What is Diane 35 and what it is used
Diane 35 is used to treat skin conditions such as acne, very oily skin and excessive hair growth in women of reproductive age. Because contraceptive properties it you should be prescribed only if your doctor determines that treatment with hormonal contraceptive appropriate.
You should take Diane 35 only if your skin condition has not improved after other therapies for acne, including topical treatments and antibiotics.
2. What you need to know before taking Diane 35
General comments
Before you can start taking Diane 35, your doctor will ask you some questions about your personal history and that of your family. The doctor will measure your blood pressure and, depending on your condition can do some research.
In this leaflet, several situations are described where you should stop taking Diane 35, or when the reliability of Diane 35 may be reduced. In such situations, or you should not have sexual intercourse or you should take extra non-hormonal measures of birth control, such as using a condom or other barrier method. Do not use rhythm or temperature methods. These methods can be unreliable, as Diane 35 leads to a change in the monthly changes of body temperature and cervical secretions.
Diane 35 as other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.
Do not take Diane 35
Tell your doctor if any of these conditions apply to you before you start using Diane 35. Your doctor may then advise you to use another treatment:
if you use another hormonal contraceptive;
if you have (or have ever had) a blood clot in the leg (thrombosis), lungs (pulmonary embolism), or other parts of the body;
if you have (or have ever had) a disease that can be an indicator of future heart attack (eg. angina, which causes severe chest pain) or "mini-stroke" (transient ischemic attack);
if you have (or have ever had) a heart attack or stroke;
if you have a condition that may increase the risk of blood clot formation in the arteries. This applies to the following conditions:
diabetes with damage to blood vessels;
very high blood pressure;
very high levels of fatty substances in your blood (cholesterol or triglycerides);
if you have bleeding problems (eg. protein C deficiency);
if you have (or have ever had) migraine with visual impairments;
If you have (or have ever had) liver disease (symptoms of which may be yellowing of the skin or itching) and your liver is not yet working normally;
If you have (or have ever had) cancer that can grow under the influence of sex hormones (eg breast or genitals);
If you have (or have ever had) a benign or malignant tumor in the liver;
If you get vaginal bleeding of unknown origin;
If you are pregnant or think you might be pregnant;
If you are allergic (hypersensitive) to ethinylestradiol or cyproterone acetate or any of the other ingredients of Diane 35. This can cause, such as itching, rash and swelling.
If any of these conditions appear for the first time while using Diane 35, stop immediately accepted and consult your doctor. Meanwhile, use a non-hormonal contraceptive methods. See also "General remarks".
Diane 35 should not be used by men.
Additional information on special populations
Use in children
Diane 35 is not intended for use in girls whose cycle has not yet begun.
Use in the elderly
Diane 35 is not intended for use in postmenopausal women.
Women with hepatic impairment
Do not take Diane 35 if you suffer from liver disease. See also "Do not take Diane 35" and "Take special care with Diane 35".
Women with renal impairment
Consult with your doctor. The available data do not suggest a need for change in the intake of Diane 35.
Warnings and Precautions
In which case you should contact your doctor
Stop taking the tablets immediately and contact your doctor if you notice signs of blood clots. The symptoms are described in section 2 'Blood clots (thrombosis). "
In some situations you should pay special attention when using Diane 35 or any other combined hormonal contraceptive, and it may be necessary and can be accessed regularly by your doctor. If any of these conditions apply to you, you should consult with your doctor before you start using Diane 35. In addition, if any of these conditions occur or worsen in using Diane 35, you should inform your doctor:
if you smoke;
if you suffer from diabetes;
if you are overweight;
if you have high blood pressure;
if you damage a heart valve or heart rhythm problems;
If you suffer from inflammation of the veins (superficial phlebitis);
if you have varicose veins;
if someone in your immediate family has had blood clots (thrombosis in the leg, lung "pulmonary embolism" or elsewhere), heart attack or stroke at a young age;
if you suffer from migraine;
if you suffer from epilepsy (see "Taking other medicines");
if you or someone in your family have or have had high levels of cholesterol or triglycerides (fatty substances) in the blood;
if someone in your family is suffering from breast cancer;
if you have liver disease or gallbladder disease;
if suffering from Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
if you suffer from systemic lupus erythematosus (CLE: a disease affecting the skin all over the body);
you have haemolytic uraemic syndrome (HUS: bleeding disorder resulting in acute renal failure);
if you have sickle cell anemia;
if you have a condition that occurred for the first time or worsened during pregnancy or previous use of sex hormones (eg hearing loss, metabolic disease called porphyria, skin disease called herpes gestationis, a neurological disease called Sydenham's chorea);
if you have (or have ever had) golden brown pigment spots on the skin, so called "pregnancy patches", especially on the face (chloasma). In such cases, avoid excessive exposure to sun or ultraviolet light;
if you have hereditary angioedema: Consult your doctor immediately if you experience any of the symptoms of angioedema such as swollen face, tongue or throat and / or difficulty swallowing or hives together with difficulty breathing. Products containing estrogen may cause or worsen symptoms of angioedema.
