LIZA Drospirenone / Ethinylestradiol 3mg / 30mcg Film-Coated Tablet 21's

Contraceptive used to prevent pregnancy.
Oral contraceptives are very effective method of birth control. The chance of becoming pregnant is very low when the pill is taken correctly.
Liza may also have non-contraceptive health benefits: Prevent weight gain and other symptoms eg, 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. With these special properties, drospirenone is similar to the natural progesterone hormone produced by the body.
The risk of anemia may be lower since the period may be lighter and shorter. The menstrual pains may also become less severe and completely disappear.

 

Preparation of the Pack: Take Liza tablet everyday, with some water if needed. The patient can take the tablets with or without food, but should take Liza approximately at the same time everyday.
One pack (blister) contains 21 tablets. The day of the week to take the tablet is printed at the side of each tablet. If for example, 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 have used the 21 tablets.
The patient should then not take any tablets for 7 days. During these 7 days when the patient do not take any tablets (called drug-free interval), she should menstruate. Menstruation which can also be called withdrawal bleeding, usually starts on the 2nd or 3rd day of the drug-free interval.
On the 8th day from taking the last Liza 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 which she started the previous week and menstruation should occur during the same dates of every month.
If the patient uses Liza as described, she is also protected against pregnancy during the 7 days the patient does not take any tablet.
When to Start the First Pack: If the Patient has not taken any hormonal contraceptive in the previous month: Start taking Liza on the 1st day of the cycle (that is the 1st day of menstruation). If the patient start taking Liza on the 1st day of the menstruation, she will be immediately protected against pregnancy. The patient can also start from the 2nd to the 5th day of cycle, but she should use additional contraceptive (eg, a condom) for the 1st 7 days.
Changing from Another Combined Hormonal Contraceptive, Combined Contraceptive Vaginal Ring or Patch: The patient can start taking Liza the next day after the drug-free interval of the patient's previous contraceptive (or after taking the last inactive tablet). When changing from a combined contraceptive vaginal ring or patch, follow 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 she like (if the patient had an implant or an intrauterine device, use the new tablet the day it was removed; if the patient used injections, use the new tablet on the day when she would have injected again), but it is recommended, in all cases, that the patient use additional protection (eg, a condom) for the first 7 days of taking the tablets.
After Abortion: Follow the doctor's recommendations.
After Having a Child: The patient can start taking Liza between 21 and 28 days after having a child. If the patient starts later, she should use a barrier contraceptive (eg, a condom) for the first 7 days the patient take Liza. If after having a child, the patient has already had sexual relations before starting Liza again, the patient must be sure that she is not pregnant or wait for the next period.
Seek the doctor's advice if the patient is not sure when to start.
If the patient is breastfeeding and wants to start taking Liza again after having a child. (See Use in lactation under Precautions.)
Missed Dose: If the patient is <12 hrs late in taking a tablet, the protection from pregnancy is not reduced. Take the tablet as soon as the patient realize and the following tablets at the usual time.
If the patient is >12 hrs late in taking a tablet, protection from pregnancy may be reduced. The more tablets that the patient has forgotten to take, the greater the risk of reducing the contraceptive effect.
The risk of reduced protection against pregnancy is highest if the patient forgets to take the tablet at the beginning at 1st row and end of week 3 at 3rd row in the pack. Consequently, the patient should adopt the following measures (see figure).

