150 micrograms / 30 micrograms film-coated tablets
levonorgestrel / ethinyl estradiol
What Leverette 21 is and what it is used for
- Leverette 21 is a birth control pill and is used to prevent pregnancy.
- Each tablet contains a small amount of two different female sex hormones, namely levonorgestrel and ethinyl estradiol.
- Birth control pills that contain two hormones are called combined birth control pills .
Levonorgestrel and Ethinyl estradiol contained in Leverette 21 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 taking Leverette 21
Before using Leverette 21, read the information on blood clots in section 2. You must read the information on the symptoms of blood clots – see section 2, “Blood clots”.
Before you can start taking Leverette 21, your doctor will ask you some questions about your personal and immediate relatives’ medical history. Your doctor will also measure your blood pressure and possibly do some other tests, depending on your situation.
This leaflet describes several situations when you should stop taking Leverette 21, or when the protective effect of the contraceptive pill may be reduced. In these situations, you should not have intercourse or you should use additional protection in the form of a non-hormonal contraceptive, e.g. condom or another barrier method. Do not use “safe periods” based on the menstrual cycle or temperature changes. Such methods can be unreliable because Leverette 21 disrupts the normal changes in body temperature and cervical mucosa during the menstrual cycle.
Like other pill protects Leverette 21 not against HIV – infection ( AIDS ) and other sexually transmitted diseases.
Do not take Leverette 21
Do not use Leverette 21 if you have any of the conditions listed below. If you have any of these conditions, you need to tell your doctor. The doctor will discuss what other 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 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 may be a first sign of a heart attack) or transient ischemic attack ( TIA – transient stroke symptoms).
- If you have any of the following conditions that may increase the risk of a blood clot in your arteries:
- severe diabetes with damaged blood vessels
- very high blood pressure
- a very high level of fat in the blood ( cholesterol or triglycerides )
- a condition called hyperhomocysteinemia.
- If you have (or have had) a type of migraine called “migraine with aura”.
- If you have (or have had) a liver disease and your liver values are still not normal.
- If you have (or have had) a tumor in your liver.
- If you have (or have had) or are suspected of having breast or genital cancer.
- If you have unexplained vaginal bleeding.
- If you are allergic to ethinyl estradiol, levonorgestrel or any of the other ingredients of this medicine (listed in section 6). An allergic reaction can cause itching , rash or swelling.
- If you have hepatitis C and are being treated with medicines containing ombitasvir / paritaprevir / ritonavir, dasabuvir, glekaprevir / pibrentasvir andsofosbuvir / velpatasvir / voxilaprevir (see also section “Other medicines and Leverette 21”).
Warnings and cautions
When should you contact a doctor?
Seek medical attention immediately
- if you notice signs of a blood clot that may indicate that you have a blood clot in your leg (ie deep vein thrombosis ), a blood clot in your lung (ie pulmonary embolism ), a heart attack or a stroke (see section “Blood clots” below).
The symptoms of these serious side effects are described in more detail in the section “How to recognize a blood clot” below.
Tell your doctor if any of the following apply to you.
If any of the following occur or occur while using Leverette 21, consult a physician. In some situations, you may need to be especially careful when using Leverette 21 or any other combined pill, and you may need to be examined regularly by a doctor.
- If a close relative has or has had breast cancer.
- If you have a disease of the liver or gallbladder.
- If you have diabetes .
- If you have depression. Some women who use hormonal contraceptives, including Leverette 21, have reported depression or depression. Depression can be a serious condition and can sometimes lead to suicidal thoughts. If you notice mood swings and depressive symptoms, you should contact a doctor for medical advice as soon as possible.
- 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 high blood fats ( hypertriglyceridemia ) or a hereditary condition of this condition. Hypertriglyceridemia has been linked to 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, the risk of getting a blood clot is higher. Ask your doctor how soon after giving birth you can start using Leverette 21.
- If you have inflammation of the veins under the skin (superficial thrombophlebitis ).
- If you have varicose veins.
- If you have epilepsy (see section “Other medicines and” Leverette 21 ”).
- If you have a condition that first appeared during pregnancy or previous use of sex hormones (eg, hearing loss, a blood disease called porphyria , skin rash with blisters during pregnancy ( herpes gestationis), a nerve disease that causes sudden body movements (Sydenhams korea) ).
- If you have or have had chloasma (yellow-brown pigment spots, especially on the face or neck, so-called pregnancy spots). If this is the case, you should avoid direct 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 .
Using combined hormonal contraceptives such as Leverette 21 increases the risk of blood clots compared to if you do not use such drugs. In rare cases, a blood clot can block the blood vessels and cause serious problems.
