Kleira - a drug used for oral contraception.
Release form and composition
Klayru is produced in the form of film-coated tablets (biconvex, round, in the transverse section - the core is from almost white to white), 28 pcs. Each. in aluminum foil / PVC blisters, 1 or 3 blisters glued into a folding book, complete with a reception calendar.
In the blister pills of five kinds.
The composition of 1 dark-yellow tablet with the inscription “DD” in a regular-shaped hexagon on one side (2 pieces in a blister) contains the active substance: estradiol valerate, micro 20 - 3 mg.
Auxiliary components: lactose monohydrate - 48.36 mg; pregelatinized corn starch - 9.6 mg; corn starch - 14.4 mg; Povidone 25, 4 mg; magnesium stearate - 0.64 mg.
The composition of the shell: titanium dioxide - 0,584 mg; macrogol 6000 - 0.3036 mg; hypromellose - 1,5168 mg; talc - 0.3036 mg; Iron oxide yellow dye - 0.292 mg.
The composition of 1 pink tablet with the inscription "DJ" in the hexagon of the correct form on one of the sides (in the blister - 5 pcs.) Includes active substances:
- Estradiol valerate, micro 20 - 2 mg;
- Dienogest, micro - 2 mg.
Auxiliary components: lactose monohydrate - 47.36 mg; corn starch - 14.4 mg; pregelatinized corn starch - 9.6 mg; Povidone 25, 4 mg; magnesium stearate - 0.64 mg.
The composition of the shell: macrogol 6000 - 0.3036 mg; hypromellose - 1,5168 mg; talc - 0.3036 mg; titanium dioxide - 0.83694 mg; red oxide of iron dye - 0.03906 mg.
The composition of 1 pale yellow tablet with the inscription "DH" in the hexagon of the correct form on one side (in the blister - 17 pcs.) Contains the following substances:
- Estradiol valerate, micro 20 - 2 mg;
- Dienogest, micro - 3 mg.
Auxiliary components: lactose monohydrate - 46.36 mg; corn starch - 14.4 mg; pregelatinized corn starch - 9.6 mg; Povidone 25, 4 mg; magnesium stearate - 0.64 mg.
The composition of the shell: titanium dioxide - 0.83694 mg; hypromellose - 1,5168 mg; talc - 0.3036 mg; macrogol 6000 - 0.3036 mg; Iron oxide yellow dye - 0.03906 mg.
The composition of 1 red tablet with the inscription "DN" in the hexagon of the correct form on one side (2 pieces in a blister) contains the active substance: estradiol valerate, micro 20 - 1 mg.
Auxiliary components: pregelatinized corn starch - 9.6 mg; lactose monohydrate - 50.36 mg; corn starch - 14.4 mg; magnesium stearate - 0.64 mg; Povidone 25-4 mg.
The composition of the shell: titanium dioxide - 0,5109 mg; talc - 0.3036 mg; hypromellose - 1,5168 mg; macrogol 6000 - 0.3036 mg; red oxide of iron dye - 0,3651 mg.
Tablets (placebo) in white with the inscription "DT" in the hexagon of the correct form on one side (in a blister - 2 pcs.).
Auxiliary components: corn starch - 24 mg; lactose monohydrate - 52.1455 mg; magnesium stearate - 0.8 mg; Povidone 25 - 3.0545 mg.
The composition of the shell: talc - 0.2024 mg; hypromellose - 1,0112 mg; titanium dioxide - 0.7864 mg.
Indications for use
Klayru can not be used in the presence of any of the following conditions or in their development while taking the drug:
- Thrombosis (arterial and venous) and thromboembolism, including deep vein thrombosis (DVT), myocardial infarction (MI), pulmonary embolism (PE), stroke (in history or present);
- The presence of risk factors for venous or arterial thrombosis (multiple or severe), including uncontrolled arterial hypertension, extensive surgical interventions with prolonged immobilization, complicated by pathologies of the valvular apparatus of the heart;
- Pre-thrombosis conditions, including angina pectoris, transient ischemic attacks (in history or at present);
- Severe liver disease and liver failure (taking Klyry possible after the normalization of indicators of liver function);
- Migraine with focal neurological symptoms (including in history);
- Pancreatitis with severe hypertriglyceridemia (in history or at present);
- Diabetes mellitus, accompanied by vascular complications;
- Malignant and benign liver tumors (in history or at present);
- Bleeding from the vagina of unknown origin;
- Hormone-dependent malignant tumors (identified or suspected of them);
- Pregnancy or suspicion of it;
- Hypersensitivity to the drug.
