150 micrograms / 30 micrograms film-coated tablets 
levonorgestrel / Ethinyl estradiol

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, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to a doctor/midwife, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

Important information about combined hormonal contraceptives:

  • They are one of the most reliable contraceptive methods available if used properly.
  • 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.
  • Pay attention and consult a doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

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

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

Abelonelle 28 is used as a contraceptive.

Abelonelle 28 is a combination pill that contains low amounts of two different female sex hormones. Abelonelle 28 consists of 21 tablets with active ingredients ( hormones ) and 7 hormone-free tablets (last row on the tablet map). Each hormone tablet contains both Ethinyl estradiol (an estrogen ) and levonorgestrel (a progestogen ). Due to the low levels of hormones, Abelonelle 28 is one of the low-dose birth control pills. All hormone tablets in the pack contain the same hormone at a constant dose, the contraceptive pill is therefore called monophasic.

The preventive effect of combined contraceptive pills is based on the interplay between different factors. The most important is considered to be that ovulation is inhibited and the changes in the uterine lining and by the secretions in the cervix.

Menstruation is affected so that the bleeding becomes more regular, menstruation often becomes less painful and the amount decreases

2. What you need to know before you use Abelonelle 28

Generally

Before you start using Abelonelle 28, read the information on blood clots in section 2. It is especially important that you read the symptoms of blood clots – see section 2, “Blood clots”).

This leaflet describes several situations in which you should stop taking Abelonelle 28, or when the protective effect of the contraceptive pill may be reduced. In these situations, you should not have intercourse, or you should take extra measures in the form of non-hormonal methods, e.g. condom or any other barrier method. Do not use “safe periods” based on the menstrual cycle or temperature changes. These methods may be unreliable as Abelonelle 28 disrupts the normal changes in body temperature and cervical mucosa during the menstrual cycle.

Like other pill protects against Abelonelle 28 is not HIV – infection ( AIDS ) and other sexually transmitted diseases

Do not use Abelonelle 28:

Do not use Abelonelle 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 another 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 clotting, 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 are bedridden for a long period of time (see section “Blood clots”).
  • If you have or have had a heart attack or 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 jaundice or severe liver disease
  • If you have or have had cancer that is affected by sex hormones (eg breast cancer or genital cancer).
  • If you have or have had a benign or malignant liver tumor.
  • If you have unexplained bleeding from the abdomen.
  • If you are pregnant or think you may be pregnant.
  • If you are allergic to Ethinyl estradiol or levonorgestrel or any of the other ingredients of this medicine (listed in section 6).

If any of the above occur for the first time when you take the pill, stop using the tablets immediately, and consult a doctor.

Do not use Abelonelle 28 if you have hepatitis C and are taking medicines containing ombitasvir / paritaprevir / ritonavir, dasabuvir, glecaprevir / pibrentasvir and sofosbuvir / velpatasvir / voxilaprevir (see also section “Other medicines and Abelonelle 28”).

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 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 Abelonelle 28, you should also consult a doctor.

  • if you smoke
  • if you have diabetes
  • if you are overweight
  • if you have high blood pressure
  • if you have heart valve disease or a heart rhythm disorder
  • 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 clotting 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 Abelonelle 28
  • if you have an inflammation of the veins under the skin (superficial thrombophlebitis )
  • if you have varicose veins  
  • if a close relative has had a blood clot, heart attack, or stroke
  • if you suffer from migraines
  • if a close relative has had breast cancer
  • if you have liver or biliary tract disease
  • if you have a condition that first appeared or worsened during pregnancy or previous use of sex hormones (eg, hearing loss, a metabolic disease called porphyria, a skin disease called herpes gestationis, a neurological disease called Sydenham’s chorea)
  • if you have or have had chloasma (yellow-brown pigment spots, especially on the face); if so, you should avoid exposing yourself to too much sunlight or ultraviolet radiation.
  • contact a doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat and/or difficulty swallowing or hives, possibly with difficulty breathing. Products containing estrogen can cause or worsen the symptoms of hereditary or acquired angioedema.


Mental disorders

Some women using hormonal contraceptives, including Abelonelle 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.


