Ethinyl Estradiol / Drospirenone 0.03 mg / 3 mg Film Coated Tablets
What Midiana 28 Is And What It Is Used For
- Midiana birth control pill is used to prevent pregnancy.
- Each white tablet contains a small amount of two different female hormones,
- Ethinyl estradiol
- The green tablets do not contain any active substance and are also called placebo tablets.
- Birth control pills that contain two hormones are called combined birth control pills.
What You Need To Know Before You Use Midiana 28
Before you start using Midiana 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 Midiana 28, your doctor will ask you some questions about your general health and the health of your next of kin. Your doctor will also measure your blood pressure, and depending on your situation, may also take some other samples.
This information describes several situations where you should stop using Midiana 28, or when Midiana 28 may be less reliable. In such situations, you should either not have intercourse or use an additional non-hormonal method of contraception, e.g. a condom or another barrier method.
Do not use rhythm or temperature methods. These methods can be unreliable as Midiana 28 changes the monthly changes that occur in body temperature and cervical secretions.
Midiana 28, like other hormonal contraceptives, does not protect against HIV infection ( AIDS ) or other sexually transmitted diseases.
Do not take Midiana 28:
Do not use Midiana pills if you have any of the conditions listed below. If you have any of these conditions, you need to tell your doctor. The doctor will discuss what other type of contraception may be more appropriate.
- If you are allergic to Ethinyl estradiol or drospirenone, or any of the other ingredients of this medicine (listed in section 6). This can lead to itching, rash, or swelling.
- 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 in any other organ
- If you know you have a disease that affects blood coagulation – 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 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) a 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.
- Midiana 28 contains soy lecithin. If you are allergic to peanuts or soy, do not use this medicine.
Do not use Midiana 28 if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also section “Other medicines and Midiana 28”).
Children and young people
Midiana 28 is not intended for use by women who are not yet menstruating.
Warnings And Cautions
Talk to your doctor or pharmacist before taking Midiana pills. Show larger
|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.
In some situations, you need to be extra careful when using Midiana 28 or any other combined pill and your doctor may need to examine you regularly. If any of the following apply to you, tell your doctor before you start using Midiana pills. If the condition occurs or worsens when you use Midiana 28, you should also consult a doctor.
- If a close relative has or has ever had breast cancer
- If you have a disease of the liver or gallbladder
- If you have diabetes
- If you have depression or mood swings
- If you have epilepsy (see “Other medicines and Midiana 28”)
- If you have a disease that first appeared during pregnancy or previous use of sex hormones (eg
- Hearing loss
- A blood disease called porphyria
- Skin rash with blisters during pregnancy [herpes gestationis]
- A disease of the nerves that leads to sudden movements of the body [Sydenhams korea])
- If you have or have ever had chloasma (discoloration of the skin especially on the face or neck called “pregnancy spots”). In this case, avoid direct sunlight or ultraviolet light
- If you have hereditary angioedema. Products that contain estrogen can cause or worsen the symptoms. You should contact your doctor immediately if you experience symptoms of angioedema, e.g.
- Swelling of the face, tongue, and pharynx.
- Difficulty swallowing or hives along with difficulty breathing.
- If you have Crohn’s disease or ulcerative colitis ( chronic inflammatory bowel disease)
- If you have a 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 high blood fat ( 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 Midiana 28
- If you have an inflammation of the veins under the skin (superficial thrombophlebitis )
- If you have varicose veins.
Using combined hormonal contraceptive midiana 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 the artery (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 Midiana 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 tenderness 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 breathing severe instability or dizziness fast or irregular heartbeat severe 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 milder 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, heaviness pressure or feeling of fullness in the chest, arm, or below the sternum feeling full, indigestion or feeling of suffocation discomfort in the upper body that radiates to the back, jaw, neck, arm, and abdomen sweating, nausea, vomiting or dizziness extreme weakness, anxiety or shortness of breath fast 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 coordination Sudden, 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 Midiana contraceptive combined with hormonal has been associated with an increased risk of blood clots in a vein (venous thrombosis ). However, these Midiana 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 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 can also be higher if you start again with a combined hormonal contraceptive (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 Midiana 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 Midiana 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 that contains levonorgestrel or 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 Midiana 28, about 9-12 develop a blood clot in one year.
