0.02 mg / 3 mg film-coated tablets 
ethinyl estradiol / drospirenone

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, midwife, or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, midwife, or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

Important information about combined hormonal contraceptives:

  • They are one of the most reliable contraceptive methods available if used properly
  • The risk of a blood clot in a vein or artery increases slightly, especially during the first year or when combined hormonal contraceptives start to be used again after a break of 4 weeks or longer
  • Pay attention and consult a doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

In this leaflet: 
1. What Diza is and what it is used for 
2. What you need to know before you use Diza 
3. How to use Diza 
4. Possible side effects 
5. How to store Diza 
6. Contents of the packaging and other information 

1. What Diza is and what it is used for

  • Diza is a contraceptive ( birth control pill ) and is used to prevent pregnancy
  • All 24 tablets contain a small amount of two different female sex hormones, drospirenone, and Ethinylestradiol.
  • Birth control pills that contain two hormones are called combined birth control pills

2. What you need to know before using Diza

Do not use Diza

Before you start using Diza for the first time, talk to your doctor or midwife about how to use it.
Before you start using Diza, read the information on blood clots in section 2. You must read the symptoms of a blood clot – see section 2, “Blood clots”).
Before taking Diza, your doctor/midwife will ask you some questions about your own and your immediate relatives’ medical history. The doctor/midwife will also measure your blood pressure and also take other tests depending on your situation.
This leaflet describes several situations in which you should stop using Diza or when the reliability of Diza may be reduced. In such circumstances, you should not have sex without using supplemental non-hormonal contraceptives, such as condoms or other barrier methods. Do not use the rhythm method or the temperature method. These methods are not reliable because Diza affects the monthly changes in body temperature and cervical secretions.
Like other hormonal contraceptives protect Diza not against HIV – infection ( AIDS ) or other sexually transmitted diseases.
You must contact a doctor immediately if you experience any unusual symptoms such as unexplained pain in the chest, abdomen, or legs.

Do not take Diza

Do not use Diza if you have any of the following. If you have any of these, you must tell your doctor/midwife. The doctor/midwife will discuss which other type of contraception may be more appropriate.

  • if you have (or have had) a blood clot in a blood vessel in your leg (deep vein thrombosis ), in your lung (pulmonary embolism), or another organ
  • if you have a coagulation disorder (for example protein C deficiency, protein S deficiency, antithrombin III deficiency, Factor V Leiden, or antiphospholipid antibodies)
  • if you need surgery, or if you have been in bed for a long time (see section 2 “Blood clots”).
  • if you have (or have had) a heart attack or stroke (blood clot or bleeding in the brain)
  • if you have (or have had) angina, so-called angina pectoris (a condition that causes severe chest pain and which may be the first sign of a heart attack) or transient ischemic attack ( TIA – transient stroke-like symptoms)
  • if you have any of the following conditions that may increase the risk of blood clots in an artery:
    • severe diabetes with damaged blood vessels
    • very high blood pressure
    • very high levels of fat in the blood ( cholesterol or triglycerides )
    • a condition called hyperhomocysteinemia
  • if you have (or have had) a special form of migraine with a so-called aura
  • if you have (or have had) liver disease and your liver is still not functioning normally
  • if your kidneys are not working well ( kidney failure )
  • if you have (or have had) a tumor in your liver
  • if you have (or have had) or if you suspect breast or genital cancer
  • if you have unexplained vaginal bleeding
  • if you are allergic to Ethinyl estradiol or drospirenone or any of the other ingredients of this medicine (listed in section 6). This can cause itching, rash, or swelling.
  • if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also section 2 “Other medicines and Diza)”

Warnings and cautions

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Seek medical attention immediately if you notice possible signs of a blood clot that may mean you have a blood clot in your leg (ie deep vein thrombosis ), a blood clot in your lung (ie pulmonary embolism ), a heart attack, or a stroke (see section “Blood clots” below). For a description of the symptoms of these serious side effects, go to “How to recognize a blood clot”.

Tell your doctor if any of the following conditions apply to you.

If the condition occurs or worsens when you use Diza, you should also consult a doctor.

