Midiana 3 mg. / 0.3 mg. 21 tablets

What is Midiana 28 clams and what it is used
Midiana 28 is a contraceptive pill and is used to prevent pregnancy.
Each of the 21 white tablets contain small amounts of two different female hormones, namely drospirenone (drospirenone) and EE (ethinylestradiol).
7 green tablets do not contain active compounds and are called placebo tablets.
Contraceptive pills that contain two hormones are called "combined" pills.

2. What you should know before using Midiana 28
General comments
Before you start using Midiana 28, you should read the information on blood clots in section 2. It is particularly important to read the symptoms of a blood clot - see. point "Blood clots").
Before taking Midiana 28, your doctor will ask you some questions about your personal health as well as your immediate family. The doctor may also measure your blood pressure and depending on your state to appoint any other research.
In this leaflet describes various situations where you must stop the use of clams 28 or reliability of the tablets. In such cases, you should not have sex or you should take extra non-hormonal contraceptive measures, for example. to use a condom or other barrier method.
Do not use the rhythm method or the method of temperature measurement. These methods are not reliable because Midiana 28 affects the monthly changes in temperature and cervical mucus.
Midiana 28, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other infection transmitted sexually.

Do not use Midiana 28
You should not use Midiana 28 if you have any of the diseases listed below. If you have any of these, you should tell your doctor. He will discuss with you what other form of contraception would be more appropriate:
if you are allergic to ethinylestradiol or drospirenone, or any of the other ingredients of this medicine (listed in section 6). This may occur as itching, rash or swelling;
If you have (or have had) a blood clot in a blood vessel in the legs (deep vein thrombosis (DVT)), lungs (pulmonary embolism (PE)) or other organs;
if you know that you have a disease that affects blood clotting - such as a shortage of protein C deficiency, protein S, antithrombin deficiency III, Factor V Leiden or of antiphospholipid antibodies;
if you need surgery or if you are immobilized for long periods of time (see "Blood clots");
If you have (or have had) a heart attack or stroke;
If you have (or have had) angina (a disease that causes severe pain in the chest area and may be the first sign of a heart attack) or transient ischemic attack (TIA - transient symptoms of stroke);
if you have any of these diseases, which can increase the risk of blockage in the arteries. This applies to the following diseases:
severe diabetes with blood vessel damage;
very high blood pressure;
very high levels of blood fats (cholesterol or triglycerides);
disease known as hyperhomocysteinemia;
If you have (or have had) a type of migraine called "migraine with aura";
If you have (or have had) an inflammation of the pancreas (pancreatitis);
if you have or have previously had liver disease and your liver function is still not normalized;
if your kidneys are not working well (renal failure);
If you have (or have had) a liver tumor;
If you have (or have had) or suspect you have cancer of the breast or genitals;
if you have unexplained vaginal bleeding.
Warnings and Precautions
Talk to your doctor or pharmacist before taking 28 clams.

When should you contact your doctor?
Seek emergency medical help
if you notice possible signs of a blood clot in the leg (ie DVT), a blood clot in the lung (ie pulmonary embolism) for heart attack or stroke (see "Blood clots" more down).
For a description of the symptoms of these serious side effects, please see "How to recognize a blood clot."

Tell your doctor if you suffer from any of these diseases.
In some cases, you need to take special care with clams 28 or any other combination pill, and it may be necessary to regularly review with your doctor. If any of these conditions apply to you, you should tell your doctor before you start using Midi 28.