BLOOD CLOTS

Using combined hormonal contraceptives such as Abelonelle 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 Abelonelle 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 soreness 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 breathingsudden cough for no apparent reason that could possibly cause you to cough up bloodsevere chest pain that may increase with deep breathingsevere instability or dizzinessfast or irregular heartbeatsevere pain in the abdomenIf 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, heavinesspressure or feeling of fullness in the chest, arm or below the sternumfeeling full, indigestion or feeling of suffocationdiscomfort in the upper body that radiates to the back, jaw, neck, arm and abdomensweating, nausea, vomiting or dizzinessextreme weakness, anxiety or shortness of breathfast 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 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 legsevere pain in the abdomen ( acuteabdomen) 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 did not use a combined hormonal contraceptive.

When you stop using Abelonelle 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 Abelonelle 28 is small. Of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel such as Abelonelle 28, approximately 5‑7 develop a blood clot in one year.


Risk of developing a blood clot during a year
Women who do not use combined pills and who are not pregnant About 2 out of 10,000 women
Women using a combined hormonal contraceptive containing levonorgestrel such as Abelonelle 28 About 5-7 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 Abelonelle 28 is small but some conditions increase the risk. The risk is higher:

  • if you are 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. Abelonelle 28 may need to be discontinued for several weeks before surgery or while you are less mobile. If you have to stop taking Abelonelle 28, ask your doctor when you can start taking 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 (over 4 hours) can temporarily increase the risk of a blood clot, especially if you have any of the other factors listed here.

It is important that you 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 Abelonelle 28.

If any of the above conditions change when you use Abelonelle 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?

Like a blood clot in a vein, a clot in an artery can lead to serious problems. It can e.g. cause a heart attack or stroke.

Factors that may increase the risk of a blood clot in an artery

It is important to know that the risk of a heart attack or stroke due to the use of Abelonelle 28 is very small but may increase:

  • with increasing age (after about 35 years of age)
  • if you smoke. When you use Abelonelle 28 combined hormonal contraceptives 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 that is not controlled with treatment
  • 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 you use Abelonelle 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.

Birth control pills and cancer

Breast cancer is diagnosed slightly more often in women who use birth control pill than in women of the same age who do not use birth control pills. The small increase in the number of breast cancer diagnoses gradually decreases during the first ten years after discontinuation of use. It is not known whether this difference is due to the contraceptive pill. It may be that women who use birth control pills are examined more often and thus any cancer is detected earlier.

In rare cases, benign liver tumors and, even more unusually, malignant liver tumors have been reported in birth control pill users. These tumors can cause internal bleeding. Contact a doctor immediately if you have severe pain in the abdominal region.

The most important risk factor for cervical cancer is an infection by the human papillomavirus ( genital warts ). Some studies have shown that long-term use of birth control pills can contribute to an increased risk of condyloma. However, it is not clear to what extent this is due to other factors such as sexual habits (including reduced condom use) or increased detection due to more regular cell sampling in the cervix in women using birth control pills.

Other medicines and Abelonelle 28

Do not use Abelonelle 28 if you have hepatitis C and are being treated with medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir / pibrentasvir, and sofosbuvir / velpatasvir / voxilaprevir, as treatment with these products may lead to elevated liver enzyme levels ( ALAT increase ).

Your doctor will prescribe you another type of contraceptive before starting such treatment.

Treatment with Abelonelle 28 can be resumed approximately 2 weeks after stopping treatment with ombitasvir / paritaprevir/ritonavir and dasabuvir. See the section “Do not use Abelonelle 28”.

Some medicines can affect the levels of birth control pills in the blood and thus prevent birth control pills from working properly. This applies, among other things, to medicines for the treatment of:

  • epilepsy (eg primidone, phenytoin, barbiturate, carbamazepine, oxcarbazepine, topiramate, felbamate);
  • tuberculosis (eg rifampicin and rifabutin);
  • HIV and hepatitis C virus infections;
  • fungal infections (griseofulvin, azole antifungals such as itraconazole, voriconazole, fluconazole );
  • bacterial infections (macrolide antibiotics, eg clarithromycin, erythromycin);
  • certain heart diseases, high blood pressure (calcium channel blockers, eg verapamil, diltiazem );
  • osteoarthritis, rheumatism (etoricoxib);
  • herbal medicines containing St. John’s wort (used mainly to treat depression).

Birth control pills can also affect the effectiveness of other medicines, for example:

  • ciclosporin, a drug that inhibits the immune system;
  • omeprazole, a medicine for gastrointestinal ulcers and acid reflux;
  • lamotrigine, an antiepileptic drug;
  • melatonin, a sleeping pill;
  • midazolam, a sleeping pill for use in anesthesia;
  • tizanidine, a muscle relaxant;
  • selegiline, a drug used to treat Parkinson’s disease

Tell your doctor/midwife or pharmacist if you are taking, have recently taken, or might take any other medicines. Also, tell other doctors or dentists who prescribe other medicines to you that you are using Abelonelle 28. They may tell you if you need to use additional methods of contraception and if so, for how long. You can also get advice at the pharmacy.

