0.03 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, pharmacist, or nurse.

– This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. 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”).

This leaflet contains information about: 
1. What Dizmine 28 is and what it is used for 
2. What you need to know before using Dizmine 28 
3. How to use Dizmine 28 
4. Possible side effects 
5. How to store Dizmine 28 
6. Contents of the packaging and other information 

1. What Dizmine 28 is and what it is used for

Dizmine 28 is a birth control pill and is used to prevent pregnancy.

Each of the 21 yellow tablets contains a small amount of two different female sex hormones; drospirenone and Ethinylestradiol.

The 7 white tablets do not contain any active substance and are also called placebo tablets.

Birth control pills that contain two hormones are called combination birth control pills.

Drospirenone and Ethinyl estradiol contained in Dizmine 28 may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you use Dizmine 28

Do not use Dizmine 28

General notes
Before you start using Dizmine 28, read the information on blood clots in section 2. You must read the symptoms of blood clots – see section 2, “Blood clots”).
Before you can start taking Dizmine 28, 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 it is possible that the doctor/midwife, depending on your personal situation, will also take other samples.

This leaflet describes several situations in which you must stop taking Dizmine 28 or when the reliability of Dizmine 28 may be reduced. In such situations, you should either refrain from having sex or use other, non-hormonal contraceptives e.g. use a condom or any other barrier method. Do not use the rhythm method or the temperature method. These methods can be unreliable, as Dizmine 28 affects the monthly changes in body temperature and cervical secretions.

Dizmine 28 protects, like other hormonal contraceptives, is not against HIV – infection ( AIDS ) or other sexually transmitted diseases.

When not to use Dizmine 28

Do not use Dizmine 28 if you have any of the conditions listed below. If you have any of these conditions, you must tell your doctor/midwife. The doctor/midwife will discuss which other type of contraception may be more appropriate.

Do not use Dizmine 28

  • if you have (or have had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs ( pulmonary embolism ), or any other organ
  • if you know you have a disease that affects blood clotting – e.g. protein C ‑ deficiency, protein S ‑ deficiency, antithrombin ‑ III ‑ deficiency, Factor V Leiden or antiphospholipid antibodies
  • if you need to have an operation or if you stay in bed for a longer period (see section “Blood clots”)
  • if you have (or have had) a heart attack or a stroke (stroke)
  • if you have (or have had) angina (a condition that causes severe chest pain and maybe the first sign of a heart attack) or transient ischemic attack ( TIA – transient stroke symptoms)
  • if you have any of the following conditions that may increase the risk of a blood clot in your arteries:
    • severe diabetes with damaged blood vessels
    • very high blood pressure
    • a very high level of fat in the blood ( cholesterol or triglycerides )
    • a condition called hyperhomocysteinemia
  • if you have (or have had) a type of migraine called “migraine with aura”.
  • if you have (or have had) liver disease and your liver function is not yet normal
  • if your kidneys are not working properly ( kidney failure )
  • if you have (or have had) a tumor in your liver
  • if you have (or have had) or if you suspect you may have 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 use medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also section Other medicines and Dizmine 28).

Warnings and cautions

Talk to your doctor, midwife, or pharmacist before taking Dizmine 28.

When should you contact a doctor?
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.

Talk to your doctor, midwife, or pharmacist before using Dizmine 28. In some situations, you need to be especially careful when using Dizmine 28 or other combination pills, and it may be necessary to check with your doctor/midwife regularly. If the condition occurs or worsens when you use Dizmine 28, 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 natural 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 Dizmine 28
  • if you have an inflammation of the veins under the skin (superficial thrombophlebitis )
  • if you have varicose veins
  • if you have epilepsy (see “Other medicines and Dizmine 28”)
  • 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, chloasma (a discoloration of the skin, especially on the face or neck, so-called “pregnancy spots”). In this case, avoid direct exposure to sunlight or ultraviolet light.
  • If you have hereditary angioedema, estrogen-containing products may 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 Dizmine 28 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 Dizmine 28 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 walk increased 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
If 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 or blurred 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 sternum feeling 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 eyes sudden 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 Dizmine 28, 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 Dizmine 28 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 Dizmine 28, approximately 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 Dizmine 28 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 Dizmine 28 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 someone in your family has had a blood clot in their 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 Dizmine 28 may need to be stopped for several weeks before an operation or while you are less mobile. If you have to stop taking Dizmine 28, 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 conditions 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 any of these conditions apply to you, even if you are unsure. Your doctor may decide that you must stop taking Dizmine 28.