- The risk of a blood clot 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 a combined hormonal contraceptive (on 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 Midiana 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 Midiana 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 a close relative has had a blood clot in the bones, lungs, or other organs at a young age (eg under 50 years). In this case, you may have a hereditary blood clotting disease
- If you need to undergo surgery, stay in bed for an extended period of time due to injury or illness, or if your leg is plastered. The use of Midiana 28 may need to be stopped several weeks before surgery or while you are less mobile. If you have to stop taking Midiana 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 more conditions you have, the greater the risk of developing a blood clot.
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 need to stop taking Midiana 28.
If any of the above conditions change when you use Midiana 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?
In the same way as 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 Midiana 28 is very small but may increase:
- With increasing age (after about 35 years of age)
- If you smoke. When you use combined hormonal contraceptives Midiana 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 Midiana contraceptive pill
- 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 for 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 severe, the risk of developing a blood clot can be even greater.
If any of the above conditions change when you use Midiana 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.
Midiana 28 and cancer
Breast cancer has been observed slightly more often in women using combined oral contraceptives, but it is not known if this is due to the treatment. For example, it may be that more tumors are detected in women who use combined Midiana contraceptive pills because they are examined more often by doctors.
The incidence of breast tumors gradually decreases after stopping the use of combined hormonal contraceptives. It is important that you check your breasts regularly and that you contact your doctor if you feel a lump.
In rare cases, benign liver tumors, and even rare malignant tumors, have been reported in Midiana birth control pill users. Contact your doctor if you have unusually severe abdominal pain.
Some women using the hormonal Midiana contraceptive pill, including Midiana 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.
Bleeding between periods
During the first months of taking Midiana 28, you may experience unexpected bleeding (bleeding outside of the week of stay). If this bleeding occurs for more than a few months, or if it starts after a few months, contact your doctor so that he/she can check if something is wrong.
If you do not experience any bleeding during the placebo week, do the following:
If you have taken all the tablets correctly, have not vomited or had severe diarrhea, and 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.
Do not start with the next tablet card until you are sure you are not pregnant.
Other Medicines And Midiana 28
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Also, tell other doctors or dentists who prescribe other medicines (or the pharmacy staff) that you are using Midiana 28. They may tell you if you need to use additional protection (eg condoms) and if so, for how long, or if the use of another medicine that you need needs to be changed.
Do not use Midiana 28 if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, as this may cause elevated liver function levels in the blood (increase in the liver enzyme ALT ).
Your doctor will prescribe another type of contraceptive before you start treatment with these drugs.
You can start with Midiana 28 again about 2 weeks after stopping this treatment. See section “Do not use Midiana 28”.
Some medicines may affect the level of Midiana 28 in the blood and may make Midiana 28 less effective in preventing pregnancy or causing unexpected bleeding. This includes drugs used to treat
- Epilepsy (eg barbiturate , carbamazepine, phenytoin , primidone, felbamate, oxcarbazepine, topiramate)
- Tuberculosis (eg rifampicin)
- HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, eg ritonavir, nevirapine, efavirenz)
- High blood pressure in the blood vessels of the lungs ( bosentan )
- Fungal infections (eg griseofulvin, ketoconazole )
- Treatment of the symptoms of osteoarthritis (etoricoxib)
- The natural remedy is St. John’s wort (Hypericum perforatum). If you want to use St. John’s wort while you are taking Midiana 28, consult your doctor first.
Midiana 28 may affect the effectiveness of other medicines, e.g.
- Ciclosporin (a medicine used to prevent transplant rejection )
- The epilepsy drug lamotrigine (this may lead to an increased number of seizures)
- Tizanidine (a medicine used to treat muscle cramps)
- Theophylline (a medicine used to treat asthma ).
Ask your doctor or pharmacist for advice before taking any medicine.
Midiana 28 With Food and drink
Midiana 28 can be taken with or without food, if necessary with a small amount of water.
If you have to take blood samples, tell your doctor or laboratory staff that you are taking Midiana birth control pills as hormonal contraceptives may affect the results of certain tests.