Abelonelle 28 with food and drink

You should not drink grapefruit juice while using Abelonelle 28 as it could increase the risk of side effects.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Abelonelle 28 should not be used by pregnant women or women who think they may be pregnant. If you suspect you are pregnant and you are already using Abelonelle 28, you should contact your doctor/midwife as soon as possible.

Breast-feeding

Abelonelle 28 is not recommended during breast-feeding. If you want to use birth control pills while breastfeeding, you should consult your doctor/midwife.

Driving and using machines

Abelonelle 28 has no or negligible influence on the ability to drive and use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is 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. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Abelonelle 28 contains lactose monohydrate

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

3. How to use Abelonelle 28

Always use this medicine exactly as your doctor/midwife or pharmacist has told you. Always follow the doctor’s / midwife’s prescription and the instructions on the pharmacy label. If you are not sure, talk to your doctor/midwife or pharmacist.

When and how to take the tablets

The Abelonelle 28 pack contains tablet tablets with 28 tablets each. The tablet should be taken at about the same time each day, along with some liquid. Follow the direction of the arrows until all 28 tablets have been taken (a detailed description can be found in the section “How to prepare the tablet map for use”). You usually get menstrual-like bleeding (loss of bleeding) two to three days after taking the last hormone tablet (ie during the time you are taking tablets from the last line of the tablet chart). The day after you finish a tablet chart, start a new one even if you are still bleeding. No tablet pause should be left between the tablet maps. This means that you always start on a new tablet chart on the same day of the week and that you will have your dropout bleeding on approximately the same days each month.

How to start with your first tablet map Abelonelle 28

When no hormonal contraceptive method has been used in the last month

Start taking Abelonelle 28 on the first day of the menstrual cycle, ie the first day of bleeding. Then take the tablets in turn in the direction of the arrows. Abelonelle 28 works from day one so no further contraceptive method is necessary.

You can also start taking Abelonelle 28 on days two to five of the menstrual cycle, but then you must use an extra method of contraception ( barrier method such as condoms) as a supplement during the first seven days of tablet treatment in the first menstrual cycle.

When changing from another combination contraceptive ( contraceptive pill, vaginal ring, or patch )

You can start taking Abelonelle 28 the day after the last tablet of the previous pill (this means that there should be no tablet interruption). If you already use a contraceptive pill where there are a few hormone-free tablets per map (ie delivered with 28 tablets per map), you can start with Abelonelle 28 after the last hormone tablet (if you are unsure which tablet it is, you can ask your doctor/midwife, or ask at the pharmacy). You can also start later, but never later than the day after the tablet-free interval (or the day after the last hormone-free tablet) for your previous pill. If you have used a vaginal ring or a patchy should preferably start using Abelonelle 28 on the same day as the ring or patch is removed and at the latest when treatment with the next ring or patch should have started. If you follow these instructions, no additional method of contraception is needed.

When changing from mini-pills ( birth control pills that only contain progestogens )

You can stop taking the mini-pills any day and start taking Abelonelle 28 at the same time the next day. Note that you should use another method of contraception (a barrier method ) if you have intercourse during any of the first seven days of treatment.

When changing from the contraceptive methods contraceptive syringe, contraceptive rod, or IUD

Start taking Abelonelle 28 on the day you should have received a new syringe or the day the contraceptive pill or hormonal IUD is removed. Note that you should use another method of contraception (a barrier method, such as a condom or pessary ) if you have intercourse during any of the first seven days of treatment.

After childbirth

If you have just given birth, a doctor/midwife may ask you to wait with Abelonelle 28 until you have had your first normal period. Sometimes you can start earlier, ask your doctor/midwife for advice. If you are breast-feeding and want to use Abelonelle 28, you should discuss this with your doctor/midwife before you start.

After abortion or miscarriage

Ask your doctor for advice.

How to prepare the tablet map for use

The packs of Abelonelle 28 contain both tablet charts (with 21 active hormone tablets and 7 inactive hormone-free ( placebo ) tablets (in the last row)) and self-adhesive labels to put on the tablet charts. Each set of self-adhesive labels contains seven strips with the days of the week. Select the strip that starts with the day you plan to start taking tablets. If you e.g. start on the tablet map on a Wednesday, select the strip that begins with “Wed”.