  • if a close relative has or has had breast cancer
  • if you have any liver or bile disease
  • if you have diabetes
  • if you suffer from depression
  • if you have Crohn’s disease or ulcerative colitis ( chronic inflammatory bowel disease)
  • if you have systemic lupus erythematosus ( SLE – a disease that affects your immune system)
  • if you have hemolytic uremic syndrome (HUS – a disorder of blood coagulation that leads to kidney failure )
  • if you have sickle cell anemia (a hereditary disease of the red blood cells )
  • if you have increased blood fats ( hypertriglyceridemia ) or a hereditary condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas)
  • if you need to have an operation or stay in bed for a longer period (see section 2 “Blood clots”)
  • if you have just given birth, you are at increased risk of getting blood clots. Ask your doctor how soon after giving birth you can start using Diza
  • if you have an inflammation of the veins under the skin (superficial thrombophlebitis )
  • if you have varicose veins.
  • if you have epilepsy (see section “Other medicines and Diza”)
  • if you have a disease that first appeared during pregnancy or during previous use of sex hormones (eg hearing loss, a blood disease called porphyria, skin rash with blisters during pregnancy (pregnancy herpes), a nerve disease that causes sudden twitching in the body (Sydenhams Korea ).
  • if you have or have had golden-brown pigment spots (chloasma), so-called “pregnancy spots”, especially on the face, in which case you should avoid direct exposure to sunlight or ultraviolet light.
  • If you have hereditary angioedema , products that contain estrogen can cause or worsen the symptoms. You should see a doctor immediately if you experience symptoms of angioedema , such as swelling of the face, tongue, and/or pharynx and/or difficulty swallowing or hives together with difficulty breathing.

Blood clots

Using combined hormonal contraceptives such as Diza increases the risk of blood clots compared to if you do not use these drugs. In rare cases, a blood clot can block the blood vessels and cause serious problems.

Blood clots can form:

  • in veins (called venous thrombosis , venous thromboembolism, or VTE)
  • in arteries (called arterial thrombosis , arterial thromboembolism or ATE).

It is not always possible to fully recover from blood clots. In rare cases, they can have serious lasting effects and, in very rare cases, be fatal.

It is important to remember that the overall risk of a dangerous blood clot due to Diza is small.

HOW TO FEEL A BLOOD CLOTH AGAIN

Seek medical attention immediately if you notice any of the following signs or symptoms.

Do you experience any of these signs? What can you possibly suffer from?
swelling of a leg or along a vein in the leg or foot, especially if you also get: pain or soreness in the leg that is only felt when you stand or walkincreased heat in the affected leg discoloration of the skin on the leg, e.g. pale, red or blue Deep vein thrombosis
sudden unexplained shortness of breath or rapid breathing sudden cough for no apparent reason that could cause you to cough up blood severe chest pain that may increase with deep breathingsevere instability or dizziness fast or irregular heartbeatsevere pain in the abdomen you are not sure, talk to a doctor because some of these symptoms, e.g. cough and shortness of breath, can be mistakenly interpreted as a mild condition such as a respiratory infection (such as a common cold). Pulmonary embolism
Symptoms that usually occur in one eye: immediate loss of vision orblurred vision without pain that can lead to vision loss Retinal venous thrombosis (blood clot in the eye)
chest pain, discomfort, pressure, heavinesspressure or feeling of fullness in the chest, arm, or below the sternumfeeling full, indigestion or feeling of suffocationdiscomfort in the upper body that radiates to the back, jaw, neck, arm, and abdomensweating, nausea, vomiting or dizziness extreme weakness, anxiety or shortness of breakfast or irregular heartbeat Myocardial infarction
sudden weakness or numbness in the face, arms or legs, especially on one side of the body sudden confusion, difficulty speaking or understanding sudden vision problems in one or both eyessudden difficulty walking, dizziness, loss of balance or coordinationsudden, severe or prolonged headache without known cause unconsciousness or fainting with or without seizures
Sometimes the symptoms of a stroke can be short-lived with almost immediate or complete recovery, but you should still seek medical attention immediately because you are at risk of having a new stroke.
Stroke
swelling and slight blue discoloration of an arm or leg severe pain in the abdomen ( acute abdomen) Blood clots that block other blood vessels

BLOOD CLOTS IN A FRIEND

What can happen if a blood clot forms in a vein?

  • The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in the vein (venous thrombosis ). However, these side effects are rare. They usually occur during the first year of using a combined hormonal contraceptive.
  • If a blood clot forms in a vein in the leg or foot, it can lead to deep vein thrombosis (DVT).
  • If a blood clot moves from the bone and stays in the lung, it can lead to a pulmonary embolism.
  • In very rare cases, a blood clot can form in a vein in another organ such as the eye ( retinal venous thrombosis ).

