0.03mg / 3mg film-coated tablets
ethinyl estradiol / drospirenone
What Rosal 28 is and what it is used for
• Rosal 28 is a birth control pill and is used to prevent pregnancy.
• Each of the 21 yellow tablets contains a small amount of two different female sex hormones; drospirenone and Ethinyl estradiol.
• The 7 white tablets do not contain any active substances and are called – placebo tablets.
• Birth control pills that contain two hormones are called combination birth control pills.
Ethinyl estradiol/drospirenone contained in Rosal 28 may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Rosal 28
| General notes Before you start using Rosal 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 Rosal 28, your doctor/midwife will ask you some questions about your own and your immediate relatives’ medical history. The doctor/midwife will also measure your blood pressure and it is possible that the doctor/midwife, depending on your situation, will also take other samples. This leaflet describes several situations in which you need to stop taking Rosal 28 or when your Rosal 28 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 Rosal 28 affects the monthly changes in body temperature and cervical secretions. Rosal 28, like other hormonal contraceptives, does not protect against HIV infection ( AIDS ) or other sexually transmitted diseases. |
Do not use Rosal 28
Do not use Rosal 28 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 2 “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 (listed in section 6). This can cause itching, rash, or swelling
Do not use Rosal 28 if you have hepatitis C and are taking medicines containing ombitasvir / paritaprevir / ritonavir and dasabuvir or glekaprevir / pibrentasvir
(see also section “Other medicines and Rosal 28”).
Additional information on specific patient groups
Children and young people
Rosal 28 is not intended for use by women who are not yet menstruating.
Older women
Rosal 28 is not intended for use after menopause.
Women with hepatic impairment
Do not use Rosal 28 if you have liver problems. See also sections “Do not use Rosal 28” and “Warnings and precautions”.
Women with renal impairment
Do not use Rosal 28 if you have kidney problems or acute kidney failure. See also sections “Do not use Rosal 28” and “Warnings and precautions”.
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 Rosal 28, you should also consult a doctor. In some situations, you need to be especially careful when using Rosal 28 or other combination pills, and it may be necessary to check with your doctor/midwife regularly.
Talk to your doctor or pharmacist before taking Rosal 28:
• if a close relative has or has had breast cancer
• if you have any liver or bile disease
• if you have diabetes
• if you suffer from depression.
• if you have Crohn’s disease or ulcerative colitis ( chronic inflammatory bowel disease)
• if you have 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 Rosal 28
• if you have an inflammation of the veins under the skin (superficial thrombophlebitis )
• if you have varicose veins.
• if you have epilepsy (see “Other medicines and Rosal 28l”)
• if you have a disease that first appeared during pregnancy or during previous use of sex hormones (eg hearing loss, a blood disease called porphyria, skin rash with blisters during pregnancy (pregnancy herpes), a nerve disease that causes sudden twitching in the body (Sydenhams Korea)
• if you have or have had chloasma (a discoloration of the skin, especially on the face or neck, so-called “pregnancy spots”). In this case, avoid direct exposure to sunlight or ultraviolet light while taking this medicine.
• if you experience symptoms of angioedema, such as a swollen face, swollen tongue and/or swollen throat, and/or difficulty swallowing or rash in combination with difficulty breathing, contact a doctor immediately. Estrogen products may induce or worsen the symptoms of hereditary and acquired angioedema.
BLOOD CLOTS
If you use combined hormonal contraceptives such as Rosal 28, the risk of blood clots increases 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 Rosal 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• 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). | 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 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 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 as you are at risk of a new stroke. • 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. | 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 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 Rosal 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 Rosal 28 is small.
– Of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 develop a blood clot in one year.
Of 10,000 women who use a combined hormonal contraceptive containing levonorgestrel or norethisterone or norgestimate, 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 Rosal 28, about 9-12 develop a blood clot in a 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 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 Rosal 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 Rosal 28 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 another 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 due to injury or illness, or if your leg is plastered. The use of Rosal 28 may need to be stopped for several weeks before an operation or while you are less mobile. If you have to stop taking Rosal 28, 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 must stop taking [the name of the medicine].
If any of the above conditions change when using Rosal 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 Rosal 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 Rosal 28, you should stop smoking. If you can not stop smoking and are over 35 years old, your doctor may advise you to use another type of contraceptive
• if you are overweight
• if you have high blood pressure
• if a close relative has had a heart attack or stroke at a young age (younger than 50 years). In this case, you may also be at greater risk 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 serious, the risk of developing a blood clot can be even greater.
If any of the above conditions change when using Rosal 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.
