0.02mg / 3mg film-coated tablets
ethinyl estradiol / drospirenone
1. What Estron is and what it is used for
• Estron is a birth control pill and is used to prevent pregnancy.
• Each of the 21 pink tablets contains a small amount of two different female sex hormones; drospirenone and Ethinylestradiol.
• The 7 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/drospirenone contained in Estron may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 you take Estron
Do not use Estron
Before using Estron, 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 Estron, 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 when you need to stop taking Estron or when Estron reliability may be impaired. 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 Estron affects the monthly changes in body temperature and cervical secretions.
Estrone protection, like other hormonal contraceptives, is not against HIV – infection ( AIDS ) or other sexually transmitted diseases.
Do not use Estron:
Do not use Estron if you have any of the conditions listed below. If you have any of these conditions, tell your doctor. The doctor will discuss what other type of contraception may be more appropriate.
• 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 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 (or have had) a heart attack or 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 diseases that may increase the risk of a blood clot in the 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 (see section 6). This can cause itching, rash, or swelling
Do not use Estron if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see also section “Other medicines and Estron”).
Warnings and cautions
|When should you contact a doctor? Seek medical attention immediately– if you notice any possible signs of a blood clot which may mean that you have a blood clot in your leg (ie deep vein thrombosis ), a blood clot in your lung (ie pulmonary embolism ), a heart attack, or a stroke (see section “Blood clots” below). For a description of the symptoms of these serious side effects, go to “How to recognize a blood clot”.|
Tell your doctor if any of the following conditions apply to you.
If the condition occurs or worsens when you use Estron, you should also consult a doctor.
In some situations, you need to be especially careful when using Estron or other oral contraceptives, and you may need to be checked regularly by your doctor/midwife.
Talk to your doctor or pharmacist before taking Estron.
• if a close relative has or has had breast cancer
• if you have cancer
• if you have any liver (such as an obstruction in the bile duct, which can cause jaundice with symptoms such as itching ) – or biliary disease (such as gallstones )
• if you have other kidney problems and are taking medicines that increase the levels of potassium in your blood
• if you have diabetes
• if you suffer from depression. Some women who use hormonal contraceptives, including Estron, 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.
• 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 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 Estron
• 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 Estron”)
• 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 high blood pressure during treatment that cannot be controlled with medication
• 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 while taking this medicine
• if you have hereditary angioedema, products containing estrogen 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.
Using combined hormonal contraceptives such as Estron 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 Estron 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• strong feeling of instability or dizziness• fast or irregular heartbeat• severe 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 milder condition such as a respiratory infection (such as a common cold).
|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 suffocated• 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 a 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.
|• 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 may 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 Estron, 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 Estron 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, 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 Estron, about 9-12 develop a blood clot in one year.
– The risk of blood clots varies depending on your medical history (see “Factors that may increase the risk of a blood clot” below).
|Risk of developing a blood clot during a year|
|Women who do not use combined pills/patches/rings 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 Estron||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 Estron is small, but certain conditions increase the risk. The risk is higher:
• if you are overweight (body mass index or BMI over 30 kg / m2)
• if someone in your family has had a blood clot in a bone, lung, or other organ at a young age (eg under 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. Estrogen use may need to be stopped for several weeks before surgery or while you are less mobile. If you have to stop taking Estron, ask your doctor when you can start taking it again
• with increasing age (especially if you are over 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 (> 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 Estron.
If any of the above conditions change when you use Estron, 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 Estron is very small but may increase:
• with increasing age (after about 35 years of age)
• if you smoke. When you use combined hormonal contraceptives Estron 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 Estron, 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.
Estron 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, tumors may be detected in women who use the contraceptive pill because they are examined more often by a doctor. The incidence of breast tumors gradually decreases after stopping treatment with combined hormonal contraceptives. It is important to 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 unusual severe abdominal pain, swelling of the abdomen (which may be due to enlargement of the liver), or bleeding from the stomach.
