ethinylestradiol + drospirenone


Laboratorios Leon Farma


Full Prescribing Info
Drospirenone, ethinylestradiol.
Each pink active film-coated tablet contains drospirenone 3 mg and ethinylestradiol 20 mcg as active substances. The white film-coated tablets do not contain active substances. It also contains the following ingredients: Pink active film-coated tablets: Tablet Core: Lactose monohydrate, pregelatinized starch (maize), povidone, croscarmellose sodium, polysorbate 80, magnesium stearate. Coating: Partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172). White film-coated tablets: Tablet Core: Anhydrous lactose, povidone, magnesium stearate. Coating: Partially hydrolized polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.
Each blister contains 28 tablets, 24 pink, active film-coated tablets in the 1st, 2nd, 3rd and 4th rows of the strip and 4 white placebo film-coated tablets in row 4. The core of the tablet is coated.
Each of the 24 active tablet contains a small quantity of 2 different female hormones, called drospirenone (a progestogen) and ethinylestradiol (an estrogen). Due to the small quantity of the hormones, Lizelle is considered a low-dose oral contraceptive. Since all tablets in the pack combine the same hormones in the same dose, it is considered a monophasic combined oral contraceptive.
The 4 tablets do not contain active ingredients and are called placebo tablets.
Contraceptive used to prevent pregnancy.
Oral contraceptives are a very effective method of birth control. The chance of becoming pregnant is very low when the pill is taken correctly.
Lizelle may also have noncontraceptive health benefits. It can prevent weight gain and other symptoms like bloating and swelling which are related to fluid retention.
Drospirenone also has antiandrogenic activity which can help to reduce acne and greasiness of the skin and hair. The risk of anemia may be lower since the period will be lighter and shorter. The menstrual pains may also become less severe or may completely disappear.
Dosage/Direction for Use
Take 1 tablet once daily, may be taken with food or without food, if necessary with a small amount of water. Lizelle should be taken approximately the same time everyday. Always take Lizelle exactly as the physician has recommended. Check and ask with the physician or pharmacist if unsure.
Each blister contains 24 active pink tablets and 4 white placebo tablets. The 2 different colored tablets are arranged in order. A strip contains 28 tablets.
Do not get confused with the tablet, take a pink tablet for the first 24 days, and then a white tablet for the last 4 days. Then start a new strip straightaway (24 pink and then 4 white tablets). There is therefore, no gap between 2 strips. Because of the different composition of the tablets, it is necessary to begin with the 1st tablet on the upper left and that tablets may be taken every day. For the correct order, the direction of the arrows on the strip must be followed.
Preparation of the Strip: To help keep track, there are 7 stickers each with 7 days of the week for each strip of Lizelle. Choose the week sticker that starts with the day the patient begun taking the tablets. For example, if started on a Wednesday, use the week sticker that starts with "WED". Then stick the corresponding strip in the upper left hand corner of the pack, on the "Start" position. There is now a day indicated above every tablet and can be seen whether the tablet have been taken. The arrows show the order of the tablets to be taken.
During the 4 days when taking the white placebo tablets (the placebo days), bleeding should start (also called withdrawal bleeding). Normally, the period will begin on the 2nd or 3rd day after the last pink active tablet Lizelle was taken. Once the last white tablet have been taken, the next strip should be started even if bleeding have not stopped. This means that the patient should start every strip on the same day of the week, and menstruation should occur during the same days of every month.
If Lizelle was taken as indicated, there is protection against pregnancy for the 4 days the placebo tablets are taken.
Disposal: Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose medicines when no longer required. These measures will help to protect the environment.
Starting the 1st Strip: If the Patient Has Not Taken Any Hormonal Contraceptive in the Previous Month: Start taking Lizelle on the 1st day of the cycle (the 1st day of menstruation). If the patient started taking on the 1st day of menstruation, there will be immediate protection against pregnancy. The patient can also start from the 2nd-5th day of the cycle, but an additional contraceptives (eg, a condom) should be used for the first 7 days.