Blood clots can form
- in the veins (called venous thrombosis , venous thromboembolism or VTE)
- in artery engines (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 Leverette 21 is small.
HOW to DO YOU IGE N Emboli
Seek medical attention immediately if you notice any of the following signs or symptoms. Show larger
|Do you experience any of these signs?||What could it be due to?|
|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 altered skin color of 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. 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 most common in one eye: immediate loss of vision or blurred vision without pain that can lead to vision loss.||Retinal venous thrombosis (blood clot in the eye)|
|Chest pain, discomfort, pressure, heavinesspressure or feeling of fullness in the chest, arm, or below the sternum feeling full, indigestion or suffocationdiscomfort in the upper body that radiates to the back, jaw, neck, arm, and abdomen sweating, nausea, vomiting or dizziness extreme weakness, anxiety or shortness of breath fast 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. The symptoms of a stroke can sometimes be short-lived with almost immediate or complete recovery, but you should still seek medical attention immediately as 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 a blood clot in a 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 gets stuck 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 had not used a combined hormonal contraceptive.
When you stop using Leverette 21, 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 overall risk of a blood clot in the leg or lung with Leverette 21 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 over a 1-year period.
- Of the 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel, such as Leverette 21, approximately 5-7 develop a blood clot over a 1-year period.
- The risk of getting a blood clot varies depending on your personal medical history (see “Factors that increase the risk of a blood clot” below).
|Risk of developing a blood clot over 1 year|
|Women who do not use combined contraceptive pills/patches / contraceptive rings and who are not pregnant||About 2 out of 10,000 women|
|Women using combined oral contraceptives containing levonorgestrelsuch as Leverette 21||About 5-7 out of 10,000 women|
|Women using Leverette 21||About 5-7 out of 10,000 women|
Factors that increase the risk of a blood clot in a vein
The risk of a blood clot with Leverette 21 is small, but certain circumstances increase the risk. The risk is higher:
- if you are severely overweight (body mass index or BMI over 30 kg / m 2 )
- if a close relative has had a blood clot in the bone, lung or other organ at a young age (eg under about 50 years); in that 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 Leverette 21 may need to be discontinued for several weeks before surgery or while you are less mobile. If you have to stop taking Leverette 21, 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 of these conditions that exist.
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 circumstances apply to you, even if you are unsure. Your doctor may decide that you must stop taking Leverette 21.
Talk to your doctor if any of the above circumstances change while you are using Leverette 21, e.g. if a close relative suffers from a blood clot for an unknown reason or if you gain a lot of weight.
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. Such a blood clot can e.g. cause a heart attack or stroke.
Factors that 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 Leverette 21 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 Leverette 21, 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 such a case, you may also be at greater risk of a heart attack or stroke .
- if you or a close relative have high blood fat levels ( cholesterol or triglycerides )
- if you have migraine attacks, especially migraines with aura
- if you have heart problems (valve disease, a heart rhythm disorder called atrial fibrillation )
- if you have diabetes .
If more than one of the above circumstances applies to you or if any of them are particularly serious, the risk of developing a blood clot can be even greater.
Talk to your doctor if any of the above circumstances change when you use Leverette 21, e.g. if you start smoking, a close relative suffers from thrombosis of unknown cause, or if you gain a lot of weight.
Leverette 21 and cancer
Breast cancer is diagnosed somewhat more often in women who use combined contraceptive pills, but it is not known if this is due to the treatment. For example, it may be that more tumors are detected in women who use birth control pills because they are examined more often.
The incidence of breast tumors gradually decreases after discontinuation of combined hormonal contraceptives. You must be examined by a doctor if you feel a lump.
In rare cases, benign liver tumors and, even more rarely, malignant liver tumors have been reported in birth control pill users. Contact a doctor immediately if you have unusually severe pain in the abdominal region.
Cervical cancer has been observed somewhat more frequently in long-term contraceptive users compared to non-users, but it is unclear to what extent this is related to sexual behavior and other factors, such as human papillomavirus (HPV).
During the first months of taking Leverette 21, you may experience unexpected bleeding (bleeding at times other than during the tablet-free period). If such bleeding occurs for more than a few months or only occurs after a few months, talk to your doctor to find out what is wrong.
What to do if you do not experience any bleeding during the tablet-free period
If you have taken all the tablets correctly, have not vomited, or had severe diarrhea and you have not taken any other medicines, it is highly unlikely that you are pregnant.
If the expected bleeding does not occur twice in a row, you may be pregnant. Contact a doctor immediately. Do not start with the next tablet card until you are sure you are not pregnant.