Pregnancy And Breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
You must not take Midiana 28 if you are pregnant. If you become pregnant while taking Midiana 28, you must stop taking the medicine immediately and contact your doctor. If you want to get pregnant, you can stop taking Midiana 28 at any time (see also “If you stop taking Midiana 28”).
Women should not take Midiana 28 while breastfeeding. If you want to take midiana birth control pills while breastfeeding, contact your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving And Using Machines
There is no information to suggest that Midiana 28 affects the ability to drive or use machines.
Midiana 28 Contains Lactose, Soy Lecithin, And Para-orange
The white active film-coated tablets contain 48.17 mg of lactose monohydrate and the green inactive tablets contain 37.26 mg of anhydrous lactose per film-coated tablet. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The white active film-coated tablets in Midiana 28 contain soy lecithin. If you are allergic to peanuts or soy, do not use this medicine.
The hormone-free ( placebo ) tablets contain the dye “para-orange” (E110) which can cause allergic reactions.
How To Take Midiana Contraceptive Pill
- Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
- Each blister pack contains 21 active tablets and 7 green placebo tablets. The two different colored tablets of Midiana 28 are placed in order. One tablet map contains 28 tablets.
- Take a tablet of Midiana 28 every day, if necessary with a little water. You can take the tablets with or without food, but you should take them at about the same time each day.
- Do not mix the tablets: take one white tablet every day for the first 21 days and then one green tablet for the last 7 days. Then start with a new pack (21 white tablets and 7 green tablets). There is thus no pause between the tablet maps.
- The composition of the tablets is different, you need to start with the first tablet at the top left and then take one tablet every day.
- Keep track of this by following the direction of the arrows.
Preparation of the tablet map
You need to know which day of the week to take the first tablet.
To help you keep track of which tablet to take, seven adhesive strips marked with the seven days of the week are included. Select the adhesive strip that starts with the day you start taking the tablets. For example, if you start on a Wednesday, use the sticker that begins with “Wed.”
Place the arrow “→” on the adhesive strip next to the same symbol on the blister map and place the strip in the area surrounded by a black line. For each day, there will now be a row of tablets.
Above each tablet is now a day of the week and you can see if you have taken a tablet on a particular day. Follow the direction of the arrow until you have taken all 28 tablets.
During the 7 days, you take the placebo tablets (placebo week), you should have a hemorrhage (a so-called dropout hemorrhage). It usually starts on the second or third day after you take the last active white tablet of Midiana 28.
After taking the last green tablet, you should start with the next tablet, even if the bleeding has not stopped. This means that you should start with the next tablet chart on the same day of the week and that you should have your dropout bleeding on the same days each month.
If you take Midiana 28 this way, you will also be protected against pregnancy for the 7 days you take placebo tablets.
When can you start with the first tablet map?
- If you have not used a contraceptive with hormone your previous month start with Midiana 28 on the first day of the menstrual cycle (ie the day you get your period). If you start taking Midiana 28 on the first day of your period, you will receive immediate protection against pregnancy. You can also start days 2–5 of the menstrual cycle, but then you must use another method of contraception (eg a condom) for the first 7 days.
- Switching from another combined contraceptive – birth control pills, vaginal rings, or patches. You can start with Midiana 28 the day after you take the last active tablet (the last tablet containing the active substance) of your previously combined oral contraceptives, but no later than the day after stopping the tablet with your previous oral contraceptives (or after the last inactive pill). tablet of your previous birth control pills ). When changing from a vaginal ring or patch, follow the advice of your doctor.
- Switching from a progestogen-only method ( mini-pills, injection, implant or IUD)You can change any day from mini-pills (from implants or IUDs the day it is removed, from injection at the time of the next injection ) but in all these cases you must use an extra method of contraception (eg condoms) during the first 7 days you take the tablets.
- After a miscarriage or an abortion follow your doctor’s advice.
- After birth, you can start taking Midiana 28 between 21 and 28 days after giving birth. If you start later than day 28, you must use a so-called barrier method (eg condom) for the first 7 days of taking Midiana 28. If you have had intercourse after giving birth before starting Midiana 28 (again), you must first check that you are not pregnant or wait until the next menstrual period.
