–9th day of the current package, there is a risk of pregnancy (if there was sexual intercourse within 7 days before skipping the pill). In this case, you need to see a doctor. Depending on the number of missed tablets (especially on the 3rd – 24th day) and the closer they are to the phase of inactive tablets, the risk of a decrease in the contraceptive effect increases.

If a woman has missed taking active tablets and she does not have the expected menstruation while taking the last pill tablets, it is necessary to exclude the likelihood of pregnancy. Before you start taking pills from a new package, you need to consult a doctor.

With vomiting or severe diarrhea while taking any of the 26 active tablets of Qlaira, a decrease in the absorption of active substances is possible. If vomiting develops within 3-4 hours after taking the tablets, this is similar to skipping the drug, you must follow the instructions for the missed tablets. If you have severe diarrhea, you should consult a doctor. The presence of vomiting or diarrhea when taking the last 2 inactive white tablets does not affect the contraceptive effectiveness of the drug.

Discontinuation of the drug

You can stop taking Clire at any time. When you stop using the drug for pregnancy, you must wait until the next menstrual bleeding begins before conception. This will help in determining the date of birth.

Contraindications

Combined oral contraceptives should not be used in the presence of one of the following conditions or diseases:

• deep vein thrombosis of the lower extremities, pulmonary embolism or thrombosis of a different localization, now or in the past;

• acute coronary syndrome (ACS) and acute cerebrovascular accident (stroke) - ischemic or hemorrhagic in nature - now or in the past;

• prodromal manifestations of ACS (angina pectoris) or ONMK (transient ischemic attacks - TIA), now or in the past;

• migraine accompanied by focal neurological symptoms (impaired vision, speech, paresthesia or paresis of various localization);

• diabetes mellitus with vascular complications;

• pancreatitis associated with hyperlipidemia, now or in history;

• liver disease at present or in the anamnesis, while indicators of liver function are not normalized;

• hormone-dependent malignant tumors of the genital organs or mammary gland, currently or in history;

• benign or malignant liver tumor at present or in history;

• vaginal bleeding of unknown origin;

• established or probable pregnancy;

• hypersensitivity to estradiol valerate or dienogest, or other components of the drug.

You should immediately stop using the drug if one of the above conditions occurs and switch to the use of non-hormonal contraceptives (see also the SPECIAL INSTRUCTIONS section).

Side effects

When taking clare, the following side effects may develop:

Violations of organs and systems	Often ≥1 / 100 and 1 /10	Rarely ≥1 / 1000 and 1/100	Sometimes ≥1 / 10,000 and 1/1000
Infections and infestations		Fungal infection, vaginal candidiasis, vaginal infection	Candidiasis, herpes simplex, suspected histoplasmosis of the eye syndrome, lichen, urinary tract infection, bacterial vaginitis, vulvovaginal mycosis
From the side of metabolism		Increased appetite	Fluid retention in the body, hypertriglyceridemia
From the psyche		Depression / depressed mood, decreased libido, mental disorders, mood changes	Affective lability, aggression, anxiety, dysphoria, increased libido, nervousness, anxiety, sleep disturbance, stress
From the central nervous system	Headache1	Dizziness	Stray attention, paresthesia, vertigo
On the part of the organ of vision			Contact lens intolerance
From the vascular system		AH, migraine2	Varicose veins bleeding, hot flashes, arterial hypotension, vein pain
From the gastrointestinal tract	Abdominal pain3	Diarrhea, nausea, vomiting	Constipation, dyspepsia, gastroesophageal reflux
From the hepatobiliary system			Increased AlAT activity, focal nodular liver hyperplasia
On the part of the skin and subcutaneous fat	Acne	Alopecia, itching4rash5	Allergic skin reactions6, chloasma, dermatitis, hirsutism, hypertrichosis, neurodermatitis, pigmentation, seborrhea skin diseases7
From the musculoskeletal system			Back pain, muscle cramps, feeling of heaviness
From the reproductive system and mammary glands	Amenorrhea, discomfort in the mammary glands8, dysmenorrhea, intermenstrual bleeding (metrorrhagia)9	Breast enlargement and hardening, cervical dysplasia, dysfunctional uterine bleeding, dyspareunia (pain during intercourse), cystic fibrotic mastopathy, menorrhagia, menstrual irregularities, ovarian cysts, pain in the pelvic organs, premenstrual syndrome, uterine leiomyoma, uterine spasm, vaginal discharge, dry vulva and vagina	Benign diseases of the mammary glands, cyst of the mammary glands, bleeding during intercourse, galactorrhea, genital bleeding, hypomenorrhea, delayed menstruation, rupture of the ovarian cyst, burning sensation in the vagina, uterine / vaginal bleeding, including vaginal bleeding and odor, discomfort in the vulvovaginal region
On the part of the blood system and lymphatic system			Lymphadenopathy
General disorders and reactions at the injection site		Irritation, swelling	Chest pain, fatigue, malaise
Survey	Weight gain	Body weight reduction

Including:

1 headache due to a change in blood pressure;

2 migraine with or without aura;

3 increase in intra-abdominal pressure;

4 generalized itching and rash with itching;

5 macular rash;

Allergic dermatitis and urticaria;

7 feeling of tightness of the skin;

8 pain in the mammary glands and nipples, disorders of the nipples;

9 irregular menstruation.

In addition to these side effects, women who took CPC with ethinyl estradiol had cases of skin diseases such as erythema nodosum and polymorphic exudative erythema, as well as increased sensitivity and excretion from the mammary glands. Although during clinical trials