When is the risk of developing a blood clot in a vein greatest?

The risk of developing a blood clot in a vein is greatest during the first year that you use combined hormonal contraceptives for the first time. The risk may also be higher if you start again with a combined hormonal contraceptive (the same product or another product) after a break of 4 weeks or longer.

After the first year, the risk decreases, but it is always slightly higher than if you did not use a combined hormonal contraceptive.

When you stop using Diza, the risk of a blood clot returns to normal within a few weeks.

How big is the risk of developing a blood clot?

The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.

The total risk of a blood clot in the leg or lungs with Diza is small.

  • Of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 develop a blood clot in one year.
  • Of 10,000 women who use a combined hormonal contraceptive containing levonorgestrel or norethisterone or norgestimate, approximately 5‑7 develop a blood clot in one year.
  • Of 10,000 women who use a combined hormonal contraceptive that contains drospirenone such as Diza, about 9‑12 develop a blood clot in one year.
  • The risk of blood clots varies depending on your medical history (see “Factors that may increase the risk of a blood clot” below).


Risk of developing a blood clot during a year
Women who do not use combined pills and who are not pregnant About 2 out of 10,000 women
Women using a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate About 5-7 out of 10,000 women
Women using Diza About 9‑12 out of 10,000 women

Factors that may increase the risk of a blood clot in a vein

The risk of a blood clot with Diza is small but some conditions increase the risk. The risk is higher:

  • if you are overweight (body mass index or BMI over 30 kg / m 2 )
  • if a close relative of yours has had a blood clot in the bones, lungs, or another organ at a young age (eg for about 50 years). In this case, you may have a hereditary blood clotting disease
  • if you need to have surgery, or stay in bed for a long period of time due to injury or illness, or if your leg is plastered. The use of Diza may need to be stopped for several weeks before an operation or while you are less mobile. If you have to stop taking Diza, ask your doctor when you can start taking it again
  • with increasing age (especially if you are over about 35 years old)
  • if you gave birth a few weeks ago

The risk of developing a blood clot increases the more risk factors you have.

Air travel (over 4 hours) can temporarily increase the risk of a blood clot, especially if you have any of the other factors listed here.

You must tell your doctor if you have any of these risk factors, even if you are unsure. Your doctor may decide that you need to stop taking Diza.

If any of the above conditions change when you use Diza, e.g. A close relative suffers from a blood clot with an unknown cause, or you gain a lot of weight, talk to your doctor.

BLOOD CLOTS IN AN ART

What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a clot in an artery can lead to serious problems. It can e.g. cause a heart attack or stroke.

Factors that may increase the risk of a blood clot in an artery

It is important to know that the risk of a heart attack or stroke due to the use of Diza is very small but may increase:

  • with increasing age (after about 35 years of age)
  • if you smoke. When using combined hormonal contraceptives, you should stop smoking. If you can not stop smoking and are over 35 years old, your doctor may advise you to use another type of contraceptive
  • if you are overweight
  • if you have high blood pressure
  • if a close relative of yours has had a heart attack or stroke at a young age (younger than 50 years). In this case, you may also be at greater risk of a heart attack or stroke
  • if you or a close relative have high blood fats ( cholesterol or triglycerides )
  • if you get migraines, especially migraines with an aura
  • if you have heart problems (valve disease, a heart rhythm disorder called atrial fibrillation )
  • if you have diabetes.

If you have more than one of these risk factors or if any of them are particularly serious, the risk of developing a blood clot can be even greater.

If any of the above conditions change when you use Diza, e.g. If you start smoking, a close relative suffers from a blood clot for an unknown reason, or you gain a lot of weight, talk to your doctor.

Diza and cancer

Breast cancer has been observed somewhat more frequently in women using combined oral contraceptives , but it is not known if this is caused by the treatment. For example, it may be that more tumors are detected in women who use combined contraceptive pills because they are examined by doctors more often.

The incidence of breast tumors gradually decreases after stopping treatment with combined hormonal contraceptives. You must examine your breasts regularly, and you should consult your doctor if you feel any lump.

In rare cases, benign liver tumors, and in even fewer cases malignant liver tumors, have been reported in birth control pill users. Contact your doctor if you experience unusually severe abdominal pain.

Some studies show an increased risk of cervical cancer in women who have used birth control pills for a long time. It is unclear to what extent this may be the result of sexual behavior and other factors such as human papillomavirus (HPV).

