Leena is a combination hormone drug which is used to prevent pregnancy. The medication contains a progestin and an estrogen (ethinyl estradiol and norethindrone).
Indications for use
- Hormonal contraception.
Mechanism of action
Leena works by preventing the release of an egg (ovulation) during your menstrual cycle.
Dosage and mode of application
Each pack of Leena contains 28 tablets:
- 7 tablets each containing norethindrone 0.5mg, ethinyl estradiol 35 mcg;
- 9 tablets each containing norethindrone 1mg, ethinyl estradiol 35 mcg;
- 5 tablets each containing norethindrone 0.5mg, ethinyl estradiol 35 mcg;
- 7 inert tablets each containing inactive components only.
Use the drug as directed by your doctor. Read exact dosing instructions on the leaflet.
- Take pills orally regardless of foods;
- You may take the first pill during the first 24 hours of your period. In this case, you do not need to use an additional backup birth control. If you take the first pill on the next Sunday after your period starts, you will need to use an additional backup birth control for at least 7 days after you start taking the medication;
- Take pills at about the same time each day, in the order indicated on the blister, for 28 days in a row;
- After taking the last inert pill in the pack, begin a new pack the very next day;
- For birth control pills to be effective, they must be taken every day. Do not miss pills if you have sex rarely. Keep taking pills if you have spotting, acyclic vaginal bleeding, or nausea;
- If you are switching from another combination oral contraceptives to Leena, take the first pill on the same day that you would have started a new pack of your previous oral contraceptive. If you are switching to this drug from another hormonal birth control method (vaginal patch, vaginal ring, IUD), consult your doctor or pharmacist about when to take the first pills of Leena;
- Severe vomiting or diarrhea may decrease the effectiveness of this contraceptive. If you vomit or have diarrhea within 3-4 hours after you take an active pill, this should be considered a missed dose. Follow the guidelines given in the “What if I miss a dose” section.
Symptoms of overdose may include nausea and vomiting, unusual vaginal bleeding. If you have overdosed and have serious reactions such as fainting or trouble breathing, seek emergency medical help.
Leena side effects may include:
- nausea, vomiting;
- breast tenderness;
- swelling of the ankles/feet, weight change;
- sudden dizziness/fainting;
- missed/irregular periods;
- an increase in blood pressure;
- lumps in the breast;
- mental/mood changes;
- severe stomach/abdominal pain;
- unusual changes in vaginal bleeding;
- dark urine;
- vision problems/changes;
- yellowing eyes/skin;
- blood clots;
- worsening of migraines;
- acyclic vaginal bleeding (spotting);
- unusual sweating;
- chest/jaw/left arm pain;
- pain/swelling/warmth in the groin/calf;
- slurred speech;
- sudden shortness of breath;
- unusual headaches;
- allergic reaction (rash, itching/swelling).
This list of side effects is not complete. If you experience any severe adverse reactions after taking Leena pills, consult your healthcare provider as soon as possible.
Do not use Leena for birth control if you have any of the following conditions:
- deep vein thrombosis or pulmonary embolism, including a history;
- smoking over the age of 35;
- liver tumors or liver disease;
- cerebrovascular disease;
- inherited or acquired hypercoagulopathies;
- hypersensitivity to ethinyl estradiol and norethindrone;
- uncontrolled hypertension;
- coronary artery disease;
- thrombogenic valvular or thrombogenic rhythm diseases of the heart;
- diabetes mellitus with vascular disease;
- headaches with focal neurological symptoms;
- migraine headaches with aura;
- abnormal uterine bleeding of unknown etiology;
- breast cancer or other estrogen- or progestin-sensitive cancer, including a history.
Some products that may interact with Leena contraceptive include:
- aromatase inhibitors (anastrozole, exemestane);
- tranexamic acid;
- products used to treat chronic hepatitis C (ombitasvir/paritaprevir/ritonavir with or without dasabuvir);
- rifamycins (such as rifampin, rifabutin);
- St. John’s wort;
- drugs used to treat seizures (barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate);
- HIV drugs (nelfinavir, nevirapine, ritonavir).