If any of the above conditions appear for the first time, recur or worsen during the use of Diane 35, you should contact your doctor.
If you suffer from hirsutism, which occurred recently or worse, your doctor should be informed quickly to clarify the reason.
Diane 35 acts as an oral contraceptive. You and your doctor will need to keep in mind all the factors that normally affect the safe use of oral hormonal contraceptives
Diane 35 and blood clots (thrombosis)
Taking Diane 35 may slightly increase the risk of a blood clot (called thrombosis). The likelihood of a blood clot are only slightly elevated when taking Diane 35 compared with women not taking Diane 35 or birth control pills. Does not always occur and recovery in 1-2% of cases, the outcome can be fatal.
Blood clots in a vein
Blood clot in a vein (the condition is known as a 'venous thrombosis') can block the vein. This can happen in veins of the leg, lung (pulmonary embolism) or any other authority.
The use of combined contraceptive pills increases a woman's risk arise and such clots compared with women who do not use combined contraceptive pills. The risk of developing a blood clot in a vein is highest during the first year a woman uses the pill. The risk is not as high as the risk of developing a blood clot during pregnancy.
The risk of blood clots in a vein in women using combined contraceptive pill increases further:
with increasing age;
if you are smoker. When using a hormonal contraceptive such as Diane 35 strongly encourage you to stop smoking, especially if you are aged over 35 years;
if one of your close relatives had a blood clot in the legs, lungs or other organs at an early age;
if you are overweight;
if you have an operation, if you are immobilized for a long time due to injury or disease, or if you have a foot in cast.
If this applies to you, it is important to tell your doctor that you are using Diane 35, because you may need treatment to be stopped. Your doctor may tell you to stop using Diane 35 several weeks before surgery or while you are with limited mobility. Your doctor will tell you also when you can start again using Diane 35, once healed.
Blood clots in an artery
Blood clot in an artery can cause serious problems. For example, a blood clot in an artery of the heart may lead to heart attack and in the brain can result in stroke. The use of combined birth control pills is associated with an increased risk of clots in the arteries. This risk increases further:
with increasing age;
if you are smoker. When using a hormonal koitratseitiv as Diane 35 strongly encourage you to stop smoking, especially if you are aged over 35 years;
if you are overweight;
If you have high blood pressure;
if your close relative has had a heart attack or stroke at a young age;
if you have high levels of fatty substances in the blood (cholesterol or triglycerides);
if you get migraines;
if you have a heart problem (damage to the heart valve or heart rhythm disorders).
Symptoms of blood clots
Stop taking the tablets immediately and contact your doctor if you notice any signs of blood clots, such as .:
unusual sudden cough;
severe pain in the chest which may reach the left arm;
shortness of breath;
any unusual, severe or long-lasting headache or worsening of migraine;
partial or complete loss of vision or double vision;
slurred speech or inability to speak;
sudden changes in hearing, smell or taste;
dizziness or fainting;
weakness or numbness in any part of the body;
severe pain in the abdomen;
severe pain or swelling in one leg.
Not always after clot formation is possible full recovery. Is rarely possible to be serious permanent disabilities and possible clot even be fatal.
Immediately after giving birth, women are at increased risk of blood clots so you should ask your doctor how soon after delivery you can start taking Diane 35.
Diane 35 and cancer
Breast cancer has been diagnosed slightly more often in women who use the Pill, but it is not known whether this is due to the treatment. Perhaps the reason is that women who use combined pills are found more often tumors, since they are measured more frequently. The risk of developing breast cancer decreased gradually after discontinuation of combined hormonal contraceptives. It is important to view your breasts regularly and you should immediately contact your doctor if you feel any lump.
