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, pharmacist, or nurse.
  • 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, pharmacist, or nurse. This also applies to any side effects not mentioned in this information.

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.
  • If you think you may have symptoms of a blood clot, talk to your doctor (see section 2 “Blood clots”).

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

1. What Dizminelle is and what it is used for

Dizminelle is a birth control pill and is used to prevent pregnancy.

Each of the 24 pink tablets contains a small amount of two different female hormones, drospirenone, and Ethinylestradiol.

The 4 white tablets do not contain any active substances and are also called placebo tablets.

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

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

2. What you need to know before using Dizminelle

Do not use Dizminelle

General notes
Before you start using Dizminelle, 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 Dizminelle, your doctor will ask you some questions about your own and your immediate relatives’ medical history. The doctor will also measure your blood pressure and it is possible that the doctor, depending on your personal situation, will also take other samples.
This leaflet describes several situations in which you need to stop taking Dizminelle or when your Dizminelle reliability may be impaired. In such situations, you should either refrain from having intercourse or use other non-hormonal contraceptives, e.g. use a condom or any other barrier method. Do not use the rhythm method (safe periods) or the temperature method. These methods can be unreliable, as Dizminelle affects the monthly changes in body temperature and cervical secretions.
Dizminelle protects, like other hormonal contraceptives, is not against HIV – infection ( AIDS ) or other sexually transmitted diseases.

When not to use Dizminelle

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

  • if you have (or have had) a blood clot in a blood vessel in your leg (deep vein thrombosis, DCT), in your lungs ( pulmonary embolism ), or other organs
  • if you know you have a disease that affects blood clotting – eg 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 long time (see section “Blood clots”).
  • if you have (or have had) a heart attack or 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 blood clots in your arteries:
  • severe diabetes with damaged blood vessels
  • very high blood pressure
  • a very high level of fat in the blood ( cholesterol and 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) an inflammation of the pancreas ( pancreatitis )
  • 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.

Do not use Dizminelle if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also section “Other medicines and Dizminelle”).

Warnings and cautions

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 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 Dizminelle, you should also consult your doctor.

  • 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 heredity for this 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 blood clots. Ask your doctor how soon after giving birth you can start using Dizminelle.
  • if you have an inflammation of the veins under the skin (superficial thrombophlebitis )
  • if you have varicose veins
  • 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 epilepsy (see section “Other medicines and Dizminelle)
  • 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 Dizminelle increases the risk of blood clots compared to not using 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 Dizminelle 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 legcolor change of the skin on the leg, eg 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 as some of these symptoms such as cough and shortness of breath can be mistakenly interpreted as a milder condition such as a respiratory infection (eg 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 do not use a combined hormonal contraceptive.

When you stop using Dizminelle, 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 for VTE and the type of combined hormonal contraceptive you are taking.

The overall risk of a blood clot in the leg or lungs with Dizminelle 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 that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 develop a blood clot in one year.
  • Of 10,000 women who use a combined hormonal contraceptive that contains drospirenone such as Dizminelle, about 9-12 people 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   blood clot  during   year
Women who do not use  a combined hormonal pill/patch/ring 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 Dizminelle 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 Dizminelle is small but some conditions increase the risk. The risk is higher:

  • if you are very 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 undergo 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 Dizminelle may need to be stopped for several weeks before an operation or while you are less mobile. If you have to stop using Dizminelle, ask your doctor when you can start using 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 using Dizminelle.

If any of the above conditions change while you are using Dizminelle, such as close relative suffering from a blood clot for an unknown reason 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, for example, 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 Dizminelle 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 Dizminelle, 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 while you are using Dizminelle, such as if you start smoking, a close relative suffers from a blood clot for an unknown reason, or if you gain a lot of weight, talk to your doctor.

Dizminelle 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 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.

Intermittent bleeding

During the first few months of using Dizminelle, you may experience unexpected bleeding (bleeding outside the placebo days). If this type of bleeding lasts longer than a few months, or if it occurs after a few months, your doctor should investigate the cause.

