desogestrel / ethinyl estradiol tablets

Important information about combined hormonal contraceptives:

• They are one of the most reliable contraceptive methods available if used correctly.

• The risk of a blood clot in a vein or artery increases slightly, especially during the first year or when combined hormonal contraceptives start to be used again after a break of 4 weeks or longer.

• If you think you may have symptoms of a blood clot, talk to a doctor (see section 2 “Blood clots”).

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor/midwife or pharmacist.
  • This medicine has been prescribed for you. Do not give it to others. It can hurt them.
  • If you get any side effects, talk to your doctor/midwife or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Desolett 28 is and what it is used for 
2. What you need to know before you use Desolett 28 
3. How to use Desolett 28 
4. Possible side effects 
5. How to store Desolett 28 
6. Contents of the packaging and other information 

1. What Desolett 28 is and what it is used for

Composition and type of birth control pills

Desolett 28 is a combined contraceptive pill. Each large tablet contains a small amount of two different female hormones. These are desogestrel (yellow body hormone) and Ethinyl estradiol ( estrogen ). The small tablets do not contain any hormones at all and are called placebo tablets. Because Desolett 28 contains small amounts of hormones, it is called a low-dose birth control pill. Because all active tablets contain the same amount of hormone, it is also called a monophasic contraceptive pill.

Why use Desolett 28?

Desolett 28 is used to protect against unwanted pregnancy.

If you take the tablets correctly, the risk of getting pregnant is very small.

Desolett 28 inhibits ovulation and affects the uterine mucosa so that a fertilized egg gets more difficult to develop. The passage of sperm through the cervix is ​​also made more difficult. The effect remains even during the 7 days when the hormone-free tablets are taken. The ovaries return to their normal functions after treatment, and it is possible to become pregnant again.

Desogestrel / Ethinylestradiol contained in Desolett 28 may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Desolett 28

General information

Before using Desolett 28, read the information on blood clots in section 2. You must read the symptoms of blood clots – see section 2, “Blood clots”).

This leaflet describes several situations when you should stop using Desolett 28, or when the protection against pregnancy may be reduced. In such situations, you should not have intercourse or you should protect yourself with a contraceptive that does not contain hormones, such as condoms or another so-called barrier method. Do not use safe periods or temperature methods. They may be unsafe because Desolett 28 affects the normal changes in the temperature and mucus in the vagina that occur during the menstrual cycle.

Remember that Desolett 28, like other oral contraceptives, does not protect against HIV – infection ( AIDS ) or another sexually transmitted disease.

When using birth control pills, your doctor/midwife will call you for regular check-ups, usually once a year.

Do not use Desolett 28:

Do not use Desolett 28 if you have any of the conditions listed below. If you have any of these conditions, you must tell your doctor/midwife. Your doctor/midwife will discuss which other type of contraceptive 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, PE), or any other organ.
  • if you know you have a disease that affects blood coagulation – eg 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 long time (see section “Blood clots”).
  • if you have (or have had) a heart attack or a stroke.
  • if you have (or have had) angina (a condition that causes severe chest pain and maybe the first sign of a heart attack) or transient ischemic attack ( TIA – transient stroke symptoms).
  • if you have any of the following conditions that may increase the risk of a blood clot in your arteries:
    • severe diabetes with damaged blood vessels
    • very high blood pressure
    • a very high level of fat in the blood ( cholesterol and 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 pancreatitis ( inflammation of the pancreas) combined with high levels of blood fats.
  • if you have or have had severe liver disease and your liver is not yet functioning normally.
  • if you have or have had cancer that is affected by sex hormones (in the breast or abdomen).
  • if you have or have had a tumor in your liver.
  • if you have genital bleeding for no known reason.
  • if you have hyperplasia of the endometrium (abnormal growth of the lining of the uterus).
  • if you are allergic (hypersensitive) to desogestrel, Ethinyl estradiol, or any of the other ingredients of Desolett 28.
  • if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir (see section “Other medicines and Desolett 28”).

If you have any of the conditions described above or should be affected by any of these conditions for the first time when using Desolett 28, discontinue treatment and contact your doctor/midwife. In the meantime, use a contraceptive that does not contain hormones, such as a condom. Also, read the section “General information”.

Warnings and cautions

When should you contact a doctor?
Seek medical attention immediately
→ if you notice possible signs of a blood clot that 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 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”.

You should not use Desolett 28 to delay your period, but if you need to do so for any reason, you should contact your doctor/midwife.

