1. What Desolett Is And What It Is Used For<\/h2>\n\n\n\n
Composition and type of Birth Control Pills<\/strong><\/p>\n\n\n\n
Desolett is a combined\u00a0contraceptive pill.\u00a0Each tablet contains a small amount of two different female\u00a0hormones.\u00a0These are desogestrel (yellow body hormone) and Ethinyl estradiol (\u00a0estrogen\u00a0).\u00a0Because Desolett tablet<\/strong> contains small amounts of\u00a0hormones, it is called a low-dose\u00a0birth control pill.\u00a0Because all tablets contain the same amount of\u00a0hormone, it is also called a monophasic\u00a0birth control pill.<\/p>\n\n\n\n
Why Desolett tablet uses<\/strong><\/p>\n\n\n\n
Desolett is used to protect against unwanted pregnancy.<\/li>
If you take the tablets correctly, the risk of getting pregnant is very small.<\/li>
Desolett inhibits ovulation and affects the uterine\u00a0mucosa\u00a0so that a fertilized egg gets more difficult to develop.\u00a0The passage of sperm through the cervix is \u200b\u200balso made more difficult.\u00a0The effect remains during the tablet pause between two maps.\u00a0The ovaries return to their normal functions after treatment, and it is possible to become pregnant again.<\/li>
Desogestrel \/ Ethinylestradiol contained in Desolett may also be approved for the treatment of other conditions not mentioned in this product information.\u00a0Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.<\/li><\/ul>\n\n\n\n
2. What You Need To Know Before Using Desolett<\/h2>\n\n\n\n
General Information<\/h2>\n\n\n\n
Before you start using Desolett, read the information on blood clots in section 2. You must read the symptoms of blood clots – see section 2, “Blood clots”).<\/p>\n\n\n\n
This leaflet describes several situations when you should stop using Desolett, or when the protection against pregnancy may be reduced.\u00a0In such situations, you should not have intercourse or you should protect yourself with a contraceptive that does not contain\u00a0hormones, such as condoms or another so-called\u00a0barrier method.\u00a0Do not use safe periods or temperature methods.\u00a0They may be unsafe because Desolett affects the normal changes in temperature and vaginal mucus that occur during the menstrual cycle.<\/p>\n\n\n\n
Remember that Desolett, like other\u00a0oral contraceptives, does not protect against\u00a0HIV\u00a0–\u00a0infection\u00a0(\u00a0AIDS\u00a0) or another sexually transmitted disease.<\/strong><\/p>\n\n\n\n
When using\u00a0birth control pills, your doctor\/midwife will call you for regular check-ups, usually once a year.<\/p>\n\n\n\n
Do not use Desolett:<\/strong><\/p>\n\n\n\n
Do not use Desolett if you have any of the conditions listed below.\u00a0If you have any of these conditions, you must tell your doctor\/midwife.\u00a0Your doctor\/midwife will discuss which other type of contraceptive may be more appropriate.<\/p>\n\n\n\n
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, PE), or any other organ.<\/li>
If you know you have a disease that affects blood coagulation – eg\u00a0protein\u00a0C deficiency,\u00a0protein\u00a0S deficiency, antithrombin III deficiency, Factor V Leiden, or antiphospholipid antibodies.<\/li>
If you need to have an operation or if you stay in bed for a long time (see section “Blood clots”).<\/li>
If you have (or have had) a heart attack or a\u00a0stroke.<\/li>
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).<\/li>
If you have any of the following conditions that may increase the risk of a blood clot in your arteries:\u00a0
Symptoms that usually occur in one eye: immediate loss of vision or blurred vision without pain that can lead to vision loss <\/td>
Retinal venous thrombosis(blood clot in the eye)<\/td><\/tr>
chest pain, discomfort, pressure, heavinesspressure or feeling of fullness in the chest, arm, or below the sternum feeling full, indigestion or feeling of suffocationdiscomfort in the upper body that radiates to the back, jaw, neck, arm, and abdomensweating, nausea, vomiting or dizziness extreme weakness, anxiety or shortness of breakfast or irregular heartbeat.<\/td>
Myocardial infarction<\/td><\/tr>
sudden weakness or numbness in the face, arms, or legs, especially on one side of the body sudden confusion, difficulty speaking or understanding sudden vision problems in one or both eyes sudden difficulty walking, dizziness, loss of balance or coordinationsudden, severe or prolonged headache without known cause unconsciousness or fainting with or without seizures. Sometimes the symptoms of a stroke can be short-lived with almost immediate or complete recovery, but you should still seek medical attention immediately because you are at risk of having a new stroke.<\/td>