Changing from a Combined Hormonal Contraceptive, Combined Contraceptive Vaginal Ring or Patch: Start taking Lizelle preferably on the day after the last active tablet (the last tablet containing the active substances) of the previous pill, but at the latest on the day after the tablet-free days of the previous pill finish (or after taking the last inactive tablet of the previous pill). When changing from a combined contraceptive vaginal ring or patch, follow the physician's recommendations.
Changing from a Progestogen-Only-Method (Progestogen Only Tablet, Injection, Progestogen-Releasing IUD or Implant): The patient can change from the progestogen-only tablet whenever they like (if had an implant or an intrauterine device, use the new tablet the day it was removed; if an injection is used, use the new tablet on the day when the patient would have injected again), but it is recommended, in all cases, to use an additional protection (eg, a condom) for the first 7 days of taking Lizelle.
After Miscarriage: Follow the physician's recommendations.
After Having a Baby: Start taking Lizelle between 21 and 28 days after having a baby. If to start later than day 28, a barrier contraceptive (eg, a condom) must be used for the first 7 days of taking Lizelle.
If, after having a baby and have had sex already before starting Lizelle (again), be sure that the patient is not pregnant or wait for the next menstrual period.
If the patient is breastfeeding and wanted to start taking Lizelle (again) after having a baby, see Use in pregnancy & lactation.
Vomiting or Severe Diarrhea: If vomiting occurs 3-4 hrs after taking an active pink tablet or severe diarrhea is present, there is a risk that the active ingredients in the pill have not been totally absorbed by the body. This is similar to what happens when forgotten to take a tablet. After vomiting or having diarrhea, another pink tablet from a reserve strip should be taken as soon as possible. If possible, take it within 12 hrs of the usual time, the tablet must be taken. If not possible or >12 hrs have passed, see Missed Dose as follows.
Delay of Menstrual Period: Although it is not recommended, period may be delayed (withdrawal bleeding) until the end of a new strip, if the white placebo tablets in the 4th row are not taken and a 2nd strip of Lizelle is immediately started and finished. Specks (drops of blood or stains) or bleeding may be experienced when taking the 2nd strip. Finish the 2nd strip by taking the 4 white tablets from the 4th row. Then start the next strip.
Ask the physician for advice before deciding to delay menstrual period.
Changing the 1st Day of Period: If the tablets are taken according to the instructions, period (withdrawal bleeding) will start during the placebo days. If the patient have to change that day, it can be done by shortening (but never increasing - 4 is the maximum) the length of the placebo days. For example, if the placebo interval begins on Friday and if the patient wanted to start on Tuesday (3 days before), the patient should begin a new strip 3 days before as normally would. Withdrawal bleeding (a period) may not be experienced during this interval. But then, a light or menstruation-like bleeding may be experienced.
If unsure of what to do, consult a physician for advice.
Discontinuation of Lizelle: Lizelle may be discontinued whenever wanted. If the patient do not want to get pregnant, consult the physician about the other efficient birth control methods. If the patient wanted to become pregnant, discontinue Lizelle and wait for the menstrual period before trying to become pregnant. The patient will be able to calculate the expected delivery date more easily.
Missed Dose: The last 4 tablets in the 4th row of the strip are placebo tablets. If forgotten to take 1 of these tablets, there will have no effect on the reliability of Lizelle. Throw away the forgotten placebo.
If forgotten to take a pink, active tablet (tablets 1-24 of the blister-strip), follow these instructions: If <12 hrs late in taking a tablet, the protection from pregnancy is not reduced. Take the tablet as soon as realized and the following tablets at the usual time.
If >12 hours late in taking a tablet, protection from pregnancy may be reduced. The more tablets have forgotten to take, the greater the risk of becoming pregnant.
The risk of reduced protection against pregnancy is highest if forgotten to take a pink tablet at the beginning or at the end of the strip.
Consequently, the following measures should be adopted (see the figure): Forgot to Take >1 Tablet in a Strip: Consult a physician.
Forgot to Take 1 Tablet Between Days 1-7 (1st Row): Take the forgotten tablet as soon as realized, even if this means that the 2 tablets must be taken at the same time. Continue taking the tablets at the usual time and additional precautions eg, a condom should be used for the next 7 days. If have had sex in the week before the tablet is forgotten, there is a risk for being pregnant. In this case, consult a physician.
