Lillow is a combination contraceptive containing a progestin (levonorgestrel) and an estrogen (ethinyl estradiol) that prevent ovulation.
Indications for use
- Oral contraception.
Mechanism of action
Three-level action (inhibition of hormones involved in ovulation, changes in the properties of the endometrium to prevent implantation of the embryo and thickening of the mucus in the cervical canal in order to prevent sperm from entering the uterine cavity) allows providing a highly reliable contraceptive effect, protecting a woman of fertile age from unwanted pregnancy. In addition, the drug can reduce the intensity of menstrual bleeding and pain syndrome, normalize the menstrual periods.
Dosage and mode of application
Tablets should be taken every day according to the order indicated on the blister, approximately at the same time, with water. Take 1 pill a day for 28 days. Menstruation should begin on the day 2-3 after taking the last active tablet. Begin a new package without breaks.
First use of Lillow tablets:
If you did not use hormonal contraceptives in the previous month:
You must start taking pills on the 1 day of your period. You can start taking tablets on the days 2-5 of your period, but in this case, you need to use additional methods of contraception for the first 7 days (during the 1 course of contraception).
Switching from another COC:
Start taking tablets the next day after taking the last active pill of the previous COC, at least no later than the next day after a break in taking a 21-pill package or after taking the last inert tablet of the previous 28-pill package.
Switching from a progestogen-only method (minipills, injection, implants, intrauterine system):
You can start taking Lillow any day after discontinuing mini-pills (if you used an implant or intrauterine system – on the day they are removed, if you used an injection method – instead of the next injection). Anyway, you need to use an additional barrier method of contraception for the first 7 days (during the 1 course of contraception).
After an abortion in the I trimester of pregnancy:
You should start taking the drug immediately after an abortion. You do not need to use additional contraceptives in this case.
After childbirth or abortion in the II trimester of pregnancy:
If a woman is breastfeeding, it’s not recommended to use birth control pills.
It is recommended to start taking pills on the 21st to 28th day after childbirth or abortion in the II trimester of pregnancy. If you start taking pills later, you need to use additional barrier methods of contraception for 7 days. However, if you had sex already, you must exclude pregnancy before starting a new pack.
No serious adverse effects due to an overdose of Lillow have been reported. Patients can have the following symptoms: nausea, vomiting, spotting from the vagina (in young patients). There is no specific antidote, treatment should be symptomatic.
Some patients reported adverse effects when taking Lillow pills, but their relationship with the use of the drug was not confirmed:
- nausea, abdominal pain;
- vomiting, diarrhea;
- rash, urticaria;
- nodular erythema, exudative erythema multiforme;
- weight gain;
- oppressed state, emotional lability;
- decreased libido;
- increased libido;
- decreased body weight;
- metabolism and malnutrition;
- fluid retention;
- tenderness in the mammary glands;
- mammary gland enlargement;
- changes in vaginal secretion, secretion from the mammary glands.
Lillow cannot be used for birth control in the presence of one of the following conditions or diseases. If any of these conditions or diseases occur for the first time during the use of the contraceptive, the drug should be withdrawn:
- liver tumors, including in the anamnesis;
- diagnosed or suspected hormone-dependent malignant tumors;
- venous or arterial thrombotic / thromboembolic events, including a history;
- prodromal symptoms of thrombosis, including in the anamnesis;
- migraine with focal neurologic symptoms in a history;
- diabetes mellitus with vascular lesions;
- pancreatitis associated with severe hypertriglyceridemia, including in a history;
- severe liver disease (until the liver function is normalized);
- vaginal bleeding of unexplained etiology;
- hypersensitivity to levonorgestrel/ethinyl estradiol or another component of the drug;
- severe or multiple risk factors for venous or arterial thrombosis.
Interactions with other drugs can lead to breakthrough bleeding and / or loss of contraceptive effectiveness of Lillow tablets.
Drugs that induce microsomal enzymes. These include phenytoin, barbiturates, primidone, carbamazepine, rifampicin and oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, medicines containing St. John’s Wort. Such interactions can cause an increase in the clearance of levonorgestrel and ethinyl estradiol.
