Lizonya

Drospirenone, ethinylestradiol.

The active ingredients are Drospirenone 3 mg and Ethinylestradiol 30 mcg.
Excipients/Inactive Ingredients: Tablet core: Lactose monohydrate, pregelatinized starch, povidone, croscarmellose sodium, polysorbate 80, magnesium stearate.
Coating: Polyvinyl alcohol partially hydrolized, titanium dioxide, polyethylene glycol, yellow iron oxide, red iron oxide and black iron oxide.

Lizonya is a fixed dose combination hormonal birth control pill containing 3 mg drospirenone and 20 mcg ethinyl estradiol per tablet. Lizonya contains drospirenone, a 4th generation progestogen. Due to its anti-androgenic and anti-aldosterone activity, Lizonya can mitigate the effects of the comorbidities of PCOS such as: weight gain, bloating and swelling related to fluid retention; hirsutism (overgrowth of facial and body hair); hormonal acne; elevated blood pressure; premenstrual dysphoric disorder (PMDD). Lizonya is bio-equivalent and bioavailable compared to the originator brand Yaz (Bayer) with significant cost saving for the patient.

Drospirenone + Ethinylestradiol (Lizonya) is a contraceptive and is used to prevent pregnancy.
Lizonya is recommended by OB-Gyns for the treatment of Polycystic Ovarian Syndrome (PCOS), a debilitating condition related to hormonal dysfunction among females.

Take Drospirenone + Ethinylestradiol (Lizonya) tablet every day, with some water if needed. Take the tablets with or without food, but the patient should take them approximately at the same time every day.
One pack (blister) contains 21 tablets. The day of the week to take the tablet is printed at the side of each tablet. If the patient starts on Wednesday, the patient should take a tablet with "WED" at the side. Follow the arrow on the pack until the patient has used the 21 tablets.
The patient should then not take any tablet for 7 days. During these 7 days when the patient is not taking any tablets (called drug free interval), menstruate should start. Menstruation, which can also be called withdrawal bleeding, usually starts on the 2nd or 3rd day of the drug-free interval.
On the eighth day from taking the last Drospirenone + Ethinylestradiol (Lizonya) tablet (that is after the 7-day drug-free interval), start the following pack, even if the patient has not stopped menstruating. This means that the patient should start the following package on the same day started the previous week and menstruation should occur during the same dates of every month.
If the patient use Drospirenone + Ethinylestradiol (Lizonya) as described, the patient is also protected against pregnancy during the 7 days they do not take any tablet.
When can the patient start the first pack: If patient has not taken any hormonal contraceptive in the previous month: Start taking Drospirenone + Ethinylestradiol (Lizonya) on the first day of the cycle (that is the first day of menstruation). If the patient start taking Drospirenone + Ethinylestradiol (Lizonya) on the first day of the menstruation, the patient will be immediately protected against pregnancy. The patient can also start from the second to the fifth day of their cycle, but should use additional contraceptive (a condom for example) for the first 7 days.
Changing from another combined hormonal contraceptive, combined contraceptive vaginal ring or patch: The patient can start taking Drospirenone + Ethinylestradiol (Lizonya) the next day after the drug-free interval of the previous contraceptive (or after taking the last inactive tablet). When changing from a combined contraceptive vaginal ring or patch, follow the doctor's recommendations.
Changing from a method based exclusively on progestogens (progestogen only tablet, injection, progestogen-releasing intrauterine device or implant): The patient can change from the progestogen only tablet whenever they like (if the patient had an implant or an intrauterine device, use the new tablet the day it is removed; if the patient used injections, use the new tablet on the day when they would have injected again), but it is recommended, in all cases, that the patient use additional protection (e.g. condom) for the first 7 days of taking the tablets.
After an abortion: Follow the doctor's recommendations.
After having a child: The patient can start taking Drospirenone + Ethinylestradiol (Lizonya) between 21 and 28 days after having a child. If the patient starts later, they should use a barrier contraceptive (e.g. condom) for the first 7 days they take Drospirenone + Ethinylestradiol (Lizonya).
Missed dose: If the patient is less than 12 hours late in taking a tablet, the protection from pregnancy is not reduced. Take the tablet as soon as they realize and the following tablets at the usual time.
If more than 12 hours late in taking a tablet, protection from pregnancy may be reduced. The more tablets the patient have forgotten to take, the greater the risk of reducing the contraceptive effect.
The risk of reduced protection against pregnancy is highest if the patient forget to take the tablet at the beginning 1st row and end of week 3-3rd row in the pack. Consequently, the patient should adopt the following measures (see figure as follows):

