Anastrella 28 150 micrograms / 30 micrograms film-coated levonorgestrel and Ethinyl estradiol tablets
1. What Anastrella 28 Is And What It Is Used For
Anastrella 28 is a combination pill that contains low amounts of two different female sex hormones: estrogen (Ethinyl estradiol) and progestogen (levonorgestrel). The hormones protect you from getting pregnant, just as the body’s own hormones prevent further conception when you are already pregnant. All hormone tablets in the pack contain the same amount of the two hormones.
Levonorgestrel and Ethinylestradiol contained in Anastrella 28 may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
- Each of the 21 yellow tablets contains a small amount of levonorgestrel and Ethinyl estradiol.
- The 7 white tablets do not contain any active substances and are also called placebo tablets.
What You Need To Know Before Taking Anastrella 28
Generally
Before you start using Anastrella 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 Anastrella 28, or where the reliability of Anastrella 28 can no longer be guaranteed
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 Anastrella 28 disrupts the normal changes in body temperature and cervical mucosa during the menstrual cycle.
Like other pill protects against Anastrella 28 is not HIV – infection ( AIDS ) and other sexually transmitted diseases.
Do not use Anastrella 28
Do not use Anastrella 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.
Do Not Take Anastrella 28:
- 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 that you have a disease that affects blood coagulation – e.g.
- Protein C deficiency
- Protein S deficiency
- Antithrombin III deficiency
- Factor V Leiden
- Antiphospholipid antibodies
- If you need to have an operation or if you stay in bed for a long period of 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 diseases that may increase the risk of a blood clot in your arteries:
- Severe diabetes with damaged blood vessel
- 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 hepatitis C and are taking medicines containing
- Ombitasvir
- Paritaprevir
- Ritonavir
- Dasabuvir
- Glekaprevir
- Pibrentasvir
- Sofosbuvir
- Velpatasvir
- Voxilaprevir (see also section “Other medicines and Anastrella 28”).
- If you have (had) an inflammation of the pancreas ( pancreatitis ).
- If you have or have ever had a liver disease and your liver function is still not normal.
- If you have or have had a tumor in your liver.
- If you have (had) or are suspected of having breast or genital cancer.
- If you have had any unexplained vaginal bleeding.
- If you have any disease of the arteries are or veins in the eye.
- If you are allergic to levonorgestrel or Ethinyl estradiol or any of the other ingredients of this medicine (listed in section 6).
If any of the above occur for the first time while you are taking the pill, stop using the tablets immediately, and consult a doctor.
Warnings And Cautions
Talk to your doctor, pharmacist, or nurse before taking Anastrella 28.
| When should you contact a doctor?Seek medical attention immediatelyif 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 while you are using Anastrella 28, you should also consult a doctor.
- 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 a hereditary condition of 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 getting blood clots. Ask your doctor how soon after giving birth you can start using Anastrella 28.
- If you have inflammation of the veins under the skin (superficial thrombophlebitis).
- If you have varicose veins.
- If a close relative has or has had breast cancer.
- If you have any disease of the liver or gallbladder.
- If you have diabetes.
- If you have a disease that occurred during pregnancy or previous use of sex hormones such as
- Porphyria (a blood disease)
- Hearing loss
- Herpes gestationis (skin rash with blisters during pregnancy)
- Sydenham’s chorea (a neurological disease that causes sudden body movements)
- If you have or have had chloasma (yellow-brown pigment spots, so-called pregnancy spots, especially on the face). In this case, avoid direct exposure to sunlight or ultraviolet light.
- Contact a doctor immediately if you experience symptoms of Angioedema, such as
- Swelling of the face, tongue, and/or throat and
- Difficulty swallowing
- Hives
- Possibly with difficulty breathing.
- Products containing estrogen can cause or worsen symptoms of hereditary or acquired angioedema.
- If you already have high blood pressure and the condition worsens.