What you need to know before you start using Desolett 28

If you use combined contraceptive pills when you have any of the following diseases or conditions, you may need extra controls. Your doctor/midwife can explain this to you. Therefore, tell your doctor/midwife before starting Desolett 28 if any of the following apply to you.

Tell your doctor/midwife if any of the following conditions apply to you.

If the condition occurs or worsens when you use Desolett 28, you should also contact your doctor/midwife.

  • if you smoke
  • if you have diabetes
  • if you are overweight
  • if you have high blood pressure
  • if you have a valve or any arrhythmia in your heart
  • if someone in your immediate family has had a blood clot, heart attack, or stroke
  • if you have migraines
  • if you have epilepsy
  • if you or someone in your immediate family has or has had high blood fats ( cholesterol or triglycerides )
  • if someone in your immediate family has or has had breast cancer
  • if you have liver disease (eg jaundice) or gallbladder disease (eg gallstones )
  • if you have Crohn’s disease or ulcerative colitis ( chronic inflammatory bowel disease)
  • if you have 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 heredity for this 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 blood clots. Ask your doctor how soon after giving birth you can start using Desolett 28.
  • if you have an inflammation of the veins under the skin (superficial thrombophlebitis )
  • if you have varicose veins
  • if you have a condition that first appeared or worsened during pregnancy or previous use of sex hormones (eg hearing loss, a metabolic disorder called porphyria, a skin condition called herpes gestationis, a neurological condition called Sydenham’s chorea)
  • if you have or have had chloasma (yellow-brown pigment spots on the skin, especially on the face); in this case, avoid too much sunlight or ultraviolet rays
  • if you have previously had angioedema with symptoms such as swelling of the face, tongue, or throat, or difficulty swallowing or rash along with difficulty breathing.

Blood clots

Using combined hormonal contraceptives such as Desolett 28 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 Desolett 28 is small.

How to recognize a blood clot

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 soreness in the leg that is only felt when you stand or walk increased heat in the affected leg color change of the skin on the leg, eg 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 breathingsevere instability or dizziness fast or irregular heartbeat severe pain in the abdomen.
If you are not sure, talk to a doctor as some of these symptoms such as cough and shortness of breath can be mistakenly interpreted as a milder condition such as a respiratory infection (eg 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, 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. 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 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.
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 can form in a vein in another organ, such as the eye ( retinal venous thrombosis ).

When is the risk of developing a blood clot in a vein greatest?

The risk of developing a blood clot in a vein is greatest during the first year that you use combined hormonal contraceptives for the first time. The risk 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 do not use a combined hormonal contraceptive.

When you stop using Desolett 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 Desolett 28 is small.

  • Of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 develop a blood clot in one year.
  • Of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, norethisterone, or norgestimate, about 5-7 develop a blood clot in a year.
  • Of 10,000 women who use a combined hormonal contraceptive that contains desogestrel such as Desolett 28, about 9-12 develop a blood clot in a 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 a combined hormonal contraceptive pill/patch/ring and who are not pregnant About 2 out of 10,000 women
Women using a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate About 5-7 out of 10,000 women
Women using Desolett 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 Desolett 28 is small, but some conditions increase the risk. The risk is higher:

  • if you are very overweight (body mass index or BMI over 30 kg / m 2 )
  • 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). In this case, you may have a hereditary blood-clotting disease.
  • 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. The use of Desolett 28 may need to be stopped for several weeks before an operation or while you are less mobile. If you have to stop using Desolett 28, ask your doctor when you can start using it again.
  • with increasing age (especially if you are over about 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 using Desolett 28.

If any of the above conditions change while you are using Desolett 28, such as close relative suffering from a blood clot for an unknown reason or you gain a lot of weight, talk to your doctor.

Blood clots in an artery

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, for example, 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 Desolett 28 is very small but may increase:

  • with increasing age (after about 35 years of age)
  • if you smoke. When using combined hormonal contraceptives such as Desolett 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 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 while you are using Desolett 28, for example, 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.

Birth control pills and cancer

Breast cancer has been detected somewhat more often in women who use birth control pills than in women of the corresponding age who do not use birth control pills. If you stop taking the pill, the increased risk gradually disappears over a 10-year period. It is not known if this difference is due to the contraceptive pill. It may be that the women go for more check-ups so that the breast cancer is detected earlier.