Forgot to Take 1 Tablet Between Days 8-14 (2nd Row): Take the forgotten tablet as soon as realized, even if this means that the 2 tablets must be taken at the same time. Continue taking the tablets at the usual time. The contraceptive effect will not be reduced and should not be taken with additional precautions.
Forgot to Take 1 Tablet Between Days 15-24 (3rd or 4th Row): May choose 1 of the 2 following possibilities: 1. The tablet forgotten should be taken as soon as realized, even if this means that 2 tablets should be taken at the same time. Continue taking the following tablets at the usual time. Instead of having the white placebo tablets on this strip, throw away and start taking the next strip (the starting day will be different).
The patient will probably have period (withdrawal bleeding) at the end of the 2nd strip (while taking the white placebo tablets), but some specks or bleeding may occur when taking the active tablets of the 2nd strip.
2. The active pink tablets may also be discontinued and may directly take the 4 white placebo tablets, (before taking the placebo tablets, record the day the tablet was forgotten to be taken). If a new strip is to be started on a fixed start date, take the placebo white tablets for <4 days.
If 1 of these 2 recommendations are to be followed, the patient will be protected against pregnancy.
If forgotten to take a tablet in a strip, and there is no period during the placebo days, this could mean that the patient may be pregnant. In this case, consult the physician before continuing with the next strip. (See Figure.)

Click on icon to see table/diagram/image

Administration: Ask the physician for advice if not sure when to start. For any further questions on the use of Lizelle, ask a physician or pharmacist.
There is no proof that overdosage on Lizelle causes serious damage. However, sickness and vomiting can occur from taking lots of tablets at once. Adolescent females could suffer vaginal bleeding.
If too many Lizelle tablets are taken or a child has taken them, ask a physician or pharmacist for advice.
Hypersensitivity to ethinylestradiol or drospirenone, or any other ingredient of Lizelle. This could cause itching, a rash or inflammation.
History or active blood clots (thrombosis) in a blood vessel of the leg, lungs (pulmonary embolism) or other organs, heart attack or a stroke, any illness which could lead to a heart attack in the future (eg, angina pectoris which causes serious chest pain) or a stroke (eg, a temporary or minor stroke without residual effects), certain form of migraine (with so called focal neurological symptoms, inflammation of the pancreas (pancreatitis), liver illness and abnormal liver function, liver tumor, breast cancer or cancer of the sexual organs.
Any illness which could increase the risk of developing a clot in the arteries. This refers to the following: Diabetes with damaged blood vessels, very high blood pressure and fat levels in the blood (cholesterol or triglycerides).
Disturbance of blood clotting (eg, protein C deficiency); patients with kidney problems (renal failure); suspected breast cancer or cancer of the sexual organs; vaginal bleeding and the cause is unknown.
Special Precautions
General Information: Before taking Lizelle, the physician will ask various questions about personal and family medical history. The physician will also measure the blood pressure and depending on the personal situation, may carry out other tests.
The following describes various situations when Lizelle should be discontinued or when the effect of Lizelle could be reduced. In such situations, the patient should not have sex or should use additional nonhormonal contraceptive precautions eg, a condom or other barrier method. Do not use the rhythm or temperature method. These methods can be unreliable as Lizelle alters the monthly changes of body temperature and cervical mucus.
Lizelle, similar to other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
While receiving Lizelle, see the physician regularly at least twice a year.
If any unusual symptoms eg, unexplained pains in the chest, abdomen or legs occur, consult a physician immediately.
Special Precautions: In some situations, special care may be needed when taking Lizelle or any other combination pill, and the physician may need to carry out regular checks. If any of the following is affected, inform the physician before starting to use Lizelle. Consult a physician if the following occur or worsen during the use of Lizelle: If a close family member has or has ever had breast cancer, any liver or gallbladder illness, diabetes, depression, Crohn's disease or ulcerative colitis (an inflammatory bowel disease), hemolytic uremic syndrome (HUS; a blood illness which damages the kidneys), sickle cell anemia (a hereditary illness affecting red blood cells), epilepsy (see Interactions), systemic lupus erythematosus (SLE; an illness affecting the immune system); an illness which appeared for the 1st time during pregnancy or during previous use of sexual hormones eg, hearing loss, porphyria (a blood disease), gestational herpes (skin rash with blisters during pregnancy), Sydenham's chorea (an illness affecting the nerves, producing involuntary movements); history or active chloasma (patches of tan/brown skin discoloration, also called the "mask of pregnancy", especially on the face), avoid direct sunlight and ultraviolet rays if experienced; hereditary angioedema, products which contain estrogen can cause or worsen the symptoms of angioedema. Consult a physician immediately if experiencing symptoms of angioedema eg, swelling of the face, tongue and/or pharynx, and/or have difficulty in swallowing or break out in hives together with having difficulty in breathing.
