100 micrograms / 20 micrograms film-coated tablets
levonorgestrel / ethinyl estradiol

What Levesia® is and what it is used for

  • Levesia is a contraceptive used to prevent pregnancy.
  • The pink tablets contain low amounts of two different female sex hormones, ethinyl estradiol and levonorgestrel.
  • The white tablets do not contain any medicine, they are also called placebo tablets
  • Birth control pills that contain two hormones are called combination pills . Levesia is called a low-dose birth control pill because it contains only small amounts of hormones .

Levonorgestrel and ethinyl estradiol contained in Levesia may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.

What you need to know before using Levesia®

Do not use Levesia®

  • 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 have (or have had) a heart attack or stroke (stroke)
  • if you know you have a disease that affects blood coagulation – e.g. protein C ‑ deficiency, protein S ‑ deficiency, antithrombin ‑ III ‑ deficiency, Factor V Leiden or antiphospholipid antibodies
  • if you need to have an operation or if you stay in bed for a longer period (see section “Blood clots”)
  • if you have (or have had) any disease that may be a first sign of a heart attack (eg angina, which causes severe chest pain) or transient ischemic attack ( TIA – transient stroke symptoms)
  • if you have any of the following conditions that may increase the risk of a blood clot in your arteries:
    • 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 hepatitis C and are taking medicines containing ombitasvir / paritaprevir / ritonavir, dasabuvir, glekaprevir / pibrentasvir and sofosbuvir / velpatasvir / voxilaprevir (see also section “Other medicines and Levesia”).
  • if you have (or have had) inflammation of the pancreas ( pancreatitis )
  • if you have (or have had) a liver disease and your liver function has not yet returned to normal
  • if you have (or have had) a liver tumor
  • if you have (or have had), or are suspected of having, breast or genital cancer
  • if you have unexplained bleeding from the abdomen
  • if your period stops, possibly linked to exercise or diet
  • if you are allergic to ethinyl estradiol or levonorgestrel or any of the other ingredients of this medicine (listed in section 6).

Generally

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

Before you can start using Levesia, your doctor will ask you some questions regarding the medical history and medical history of your immediate family. Your doctor will also measure your blood pressure and, depending on your personal situation, perform other tests.

This leaflet describes several situations when you should stop taking Levesia, 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 can be unreliable as Levesia upsets the normal changes in body temperature and cervical mucosa during the menstrual cycle.

Like other pill protects against Levesia not HIV – infection ( AIDS ) and other sexually transmitted diseases.

During the time you are taking this medicine, you should see your doctor regularly, at least twice a year.

If you get any unusual symptoms such as unexplained chest pain or pain in the abdomen or legs, you must contact your doctor immediately.

Warnings and cautions

Talk to your doctor or pharmacist before using Levesia

  • if a close relative has or has had breast cancer
  • if you have liver or biliary tract disease
  • if you have diabetes
  • if you suffer from depression
  • 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 Levesia
  • if you have an inflammation of the veins under the skin (superficial thrombophlebitis )
  • if you have varicose veins
  • if you have Crohn’s disease or ulcerative colitis ( chronic inflammatory bowel disease)
  • 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 epilepsy (see section “Other medicines and Levesia”)
  • if you have a systemic lupus erythematosus ( SLE – a disease that affects your natural immune system)
  • 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 korea)
  • 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 .

When should you contact a doctor?

Seek medical attention immediately

  • if you notice any possible signs of a blood clot that may indicate 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”.

BLOOD CLOTS

Using combined hormonal contraceptives such as Levesia increases the risk of blood clots compared to not using 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 the artery (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 Levesia is small.