Blood clots
Using combined hormonal contraceptives such as Anastrella 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 Anastrella 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 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 abdomen.If you are not sure, talk to a doctor because some of these symptoms, e.g. cough and shortness of breath, can be mistakenly interpreted as a milder condition such as a respiratory infection (such as a common cold). | Pulmonary embolism |
| Symptoms that usually occur in one eye: immediate loss of vision or blurred vision without pain that can lead to vision loss. | Retinal venous thrombosis (blood clot in the eye) |
| chest pain, discomfort, pressure, 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 of anastrella 28 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 Anastrella 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 Anastrella is small.
- Of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel such as Anastrella 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 Anastrella | 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 Anastrella 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 under 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 due to injury or illness, or if your leg is plastered. The use of Anastrella 28 may need to be stopped for several weeks before an operation or while you are less mobile. If you have to stop taking Anastrella, 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 Anastrella 28.
If any of the above conditions change when you use Anastrella 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 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 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 Anastrella 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 Anastrella 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 when you use Anastrella 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.
Anastrella 28 and cancer
Breast cancer has been observed slightly more often in women using combined contraceptive pills, but it is not known if it is the treatment that is the cause. For example, it could be that more tumors are detected in women who take Anastrella birth control pills because they are examined more often by doctors. The incidence of breast cancer tumors gradually decreases after stopping treatment with combined oral contraceptives. It is important that you regularly examine your breasts and consult a doctor if you feel any lump.
In rare cases, benign liver tumors, and even more uncommonly, malignant liver tumors have been reported in birth control pill users. These tumors can cause internal bleeding. Contact a doctor if you experience unusual and severe abdominal pain.
Cervical cancer is more commonly seen in long-term users of combined Anastrella birth control pills. This does not have to be directly associated with the use of combined contraceptive pills, but may be due to the fact that women who use oral contraceptives are examined more often for cervical cancer. Some people may have different sexual behavior than those who use other contraceptives, such as condoms. The biggest risk factor for cervical cancer is long-term infection with a specific virus (human papillomavirus), which may be more common in users of combined oral contraceptives.
Mental disorders
Some women using hormonal contraceptives, including Anastrella 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
If you experience unexpected bleeding
During the first few months of taking Anastrella 28, there may be irregular bleeding between your regular periods. If these bleedings last for more than a few months, or if they start after a few months, a doctor should investigate.
What to do if there is no bleeding
If you have taken all the tablets at the right time, have not vomited or had severe diarrhea, or used other medicines, it is very unlikely that you would be pregnant.
If the bleeding does not occur twice in a row, you may be pregnant. Contact your doctor immediately. Do not start on the next tablet card until you are sure you are not pregnant.
Other Medicines And Anastrella 28
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Also, tell your doctor or dentist who is prescribing other medicines to you (or your pharmacist who is prescribing the medicine) that you are taking Anastrella 28. They may tell you if you need to use additional contraceptives (for example, condoms) and if so, how long.
Some medicines may affect the level of Anastrella 28 and make Anastrella 28 less effective in preventing pregnancy or causing unexpected bleeding. This includes drugs for the treatment of:
- Epilepsy eg
- Primidone
- Phenytoin
- Barbiturates
- Carbamazepine
- Oxcarbazepine
- Topiramate
- Felbamate
- tuberculosis eg
- Rifampicin
- HIV and hepatitis C virus infections
- fungal infections
- Griseofulvin
- Azole antifungals such as itraconazole, voriconazole, fluconazole
- Bacterial infections Macrolide antibiotics, eg
- Clarithromycin
- Erythromycin
- Troleandomycin
- Certain heart conditions
- High blood pressure calcium channel blockers, eg
- Verapamil
- Diltiazem
- Osteoarthritis
- Rheumatism (etoricoxib)
- The herbal medicine St. John’s wort
- Grapefruit juice
Anastrella 28 may also affect the effectiveness of other medicines, for example:
- Ciclosporin (a medicine that inhibits the immune system)
- Lamotrigine (a medicine used to treat epilepsy )
- Melatonin (a sleeping pill)
- Midazolam (an anesthetic for use in anesthesia)
- Theophylline (a medicine used to treat asthma )
- Tizanidine, (a muscle relaxant)
Do not use Anastrella 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 increased liver function enzyme ( ALT ).
Your doctor will prescribe you another type of contraceptive before you start treatment with these drugs.