Kleir must be taken with caution (after evaluating the benefit / risk ratio) for the following diseases / conditions:
- The presence of risk factors for thromboembolism and thrombosis, including dyslipoproteinemia, extensive surgical interventions, smoking, prolonged immobilization, obesity, arterial hypertension, heart rhythm disturbances, migraine, valvular heart disease, extensive injuries;
- Other diseases that may cause peripheral circulatory disorders, including ulcerative colitis and Crohn's disease, systemic lupus erythematosus, diabetes mellitus, hemolytic-uremic syndrome, sickle-cell anemia;
- Hereditary angioedema;
- Diseases that first arose or worsened during pregnancy or when taking previous sex hormones (for example, Sydenhem chorea, otosclerosis with impairment of hearing, cholestatic jaundice, cholelithiasis, cholestatic itching, herpes of pregnancy, porphyria);
- Postpartum period.
Dosing and Administration
Klayru take inside, regardless of the meal.
Tablets should be taken daily in the order indicated on the package, preferably at the same time. The drug is washed down with water or other liquid.
Reception Klyry should be carried out continuously within 28 days on 1 tablet. New packaging can be started after taking the last pill from the previous calendar packaging.
Typically, menstrual-like bleeding begins when you take the latest pills from the calendar package, and it may not be complete before the next calendar package starts. Sometimes menstrual bleeding begins after taking the first pills from a new calendar package.
In cases where a woman has not used hormonal contraception before (the previous month), taking the pills should be started from the first day of the natural menstrual cycle (on day 1 of the menstrual bleeding).
When switching from another combined oral contraceptive (CCP), a woman should start taking the drug from the day after she drank the last active pill (containing active substances) from the package of the previous CCP. If she used a vaginal ring or transdermal patch, Klayra is taken on the day they are removed.
In cases where previously only a progestogen contraceptive method (implant, injection, mini-pili) or an intrauterine system with release of progestogen (IUD) was used, taking Klyra can be started:
- Navy or implant - on the day of their removal;
- Injection method - on the day to which the next injection is scheduled.
In all cases, during the first nine days of taking the pills, you should additionally use a barrier method of contraception.
After an abortion in the first trimester of pregnancy, you can take Klayra immediately, without using additional contraceptive measures.
After an abortion in the second trimester of pregnancy or after childbirth, it is recommended to begin taking the drug on days 21-28 If a woman starts taking pills later, it is further recommended to use a barrier method of contraception for 9 days. In cases where sexual contact has already taken place, before you start taking the drug, you must exclude pregnancy or start using Clayra after the onset of the first menstruation.
Skipping intake of inactive (white) pills does not lead to the development of negative consequences, in this case, in order to avoid an accidental increase in the interval between taking active pills, inactive should be discarded.
When you skip taking active pills for less than 12 hours, contraceptive protection does not decrease. The woman should drink the missed pill as soon as she remembers this, and then she should take the pill at the usual time.
If you skip taking active pills for more than 12 hours, contraceptive protection may decrease. The last missed pill must be taken at any time, even if it results in taking 2 pills at the same time. In the future, the Clayra technique is resumed at the usual time.
Depending on the day of the cycle on which the pill was missed, additional contraceptive measures may be required (for example, the barrier method, in particular, the condom):
- Dark yellow pills (1-2 days) - you need to take the missed pill immediately, and the next one - at the usual time;
- Pink pills (3-7 days) - you should continue taking the pills as usual and use additional contraceptive measures for the next 9 days;
- Pale yellow pills (8-17 days) - for 9 next days it is necessary to take additional contraceptive measures;
- Pale yellow pills (18-24 days) - the current calendar packaging should be discarded and start taking from a new calendar package from the first tablet. Over the next 9 days to apply additional contraceptive measures;
- Red pills (25-26 days) - you must immediately take the missed pill, and the next one - at the usual time. Additional contraceptive measures are not required;
- White pills (placebo, 27-28 days) - the missed pill can be thrown away and continue taking Claira in the usual way. Additional contraceptive measures are not required.
If a woman forgot to start taking the drug from a new calendar package or missed 1 or more pills on days 3–9 of a calendar package, she may be pregnant (if she had sexual contact within 7 days before skipping the pill). The more pills are missed (especially with the combined active ingredients in 3-24 days), and the closer it happened to the intake pill phase, the higher the chance of pregnancy.
If after the end of the calendar package, during which you missed taking the pills, there is no menstrual bleeding, the probability of pregnancy should be considered.
In severe gastrointestinal disorders, the absorption of Clayra may be incomplete, so the woman needs to take additional contraceptive measures.
If, after 3-4 hours after taking the active pill, vomiting has occurred, in this case, you should follow the recommendations related to skipping pills. If a woman does not want to change her usual regimen of the drug, you can drink an extra pill (s) from a new package.
Klayra is not indicated for use in women after menopause.