What to do if you do not experience any bleeding during the placebo days

If you have taken all the pink active 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. Only start on the next tablet chart if you are sure you are not pregnant.

Mental disorders:

Some women who use hormonal contraceptives, including Dizminelle, 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.

Other medicines and Dizminelle

Always tell your doctor which medicines or herbal remedies you are already taking. Also, tell other doctors or dentists who prescribe other medicines (or pharmacists) that you are using Dizminelle. They can tell you if you need to use additional contraceptive protection (eg condoms), and if so for how long, or if they use of another medicine you need needs to be changed.

Some drugs

  • may affect the level of Dizminelle in the blood
  • may make Dizminelle less effective in preventing pregnancy
  • may cause unexpected bleeding.

These include:

medicines used to treat

  • epilepsy (eg primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
  • tuberculosis (eg rifampicin)
  • HIV – infection C virus (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 )
  • herbal medicines with St. John’s wort

Dizminelle 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 Dizminelle if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir as it may cause elevated liver function levels in blood tests (elevation of the liver enzyme ALT ). Your doctor will prescribe another type of contraceptive before you start treatment with these drugs. About two weeks after stopping this treatment, the use of Dizminelle may be resumed. See section “When not to use Dizminelle”.

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

Dizminelle with food, drink, and alcohol

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

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

Breast-feeding

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

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

Driving and using machines

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

Dizminelle contains excipients

Dizminelle contains lactose

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

Active Pink Dizminelle tablets contain sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

3. How to use Dizminelle

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

Each blister contains 24 active pink tablets and 4 white placebo tablets.

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

Take one tablet of Dizminelle 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 pink tablet for the first 24 days and then one white tablet for the last 4 days. You must then start on a new tablet map immediately (24 pink and then 4 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 for the start of a new tablet map 

To help you keep track of the tablets, each Dizminelle tablet card comes with seven stickers seven days a week. 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 Dizminelle map where it says “attach the memory strip here”, so that the first day is marked “1” above the tablet. 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.

During the 4 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 pink active Dizminelle tablet. After taking the last white tablet, start on 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 Dizminelle in this way, you are protected against pregnancy even during the 4 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 Dizminelle on the first day of your menstrual cycle (ie the first day of your period). If you start taking Dizminelle 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.
  • Change from a hormonal combination contraceptive pill or combination preparation in the form of a vaginal ring or contraceptive patch. You can start with Dizminelle the day after the last active tablet (the last tablet containing active substance) of your previous pill, but no later than the day after the tablet-free days with your previous pill ended (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 (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 taking Dizminelle 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 Dizminelle. If you have had intercourse before using Dizminelle (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 taking Dizminelle (again) after having a baby read the section “Breastfeeding”.

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

If you use more Dizminelle then you should  

There are no reports of serious side effects due to taking too many Dizminelle 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 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 Dizminelle

The last 4 tablets in row 4 on the tablet map are placebo tablets. If you forget one of these tablets, it does not affect Dizminelle reliability. Throw away the forgotten placebo tablet.

If you forget a pink, active tablet (tablets 1-24 on your blister card) you need to do the following:

If it has been less than 24 hours since the tablet should have been taken, 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 more than 24 hours have passed since the tablet was taken, 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 pink 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 forgot between days 1 and 7 (first line)

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 (second line)

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 forgot between days 15 and 24 (third or fourth line) 

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 (the starting day will be different). You will probably have menstruation at the end of the second tablet map – while taking the white placebo tablets – but you may experience slight or menstrual-like bleeding while using the second tablet map.
  2. You can also stop taking the active pink tablets and go directly to the 4 white placebo tablets ( before taking the placebo tablets, you must note the day you forgot your tablet). If you want to start a new tablet map on the same day, as usual, take the placebo tablets for less than four 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 placebo days, it may mean that you are pregnant. You must then consult your doctor before starting the next tablet chart.
If you forget to take Dizminelle

If you vomit or have severe diarrhea

If you vomit within 3-4 hours after taking an active pink 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, you must take a new pink 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 Dizminelle”.