Attach the weekday strip to the top of the tablet map on the side that is transparent, the side where the tablets are visible, so that the first day is above the tablet in the red start field marked with “start”.

You can now see which day of the week you should take each tablet.

If you take more Abelonelle 28 than you should

Add title

150 micrograms / 30 micrograms film-coated tablets 
levonorgestrel / Ethinyl estradiol

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, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to a doctor/midwife, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

Important information about combined hormonal contraceptives:

  • They are one of the most reliable contraceptive methods available if used properly.
  • 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.
  • Pay attention and consult a doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

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

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

Abelonelle 28 is used as a contraceptive.

Abelonelle 28 is a combination pill that contains low amounts of two different female sex hormones. Abelonelle 28 consists of 21 tablets with active ingredients ( hormones ) and 7 hormone-free tablets (last row on the tablet map). Each hormone tablet contains both Ethinyl estradiol (an estrogen ) and levonorgestrel (a progestogen ). Due to the low levels of hormones, Abelonelle 28 is one of the low-dose birth control pills. All hormone tablets in the pack contain the same hormone at a constant dose, the contraceptive pill is therefore called monophasic.

The preventive effect of combined contraceptive pills is based on the interplay between different factors. The most important is considered to be that ovulation is inhibited and the changes in the uterine lining and by the secretions in the cervix.

Menstruation is affected so that the bleeding becomes more regular, menstruation often becomes less painful and the amount decreases

2. What you need to know before you use Abelonelle 28

Generally

Before you start using Abelonelle 28, read the information on blood clots in section 2. It is especially important that you read the symptoms of blood clots – see section 2, “Blood clots”).

This leaflet describes several situations in which you should stop taking Abelonelle 28, or when the protective effect of the contraceptive pill may be reduced. In these situations, you should not have intercourse, or you should take extra measures in the form of non-hormonal methods, e.g. condom or any other barrier method. Do not use “safe periods” based on the menstrual cycle or temperature changes. These methods may be unreliable as Abelonelle 28 disrupts the normal changes in body temperature and cervical mucosa during the menstrual cycle.

Like other pill protects against Abelonelle 28 is not HIV – infection ( AIDS ) and other sexually transmitted diseases

Do not use Abelonelle 28:

Do not use Abelonelle 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 another 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 clotting, 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 are bedridden for a long period of time (see section “Blood clots”).
  • If you have or have had a heart attack or 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 jaundice or severe liver disease
  • If you have or have had cancer that is affected by sex hormones (eg breast cancer or genital cancer).
  • If you have or have had a benign or malignant liver tumor.
  • If you have unexplained bleeding from the abdomen.
  • If you are pregnant or think you may be pregnant.
  • If you are allergic to Ethinyl estradiol or levonorgestrel or any of the other ingredients of this medicine (listed in section 6).

If any of the above occur for the first time when you take the pill, stop using the tablets immediately, and consult a doctor.

Do not use Abelonelle 28 if you have hepatitis C and are taking medicines containing ombitasvir / paritaprevir / ritonavir, dasabuvir, glecaprevir / pibrentasvir and sofosbuvir / velpatasvir / voxilaprevir (see also section “Other medicines and Abelonelle 28”).

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 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 Abelonelle 28, you should also consult a doctor.

  • if you smoke
  • if you have diabetes
  • if you are overweight
  • if you have high blood pressure
  • if you have heart valve disease or a heart rhythm disorder
  • 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 clotting 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 Abelonelle 28
  • if you have an inflammation of the veins under the skin (superficial thrombophlebitis )
  • if you have varicose veins  
  • if a close relative has had a blood clot, heart attack, or stroke
  • if you suffer from migraines
  • if a close relative has had breast cancer
  • if you have liver or biliary tract disease
  • if you have a condition that first appeared or worsened during pregnancy or previous use of sex hormones (eg, hearing loss, a metabolic disease called porphyria, a skin disease called herpes gestationis, a neurological disease called Sydenham’s chorea)
  • if you have or have had chloasma (yellow-brown pigment spots, especially on the face); if so, you should avoid exposing yourself to too much sunlight or ultraviolet radiation.
  • contact a doctor immediately if you experience symptoms of angioedema, such as swelling of the face, tongue, and/or throat and/or difficulty swallowing or hives, possibly with difficulty breathing. Products containing estrogen can cause or worsen the symptoms of hereditary or acquired angioedema.


