Levlite is a combination birth control pill which contains 2 female hormones: ethinyl estradiol and levonorgestrel.
Indications for use
- Hormonal contraception.
Mechanism of action
The drug works by preventing the woman from ovulating each month.
Dosage and mode of application
Each pack of Levlite contains 28 tablets:
- 28 pink active tablets each containing 0.100 mg levonorgestrel and 0.020 mg ethinyl estradiol;
- 7 white inert tablets that are used as reminders.
Take one tablet per day for 28 days in a row. It’s important that you take tablets at about the same time each day.
Take the first active tablet on Day 1 of your menstrual bleeding or on the first Sunday after your menstrual bleeding begins. If you choose the second option, you must use an additional birth control (for example, a condom) for the first 7 days (during the first cycle only).
Do not make breaks between packages. Once you have taken the last inert tablets from the blister, start a new course of Levlite the next day.
After childbirth, you must wait 4 weeks prior to taking birth control pills (provided that you are not breastfeeding).
When switching from another COC, Levlite should be started on the Day 1 of your period following the use of the last active tablet the previous COC. Ask your doctor or pharmacist about how to switch from other methods of hormonal birth control (patch, IUD, injections) to this drug.
If you have spotting or breakthrough bleeding, you should continue taking the drug on the same regimen. This type of bleeding is usually temporary and without significance, however, if this bleeding is heavy or lasts too long, you should consult your doctor.
Serious adverse effects have not been reported following intake of large doses of Levlite tablets. Overdosage may cause severe nausea, vomiting, or unusual vaginal bleeding. In case of overdosage, consult your doctor or pharmacist. If necessary, seek emergency medical attention.
Levlite 28 tablets can cause adverse effects. Consult your doctor immediately if you have any of the following side effects while taking this medication:
- absent, missed, or irregular menstrual periods;
- bloody stools;
- changes in skin color, pain, tenderness, or swelling of the foot or leg;
- unusual tiredness or weakness;
- chest pain or discomfort;
- blurred vision;
- breast tenderness, enlargement, discharge;
- clay-colored stools;
- vomiting of blood;
- yellow eyes or skin;
- inability to move the arms, legs, or facial muscles;
- decrease in urine output or decrease in urine-concentrating ability;
- difficult, burning, or painful urination;
- itching of the vagina or outside the genitals;
- difficulty in speaking;
- dizziness or lightheadedness;
- double vision;
- dull ache or feeling of pressure or heaviness in the legs;
- fluid-filled skin blisters;
- pain or discomfort in the arms, jaw, back or neck;
- pelvic pain;
- dark or cloudy urine;
- frequent urge to urinate;
- headache, severe and throbbing;
- itching skin near damaged veins;
- skin thinness;
- slow or fast heartbeat;
- changes in appetite;
- changes in weight;
- decreased interest in sexual intercourse;
- decreased milk production;
- loss in sexual ability, desire, drive, or performance;
- mental depression;
- pain during sexual intercourse;
- pounding in the ears;
- sensitivity to the sun;
- slow speech;
- stomach bloating and cramping;
- stomach pain and tenderness;
- fast heartbeat;
- patchy brown or dark brown discoloration of the skin;
- light vaginal bleeding between regular menstrual periods;
- loss of appetite;
- stopping of menstrual bleeding;
- swollen feet and ankles;
- tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area;
- swelling, pain, or tenderness in the upper abdominal area;
- thick, white curd-like vaginal discharge without odor or with a mild odor;
- troubled breathing;
- twitching, uncontrolled movements of the tongue, lips, face, arms, or legs;
- inability to speak;
- unpleasant breath odor.
Do not use Levlite 28 if you have any of the following conditions:
- breast cancer;
- migraine headache;
- condition caused by low levels of parathyroid hormone;
- high levels of triglyceride in the blood;
- estrogen-dependent tumor;
- allergies to estrogens or progestins;
- inherited disorder of continuing episodes of swelling;
- deficiency of anti-clotting agents;
- recent surgery;
- increased risk of blood clotting;
- retinal thrombosis;
- optic disk edema;
- heart attack;
- coronary artery disease;
- lung embolism;
- family history of breast cancer;
- blood clots;
- gallbladder disease;
- increased risk of cardiovascular problems;
- risk of blood clot formation;
- liver disease;
- protein c deficiency disease.
Do not take Levlite with HCV drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
It’s not recommended to take ethinyl estradiol/levonorgestrel with the following drugs:
- phenytoin sodium;
- some protease inhibitors;
- St. John’s wort;
- certain antibiotics (ampicillin and other penicillins, tetracyclines);
- ascorbic acid (vitamin C);
Pregnancy and breastfeeding
Do not use Levlite during pregnancy since there is no indication for that.
If you become pregnant while taking oral contraceptives, stop using them immediately and contact your health care provider. Numerous studies have not established the relationship between the incidence of malformations in the fetus and the use of birth control pills during pregnancy. The likelihood of defects in the fetus is the same for women who took contraceptives during pregnancy and those who didn’t take these contraceptives during pregnancy. According to doctors, contraceptives do not pose a danger to the fetus if a woman takes these pills no more than the first month of pregnancy.
Breastfeeding women should not take this drug since its active substances can penetrate the breast milk and affect its composition.
