Diane-35 (Estradiol) Birth Control Pills 21 Tablets

Excipients: lactose monohydrate, corn starch, povidone 25, magnesium stearate, sucrose, povidone 700 000, macrogol 6000, calcium carbonate, talc, glycerol 85%, titanium dioxide, yellow iron oxide pigment, red iron oxide pigment, montanglikol wax

▼ This drug is subject to additional monitoring. This triangle will ensure the rapid identification of new safety information. You can help by reporting any side effects. You can check the end of Chapter 4 to learn how to report side effects.

Please read this INSTRUCTIONS carefully before using this medicine, as 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 to 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 DIANE 35 and what is it used for? 2. Considerations before using the DIANE 35 3. How to use the DIANE 35? 4. What are the possible side effects? 5. Storage of the DIANE 35

Headers are included.

1. What is DIANE 35 and what is it used for?

• DIANE 35 is available in blister packs with 21 dragees and dragees are in beige color. Each dragee contains 2 mg of cyproterone acetate and 0.035 mg of ethinylestradiol.

DIANE 35 contains estrogen (one of the female sex hormones) and the hormone progesterone (which is one of the female sex hormones) that has antiandrogenic activity (which removes some natural effects of male sex hormones).

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• DIANE 35 is used for the treatment of skin disorders such as moderate to severe acne treatment and / or excessive hair growth with or without excessive fat in women of childbearing age. Because of the contraceptive properties, only your doctor may be prescribed if he thinks that hormonal contraceptive (contraceptive) treatment is appropriate. DIANE 35 should be used in the treatment of acne only in cases where antibiotic treatment is applied to the skin or that affects the whole body. If you use DIANE 35 for a skin-related treatment, you should also not use a different hormonal contraceptive.

• You should return to your previously preferred / actual contraception method when your skin problem is resolved and you stop using DIANE 35.

• Do not use with other hormonal contraceptives as it acts as a birth control pill.

Treatment of skin problems Androgens are hormones that stimulate hair growth and sebaceous glands in the skin. If too much androgen is produced or if you are sensitive to the androgen effect, the sebaceous glands can produce too much sebum. This can block the sebaceous glands, so that infection can develop, inflamed acne spots can occur. DIANE 35 stops androgens from affecting your skin and reduces the amount of androgen produced.

Birth control DIANE 35 is a 21-day contraceptive pill; A dragee is taken every day for 21 days and no dragee is taken for the next 7 days.

DIANE 35 does not provide protection against chlamydia (sexually transmitted bacteria) or HIV infection (AIDS) and other sexually transmitted diseases. Contamination of such diseases can only be prevented by condoms. DIANE 35 should be taken as indicated for contraception.

2. Cautions before using

DIANE 35 DO NOT use the DIANE 35 in the following cases: Tell your doctor if you have any medical problems or illness. If any of the following conditions apply to you, tell your doctor before you start using the DIANE 35. In this case, your doctor may recommend that you take a different treatment:

If;

• Ifusing another hormonal contraceptive method simultaneously,

you are• If you are pregnant or suspect that you are pregnant• If you are

breastfeeding,

• If you have breast cancer or have breast cancer before,

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• In your leg (thrombosis), in your lungs (pulmonary embolism) or in another if there is a blood clot in the area (or if it has already happened),

• a disease that may be a heart attack indicator in the future (eg angina pectoris causing severe pain in the chest) or a mini-stroke (or transient ischemic attack),

• Cerebravascular accident sign or have a history (If you have a heart attack or stroke, or if you have already had it),

• If you have a disease that can increase the risk of blood clots in the arteries. This applies to the following diseases:

- Diabetes that affects your blood vessels - Very high blood pressure - Too high an oil level in your blood (cholesterol or triglyceride)

• If you have a hereditary or acquired predisposition to blood clotting in your venous or arteries (eg. activated protein C (APC) resistance, antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant))

• have migraine with visual disturbances (or if it was previously)

• Any time the severe If you have liver disease and your doctor has said that your liver tests have not yet returned to normal

• If you have a liver tumor or a story,

• If you are allergic to one of the substances contained in the drug. If any of these conditions happen when you first use the drug, stop using it immediately and consult your doctor. DIANE 35 is not used in men.

USE DIANE 35 CAREFULLY: Duration of use The time to relieve symptoms is at least three months. The need to continue treatment should be regularly assessed by the treating physician.

It is important that you understand the benefits and risks of using DIANE 35 before you begin or decide to continue using it. Although DIANE 35 is suitable for most healthy women, it may not be a suitable option for everyone.

Tell your doctor if you have any of the diseases or risk factors specified in these instructions for use.

Things to consider before you start using DIANE 35 Before you start taking the DIANE 35, your doctor will ask you some questions about your health history of you and your close relatives. Your doctor will also check your blood pressure and check your chances of being pregnant. Other controls, such as breast examination, may also need to be performed, but only if necessary and with specific circumstances.