Treatment with Anastrella 28 can be resumed approximately 2 weeks after stopping treatment with these drugs. See the section “Do not take Anastrella 28”.
Ask your doctor or pharmacist for advice before taking any medicine.
Impact on test results
If you need to take blood samples, tell your doctor or laboratory staff that you are taking birth control pills, as they may affect the results of certain tests.
Anastrella 28 With Food And Drink
You should not drink grapefruit juice while using Anastrella 28.
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
If you become pregnant while taking Anastrella 28, stop taking the tablets immediately, and contact your doctor.
Breast-feeding
It is generally not recommended for women who are breast-feeding to use Anastrella 28. If you want to take Anastrella birth control pills while breastfeeding, you should consult a doctor.
Driving And Using Machines
Anastrella 28 has no known effects on the ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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.
Anastrella 28 Contains Lactose
Anastrella 28 contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How To Take Anastrella 28
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Take one Anastrella 28 tablet every day, along with some water if needed. You can take the tablets with or without food, but you should take them at about the same time each day.
The tablet map contains 28 tablets; 21 active yellow tablets and 7 white placebo tablets. The two different colored tablets are arranged in order and it is marked with arrows between them. The package also contains self-adhesive label strips to put on the tablet map. Each set of self-adhesive labels contains seven strips that list seven weekdays. Select the strip that starts with the day you plan to start taking the tablets.
For example, if you start on a Wednesday, select the strip that begins with “Wed.” Attach the weekday strip to the top of the tablet chart, where “Place Label Strip Here” is indicated, so that the first day is above the tablet where “start” is indicated. Place a strip beginning with the same day of the week on each tablet chart. You can now see which day of the week you should take each tablet.
Do not mix the tablets: take one yellow tablet once a day for the first 21 days and then one white tablet a day for the last 7 days. Then start on a new tablet chart (21 yellow tablets and 7 white tablets) the following day. Consequently, there will be no tablet-free period between the tablet maps.
Due to the different compositions of the tablets, your first tablet must be one in the upper left corner and you must continue to take one tablet every day. To keep the order in order, follow the direction of the arrows on the tablet map.
During the 7 days when you take the white placebo tablets (the placebo days), the bleeding should start (so-called dropout bleeding). This usually starts on day 2 or day 3 after the last yellow active tablet of Anastrella 28. After taking the last white tablet, start with the following tablet chart for the next day, whether or not the bleeding has stopped. This means that you should start each tablet chart on the same day of the week and that dropout bleeding occurs on the same days each month.
If you take Anastrella 28 as directed, you will also be protected against pregnancy during the 7 days you are taking the placebo tablets.
How To Start With Your First Anastrella 28 Tablet Chart
- If you have not used any hormonal contraceptive method in the last month:
Start taking Anastrella 28 on the first day of your menstrual cycle, that is, the first day you have menstrual bleeding. If you start taking Anastrella 28 on the first day of your period, you will receive immediate protection against pregnancy. You can also start on days 2–5 of the menstrual cycle, but then you must use extra protection (for example a condom) for the first 7 days.
- If you are switching from any other combination hormonal contraceptive ( contraceptive pill, vaginal ring, or contraceptive patch ):
Preferably start taking Anastrella 28 the day after you take the last active tablet (that is, the last tablet containing the active substance) of the Anastrella birth control pills you used before. You can also start later, but not later than the day after the last tablet-free day (or the last inactive tablet) of your previous pill treatment. When changing from a vaginal ring or combination patch, follow the doctor’s advice.
- If you switch from one method of contraception with progestogen-only ( the pill only progestogen, p syringe, implants, or spiral that secrete progestogen):
You can change from a pill with only progestogen any day, from prod or IUD the day you removed it and from the contraceptive syringe when you should have taken the next syringe, but in all these cases you must use extra protection (for example a condom) during the first 7 days you take the tablets. - After a miscarriage:
Follow your doctor’s advice. - After you have had a baby:
After you have had a baby, you can start taking Anastrella 28 21 to 28 days after delivery. If you start later than day 28, you must use a so-called barrier contraceptive (such as a condom) during the first 7 days of using Anastrella 28. If you have had intercourse after giving birth and before starting Anastrella 28 (again), you must first make sure you are not pregnant or wait until the next menstrual period.
