Description
Latin name
Lea
Release form
Film-coated tablets
Placebo tablets: round, biconvex tablets, covered with a film membrane of white color.
Pharmacological action
Contraceptive combined (estrogen + progestogen)
Indications
– contraception
– contraception and acne treatment cf days of gravity (acne vulgaris)
– contraception and treatment of a severe form of premenstrual syndrome (PMS).
Contraindications
Taking Leia is contraindicated in the presence of any of the conditions listed below, if any of these conditions occurs for the first time during treatment with COCs, you should immediately stop taking them:
– thrombosis (venous and arterial) and thromboembolism at present or in the anamnesis (including deep vein thrombosis, pulmonary embolism, myocardial infarction), cerebrovascular disorders (including a history of)
– conditions preceding including transient ischemic attacks, angina pectoris) currently or in the history of
– a hereditary or acquired predisposition to the development of venous or arterial thrombosis, such as resistance to activated protein C. antithrombin III deficiency, de itsit protein C deficiency protein S, hyperhomocysteinemia and antiphospholipid antibody (antibodies to cardiolipin, lupus anticoagulant)
– a migraine with current focal neurological symptoms or a history of
– multiple or severe risk factors for venous or arterial thrombosis, including complicated valvular heart disease, atrial fibrillation, cerebral arterial hypertension, non-coronary artery artery dyslipoproteinemia, diabetes mellitus with vascular complications, serious surgery with prolonged immobilization smoking older than 35 years obesity with a body mass index (BMI) over 30 kg / m2 extensive trauma
– hepatic failure, severe liver disease (before normalization of liver function)
– liver tumors (benign or malignant), including: a history of
– severe renal failure, acute renal failure
– adrenal insufficiency
– pancreatitis, including history, if associated with the presence of severe triglyceridemia
– identified hormone-dependent malignant diseases (including genitals or mammary glands) or suspected
of them – vaginal bleeding of unspecified etiology
– pregnancy or suspected
– breastfeeding hypersensitivity to any of the components of the drug Leia
– lactose intolerance, lactase deficiency, glucose-galactose malabsorption (lactose monohydrate is a part).
Caution:
If the patient has any of the conditions / risk factors listed below, the potential risk and expected benefits of using COCs should be carefully weighed, including Leia:
– risk factors for thrombosis and thromboembolism: smoking, thrombosis (including a history), myocardial infarction, or cerebrovascular accident at a young age of the next of kin obesity with a BMI of less than 30 kg / m2 dyslipoproteinemia controlled arterial hypertension migraine without focal neurological symptoms of heart valve disease without complications heart rhythm disturbance
– other diseases tions under which can be marked disorders of peripheral circulation: diabetes systemic lupus erythematosus hemolytic uremic syndrome Crohn ² ¢s disease and ulcerative colitis sickle cell anemia as well as phlebitis of superficial veins
– hereditary angioedema
– hypertriglyceridemia
– liver disease
– diseases that occurred during the previous or last pregnancy intake of sex hormones (for example, jaundice, cholestasis, cholelithiasis, otosclerosis with impaired hearing, porphyria, herpes pregnant, Sydenham chorea)
– the postpartum period.
Dosage and administration
Leia is intended for oral administration daily for 28 days without interruption, at approximately the same time, with a small amount of water, in the order indicated on the blister pack. Reception of tablets from a new package begins the day after taking the last tablet from the previous package.
How to take Leia
If no hormonal contraceptives were taken in the previous month
Leia begins on the first day of the menstrual cycle (ie, on the first day of menstrual bleeding). It is allowed to start taking on the 2nd-5th day of the menstrual cycle, but in this case it is recommended to additionally use the barrier method of contraception during the first 7 days of taking tablets from a new package.
Withdrawal bleeding usually begins on the 2nd ² 3rd day after the start of taking inactive tablets and may not end before taking the tablets from the new package.
When switching from other combined oral contraceptives (COCs, vaginal ring or transdermal patch)
It is preferable to start taking Leia the day after taking the last active tablet from the previous package, but in no case later than the next day after the usual 7-day break (for drugs containing 21 active tablets) or after taking the last inactive tablet (for preparations containing 28 tablets per pack). Leia should be taken on the day the vaginal ring or contraceptive patch is removed, but no later than the day the new ring is inserted or a new patch is pasted.
When switching from contraceptives containing only progestogens (mini-pill, injection, implant or intrauterine contraceptive)
A woman can switch from mini-pill to taking Leia any day (without a break), from an implant or an intrauterine therapeutic system releasing gestagen – on the day of its removal, from an injection contraceptive – on the day when the next injection is to be made. In all cases, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets.