You should also inform your doctor if the disease develops or worsens while using clams Midiana28:
if a close relative has or had breast cancer;
if you have liver disease or gall bladder;
if you have diabetes;
if you have depression;
if you have epilepsy (see. "Other medicines and Mediana 28 ');
if you have a condition that arose for the first time during pregnancy or during previous use of sex hormones (eg hearing loss, a blood disease called porphyria, skin rash with blisters during pregnancy (gestational herpes) , disease of nerves with involuntary movements of the body (Sydenham's chorea);
if you have or have had chloasma (discoloration of the skin, especially the face or neck known as "pregnancy patches"). In this case, avoid direct exposure to sunlight or ultraviolet rays;
if you have hereditary angioedema, drugs containing estrogen can trigger the onset or worsen symptoms of angioedema. You need to see your doctor if you experience symptoms of angioedema, such as swollen face, tongue and / or pharynx and / or difficulty swallowing or hives, together with shortness of breath;
if you have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease);
if you have systemic lupus erythematosus (CLE - a disease affecting your natural defense system);
if you have haemolytic uraemic syndrome (HUS - a bleeding disorder that causes kidney failure);
if you have sickle cell anemia (an inherited disease of the red blood cells);
if you have elevated levels of fats in the blood (hypertriglyceridemia) or a family history of this disease. Hypertriglyceridemia is linked to an increased risk of development of pancreatitis (inflammation of the pancreas);
if you need surgery or are immobile for long periods of time (see section 2 'Blood clots');
if you have just given birth are at increased risk of blood clots; You should ask your doctor how long after birth can start taking Midi 28;
if you have inflammation in the veins under the skin if you have varicose veins (superficial thrombophlebitis);
if you have varicose veins.
Blood clots
If using combined hormonal contraceptive such as mussels 28, the risk of blood clots is higher than if you do not use this contraceptive. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots may form:
veins (called "venous thrombosis', 'venous thromboembolism' or VTE);
in the arteries (called "arterial thrombosis", "arterial thromboembolism" or ATE).
Restoration of blood clots is not always complete. Rarely can have serious, lasting effects or, very rarely, they can be fatal.
It is important to remember that the overall risk of a harmful blood clot due to the Midiana 28 is small.

How to Tell a blood clot
Seek emergency medical attention if you notice any of these signs or symptoms.
Do you have any of these signs? What is possible to suffer?
swelling of the leg or along the vein in the leg or foot, especially when it is accompanied by:
pain or tenderness in the leg which may be felt only when standing or walking;
Warming the affected leg;
discoloration of the skin of the feet, for example. becomes pale, red or blue.
Deep vein thrombosis
sudden unexplained shortness of breath or rapid breathing;
sudden coughing for no apparent reason, where can otkashlya blood;
acute chest pain, which may be enhanced in deep inhalation;
strong light-headedness or dizziness;
fast or irregular heartbeat;
severe stomach pain;
If you are unsure, talk to your doctor as some of these symptoms, such as cough or shortness of breath can go wrong with a mild illness such as respiratory tract infection (eg. Cold). pulmonary embolism
Symptoms, which most often are prepared in one eye:
sudden loss of vision;
painless blurring of vision, which can progress to loss of vision.
Retinal vein thrombosis (a blood clot in the eye)
pain, discomfort, pressure, heaviness in the chest;
a feeling of tightness or heaviness in the chest, arm or below the breastbone;
feeling of fullness, indigestion or choking;
discomfort in the upper body, spreading to the back, jaw, neck, arm and stomach;
sweating, nausea, vomiting or dizziness;
extreme weakness, anxiety or shortness of breath;
fast or irregular heartbeat.
Heart attack
sudden weakness or numbness of the face, arm or leg, especially on one side of the body;
sudden confusion, difficulty speaking or trouble understanding;
sudden trouble seeing in one or both eyes;
sudden trouble walking, dizziness, loss of balance or coordination;
sudden, severe or prolonged headache with no known cause;
loss of consciousness or fainting with or without seizure.
Sometimes symptoms of a stroke can be short with almost immediate and full recovery, but you still need to seek emergency medical care, because you may have a risk of another stroke. stroke
swelling and slight bruising limb;
severe pain in the stomach ( "acute abdomen").
Blood clots blocking other blood vessels

Blood clots in a vein
What can happen if a blood clot forms in a vein?
The use of combination hormonal contraceptives is associated with increased risk of blood clots in the veins (venous thrombosis). These adverse events are rare. Most often they are produced in the first year of use of combined hormonal contraceptive;
If a blood clot forms in a vein in the leg or foot, it can cause deep vein thrombosis (DVT);
If a blood clot passes through the leg and gets into the lungs, it can cause pulmonary embolism;
Very rarely a clot can form in a vein in another organ such as the eye (retinal vein thrombosis).
When the risk of a blood clot in a vein is highest?
The risk of a blood clot in a vein is highest in the first year of taking the combined hormonal contraceptive for the first time. The risk may also be higher if the resume taking combined hormonal contraceptive (same or different product) after a break of four weeks or more.
After the first year, the risk decreases, but is always slightly higher than if you do not use combined hormonal contraceptive.
When you stop taking Midiana 28, the risk of a blood clot when you are back to normal within a few weeks.