If any of the above conditions change when you use Dizmine 28, 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 Dizmine 28 is very small but may increase:

  • with increasing age (after about 35 years of age)
  • if you smoke. When using combined hormonal contraceptives such as Dizmine 28, 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 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 conditions 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 Dizmine 28, e.g. If you start smoking, a close relative suffers from thrombosis of unknown cause, or you gain a lot of weight, talk to your doctor.

Dizmine 28 and cancer

Breast cancer has been observed somewhat more often in women using the contraceptive pill, 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 the contraceptive pill because they are more often examined by a doctor. The incidence of breast tumors gradually decreases after stopping treatment with combined hormonal contraceptives. It is important that you examine your breasts regularly and you should contact your doctor if you feel any lump.

In rare cases, benign liver tumors have been reported, 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.

Mental disorders

Some women who use hormonal contraceptives, including Dizmine 28, 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 Dizmine 28, you may experience unexpected bleeding (bleeding outside the week when you take the white tablets). If this type of bleeding lasts longer than a few months, or if it occurs after a few months, your doctor/midwife must find out what is wrong.

What to do if you do not experience any bleeding during the intervening week

If you have taken all the light yellow active tablets correctly, have not had vomiting or severe diarrhea and if 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/midwife immediately. Do not start the next tablet chart until you are sure you are not pregnant.

Other medicines and Dizmine 28

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 Dizmine 28. They may tell you if you need to use additional contraceptives (eg condoms), and if so, for how long, or if the use of another medicine that you need needs to be changed.

Some medicines may affect the level of Dizmine 28 in the blood and make it less effective in preventing pregnancy and may cause unexpected bleeding.


These include:

  • 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.

Dizmine 28 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)

Do not use Dizmine 28 if you have hepatitis C and are taking medicines that contain

ombitasvir/paritaprevir/ritonavir and dasabuvir as it may lead to elevated liver values ​​(elevation of the liver enzyme ALT ). Your doctor will prescribe another contraceptive before starting treatment with this combination of medicines. Dizmine 28 can be started again about 2 weeks after stopping treatment. See section “Do not use Dizmine 28”.

Consult a doctor, midwife, or pharmacist before taking any medicine.

Dizmine 28 with food, drink, and alcohol

Dizmine 28 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 Dizmine 28. If you become pregnant while taking Dizmine 28, you must stop and contact your doctor/midwife immediately. If you want to get pregnant, you can stop taking Dizmine 28 at any time (see also “If you stop using Dizmine 28”).

Consult a doctor, midwife, or pharmacist before taking any medicine.

Breast-feeding

In general, breastfeeding is not recommended when using Dizmine 28. If you want to use birth control pills while breastfeeding, contact your doctor/midwife.

Consult a doctor, midwife, or pharmacist before taking any medicine.

Driving and using machines

There is no information to suggest that the use of Dizmine 28 affects the ability to drive or use machines.

Dizmine 28 contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor/midwife before taking Dizmine 28.

3. How to use Dizmine 28

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Each blister contains 21 active yellow tablets and 7 white placebo tablets.

Dizmine 28 tablets with two different colors are lined up in order. One tablet map contains 28 tablets.

Take one Dizmine 28 tablet daily, with a small amount of 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.

Do not mix the tablets: take one yellow tablet for the first 21 days and then one white tablet for the last 7 days. You must then immediately continue with a new tablet card (21 yellow and then 7 white tablets). There is therefore no pause between the tablet maps.

Because the tablets have different compositions, it is necessary to start with the first tablet at the top left and then take one tablet every day. To do this in the correct order, follow the arrow direction on the tablet map.

Preparation of the tablet map

To help you keep track of the tablets, each Dizmine 28 tablet card comes with seven sticky notes with the seven days of the week. You need to know which day of the week to start taking the tablets.