After an abortion in the first trimester of pregnancy
A woman can start taking Leia on the first day after an abortion. Subject to this condition, a woman does not need additional contraceptive measures.
After childbirth or abortion in the second trimester of pregnancy
It is recommended to start taking Leia on the 21-28th day after birth, in the absence of breastfeeding, or abortion in the second trimester of pregnancy. If you start later, it is necessary to use an additional barrier method of contraception during the first 7 days of taking the tablets. However, if a woman has already lived sexually, pregnancy should be ruled out before taking Leia.
Taking missed tablets
Skipping inactive tablets can be ignored. Nevertheless, they should be thrown away so as not to accidentally extend the period of taking inactive tablets.
The following recommendations apply only to skipping active tablets:
– if the delay in taking the drug was less than 24 hours, contraceptive protection does not decrease. A woman should take the missed pill as soon as possible, and take the next at the usual time
– if the delay in taking the pill was more than 24 hours, contraceptive protection may be reduced. The more tablets missed, and the closer the pass of tablets to the phase of taking inactive tablets, the higher the likelihood of pregnancy.
In this case, you can follow the following basic rules:
– the drug should never be interrupted for more than 7 days (the recommended interval for taking inactive tablets is 4 days)
– to achieve adequate suppression of the hypothalamic-pituitary-ovarian system, 7 days of continuous taking pills.
Thus, if the delay in taking active pills was more than 24 hours, you can recommend the following:
From the 1st to the 7th day:
A woman should take the last missed pill as soon as she remembers this, even if it means taking two tablets at the same time. She continues to take the following tablets in the higher the chance of pregnancy.
In this case, you can follow the following basic rules:
– the drug should never be interrupted for more than 7 days (the recommended interval for taking inactive tablets is 4 days)
– to achieve adequate suppression of the hypothalamic-pituitary-ovarian system, 7 days of continuous taking pills.
Thus, if the delay in taking active pills was more than 24 hours, you can recommend the following:
From the 1st to the 7th day:
A woman should take the last missed pill as soon as she remembers this, even if it means taking two tablets at the same time. She continues to take the following tablets in the higher the chance of pregnancy.
In this case, you can follow the following basic rules:
– the drug should never be interrupted for more than 7 days (the recommended interval for taking inactive tablets is 4 days)
– to achieve adequate suppression of the hypothalamic-pituitary-ovarian system, 7 days of continuous taking pills.
Thus, if the delay in taking active pills was more than 24 hours, you can recommend the following:
From the 1st to the 7th day:
A woman should take the last missed pill as soon as she remembers this, even if it means taking two tablets at the same time. She continues to take the following tablets in
– the drug should never be interrupted for more than 7 days (the recommended interval for taking inactive tablets is 4 days)
– to achieve adequate suppression of the hypothalamic-pituitary-ovarian system, 7 days of continuous administration of tablets are required.
Thus, if the delay in taking active pills was more than 24 hours, you can recommend the following:
From the 1st to the 7th day:
A woman should take the last missed pill as soon as she remembers this, even if it means taking two tablets at the same time. She continues to take the following tablets in
– the drug should never be interrupted for more than 7 days (the recommended interval for taking inactive tablets is 4 days)
– to achieve adequate suppression of the hypothalamic-pituitary-ovarian system, 7 days of continuous administration of tablets are required.
Thus, if the delay in taking active pills was more than 24 hours, you can recommend the following:
From the 1st to the 7th day:
A woman should take the last missed pill as soon as she remembers this, even if it means taking two tablets at the same time. She continues to take the following tablets in more than 7 days (the recommended interval for taking inactive tablets is 4 days)
– to achieve adequate suppression of the hypothalamic-pituitary-ovarian system, 7 days of continuous administration of tablets are required.
Thus, if the delay in taking active pills was more than 24 hours, you can recommend the following:
From the 1st to the 7th day:
A woman should take the last missed pill as soon as she remembers this, even if it means taking two tablets at the same time. She continues to take the following tablets in more than 7 days (the recommended interval for taking inactive tablets is 4 days)
– to achieve adequate suppression of the hypothalamic-pituitary-ovarian system, 7 days of continuous administration of tablets are required.