Mental disorders:

Some women who use hormonal contraceptives, including Diza, have reported depression or depression. Depression can be severe and can sometimes lead to suicidal thoughts. If you experience mood swings and symptoms of depression, you should contact a doctor as soon as possible for advice.

Intermittent bleeding

During the first months of using Diza, you may experience unexpected bleeding (bleeding on days other than during the tablet-free period). If this type of bleeding lasts for more than a few months, or if it occurs after a few months, your midwife / doctor should investigate the cause.

What to do if you do not experience any bleeding during the 4-day tablet-free period

If you have taken all the tablets correctly, have not had vomiting or severe diarrhea and if you have not taken any other medicines, it is very unlikely that you are pregnant.

If the expected bleeding does not occur twice in a row, you may be pregnant. Contact your doctor immediately.

If you use Diza to delay menstruation, bleeding does not normally occur every four weeks, but less frequently at intervals of up to 120 days. An unexpected pregnancy can be difficult to recognize. If for any reason you think you may be pregnant, you should do a pregnancy test. Contact a doctor or midwife if the pregnancy test is positive or if you are still unsure.

Only start on the next tablet chart if you are sure you are not pregnant.

Other medicines and Diza

Do not use Diza if you have hepatitis C and are taking medicines containing ombitasvir / paritaprevir / ritonavir and dasabuvir as this may lead to elevated liver function levels (elevated levels of the liver enzyme ALT in the blood).

Your doctor will prescribe a different type of contraceptive before you start treatment with these drugs.

Treatment with Diza can be continued for 2 weeks after the end of your treatment. See section 2 “Do not take Diza”.

Always tell your doctor / midwife which medicines or herbal remedies you are already using. Also tell other doctors or dentists who prescribe other medicines (or pharmacists) that you are using Diza. They can tell you if you need to use additional contraceptives (eg condoms), and if so, for how long, or if you need to change how you use other medicines you are taking.

Some medicines may affect the level of Diza blood and make Diza less effective in preventing pregnancy , or may cause unexpected bleeding. 
This applies, among other things, to medicines used to treat

  • epilepsy (eg primidone, phenytoin , barbiturates , carbamazepine, oxcarbazepine)
  • tuberculosis (eg rifampicin)
  • HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)
  • fungal infections (eg griseofulvin, ketoconazole )
  • arthritis, osteoarthritis (etoricoxib)
  • high blood pressure in the blood vessels of the lungs ( bosentan )
  • the herbal medicine St. John’s wort

Diza may affect the effectiveness of other medicines, e.g.

  • medicines containing ciclosporin
  • the antiepileptic drug lamotrigine (this may lead to an increase in the number of seizures)
  • theophylline (for the treatment of respiratory problems)
  • tizanidine (for the treatment of muscle pain and/or muscle cramps)

Ask your doctor or pharmacist for advice before taking any medicine.

Diza with food, drink, and alcohol

Diza can be taken with or without food, if necessary with a little water.

Laboratory samples

If you need to take a blood test, tell your doctor or laboratory staff that you are taking birth control pills , as hormonal contraceptives may affect the results of certain tests.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant, do not use Diza. If you become pregnant while taking Diza, you must stop immediately and contact your midwife/doctor. If you want to get pregnant, you can stop taking Diza at any time (see also “If you stop using Diza”).

Breast-feeding

In general, breastfeeding is not recommended when using Diza. If you want to use birth control pills while breastfeeding, consult your doctor.

Driving and using machines

There is no information to suggest that the use of Diza affects the ability to drive or use machines.

Diza contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Diza.

3. How to use Diza

Before you start using Diza for the first time, you should discuss with your doctor how to use this medicine during the different phases.

Always use this medicine exactly as your doctor or midwife has told you. Contact a doctor, pharmacist, or midwife if you are unsure.

Each tablet map contains 24 tablets.

Take one tablet of Diza every day, with a little water if necessary. You can take the tablets with or without food, but you should take the tablets at about the same time each day.

Taking tablets

Mandatory phase (days 1-24)

Start taking one tablet marked with the correct day of the week. When you start taking Diza, the tablets must be taken for at least 24 consecutive days. Then you can either:

  • make a 4-day long tablet break, you will then have your period
  • or continue taking tablets for up to 120 days (see flexible phase) to delay your period.