Stroke<\/td><\/tr>
swelling and slight blue discoloration of an arm or leg severe pain in the abdomen ( acute abdomen).<\/td>
Blood clots that block other blood vessels<\/td><\/tr><\/tbody><\/table><\/figure>\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
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.<\/li>
If a blood clot forms in a vein in the leg or foot, it can lead to deep vein thrombosis (DVT).<\/li>
If a blood clot moves from the bone and stays in the lung, it can lead to a pulmonary embolism.<\/li>
In very rare cases, a blood clot can form in a vein in another organ, such as the eye ( retinal venous thrombosis ).<\/li><\/ul>\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.\u00a0The 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.<\/p>\n\n\n\n
After the first year, the risk decreases, but it is always slightly higher than if you do not use a combined hormonal contraceptive.<\/p>\n\n\n\n
When you stop using Desolett, 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 Desolett 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.<\/li>
Of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 develop a blood clot in a year.<\/li>
Of 10,000 women who use a combined hormonal contraceptive that contains desogestrel such as Desolett, about 9-12 develop a blood clot in a year.<\/li>
The risk of blood clots varies depending on your medical history (see “Factors that may increase the risk of a blood clot” below).<\/li><\/ul>\n\n\n\n
<\/p>\n\n\n\n
<\/th>
Risk of developing a blood clot during a year<\/th><\/tr><\/thead>
Women who do not use<\/strong> a combined hormonal pill\/patch\/ring and who are not pregnant<\/td>
About 2 out of 10,000 women<\/td><\/tr>
Women using a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate<\/strong><\/td>
About 5-7 out of 10,000 women<\/td><\/tr>
Women using Desolett<\/td>
About 9-12 out of 10,000 women<\/td><\/tr><\/tbody><\/table><\/figure>\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 Desolett is small, but certain conditions increase the risk. The risk is higher:<\/p>\n\n\n\n
If you are very overweight (body mass index or\u00a0BMI\u00a0over 30 kg \/ m\u00a02<\/sup>\u00a0)<\/li>
If someone in your family has had a blood clot in their bones, lungs, or another organ at a young age (eg for about 50 years).\u00a0In this case, you may have a hereditary blood-clotting disease.<\/li>
If you need to undergo surgery or stay in bed for a long period of time due to injury or illness, or if your leg is plastered.\u00a0The use of Desolett may need to be stopped for several weeks before an operation or while you are less mobile.\u00a0If you have to stop using Desolett, ask your doctor when you can start using it again.<\/li>
With increasing age (especially if you are over about 35 years old)<\/li>
If you gave birth a few weeks ago.<\/li><\/ul>\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. Your doctor may decide that you need to stop using Desolett.<\/p>\n\n\n\n
If any of the above conditions change while you are using Desolett, such as close relative suffering from a blood clot for an unknown reason or you gain a lot of weight, talk to your doctor.<\/p>\n\n\n\n
Blood clots in an\u00a0artery<\/strong><\/p>\n\n\n\n
What can happen if a blood clot forms in an artery?<\/strong><\/p>\n\n\n\n
Like a blood clot in a vein, a clot in an\u00a0artery\u00a0can lead to serious problems.\u00a0It can, for example, cause 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\u00a0stroke\u00a0due to the use of Desolett is very small but may increase:<\/p>\n\n\n\n
With increasing age (after about 35 years of age)<\/li>
If you smoke<\/strong>.\u00a0When using combined hormonal contraceptives such as Desolett, you should stop smoking.\u00a0If you can not stop smoking and are over 35 years old, your doctor may advise you to use another type of contraceptive.<\/li>
If you are overweight<\/li>
If you have high\u00a0blood pressure<\/li>
If a close relative has had a heart attack or\u00a0stroke\u00a0at a young age (younger than 50 years).\u00a0In this case, you may also be at greater risk of a heart attack or\u00a0stroke.<\/li>