Consult a doctor if you are unsure when to start.
- If you are breast-feeding and want to start taking Anastrella 28 after you have had a baby:
Read the section “Breastfeeding”.
There have been no reports of serious adverse effects after taking too many Anastrella 28 tablets. If you take several tablets at the same time, you may experience nausea or vomiting. Young girls may experience vaginal bleeding.
If You Forget To Take Anastrella 28
The tablets in row 4 of the tablet map are placebo tablets. If you forget one of these tablets, it does not affect the reliability of Anastrella 28. Discard the forgotten placebo tablet.
If you miss a yellow active tablet from line 1, 2, or 3 (Week 1-3), do the following:
- 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 more than 12 hours have passed, the effect of the contraceptive pill may be reduced. The more tablets in a row that you have missed, the higher the risk that the protective effect against pregnancy has decreased.
The risk of getting pregnant is especially high if you forget a yellow tablet at the beginning or end of the tablet chart. Therefore, always follow the instructions given below:
More than one forgotten tablet in the current tablet map
Contact your doctor.
A forgotten tablet 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 and use extra protection for the next 7 days, such as a condom. If you have had intercourse during the week before the forgotten tablet, you should be aware that there is a risk that you may be pregnant. If this is the case, contact your doctor.
A forgotten tablet during week 2
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. You still have effective protection against pregnancy provided you have taken the tablets on time for the previous 7 days. Otherwise, you should use extra protection for the next 7 days.
A forgotten tablet during week 3
You can choose between the following two options:
- 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. Instead of taking the white placebo tablets on this tablet, discard them, and start immediately on the next tablet. You will probably have your period (dropout bleeding) at the end of the second tablet chart, while you are taking the white placebo tablets, but you may also have splashing or breakthrough bleeding while taking the second tablet chart.
- You can also stop taking the active yellow tablets and go directly to the 7 white placebo tablets ( before taking the placebo tablets, make a note of the day you forgot your tablet ). If you want to start a new tablet map on the same day of the week as before, take the white placebo tablets for less than 7 days.
If you follow either of these two recommendations, you will continue to have protection against pregnancy.
If you have forgotten to take tablets on a tablet chart and do not get your period during the normal placebo days, you may be pregnant. Contact your doctor before starting the next tablet map.
Overview of the procedure in case of missed tablet
If you experience vomiting or severe diarrhea
If you vomit within 3-4 hours after taking a tablet, or if you get severe diarrhea, there is a risk that your body will not absorb the active substance in the tablet properly. It’s kind of like forgetting to take a tablet. After vomiting or having diarrhea, you must take another tablet from a spare card as soon as possible. If possible, take it within 12 hours of the time you usually take the tablet. If this is not possible or if more than 12 hours have elapsed, follow the advice in the section “If you forget to take Anastrella 28”.
Important to know if you want to postpone a period
Although not recommended, it is possible to postpone menstruation (bleeding) by not taking the white placebo tablets from line 4 and going directly to a new tablet map of Anastrella 28 and ending it. You may experience spotting (drops or small patches of blood) or breakthrough bleeding while using the other tablet map. End the second tablet map by taking the 7 white tablets from row 4. Then start your next tablet map.
Feel free to consult a doctor before you decide to postpone your period.
It is important to know if you want to change the start day for your period
If you take the tablets according to the instructions, your menstruation/loss of bleeding will start during the placebo week. If you need to change the start date of your period, do so by reducing the number of placebo days – when you take the white placebo tablets (but never increasing them – 7 is the maximum). For example: if you normally start taking placebo tablets on a Friday, and you want to change this to a Tuesday (three days earlier), you must start on a new tablet chart 3 days earlier than usual. If you make the placebo period very short (eg three days or less) you may not have any bleeding during these days. Instead, you may experience spotting (drops or small patches of blood) or breakthrough bleeding.
If you are not sure how to do this, you can contact your doctor for advice. 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 recur, you should inform your doctor.
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 to take Anastrella 28 as usual. If the bleeding does not occur twice in a row, you may be pregnant. Inform the doctor immediately. Do not start on the next tablet card until your doctor has checked that you are not pregnant.