In the application of Klaira, the development of disorders by various body systems is possible:
- Invasions and infections: infrequently - candida vagina, fungal infection, vaginal infection unspecified; rarely, bacterial vaginosis, herpes, candidiasis, urinary tract infections, presumptive histoplasmosis syndrome of the eye, vulvovaginal fungal infection, versicolor versicolor;
- Nervous system: often - headache (including tension headache); infrequently - mood changes, depression / decrease in mood, mental disturbance, decrease in libido, dizziness; rarely - paresthesia, aggressiveness, affective lability, impaired attention, anxiety, dysphoria, nervousness, increased libido, sleep disturbance, anxiety, stress, vertigo;
- Metabolism and nutritional disorders: infrequently - increased appetite; rarely - hypertriglyceridemia, fluid retention;
- Cardiovascular system: infrequently - increase in arterial pressure, migraine (including with and without aura); rarely - hot flushes to the face, bleeding from varicose veins, pain along the veins, lowering blood pressure;
- Body of vision: rarely - intolerance to contact lenses;
- The reproductive system: often - discomfort and pain in the mammary glands, amenorrhea, disorders in the nipples, dysmenorrhea, pain in the nipples, irregular menstrual-like bleeding (metrorrhagia); infrequently - fibrocystic mastopathy, uterine leiomyoma, menorrhagia, dyspareunia, cervical epithelium dysplasia, diffuse seal of the mammary glands, enlargement of the mammary glands, dysfunctional uterine bleeding, pain in the pelvic region, cysts in the ovaries, premenstrual syndrome, dryness in the vulvovaginal region. uterus, vaginal discharge; rarely - hypomenorrhea, vaginal bleeding, breast cyst, galactorrhea, benign neoplasm in the breast, bleeding during sexual intercourse, delayed menstrual bleeding, burning sensation in the vagina, rupture of an ovarian cyst, uterine / vaginal bleeding (including odor from vagina, spotting, vulvovaginal discomfort);
- Hepatobiliary system: rarely - focal nodular liver hyperplasia, increased alanine aminotransferase (ALT) activity;
- Digestive system: often - abdominal pain (including bloating); infrequently - nausea, diarrhea, vomiting; rarely, gastroesophageal reflux;
- Musculoskeletal system: rarely - muscle spasms, back pain, feeling of heaviness;
- Skin and hypoderm: often - acne; infrequently - alopecia, pruritus (including generalized itching and itchy rash), rash (including spotted rash); rarely, allergic skin reactions, including allergic dermatitis and urticaria, seborrhea, dermatitis, chloasma, hypertrichosis, hirsutism, pigmentation disturbances, neurodermatitis, unspecified skin lesions, including a feeling of skin tightness;
- Common symptoms: often - increase in body weight; infrequently - swelling, irritability, weight loss; rarely - chest pain, lymphadenopathy, malaise, fatigue.
The greatest likelihood of venous thromboembolism (VTE) is observed in the first year of taking Klayra, mainly during the first 3 months. Thrombosis of other blood vessels (for example, mesenteric, hepatic, renal) when using the drug is extremely rare.
The risk of thromboembolism and thrombosis (arterial and / or venous) increases: in smokers, with age, with hypertension, obesity, family history, migraine, dyslipoproteinemia, extensive surgery, atrial fibrillation, valvular heart disease, prolonged immobilization.
When assessing the benefit / risk ratio, it must be borne in mind that therapy of the respective condition may reduce the associated risk of thrombosis. It is also necessary to take into account that the risk of thromboembolism and thrombosis during pregnancy is higher than when taking Klayra.
In some cases, while taking the drug, the development of benign or malignant (in extremely rare cases) liver tumors was observed. If you experience severe pain in the upper abdomen, an increase in the size of the liver or signs of intra-abdominal bleeding during a differential diagnosis, liver tumors should be excluded.
If a persistent, clinically significant increase in blood pressure develops while taking the drug, Kleir should be canceled and therapy for hypertension should begin. After normalization of pressure, the drug can be resumed.
The drug does not protect against sexually transmitted diseases, including HIV infection (AIDS).
Before you start taking Klayra, you should carefully evaluate the contraindications for his appointment on the basis of the history of life and family history of the woman, as well as gynecological and general medical examinations. The nature and frequency of these surveys should take into account the individual characteristics of the woman.
Patients who during the first 3 months of taking the drug (during the adaptation period) had episodes of dizziness and impaired concentration of attention should be careful when driving.
The interaction of Clayra with other drugs can lead to a lack of contraceptive effect and / or to the appearance of breakthrough uterine bleeding.
When certain groups of antibiotics are taken (for example, the tetracycline and penicillin groups), the enterohepatic circulation of estrogens may decrease, which may lead to a decrease in the estradiol concentration.
Women who use drugs that induce microsomal enzymes or antibiotics, in addition to Klaire, it is recommended to use a barrier or another method of contraception. The barrier method of protection must be used during the entire period of use of concomitant drugs, as well as for another 28 days after their cancellation.
Clayra can affect the metabolism of a number of other drugs (for example, lamotrigine), which can cause an increase or decrease in the concentration of these substances in tissues and blood plasma. Inhibition of CYP enzymes in the application of Klayra in therapeutic doses is unlikely.
Terms and conditions of storage
Keep out of reach of children at temperature up to 30 ° C.
Shelf life - 4 years.