Mental disorders

Some women using hormonal contraceptives, including Abelonelle 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.


BLOOD CLOTS

Using combined hormonal contraceptives such as Abelonelle 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 Abelonelle 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 soreness 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 breathingsudden cough for no apparent reason that could possibly cause you to cough up bloodsevere chest pain that may increase with deep breathingsevere instability or dizzinessfast or irregular heartbeatsevere pain in the abdomenIf 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, heavinesspressure or feeling of fullness in the chest, arm or below the sternumfeeling full, indigestion or feeling of suffocationdiscomfort in the upper body that radiates to the back, jaw, neck, arm and abdomensweating, nausea, vomiting or dizzinessextreme weakness, anxiety or shortness of breathfast 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 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 legsevere pain in the abdomen ( acuteabdomen) 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 did not use a combined hormonal contraceptive.

When you stop using Abelonelle 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 Abelonelle 28 is small. Of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel such as Abelonelle 28, approximately 5‑7 develop a blood clot in one year.



Risk of developing a blood clot during a year
Women who do not use combined pills and who are not pregnant About 2 out of 10,000 women
Women using a combined hormonal contraceptive containing levonorgestrel such as Abelonelle 28 About 5-7 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 Abelonelle 28 is small but some conditions increase the risk. The risk is higher:

  • if you are 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. Abelonelle 28 may need to be discontinued for several weeks before surgery or while you are less mobile. If you have to stop taking Abelonelle 28, ask your doctor when you can start taking 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 (over 4 hours) can temporarily increase the risk of a blood clot, especially if you have any of the other factors listed here.

It is important that you 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 Abelonelle 28.

If any of the above conditions change when you use Abelonelle 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?

Like a blood clot in a vein, a clot in an artery can lead to serious problems. It can e.g. cause a heart attack or stroke.

Factors that may increase the risk of a blood clot in an artery

It is important to know that the risk of a heart attack or stroke due to the use of Abelonelle 28 is very small but may increase:

  • with increasing age (after about 35 years of age)
  • if you smoke. When you use Abelonelle 28 combined hormonal contraceptives 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 that is not controlled with treatment
  • 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 you use Abelonelle 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.

Birth control pills and cancer

Breast cancer is diagnosed slightly more often in women who use birth control pill than in women of the same age who do not use birth control pills. The small increase in the number of breast cancer diagnoses gradually decreases during the first ten years after discontinuation of use. It is not known whether this difference is due to the contraceptive pill. It may be that women who use birth control pills are examined more often and thus any cancer is detected earlier.

In rare cases, benign liver tumors and, even more unusually, malignant liver tumors have been reported in birth control pill users. These tumors can cause internal bleeding. Contact a doctor immediately if you have severe pain in the abdominal region.

The most important risk factor for cervical cancer is an infection by the human papillomavirus ( genital warts ). Some studies have shown that long-term use of birth control pills can contribute to an increased risk of condyloma. However, it is not clear to what extent this is due to other factors such as sexual habits (including reduced condom use) or increased detection due to more regular cell sampling in the cervix in women using birth control pills.

Other medicines and Abelonelle 28

Do not use Abelonelle 28 if you have hepatitis C and are being treated with medicines containing ombitasvir/paritaprevir/ritonavir, dasabuvir, glecaprevir / pibrentasvir, and sofosbuvir / velpatasvir / voxilaprevir, as treatment with these products may lead to elevated liver enzyme levels ( ALAT increase ).

Your doctor will prescribe you another type of contraceptive before starting such treatment.

Treatment with Abelonelle 28 can be resumed approximately 2 weeks after stopping treatment with ombitasvir / paritaprevir/ritonavir and dasabuvir. See the section “Do not use Abelonelle 28”.

Some medicines can affect the levels of birth control pills in the blood and thus prevent birth control pills from working properly. This applies, among other things, to medicines for the treatment of:

  • epilepsy (eg primidone, phenytoin, barbiturate, carbamazepine, oxcarbazepine, topiramate, felbamate);
  • tuberculosis (eg rifampicin and rifabutin);
  • HIV and hepatitis C virus infections;
  • fungal infections (griseofulvin, azole antifungals such as itraconazole, voriconazole, fluconazole );
  • bacterial infections (macrolide antibiotics, eg clarithromycin, erythromycin);
  • certain heart diseases, high blood pressure (calcium channel blockers, eg verapamil, diltiazem );
  • osteoarthritis, rheumatism (etoricoxib);
  • herbal medicines containing St. John’s wort (used mainly to treat depression).