Rosal 28 and cancer
Breast cancer has been observed somewhat more frequently in women using the contraceptive pill, but it is not known if this is caused by the treatment. For example, it may be that more tumors are detected in women who use the contraceptive pill because they are more often examined by a doctor. The incidence of breast tumors gradually decreases after the end of treatment with combined hormonal contraceptives. It is important to examine your breasts regularly and you should consult your doctor if you feel any lumps.
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.
Mental disorders
Some women who use hormonal contraceptives, including Rosal 28, have reported depression or depression. Depression can be severe and can sometimes lead to suicidal thoughts. If you experience mood swings and symptoms of depression, you should contact a doctor as soon as possible for advice.
Intermittent bleeding
During the first few months of using Rosal 28, 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 yellow 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 Rosal 28
| Tell your doctor/midwife which medicines or herbal medicines you are already taking, have recently taken, or may be taking. Also, tell other doctors or dentists who prescribe other medicines (or pharmacists) that you are using Rosal 28. They may tell you if you need to use additional contraceptive protection (eg condoms), and if so, for how long time. |
Some medicines may affect the blood levels of Rosal 28 and make it less effective in preventing pregnancy or may 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, and nevirapine)
o fungal infections (grisofulvin, ketoconazole )
o arthritis, osteoarthritis (etoricoxib)
o high blood pressure in the blood vessels of the lungs ( bosentan )
• the herbal medicine St. John’s wort
Rosal 28 may affect the effectiveness of other medicines, e.g.
• medicines containing ciclosporin
• the antiepileptic drug lamotrigine (this may lead to an increase in the number of seizures)
• theophylline (for the treatment of respiratory problems)
• tizanidine (for the treatment of muscle pain and/or muscle cramps)
Your doctor may take blood samples to check your potassium levels if you are taking certain medicines to treat heart problems (such as diuretics).
Do not use Rosal 28 if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glekaprevir / pibrentasvir 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.
Rosal 28 can be used again about 2 weeks after stopping treatment with these drugs. See section “Do not take Rosal 28”.
Rosal 28 with food, drink, and alcohol
Rosal 28 can be taken with or without food, if necessary with a small amount of 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 Rosal 28. If you become pregnant while taking Rosal 28, stop immediately and contact your doctor/midwife. If you want to get pregnant, you can stop taking Rosal 28 at any time (see also “If you want to stop using Rosal 28”)
Breast-feeding
In general, breastfeeding is not recommended when using Rosal 28. If you want to use birth control pills while breastfeeding, consult your doctor/midwife.
If you are pregnant or breastfeeding, 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 Rosal 28 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
uncertain.
Rosal 28 contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Rosal 28.
How to use Rosal 28
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 yellow tablets and 7 white placebo tablets.
Rosal 28 tablets with two different colors are lined up in order. One tablet map contains 28 tablets.
Take one tablet of Rosal 28 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.
One blister card contains 28 tablets, each marked with a day of the week. Start by taking a tablet with the correct day of the week. For example, if you are starting on a Wednesday, take a tablet marked with “ONS” on the side. Take one tablet every day. Follow the direction of the arrows on the blister map until you have taken all 28 tablets. Do not mix the tablets: take one yellow tablet for the first 21 days and then one white tablet for the last 7 days. You must then start on a new tablet chart immediately (21 yellow and then 7 white tablets). There is therefore no pause between the tablet maps.
During the 7 days when you take the white placebo tablets (the placebo days), the bleeding should start (so-called dropout bleeding). This usually starts on the second or third day after the last yellow active Rosal 28 tablet. After taking the last white tablet, start with the next tablet chart regardless of whether the bleeding has stopped or not. This means that you should start each tablet chart on the same day of the week and that the bleeding should occur on the same days of each month.
If you take Rosal 28 in 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 hormonal contraceptive in the previous month
Start with Rosal 28 on the first day of your regular menstrual cycle (ie the same day as your period begins). If you start taking Rosal 28 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 Rosal 28 the day after the last active tablet (the last tablet containing active substances) of your previous pill, but no later than the day after the tablet-free period of your previous pill (or after the last inactive tablet of your previous birth control pill ). When you change from a combination preparation in the form of a vaginal ring or patch, you should preferably start with Rosal 28 on the day the vaginal ring or the patch is removed, but no later than the day when a new ring or patch should be inserted.
• 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 (from implants or IUDs, however, you should change on the day it is removed, 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 or abortion
Follow your doctor’s advice.
• After delivery
You can start with Rosal 28 between 21 and 28 days after delivery. If you start later than day 28, use a so-called barrier method (eg condom) for the first seven days you use Rosal 28.
If you have had sex before using Rosal 28 (again) after giving birth, make sure you are not pregnant or wait until your next period.
• If you are breastfeeding and want to start using Rosal 28 after giving birth.