Rare cases of benign liver tumors and even more rarely - malignant liver tumors in women taking the pills. In isolated cases, these tumors may lead to life-threatening internal bleeding. Immediately contact your doctor if you experience unusually severe abdominal pain.
The most important risk factor for developing cancer of the cervix is repeated infection with human papilloma virus (HPV). In some studies reported an increased risk of cervical cancer in long-term use of pills. However, it is unclear how sexual behavior or other factors, such as human papilloma virus (HPV) increases this risk.
Bleeding between menstrual cycles
In all Pills, for the first few months, you can get irregular vaginal bleeding (spotting or breakthrough bleeding) between menstrual cycles. You may need to use sanitary protection, but continue to take the tablets as usual. This irregular bleeding stops when your body adapts to Pills (usually after about 3 cycles the pill). If this continues to worsen or starts again, tell your doctor.
What to do if bleeding occurs
If you've taken all the tablets correctly, have not had vomiting or severe diarrhea and you have not taken any other medicines, it is very unlikely that you are pregnant. Continue to take Diane 35 as usual.
If you have not taken the tablets correctly or if you have taken the tablets correctly, but the expected bleeding does not appear twice in a row, you may be pregnant. Immediately consult your doctor. Do not start the next strip until you are sure you are not pregnant. Meanwhile, use a non-hormonal contraceptive measures. See also "General remarks".
Taking other medicines
Always tell your doctor what drugs or herbs you already use. In addition, tell your doctor or dentist prescribes another medicine (or the pharmacist in pharmacy from whom you buy the drug) that use Diane 35. They can inform you whether you need to take additional precautions for birth control (eg, condom ) and if so, how long to do this.
Some medicines may reduce the efficacy of Diane 35 in the prevention of pregnancy or cause unexpected bleeding. These include:
drugs used for treatment of:
epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
tuberculosis (eg rifampicin);
HIV infection (such as ritonavir, nevirapine) or other infections (antibiotics such as penicillins, tetracyclines, griseofulvin);
the herb St. John's Wort.
Diane 35 may influence the effect of other drugs, such as:
lamotrigine;
cyclosporine.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
laboratory tests
If you need a blood test, tell your doctor or laboratory personnel that you are taking Diane 35 as oral contraceptives can affect the results of some research.
Pregnancy, lactation and fertility
You should not take Diane 35 if you are pregnant or think you are pregnant. If you become pregnant while taking Diane 35 should immediately stop using it and tell your doctor. If you want to become pregnant, you should stop taking Diane 35 at any time (see also "If you want to stop taking Diane 35 ').
Using Diane 35 is not recommended during lactation. If you wish to continue taking the pill while breastfeeding, talk to your doctor.
Ask your doctor or pharmacist before taking any medicine if you are pregnant or breast-feeding.
Driving and using machines
No studies on the effects on the ability to drive and use machines.
No effects on ability to drive and use machines.
Important information about some of the ingredients of Diane 35
Diane 35 contains lactose and sucrose.
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this product.
3. How to take Diane 35
Always take Diane 35 exactly as your doctor tells you. If you are not sure, ask your doctor or pharmacist.
Diane 35 must be taken regularly to achieve a therapeutic effect, and the required contraceptive protection. The dosage of Diane 35 is similar to the usual dosage of the pill. Must follow the same rules to its adoption. Combined oral contraceptives have a failure rate of approximately 1% per year. Irregular intake of Diane 35 can cause breakthrough bleeding and interfere with its therapeutic and contraceptive effect.
When and how to take the tablets?
Diane 35 pack contains 21 tablets. The packaging on each tablet is marked the day of the week when you will accept. Take your tablet each day at about the same time with a little water if needed. Follow the direction of the arrows until the end to use all 21 tablets. Next 7 days will not take tablets. At this time should have bleeding (withdrawal bleeding). Usually, it begins 2-3 days after the last dose of the tablet Diane 35. Start a new pack on the 8th day (the day after the 7-day free interval the tablet), even if the bleeding continues. This means that you will always start new packs on the same days of the week and you will have bleeding almost at the same time each month.
When can you start with the first strip?
When the last month is not used hormonal contraceptive.
Start taking Diane 35 on the first day of your cycle (ie the first day of menstrual bleeding). Take a tablet marked with that day of the week. For example, if your period starts on Friday, take a tablet marked Friday. Then follow the days in order.