Flexible phase (day 25-120)

During days 25-120, the tablets can be taken for up to a maximum of 120 consecutive days (until all tablets in the tablet charts in this pack are exhausted). During this period, you can decide for yourself whether you want to delay your period or take a 4-day tablet break.

If you have not taken a tablet break during the flexible phase, a 4-day tablet break must be taken after taking Diza for 120 consecutive days.

During the 4-day tablet-free period, you will have your period.

If you experience bleeding that lasts 3 days in a row during the flexible phase (days 25-120), it is recommended that you take a 4-day tablet break so that you have your period. This will reduce the total number of bleeding days.

Tablet break

A tablet break should never be longer than 4 days and should only be started if you have taken tablets for at least 24 consecutive days.

During the 4-day tablet-free period, you will usually experience bleeding and sometimes it will not stop until the next period of tablet-taking has begun.

After each tablet-off period of 4 days, a new period is started with the intake of tablets for a minimum of 24 days and for a maximum of 120 days . After the obligatory phase of taking tablets for 24 consecutive days, you can again choose when between day 25 and day 120 you want to take the next tablet break.

It is recommended that you start a new tablet chart containing 24 tablets for the obligatory phase and after a 4-day tablet break, to make it easier for you to follow the dosing instructions correctly.

General dosing instructions

  • A 4-day tablet break can only be started if you have taken tablets for at least 24 consecutive days, ie after the obligatory phase has ended.
  • After a 4-day tablet break, a new mandatory phase begins. Tablets must then be taken for at least 24 days before a new tablet break can begin.

Preparation for the start of a new tablet map

To help you remember to take your birth control pill, each pack of Diza contains 35 (5×7) pieces of adhesive strips with the seven days of the week printed on them. You need to know which day of the week to start taking the tablets.

Select the weekday strip that starts with the day of the week when you start taking the tablets. An example: If you start on a Wednesday, use the weekly day strip that starts with “ONS”.

Paste the weekday strip at the top of the tablet map where it says “Attach the memory strip here”. Now a day of the week is indicated above each tablet and you can see if you have taken the tablet on a certain day. The arrows show the order in which you should take the tablets.

If you use Diza in this way, you are protected against pregnancy even during the 4 days when you do not take tablets.

If you have unfinished tablet maps (with tablets left), you can take the remaining tablets during the flexible phase. Choose a new weekday strip that has the day of the week that you start taking the remaining tablets. Place this above the first remaining tablet on the tablet map that you are going to take. Place the new weekday strip on top of the weekday strip that has been on the tablet map before. See “Preparing to start a new tablet map”.

Prescribing of the next package must be done on time, e.g. before starting the last tablet chart in the box to ensure you do not run out of tablets.

Contact a doctor or midwife if you are not sure what to do.

When can you start with the first tablet map?

  • If you have not used a hormonal contraceptive in the previous month start with Diza on the first day of your menstrual cycle (ie the first day of your period). If you start taking Diza on the first day of your period, you will immediately have protection against pregnancy. You can also start on days 2-5 of the menstrual cycle, but then you must use extra protection methods (eg condoms) for the first 7 days.
  • Change from a hormonal combination contraceptive pill or combination preparation in the form of a vaginal ring or contraceptive patch you can start with Diza the day after the last active tablet (the last tablet containing active substance) of your previous birth control pills, but no later than the day after the tablet-free days with your previous birth control pill (or after the last inactive tablet of your previous birth control pill ). When changing from a combination product in the form of a vaginal ring or contraceptive patch , follow your doctor’s advice.
  • Switching from a progestogen- only method ( mini-pills, injection, IUD, or a progestogen-secreting intrauterine system (hormonal IUD))You can change from mini-pills at any time (from a contraceptive pill or IUD on the day of its removal, from an injectable contraceptive at the time of the next injection ), but in all these cases you must use extra protection (eg condoms ) during the first 7 days of tablet intake.
  • After a miscarriage follows your doctor’s advice.
  • After childbirth, you can start with Diza between 21 and 28 days after delivery. If you start later than day 28, you must use a so-called barrier method (eg condom) for the first seven days you use Diza.If you have had intercourse before you start using Diza (again) after giving birth, you must first check that you are not pregnant or wait until the next period.
  • If you are breast-feeding and want to start using Diza (again) after having a baby read the section “Breastfeeding”.

Ask your midwife/doctor what to do if you are unsure when to start.

If you use more Diza than you should  

There are no reports of serious side effects due to taking too many Diza tablets.

