0.03mg \/ 3mg film-coated tablets
ethinyl estradiol \/ drospirenone<\/p>\n\n\n\n
\u2022 Rosal 28 is a birth control pill and is used to prevent pregnancy.<\/p>\n\n\n\n
\u2022 Each of the 21 yellow tablets contains a small amount of two different female sex hormones;\u00a0drospirenone and Ethinyl estradiol.<\/p>\n\n\n\n
\u2022 The 7 white tablets do not contain any active substances and are called – placebo tablets.<\/p>\n\n\n\n
\u2022\u00a0Birth control pills\u00a0that contain two\u00a0hormones\u00a0are called combination\u00a0birth control pills.<\/p>\n\n\n\n
Ethinyl estradiol\/drospirenone contained in Rosal 28 may also be approved for the treatment of other conditions not mentioned in this leaflet.\u00a0Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.<\/p>\n\n\n\n
| General notes<\/strong> 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, \u201cBlood clots\u201d). Before you can start taking Rosal 28, your doctor\/midwife will ask you some questions about your own and your immediate relatives’ medical history.\u00a0The doctor\/midwife will also measure your\u00a0blood pressure\u00a0and 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.\u00a0In such situations, you should either refrain from having sex or use other, non-hormonal contraceptives, e.g.\u00a0use a condom or any other\u00a0barrier method.\u00a0Do not use the rhythm method or the temperature method.\u00a0These 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\u00a0HIV\u00a0infection\u00a0(\u00a0AIDS\u00a0)\u00a0or other sexually transmitted diseases.<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n Do not use Rosal 28<\/strong><\/p>\n\n\n\n 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.<\/p>\n\n\n\n \u2022 if you have (or have had) a blood clot in a blood vessel in your legs (deep\u00a0vein thrombosis, DVT), in your lungs (\u00a0pulmonary embolism\u00a0), or any other organ<\/p>\n\n\n\n \u2022 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<\/p>\n\n\n\n \u2022 if you need to have an operation or if you stay in bed for a longer period (see section 2 \u201cBlood clots\u201d)<\/p>\n\n\n\n \u2022 if you have (or have had) a heart attack or stroke (stroke)<\/p>\n\n\n\n \u2022 if you have (or have had) angina (a condition that causes severe chest pain and maybe the first sign of a heart attack) or\u00a0transient\u00a0ischemic attack (\u00a0TIA\u00a0– transient stroke symptoms)<\/p>\n\n\n\n \u2022 if you have any of the following diseases that may increase the risk of a blood clot in the arteries:<\/p>\n\n\n\n – severe diabetes with damaged blood vessels<\/p>\n\n\n\n – very high blood pressure<\/p>\n\n\n\n – a very high level of fat in the blood ( cholesterol or triglycerides )<\/p>\n\n\n\n – a condition called hyperhomocysteinemia<\/p>\n\n\n\n \u2022 if you have (or have had) a type of migraine called \u201cmigraine with aura\u201d.<\/p>\n\n\n\n \u2022 if you have (or have had) liver disease and your liver function is not yet normal<\/p>\n\n\n\n \u2022 if your kidneys are not working properly ( kidney failure )<\/p>\n\n\n\n \u2022 if you have (or have had) a tumor in your liver<\/p>\n\n\n\n \u2022 if you have (or have had) or if you suspect you may have breast or genital cancer<\/p>\n\n\n\n \u2022 if you have unexplained vaginal bleeding<\/p>\n\n\n\n If you are allergic to Ethinyl estradiol or drospirenone, or any of the other ingredients of this medicine (listed in section 6).\u00a0This can cause\u00a0itching, rash, or swelling<\/p>\n\n\n\n Do not use Rosal 28 if you have hepatitis C and are taking medicines containing ombitasvir \/ paritaprevir \/ ritonavir and dasabuvir or glekaprevir \/ pibrentasvir<\/p>\n\n\n\n (see also section \u201cOther medicines and Rosal 28\u201d).<\/p>\n\n\n\n Additional information on specific patient groups<\/strong><\/p>\n\n\n\n Children and young people<\/em><\/p>\n\n\n\n Rosal 28 is not intended for use by women who are not yet menstruating.<\/p>\n\n\n\n Older women<\/em><\/p>\n\n\n\n Rosal 28 is not intended for use after\u00a0menopause.<\/p>\n\n\n\n Women with hepatic impairment<\/em><\/p>\n\n\n\n Do not use Rosal 28 if you have liver problems. See also sections \u201cDo not use Rosal 28\u201d and \u201cWarnings and precautions\u201d.<\/p>\n\n\n\n Women with renal impairment<\/em><\/p>\n\n\n\n Do not use Rosal 28 if you have kidney problems or\u00a0acute\u00a0kidney failure.