- If you are breastfeeding and want to start taking Midiana 28 (again) after giving birth. Read the section on “Breastfeeding”.
Ask your doctor what to do if you are not sure when to start.
If You Take More Midiana 28 Than You Should
There are no reports of adverse effects from taking too many Midiana 28 tablets.
If you take several tablets at the same time, you may feel nauseous or vomiting, or bleeding from the vagina. Even girls who have not yet been menstruated can have such bleeding if they have taken this medicine by mistake.
If You Forget To Take Midiana Contraceptive Pill
The last seven tablets on the tablet map are placebo tablets. If you forget to take one of these tablets, it does not affect the protective effect of Midiana 28. You should discard the forgotten placebo tablet so that you do not prolong the placebo week. This could hurt the protective effect of Midiana 28.
If you have forgotten a white active tablet on the tablet card (film-coated tablet 1-21), you must follow the advice below:
- If it has been less than 12 hours since you were to take a tablet, the protection against pregnancy is not reduced. Take the tablet as soon as you remember and then take the following tablets at the usual time.
- If it has been more than 12 hours since you were taking a tablet, the protection against pregnancy may be reduced. The more tablets you have forgotten, the greater the risk that you will become pregnant.
The risk of incomplete protection against pregnancy is greater if you forget to take a tablet when you start with a tablet chart or at the end of the third week. Therefore, follow the rules below (see also the diagram below):
- If you have forgotten more than one tablet on the tablet map contact your doctor.
- You forgot a tablet in week 1 Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Continue to take the tablets at the usual time and use an additional method of contraception for the next 7 days, e.g. condom. If you had intercourse the week before you forgot the tablet, you may be pregnant. In this case, contact your doctor.
- You forgot a tablet in 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 the tablets at the usual time. The protection against pregnancy is not reduced and you do not need to use any additional method of contraception.
- You forgot a tablet week 3 You can choose between two options:
- Take the forgotten tablet as soon as you remember, even if it means taking two tablets at the same time. Continue to take the tablets at the usual time. Instead of taking the placebo tablets, discard them and start with the next tablet chart. You will probably have a period at the end of the second tablet map when you take the green placebo tablets, but you may experience slight or menstrual-like bleeding when you take the second tablet map.
- You can also stop taking the active white tablets and continue immediately with the 7 green placebo tablets (Also note which day you forgot to take the tablet so that the number of placebo days does not exceed the maximum of 7 days). If you want to start with a new tablet chart on your regular start day, take the placebo tablets for less than 7 days.
If you follow either of these two recommendations, you will continue to be protected against pregnancy.
If you forget to take any of the tablets and do not get your bleeding during the usual placebo week, it could mean that you are pregnant. You must contact your doctor before continuing with the next tablet map.
Do this if you get vomiting or severe diarrhea
If you vomit within 3-4 hours after taking an active white tablet or if you develop severe diarrhea, there is a risk that the active substances in the tablets will not be completely absorbed by your body. The situation is almost the same as if you forget a tablet.
After vomiting or diarrhea, take a new white tablet from a spare tablet card as soon as possible. If possible, take the tablet within 12 hours after you would normally take the tablet. If this is not possible, or if 12 hours have elapsed, follow the advice in the section “If you have forgotten to take Midiana 28”.
Postpone a menstrual period: this is what you need to know:
Although not recommended, you can postpone a menstrual period by not taking the green placebo tablets (tablets 22-28) and immediately start a new tablet map Midiana 28. You may experience slight or menstrual-like bleeding when using the second tablet map. Finish the second tablet map by taking the 7 green tablets. Then start with the next tablet chart.
You can ask your doctor for advice before you decide to postpone a menstrual period.
Change the first day of menstruation; you need to know this:
If you take the tablets as directed, your period will begin during the placebo week. If you have to change the day, reduce the number of placebo days – when you take the green placebo tablets – (but never increase the number of days – 7 is the maximum!).
Example: If you normally start taking the placebo tablets on a Friday, and you want to change it to a Tuesday (3 days earlier), start with a new tablet chart 3 days earlier than usual. If you make the placebo period very short (eg 3 days or less), you may not experience any bleeding during these days. You may then experience slight or menstrual-like bleeding.