What if I miss a pill?
- If you miss 1 active pill, take two pills on the day you remember. Then continue taking 1 pill per day until the pack is finished;
- If you miss 2 active pills in a row in Week 1 or 2, take two pills a day for two days in a row. Then continue taking 1 pill a day until the pack is finished. Use an additional non-hormonal birth control for 7 days following the missed pills;
- If you miss 2 active pills in a row in Week 3, discard the rest of the pills and start a new pack the same day if you are a Day 1 starter. If you are a Sunday starter, take 1 pill per until Sunday. Then discard the rest of the pills and start a new pack the same day;
- If you miss 3 active pills in a row in Week 1, 2, or 3, discard the rest of the pills and start a new pack the same day if you are a Day 1 starter. If you are a Sunday starter, take 1 pill per until Sunday. Then discard the rest of the pills and start a new pack the same day;
- If you miss an inert pill, discard it and continue taking 1 pill a day until the pack is finished. You do not need an additional non-hormonal birth control for 7 days if you miss an inert pill.
Important: If you miss two or more active pills, you may not have menstrual bleeding during the month. If you miss menstrual bleeding for 2 months in a row, contact your health care provider because you might be pregnant.
Do not take Levlite tablets if you have not started your periods yet.
This drug is very effective, however, you may get pregnant in the following cases:
If you have just started to prevent pregnancy with oral contraceptives and do not use additional methods of protection in the first 7 of taking the drug. This condition is recommended to be observed only in the first cycle.
If the delay in taking an active pill is more than 12 hours, the effect of contraception will be lower. Consequently, the risk of becoming pregnant will increase.
If you have vomiting or diarrhea less than three hours after taking an active pill.
Before starting a course of Levlite and, subsequently, every 6 months, a general medical and gynecological examination (a cytological analysis of a vaginal smear, an assessment of the mammary glands, blood glucose, cholesterol, liver function, blood pressure, urinalysis) is recommended to exclude diseases that are contraindicated for oral contraceptives, as well as pregnancy.
The use of any combination oral contraceptive increases the risk of venous thromboembolic diseases. The risk of these diseases reaches a maximum in the first year of hormonal contraception.
Levlite tablets are not recommended to women with thromboembolic diseases at a young age and increased blood clotting in family history.
The use of the drug is allowed no earlier than 6 months after suffering from viral hepatitis with the normalization of liver function.
Long-term use of hormonal contraceptives, in very rare cases, can cause benign and malignant liver tumors which in some cases can lead to life-threatening bleeding in the abdominal cavity. If you feel have pain in the upper abdomen and signs of intra-abdominal bleeding, a liver tumor may be suspected. If necessary, the drug should be discontinued.
If you have an abnormal liver function, it is necessary to undergo medical control every 2-3 months.
If your liver function deteriorates while taking COCs, consultation of the doctor is necessary.
If you have moderate acyclic (intermenstrual) bleeding, keep taking the drug, because in most cases, this bleeding stops spontaneously. If acyclic (intermenstrual) bleeding does not stop or recurs, a medical examination should be conducted to exclude organic pathology of the reproductive system.
If you have vomiting or diarrhea, keep taking the drug and use additional, non-hormonal method of contraception.
Smoking women who take Levlite for birth control have an increased risk of developing vascular diseases with serious consequences (myocardial infarction, stroke). The risk increases with age and depending on the number of cigarettes smoked (especially in women older than 35 years).
In a large number of epidemiological studies, the incidence of ovarian, endometrial, cervical, and breast cancer among women taking combined oral contraceptives was studied. Studies have proven that these drugs protect women from ovarian and endometrial cancer.
Some studies have found an increase in the incidence of cervical cancer among women who have taken oral contraceptives for a long time, but the results are mixed. The link between cervical cancer and the use of COCs has not been proven.
The relative risk of developing breast cancer is somewhat higher among women taking COCs. In the next 10 years after discontinuation of combined oral contraceptives, the risk is gradually reduced.
The drug should be canceled immediately in the following cases:
- first-time migraines or unusually severe headaches;
- early signs of phlebitis or phlebothrombosis (unusual pain or distended veins in the legs);
- jaundice or hepatitis without jaundice;
- acute deterioration of visual acuity;
- cerebrovascular disorders;
- stabbing pains of unclear etiology when breathing or coughing,
- pain and chest tightness,
- a sharp increase in blood pressure;
- signs of thrombosis or a heart attack;
- generalized itching;
- an increase in epileptic seizures;
- 3 months before the planned pregnancy;
- 6 weeks before the planned operation;
- during prolonged immobilization (for example, after injuries);
- if pregnancy occurs.
If a woman has used birth control pills for no more than six months in a row, then there are greater chances of conceiving almost immediately after discontinuation of pills. The ability to fertilize the egg is restored to its normal state immediately after the withddrawal of contraceptives.If a woman has used birth control pills for many years continuously, sexual function becomes completely depressed. It takes several years to restore the reproductive system. The recovery period depends on the age of the woman. Experts advise taking a break when taking hormonal contraceptives for about three months.
Levlite does not affect the ability to drive vehicles and operate mechanisms.
Store at room temperature away from heat, direct sunlight, and moisture.
Keep out of reach of children.