In rare cases, benign liver tumors, and in even more rare cases, malignant liver tumors, have been reported among women using birth control pills. These tumors can cause internal bleeding. Contact a doctor immediately if you experience severe abdominal pain.

Cervical cancer is caused by an infection with the human papillomavirus (HPV). Cervical cancer has been reported more frequently in women who use combined oral contraceptives for a long time. It 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).

Mental disorders 
Some women who use hormonal contraceptives, including Desolett 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.

Children and young people

Efficacy and safety have not been studied in adolescents under 18 years of age.

Other medicines and Desolett 28

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 28. They can tell you if you need to use additional protection (for example condoms) and if so for how long or if the use of any other medicine you need needs to be changed.

Do not use Desolett 28 if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir as it may cause elevated liver function levels (elevation of the liver enzyme ALT ).

Your doctor will prescribe another type of contraceptive before starting treatment with these drugs.

Desolett 28 can be used again approximately 2 weeks after the end of this treatment (see section “Do not use Desolett 28”).

Some drugs

  • may affect the blood levels of Desolett 28
  • may make it less effective in preventing pregnancy
  • may cause unexpected bleeding.

This applies to medicines for the treatment of:

  • epilepsy (eg primidone, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, topiramate, felbamate)
  • tuberculosis (eg rifampicin, rifabutin)
  • HIV – infection (for example, ritonavir, nelfinavir, nevirapine, efavirenz)
  • hepatitis C virus infection (eg boceprevir, telaprevir)
  • other infectious diseases (eg griseofulvin)
  • high blood pressure in the blood vessels of the lungs ( bosentan )
  • depression ((traditional) herbal medicines containing St. John’s wort ).

If you are taking other medicines or (traditional) herbal medicines that could reduce the effect of Desolett 28, you should also use a barrier method. Some medicines may affect the effect of Desolett 28 up to 28 days after stopping treatment. It is, therefore, necessary to use barrier method one during this time.


Desolett 28 may affect the effectiveness of other medicines, e.g.

  • medicines containing ciclosporin
  • the epilepsy drug lamotrigine (this may lead to an increased frequency of seizures)

Laboratory samples

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.

Pregnancy and breastfeeding

Pregnancy

Desolett 28 should not be used by women who are pregnant or who think they may be pregnant.

If you think you are pregnant while you are already taking Desolett 28, stop treatment and contact your doctor/midwife as soon as possible.

Breast-feeding

In general, Desolett 28 is not recommended for use during breast-feeding. If you want to use birth control pills while breastfeeding, contact your doctor/midwife.

Driving and using machines

There is no reason to believe that Desolett 28 would affect your ability to drive.

Desolett 28 contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor/midwife before taking this medicine.

3. How to use Desolett 28

Always use Desolett 28 exactly as your doctor/midwife has told you. If you are not sure, talk to your doctor/midwife or pharmacist.

Each tablet map contains 28 white tablets: 21 large tablets with active substance (numbers 1-21) and 7 small hormone-free tablets (numbers 22-28). Take one tablet at about the same time of day, along with fluids if needed. Start the first day of menstruation with tablet number 1, which is located in the upper left corner (marked with start). Then follow the direction of the arrows until all 28 tablets are exhausted. You first take all large tablets and finally the small hormone-free tablets. During the seven days, you take the hormone-free tablets, menstruation usually begins (bleeding). It usually starts 2-3 days after the last white tablet. Start with the next card immediately after the last hormone-free tablet, even if you are still menstruating. This 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. Occasionally there may be no bleeding. If you have taken the tablets according to the instructions, it does not necessarily mean that you have become pregnant. Therefore, start as usual on the new map.

It is important to take birth control pills regularly according to the instructions to get adequate protection.

