Yasmin (Estradiol) Birth Control Pills 21 Tablets

• Active substances: Each film-coated tablet contains 3 mg of drospirenone and 0.03 mg of ethinylestradiol.

• Excipients: Lactose monohydrate, corn starch, modified starch, povidone, magnesium stearate, hydroxypropylmethyl cellulose, macrogol 6000, talc, titanium dioxide, yellow iron oxide pigment.

Please read this INSTRUCTIONS carefully before you start using this medicine because it contains important information for you.

• Keep these instructions for use. You can need to read again.

• If you have other questions, please talk your doctor or pharmacist.

• This medicine has been prescribed for you personally, please do not give it to others.

• When using this medicine, tell your doctor that you are taking this medicine when you go to a doctor or hospital.

• Follow the instructions in this manual. Do not use high or low doses other than the recommended dose for the drug.

In these Instructions for Use:

1. What is YASMIN and what is it used for? 2. Things to consider before using YASMIN 3. How to use YASMIN? 4. What are the possible side effects? 5. Heading of the YASMIN is

included.

1. What is YASMIN and what is it used for?

• YASMIN is available in packages of 21 tablets. Each tablet contains 3 mg of drospirenone, 0.03 mg of ethinylestradiol. These tablets; on the one side of the smooth hexagonal ed DO eks embossed round biconvex light yellow film-coated tablets.

• Birth control pills with two hormones are called combined oral contraceptives.

• The contraceptive effect of combined oral contraceptives occurs when many factors interfere with ovulation and changes in uterine secretions.

• YASMIN is used to prevent pregnancy. Apart from this, it is used in women who suffer from hormone-related water retention, acne and fat in the skin.

2. Things to consider before using YASMIN Do NOT use YASMIN if:

• If you have a vascular occlusion, a disease related to your cerebral vessels, or if you have had in the past

• If you have signs of vascular obstruction or if you have had in the past

• If you have a history of migraines that give symptoms related to the nervous systemIf you

•have diabetes that has affected veins

• Serious or numerous risks for vascular occlusion If you have

severe liver diseaseIf you have

•severe renal failureIf you have a

•liver tumor or if you have had it earlierIf you have

•known or suspected malignant diseases of sex organs or breast affected by sex steroidsIf you have

•undiagnosed vaginal bleeding

• If you are pregnant or suspect that you are pregnant

• If you are allergic to any ofingredients in Yasmincontent

theYasmin USE CAREFULLYin the following cases:

if;

• If you have a circulatory disorderIf you have

•vascular disease or a similar vascular diseaseIf you are inIf you

•advanced agesmoke

•• A

family history of circulatory disturbance (thrombosis in the legs (blood clot formation)), pulmonary embolism (clot formation) in the lungs or embolism elsewhere attack or stroke) If

• swelling If you're

• Blood fats are high

• if you have high blood pressure

• If you have migraine

• If you have heart valve disease

• If you have a heart rhythm disorder

• If you're a long period of inactivity or have had surgery

• are pregnant Lohusa

• If you have diabetes

• joint pain and skin rash If that causes systemic lupus erythematosus,

hemolytic uremic syndrome • If you have a clotting disorder that causes kidney failure

in causing ulcers • bowel or thickening of the bowel wall, ulcers in the mucosa and regional lymph di You prominent Crohn's disease with growth in surements (chronic inflammatory bowel disease) If

• If you have epilepsy

• if you have high blood potassium levels due to renal disease

• If you have sickle cell anemia, which is a type of anemia

• If you have kidney failure

• If you have audiences in the genitals and nipples

• bile duct obstruction if you have jaundice, pruritus

• If

you have porphyria, if you have iron accumulationIf you

•have Sydenham's chorea which is a brain-related disease

• If you have herpes due to pregnancyIf you have

•hearing lossIf you have

•familial angioedema (swelling of lips, tongue)If you have

•liver dysfunction

• If you have yellow-brown spots due to pregnancy,

clot formation in the veins may be life threatening or fatal (in 1-2% of cases).

Clot formation in arteries can be life-threatening or fatal.

Epidemiological studies have shown that the risk of clotting (VTE) in the veins for drospirenone-containing combined oral contraceptives (POPs) is greater than that of COCs containing levonorgesterol (known as the second generation), and this risk is known as the third generation of POPs containing desogestrel / gestoden. drugs have shown to be similar.