\u00a0See also sections \u201cDo not use Rosal 28\u201d and \u201cWarnings and precautions\u201d.<\/p>\n\n\n\n Tell your doctor if any of the following conditions apply to you.<\/strong><\/p>\n\n\n\n If the condition occurs or worsens when you use Rosal 28, you should also consult a doctor.\u00a0In some situations, you need to be especially careful when using Rosal 28 or other combination\u00a0pills, and it may be necessary to check with your doctor\/midwife regularly.<\/p>\n\n\n\n Talk to your doctor or pharmacist before taking Rosal 28:<\/p>\n\n\n\n \u2022 if a close relative has or has had breast cancer<\/p>\n\n\n\n \u2022 if you have any liver or bile disease<\/p>\n\n\n\n \u2022 if you have diabetes<\/p>\n\n\n\n \u2022 if you suffer from depression.<\/p>\n\n\n\n \u2022 if you have Crohn’s disease or ulcerative colitis ( chronic inflammatory bowel disease)<\/p>\n\n\n\n \u2022 if you have a systemic lupus erythematosus ( SLE – a disease that affects your natural immune system)<\/p>\n\n\n\n \u2022 if you have\u00a0hemolytic uremic syndrome\u00a0(HUS – a disorder of blood coagulation that leads to\u00a0kidney failure\u00a0)<\/p>\n\n\n\n \u2022 if you have sickle cell anemia (a hereditary disease of the red blood cells )<\/p>\n\n\n\n \u2022 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)<\/p>\n\n\n\n \u2022 if you need to have an operation or stay in bed for a longer period (see section 2 \u201cBlood clots\u201d)<\/p>\n\n\n\n \u2022 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<\/p>\n\n\n\n \u2022 if you have an inflammation of the veins under the skin (superficial thrombophlebitis )<\/p>\n\n\n\n \u2022 if you have varicose veins.<\/p>\n\n\n\n \u2022 if you have epilepsy (see “Other medicines and Rosal 28l”)<\/p>\n\n\n\n \u2022 if you have a disease that first appeared during pregnancy or during previous use of sex hormones (eg hearing loss, a blood disease called\u00a0porphyria, skin rash with blisters during pregnancy (pregnancy herpes), a nerve disease that causes sudden twitching in the body (Sydenhams Korea)<\/p>\n\n\n\n \u2022 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.<\/p>\n\n\n\n \u2022 if you experience symptoms of\u00a0angioedema, 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.\u00a0Estrogen\u00a0products\u00a0may induce or worsen the symptoms of hereditary and acquired\u00a0angioedema.<\/p>\n\n\n\n BLOOD CLOTS<\/strong><\/p>\n\n\n\n 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.<\/p>\n\n\n\n Blood clots can form<\/p>\n\n\n\n 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.<\/p>\n\n\n\n It is important to remember that the overall risk of a dangerous blood clot due to Rosal 28 is small.<\/strong><\/p>\n\n\n\n HOW TO FEEL A BLOOD CLOTH AGAIN<\/strong><\/p>\n\n\n\n Seek medical attention immediately<\/em> if you notice any of the following signs or symptoms.<\/p>\n\n\n\n BLOOD CLOTS IN A FRIEND<\/strong><\/p>\n\n\n\n What can happen if a blood clot forms in a vein?<\/strong><\/p>\n\n\n\n \u2022 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.<\/p>\n\n\n\n \u2022 If a blood clot forms in a vein in the leg or foot, it can lead to deep vein thrombosis (DVT).<\/p>\n\n\n\n \u2022 If a blood clot moves from the bone and stays in the lung, it can lead to a\u00a0pulmonary embolism.<\/p>\n\n\n\n \u2022 In very rare cases, a blood clot may form in a vein in another organ such as the eye ( retinal venous thrombosis ).<\/p>\n\n\n\n When is the risk of developing a blood clot in a vein greatest?<\/strong><\/p>\n\n\n\n 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.<\/p>\n\n\n\n After the first year, the risk decreases, but it is always slightly higher than if you did not use a combined hormonal contraceptive.<\/p>\n\n\n\n When you stop using Rosal 28, the risk of a blood clot returns to normal within a few weeks.<\/p>\n\n\n\n How big is the risk of developing a blood clot?<\/strong><\/p>\n\n\n\n The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.<\/p>\n\n\n\n The total risk of a blood clot in the leg or lungs with Rosal 28 is small.<\/p>\n\n\n\n – 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.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n – 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.