HOW TO FEEL A BLOOD CLOTH AGAIN
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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 tenderness 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 breathing sudden cough for no apparent reason that could cause you to cough up blood severe chest pain that may increase with deep breathing severe instability or dizziness fast or irregular heartbeat severe pain in the abdomen 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 blurred vision without pain that can lead to vision loss Retinal venous thrombosis (blood clot in the eye)
chest pain, discomfort, pressure, heavinesspressure or feeling of fullness in the chest, arm, or below the sternum feeling satiated, indigestion or feeling of suffocationdiscomfort in the upper body that radiates to the back, jaw, neck, arm and abdomensweating, nausea, vomiting or dizziness extreme weakness, anxiety or shortness of breakfast or irregular heartbeat Myocardial infarction
sudden weakness or numbness in the face, arms, or legs, especially on one side of the body sudden confusion, difficulty speaking or understanding sudden vision problems in one or both eyes sudden difficulty walking, dizziness, loss of balance or coordination Sudden, severe or prolonged headache for no known reason consciousness or fainting with or without seizures sometimes the symptoms of a stroke can be short-lived with almost immediate or complete recovery, but you should still seek medical attention immediately because you are at risk of having a new stroke. Stroke
swelling and slight blue discoloration of an arm or leg severe pain in the abdomen ( acute abdomen) Blood clots that block other blood vessels

BLOOD CLOTS IN A FRIEND

What can happen if a blood clot forms in a vein?

  • The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in the vein (venous thrombosis ). However, these side effects are rare. They usually occur during the first year of using a combined hormonal contraceptive.
  • If a blood clot forms in a vein in the leg or foot, it can lead to deep vein thrombosis (DVT).
  • If a blood clot moves from the bone and stays in the lung, it can lead to a pulmonary embolism .
  • In very rare cases, a blood clot can form in a vein in another organ such as the eye ( retinal venous thrombosis ).

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

The risk of developing a blood clot in a vein is greatest during the first year that you use combined hormonal contraceptives for the first time. The risk can also be higher if you start again with a combined hormonal contraceptive (same product or another product) after a break of 4 weeks or longer.

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 Levesia, 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 Levesia is small.

  • Of 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 develop a blood clot in one year.
  • Of 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, noretisterone, or norgestimate, about 5‑7 develop a blood clot in one year.
  • The risk of developing a blood clot will vary depending on your personal medical history (see “Factors that may increase the risk of a blood clot in a vein” below)

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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 taking a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate About 5-7 out of 10,000 women
Women using Levesia 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 Levesia is small but some conditions increase the risk. The risk is higher:

  • if you are overweight (body mass index or BMI over 30 kg / m2)
  • if someone in your family has had a blood clot in their bones, lungs or other 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 an extended period of time due to injury or illness, or if your leg is plastered. The use of Levesia may need to be stopped for several weeks before surgery or while you are less mobile. If you have to stop taking Levesia, 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 more conditions you have, the greater the risk of developing a blood clot.

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.

You must tell your doctor if any of these conditions apply to you, even if you are unsure. Your doctor may decide that you need to stop taking Levesia.

If any of the above conditions change when you use Levesia, 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?

In the same way as 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 Levesia is very small but may increase:

  • with increasing age (after about 35 years of age)
  • if you smoke. When you use combined hormonal contraceptives Levesia, 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 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 Levesia, 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.

Lesia and cancer

Breast cancer is diagnosed slightly more often in women who use birth control pills, but it is not known if the increase is due to birth control pills. It may be that women who use birth control pills are examined more often and thus any cancer is detected earlier. The small increase in the number of breast cancer diagnoses gradually decreases after discontinuation of use. It is important to examine your breasts regularly and consult a doctor if you notice any lump in your breasts.

In rare cases, benign liver tumors and, even more uncommonly, malignant liver tumors have been reported in birth control pill users. Contact a doctor if you have severe pain in the abdominal region.

Cervical cancer has been reported in association with the long-term use of birth control pills. However, it is not clear to what extent this is due to sexual behavior or other factors, such as infection by the human papillomavirus (HPV).

Mental disorders

Some women who use hormonal contraceptives, including Levesia, 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.

Bleeding between periods

During the first few months that you use Levesia, there may be irregular bleeding (bleeding outside the week you take placebo tablets – tablets without medication). If these bleedings persist for more than a couple of months or if they return after a few months, consult a doctor to find out what is wrong.