If you or a close relative have high blood fats (\u00a0cholesterol\u00a0or\u00a0triglycerides\u00a0)<\/li>
If you get\u00a0migraines, especially\u00a0migraines\u00a0with an\u00a0aura<\/li>
If you have heart problems (valve disease, a heart rhythm disorder called\u00a0atrial fibrillation\u00a0)<\/li>
If you have\u00a0diabetes.<\/li><\/ul>\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 while you are using Desolett, such as if you start smoking, a close relative suffers from a blood clot for an unknown reason, or if you gain a lot of weight, talk to your doctor.<\/p>\n\n\n\n
Birth control pills and cancer<\/strong><\/p>\n\n\n\n
Breast cancer has been detected somewhat more often in women who use\u00a0birth control pills\u00a0than in women of the corresponding age who do not use\u00a0birth control pills.\u00a0If you stop\u00a0taking the pill, the increased risk disappears gradually, over a 10-year period.\u00a0It is not known if this difference is due to the contraceptive pill.\u00a0It may be that the women go for more check-ups so that the breast cancer is detected earlier.<\/p>\n\n\n\n
In rare cases, benign liver tumors, and in even more rare cases, malignant liver tumors, have been reported among women using\u00a0birth control pills.\u00a0These\u00a0tumors can cause internal bleeding.\u00a0Contact your doctor immediately if you experience severe abdominal pain.<\/p>\n\n\n\n
Cervical cancer is caused by an\u00a0infection\u00a0with the human\u00a0papillomavirus\u00a0(HPV).\u00a0Cervical cancer has been reported more frequently in women who use combined\u00a0oral contraceptives\u00a0for a long time.\u00a0It is not certain that the contraceptive pill itself is the cause, but it may also be due to sexual habits or other factors (eg cell sampling).<\/p>\n\n\n\n
Mental disorders<\/strong><\/p>\n\n\n\n
Some women who use hormonal contraceptives, including Desolett, have reported depression or depression.\u00a0Depression can be severe and can sometimes lead to suicidal thoughts.\u00a0If you experience mood swings and symptoms of depression, you should contact a doctor as soon as possible for advice.<\/p>\n\n\n\n
Children And Young People<\/h2>\n\n\n\n
Efficacy and safety have not been studied in adolescents under 18 years of age.<\/p>\n\n\n\n
Other Medicines And Desolett<\/h2>\n\n\n\n
Always tell your doctor\/midwife which medicines or (traditional) herbal medicines you are already using. Also, tell other doctors or dentists who prescribe medicines and the relevant pharmacy staff that you are using Desolett. They can tell you if you need to use supplemental protection (such as a condom) and if so, for how long or if the use of any other medicine you need needs to be changed. <\/p>\n\n\n\n
Do not use Desolett if you have hepatitis C and are taking medicines containing ombitasvir\/paritaprevir\/ritonavir and dasabuvir as it may cause elevated liver function values \u200b\u200b(elevation of the liver enzyme ALT ).<\/p>\n\n\n\n
Your doctor will prescribe another type of contraceptive before starting treatment with these drugs.<\/p>\n\n\n\n
Desolett can be used again approximately 2 weeks after the end of this treatment (see section \u201cDo not use Desolett\u201d).<\/p>\n\n\n\n
Some drugs<\/p>\n\n\n\n
May affect the blood levels of Desolett<\/li>
May make it\u00a0less effective in preventing pregnancy<\/strong><\/li>
May cause unexpected bleeding<\/li><\/ul>\n\n\n\n
This applies to medicines for the treatment of:<\/p>\n\n\n\n
Epilepsy\u00a0eg
Primidone<\/li>
Phenytoin<\/li>
Phenobarbital<\/li>
Carbamazepine<\/li>
Oxcarbazepine<\/li>
Topiramate<\/li>
Felbamate<\/li><\/ul><\/li>
Tuberculosis\u00a0eg
Rifampicin<\/li>
Rifabutin<\/li><\/ul><\/li>
HIV\u00a0–\u00a0infection\u00a0for example
Ritonavir<\/li>
Nelfinavir<\/li>
Nevirapine<\/li>
EfavirenzH<\/li><\/ul><\/li>
Hepatitis\u00a0C virus infection eg
Boceprevir<\/li>
Telaprevir<\/li><\/ul><\/li>
Other infectious diseases eg
Griseofulvin<\/li><\/ul><\/li>
High\u00a0blood pressure\u00a0in the blood vessels of the lungs (\u00a0bosentan\u00a0)<\/li>
If you are taking other medicines or (traditional) herbal medicines that could reduce the effect of Desolett, you should also use a\u00a0barrier method.\u00a0Some medicines may affect the effect of Desolett for up to 28 days after stopping treatment.\u00a0It is, therefore, necessary to use\u00a0barrier\u00a0method\u00a0one during this time.<\/li>
Desolett may affect the effectiveness of other medicines, e.g.