What is the risk of a blood clot?
The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive use.

The overall risk of developing a blood clot in the leg or lung (DVT) or (WAS) when using Midiana 28 is small:
10 000 women not using any combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot within a year;
10 000 women who use a combined hormonal contraception containing levonorgestrel, norethisterone, or norgestimate, about 5-7 will develop a blood clot within a year;
Of the 10 000 women who use combined hormonal contraceptive containing drospirenone, such as mussels 28, between 9 and 12 women will develop a blood clot within a year;
The risk of blood clot formation varies according to your personal medical history (see. "Factors that increase your risk of a blood clot" below).
Risk of blood clot formation within a year:
Women who do not use combined hormonal contraceptive in the form of a pill / patch / ring and are not pregnant - About 2 10 000 women;
Women who use combined hormonal contraceptive in the form of a pill containing levonorgestrel, norethisterone or norgestimate - Around 5-7 per 10 000 women;
Women who Midi 28 - Around 9-12 per 10 000 women.
Factors that increase the risk of a blood clot in a vein in your
The risk of a blood clot in the Midi 28 is small, but certain conditions it increases. Your risk is higher:
if you are overweight (body mass index (BMI) over 30 kg / m2);
if one of your closest relatives had a blood clot in the leg, lung or other organ when he was young (eg. less than 50 years). In this case, you may have inherited disorder of blood clotting;
if you need an operation or if you are immobilized for long periods of time due to injury or illness, or if your leg is in a cast. You may need the use of clams 28 to end several weeks before surgery or while you are less mobile. If you need to stop taking [Invented name], ask your doctor when you can start using it again;
with age (especially over 35 years);
if you are born for less than a few weeks.
The more conditions you have, the more increases the risk of blood clot formation.
Air travel (> 4 hours) may temporarily increase the risk of blood clot formation in you, especially if you have some of the other listed factors.
It is important to tell your doctor if any of these apply to you, even if you are not sure. Your doctor may decide that the use of Media 28 should be discontinued.
Tell your doctor if any of the above conditions change while using Midi 28, for example, close your relative get thrombosis of unknown cause or if your weight greatly increased.

Blood clots in arteries
What can happen if a blood clot forms in an artery?
Like blood clot in a vein, a clot in an artery can cause serious problems. For example, it can cause heart attack or stroke.

Factors that increase the risk of a blood clot in an artery to you
It is important to note that the risk of heart attack or stroke due to use of the Midi 28 is very small, but can be increased:
with age (after 35 years);
if you smoke. When using combined hormonal contraceptive such as mussels 28, it is advisable to stop smoking. If you do not possible to stop smoking and you are aged over 35, your doctor may advise you to use a different type of contraceptive;
if you are overweight;
if you have high blood pressure;
if one of your closest relatives had a heart attack or stroke at a young age (under 50 years). In this case, the risk of obtaining a heart attack or stroke may be higher and search;
if you or someone in your immediate family have high levels of blood fats (cholesterol or triglycerides);
if you get a migraine, particularly migraine with aura;
If you have a problem with your heart (valvular disease, rhythm condition called atrial fibrillation);
if you have diabetes.
If more than one of these disorders or if some of them are particularly severe, the risk of developing a blood clot may be increased even more.
Tell your doctor if any of the above conditions change while using Midi 28, for example, start smoking, a close relative of yours got thrombosis of unknown cause, or if your weight greatly increased.

Midiana 28 and cancer
Breast cancer has been observed slightly more often in women using combination tablets, but it is not known whether this is due to the treatment. For example, it is possible that more cancers are diagnosed in women taking combination pills because they are examined more frequently with your doctor.
The appearance of breast cancer decreased gradually after discontinuation of combined hormonal contraceptives. It is important to regularly check your breasts and if you find a lump to contact your doctor.
It has been reported rare cases of benign liver tumors and even fewer cases malignant liver tumors in women consuming the tablet. Contact your doctor if you experience unusual pain in the abdomen.

Bleeding between menstrual cycles
In the first few months since taking 28 clams you may have unexpected bleeding (bleeding outside week intake of green tablets). If bleeding occurs more than a few months or if it begins after some months, your doctor must investigate the cause.