The results of some clinical studies suggest that the level of ethinyl estradiol may decrease when it’s combined with certain antibiotics (penicillin and tetracycline series).
When taking any of the above drugs, you must temporarily resort to an additional barrier method of contraception or choose another method of contraception. When taking drugs that induce microsomal enzymes, you need to use an additional barrier method throughout the course of treatment with the appropriate drug and for another 28 days after discontinuation of its use. If you are treated with antibiotics (with the exception of rifampicin and griseofulvin), you need to use an additional barrier method for another 7 days after its withdrawal.
Lillow contraceptive can affect the metabolism of other drugs. In connections with this, the concentrations of active substances in blood plasma and tissues (cyclosporine) can vary.
Note: to determine the risk of Lillow interaction with drugs, it is recommended that you read the instructions for use of these drugs.
Influence on laboratory studies:
COCs may affect the results of some laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, blood plasma levels of proteins such as globulin, sex hormone binding, carbohydrate metabolism parameters, parameters of coagulation and fibrinolysis. Usually, such changes are within the normal limits.
Pregnancy and breastfeeding
Lillow is contraindicated for use during pregnancy. If the pregnancy occurred during the use of birth control pills, they should be discontinued. Nevertheless, the results of epidemiological studies do not indicate an increase in the risk of congenital deficiencies in children born from patients taking COCs prior to pregnancy, as well as the existence of teratogenic effects when COCs were taken early in pregnancy.
Birth control pills can affect lactation because under their influence, the amount of breast milk can decrease and its composition may change. In connection with this, Lillow drug is not recommended for use during breastfeeding. The active ingredients in the formulation and / or their metabolites are excreted in small amounts with breast milk, although there is no evidence that this has a negative effect on the health of the infant.
What if I miss a pill?
The following instructions should be followed in case of missing an active tablet(s). If you missed an inert tablet during the 4th week, throw it away since it contains no medication and is used as a reminder.
If the delay in taking a dose does not exceed 12 hours, the contraceptive effect of the drug does not decrease. The missed tablet should be taken immediately. The next tablet should be taken at the usual time.
If the delay in taking a dose exceeds 12 hours, the contraceptive effect may decrease. In this case, you can choose which rule to follow:
- A break in taking doses should not exceed 7 days;
- Adequate oppression of the hypothalamus – pituitary – ovary system is achieved with continuous intake of birth control pills for 7 days.
According to this, the given recommendations should be followed:
Missing an active tablet in the 1st week:
You need to take the missed tablet as soon as possible, even if you have to take two pills per day. After this, keep on taking pills at the usual time. In addition, use a barrier method of contraception for the next 7 days. If you had sexual intercourse in the previous 7 days, you could be pregnant. The more tablets you missed and the closer they are to an inert-medication-phase, the higher the risk of pregnancy.
Missing an active tablet in the 2nd week:
You need to take the missed pill as soon as possible, even if you have to take 2 pills at a time. After this, keep on taking pills at the usual time. If you took pills correctly in the last 7 days before missing a dose, you do not need to use additional contraceptives. Otherwise (or if you missed 2 tablets), it is recommended to use a barrier method of contraception for the next 7 days.
Missing an active tablet in the 3rd week:
The risk of a decrease in reliability increases with the approach of an inert-medication-phase. If one of the 2 following options is followed, then there will be no need to use additional contraceptives provided that you took birth control pills correctly in the previous 7 days before missing a dose. If this is not the case, you should follow the first option and use additional contraceptive methods during the next 7 days.
- It is recommended to take the last missed pill as soon as possible, even if you need to take 2 pills at a time. After this, keep on taking pills at the usual time. Tablets from the next package should be taken immediately after you have taken the last active tablets from the previous Lillow, that is, there should not be an inert-medication-phase. It is unlikely that a woman will have menstrual bleeding until she finishes the second package, although she may have spotting or breakthrough bleeding during the period;
- It is also recommended to stop taking tablets from the current pack. In this case, the break between packs should be up to 7 days, including the days of missed tablets; The next package should be started.