Venous and Arterial Blood Clots: Venous Thrombosis: The use of any combination pill, including Lizelle, increases the risk of developing a venous blood clot (venous thrombosis), compared to women who do not take any contraceptive pill.
The risk of developing venous thrombosis when taking combination pills increases in patients with increasing age, if overweight, with any of the close family members have had blood clots in the leg, lungs (pulmonary embolism) or any other organ at an early age, surgery, or are going to be immobilized for a long time or have suffered a serious accident. It is important to inform the physician in advance when using Lizelle as the treatment may be discontinued. The physician will inform the patient when to start taking Lizelle again. It usually takes about 2 weeks.
Arterial Thrombosis: The use of combination pills has been linked to an increased risk of developing an arterial blood clot (arterial thrombosis) eg, in the blood vessels of the heart (heart attack) or the brain (stroke).
The risk of developing an arterial blood clot when taking combination pills increases in patients who are smoking, with high levels of blood cholesterol or triglycerides, if overweight, close relatives had a heart attack or stroke at young age, blood pressure is high, migraines and heart problems (valve disorders, changes in the heart rhythm). When taking Lizelle, it is strongly advised to quit smoking especially if the patient is >35 years of age.
Discontinue Lizelle and contact a physician immediately if possible signs of blood clot is noticed eg, severe pain and/or swelling in one of the legs; sudden severe pain in the chest which may reach the left arm, sudden breathlessness and cough without an obvious cause; any unusual, severe or long-lasting headache or worsening of migraine; partial or complete blindness or double vision; difficulty in speaking or inability to speak; giddiness or fainting; weakness, strange feeling or numbness in any part of the body.
Cancer: Women who take combination pills have a slightly higher rate of breast cancer, but it is not known if this is due to the medication. For example, it is possible that more tumors are detected in women who take combination pills because they are examined by their physician more frequently. The breast cancer rate reduces gradually after deciding to stop taking combined hormonal contraceptives. It is important to regularly examine the breasts and to consult a physician if any lumps are found.
Benign liver tumors have been found in women who use combined contraceptives on rare occasions and malignant tumors are even rarer. Consult a physician if a sudden, intense abdominal pain is experienced.
Bleeding Between Periods: During the 1st few months of using Lizelle, bleeding may be experienced unexpectedly (bleeding outside the placebo days). If such bleeding is experienced for more than a few months, or they begin after a few months, the physician must find the cause.
If Bleeding Do Not Occur During the Placebo Days: If all the pink active tablets have been taken correctly, have not vomited or had bad diarrhea, and have not taken any other medication, it is very unlikely to get pregnant.
If 2 consecutive periods are missed, the patient could get pregnant. Contact the physician immediately. The next strip should not be taken until it is sure that the patient is not pregnant.
Taking Other Medicines: Always inform the physician about the medication or herbal preparations already being taken. Also inform other physicians or dentist who has prescribed other medication (or pharmacist) that Lizelle is being taken. They may inform patient if the use of additional contraceptive precautions is needed (eg, condoms) and, if so, for how long may be needed.
Laboratory Tests: If a blood test is needed, inform the physician or laboratory staff that Lizelle is being taken, as hormonal contraceptives can affect the results of some tests.
Important Information About Some of the Ingredients: Lizelle contains lactose. If the patient had been informed of having an intolerance to some sugars, contact a physician before taking Lizelle.
Effects on the Ability to Drive or Operate Machinery: There is no information which suggests that using Lizelle had an effect on the ability to drive or use machinery.