Birth control pills can also affect the effectiveness of other medicines, for example:

  • ciclosporin, a drug that inhibits the immune system;
  • omeprazole, a medicine for gastrointestinal ulcers and acid reflux;
  • lamotrigine, an antiepileptic drug;
  • melatonin, a sleeping pill;
  • midazolam, a sleeping pill for use in anesthesia;
  • tizanidine, a muscle relaxant;
  • selegiline, a drug used to treat Parkinson’s disease

Tell your doctor/midwife or pharmacist if you are taking, have recently taken, or might take any other medicines. Also, tell other doctors or dentists who prescribe other medicines to you that you are using Abelonelle 28. They may tell you if you need to use additional methods of contraception and if so, for how long. You can also get advice at the pharmacy.

Abelonelle 28 with food and drink

You should not drink grapefruit juice while using Abelonelle 28 as it could increase the risk of side effects.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.


Pregnancy

Abelonelle 28 should not be used by pregnant women or women who think they may be pregnant. If you suspect you are pregnant and you are already using Abelonelle 28, you should contact your doctor/midwife as soon as possible.

Breast-feeding

Abelonelle 28 is not recommended during breast-feeding. If you want to use birth control pills while breastfeeding, you should consult your doctor/midwife.

Driving and using machines

Abelonelle 28 has no or negligible influence on the ability to drive and use machines.


You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is 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. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Abelonelle 28 contains lactose monohydrate

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


3. How to use Abelonelle 28

Always use this medicine exactly as your doctor/midwife or pharmacist has told you. Always follow the doctor’s / midwife’s prescription and the instructions on the pharmacy label. If you are not sure, talk to your doctor/midwife or pharmacist.

When and how to take the tablets

The Abelonelle 28 pack contains tablet tablets with 28 tablets each. The tablet should be taken at about the same time each day, along with some liquid. Follow the direction of the arrows until all 28 tablets have been taken (a detailed description can be found in the section “How to prepare the tablet map for use”). You usually get menstrual-like bleeding (loss of bleeding) two to three days after taking the last hormone tablet (ie during the time you are taking tablets from the last line of the tablet chart). The day after you finish a tablet chart, start a new one even if you are still bleeding. No tablet pause should be left between the tablet maps. This means that you always start on a new tablet chart on the same day of the week and that you will have your dropout bleeding on approximately the same days each month.

How to start with your first tablet map Abelonelle 28


When no hormonal contraceptive method has been used in the last month

Start taking Abelonelle 28 on the first day of the menstrual cycle, ie the first day of bleeding. Then take the tablets in turn in the direction of the arrows. Abelonelle 28 works from day one so no further contraceptive method is necessary.


You can also start taking Abelonelle 28 on days two to five of the menstrual cycle, but then you must use an extra method of contraception ( barrier method such as condoms) as a supplement during the first seven days of tablet treatment in the first menstrual cycle.


When changing from another combination contraceptive ( contraceptive pill, vaginal ring, or patch )

You can start taking Abelonelle 28 the day after the last tablet of the previous pill (this means that there should be no tablet interruption). If you already use a contraceptive pill where there are a few hormone-free tablets per map (ie delivered with 28 tablets per map), you can start with Abelonelle 28 after the last hormone tablet (if you are unsure which tablet it is, you can ask your doctor/midwife, or ask at the pharmacy). You can also start later, but never later than the day after the tablet-free interval (or the day after the last hormone-free tablet) for your previous pill. If you have used a vaginal ring or a patchy should preferably start using Abelonelle 28 on the same day as the ring or patch is removed and at the latest when treatment with the next ring or patch should have started. If you follow these instructions, no additional method of contraception is needed.


When changing from mini-pills ( birth control pills that only contain progestogens )

You can stop taking the mini-pills any day and start taking Abelonelle 28 at the same time the next day. Note that you should use another method of contraception (a barrier method ) if you have intercourse during any of the first seven days of treatment.

When changing from the contraceptive methods contraceptive syringe, contraceptive rod, or IUD

Start taking Abelonelle 28 on the day you should have received a new syringe or the day the contraceptive pill or hormonal IUD is removed. Note that you should use another method of contraception (a barrier method, such as a condom or pessary ) if you have intercourse during any of the first seven days of treatment.

After childbirth

If you have just given birth, a doctor/midwife may ask you to wait with Abelonelle 28 until you have had your first normal period. Sometimes you can start earlier, ask your doctor/midwife for advice. If you are breast-feeding and want to use Abelonelle 28, you should discuss this with your doctor/midwife before you start.