If menstruation is absent

If you have taken all the pink tablets at the right time, have not vomited or had severe diarrhea in the meantime, or used other medicines, it is very unlikely that you would be pregnant.

If there is no bleeding 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.

Other medicines and Levesia®

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. They can tell you if you need to use additional contraceptive methods (eg condoms) and if so, for how long.

Some medicines can affect the levels of Levesia in the blood and thus make the medicine less effective in preventing pregnancy, and can cause unexpected bleeding:

  • This includes treatment with drugs for:
    • epilepsy (eg primidone, phenytoin , barbiturates , carbamazepine, oxcarbazepine, topiramate or felbamate)
    • tuberculosis (eg rifampicin)
    • osteoarthritis , rheumatism (etoricoxib)
    • HIV – infection (for example ritonavir, nelfinavir, efavirenz)
    • fungal infections (eg griseofulvin)
    • high blood pressure in the blood vessels of the lungs ( bosentan )
  • Herbal medicines containing St. John’s wort

Levesia can also affect the effectiveness of other medicines, for example:

  • medicines containing ciclosporin
  • Lamotrigine, a drug for epilepsy (this may increase the frequency of seizures)
  • theophylline (used to treat respiratory problems)
  • tizanidine (used to treat muscle pain and / or muscle cramps)

Treatment with troleandomycin may increase the risk of worsening or total obstruction of bile flow from the liver to the small intestine when taken with combination pills.

Do not use Levesia if you have hepatitis C and are taking medicines containing ombitasvir / paritaprevir / ritonavir, dasabuvir, glekaprevir / pibrentasvir and

sofosbuvir / velpatasvir / voxilaprevir as treatment with these products may lead to elevated liver function values ​​in the blood (an increase in the liver enzyme ALT ).

Your doctor will prescribe a different type of contraceptive before you start treatment with these drugs.

Levesia can be started about 2 weeks after the end of this treatment. See section “Do not use Levesia”.

Ask your doctor or pharmacist for advice before taking any other medicine.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Laboratory tests

If you have a blood test, tell your healthcare provider that you are using Levesia as it may affect the results of some tests.

Pregnancy, breastfeeding and fertility

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

Pregnancy

Levesia should not be used by pregnant women. If you become pregnant while taking Levesia, stop treatment immediately and contact your doctor. If you want to get pregnant, you can stop the treatment at any time (see also the section “If you stop using Levesia”).

Breast-feeding

Levesia is not recommended during breastfeeding. If you want to use birth control pills while you are breastfeeding, you should consult your doctor.

Driving and using machines

Levesia 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.

Levesia® contains excipients

Levesia 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.

Levesia contains Allura red AC and soy lecithin

Film coating at Levesia contains all-red AC aluminum lacquer (E129) and soy lecithin, substances that can cause allergic reactions. If you are allergic to peanuts or soy, do not use this medicine.

How to use Levesia®

Always use Levesia exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.

If you have used another contraceptive before starting treatment with Levesia 28 tablets, you know that the majority of contraceptives contain 21 tablets. With these contraceptives, you take one tablet for 21 days and then a week follows when you do not take any tablets (drug-free period).

The system to follow when using Levesia 28 tablets is different. Once you have taken the 21 pink tablets, you must continue and take 7 placebo tablets; Consequently, there is no drug-free period, but one placebo week (the week you take the placebo tablets in row 4). Since you have to take one tablet every day and there is thus no drug-free period between two packs, it becomes a routine to take the tablets and consequently, there is less risk that you forget to take one tablet.

The two different colors of Levesia 28 tablets are placed in order. One pack contains 28 tablets.

Take one tablet of Levesia every day. Levesia can be taken with or without food, if necessary with a small amount of water. You should take the tablets every day around the same time.

Do not mix the tablets: take one pink tablet once a day for the first 21 days and then a white tablet once a day for the last 7 days. You must start a new tablet immediately (21 pink tablets and then 7 white tablets). So that there is no tablet-free period between two tablet maps.