Forgetting to Take More Than One Tablet in a Pack: Consult the doctor.
Forgetting to Take One Tablet in Week One: Take the tablet as soon as the patient realize, even if this means that she has to take 2 tablets at the same time. Continue taking the following tablets at the usual time and take additional precautions eg, a condom, for the next 7 days. If the patient has had sexual relations in the week before she forgot to take the tablet, there is a risk of getting pregnant. In this case, consult the doctor.
Forgetting to Take One Tablet in Week Two: Take the tablet as soon as the patient realize even if this means that she has to take 2 tablets at the same time. Continue taking 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 Three: The patient can choose 1 of 2 possibilities: 1) Take the tablet as soon as the patient realize, even if this means that she has to take 2 tablets at the same time. Continue taking the following tablets at the usual time. Instead of having a drug-free week, start taking the next pack.
The patient will probably have the period (withdrawal bleeding) at the end of the 2nd pack, but the patient could also have some specks or bleeding when taking the 2nd pack.
2) The patient can also stop taking the tablets. 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 <7 days.
If the patient follows 1 of these 2 recommendations, she 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, consult the doctor before continuing with the 2nd pack.
If the Patient is Sick or Have Bad Diarrhea: If the patient vomits 3-4 hrs after taking the tablet or the patient has 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 the patient forget to take a tablet. After vomiting or having diarrhea, the patient must take a tablet from reserve pack as soon as possible. If possible, take it within 12 hrs of the usual time that the patient take the tablet. If this is not possible, or >12 hrs have passed, follow the advice in Missed Dose as mentioned previously.
Bleeding Between Periods: During the 1st month of using Liza, 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, the doctor must find the cause.
If The Patient Does Not Have a Period During the Drug-Free Interval: If the patient has taken all the tablets correctly, has not vomited or had bad diarrhea and has not taken any other medication, it is very unlikely she is pregnant.
If the patient does not have 2 consecutive periods, she could be pregnant. Go to the doctor immediately. Do not start taking the next pack until the patient is sure that she is not pregnant.
Delaying the Period: Although it is not recommended, the patient can delay the period (withdrawal bleeding) until the end of a new pack if she continues to take a 2nd pack of Liza instead of the drug-free interval. The patient may experience specks (drops of blood or stains) or bleeding when taking the 2nd pack. After the usual drug-free interval of 7 days, continue with the next pack. The patient should consult the doctor before deciding to delay the period.
Changing the First Day of Period: If the patient take the tablets according to instructions, the period (withdrawal bleeding) will start during the drug-free interval. If the patient has to change that day, she 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 wants to start on Tuesday (3 days before), the patient should begin a new pack 3 days before the patient normally would. If the patient makes the drug-free interval very short (eg, ≤3 days), she may not have withdrawal bleeding (a period) during this interval. Consequently, the patient could experience specks (drop of blood or stains) or bleeding.
If the patient is unsure how to proceed, consult the doctor for an examination.
If the Patient Stops Taking Liza: The patient can stop taking Liza whenever she wants. If the patient does not want to get pregnant, consult the doctor about other efficient birth control methods.
If the patient has any other doubt about using Liza, consult the doctor or pharmacist.

 

Overdosage

May be taken with or without food.

Hypersensitivity to drospirenone or ethinylestradiol or any other ingredient in Liza. This could cause itching, a rash or inflammation.
Patients that have (or have had in the past) blood clots (thrombosis) in a blood vessel of the leg, lungs (embolism) or other organs; a heart attack or stroke; any illness which could lead to a heart attack (eg, angina pectoris which causes serious pain in the chest) or a stroke (eg, a temporary or minor stroke without residual effects); certain form of migraine (focal neurological symptoms); inflammation of the pancreas (pancreatitis); liver illness and hepatic function have not yet normalized; kidneys do not work well (kidney failure); liver tumor; suspect breast cancer or cancer of the sexual organs.
Any illness which could increase the risk of developing artery thrombosis eg, diabetes with damaged blood vessels, very high blood pressure, very high fat levels in the blood (cholesterol or triglycerides); disturbance of blood clotting (eg, protein C deficiency); vaginal bleeding and the cause is unknown.
Use in Pregnancy: If the patient is pregnant, do not take Liza. If the patient is pregnant when taking Liza, stop taking it immediately and contact the doctor.
Consult the doctor or pharmacist before taking any medicine.