Read the section “Breastfeeding”.
Ask your doctor/midwife what to do if you are unsure when to start.
If you use more Rosal 28 than you should
There are no reports of serious adverse effects due to taking too many Rosal 28 tablets.
If you take several tablets at the same time, you may experience nausea, vomiting, or bleeding from the vagina. Even girls who have not had their first period but have accidentally used this medicine may experience this type of bleeding.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to use Rosal 28
The tablets in the fourth row of the tablet map are placebo tablets. If you forget one of these tablets, it does not affect Rosal 28’s reliability. Throw away the forgotten placebo tablet.
If you forget a yellow, active tablet in rows 1, 2, or 3, do the following:
• If less than 12 hours have passed since you should have taken your tablet, the preventive protection is not reduced. Take the tablet as soon as you remember and then take the next tablet at the usual time.
• If more than 12 hours have passed since you should have taken your tablet, the preventive protection may be reduced. The more tablets you have forgotten, the greater the risk of getting pregnant.
The risk of incomplete protection against pregnancy is greatest if you forget a yellow tablet at the beginning or end of the tablet chart. Therefore, you should follow the following rules (see also the diagram):
• More than one tablet forgotten in the tablet map
Contact your doctor/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 also experience slight or menstrual-like bleeding while using the second tablet chart.
You can also stop taking the active yellow 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 on 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 yellow tablet, or if you have severe diarrhea, there is a risk that the active substances in the pill will not be completely absorbed by the body in these cases, you may need to use extra protection (such as a condom) to avoid becoming pregnant. This situation is almost the same as forgetting a tablet. After vomiting or diarrhea, take a new yellow tablet from a spare tablet card as soon as possible. If possible, take it within 12 hours from the time you normally take your pill. If this is not possible or if 12 hours have already passed, you should follow the advice under “If you forgot to take Rosal 28”.
Postponing menstruation: what you need to know
Even if it is not recommended, you can advance your period by not taking the white placebo tablets from the fourth row, but start directly on a new tablet map with Rosal 28 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 Rosal 28
You can stop taking Rosal 28 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 Rosal 28 and wait for your period before trying to conceive. You will then be able to more easily calculate the expected date of birth.
If you have any further questions on the use of this product, ask your doctor, midwife, or pharmacist.
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 Rosal 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 in 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 Rosal 28”.
The following is a list of side effects that have been linked to the use of Rosal 28.
Common side effects (may affect up to 1 in 10 people):
- menstrual disorders, intermittent bleeding, chest pain, sore breasts
- headache, depression
- migraine
- nausea
- whitish thick discharge from the vagina and fungal infection in the vagina.
Uncommon side effects (may affect up to 1 in 100 people):
- enlarged breasts changed interest in sex
- high blood pressure, low blood pressure
- vomiting, diarrhea
- acne, rash, itching, hair loss ( alopecia )
- vaginal infection
- accumulation of fluid in the body and changes in body weight.
Rare side effects (may affect up to 1 in 1,000 people):
- allergic reactions (hypersensitivity), asthma
- fluid secretion from the breasts
- impaired hearing
- skin conditions such as erythema nodosum (characterized by painful reddish nodules in the skin) or erythema multiforme (characterized by a rash with annular redness or sores).
- dangerous blood clots in a vein or artery, eg:
- in one leg or foot (ie DVT)
- in the lungs
- myocardial infarction
- stroke
- mini-stroke or transient stroke-like symptoms, called transient ischemic attack ( TIA )
- blood clots in the liver, stomach/intestines, kidneys, or eyes.
The risk of developing a blood clot may be higher if you have other conditions that increase this risk (see section 2 for more information on the conditions that increase the risk of blood clots and the symptoms of a blood clot).
Contact a doctor immediately if you experience any of the following symptoms of angioedema: swollen face, swollen tongue and/or swollen throat, and/or difficulty swallowing or rash in combination with difficulty breathing (see also section “Warnings and precautions”).
How to store Rosal 28
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the blister/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.
Contents of the packaging and other information
Content declaration
A blister of Rosal 28 contains 21 yellow active tablets on the first, second and third rows and 7 white placebo tablets on the fourth row.
Active tablets:
The active substances are Ethinyl estradiol 0.03 mg and drospirenone 3 mg.
Other ingredients are:
Tablet core: Lactose monohydrate, maize starch, pregelatinized starch (maize), crospovidone, povidone, polysorbate 80, magnesium stearate.
Tablet coating: Partially hydrolyzed polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172).
Placebo tablets:
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 yellow, round, film-coated tablets.
Placebo tablets are white, round, film-coated tablets.
Rosal 28 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
Evolan Pharma AB
Box 120
SE-182 12 Danderyd