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using the DIANE 35

• Your doctor will usually ask you to have regular inspections when you need another DIANE 35 prescription.

• You should regularly take a cervical smear test (cervical cancer screening test).

• Check your nipples and tits to see if there are any changes every month, or tell your doctor if you notice something strange, such as pitting or a lump on your skin.

• Tell your doctor or laboratory staff that you are using DIANE 35 if a blood test is required, as this type of medication may affect the results of some tests.

• When you need to have an operation, your doctor should know that you are using this pill. You may have to stop using DIANE 35 4 to 6 weeks before the operation. The reason for this is to reduce the risk of blood clots. Your doctor will tell you when you can start using the DIANE 35 again.

• If you have to stop using DIANE 35, if you trust DIANE 35 for contraception, do not forget to use another method of contraception (eg condom).

Conditions that you should consult with your doctor If you experience any possible signs of blood clot release, discontinue the drug and contact your doctor immediately. These symptoms are listed under t Blood clots (Thrombosis) “and er 4. What are the Possible Side Effects? Ol. DIANE 35 also acts as a contraceptive pill. You and your doctor should normally consider all aspects that apply to the safe use of oral hormonal contraceptives. Blood clots (Thrombosis)

DIANE 35 may increase your risk of blood clots. Using DIANE 35 can only increase the risk of developing blood clots only slightly compared to women who do not use DIANE 35 or any other contraceptive pill. There may not always be full recovery and 1-2% of the cases can be fatal.

Intra-blood clot in

venous blood clots The development of aa vein (known as venous thrombosis) can cause vessel blockage. This may occur in a vein in the leg, lung (lung embolism) or any other organ. The combined use of pills increases the risk of developing this type of clot in women compared to women who do not use any combined pill. The first year in which the risk of developing blood clots in a vein is the highest. The risk is not as high as the risk of developing blood clots during pregnancy.

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The risk of developing a blood clot is only slightly increased when you use the DIANE 35.

• About 5 to 10 out of 100,000 non-pregnant women who do not use DIANE 35 and do not take birth control pills will have a blood clot in one year.

• Approximately 40% of 100,000 women who use DIANE 35 or who receive birth control pills will have blood clots within one year.

• Approximately 60% of the 100,000 pregnant women will have a blood clot within one year.

The risk of an intravenous blood clot in the combined pills is further increased by:

• advancing age;

• Smoking. If you are older than 35 years of age, it is highly recommended that you stop smoking when using a contraceptive pill, such as DIANE 35.

• If a relative has had blood clots in a leg, lung, or other organ at a young age;

• If you are overweight;

• If you need to undergo an operation or if you do not step on your feet for a long time due to injury or illness, or if your leg is in plaster;

• If you have polycystic ovarian syndrome (ovarian cysts);

• If you have recently given birth;

• You have a number of rare medical problems, such as systemic lupus erythematosus (a disease that causes joint pain and skin rash), Crohn's disease (chronic inflammatory bowel disease) or ulcerative colitis (an inflammatory disease of the large intestine);

• Ifsick with sickle cell anemia (hereditary blood disease)

you areIt is important to tell your doctor that you are using DIANE 35 if you have to discontinue your treatment if any of these are true to you. Your doctor may tell you to stop using DIANE 35 weeks before surgery or immobilization. Your doctor will also tell you when you can stand up when you can start using the DIANE 35 again. Arterial

blood clots The formation of blood clots in an artery can cause serious problems. For example, a blood clot in one of the arteries in the heart can cause a heart attack, which can cause a stroke in the brain. The combined use of pills has been associated with an increased risk of clots in the arteries. This risk increases further:

• Advancing age;

• Smoking. If you are over 35, it is highly recommended that you stop smoking when using a hormonal contraceptive pill, such as DIANE 35

.

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• If you have high blood pressure;

• If a relative has developed a heart attack or stroke at a young age;

• If the blood level in your blood is high (cholesterol or triglycerides);

• If you have migraine;

• If you have a heart condition (valvular disease, rhythm disorder);

• If you have polycystic ovarian syndrome (ovarian cysts);

• If you have diabetes (diabetes);

• You have a number of rare medical problems, such as systemic lupus erythematosus (a disease that causes joint pain and skin rash);

• If you have sickle cell anemia (hereditary blood disease).

Blood clot symptoms If yousigns of blood clots,the

experience any possiblesuch asfollowing, stop using the drug and talk to your doctor immediately:

• Unusual coughing;

• severe chest pain spreading or not spreading to the left arm;

• Faintness;

• severe migraine or unusual, prolonged, severe headache;

• Partial or full blindness or double vision;

• Peltek speech or speech disorder;

• Hearing, smell, sudden changes in the senses of taste;

• dizziness or fainting;

• weakness or numbness in any part of the body;

• Severe pain in the abdomen;

• Severe pain or swelling in one of the legs.