During the first months of using Estron, you may experience unexpected bleeding (bleeding outside the placebo period). 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 placebo period
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/midwife immediately. Only start on the next tablet chart if you are sure you are not pregnant.
Other medicines and Estron
|Tell your doctor/midwife which medicines or herbal remedies you are already using, have recently used, or might use. Also, tell other doctors or dentists who prescribe other medicines (or pharmacists) that you are using Estron. They can tell you if you need to use additional contraceptive protection (eg condoms), and if so, for how long.|
Do not use Estron if you have hepatitis C and take medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir as it may cause elevated liver function levels (increase in the liver enzyme ALT ).
Your doctor will prescribe another type of contraceptive before starting treatment with these medicines.
Estrogen can be used again about 2 weeks after stopping treatment with these drugs. See the section “Do not take Estron”
Some medicines can affect the levels of Estron in the blood and make it less effective in preventing pregnancy or can cause unexpected bleeding. These include:
• medicines used to treat
o Epilepsy (eg primidone, phenytoin , barbiturates , carbamazepine, oxcarbazepine, felbamate, topiramate)
or tuberculosis (eg rifampicin)
o HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz)
o fungal infection (griseofulvin, ketoconazole )
o arthritis or osteoarthritis (etoricoxib)
o high blood pressure in the blood vessels in the lungs ( bosentan )
• the herbal medicine St. John’s wort
If you are taking any of the above medicines with Estron, use additional contraceptive methods (eg condoms) during treatment and 28 days after.
Estrogen can affect the effectiveness of other drugs, 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)
Your doctor may monitor your blood potassium levels if you are taking certain medicines to treat heart problems (eg diuretics).
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 and breastfeeding
If you are pregnant, do not use Estron. If you become pregnant while taking Estron, stop immediately and contact your doctor/midwife. If you want to get pregnant, you can stop taking Estron at any time (see also “If you want to stop using Estron”)
In general, breastfeeding is not recommended when using Estron. If you want to use birth control pills while breastfeeding, contact your doctor/midwife.
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
There is no information to suggest that the use of Estron would affect the ability to drive or use machines.
You are responsible for assessing whether you are fit to drive or perform motor vehicle
works that require sharpened attention. One of the factors that can affect your ability in
These aspects are the use of drugs due to their effects and/or side effects.
Descriptions of these effects and side effects can be found in other sections. Therefore read all information
in this leaflet for guidance. Discuss with your doctor or pharmacist if you are
Estrone contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Estron. This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’. is largely “sodium-free”.
3. How to take Estron
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 21 active pink tablets and 7 white placebo tablets.
Estron tablets with two different colors are lined up in order. One tablet map contains 28 tablets.
Take one tablet of Estron 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.
Prepare the map
Each package of Estron comes with 7 labels for each blister card, each with the 7 days of the week. Each label starts with different days. Choose the weekly label that starts with the day you start taking the tablets. For example, if you started on a Wednesday, use the label that begins with “ONS”. Attach the weekly label along the top edge of the map where it says “Place the label here” so that the first day on the label is placed at “START”. You should always start with the pink tablets and finish with the white tablets.
You must continue to take the tablets in the direction of the arrows.
Always start a new tablet row with the tablet on the far left.
(Picture of labels and blister card – see package leaflet in the package)
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 pink active 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 take Estron this way, you will be protected from pregnancy even during the 7 days you are taking the placebo tablet.
When can you start with the first tablet map?
• If you have not used a contraceptive with hormones in the previous month
Start with Estron on the first day of your regular menstrual cycle (ie the same day as your period begins). If you start taking Estron on the first day of your period, you will immediately have protection against pregnancy. You can also start on days 2 – 5 of the menstrual cycle, but then you must use extra protection methods (eg condoms) for the first 7 days.
• Change from a hormonal combination contraceptive pill, or combination preparation in the form of a vaginal ring or patch.