Thus, if the delay in taking active pills was more than 24 hours, you can recommend the following:
From the 1st to the 7th day:
A woman should take the last missed pill as soon as she remembers this, even if it means taking two tablets at the same time. She continues to take the following tablets in even if it means taking two tablets at the same time. She continues to take the following tablets in even if it means taking two tablets at the same time. She continues to take the following tablets inNormal time. In addition, over the next 7 days, it is necessary to additionally use a barrier method of contraception (for example, a condom). If sexual intercourse took place within 7 days before skipping a pill, you should consider the possibility of pregnancy.
From the 8th to the 14th day:
A woman should take the last missed pill as soon as she remembers this, even if it means taking two tablets at the same time. The following tablets should be taken at the usual time.
Provided that the woman took the pill correctly within 7 days preceding the first missed pill, there is no need to use additional contraceptive measures. Otherwise, as well as when skipping two or more tablets, it is necessary to additionally use barrier methods of contraception (for example, condom) for 7 days.
From day 15 to day 24:
The risk of a decrease in reliability is inevitable due to the approaching phase of taking inactive tablets. A woman should strictly adhere to one of the following two options. In this case, if in the 7 days preceding the first missed tablet, the psy tablets were taken correctly, there is no need to use additional contraceptive methods. Otherwise, she needs to use the first of the following schemes and additionally use the barrier method of contraception (for example, a condom) for 7 days.
1 option:
A woman should take the last missed pill as soon as she can remember (even if that means taking two tablets at the same time). The following tablets are taken at the usual time until the active tablets in the pack run out. Four inactive tablets should be discarded and tablets should be taken immediately from the next pack. Withdrawal bleeding is unlikely until the active tablets in the second pack run out, but spotting and breakthrough bleeding may occur while taking the tablets.
Option 2:
A woman may also stop taking pills from the current package. Then she should take a break of no more than 4 days, including days of skipping pills, and then start taking pills from a new package. If a woman missed active pills, and there was no withdrawal bleeding while taking inactive pills, pregnancy should be excluded.
Recommendations for gastrointestinal disorders
In severe gastrointestinal disorders, absorption of the drug may be incomplete, therefore, additional contraceptive measures should be taken.
If vomiting occurs within 4 hours after taking the active tablet, you should be guided by the recommendations when skipping tablets. If a woman does not want to change her usual regimen and postpone the onset of menstruation to another day of the week, an additional active pill should be taken from another package.
Change the day onset of menstrual bleeding
In order to delay the onset of menstrual bleeding, a woman should continue taking pills from the next package by skipping inactive tablets from the current package. Thus, the cycle can be extended, if desired, for any period until the active tablets from the second package end. Against the background of taking tablets from the second package, a woman may have spotting or breakthrough uterine bleeding. Regular intake of the drug Leia resumes after the end of the phase of taking inactive tablets.
In order to move the day the menstrual bleeding begins to another day of the week, a woman should reduce the next phase of taking inactive tablets by the desired number of days. The shorter the interval, the higher the risk that she will not have withdrawal bleeding and there will be spotting spotting and breakthrough bleeding in the future when taking the second package (as well as in the case when she would like to delay the onset of menstrual bleeding).
How to delay withdrawal bleeding
To delay the onset of menstruation, a woman should switch to taking pills from a new package of Leia, skipping taking a placebo pill. This extension of the cycle can be continued until the active tablets of the second package run out. During this extension, a woman may experience breakthrough bleeding or spotting. In the future, regular administration of Leia should be resumed after the usual interval without taking tablets, which is 7 days. To postpone the onset of menstruation to another day, more suitable for the usual schedule of a woman, you can reduce the second phase of taking placebo tablets for as many days as needed. The shorter this phase, the higher the risk that withdrawal bleeding will not develop, and that breakthrough bleeding or spotting will appear during the administration of tablets from the second package (as well as with delayed menstruation).
Special patient groups
Children and adolescents
The drug Leia is indicated only after the onset of menarche. Available data do not suggest dose adjustment in this group of patients.
Elderly patients
Not applicable. Leia is not indicated after menopause.
Patients with impaired liver function
The drug Leia is contraindicated in women with severe liver diseases until liver function indicators return to normal.
Patients with impaired renal function
Leia is contraindicated in women with severe renal failure or acute renal failure. (Cm. sections Contraindications and Pharmacological properties).
Overdose of
To date, there have been no cases of overdose of the drug Leia. Given the clinical experience of using COCs, in case of an overdose of the drug, the following symptoms may be observed: nausea, vomiting, spotting, spotting, or metrorrhagia. The antidote does not exist, the treatment is symptomatic.
Storage conditions
Store in a dry place, at a temperature not exceeding 30 ° C.
Keep out of the reach of children.
Sindera Pharma S.L., Spain