Other medicines and Leverette 21
Always tell the doctor/midwife who prescribes Leverette 21 if you are taking, have recently taken, or might take any other medicines, including (traditional) herbal medicines and herbal remedies. Also, tell other doctors or dentists who prescribe other medicines (or the pharmacy staff) that you are taking Leverette 21. They may tell you if you need to use additional contraceptives (eg condoms) and if so, for how long.
Do not use Leverette 21 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 values (elevated levels of the liver enzyme ALT ).
Your doctor will prescribe another contraceptive before starting treatment with these medicines.
Leverette 21 can be started again about 2 weeks after the end of treatment. See section “Do not use Leverette 21”.
Some medicines can affect the levels of Leverette 21 in the blood and can reduce the protection against pregnancy or cause unexpected bleeding. These include:
- drugs for the treatment of:
- epilepsy (eg primidone, phenytoin , barbiturates , carbamazepine, oxcarbazepine)
- tuberculosis (eg rifampicin)
- HIV and hepatitis C virus infections (so-called protease inhibitors and non-nucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz)
- fungal infections (eg griseofulvin)
- arthritis , osteoarthritis (eg etoricoxib)
- high blood pressure in the blood vessels of the lungs ( bosentan )
- (traditional) herbal medicines containing St. John’s wort .
Leverette 21 may affect the effectiveness of other medicines, for example:
- medicines containing ciclosporin
- the epilepsy drug lamotrigine (this may lead to an increased number of epileptic seizures)
- theophylline (for the treatment of respiratory problems)
- tizanidine (for the treatment of muscle pain and / or muscle cramps).
Leverette 21 with food and drink
Leverette 21 can be taken with or without food, if necessary with a little water.
If you need to take a blood test, tell your doctor or laboratory staff that you are taking birth control pills as hormonal contraceptives may affect certain test results.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor/midwife or pharmacist for advice before taking this medicine.
Do not take Leverette 21 if you are pregnant. If you become pregnant while taking Leverette 21, stop taking the contraceptive pill immediately and contact a doctor/midwife. If you want to get pregnant, you can stop taking the contraceptive pill at any time (see also “If you want to stop taking Leverette 21”).
The use of Leverette 21 is generally not recommended for breastfeeding women. If you want to use birth control pills while you are breastfeeding, contact your doctor/midwife.
Driving and using machines
There is no information to suggest that the use of Leverette 21 affects 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 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. Therefore, always read all the information in this leaflet for guidance. If you are not sure, talk to your doctor/midwife or pharmacist.
Leverette 21 contains lactose
This medicine 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 Leverette 21
Always take this medicine exactly as your doctor/midwife has told you. If you are not sure, talk to your doctor/midwife or pharmacist.
Remember to take Leverette 21 according to the instructions as forgotten tablets may reduce the effect of the medicine.
How and when to use Leverette 21:
Each tablet map contains 21 tablets.
Take a Leverette 21 tablet every day, if necessary with a little water. You should take the tablets at about the same time each day.
The day of the week that the tablet is to be taken is printed next to each tablet. Start by taking a tablet from the first row marked with the current day of the week. For example, if you start on a Wednesday, take a tablet with “ONS” next to it. Follow the direction of the arrows until you have taken all 21 tablets. You should then not take any tablets for the next seven days. During these seven tablet-free days (also called tablet-free or tablet-free weeks), you should experience menstrual-like bleeding. This so-called dropout bleeding usually begins on the second or third day of the tablet-free week.
On the eighth day after the last Leverette 21 tablet (ie after the 7-day tablet pause), start with the next tablet chart, whether or not the bleeding has stopped. This means that you should start each tablet chart on the same day of the week and the bleeding should occur on the same days each month.
If you use Leverette 21 in this way, you are protected against pregnancy even during the 7 days when you do not take any tablets.
When you can start taking Leverette 21
- If you have not used any hormonal contraceptives in the previous monthStart taking Leverette 21 on the first day of the menstrual cycle (ie the first day of bleeding). If you start with Leverette 21 on the first day of menstruation, you are immediately protected against pregnancy. You can also start on day 2‑5 of the cycle, but then you must use additional contraceptives (eg condoms) for the first 7 days.
- If you change from a combined contraceptive pill , vaginal ring or contraceptive patchYou should preferably start taking Leverette 21 on the day after the last active tablet (the last tablet containing active substances) of your previous pill and no later than the day after stopping the tablet with your previous pill ).If you change from a vaginal ring or contraceptive patch , follow the doctor’s / midwife’s advice.
- If you change from a contraceptive with only progestogens (mini-pills, contraceptive syringe , contraceptive pill or IUD)You can change from mini-pills any day (from the IUD or IUD the same day the IUD is removed, and from the IUD) gun the day you would get the next injection ). In all these cases, you must use additional contraceptives (eg condoms) during the first 7 days of Leverette 21.