Click on icon to see table/diagram/image

Forgetting to take more than one tablet in a pack: Consult a doctor.
Forgetting to take one tablet in week 1: Take the tablet the patient has forgotten as soon as the patient realize, even if this means that they have to take two tablets at the same time. Continue the following tablets at the usual time and take additional precautions, for example a condom, for the next 7 days. If the patient had sexual relations in the week before they forgot to take the tablet, there is a risk the patient may be pregnant. In this case, consult a doctor.
Forgetting to take one tablet in week 2: Take the tablet the patient has forgotten as soon as they realize even if this means that the patient have to take two tablets at the same time. Continue the following tablets at the usual time. The contraceptive effect will not be reduced and the patient do not need to take additional precautions.
Forgetting to take one tablet in week 3: The patient can choose one of two possibilities: Take the tablet the patient have forgotten as soon as they realize, even if this means that the patient have to take two tablets at the same time. Continue the following tablets at the usual time. Instead of having a drug-free week, start taking the next pack.
The patient will probably have a period (withdrawal bleeding) at the end of the second pack, but they could also have some specks or bleeding when taking the second pack.
The patient can also stop taking the tablets and start a drug-free interval of 7 days (taking note of the day the patient forgot to take the tablet). If the patient wants to start a new pack on the fixed start date, the drug-free interval should be less than 7 days.
If the patient followed one of these two recommendations, the patient will be protected against pregnancy.
If the patient has forgotten to take a tablet and do not have a period during the drug-free interval, this could mean that the patient is pregnant. In this case, the patient should consult a doctor before continuing with the second pack.
What to do if the patient is sick or has bad diarrhea: If the patient vomits 3-4 hours after taking the tablet or have bad diarrhea, there is a risk that the active ingredients have not been totally absorbed by the body. This is similar to what happens when they forget to take a tablet. After vomiting or having diarrhea, the patient must take a tablet from a reserve pack as soon as possible. If possible, take it within 12 hours of the usual time that they take the tablet. If this is not possible, or more than 12 hours have passed, follow the advice in "Missed dose" as previously mentioned.
Bleeding between periods: During the first months of using Drospirenone + Ethinylestradiol (Lizonya), the patient may bleed unexpectedly (bleeding outside the drug-free interval). If the patient experience such bleeding for more than a few months, or they begin after a few months, a doctor must find the cause.
What to do if the patient has a period during the drug-free interval: If the patient has taken all the pink tablets correctly, they have not vomited or had bad diarrhea and have not taken any other medication, it is very unlikely they are pregnant. If the patient does not have two consecutive periods, they could be pregnant. Go to a doctor immediately. Do not start the next pack until the patient is sure that they are not pregnant.
Delaying period: Although it is not recommended, the patient can delay their period (withdrawal bleeding) until the end of a new pack if the patient continue to take a second pack of Drospirenone + Ethinylestradiol (Lizonya) instead of the drug-free interval. The patient may experience specks (drops of blood or stains) or bleeding when taking the second pack. After the usual drug-free interval of 7 days, continue with the next pack. Consult the doctor before the patient decides to delay the period.
Changing the first day of period: If the patient takes the tablets according to the instructions, the period (withdrawal bleeding) will start during the drug-free interval. If the patient has to change that day, they can do so by shortening (but never increasing) the length of the drug-free interval. For example, if the drug-free interval begins on Friday and want it to start on Tuesday (3 days before), they should begin a new pack 3 days before they normally would. If the patient makes the drug-free interval very short (3 days or less for example), they may not have withdrawal bleeding (a period) during this interval. Consequently, the patient could experience specks (drops of blood or stains) or bleeding.
Consult a doctor if unsure how to proceed.
The patient can stop taking Drospirenone + Ethinylestradiol (Lizonya) whenever they want. If the patient does not want to get pregnant consult a doctor about other efficient birth control methods.