Tumors can be life-threatening or fatal.

Oral contraceptives are not protective against HIV infection (AIDS) and other sexually transmitted diseases.

In all combined oral contraceptives, especially in the first months of use, irregular bleeding (spotting or intermittent bleeding) may occur. Therefore, evaluation of any irregular bleeding is significant after an adaptation period of approximately 3 cycles. If bleeding irregularity persists or if hemorrhages occur regularly, non-hormonal factors should be considered and appropriate diagnostic interventions should be undertaken to exclude malignancy or pregnancy to include abortion.

In some women, withdrawal bleeding may not occur in the period when tablets are not taken. If combined oral contraceptives, Eğer 3. The woman is not expected to be pregnant if she is used as described in. How to use YASMIN Y. However, if combined oral contraceptives have not been used in accordance with the rules of use prior to the first non-withdrawal bleed, or if withdrawal bleeding has not occurred twice, the pregnancy should be excluded before continuing the use of combined oral contraceptives.

The efficacy of combined oral contraceptives may be reduced in the case of forgotten tablet ingestion, gastrointestinal disorders, or concurrent drug therapy.

Please consult your doctor if these warnings are valid for you, even at any time in the past.

Using YASMIN with food and drink Tablets should be swallowed whole with a sufficient amount of water.

Pregnancy Consult your doctor or pharmacist before using the medicine.

YASMIN should not be used during pregnancy.

If you discover that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

Breastfeeding Consult your doctor or pharmacist before using the medicine.

YASMIN should not be used in nursing mothers.

Use of tools and machines No studies have been carried out on the effect on the ability to drive and use machines. The use of combined oral contraceptives had no effect on the ability to drive and use machines.

The YASMIN contains lactose, which contains important information on the excipients contained in the YASMIN. If you have been told by your doctor that you are intolerant of some sugar varieties (without tolerance), consult your doctor before using this medicine.

Use with other drugs When used in combination with certain drugs, the effect of YASMIN or the other drug used may vary. If you are using Yasmin with the following medicines Please tell your doctor:

• used in the treatment of epilepsy phenytoin, primidone, carbamazepine, oxcarbazepine,

topiramate, felbamate, lamotrigine, barbiturates

• rifampicin, an antibiotic, penicillin, tetracyclines

• griseofulvin, which is a fungicide

• Hypericum

• HIV (AIDS) ritonavir used in the treatment and nevirapine

• cyclosporin used in the treatment of immune system diseases

• angiotensin used to treat high blood pressure-II receptor antagonists

• Potassium-sparing diuretics

• diuretic is an aldosterone antagonist

If prescription or nonprescription any drug currently please inform your doctor or pharmacist if you use them or have recently used them.

3. How to use YASMIN Instructions for appropriate use and dose / frequency of administration: If the pill is not used in the previous month: Tablets should be started on the first day of bleeding. It may also be acceptable to start bleeding on tablets between days 2 and 5, but in this case, a barrier contraception should be used for seven days after the beginning of taking tablets for the first cycle.

Passing from another birth control pill: The day after the last tablet of the previous birth control pill is taken, YASMIN should be started. Most breaks can be made until the last day of the tablet-free period. If a vaginal ring or patch is used, the YASMIN acquisition should be started on the day of their removal, or on the day of the new application.

Transition from a progestagen-containing method (minipil, injection, implant) or progestagen-release intrauterine system (RIS) only: any day of miniple treatment (day on which the implant or RIS is removed, and the next injection on the day of injection). However, under all these conditions, it is recommended to use an additional barrier method during the first 7 days of tablet intake.

After the abortion in the first 3 months of pregnancy: It can be started immediately. No additional method is required. Use according to your doctor's advice.

After the birth or after the second 3 months of abortion: The nursing mother should not use the baby until weaning. In women who did not breast-feed or who had low abortion 21-28. days. If it is to start later, an additional method should be used in the first 7 days of use. If you have had a sexual intercourse before you start using the tablet, make sure that there are no pregnancies before the birth control pill, or the next bleeding should be expected.