If you take several tablets at the same time, you may experience symptoms of nausea or vomiting. Young girls may experience vaginal bleeding.

If you have taken too many Diza tablets or find that a child has ingested tablets, contact your doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to use Diza

If you forget a tablet (one of 24 tablets on your tablet card) you need to do the following:

  • If less than 24 hours have passed since the tablet was taken, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and then take the next tablet at the usual time.
  • If more than 24 hours have passed since the tablet was taken, the protection against pregnancy may be reduced. The more tablets you have forgotten, the greater the risk of getting pregnant.

The risk of incomplete protection against pregnancy is greatest if you forget a tablet at the beginning or end of the tablet chart. Therefore, you should follow the following rules (see also the diagram):

More than one tablet forgotten in the tablet map 
Contact your midwife/doctor.

  • One tablet forgot between days 1 and 7  

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Then continue to take the tablets at the usual time and use extra protection for the next seven days, e.g. condom. If you have had intercourse the week before you forgot the tablet, you must be aware that there is a risk of pregnancy. In this case, contact your doctor.

  • One tablet forgot between days 8 and 14

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Then continue to take the tablets at the usual time. The protection against pregnancy is not reduced, and you do not need to use extra protection. 

  • One tablet forgotten between day 15 and 24You can choose between two options:
  1. Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Then continue to take the tablets at the usual time until all 24 tablets have been taken. Skip the 4-day tablet break and start on the next tablet chart (start day will be different). You will probably get menstruation at the end of the second tablet chart – during the 4-day tablet break – but you may experience a slight or menstrual-like bleeding while using the second tablet chart.
  2. You can also stop taking the tablets and immediately start a 4-day tablet break ( before starting this tablet break, you must note which day you forgot your tablet) . If you want to start a new tablet map on the same day, as usual, take a break from tablets for less than four days.

If you follow either of these two recommendations, you are still protected against pregnancy.

  • One tablet forgotten between day 25-120You can choose one of the following options without the need for additional protection.
  1. Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Thereafter, the tablets are taken at the usual time until at least 7 tablets have been taken without interruption.
  2. Stop taking the tablets and start a 4-day tablet break (even count the day you forgot to take your tablet) and then start a new period with Diza.
  • If you have forgotten a tablet in a tablet chart and you do not experience any bleeding during the 4-day tablet-free period, it may mean that you are pregnant. You must then contact your doctor/midwife before starting the next tablet chart.
Table1

If you vomit or have severe diarrhea

If you vomit within 3-4 hours after taking a tablet, or if you have severe diarrhea, there is a risk that the active substances in the tablet will not be completely absorbed by the body. This is almost the same as forgetting a tablet. After vomiting or diarrhea, you must take a new tablet from another tablet chart as soon as possible. If possible, take it within 24 hours from the time you normally take your tablet. If this is not possible or if 24 hours have already passed, you should follow the advice under “If you forget to take Diza”.

If you stop using Diza

You can stop taking Diza whenever you want. If you do not want to get pregnant, talk to your doctor about other reliable contraceptive methods. If you want to get pregnant, stop taking Diza and wait for your period before trying to conceive. You will then be able to more easily calculate the expected date of birth.

If you have any further questions on the use of this product, ask your midwife/doctor or pharmacist.

4. Possible side effects

Like all medicines, Diza can cause side effects, although not everybody gets them. If you get any side effects , especially if they are serious or persistent, or if your health changes and you think it may be due to Diza, talk to your doctor.

As with all women taking combined hormonal contraceptives, there is an increased risk of getting blood clots in your veins (venous thromboembolism , VTE) or blood clots in your arteries ( arterial thrombosis, ATE). For more information on the different risks when taking combined hormonal contraceptives, see section 2 “What you need to know before you take Diza”.

  • F Annualy blood clots in a vein or artery, eg .:
    • in one leg or foot (ie DVT)
    • in the lungs
    • myocardial infarction
    • stroke
    • mini-stroke or transient stroke-like symptoms, called transient ischemic attack ( TIA )
    • blood clots in the liver, stomach / intestines, kidneys, or eyes.

The risk of developing a blood clot may be higher if you have other risk factors that increase this risk (see section 2 for more information on the conditions that increase the risk of blood clots and the symptoms of a blood clot).