There is no proof that overdosing on Drospirenone with Ethinylestradiol causes serious damage. However, sickness and vomiting can occur from taking lots of tablets at once. Adolescent females could suffer vaginal bleeding.
If the patient has taken too many Drospirenone + Ethinylestradiol (Lizonya) tablets, or discover that a child has taken them, consult a doctor or pharmacist.

Do not take Drospirenone + Ethinylestradiol (Lizonya): If the patient has (or have had in the past) blood clots (thrombosis) in a blood vessel of the leg, lungs (embolism) or other organs.
If the patient has (or have had in the past) a heart attack or a stroke.
If the patient has (or have had in the past) any illness which could lead to a heart attack (for example, angina pectoris which causes serious pain in the chest) or a stroke (for example a temporary or minor stroke without residual effects).
If the patient has any illness which could increase the risk of developing artery thrombosis. This refers to the following illnesses: Diabetes with damaged blood vessels; Very high blood pressure; Very high fat levels in the blood (cholesterol or triglycerides).
If the patient has a disturbance of blood clotting (for example, protein C deficiency).
If the patient has (or have had) a certain form of migraine (with so called focal neurological symptoms).
If the patient has (or have had) inflammation of the pancreas (pancreatitis).
If the patient has or have had in the past a liver illness and its hepatic functions have not yet normalized.
If the patient's kidneys do not work well (kidney failure).
If the patient has or have had a liver tumour. If the patient has (or have had), or suspects to have breast cancer or cancer of the sexual organs.
If the patient has vaginal bleeding and the cause is unknown.
If the patient is allergic to Drospirenone or Ethinylestradiol, or any other ingredient in Drospirenone + Ethinylestradiol (Lizonya). This could cause itching, a rash or inflammation.

Do not use the rhythm or temperature method. These methods can be unreliable as Drospirenone+ Ethinylestradiol (Lizonya) alters the monthly changes of body temperature and cervical mucus.
Drospirenone + Ethinylestradiol (Lizonya), similar to other hormonal contraceptives, does not protect against HIV (AIDS) or any other sexually transmitted infection.
While the patient is receiving the medication, they should see their doctor regularly at least every six to twelve months.
If the patient has any unusual symptoms such as unexplained pains in the chest, abdomen or legs, consult a doctor immediately.
Drospirenone + Ethinylestradiol (Lizonya) contains lactose. If the patient has been told by a doctor that they have an intolerance to some sugars, contact the doctor before giving this medicinal product.