<\/p>\n\n\n\n – The risk of a blood clot varies depending on your medical history (see “Factors that may increase the risk of a blood clot” below).<\/p>\n\n\n\n Factors that may increase the risk of a blood clot in a vein<\/strong><\/p>\n\n\n\n The risk of a blood clot with Rosal 28 is small, but certain conditions increase the risk. The risk is higher:<\/p>\n\n\n\n \u2022 if you are overweight (body mass index or BMI over 30 kg \/ m2)<\/p>\n\n\n\n \u2022 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).\u00a0In this case, you may have a hereditary blood-clotting disease<\/p>\n\n\n\n \u2022 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.\u00a0The use of Rosal 28 may need to be stopped for several weeks before an operation or while you are less mobile.\u00a0If you have to stop taking Rosal 28, ask your doctor when you can start taking it again<\/p>\n\n\n\n \u2022 with increasing age (especially if you are over 35 years old)<\/p>\n\n\n\n \u2022 if you gave birth a few weeks ago<\/p>\n\n\n\n The risk of developing a blood clot increases the more conditions you have.<\/p>\n\n\n\n Air travel (> 4 hours) can temporarily increase the risk of a blood clot, especially if you have any of the other factors listed here.<\/p>\n\n\n\n You must tell your doctor if any of these conditions apply to you, even if you are unsure.\u00a0Your doctor may decide that you must stop taking [the name of the medicine].<\/p>\n\n\n\n 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.<\/p>\n\n\n\n BLOOD CLOTS IN AN ART<\/strong><\/p>\n\n\n\n What can happen if a blood clot forms in an\u00a0artery?<\/strong><\/p>\n\n\n\n In the same way as a blood clot in a vein, a clot in an\u00a0artery\u00a0can lead to serious problems.\u00a0It can e.g.\u00a0cause a heart attack or\u00a0stroke.<\/p>\n\n\n\n Factors that may increase the risk of a blood clot in an artery<\/strong><\/p>\n\n\n\n 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:<\/p>\n\n\n\n \u2022 with increasing age (after about 35 years of age)<\/p>\n\n\n\n \u2022 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<\/p>\n\n\n\n \u2022 if you are overweight<\/p>\n\n\n\n \u2022 if you have high blood pressure<\/p>\n\n\n\n \u2022 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<\/p>\n\n\n\n \u2022 if you or a close relative have high blood fats ( cholesterol or triglycerides )<\/p>\n\n\n\n \u2022 if you get\u00a0migraines, especially\u00a0migraines\u00a0with an\u00a0aura<\/p>\n\n\n\n \u2022 if you have heart problems (valve disease, a heart rhythm disorder called atrial fibrillation )<\/p>\n\n\n\n \u2022 if you have\u00a0diabetes.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n If any of the above conditions change when using Rosal 28, e.g.\u00a0If you start smoking, a close relative suffers from thrombosis\u00a0of unknown cause, or you gain a lot of weight, talk to your doctor.<\/p>\n\n\n\n Rosal 28 and cancer<\/strong><\/p>\n\n\n\n Breast cancer has been observed somewhat more frequently in women using\u00a0the contraceptive pill, but it is not known if this is caused by the treatment.\u00a0For example, it may be that more\u00a0tumors\u00a0are detected in women who use\u00a0the contraceptive pill\u00a0because they are more often examined by a doctor.\u00a0The incidence of breast tumors gradually decreases after the end of treatment with combined hormonal contraceptives.\u00a0It is important to examine your breasts regularly and you should consult your doctor if you feel any lumps.<\/p>\n\n\n\n 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.\u00a0Contact 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.<\/p>\n\n\n\n Mental disorders<\/strong><\/p>\n\n\n\n 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.<\/p>\n\n\n\n Intermittent bleeding<\/strong><\/p>\n\n\n\n During the first few months of using Rosal 28, you may experience unexpected bleeding (bleeding outside the placebo period).\u00a0If 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.<\/p>\n\n\n\n What to do if you do not experience any bleeding during the placebo period<\/strong><\/p>\n\n\n\n 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.<\/p>\n\n\n\n If the expected bleeding does not occur twice in a row, you may be pregnant.\u00a0Contact your doctor\/midwife immediately.\u00a0Only start on the next tablet chart if you are sure you are not pregnant.<\/p>\n\n\n\n |