The epilepsy drug lamotrigine (this may lead to an increased frequency of seizures)<\/li><\/ul>\n\n\n\n
Laboratory samples<\/em><\/p>\n\n\n\n
If you need to take a blood or urine sample, tell your doctor or laboratory staff that you are taking birth control pills as they may affect the results of certain tests.<\/p>\n\n\n\n
Pregnancy And Breastfeeding<\/h2>\n\n\n\n
Pregnancy<\/em><\/p>\n\n\n\n
Desolett should not be used by women who are pregnant or who think they may be pregnant.<\/p>\n\n\n\n
If you think you are pregnant while you are already taking Desolett, stop treatment and contact your doctor\/midwife as soon as possible.<\/p>\n\n\n\n
Breast-feeding<\/em><\/p>\n\n\n\n
In general, Desolett is not recommended for use during breast-feeding. If you want to use birth control pills while breastfeeding, contact your doctor\/midwife.<\/p>\n\n\n\n
Driving And Using Machines<\/h2>\n\n\n\n
There is no reason to believe that Desolett would affect its ability to drive.<\/p>\n\n\n\n
Desolett Contains Lactose<\/h2>\n\n\n\n
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor\/midwife before taking this medicine.<\/p>\n\n\n\n
3. How To Use Desolett<\/h2>\n\n\n\n
Always use Desolett exactly as your doctor\/midwife has told you.\u00a0If you are not sure, talk to your doctor\/midwife or pharmacist.<\/li>
Each tablet map contains 21 tablets and has a day-by-day marking.\u00a0Take one tablet at about the same time of day, along with fluids if needed.\u00a0Then follow the direction of the arrows until all tablets are exhausted.\u00a0After that, do not take any tablets for 7 days.\u00a0During the period when you are not taking any tablets, bleeding (menstruation) usually occurs.\u00a0It usually starts 2-3 days after the last tablet.\u00a0Start with the next map on the eighth day, even if you are still menstruating.\u00a0This means that you will always start a new map on the same day of the week and that you will have your period for about the same day each month.\u00a0Occasionally there may be no bleeding.\u00a0If you have taken the tablets according to the instructions, it does not necessarily mean that you have become pregnant.\u00a0Therefore, start as usual on the new map.<\/li>
It is important to take\u00a0birth control pills\u00a0regularly according to the instructions to get adequate protection.<\/li><\/ul>\n\n\n\n
When to start using Desolett<\/strong><\/p>\n\n\n\n
When you have not used any hormonal method the month before <\/em>Start using Desolett on the first day of your menstrual cycle, ie the first day of bleeding.\u00a0Desolett will start working immediately, you do not need to use any extra protection.\u00a0You can also start on days 2-5, but then you must use extra protection (\u00a0barrier method, eg condom) for the first 7 days. <\/li>
When switching from a combined contraceptive (combined\u00a0contraceptive pill,\u00a0vaginal ring,\u00a0or\u00a0patch\u00a0) You can start using Desolett the day after the last tablet from your current\u00a0oral contraceptive pill\u00a0(ie without taking a tablet break).\u00a0If your current\u00a0contraceptive pill\u00a0contains hormone-free tablets (\u00a0placebo\u00a0), you can start taking Desolett the day after you take the last\u00a0active\u00a0tablet (if you are\u00a0not sure\u00a0what to do, talk to your doctor\/midwife or pharmacist).\u00a0You can also start later, but not later than the day after that tablet break with your current\u00a0birth control pill(or the day after the last placebo tablet from your current\u00a0oral contraceptive pill\u00a0).\u00a0If you have used a\u00a0vaginal ring\u00a0or a\u00a0patch, you should preferably start with Desolett on the day you remove the ring or remove the patch.\u00a0You can also start with Desolett on the day you should have started with a new ring or a new\u00a0patch, but not at a later time than that.\u00a0If you have used your\u00a0birth control pills,\u00a0patches,\u00a0or\u00a0vaginal ring correctly and without interruption and are sure that you are not pregnant, you can stop using your previously combined hormonal contraceptive at any time and start immediately with Desolett.\u00a0If you follow these tips, you do not need to use any extra protection. <\/li>