When to start using Desolett 28

  • When you have not used any hormonal method the month before 
    Start using Desolett 28 on the first day of your menstrual cycle, ie the first day of bleeding. Desolett 28 will start working immediately, you do not need to use any extra protection. You can also start on days 2-5, but then you must use extra protection ( barrier method such as a condom) for the first 7 days.
  • When switching from a combined contraceptive (combined contraceptive pill, vaginal ring, or patch )
  • You can start using Desolett 28 the day after the last tablet from your current contraceptive pill (ie without taking a tablet break). If your current contraceptive pill contains hormone-free tablets ( placebo ), you can start with Desolett 28 the day after you take the last active tablet (if you are not sure what to do, talk to your doctor/midwife or pharmacist). You can also start later, but not later than the day after stopping the tablet with your current pill (or the day after the last placebo tablet from your current pill ). If you have used a vaginal ring or a patch you should preferably start with Desolett 28 on the day you remove the ring or remove the patch. You can also start with Desolett 28 on the day you should have started with a new ring or patch, but not at a later time than that. If you have used your birth control pills, patches, or vaginal 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 28. If you follow this advice, you do not need to use any extra protection.
  • When switching from a progestogen-only contraceptive pill ( mini-pills )
    You can stop taking mini-pills any day and start taking Desolett 28 the next day, at the same time. If you have intercourse, use extra protection (a barrier method, such as a condom) for the first seven days of taking Desolett 28.
  • When changing from injections, implants, or gestagenfrisättande spiral 
    Start with Desolett 28, the same day that you would have had the next injection or the date of your implant or IUD is removed. If you have intercourse, use extra protection (a barrier method, such as a condom) for the first seven days of taking Desolett 28.
  • After giving birth 
    If you have just given birth, your doctor/midwife will probably ask you to wait to start using Desolett 28 until you have had your period back. In some cases, you can start earlier. Your doctor/midwife will give you advice. If you are breast-feeding and want to start using Desolett 28, you should first discuss this with your doctor/midwife.
  • After a miscarriage or abortion 
    Your doctor/midwife will
    inform you when you can start.

If you take more Desolett 28 then you should

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.

There are no reports of serious injuries if you have taken several tablets of Desolett 28 at the same time. If you take several tablets at the same time, you may feel sick, vomit and have bleeding from the abdomen.

If you forget to take Desolett 28

  • If less than 12 hours have passed since you should have taken your tablet, you are still protected against pregnancy. Take the tablet as soon as you remember and take the next tablet at the usual time.
  • If it has been more than 12 hours since you should have taken your tablet, the protection against pregnancy may be reduced. The more tablets in a row that you have forgotten, the greater the risk that the contraceptive effect has decreased. The risk of getting pregnant is especially high if you forget tablets at the beginning of the tablet chart or if you forget any of the tablets in the third week (the week before you start with the small tablets). Therefore, always follow the instructions given below (see also the diagram):

  • More than 1 forgotten tablet in the tablet map:Contact your doctor / midwife for advice.

  • 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). Take the following tablets at the usual time, but do not forget to use extra protection ( barrier method , eg condom) for seven days. If you had intercourse during the week before the forgotten tablet, there is a risk that you will become pregnant. Therefore, you should contact your doctor / midwife immediately.

  • 1 tablet forgotten during week 2: Take the forgotten tablet as soon as you remember it (even if it means taking two tablets at the same time) Take the next tablet at the usual time. Assuming you have taken the tablet correctly for the next 7 days before the forgotten tablet, the combined oral contraceptives still have the desired effect and you do not need to use extra protection.

  • 1 tablet forgotten during week 3:You can choose between two options, without the need for extra protection:
    1. 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. Take the following white active tablets at the usual time, but skip the small white hormone-free tablets and start on the next map immediately. You will probably not have a proper dropout bleeding until the end of the second tablet chart, and you may experience irregular bleeding (splashing and breakthrough bleeding) during the days you are taking active tablets.
      Or:
       

    2. You can stop taking the white active tablets and instead take the small white hormone-free tablets for a maximum of 6 days (the total number of placebo tablets including the forgotten tablet must never be more than seven). Then start on a new tablet map as usual. If you do it this way, you can always start on a map on the same day of the week that you are used to.

  • 1 tablet forgotten during week 4:You still have the protection of your birth control pills . Take the tablet as soon as you remember and take the next tablet at the usual time.

  • If you forget to take tablets on a tablet chart and you do not experience bleeding during the first normal period of placebo tablets, you may have become pregnant. In this case, you must contact your doctor / midwife before starting the next tablet chart.

If you forget to take Desolett 28

If you have stomach upset (vomiting and diarrhea)

If you vomit or have severe diarrhea, the body may not absorb the hormones in the tablets well enough and the protection against pregnancy will be reduced. In such situations, you should use extra protection (non-hormonal, eg condoms) for seven days. If you vomit within 3-4 hours after taking the tablet, follow the same advice as if you had forgotten a tablet.