In some situations, the patient will have to take special care when taking Drospirenone + Ethinylestradiol (Lizonya) or any other combined hormonal contraceptives, and a doctor may need to carry out regular checks. If any of the following affects the patient, tell doctor before using Drospirenone + Ethinylestradiol (Lizonya). Patient should also consult a doctor if the following occur or worsen during the use of Drospirenone + Ethinylestradiol (Lizonya).
If any close family member has or has had breast cancer.
If the patient has any liver or gallbladder illness.
If the patient has diabetes.
If the patient has depression.
If the patient has Crohn's disease or ulcerative colitis (an inflammatory bowel disease).
If the patient has HUS (haemolytic uremic syndrome; a blood illness which damages the kidneys).
If the patient has sickle cell disease (a hereditary illness affecting red blood cells).
If the patient has epilepsy (see Interactions).
If the patient has SLE (Systemic lupus erythematosus; an illness affecting the immune system).
If the patient has an illness which appeared for the first time during pregnancy or during previous use of sexual hormones; for example, hearing loss, porphyria (a blood disease), gestational herpes (skin rash with pimples during pregnancy), Sydenham's chorea (an illness affecting the nerves, producing involuntary movements).
If the patient has or have had chloasma (patches of tan/ brown skin discoloration, also called the "mask of pregnancy", especially on the face). If the patient experience this, they have to avoid direct sunlight and ultraviolet rays.
If the patient has hereditary angioedema, products which contain estrogen can cause or worsen the symptoms of angioedema. They must go to a doctor immediately if they experience symptoms of angioedema such as 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.
Surgery, long periods of immobilization or serious accidents during treatment with Drospirenone + Ethinylestradiol (Lizonya): It is important that the patient informs their doctor in advance that they are taking Drospirenone + Ethinylestradiol (Lizonya) as their risk of venous thrombosis is increased in these circumstances and they have to stop taking the treatment for a while.
The doctor will tell the patient when to start taking Drospirenone + Ethinylestradiol (Lizonya) again. This usually happens two weeks after the patient regain mobility.
Venous thrombosis: The use of any combined contraceptive, Drospirenone + Ethinylestradiol (Lizonya) included, increases the risk of developing venous thrombosis (formation of clots in blood vessels), in comparison with a woman who does not take any contraceptives.
The risk of developing venous thrombosis when taking combined contraceptives increases: With age; If the patient is overweight; If any of their close family members have had blood clots (thrombosis) in the leg, lungs or any other organ at an early age; If they are going to have surgery, or are going to be immobilized for a long time or have suffered a serious accident [to know what to do, see previously mentioned "Surgery, long period of immobilization or serious accidents during treatment with Drospirenone + Ethinylestradiol (Lizonya)"].
Arterial Thrombosis: The use of combined contraceptive has been linked to an increased risk of developing arterial thrombosis (obstruction of an artery), for example, in the blood vessels of the heart (heart attack) or the brain (stroke).
The risk of developing arterial thrombosis when taking combined contraceptives increases: If the patient smokes; if they use Drospirenone + Ethinylestradiol (Lizonya), it is strongly advised that the patient quit smoking, especially if they are over 35 years of age. If the patient has high levels of fat in the blood (cholesterol or triglycerides); If they are overweight; If the patient or one of their family members has had a heart attack or stroke at an early age; If they have high blood pressure; If they have migraines; If they have heart problems (valve disorders, changes in heart rhythm).
The patient should stop using Drospirenone + Ethinylestradiol (Lizonya) and immediately go to a doctor if they have possible signs of thrombosis (see "Stop the treatment if" as follows).
Drospirenone + Ethinylestradiol (Lizonya) and cancer: Women who take combined contraceptives 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 contraceptives because they are examined by their doctor more frequently. The breast cancer rate reduces gradually after the patient decides to stop taking combined hormonal contraceptives.
It is important to regularly examine the breasts and go to a doctor if the patient find any lump.
Benign liver tumors have been found in women who use combined contraceptives on rare occasions and malignant tumors are even rarer. Consult a doctor if the patient experience sudden intense abdominal pain.
Stop the treatment if: Stop using Drospirenone + Ethinylestradiol (Lizonya) and immediately go to a doctor if the patient has possible signs of thrombosis, such as: Extreme pain and/or inflammation of one of the legs; Intense and sudden chest pain, which may reach the left arm; Sudden difficulty breathing; Sudden cough without clear cause; Unusual headache, intense or prolonged, or worsening of a migraine; Partial or complete vision loss, or double vision; Difficulty or inability to speak; Vertigo or fainting; Weakness, abnormal sensations, or numbness of any part of the body.
Driving and using machines: There is no information which suggests that using Drospirenone + Ethinylestradiol (Lizonya) has an effect on the ability to drive or use machinery.