Select the memory 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 memory strip that starts with “ONS”. Paste the memory strip at the top of the Dizmine 28 map where it says “attach the memory strip here”, so that the first day is above the tablet marked “Start”. Now a day of the week is indicated above each tablet and you can easily see if you have taken the tablet on a certain day. The arrows show the order in which you should take the tablets.

During the 7 days when you take the white placebo tablets (the placebo days), the bleeding should start (so-called dropout bleeding). This usually starts on the second or third day after the last yellow active Dizmine 28 tablet. After taking the last white tablet, start with the next tablet chart regardless of whether the bleeding has stopped or not. This means that you should start each tablet chart on the same day of the week and that the bleeding should occur on the same days of each month.

If you use Dizmine 28 in this way, you are protected against pregnancy even during the 7 days when you take a placebo tablet.

When can you start with the first tablet map?

  • If you have not used a hormonal contraceptive in the previous month

Start with Dizmine 28 on the first day of the menstrual cycle (ie the same day as your period begins). If you start taking Dizmine 28 on the first day of your period, you will have immediate 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.

  • Changing from a hormonal combination contraceptive pill, or combination preparation in the form of a vaginal ring or patch

You can start with Dizmine 28 the day after the last active tablet (the last tablet containing active substances) of your previous pill, but no later than the day after the tablet-free period with your previous pill (or after the last inactive tablet of your previous birth control pill ). When switching from a combination product in the form of a vaginal ring or patch, follow your doctor’s advice.

  • Switching from a progestogen-only method ( mini-pills, injection, implants, or a progestogen-secreting intrauterine system (hormonal IUD))

You can change from mini-pills at any day (from implants or IUDs on the day it is removed, from an injectable contraceptive at the time of the next injection ) but in all these cases use extra protection (eg condoms) for the first 7 days of tablet intake.

  • After a miscarriage

Follow your doctor’s advice.

  • After childbirth

You can start with Dizmine 28 between 21 and 28 days after delivery. If you start later than day 28, use a so-called barrier method (eg condom) for the first seven days you use Dizmine 28.

If you have had sex before using Dizmine 28 (again) after giving birth, make sure you are not pregnant or wait until your next period.

  • If you are breast-feeding and want to start taking Dizmine 28 (again) after giving birth.

Read the section “Breastfeeding”.

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

If you use more Dizmine 28 then you should 

There are no reports of serious side effects from taking too many Dizmine 28 tablets. If you take several tablets at the same time, you may feel sick or vomit or have vaginal bleeding.

Even girls who have not had their first period but have accidentally used this medicine may experience this type of bleeding.

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to use Dizmine 28

The tablets in the fourth row of the tablet map are placebo tablets. If you forget one of these tablets, it has no effect on the reliability of Dizmine 28. Throw away the forgotten placebo tablet.

If you forget a light yellow, active tablet in rows 1, 2 or 3 , do the following:

  • If less than 12 hours have passed since you should have taken your tablet, the preventive protection is not reduced. Take the tablet as soon as you remember and then take the next tablet at the usual time.
  • If it has been more than 12 hours since you should have taken your tablet, the preventive protection 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 light yellow 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 doctor.

  • One tablet forgotten during week 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 tablets at the usual time, and use extra protection for the next seven days, e.g. condom. If you had sex the week before you forgot the tablet, you may be pregnant. In this case, contact your doctor.

  • One tablet forgotten during week 2

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

  • One tablet forgotten during week 3

You 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. Instead of taking the white placebo tablets on this tablet, discard them and start on the next tablet.You will probably have menstruation at the end of the second tablet chart while taking the white placebo tablets – but you may experience a slight or menstrual-like bleeding while using the second tablet chart.
  2. You can also stop taking the active light yellow tablets and go directly to the 7 white placebo tablets ( before taking the placebo tablets, note the day you forgot your tablet ). If you want to start on a new tablet chart on the same day as usual, take the placebo tablets for less than 7 days.

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

  • If you have forgotten a tablet in a tablet chart and you do not experience any bleeding during the normal placebo days, it may mean that you are pregnant. Contact your doctor before starting the next tablet map.
Forgotten tablet

If you vomit or have severe diarrhea

If you vomit within 3-4 hours after taking an active yellow tablet or if you have severe diarrhea, there is a risk that the active substances in the tablet will not be completely absorbed by your body. This situation is almost the same as forgetting a tablet. After vomiting or diarrhea, take a new yellow tablet from a spare tablet card as soon as possible. If possible, take it within 12 hours from the time you normally take your tablet. If this is not possible or if 12 hours have already passed, you should follow the advice given above in the section “If you have forgotten to take Dizmine 28”.