If you want to change the start date

If you take your tablets according to the instructions, you will have your period on about the same day every four weeks. If you want to change this, you can shorten (never prolong) the next period with hormone-free tablets. For example, if you usually get your period on a Friday and instead want it on a Tuesday (three days earlier), you should start on the next tablet chart three days earlier than usual. If you take a few hormone-free tablets (three days or less) you may not get your period that time. You may also experience irregular bleeding (splashing or breakthrough bleeding) when taking the large tablets on the next map.

If you experience unexpected bleeding

During the first months of using the contraceptive pill , you may experience irregular bleeding (breakthrough bleeding or splashing). You may need to use menstrual protection, at least continue to take your tablets as usual. The irregular bleeding usually disappears when the body has adapted to the contraceptive pill (usually after about three months). Talk to your doctor / midwife if you continue to have irregular bleeding after three months, if it becomes heavier or if irregular bleeding suddenly occurs after three months.

If you do not get a period

If you have taken all your tablets at the right time, and you have not vomited, had severe diarrhea or used other medicines at the same time, it is unlikely that you are pregnant. Continue to take Desolett 28 as usual.

If you do not get your period twice in a row, you may be pregnant. Contact your doctor / midwife immediately. Do not start the next tablet card until you have been confirmed that you are not pregnant.

If you stop using Desolett 28

You can stop using Desolett 28 whenever you want. If you do not want to get pregnant, ask your doctor / midwife for advice on another method of contraception.

If you stop taking Desolett 28 because you want to get pregnant, it is recommended that you wait until you have had a natural menstrual period before trying to conceive. This will make it easier for you to calculate the expected date of birth.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. 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 Desolett 28, talk to your doctor.

An increased risk of blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries are ( arterial thromboembolism (ATE)) are all women who use combined hormonal contraceptives. For more information on the different risks of using combined hormonal contraceptives, see section 2 “What you need to know before using Desolett 28”.

During the first months of treatment, a large proportion (10-30%) of women may experience some side effects, such as chest tightness, nausea, spotting. These side effects are often mild and usually go away within 2-4 months. If the bleeding becomes troublesome, you should contact a doctor / midwife. Contact your doctor / midwife if you experience side effects , especially if they are serious or do not go away, or if you notice anything else with your body that you think may be due to the contraceptive pill.

Serious side effects and symptoms that may be related to birth control pills are described in the sections: “Blood clots / Birth control pills and cancer”.

Common side effects (affects more than 1 in 100 women)

  • depression, mood swings,
  • headache
  • nausea, abdominal pain
  • sore breasts, chest tightness
  • weight gain
  • abdominal bleeding

Uncommon side effects (affects more than 1 user in 1,000 but less than 1 in 100 women)

  • fluid retention
  • decreased sexual desire
  • migraine
  • vomiting, diarrhea
  • redness , rash, hives
  • breast augmentation
  • no loss of bleeding
  • high blood pressure

Rare side effects (affects less than 1 in 1,000 women)

  • hypersensitivity s
  • increased sexual desire
  • difficulty wearing contact lenses, due to reduced tear flow
  • erythema nodosum, erythema multiforme (a form of reddening of the skin), chloasma (brown pigmented skin spots), itching
  • exuding breasts, discharge from the abdomen
  • weight loss
  • changes in liver function values, jaundice, gallstones , benign liver tumors
  • elevated blood sugar, decreased glucose tolerance, increased insulin requirements
  • dangerous blood clots in a vein or artery , such as:
    • 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).

5. How to store Desolett 28

Keep this medicine out of the sight and reach of children.

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 will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substances are:

in the large tablets: ethinyl estradiol 30 ochg and desogestrel 150 .g

in the smaller tablets: no active substances

Other ingredients are

in the large tablets: potato starch, anhydrous colloidal silica, lactose monohydrate , povidone, stearic acid, alpha-tocopherol.

in the smaller tablets: lactose monohydrate , magnesium stearate, potato starch

What the medicine looks like and contents of the pack

Desolett 28 is available in packs of 3 tablet maps. Each map contains 28 tablets (21 large and 7 smaller).

The large tablets are round, biconvex and 6 mm in diameter (active tablets). On one side, the tablet is marked with TR5 and with ORGANON and a five-pointed star on the other.

The smaller hormone-free tablets are round, white and marked with KH2 on one side and a small square on the other.

Desolett 28 is available in packs of 3 tablet maps. Each map contains 28 tablets.

Marketing Authorisation Holder

Merck Sharp & Dohme BV

Box 581

2003 PC Haarlem

Netherlands

Muhammad Nadeem

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