This contraceptive may affect the results of some laboratory tests (such as blood clotting factors, thyroid, and others). Make sure all your doctors know you use birth control pills.
Do not take any new drugs without consulting a doctor.
Pregnancy and breastfeeding
Do not use Leena pills if you are pregnant or if you have recently had a baby. Stop taking the drug and consult your doctor if you become pregnant. If you have recently had a baby, wait at least four weeks before taking this medication.
Breastfeeding is not recommended during use of this contraceptive. Birth control pills may reduce milk production and change its composition. Besides, they may cause jaundice and breast enlargement in the nursing infant.
What if I miss a pill?
- If you miss one active pill, take two pills as soon as you remember. Take one pill the next day at your regular time. Keep taking one pill until you finish the pack;
- If you miss two active pills in a row in Week 1 or 2, take these two missed pills the day you remember and 2 more pills the next day. Then take one pill a day until you finish the pack. You must use an additional backup birth control for at least 7 days following the missed pills;
- If you miss two active pills in a row in Week 3, discard the remaining pills and start a new pack the same day if you are a Day 1 starter. If you are a Sunday starter, continue taking one pill per day until Sunday. On Sunday, discard the remaining pills and start a new pack that same day. You must use an additional backup birth control for at least 7 days following the missed pills;
- If you miss three active pills in a row in Week 1, 2, or 3, discard the remaining pills and start a new pack the same day if you are a Day 1 starter. If you are a Sunday starter, continue taking one pill per day until Sunday. On Sunday, discard the remaining pills and start a new pack that same day. You must use an additional backup birth control for at least 7 days following the missed pills;
- If you miss an inert pill in Week 4, just throw it away and continue taking one pill a day at your usual time until you finish the pack. You do not need to use an additional backup birth control if you miss an inert pill.
Warning: If you miss two or more active pills in a row, you may not have your period during this month. If you do not have your period for 2 months in a row, consult your doctor because you might be pregnant.
While taking Leena drug, you will need to visit your gynecologist regularly (every 6 months).
This medication does not protect you from sexually transmitted diseases.
Stop taking birth control pills if an arterial or deep venous thrombotic event occurs, if you have a sudden loss of vision, diplopia, papilledema, proptosis, or retinal vascular lesions.
Stop hormonal contraception at least 4 weeks before the planned major surgery.
The use of combination oral contraceptives (COCs) increases the risk of a venous thrombotic event. This risk is highest during the first year and gradually disappears after the drug use is stopped.
The Use of COCs increases the risk of strokes and myocardial infarctions. The risk is highest in smoking women over the age of 35.
If you have cardiovascular disease risk factors, use this drug with caution.
Taking COCs may cause an increase in blood pressure and worsen existing gallbladder disease.
Take COCs with caution if you have diabetes since such drugs may decrease glucose tolerance.
If you have uncontrolled dyslipidemias, choose an alternative birth control method.
Women with hypertriglyceridemia or predisposition to it may have an increased risk of pancreatitis when using Leena pills.
If severe/unusual headaches/migraines occur, discontinue hormonal contraception.
Unscheduled bleeding/spotting may occur during the first 3 months of use. If this bleeding continues after 3 months of use or becomes heavy, consult a doctor.
Women using COCs may experience amenorrhea or oligomenorrhea, especially if they had such conditions previously.
If the scheduled period does not occur, you need to exclude the possibility of pregnancy (especially if you missed active pills during this months)
Women with a history of depression should use this drug with caution and discontinue hormonal contraception if depression recurs.
According to some studies, COCs may increase the risk of breast cancer, cervical cancer or intraepithelial neoplasia.
In women with hereditary angioedema, COCs may cause or worsen symptoms of angioedema.
In women with a history of chloasma gravidarum, COCs may cause chloasma (especially in those with a history of this condition). Women with a tendency to chloasma should avoid exposure to the sun and ultraviolet radiation while taking birth control pills.
Store at room temperature away from heat and moisture, children and pets.