You should preferably start with Estron 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 of your previous pill (or after the last inactive tablet of your former contraceptive pill ). When changing from a combination product in the form of a vaginal ring or patch, you should preferably start with Estron on the day you remove the ring/patch, but no later than the day when the next application was to be made.
• 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 time, however, from implants or IUDs, you should change on the day when this is removed, from an injectable contraceptive at the time of the next injection ) but in all these cases you must use extra protection (eg condom) during the first 7 days of tablet intake.
• After miscarriage or termination of pregnancy
Follow your doctor’s advice.
• After delivery
You can start taking Estron 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 of using Estron.
If you have had sex before using Estron 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 Estron (again) after giving birth.
Read the section “Breastfeeding”.
Ask your doctor/midwife what to do if you are unsure when to start.
If you take more Estron than you should
There are no reports of serious side effects from taking too many Estron tablets.
If you take several tablets at the same time, you may feel unwell, vomit or have vaginal bleeding. Even girls who have not had their first period but have accidentally used this drug may experience this type of bleeding.
If you have taken too many Estron tablets or find that a child has ingested tablets, contact your doctor, hospital, or the Poison Information Center tel. for risk assessment and advice.
If you forget to take Estron
The tablets in the fourth row of the tablet map are placebo tablets. If you forget one of these tablets, it does not affect Estron’s reliability. Throw away the forgotten placebo tablet.
If you forget a pink, active tablet in rows 1, 2, or 3, do the following:
• If less than 12 hours have passed since you took 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 took 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 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/midwife.
• 1 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 have had sex the week before you forgot the tablet, you should contact a doctor as there is a possibility that you have become pregnant.
• 1 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.
• 1 tablet forgotten during 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. 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 slight or menstrual-like bleeding while using the second tablet chart.
You can also stop taking the active pink tablets and go straight and take up to 7 white placebo tablets (including the tablets for the days you missed before taking the placebo tablets, note which day you forgot your tablet ). If you want to start a new tablet chart on the same day, as usual, take the placebo tablets for less than seven 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 normal placebo days, it may mean that you are pregnant. Contact your doctor/midwife before starting the next tablet chart.
The following diagram describes what to do if you forget to take your tablet (s):
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 pill will not be completely absorbed into the body in these cases, you may need to use additional protection (such as
a condom) to avoid pregnancy. This situation is almost the same as forgetting a tablet. After vomiting or diarrhea, take a new pink tablet from a spare tablet chart as soon as possible. If possible, take it within 12 hours from the time you normally take your pill. If this is not possible or if 12 hours have already passed, you should follow the advice under “If you forget to take Estron”.
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 Estron and end 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 7 white tablets in row four. Then start on the next tablet map.
You should consult your doctor/midwife 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 slight or menstrual-like bleeding.
Contact your doctor/midwife if you are not sure what to do.
If you stop using Estron
You can stop taking Estron whenever you want. If you do not want to get pregnant, consult your doctor/midwife about other reliable methods of contraception. If you want to get pregnant, stop taking Estron 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, midwife, or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects are but not everybody gets dem. Om, you get any side effects, especially if severe or persistent, or if your health changes and you think it may be due to Estrone, 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 using Estron”.
If any of these side effects are occurring, you may need urgent medical attention. Stop taking Estron and contact a doctor or go to the nearest hospital immediately.
Less common side effects are (may affect up to 1 in 100 people):
- sudden swelling of the skin and/or mucous membranes (eg tongue or throat), and/or difficulty swallowing or hives together with difficulty breathing (angioedema).
- harmful blood clots in the lungs (ie pulmonary embolism (PE))
Rare side effects are (may affect up to 1 in 1,000 people):
- harmful blood clots in a vein or artery, for example:
- in one leg or foot (ie deep vein thrombosis (DVT))
- heart attack
- mini-stroke or temporary stroke-like symptoms, known as a transient ischemic attack ( TIA )
- blood clots in the liver, stomach/intestines, kidneys, or eyes.
The risk of getting a blood clot may be higher if you have any other conditions that increase the risk (see section 2 for more information on the conditions that increase the risk of blood clots and symptoms of blood clots).