Use in Pregnancy & Lactation: If pregnant, Lizelle must not be taken. If becomes pregnant while taking Lizelle, discontinue use immediately and contact the physician. If wanted to become pregnant, discontinue Lizelle at any time (see Dosage & Administration).
It is generally not recommended to take Lizelle when breastfeeding. If the patient wanted to use contraceptive while breastfeeding, consult a physician.
Ask the physician or pharmacist for advise before taking any medicine.
Use In Pregnancy & Lactation
If pregnant, Lizelle must not be taken. If becomes pregnant while taking Lizelle, discontinue use immediately and contact the physician. If wanted to become pregnant, discontinue Lizelle at any time (see Dosage & Administration).
It is generally not recommended to take Lizelle when breastfeeding. If the patient wanted to use contraceptive while breastfeeding, consult a physician.
Ask the physician or pharmacist for advise before taking any medicine.
Adverse Reactions
The following is a list of the side effects that have been linked with the use of Lizelle: Common (between 1-10 in every 100 users may be affected): Mood swings, headache, nausea, breast pain, problem with periods eg, irregular menstruations and absence of periods.
Uncommon (between 1-10 in every 1000 users may be affected): Depression, loss of interest in sex, nervousness, sleepiness; dizziness, "pins and needles"; migraine, varicose veins, increased blood pressure; stomach ache, vomiting, indigestion, intestinal gas, inflammation of the stomach, diarrhea; acne, itching, rash; aches and pains eg, back pain, limb pain, muscular cramps; vaginal fungal infection, pelvic pain, breast enlargement, benign breast lumps, uterine/vaginal bleeding (which usually subsides during continued treatment), genital discharge, hot flushes, inflammation of the vagina (vaginitis), problems with periods; painful, reduced and very heavy periods; vaginal dryness, abnormal cervical smear; lack of energy, increased sweating, fluid retention, increased weight.
Rare (between 1-10 in every 10,000 users may be affected): Candida (fungal infection), anemia, increased number of platelets in the blood, allergic reaction, hormonal (endocrine) disorder; increased appetite, loss of appetite, abnormally high concentration of potassium in the blood, abnormally low concentration of sodium in the blood; failure to experience an orgasm, insomnia; giddiness, tremor; eye disorders eg, inflammation of the eyelid, dry eyes; abnormally rapid heartbeat, inflammation of a vein, nosebleed, fainting; enlarged abdomen, bowel disorder, feeling bloated, stomach hernia, fungal infection of the mouth, constipation, dry mouth; pain of bile ducts or gallbladder, inflammation of gallbladder; yellow-brown patches on the skin, eczema, hair loss; lumpy, light-sensitive and acne-like skin inflammation; dry skin, excessive hair growth, skin disorder, stretch marks on the skin, skin inflammation, skin nodules; difficult or painful sex, vaginal inflammation (vulvovaginitis), bleeding following intercourse, withdrawal bleeding, breast cyst, increased number of breast cells (hyperplasia), malignant breast lumps, abnormal growth on the mucosal surface of the neck of the womb, shrinkage or wasting of the lining of the womb, ovarian cysts, womb enlargement, feeling generally unwell, weight loss.
The following adverse effects have also been reported, but their frequency cannot be estimated from the available data: Hypersensitivity, erythema multiforme (rash with target-shaped reddening or sores).
If any of the adverse effects get serious, or if any side effects not listed is noticed, inform a physician or pharmacist.
Drug Interactions
Some medicines can cause Lizelle to lose its contraceptive effect or can cause unexpected bleeding. These include medicines used for the treatment of epilepsy (eg, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine), tuberculosis (eg, rifampicin), HIV infections (ritonavir, nevirapine) and other infectious diseases (antibiotics eg, griseofulvin, penicillins, tetracyclines), the herbal remedy St. John's wort, high blood pressure in the blood vessels of the lungs (bosentan).
Lizelle may influence the effect of other medicines eg, medicines containing ciclosporin and the antiepileptic lamotrigine (could lead to an increased frequency of seizure).
Inform the physician or pharmacist if taking or have recently taken any other medicines, including medicines obtained without a prescription.
Store at temperatures not exceeding 30°C.
ATC Classification
G03AA12 - drospirenone and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.
Film-coated active tab (pink, round) and placebo tab (white, round) x 28's.
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