Pregnancy: If the patient is pregnant they should not take Drospirenone + Ethinylestradiol (Lizonya). If the patient is pregnant, when taking Drospirenone + Ethinylestradiol (Lizonya) they should stop taking it immediately and contact a doctor. Consult a doctor or pharmacist before taking any medicine.
Breastfeeding: It is generally not recommended to take Drospirenone + Ethinylestradiol (Lizonya) when breastfeeding. If the patient wants to use the contraceptive while breastfeeding, they should consult a doctor. Consult a doctor or pharmacist before taking any medicine.

Like all medicines Drospirenone + Ethinylestradiol (Lizonya) can cause side effects, although not all patient gets them.
Drospirenone + Ethinyllestradiol (Lizonya): Common (affecting more than 1 in 100, but less than 1 in 10 women) side effects: emotional, headache, abdominal pain (tummy ache), acne, sore breasts, enlargement of breasts, painful or irregular menstruation, weight gain.
Uncommon (affecting more than 1 in 1,000, but less than 1 in 100 women): vaginal infection, herpes simplex (in lips), allergic reactions which can be severe on occasions (angioedema) with skin swelling and/or, mucosa, increase of appetite, depression, nervousness, sleeping disorders, loss of interest in sex, pins and needles, vertigo, visual problems, irregular heart beat or unusually fast, clots (thrombosis) in a blood vessel of the leg or lungs (pulmonary embolism), increase in blood pressure, migraine, varicose veins, sore throat, stomach and/or intestine swelling, nausea, vomiting, diarrhea, constipation, hair loss, itching, skin rash, dry skin, seborrheic dermatitis, neck pain, mascular cramps, bladder infection, breast lumps, producing a milky fluid from the nipples, cyst in the ovaries, flushes, absence of period, excessive period, vaginal secretion, vaginal dryness, abdominal pain, abnormal cervical smears, water retention, lack of energy, excessive thirst sensations, an increase in sweating, weight loss.
If the patient experience side effects which have not been mentioned in this information sheet or one of the side effects is particularly strong, consult a doctor or pharmacist.

Taking other medicine: Always tell the doctor who has prescribed the Drospirenone + Ethinylestradiol (Lizonya) about the medication or herbal preparations the patient are taking. Also tell any other doctor or dentist that has prescribed other medication (or a pharmacist) that the patient is taking Drospirenone + Ethinylestradiol (Lizonya). They may tell that the patient needs to use additional contraceptives (condoms for example) and if they do, they will tell how long for.
Some medicine can cause Drospirenone + Ethinylestradiol (Lizonya) to lose its contraceptive effect, or can cause unexpected bleeding. This applies to medicines used to treat epilepsy (Primidone, Phenytoin, barbiturates, Carbamazepine, Oxcarbazepine) and tuberculosis (for example: Rifampicin), HIV (Ritonavir), other infectious diseases (Griseofulvin, Ampicillin, tetracyclines) and the medicinal herb St. John's wort.
If the patient wants to use herbal preparations which contain St. John's wort while they are taking Drospirenone + Ethinylestradiol (Lizonya), they should consult a doctor beforehand.
Drospirenone + Ethinylestradiol (Lizonya) can affect other medicines, for example, those which contain Ciclosporin or the anticonvulsant drug Lamotrigine (this can increase the frequency of convulsions).
Please tell a doctor or pharmacist if the patient is taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Drospirenone + Ethinylestradiol (Lizonya) with food and drink: Take a Drospirenone + Ethinylestradiol (Lizonya) tablet every day, with some water if needed. The patient can take the tablets with or without food, but they should take them approximately at the same time very day.
Clinical tests: If the patient needs a blood analysis, tell the doctor or laboratory staff that they are taking a contraceptive, as oral contraceptives can affect the results of some tests.

Medicines should not be disposed of via waste water or household waste. Ask a pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

Store at temperatures not exceeding 30°C.
Shelf Life: 24 months.

Oral Contraceptives / Acne Treatment Preparations

G03AA12 - drospirenone and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.

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