Common adverse s (between 1 and 10 of 100 users may be affected):

  • Mood swings
  • headache
  • nausea
  • chest pain, menstrual problems, e.g. irregularmenstruation, missed menstruation
  • emotional storms, depression, decreased sex drive

Less common side effects are (between 1 and 10 1 000 users may be affected):

  • depression decreased interest in sex, nervousness, drowsiness
  • dizziness, and crawling/tingling
  • migraine, varicose veins, high blood pressure
  • stomach pain, vomiting, digestive problems, flatulence, inflammation in the stomach, diarrhea
  • acne, itching, rash
  • pain and aches, e.g. back pain, pain in arms / legs, muscle cramps
  • vaginal fungal infection, pelvic pain, enlargement of the breasts, benign lumps of the breast, bleeding from the uterus/vagina (which usually stops with continued treatment), discharge from the vagina, hot flashes, inflammation of the vagina ( vaginitis ), menstrual problems, painful menstruation, decreased menstrual bleeding, very heavy menstrual bleeding, dry vagina, abnormal cell smear (cell sample), decreased sex drive
  • lack of energy, increased sweating, fluid retention
  • weight gain

Depression, decreased sex drive and migraines are common side effects related to the use of Diza in an adaptable dosage regimen for up to 120 days.

Rare side effects are (between 1 and 10 10 000 users may be affected):

  • dangerous blood clots in a vein or artery , eg:
    • in one leg or foot (ie DVT)
    • in the lungs
    • myocardial infarction
    • stroke
    • mini-stroke or transient stroke-like symptoms, called transient ischemic attack ( TIA )
    • blood clots in the liver, stomach/intestines, kidneys or eyes.
  • candida (fungal infection)
  • anemia ( anemia ), increased number of platelets in the blood
  • allergic reactions
  • hormonal ( endocrine ) disorders
  • increased appetite, decreased appetite, abnormally high concentration of potassium in the blood, abnormally low concentration of sodium in the blood
  • inability to orgasm, insomnia
  • shaking
  • eye problems, e.g. inflammation of the eyelid, dry eye
  • unusually high heart rate
  • inflammation of a vein, nosebleeds, fainting
  • enlarged abdomen, intestinal disorders, feeling of bloating, abdominal hernia, a fungal infection in the mouth, constipation, dry mouth
  • pain in the bile ducts, inflammation of the gallbladder
  • yellow-brown spots on the skin, eczema, hair loss, acne-like skin inflammation, dry skin, lumpy inflammation of the skin, increased hair growth, stretch marks in the skin, dermatitis, dermatitis caused by photosensitivity, skin tumors
  • difficulty or pain during intercourse, inflammation of the vagina (vulvovaginitis), bleeding after intercourse, bleeding, breast cysts, increased number of breast cells ( hyperplasia ), malignant lumps in the breasts, abnormal growth of the cervical mucosa , shrinkage or rejection of the uterine lining, uterine cysts uterus
  • general malaise
  • weight loss

The risk of developing a blood clot may be higher if you have other risk factors that increase this risk (see section 2 for more information on the conditions that increase the risk of blood clots and the symptoms of a blood clot).


The following side effects have also been reported, but the frequency with which they occur cannot be calculated from the available information: hypersensitivity, erythema multiforme (rash with annular redness or sores).

5. How to store Diza

Keep this medicine out of the sight and reach of children.

Do not store above 30 ° C.

Do not use this medicine after the expiry date which is stated on the tablet carton and the carton after “EXP”. The expiration date is the last day of the specified month.

The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

What Diza contains

  • The active substances are Ethinyl estradiol and drospirenone. Each film-coated tablet contains 0.02 mg Ethinyl estradiol and 3 mg drospirenone.
  • The other ingredients are Lactose monohydrate, pregelatinized starch (maize), povidone (E1201), croscarmellose sodium, polysorbate 80, magnesium stearate (E470b), polyvinyl alcohol, titanium dioxide (E171), macrogol, talc (E172 oxide, red oxide) E172), black iron oxide (E172).

What the medicine looks like and contents of the pack

  • Each tablet map contains 24 film-coated tablets.
  • Diza is supplied in a carton of 1 tablet or 5 tablets. The total number of tablets per carton is 24 or 120 tablets.
  • Each Diza carton contains 35 (5 x 7) stickers with the seven days of the week printed on them.

Marketing Authorization Holder and Manufacturer

Exeltis Healthcare SL

Av.Miralcampo 7-Poligono Ind.Miralcampo 
19200 Azuqueca de Henares, Guadalajara 
Spain

Muhammad Nadeem

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