After abortion or miscarriage

Ask your doctor for advice.


How to prepare the tablet map for use

The packs of Abelonelle 28 contain both tablet charts (with 21 active hormone tablets and 7 inactive hormone-free ( placebo ) tablets (in the last row)) and self-adhesive labels to put on the tablet charts. Each set of self-adhesive labels contains seven strips with the days of the week. Select the strip that starts with the day you plan to start taking tablets. If you e.g. start on the tablet map on a Wednesday, select the strip that begins with “Wed”.

Attach the weekday strip to the top of the tablet map on the side that is transparent, the side where the tablets are visible, so that the first day is above the tablet in the red start field marked with “start”.

You can now see which day of the week you should take each tablet. Heading

If you want to quit Abelonelle 28

You can stop taking Abelonelle 28 at any time. If you stop because you want to get pregnant, it is recommended that you wait until you have had your first natural menstrual bleeding before trying to get pregnant. This facilitates the calculation of when the birth is to take place. Ask your doctor/midwife about other methods of contraception if you do not want to become pregnant.

If you forget to take Abelonelle 28

If you forgot to take tablets from the fourth row on the tablet map, it does not matter. You are still protected against pregnancy because they do not contain any active ingredients. To maintain reliable protection against pregnancy, it is important that you do not change the dosing schedule. To avoid confusion, discard the forgotten tablets and take the next tablet as usual. If you have forgotten a tablet in row 4 on your current tablet map, it is important that you take the first tablet from the next map at the right time.

The following advice applies if you forgot to take hormone tablets (lines 1-3 on the tablet map):

If less than 12 hours have passed since you took your hormone tablet, you are still protected against pregnancy. Take the tablet as soon as you remember and the next tablet at the usual time.

If more than 12 hours have passed, the effect of the contraceptive pill may be reduced. The more hormone tablets in a row that you have missed, the higher the risk that the preventive effect has decreased. The risk of getting pregnant is especially high if you forget tablets at the beginning of the tablet chart or at the end of week 3 (third line on the tablet chart). Therefore, always follow the instructions given below (see also the diagram):

  • More than 1 tablet in the tablet map has been forgotten:
  • Contact your doctor/midwife for advice.
  • 1 tablet forgotten during week 1: 
    Take the skipped 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 contraceptive protection ( barrier method, eg condom) for the next seven days. If you have had intercourse during the week before the forgotten tablet, there is a risk that you will become pregnant. Inform your doctor/midwife immediately.
  • 1 tablet forgotten during week 2: 
    Take the skipped 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. The contraceptive pill still has the desired effect and you do not need to use extra preventive protection. If more than 1 tablet is forgotten, supplementary contraceptive protection should be used for 7 days.
  • 1 tablet forgotten during week 3: 
    You can choose between one of the following two options and you do not need to use extra contraceptive protection:
    1. Take the skipped 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. When the hormone tablets on the tablet chart are finished (after row 3), start on the next tablet chart immediately, without stopping the tablet. (The seven hormone-free tablets should not be used.) You will probably not have proper bleeding until you reach the end of row 3 on the second tablet map. However, you may experience spotting and breakthrough bleeding during the days you take tablets.
      or:
    2. You can stop taking hormone tablets and switch to hormone-free tablets (row 4 on the tablet map). It is important that the number of hormone-free days never exceeds a total of 7 days. Then start on a new tablet map as usual.
  • If you have forgotten to take tablets in a tablet chart and you do not get your expected period while taking tablets from line 4, you may be pregnant. Consult your doctor/midwife before starting the next tablet chart.

If you suffer from gastrointestinal problems (eg vomiting or severe diarrhea)

If you vomit or have severe diarrhea after taking tablets from lines 1-3 on the tablet map, the active ingredients in Abelonelle 28 may not be fully absorbed. If you vomit within 3-4 hours after taking the tablet, it gives the same situation as if you have not taken the tablet. Therefore, follow the instructions for the forgotten tablet above. Contact a doctor if you have severe diarrhea. Vomiting or diarrhea while taking tablets from row 4 on the tablet map does not affect the protection against pregnancy.