If you are not sure what to do, talk to your doctor.
If You Stop Taking Midiana 28
You can stop taking Midiana 28 whenever you want. If you do not want to get pregnant, you can ask your doctor for advice on other reliable Midiana contraceptive pill methods.
If you want to get pregnant, stop taking Midiana 28 and wait for your regular period before trying to conceive. This will make it easier to calculate the expected date of birth.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
Possible Side Effects Of Midiana Contraceptive Pill
Midiana 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 severe or persistent, or if your health changes and you think it may be due to Midiana 28, talk to your doctor.
An increased risk of blood clots in the veins (venous thromboembolism, VTE) or blood clots in the arteries ( arterial thrombosis, ATE) is present for all women taking hormonal combined contraceptives. For more information on the different risks of using combined hormonal contraceptives, see section 2 “What you need to know before using Midiana 28”.
The following is a list of side effects that have been linked to the use of Midiana 28:
Common side effects ( may affect up to 1 in 10 people):
- Menstrual disorders, menstrual bleeding, breast pain, breast tenderness
- Headache, depressed state
- Thick, whitish discharge from the vagina and yeast infection in the vagina.
Uncommon Midiana side effects ( may affect up to 1 in 100 people):
- Breast augmentation, altered sexual interest
- High blood pressure, low blood pressure
- Vomiting, diarrhea
- Acne (pimples)
- Severe itching
- Hair loss ( alopecia )
- Vaginal infection
- Fluid in the body and altered body weight.
Rare Midiana side effects ( may affect up to 1 in 1,000 people):
- Allergic reactions (hypersensitivity)
- Excretion from the breasts
- Hearing loss
- Blockage of a blood vessel by a clot formed elsewhere in the body
- The skin diseases erythema nodosum (characterized by painful reddish lumps on the skin) or erythema multiforme (characterized by an annular rash with redness or sores)
- Dangerous blood clots in a vein or artery, e.g.
- In one leg or foot (ie DVT)
- In the lungs
- Myocardial infarction
- Ministroke 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).
How To Store Midiana 28
- Keep this medicine out of the sight and reach of children.
- Use before the expiry date which is stated on the blister and carton after EXP. The expiration date is the last day of the specified month.
- Do not store above 30 ° C. Store in the original package. Sensitive to light.
- 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.
Contents Of The Pack And Other Information
- The active substances are 0.03 mg Ethinyl estradiol and 3 mg drospirenone in each tablet.
- Other ingredients are Active film-coated tablets:
- Tablet core:
- Lactose monohydrate
- Corn starch
- Pregelatinized corn starch
- Povidone K-25
- Magnesium stearate film coating:
- Poly (vinyl alcohol)
- Titanium dioxide (E171)
- Talc (E553b), macrogol 3350
- Lecithin (soy)
- Film-coated placebo tablets: Tablet core:
- Microcrystalline cellulose
- Anhydrous lactose
- Pregelatinized maize starch
- Magnesium stearate
- Anhydrous colloidal silica film coating:
- Poly (vinyl alcohol)
- Titanium dioxide (E171)
- Macrogol 3350
- Talc (E553b)
- Indigo carmine (E132)
- Quinoline yellow (E104)
- Black iron oxide (E172)
- Para-orange FCF (E110)
What The Medicine Looks Like And Contents Of The Pack
- The active film-coated tablet is a white or almost white, round biconvex film-coated tablet with a diameter of about 6 mm. Embossing on one side: “G63”, no embossing on the other side.
- The film-coated placebo tablet is a green, round, biconvex film-coated tablet with a diameter of approximately 6 mm without embossing.
- Midiana 28 0.03 mg / 3 mg film-coated tablets are packaged in PVC / PVDC / Al blister packs. The blister packs are packed in a folding box with a package leaflet. A storage case and stickers for the weekdays are included in each box.
- 1 × 28 film-coated tablets
- 3 × 28 film-coated tablets
- 6 × 28 film-coated tablets
- 13 × 28 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Gedeon Richter Plc.
Gyömrői out 19-21