Due to the different compositions of the tablets, it is necessary that you start with the first tablet at the top left (near the label “START”) and that you take one tablet per day. For the correct order, follow the direction of the arrow on the tablet map.

For you to remember to take the tablet, Levesia is included in each pack, one self-adhesive sticker per tablet card that contains 7 self-adhesive weekly stickers that have the days of the week printed on them. Choose the weekly label that starts with the day you start taking the tablets. For example, if you start on a Wednesday, use the weekly label that begins with “ONS”.

Place the weekly label at the top of the tablet map where you can read “Attach the weekly adhesive strip here”.

There will then be a specified day of the week above each tablet and you can see if you have taken one tablet on a particular day. The arrows show the order in which you should take the tablets.

During the 7 days when you take the white placebo tablets (placebo days), the bleeding should start (so-called dropout bleeding). It usually starts 2 or 3 days after you take the last pink (active) tablet. After taking the last white tablet, start with the following tablet chart, regardless of whether the bleeding has stopped or not. This means that you should start each tablet chart on the same day of the week, and that dropout bleeding should occur on the same days each month.

If you use Levesia in this way, you will also be protected against pregnancy during the 7 days when you take a white placebo tablet.

How to start with your first tablet map

  • When no hormonal contraceptive method has been used in the last monthStart taking Levesia on the first day of the menstrual cycle (ie the first day of bleeding). If you start with Levesia on the first day of the menstrual cycle, you have immediate protection against pregnancy. You can also start taking Levesia on days 2-5 of the menstrual cycle, but then you must use an extra method of contraception (eg condoms) as a supplement for the first 7 days.
  • When changing from another contraceptive of combination type – birth control pill , vaginal ring or patchYou can start taking Levesia the day after the last tablet of the previous pill (the last tablet containing medicines), but never later than the day after the tablet-free interval (or the day after the last hormone-free tablet) of your previous pill . If you are changing from a vaginal ring or a combination- type patch , follow your doctor’s instructions.
  • When changing from the contraceptive methods with only progestogens (mini- pills , contraceptive syringe , contraceptive rod or IUD)You can stop taking the mini-pills any day and start taking Levesia. For the contraceptive rod or IUD, the change must take place on the day the IUD or IUD is removed. For p- syringe , start taking Levesia on the day you should have received a new syringe . In all these cases, you should use an additional method of contraception (such as a condom) during the first seven days of taking the tablet.
  • After abortion or miscarriageAsk your doctor for advice.
  • After childbirthYou can start treatment between 21 and 28 days after you have had a child. If you start after day 28, use a so-called barrier method (eg condom) for the first seven days of using Levesia.If you have had sex after giving birth but before starting Levesia (again), make sure you are not pregnant or wait until the next period.
  • If you are breast-feeding and want to start treatment with Levesia (again) after giving birthRead the section “Breastfeeding”.

Ask your doctor if you are unsure when to start.

If you use more Levesia® than you should 

No serious adverse effects have been reported after taking too many Levesia tablets at the same time. If you have taken several tablets at the same time, you may experience nausea or vomiting. Younger women may experience genital bleeding.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects are

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, possibly with difficulty breathing (see also section “Warnings and precautions”).

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 you use Levesia”.

The following side effects may be associated with the use of Levesia.

Common (may affect up to 1 in 10 people)

  • mood swings, depression
  • headache
  • nausea, abdominal pain
  • sore breasts
  • weight gain
  • rash

Uncommon (may affect up to 1 in 100 people)

  • decreased sexual desire
  • migraine
  • vomiting, diarrhea
  • itching , rash
  • enlarged breasts
  • fluid retention in the body ( edema )

Rare (may affect up to 1 in 1,000 people)

  • difficulty wearing contact lenses
  • allergic reactions
  • increased sexual desire
  • vaginal discharge, discharge from the breasts
  • painful reddish nodules in the skin (tuberose, erythema nodosum)
  • skin rash with annular redness or sores (erythema multiforme)
  • weight loss

The following serious side effects have been reported slightly more frequently in women taking oral contraceptives (see section 2: Warnings and precautions):

  • blood clots in a friend
  • blood clots in an artery
  • high blood pressure
  • liver tumors or breast cancer
  • functional disorders in the liver
  • harmful blood clots in a vein or artery , for example:- in one leg or foot (so-called DVT)- in a lung (so-called PE)- heart attack- stroke- mini- stroke or transient stroke-like symptoms called transient ischemic attack ( TIA ) or blood clots in the liver, stomach / intestines, kidneys or eyes.