Method and method of administration: Tablets should be swallowed with sufficient amount of water at the same time each day in the direction shown above the package. One tablet is taken every day for 21 consecutive days. Each next package is followed by a period of 7 days, often with withdrawal bleeding, followed by a non-tablet period. This bleeding is usually followed by the 2nd tablet following the last tablet. The day starts and may not be interrupted when the next package is started.

When combined oral contraceptives are used correctly, there is a 1% risk of failure per year. This rate increases if drug intake is forgotten or misused.

Different age groups: Use in children: YASMIN is used only after the first menstrual period. Use in the elderly: YASMIN does not use in the elderly. YASMIN is not effective after menopause.

Special Use Cases: Renal insufficiency: YASMIN should not be used in severe renal failure. Liver failure: YASMIN should not be used in case of severe liver disease.

If you have an impression that the effect of YASMIN is too strong or too weak, talk to your doctor or pharmacist.

If you have used more YASMIN than you should: Talk to a doctor or pharmacist if you have used more than you should use from YASMIN.

In overdose, nausea, vomiting and mild vaginal bleeding may occur in young girls. If you have these symptoms, consult your doctor.

If you forget to use YASMIN, you should take the tablet if you remember less than 12 hours. Subsequent tablets should also continue to be taken as usual.

More than 12 hours passed; The following 2 simple rules apply;

1. The tablet will never be interrupted for more than 7 days. 2. It is necessary to take the tablet for 7 days without the interval.

In daily practice the following suggestions can be given:

1. week: The last forgotten tablet should be taken to be remembered. Next tablets should be continued to be taken as usual. An additional method should be used for the first 7 days. If there was a sexual intercourse before 7 days, the possibility of pregnancy should be taken into consideration.

2nd week: The last forgotten tablet should be taken to be remembered. Next tablets should be continued to be taken as usual. If tablets are taken without error for 7 days until the first forgotten tablet, there is no need to use additional methods. Otherwise, or if more than one tablet is forgotten, additional methods should be used.

In the 3rd week:. If the tablets were taken without error for 7 days until the forgotten tablet, no additional method is required by applying one of the following 2 options. Otherwise, additional method should be used in addition to option 1. 1- The last forgotten tablet should be taken to be remembered. The remaining tablets should be used in normal time until they are finished. The next box should be switched immediately. Bleeding is not expected in the user until the tablets of the second canister are exhausted, but spotting or intermittent bleedings may be seen on tablets taken days. 2- The box should be used. After 7 days (including forgotten days on the tablet) the new box starts.

In case of gastrointestinal disorder additional method should be used. Recommendations for forgotten tablets are valid if vomiting occurs within 3-4 hours after tablet ingestion. If the normal tablet retrieval program is not desired, the extra tablets required should be taken from another box.

Advancement or postponement of menstruation: In order to postpone the menstruation, YASMIN is continued to take 7 days without prior notice. This extension is as sustainable as possible until the 2nd packet is finished. During this time, rupture bleeding or spotting may occur. Then, after the usual 7-day interval, the purchase of YASMIN is continued as normal.

To shift the bleeding to another day of the week, the tablet-free period can be shortened as desired. The shorter the interval, the higher the risk of bleed bleeding or smearing (as with the postponement of bleeding) when using the second pack.

Do not take double doses to compensate for forgotten doses.

You can leave YASMIN at any time when you want to use YASMIN. If you leave YASMIN to get pregnant, it is recommended that you wait for your first menstrual bleeding before you become pregnant. Waiting for your menstrual bleeding will give you an idea of ​​how you should have a relationship in order to become pregnant. If you do not wish to become pregnant, consult your doctor for other reliable methods of contraception. If you have any further questions regarding the use of this medicine, ask your doctor.

4. What are the possible side effects? Like all medicines, side effects may occur in people who are sensitive to the substances contained in the YASMIN.

If you have any of the following, stop using YASMIN and IMMEDIATELY inform your doctor or contact the emergency department of the hospital nearest you:

• Swelling on the leg or on one leg in the leg; pain or tenderness, which can only be felt when standing or walking; deep vein thrombosis with symptoms such as redness or discoloration of the skin.