Once a blood clot has formed, it may not always be full recovery. Rarely, permanent severe disability may occur, or blood clots can be fatal.

Immediately after birth, the risk of blood clots in women increases, so you should consult with your doctor about how long you can start using DIANE 35 after delivery.

In the event of severe depression, severe allergic reaction, worsening of hereditary angioedema (swelling of the body areas), symptoms related to breast cancer or cervical cancer, or severe liver (signs and signs described in the, 4. What are the possible side effects?) You should consult.

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DIANE 35 and cancer Although high-dose combined birth control pills reduce the risk of ovarian and uterine cancer when used for a long period of time, it is not known exactly whether low-dose estrogen-progesterone-containing contraceptive pills, such as DIANE 35, have the same protective effects. However, the use of DIANE 35 seems to slightly increase the risk of cervical cancer; however, it may be that the condom is not used in sexual intercourse rather than DIANE 35. All women should have a regular smear test.

If you have breast cancer or have already been diagnosed with breast cancer, you should not use DIANE 35 or other contraceptive pills because they increase the risk of breast cancer slightly. This risk increases as DIANE 35 continues to use, but returns to normal within about 10 years after discontinuation. Breast cancer is rare in women younger than 40 years of age, and those who use DIANE 35 or those who have used it recently have fewer breast cancer cases. For example:

• 10,000 women who have never used DIANE 35 will have a breast cancer of approximately 16 until they are 35 years of age.

• In the early twenties, there are about 17-18 women with DIANE 35 for 5 years or about 10,000 women who have used birth control pills until they are 35 years old.

• Up to 10,000 women who have never used DIANE 35 are likely to have breast cancer until they are 45 years of age.

• In the early thirties, there are about 110 women who have not used DIANE 35 or birth control pills for 5 years, until the age of 45 years.

The risk for breast cancer is higher in the following cases:

• A history of breast cancer in a close relative (mother, sister, or grandmother)

• Severe overweightthe

If you notice any changes inbreast such as pitting, nipples, or any visible or visible lump consult a doctor in time.

• DIANE 35 has been associated with liver diseases such as jaundice and non-cancerous liver tumors, but this is rare. Very rarely; DIANE 35 has also been associated with some types of liver cancer in long-term women.

In case of severe pain in your stomach or yellowing in your skin or eyes (yellowing), consult a doctor as soon as possible. You may need to stop using DIANE 35.

Conditions that may be worsened during pregnancy or through previous use of the contraceptive pill: The following conditions have been reported to occur or deteriorate both by pregnancy and by the use of a combination of estrogen / progesterone, such as a POP or DIANE 35. If any of the following occur during use, release the DIANE 35:

• Jaundice and / or pruritus associated with cholestasis

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• Gallbladder

• Systemic lupus erythematosus (a disease that causes joint pain and skin rash)

• Herpes gestationis (Rash similar to collecting water during pregnancy)

• Otosclerosis hearing loss

• Sickle cell anemia (hereditary blood disease)

• Renal dysfunction (renal dysfunction)

• Hereditary angioedema (swelling of the body areas)

• In a single woman during pregnancy or in previous POP or any other condition reported to deteriorate during the use of DIANE 35.

DIANE 35 may cause some diseases to worsen Some of the conditions listed below may deteriorate with the use of DIANE 35. In other words, it may mean less suitable for you. You can still use the DIANE 35 but you need to be more careful and have more frequent health checks.

• If you or your family have problems with heart or circulation such as high blood pressure

• If you or your family have problems with blood clotting /

If you have migraines / If you

have experienced depression in your present or past

• If you are overweight (obese)

• Porphyria If you have a hereditary diseaseIf you have

•diabetes

• If you have pancreatitis (pancreatitis) or you may increase the risk of developing pancreatitis, you have a history of high levels of blood fat (hypertriglyceridemia) in your family or your family

• Brown spots on your face or body (chloasma) If you have (see. "tanning devices by DIANA 35 and solariums")

• If you have during pregnancy or prior birth control pills or DIANE worsening of the disease while using 35 (see. section "4. Possible Side Effects What?")

any of these cases you Apply to i Tell your doctor. You should also tell your doctor if you have experienced any of these conditions for the first time, or if these conditions have deteriorated or have recurred, as you may have to stop using DIANE 35.

Bronzing devices with DIANE 35 and solariums Some women use solariums to get rid of acne or get tanned. This is not a very useful treatment for acne. Do not enter theorwhen using the DIANE 35

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tanning roomuse atanning device and avoid sunbathing for long periods. Their use increases the risk of chloasmia, which causes discoloration on the skin (normal contraceptives increase the risk). Changes in menstrual periods

Decrease in menstruation: This is not unusual and is expected to occur in some women. Lack of menstruation: Sometimes there is no menstrual bleeding. If the dragees are taken correctly, pregnancy is unlikely. If withdrawal occurs in the period of discontinuation of the dragee, consult your doctor if you are pregnant.