If the tablets are missed and you have no menstrual bleeding during an inert-medication-phase, you need to consider the likelihood of pregnancy.
The drug does not affect the ability to drive vehicles and work with mechanisms.
If you have any of the following conditions / risk factors, the benefits of using Lillow and the possible risk should be weighed individually before using this drug. In case of aggravation, worsening or first occurrence of any of the following conditions or risk factors, it is recommended to consult a doctor. The doctor must decide whether it’s necessary to stop using COCs.
Based on the results of epidemiological studies, there is a link between the use of birth control pills and an increased risk of venous and arterial thrombotic and thromboembolic diseases, such as myocardial infarction, stroke, deep vein thrombosis and pulmonary embolism. The below-listed conditions are very rare.
1. Venous thromboembolism:
Venous thromboembolism – acute vein thrombosis and / or pulmonary embolism can occur when using any COCs.
The risk of venous thromboembolism is very high during the first year of use of Lillow. The frequency of venous thromboembolism in patients taking oral low-dose oral contraceptives is 4 cases per 10,000 women / year compared with women who do not use oral contraceptives – 0.5-3 cases per 10,000 women / year. The frequency of venous thromboembolism associated with pregnancy is 6 cases per 10 000 women / year.
In very rare cases, patients reported cases of thrombosis of other blood vessels, for example, arteries and veins of the liver, kidneys, mesenteric vessels, cerebral vessels or retina.
There is no general conclusion about the connection of these complications with the use of the contraceptive drug.
Symptoms of venous or arterial thrombotic / thromboembolic events or cerebrovascular disorders may include: unilateral pain in the lower extremities or their edema; sudden severe pain in the chest, which can radiate into the left arm; sudden shortness of breath; sudden coughing; any unusual, strong, prolonged headache; sudden decrease or total loss of vision; diplopia; speech disorder or aphasia; vertigo; collapse with or without a partial epileptic seizure; weakness, sudden numbness of one side or one part of the body; motor impairment.
Factors that increase the risk of venous or arterial thrombotic / thromboembolic events or cerebrovascular disorders: age; smoking (especially in women over the age of 35); family history (for example, cases of venous or arterial thromboembolism in brothers or sisters or parents at a relatively early age); obesity (body mass index exceeding 30 kg / m2); dyslipoproteinemia; AH; migraine; heart valve disease; atrial fibrillation; prolonged immobilization, radical surgical interventions, surgical operations on the lower limbs, serious injuries. In these cases, it is recommended to discontinue taking birth control pills (at least 4 weeks before the planned operation).
It is necessary to take into account the increased risk of thromboembolism in the postpartum period.
Other diseases that can be associated with circulatory disorders include: diabetes mellitus; systemic lupus erythematosus; hemolytic uremic syndrome; chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis) and sickle-cell anemia.
An increased incidence of migraine headaches or their exacerbations during the use of the drug may require the immediate withdrawal of Lillow.
Biochemical parameters that may be characteristic of a hereditary or acquired propensity to venous or arterial thrombosis include: resistance to activated protein C (APC), hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies).
Analyzing the risk / benefit ratio, a doctor should take into account the fact that adequate treatment of the conditions mentioned above can reduce the associated risk of thrombosis and that the risk of thrombosis associated with pregnancy is higher than when using low-dose combination oral contraceptives.
An important risk factor for cervical cancer is the persistence of papillomavirus. The results of some epidemiological studies indicate an additional increase in this risk with prolonged use of birth control pills containing levonorgestrel and ethinyl estradiol, however this statement is inconsistent since it is not completely clear to what extent these data take into account co-occurring risk factors, for example, screening of the cervix and sexual behavior, including the use of barrier birth control methods.
The results of 54 conducted epidemiological studies indicate a slight increase in the risk of breast cancer in women using combination oral contraceptives. The risk is gradually reduced within 10 years after the end of hormonal contraception. Breast cancer in women under the age of 40 is rarely detected, so the increase in the number of breast cancer diagnoses in patients using or currently using COCs is insignificant relative to the overall risk of developing breast cancer. The results of these studies do not prove the existence of a causal relationship. Increased risk may be due to both earlier diagnosis of breast cancer in women using COCs and the biological effect of COCs or the effect of both factors. There is a tendency that breast cancer detected in patients taking COCs is clinically less pronounced than in those who have never taken such medications.