• Sudden, unexplained shortness of breath or rapid breathing; sudden cough in which blood may be involved; sharp chest pain that may increase with deep breathing; feeling of nervousness; severe imbalance or dizziness; pulmonary embolism with rapid or irregular heartbeat (clotting)

• Arterial and venous thromboembolism (occlusion of arterial and venous blood vessels due to blood clots) These include:

o sudden numbness or weakness in the face, leg or arm, especially on one side of the body; sudden confusion (confusion, dizziness), difficulty in speaking or comprehension; sudden visual difficulty in one or both eyes; sudden walking difficulty, dizziness, loss of balance or coordination; sudden, severe or prolonged headache without known cause; loss of consciousness or accompanied by seizures or with symptoms of fainting alone. o Steady abdominal pain, sudden pain in the extremities (arms and legs), swelling or discoloration of other arterial blood vessels with symptoms such as blood clots o Chest, arm or feeling of pain, discomfort, pressure, weight, suffocation or fullness under the breastbone; discomfort in the back, jaw, throat, arm and stomach; feeling of fullness, indigestion or compression; sweating, nausea, vomiting or dizziness; excessive weakness, anxiety (irritability, tension) or shortness of breath; heart attack with symptoms such as rapid or irregular heartbeats

These are all very serious side effects. If you have one of these, you have a serious allergy to YASMIN. You may need urgent medical attention or hospitalization.

If you notice any of the following, report it immediately to your doctor or contact the emergency department of the hospital nearest you:

• A disease manifested by the skin's accumulation of water in the mouth and throughout the body (erythema multiforme)

• Unusual vaginal bleeding

• Unspecified vaginal bleeding

• Severe leg or chest pain (due to clots in veins and arteries)

These are all serious side effects. Emergency medical intervention may be required.

If you notice any of the following, tell your doctor:

• Nausea

• Migraine

• Depression

• Depressive mood

• Change in mood

• Loss of sexual desire or loss

• Breast pain

These are mild side effects of YASMIN.

The following are side effects that are considered to be related to the group of combined oral contraceptives, with a very low incidence or a late symptom onset:

Tumors - The frequency of the diagnosis of breast cancer is slightly increased among those using oral contraceptives. - Liver tumors (benign and malignant)

Other conditions: - erythema nodosum, a painful, inflammatory disease in which a large number of sensitive swellings occur in response to antigenic stimuli - Elevated blood fat (increased risk of pancreatitis) - High blood pressure - With the use of combined oral contraceptives Occurrence or worsening of non-definite conditions: jaundice and / or pruritus of saffron in small bile ducts in the liver (cholestasis); gallstone formation; metabolism related to the production of chemical substances known as porphyria; systemic lupus erythematosus (a disease caused by a number of manifestations due to many tissues and organ inflammation, such as skin, joints, kidneys, heart membranes, lung membranes, and a disorder caused by malfunction of the immune system); anemia (hemolytic uremic syndrome) as a result of capillary bleeding; Frequenthead and tonguewhich are often less frequent in the hand

short-term movements of the(Rheumatismal Korea / Sydenham chorea),; herpes gestationis (very pruritic rashes which begin as rough on the puffy out of the skin in pregnant women and become into the form of bubbles) hearing loss due to otosclerosis (a bone disease in the ear) - Exogenouswith familial angioedema (an allergic reaction associated with the development of diffuse skin edema with or without rash)

estrogens in womencan lead to angioedema symptoms or exacerbation of liver function - Glucose change in tolerance or effect on peripheral insulin resistance - esophagus, stomach, thin and large intestine that can hold one or more parts of the intestine, thickening of the retained part, ulcers forming disease (Crohn's disease), thick intestine covering layer (mucosa-submucosa) inflammation (ulcerative colitis) - Percentage of yellow-brown stain (Chloasma) - Hypersensitivity (including symptoms such as rash, urticaria) - Sara - Mass in the uterus

Possible side effects are also listed below by their frequency of occurrence d.

The frequency of the following side effects is very common (≥ 1/10); common (≥1 / 100 to <1/10); non-common (≥ 1/1000 to <1/100); infrequently (≥1 / 10.000 to <1/1000); very rare (<1 / 10,000), unknown (unpredictable).

Common:

• Emotion change

• Depression / Depressive mood

• Loss of sexual desire or loss

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