If you want to postpone a period

You can postpone your period if you continue to take the hormone tablets from a new tablet map Abelonelle 28 immediately after line 3 on the previous map has been used up (do not take the tablets from line 4). You can continue to take tablets from the new map for as long as you wish until all the hormone tablets (they end inline 3) on the new map are used up. If you want your period to start earlier than that, just stop taking the tablets from the other map. Take a tablet break for a maximum of seven days (during which you get your period) and then start a new pack. Under the second tablet map, you may experience breakthrough bleeding or spotting even on days when you are taking tablets.

If you want to change the start date for your period

If you take your tablets according to the instructions, you will experience loss of bleeding approximately on the same day of the week every four weeks. If you want to change this to another day, you can refrain from taking all the tablets in row 4 before starting on the next tablet chart. For example. If you usually start bleeding on a Friday and in the future want the bleeding to start on a Tuesday (three days earlier), you can start on the next tablet chart three days earlier than usual. Discard the three remaining hormone-free tablets on the current tablet map and start on a new tablet map without pausing between maps. If you take very few tablets from line 4 (eg three or less), there may be no bleeding. You may instead experience breakthrough bleeding or spotting while using the next tablet chart.

If you experience unexpected bleeding

When using all birth control pills, during the first months there may be irregular bleeding (breakthrough bleeding and splashing bleeding) between your regular dropout bleeding. You may need to use menstrual pads, but continue to take the tablets as usual. The irregular bleeding usually stops as soon as the body has adapted to the contraceptive pill (normally after about three rounds of treatment). If they persist after this, become stronger or return, you should inform the doctor/midwife.

If menstruation is absent

If you have taken all the tablets at the right time, have not vomited or had severe diarrhea while taking tablets from lines 1-3, or used other medicines, it is very unlikely that you would be pregnant. Continue taking Abelonelle 28 as usual. If the bleeding does not occur twice in a row, you may be pregnant. Inform the doctor/midwife immediately. Do not start on the next tablet card until your doctor/midwife has verified that you are not pregnant.

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 Abelonelle 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 thrombosis, ATE) are all women taking hormonal contraceptives combined. For more information on the different risks of using combined hormonal contraceptives, see section 2 “What you need to know before using Abelonelle 28”

During the first rounds of treatment, you can be expected to get some side effects, e.g. chest tightness, nausea, and spotting. These initial side effects usually disappear within 2 to 4 months of treatment.

Serious side effects:

Contact a doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue and/or throat and/or difficulty swallowing, hives, possible breathing, and difficulty breathing (see also section “Warnings and precautions”).

Other side effects:

Common side effects are (may affect up to 1 in 10): Weight gain, headaches, depression, mood changes, nausea, abdominal pain, breast tenderness, breast pain, breast pain, and bleeding.

Less common side effects are (may affect up to 1 in 100): Fluid (accumulation of fluid in the body), migraine, decreased sexual desire, moderate hypertension, vomiting, diarrhea, rash, hives, missed menstrual bleeding, and breast enlargement.

Rare side effects are (may affect up to 1 in 1000 patients): hypersensitivity, reduced glucose tolerance, elevated blood sugar, increased insulin requirements, weight loss, increased sexual desire, decreased lacrimation, difficulty wearing contact lenses, liver disorders, itching, jaundice, gallstones, chloasma (brown pigmented spots on the face), skin reactions, fluid secretion from the breasts and altered discharge from the vagina, dangerous blood clots in a vein or artery which includes heart attack, stroke, blood clot in a leg or foot, in the lungs.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Abelonelle 28

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

Do not store above 30 ° C. 
Use before the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

The medicine 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

Active tablets

  • The active substances are 30 micrograms Ethinyl estradiol and 150 micrograms levonorgestrel.
  • The other ingredients are lactose monohydrate, maize starch, gelatin, magnesium stearate, hypromellose, macrogol, titanium dioxide (E 171), and yellow iron oxide (E 172).

Hormone-free tablets

The hormone-free tablets do not contain any active substance.

  • Ingredients are lactose monohydrate, corn starch, gelatin, magnesium stearate, hypromellose, macrogol, titanium dioxide (E 171), and red iron oxide (E 172).

What the medicine looks like and the contents of the pack

Appearance

The active tablets are brownish and round convex.

The hormone-free tablets are red and round convex.

Pack sizes

Abelonelle 28 comes in calendar packs of 3×28 tablets or 13×28 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Alternova A / S, Lodshusvej 11, 4230 Skælskør, Denmark

Manufacturer

Pharbil Waltrop GmbH, Im Wirrigen 25, Germany

or

Orifarm Generics A / S, Energivej 15, 5260 Odense S, Denmark

Muhammad Nadeem

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