Postponing menstruation: what you need to know

Even if it is not recommended, you can advance your period by not taking the white placebo tablets from the fourth row, but start directly on a new tablet map with Dizmine 28 and finish the entire tablet map. You may experience a slight or menstrual-like bleeding while taking the second tablet map. Finish the second tablet map by taking the 7 white tablets in row four. Then start on the next tablet map.

You can consult your doctor before deciding to postpone your period.

Change the first day of menstruation: what you need to know

If you take your tablets according to the instructions, your period will start  during the placebo week . If you need to change this day, you can reduce the number of placebo days – the days you take the white placebo tablets – ( but never extend – 7 is the maximum! ). For example, if you normally start taking the placebo tablets on a Friday, and you want to change this to a Tuesday (three days earlier), start on a new tablet chart three days earlier than usual. If you make the placebo interval very short (for example, three days or less), you may not experience any bleeding during this time. You may then experience a slight or menstrual-like bleeding.

Contact your doctor if you are not sure what to do.

If you stop using Dizmine 28

You can stop taking Dizmine 28 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 Dizmine 28 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 doctor or pharmacist .

4. Possible side effects

Like all medicines, this medicine 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 Dizmine 28, talk to your doctor.

An increased risk of blood clots in the veins (venous thromboembolism , VTE), or blood clots in the arteries are ( arterial thrombosis , ATE) are all women taking hormonal contraceptives combined. For more information on the different risks of using combined hormonal contraceptives, see section 2 “What you need to know before you take Dizmine 28”.

The following is a list of side effects that have been linked to using Dizmine 28.

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

  • menstrual disorders, intermittent bleeding, chest pain, sore breasts
  • headache, depression
  • migraine
  • nausea
  • whitish thick discharge from the vagina and fungal infection in the vagina

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

  • enlarged breasts, changed interest in sex
  • high blood pressure , low blood pressure
  • vomiting, diarrhea
  • acne , rash, itching , hair loss ( alopecia )
  • infection of the vagina
  • accumulation of fluid in the body and changes in body weight.

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

  • allergic reactions (hypersensitivity), asthma
  • fluid secretion from the breasts
  • impaired hearing
  • thrombotic disease
  • 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.

The risk of developing a blood clot may be higher if you have other conditions 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).

  • skin conditions such as erythema nodosum (characterized by painful reddish nodules in the skin) or erythema multiforme (characterized by rash with annular redness or sores).

5. How to store Dizmine 28

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 blister and carton after EXP. The expiration date is the last day of the specified month.

Medicines 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

Each Dizmine 28 blister contains 21 yellow film-coated active tablets on rows 1, 2 and 3 of the tablet map and 7 white film-coated placebo tablets on row 4.

  • The active substances are drospirenone and ethinyl estradiol.

Each yellow active film-coated tablet contains 3 milligrams of drospirenone and 0.030 milligrams of ethinyl estradiol.

The white film-coated tablets do not contain any active substances.

  • Other ingredients are

Yellow active film-coated tablets: lactose monohydrate , maize starch, pregelatinised maize starch, crospovidone type B, povidone (E1201), polysorbate 80 (E433), magnesium stearate (E470b), polyvinyl alcohol, titanium dioxide (E171) (E1712), yellow oxide (E171) ).

White inactive film-coated tablets: lactose anhydrous, povidone (E1201), magnesium stearate (E470b), polyvinyl alcohol, titanium dioxide (E171), macrogol, talc (E553b).

What the medicine looks like and contents of the pack

  • Each Dizmine 28 blister contains 21 yellow, round film-coated tablets and 7 white, round film-coated placebo tablets.
  • Dizmine 28 is available in packs of 1, 2, 3, 6 and 13 tablets and each tablet contains 28 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Exeltis Healthcare SL

Avenida Miralcampo 7-Poligono Industrial Miralcampo

19200 Azuqueca de Henares, Guadalajara

Spain

Muhammad Nadeem

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