If You Want To Stop Taking Anastrella 28
You can stop taking Anastrella 28 whenever you want. If you do not want to get pregnant, consult your doctor about other reliable methods of contraception.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible Side Effects Of Anastrella 28
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any side effects of anastrella 28, especially if they are serious or persistent, or if your health changes and you think it may be due to Anastrella 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 Anastrella 28”.
Serious side effects of anastrella 28 are
Contact a doctor immediately if you experience any of the following symptoms of angioedema:
- Swelling of the face, tongue and/or throat and
- Difficulty swallowing
- Hives
- Possibly with difficulty breathing (see also section “Warnings and precautions”).
Uncommon side effects of anastrella 28 (may affect up to 1 in 100 people)
- Breast cancer. Contact a doctor if you feel a lump in your chest.
- Liver cancer. Both benign and malignant liver tumors can cause internal bleeding. Contact your doctor if you have unusual and severe pain in the abdominal region.
- Cervical cancer can cause bleeding and discharge from the abdomen as well as pain and bleeding during sex. Contact a doctor.
- Inflammation of the pancreas with severe abdominal pain and fever. Contact a doctor immediately.
- Bile duct disease (including gallstones ) with severe pain under the right thorax. Contact a doctor immediately.
Rare side effects of anastrella 28 (may affect up to 1 in 1,000 people)
- Dangerous blood clots in the vein or artery, such as
- Heart attack
- Stroke
- Blood clot in the legs, feet, or lungs. Contact a doctor immediately.
- A hypersensitivity reaction is e.g.
- Sudden rash
- Swelling of the tongue lips, and face
- Difficulty breathing
- Fainting ( angioedema ). Contact a doctor immediately.
- Allergic reactions can sometimes be severe with swelling of the skin and/or mucous membranes (erythema nodosum and erythema multiforme). Contact a doctor immediately.
Common side effects of anastrella 28 (may affect up to 1 in 10 people)
- Mood swings
- Depression
- Headache
- Abdominal pain
- Chest pain
- Chest pain
- Chest tension
- Weight gain
- Nausea
Uncommon side effects (may affect up to 1 in 100 people)
- Vomiting
- Diarrhea
- Fluid retention (accumulation of fluid in the body)
- Migraine
- Decreased sex drive
- Breast enlargement
- Itchy red rash on the skin ( urticaria )
- Rash
- Visual disturbances
Rare side effects of anastrella 28 (may affect up to 1 in 1,000 people)
- Hypersensitivity to contact lenses
- Allergic reactions
- Weight loss
- Increased sex drive
- Discharge from the breasts
- Discharge from the vagina
- Itching
- Pigment spots on the face
Reporting of side effects of anastrella 28
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 Anastrella 28
- Keep this medicine out of the sight and reach of children.
- Do not store above 30 ° C.
- Do not use this medicine after the expiry date which is stated on the carton. 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
One tablet map contains 21 yellow active tablets in rows 1, 2, and 3 of the tablet map and 7 white placebo tablets in row 4.
Active tablets:
- The active substances are levonorgestrel 150 micrograms and Ethinyl estradiol 30 micrograms.
- The other ingredients are Tablet core: lactose monohydrate, povidone K-30, crospovidone, and magnesium stearate. Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc (E553b), and iron oxide yellow (E172).
Placebo tablets:
- Tablet core: lactose, anhydrous, povidone K-30, magnesium stearate.
- Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc (E553b).
What The Medicine Looks Like And The Contents Of The Pack
- Active tablets are yellow, round, film-coated tablets with a diameter of 6 mm.
- The placebo tablets are white, round, film-coated tablets with a diameter of 6 mm.
- Anastrella 28 is available in cartons of 3 or 13 tablet cartridges of 28 tablets each (21 active tablets plus 7 placebo tablets).
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Orifarm Generics A / S
Energivej 15
5260 Odense S
Denmark
Local representative:
Orifarm Generics AB,
Box 56048
102 17 Stockholm
info@orifarm.com
This medicinal product is authorized under the European Economic Area under the names:
Denmark, : Anastrella 28