General: Before taking Liza, the doctor will have asked the patient various questions about personal and family medical history. The doctor will also measure blood pressure and depending on actual health, may carry out other tests.
This information sheet describes various situations when the patient should stop using Liza or when the effect of Liza could be reduced. In such situations, the patient should not have sexual relations or should use additional nonhormonal contraceptives eg, a condom or other barrier method.
Do not use the rhythm or temperature method. These methods can be unreliable as Liza alters the monthly changes of body temperature and cervical mucus.
Liza, similar to other hormonal contraceptives does not protect against HIV (AIDS) or any other sexually transmitted infection. While receiving this medication, see the doctor regularly at least every 6-12 months.
If the patient has any unusual symptoms eg, unexplained pain in the chest, abdomen or legs, consult the doctor immediately.
In some situations, the patient will have to take special care when taking Liza or any other combined hormonal contraceptives and the doctor may need to carry out regular checks. If any of the following affect the patient, inform the doctor before using Liza. The patient should consult the doctor if the following occur or worsen during the use of Liza. If any close family member has or has had breast cancer; 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 kidney); sickle cell disease (a hereditary illness affecting red blood cells); epilepsy (see Interactions); systemic lupus erythematosus (SLE) (an illness affecting the immune system); 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 pimples during pregnancy), Sydenham's chorea (an illness affecting the nerves, producing involuntary movements); have 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, avoid direct sunlight and ultraviolet rays.
If the patient has hereditary angioedema, products which contain estrogen can cause or worsen the symptoms of angioedema. The patient must go to the doctor immediately, if she experience symptoms of angioedema eg, swelling of the face, tongue and/or pharynx, and/or have difficulty in swallowing or break out hives together with having difficulty in breathing.
Surgery, Long Periods of Immobilization or Serious Accidents During Treatment: It is important that the patient tell the doctor in advance that they are taking Liza because the risk of venous thrombosis is increased in these circumstances, the patient must stop taking treatment for a while.
The doctor will inform the patient when to start taking Liza again. This usually happens 2 weeks after the patient regain mobility.
Thrombosis: Venous Thrombosis: The use of any combined contraceptive, Liza 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, overweight, close family members have had blood clots (thrombosis) in the legs, lungs or any other organ at an early age, going to have surgery, or are going to be immobilized for a long time or have suffered a serious accident (see Surgery, Long Periods of Immobilization or Serious Accidents During Treatment as mentioned previously).
Arterial Thrombosis: The use of combined contraceptive has been linked to an increased risk of developing arterial thrombosis (obstruction of an artery) eg, in the blood vessel of the heart (heart attack) or the brain (stroke).
The risk of developing arterial thrombosis when taking combined contraceptives increases if the patient smokes, (it is strongly advised that the patient quit smoking especially if the patient >35 years); high levels of fat in the blood (cholesterol or triglycerides); overweight, patient's family members has had a heart attack or stroke at an early age; high blood pressure; migraines; heart problems (valve disorders, changes in heart rhythm). Stop using Liza and immediately go to the doctor if the patient has possible signs of thrombosis.
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 the doctor more frequently. The breast cancer rate reduces gradually after the patient decided to stop taking combined hormonal contraceptives.
It is important to regularly examine the breast and go to the doctor if the patient finds any lump.
Benign kidney tumors have been found in women who use combined contraceptives on rare occasions and malignant tumors are even rarer. Go to the doctor if the patient experiences sudden intense abdominal pain.
Liza contains lactose. If the patient have been told by the doctor that she has an intolerance to some sugars, contact the doctor before taking Liza.
Stop using Liza and immediately go to the doctor if the patient has possible signs of thrombosis eg, extreme pain and/or inflammation of one of the legs, intense and sudden chest pain which may reach your left arm; sudden difficulty breathing and 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.
Effects on the Ability to Drive or Operate Machinery: There is no information which suggests that using Liza has an effect on the ability to drive or use machinery.
Use in Lactation: It is generally not recommended to take Liza when the patient is breastfeeding. If the patient wants to use the contraceptive while breastfeeding, she should consult the doctor. Consult the doctor or pharmacist before taking any medicine.

 

Use In Pregnancy & Lactation

Emotional lability, headache, abdominal pain, acne, sore & enlarged breasts, painful or irregular menstruation, wt gain.

Always inform the prescriber about the medications or herbal preparations the patient are taking. Also inform any other health professional that has prescribed other medication (or the pharmacist) that the patient is taking Liza. The healthcare professional may inform the patient the need to use additional contraceptives (eg, condom) and inform the patient the duration.
Some medicine can cause Liza to lose its contraceptive effect or can cause unexpected bleeding. This applies to medicines used to treat epilepsy (eg, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine) and tuberculosis (eg, rifampicin), HIV (ritonavir), other infectious disease (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 taking Liza, she should consult the doctor beforehand. Liza can affect other medicines eg, those which contain ciclosporin or the anticonvulsant drug lamotrigine (this can increase the frequency of convulsions).
Consult the doctor or pharmacist before taking any medicine. Inform the doctor or pharmacist if the patient is taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Liza with Food and Drink: Take Liza tablet everyday with some water if needed. The patient can take the tablets with or without food, but should take Liza approximately at the same time everyday.
Laboratory Tests: If the patient need a blood analysis, inform the doctor or laboratory staff that the patient is taking a contraceptive, as oral contraceptives can affect the results of some test.

Storage

Action

Oral Contraceptives / Acne Treatment Preparations