In unique cases, patients taking COCs reported benign and malignant liver tumors, leading in some cases to life-threatening intra-abdominal bleeding.
3. Other conditions:
Women with hypertriglyceridemia (including family history) are at risk for developing pancreatitis when using Lillow tablets.
A slight increase in blood pressure was reported in many women taking COCs, but a clinically significant increase in blood pressure was very rare. Nevertheless, if a prolonged clinically pronounced hypertension occurs during the use of the contraceptive, it is necessary to cancel the drug and start treating hypertension. If its level return to normal, the use of birth control pills can be resumed.
There were reports of aggravation of the following diseases during pregnancy and with the use of combination oral contraceptives, but their connection has not been confirmed: jaundice, skin itching associated with cholestasis, gallstones, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, herpes pregnant, hearing loss associated with otosclerosis.
In acute or chronic violations of liver function, it may be necessary to stop taking the tablets to normalize the liver function. When the recurrence of cholestatic jaundice, which first occurred during pregnancy or previous reception of sex hormones, the use of the drug should be discontinued.
Although contraceptives with levonorgestrel and ethinyl estradiol can affect peripheral insulin resistance and glucose tolerance, there is no evidence of the need for a change in the therapeutic regimen in patients with diabetes mellitus taking low-dose COCs. Nevertheless, patients with diabetes should be under the supervision of a doctor during the period of taking hormonal contraceptives.
Crohn’s disease and ulcerative colitis can be associated with the use of birth control pills.
Sometimes, chloasma may occur, especially in patients with a history of chloasma. Patients who are prone to develop chloasma should avoid exposure to direct sunlight or ultraviolet irradiation during the use of oral contraceptives.
Before taking the drug, a complete medical examination should be carried out and the patient’s anamnesis should be studied in detail, taking into account contraindications and cautions. When using the drug, it is recommended to conduct periodic examinations since the conditions indicated in the “Contraindications” section or risk factors may occur for the first time already during the use of hormonal contraceptives. The frequency and nature of these examinations should be based on existing standards of medical practice, taking into account the individual characteristics of each patient. Particular attention is paid to the examination of pelvic organs, including a standard cytological analysis of the cervix, abdominal organs, mammary glands, blood pressure control.
It is necessary to warn the patient that oral contraceptives do not protect against HIV infection and other sexually transmitted diseases.
Decreased efficiency of the drug:
The effectiveness of Lillow can be reduced as a result of missing a pill, abnormal gastrointestinal function, or other medications.
Control of menstrual periods:
Woman taking oral contraceptives may experience intermenstrual bloody discharge (spotting or breakthrough bleeding), especially during the first few months. Taking this into account, the examination of a patient with any intermenstrual secretions should be carried out only after the period of adaptation of the body to the preparation (about 3 months).
If period disorders continue or have occurred after several normal periods, you should consider nonhormonal causes of bleeding and conduct appropriate examinations to exclude the presence of tumors and pregnancy.
Some patients may not have menstrual bleeding during a break in taking active tablets. In case of taking the drug according to the instructions, the probability of pregnancy is low. Nevertheless, if the contraceptive was not taken regularly and if menstrual bleeding is absent for 2 months in a row, it is necessary to exclude pregnancy before starting a new course of Lillow.
Recommendations in case of digestive disorders:
In case of severe impairment of functions, the active substances of the medication may not be completely absorbed; in this case, you need to use additional contraceptives.
If vomiting occurs within 3-4 hours after taking an active pill, it is advisable to use the recommendations regarding missing a dose. If the patient does not want to change her usual pattern of drug use, she needs to take an additional pill from another package.
To delay menstruation, you need to continue taking tablets from the new package without taking 7 inert tablets. If desired, you may take pills from the new package until it’s empty. In this case, it is impossible to exclude breakthrough bleeding or spotting.
To shift the time of menstruation on the next day of the week, it is recommended to shorten the phase of taking inert tablets for the required number of days.