Conditions that may occur or worsen during pregnancy or previous use of birth control pills include:
- the systemic lupus erythematosus ( SLE, a disease that affects the immune system)
- inflammation of the colon or other parts of the intestine (with symptoms such as bloody diarrhea, pain when visiting the toilet, pain in the abdomen) ( Crohn’s disease and ulcerative colitis )
- uterine myoma (a benign tumor that grows in muscle tissue in the uterus)
- a blood pigment disease ( porphyria )
- bladder-like rash ( herpes gestationis) during pregnancy
- Sydenham’s chorea (a nerve disease in which sudden body movements can occur)
- a blood disease that causes kidney damage ( hemolytic uremic syndrome with symptoms such as decreased urine production, blood in the urine, low red blood cell count, nausea, vomiting, confusion, and diarrhea)
- yellowing of the skin or whites of the eyes due to obstruction of the bile duct (cholestatic jaundice)
Also, breast cancer (see section 2 “Estron and cancer”) and benign (benign) and cancer (malignant) liver tumors (with symptoms such as the swollen abdomen, weight loss, abnormal liver function, which can be seen in blood tests) and chloasma (yellow-brown spots on the skin and in especially on the face, so-called “pregnancy spots”), which may be permanent, especially in women who have previously had chloasma during pregnancy, have been observed.
Other possible side effects are
Common side effects are (may affect up to 1 in 10 people):
– Mood swings
– abdominal pain
– chest pain, breast enlargement, sore breasts, painful or irregular periods
– weight gain
Less common side effects are (may affect up to 1 in 100 people):
– candida (fungal infection)
– herpes blisters ( herpes simplex)
– allergic reactions
– increased appetite
– depression, nervousness, sleep problems
– ant crawling/tingling, dizziness ( vertigo )
– visual disturbances
– irregular heartbeat or unusually high heart rate
– high blood pressure, decreased blood pressure, migraine, varicose veins
nausea, vomiting, inflammation of the stomach and/or intestines, diarrhea, constipation
– hair loss ( alopecia ), eczema, itching, rash, dry skin, increased skin peeling ( seborrhea )
– neck pain, pain in arms/legs, muscle cramps
– inflammation of the bladder
lumps in the breasts (benign and cancerous), milk production without being pregnant
( galactorrhea ), an ovarian tumor ( cyst ), hot flashes, lack of menstrual bleeding, very heavy menstrual bleeding, vaginal secretions, dry vagina, infection or inflammation of the vagina, pelvic pain, abnormal smears (cell samples) from the cervix, decreased sex drive
– fluid retention, weakness, severe thirst, increased sweating
– weight loss
– general pain
Rare side effects are (may affect up to 1 in 1,000 people)
– impaired hearing
– erythema nodosum (characterized by painful reddish nodules in the skin)
erythema multiforme (characterized by a rash with annular redness or sores).
5. How to store Estron
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage instructions.
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 are to protect the environment.
6. Contents of the packaging and other information
What Estron contains
A blister of Estron contains 21 pink active tablets on the first, second and third rows and 7 white placebo tablets on the fourth row.
The active substances are ethinylestradiol 0.02 mg and drospirenone 3 mg.
Other ingredients are:
Tablet core: Lactose monohydrate, pregelatinized starch (maize), povidone, croscarmellose sodium, polysorbate 80, magnesium stearate.
Tablet coating: Partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).
Tablet core: Anhydrous lactose, povidone, magnesium stearate.
Tablet coating: Partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc.
What the medicine looks like and the contents of the pack
Active tablets are pink, round, film-coated tablets.
Placebo tablets are white, round, film-coated tablets.
Estron is available in cartons of 1, 2, 3, 6, and 13 blisters, each containing 28 tablets (21 active plus 7 placebo tablets).
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Evolan Pharma AB
SE-182 12 Danderyd
Laboratories León Farma, SA
Terminal. Ind. Navatejera
C / La Vallina s / n