The risk of developing a blood clot may be higher if you have any other conditions that increase this risk (see section 2 for more information on the conditions that increase the risk of blood clots and symptoms of a blood clot).

The following conditions can occur or be exacerbated with combined oral contraceptives: Crohn’s disease, ulcerative colitis, epilepsy, migraine, endometriosis, porphyria (metabolic disease-causing stomach pain and mental illness), systemic lupus erythematosus ( SLE, where the body attacks and damages its organs and tissue er), herpes during late pregnancy, Sydenham’s chorea (rapid involuntary jerky movements), Hemolytic uremic syndrome (a condition that occurs after diarrhea caused by E.coli), liver problems manifested by jaundice, diseases affecting the gallbladder or gallstone formation.

How to store Levesia®

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

Do not use this medicine after the expiry date which is stated on the carton and tablet carton after EXP.

The expiration date is the last day of the specified month.

No special storage instructions.

Levonorgestrel / Ethinyl estradiol may affect aquatic organisms. 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.

Contents of the pack and other information

Content declaration

The active substances are 100 micrograms of levonorgestrel and 20 micrograms of Ethinyl estradiol

Levesia contains tablets in 2 colors:

  • The pink tablets contain 100 micrograms levonorgestrel and 20 micrograms ethinyl estradiol. The other ingredients are: anhydrous lactose , povidone K-30 (E1201), magnesium stearate (E470b) and in the pink film coating (polyvinyl alcohol, partially hydrolysed (E1203), talc (E553b), titanium dioxide (E171), macrogol 3350, alluric red AC aluminum lacquer ), lecithin (E322), iron oxide, red (E172) and indiogocarmin aluminum lacquer (E132)].
  • The white tablets (inactive tablet or placebo tablet) contain only additives (no active substance) namely: anhydrous lactose , povidone K-30 (E1201), magnesium stearate (E470b) and in the white film coating (polyvinyl alcohol, partially hydrolysed (E1203), talc (E553b) ), titanium dioxide (E171), macrogol 3350].

What the medicine looks like and contents of the pack

The active tablets are pink, round, and have a diameter of approximately 5.7 mm.

The placebo tablets are white, round, and have a diameter of approximately 5.7 mm.

Each tablet map contains 21 light pink active film-coated tablets in the first, second, and third rows of the tablet map and 7 white film-coated placebo tablets in row 4.

Levesia is supplied in packs of 1, 3, 6, or 13 tablet tablets with 28 tablets each.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Manufacturer

Leon Farma Laboratories, SA

Polígono Industrial Navatejera, La Vallina S / N

24008 Navatejera (Leon) – Spain

This medicinal product is authorized under the European Economic Area under the names:

Belgium: Levesialle Continue 20 0.02 mg / 0.10 mg film-coated tablets / compressed pellets / film tablets

Denmark: Mirabella 28

Finland: Levesia 100 micrograms / 20 micrograms calvopäällysteiset tablet

France: Asterluna continuous 20 100 micrograms / 20 micrograms, compressed pelleted

Italy: Lasca

Luxembourg: Levesialle Continue 20 0.02 mg / 0.10 mg compressed pellets

Norway: Mirabella

Portugal: Levesialle 28

Spain: Levesialle Diario 0.10 mg / 0.02 mg compresses recovered with EFG film

Sweden: Levesia

Germany: Asumate 20/21 + 7 0.10 mg / 0.02 mg Film tablet

Muhammad Nadeem

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