- If you have had a miscarriageFollow the doctor’s / midwife’s advice.
- After childbirthYou can start taking Leverette 21 between 21 and 28 days after delivery. If you start later than day 28, use a barrier method (eg condom) for the first 7 days.If you have had intercourse after giving birth before taking Leverette 21, you must be sure that you are not pregnant or wait until the next period before taking this medicine.
- During breastfeedingIf you are breast-feeding and want to start taking Leverette 21 again after having a baby, read the section “Pregnancy and breast-feeding”.
Ask your doctor/midwife if you are unsure when to start taking Leverette 21.
If you take more Leverette 21 than you should
No serious adverse effects have been reported after taking too many Leverette 21 tablets. If you have taken several tablets at the same time, you may experience nausea or vomiting. Young girls may experience vaginal bleeding.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Talk to your doctor if you get a side effect, especially if it is serious or persistent, or if your health changes and you think it may be due to Leverette 21.
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, possible nausea, and difficulty breathing (see also section “Warnings and precautions”).
All women who use combined hormonal contraceptives have an increased risk of blood clots in the veins (venous thromboembolism, VTE), or blood clots in the arteries are ( arterial thromboembolism, ATE). For more information on the different risks of using combined hormonal contraceptives, see section 2: “What you need to know before taking Leverette 21”).
Listed below are side effects that have been linked to the use of Leverette 21:
Common side effects are (may affect up to 1 in 10):
- abdominal pain
- weight gain
- mood change
- sore breasts
- chest pain.
Less common side effects are (may affect up to 1 in 100):
- fluid retention
- decreased sexual desire
- breast augmentation
- hives ( urticaria ).
Rare side effects are (may affect up to 1 in 1000 people):
- contact lens intolerance (difficulty wearing contact lenses)
- weight loss
- increased sexual desire
- fluid secretion from the breasts
- discharge from the vagina
- a type of dermatitis that causes reddish, painful, sore lumps (erythema nodosum)
- a skin condition that causes red, target-like spots or sores (erythema multiforme)
- dangerous blood clots in a vein or artery , eg:
- in one leg or foot (ie DVT)
- in a lung
- myocardial infarction
- ministroke or transient stroke-like symptoms, a so-called transient ischemic attack ( TIA )
- blood clots in the liver, stomach / intestines, kidneys or eye.
The risk of getting a blood clot may be greater if you have another condition that increases this risk (section 2 contains more information on factors that increase the risk of blood clots and the symptoms of a blood clot).
The following serious side effects have been reported somewhat more frequently in women taking oral contraceptives but it is unclear whether this is due to treatment (see section 2: “Warnings and precautions”):
- high blood pressure
- liver tumors or breast cancer.
The following conditions have also been associated with combined oral contraceptives:
Crohn’s disease, ulcerative colitis, epilepsy, migraine, endometriosis, porphyria (metabolic disease that causes abdominal pain and mental disorders), systemic lupus erythematosus (in which the body attacks and damages its organs and tissues ), herpes late in pregnancy, Sydenham’s chorea (rapid involuntary jerky and jerky movements), hemolytic uremic syndrome (a condition that occurs after diarrhea caused by the bacterium E.coli), liver problems that manifest as jaundice, gallbladder disease or gallstone formation.
How to store Leverette 21
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 and tablet carton after “EXP”. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
- The active substances are levonorgestrel and ethinyl estradiol. Each tablet contains 150 micrograms levonorgestrel and 30 micrograms ethinyl estradiol.
- Other ingredients are:Tablet core: lactose monohydrate , povidone, crospovidone and magnesium stearate.Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc (E553b) and yellow iron oxide (E172)
What the medicine looks like and contents of the pack
- Each tablet map with Leverette 21 contains 21 yellow film-coated tablets.
- The Leverette 21 tablets are film-coated. The tablets are yellow, round and have a diameter of 6 mm and are approximately 4 mm thick.
- Leverette 21 is available in packs of 1, 3, 6 or 13 tablet cards with 21 tablets on each card. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Exeltis Healthcare SL
Avenida Miralcampo 7
Poligono Industrial Miralcampo
19200 Azuqueca de Henares, Guadalajara
Leon Farma Laboratories, SA
C / La Vallina s / n, Pol. Ind. Navatejera
24008 – Navatejera, León.
This medicinal product is authorized under the European Economic Area under the names
|Netherlands:||Levonorgestrel / Ethinylestradiol Sandoz BV 150/30 micrograms, film-coated tablets|
|UK:||Amelina 150/30 microgram film-coated tablets|
|Sweden:||Leverette 21 150 micrograms / 30 micrograms, film-coated tablets|
|Germany:||Asumate 30 0.15 mg / 0.03 mg Film tablets|