When switching from a\u00a0progestogen-only\u00a0contraceptive pill\u00a0(\u00a0mini-pills\u00a0)\u00a0 You can stop\u00a0taking mini-pills\u00a0any day and start taking Desolett the next day at the same time.\u00a0If you have intercourse, use extra protection (a\u00a0barrier method, such as a condom) for the first seven days of taking Desolett. <\/li>
When changing from\u00a0injections,\u00a0implants,\u00a0or gestagenfris\u00e4ttande\u00a0spiral\u00a0 Start with Desolett the day you would have had the next\u00a0injection\u00a0or the date of your\u00a0implant\u00a0or IUD is removed.\u00a0If you have intercourse, use extra protection (a\u00a0barrier method, such as a condom) for the first seven days of taking Desolett. <\/li>
After giving birth\u00a0 If you have just given birth, your doctor\/midwife will probably ask you to wait to start using Desolett until you have had your period back.\u00a0In some cases, you can start earlier.\u00a0Your doctor\/midwife will give you advice.\u00a0If you are breast-feeding and want to start using Desolett, you should first discuss this with your doctor\/midwife.<\/li>
After a miscarriage or abortion\u00a0 Your doctor\/midwife will inform you when you can start.<\/li><\/ul>\n\n\n\n
If You Take More Desolett Than You Should<\/h2>\n\n\n\n
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.<\/p>\n\n\n\n
There are no reports of serious injuries if you have taken several tablets of Desolett at the same time. If you take several tablets at the same time, you may feel sick, vomit, and have bleeding from the abdomen.<\/p>\n\n\n\n
If You Forget To Take Desolett<\/h2>\n\n\n\n
If\u00a0less than 12 hours<\/strong>\u00a0have passed since you should have taken your tablet, you are still protected against pregnancy.\u00a0Take the tablet as soon as you remember and take the next tablet at the usual time. <\/li>
If it has been\u00a0more than 12 hours<\/strong>\u00a0since you should have taken your tablet, the protection against pregnancy may be reduced.\u00a0The more tablets in a row that you have forgotten, the greater the risk that the contraceptive effect has decreased.\u00a0The risk of getting pregnant is especially high if you forget tablets at the beginning or end of the tablet chart.\u00a0Therefore, always follow the instructions given below (see also the diagram) <\/li>
More than 1 forgotten tablet in the tablet map<\/strong>: Contact your doctor\/midwife for advice. <\/li>
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).\u00a0Take the following tablets at the usual time, but do not forget to use extra protection (\u00a0barrier method, eg condom) for seven days.\u00a0If you had intercourse during the week before the forgotten tablet, there is a risk that you will become pregnant.\u00a0Therefore, you should contact your doctor\/midwife immediately.<\/li>
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).\u00a0Take the next tablet at the usual time.\u00a0Assuming you have taken the tablet correctly for the next 7 days before the forgotten tablet, the combined pill still has the desired effect and you do not need to use extra protection. <\/li>
1 tablet forgotten during week 3:You can choose between two options, without the need for extra protection:
Take the forgotten tablet as soon as you remember (even if it means taking two tablets at the same time), and take the next tablet at the usual time.\u00a0Start immediately on the next tablet map without making any tablet pauses.\u00a0You will probably not have a proper fallout until the end of the second tablet chart, and you may experience irregular bleeding (splashing and breakthrough bleeding) during the days you are taking tablets. Or: <\/li>
You can stop taking the tablets and take a tablet break of 7 days or less (including the forgotten tablet).\u00a0Then start on a new tablet map as usual.\u00a0If you do it this way, you can always start on a map on the same day of the week that you are used to. <\/li><\/ol><\/li>
If you forget to take tablets on a tablet chart and you do not experience bleeding during the first normal tablet-free period, you may have become pregnant.\u00a0In this case, you must contact your doctor\/midwife before starting the next tablet chart.<\/li><\/ul>\n\n\n\n<\/a><\/figure>\n\n\n\n