Postponing menstruation: what you need to know

Even if it is not recommended, you can move your period forward. You can delay your bleeding by just taking the pink active tablets (not the white placebo tablets from the fourth row) and then starting directly on a new tablet map with Dizminelle and ending the entire tablet map.

You may experience slight or menstrual-like bleeding while taking the second tablet map. Finish the second tablet map by taking the four 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 the tablets as directed, your period will begin during the placebo days. 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 – 4 is the maximum! ). For example, if you start taking the placebo tablets on a Friday and you want to change this to a Tuesday (three days earlier), you must start on a new tablet map three days earlier than usual. You may not experience any bleeding during this time. You may then experience slight or menstrual-like bleeding.

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

If you stop using Dizminelle

You can stop taking Dizminelle 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 Dizminelle 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 Dizminelle, talk to your doctor.

An increased risk of blood clots in the veins (venous thromboembolism (VTE) or arterial blood clots ( arterial thromboembolism (ATE)) is available for all women who use combined hormonal contraceptives. For more information on the different risks of using combined hormonal contraceptives, see section 2 “What you need to know before using Dizminelle “.

  • Common adverse s (between 1 and 10 of 100 users may be affected):
    • Mood swings
    • headache
    • nausea
    • chest pain, menstrual problems, e.g. irregular periods, missed periods
  • Less common side effects are (between 1 and 10 1 000 users may be affected):
    • depression, nervousness, drowsiness
    • dizziness, and crawling/tingling
    • migraine, varicose veins, high blood pressure
    • abdominal pain, vomiting, indigestion, flatulence, inflammation of the stomach, diarrhea
    • acne, itching, rash
    • pain and aches, e.g. back pain, pain in arms/legs, muscle cramps
    • vaginal fungal infection, pelvic pain, breast enlargement, benign lumps, uterus / vaginal bleeding (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
  • Rare side effects are (between 1 and 10 10 000 users may be affected):
    • candida (fungal infection)
    • 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, skin problems, stretch marks in the skin, skin inflammation, light-sensitive skin inflammation, 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
    • dangerous blood clots in a vein or artery, eg:
  • in one leg or foot (ie DVT)
  • in the lungs (ie PE)
  • 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).

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

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

5. How to store Dizminelle

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

Do not store above 30 ° C.

Expiration date

Do not use this medicine after the expiry date which is stated on the 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

  • The active substances are Ethinyl estradiol and drospirenone. Each pink active film-coated tablet contains 0.020 milligrams of Ethinyl estradiol and 3 milligrams of drospirenone.
    The white inactive film-coated tablets do not contain any active substances.
  • Other ingredients are Pink active film-coated tablets: lactose monohydrate, maize starch, povidone (E1201), sodium croscarmellose, polysorbate 80, magnesium stearate (E572), polyvinyl alcohol, titanium dioxide (E171), macrogol, talc (E553b), yellow iron oxide (E172) (iron217) ), black iron oxide (E172)
    White inactive film-coated tablets: anhydrous lactose, povidone (E1201), magnesium stearate (E572), polyvinyl alcohol, titanium dioxide (E171), macrogol, talc (E553b),

What the medicine looks like and the contents of the pack

  • Each Dizminelle blister contains 24 pink film-coated active tablets on rows 1, 2, 3, and 4 of the tablet map and 4 film-coated placebo tablets on row 4.
  • The Dizminelle tablets, both pink and white, are film-coated, ie. the core of the tablet is covered by an outer layer.
  • Dizminelle is available in packs of 1,3, 6, and 13 tablet tablets, and each tablet card contains 28 (24 + 4) 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

Manufacturer

Laboratories León Farma, SA

C / La Vallina s / n, Pol. Ind. Navatejera.

24008 – Navatejera, León.

Spain

Stada Arzneimittel AG

Stadastr. 2-18

61118 Bad Vilbel

Germany

Muhammad Nadeem

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