150 micrograms / 30 micrograms film-coated tablets
levonorgestrel / ethinyl estradiol
What Leverette is and what it is used for
- Leverette is a contraceptive pill and is used as a contraceptive.
- The 21 yellow tablets contain a small amount of two different female hormones , levonorgestrel and ethinyl estradiol.
- The 7 white tablets do not contain any active substance and are also called placebo tablets.
- Birth control pills that contain two different hormones are called combined birth control pills .
Levonorgestrel and Ethinyl estradiol contained in Leverette 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 Leverette
Do not use Leverette
| General remarks before you start using Leverette, read the information on blood clots in section 2. You must read the symptoms of blood clots – see section 2, “Blood clots”). Before you can start using Leverette, your doctor will ask you some questions about your personal medical history and the medical history of your close relatives. The doctor will also measure your blood pressure and depending on your situation, the doctor may perform other tests. This leaflet describes several situations when you need to stop using Leverette or where the reliability of Leverette may be impaired. In such situations, you should either refrain from intercourse or use additional non-hormonal contraceptives e.g. use a condom or other barrier method. Do not use rhythm or temperature methods. These methods can be unreliable because Leverette affects the monthly changes in body temperature and cervical secretions. Leverette, like other hormonal contraceptives, does not protect you against HIV – infection ( AIDS ) or other sexually transmitted diseases. |
Do not take Leverette:
Do not use Leverette 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 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 are in bed for a longer period (see section “Blood clots”)
- if you have (or have had) a heart attack or stroke (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 ever had) a liver disease and your liver function is still not normal
- if you have (or ever had) a liver tumor
- if you have (or ever had) or are suspected of having breast or genital cancer
- if you have vaginal bleeding for unknown reasons
- 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 and swelling.
- if you have hepatitis C and use medicines containing ombitasvir / paritaprevir / ritonavir, dasabuvir, glekaprevir / pibrentasvir and sofosbuvir / velpatasvir / voxilaprevir (see also section Other medicines and Leverette).
Warnings and cautions
| When should you contact a doctor? Seek medical attention immediately 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”. |
Tell your doctor if any of the following conditions apply to you.
Talk to your doctor before taking Leverette. In some situations, you need to be especially careful when using Leverette or any other combination pill and it may be necessary to check with your doctor regularly. If the condition occurs or worsens when you use Leverette, you should also consult a doctor
- if a close relative has or has had breast cancer
- if you have any liver or bile disease
- if you have diabetes
- if you suffer from depression; Some women who use hormonal contraceptives, including Leverette, 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 have Crohn’s disease or ulcerative colitis ( chronic inflammatory bowel disease)
- if you have systemic lupus erythematosus ( SLE – a disease that affects your 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. 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 Leverette
- if you have an inflammation of the veins under the skin (superficial thrombophlebitis )
- if you have varicose veins.
- if you have epilepsy (see section “Other medicines and Leverette”)
- if you have a disease that first appeared during pregnancy or during previous use of sex hormones (eg hearing loss, a blood disease called porphyria , skin rash with blisters during pregnancy (pregnancy herpes), a nerve disease that causes sudden twitching in the body (Sydenhams korea ).
- if you have or have had golden brown pigment spots (chloasma), so-called “pregnancy spots”, especially on the face, in which case you should 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 / or difficulty swallowing or hives , possibly with difficulty breathing. Products containing estrogen can cause or worsen the symptoms of hereditary or acquired angioedema .
BLOOD CLOTS
Using combined hormonal contraceptives such as Leverette 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 Leverette is small.
HOW TO FEEL A BLOOD CLOTH AGAIN
Seek medical attention immediately if you notice any of the following signs or symptoms.
| Do you experience any of these signs? | What can you possibly suffer from? |
|---|---|
| swelling of a leg or along a vein in the leg or foot, especially if you also get: pain or 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 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 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 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 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 Leverette, 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 lungs with Leverette is small.
- Of 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 develop a blood clot in one year.
- Of 10,000 women who use a combined hormonal contraceptive containing levonorgestrel or norethisterone or norgestimate, approximately 5‑7 develop a blood clot in one year.
- The risk of blood clots varies depending on your medical history (see “Factors that may increase the risk of a blood clot” below).
| Risk of developing a blood clot during a year | |
| Women who do not use combined pills/patches / rings and who are not pregnant | About 2 out of 10,000 women |
| Women using a combined hormonal contraceptive containing levonorgestrel or norethisterone or norgestimate | About 5-7 out of 10,000 women |
| Women using Leverette | 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 Leverette 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 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 Leverette may need to be discontinued for several weeks before surgery or while you are less mobile. If you have to stop taking Leverette, 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 Leverette.
If any of the above conditions change when using Leverette, 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 Leverette is very small but may increase:
- with increasing age (after about 35 years of age)
- if you smoke. When you use combined hormonal contraceptives Leverette, 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 using Leverette, 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.
Liver and cancer
Breast cancer has been observed slightly more often in women using birth control pills, but it is not known if this is due to the treatment. For example, it may be that women who use birth control pills visit doctors more often and thus more tumors are detected.
The incidence of breast tumors gradually decreases after stopping treatment with the contraceptive pill. It is important to see a doctor regularly if you feel a lump.
In rare cases, benign liver tumors and in even fewer cases, malignant liver tumors have been reported in users of birth control pills. Contact a doctor if you experience unusually severe abdominal pain.
Some studies show an increased risk of cervical cancer in women who have used birth control pills for a long time. It is unclear to what extent this may be the result of sexual behavior and other factors such as human papillomavirus (HPV).
Bleeding between menstruations (dropout bleeding)
During the first few months of using Leverette, you may experience unexpected bleeding (bleeding outside the placebo days). If these bleedings occur for more than a few months or if they occur after a few months, talk to your doctor who will find out what is wrong.
What to do if bleeding does not occur during the placebo days
If you have taken all the tablets correctly, you have not vomited or have not had severe diarrhea and you have not taken any other medicine, it is very unlikely that you are pregnant.
If the expected bleeding (loss of bleeding) does not occur twice in a row, you may be pregnant. Contact a doctor immediately. Do not start on the following tablet chart until you are sure you are not pregnant.
Laboratory tests
If a blood sample needs to be taken, tell your doctor or laboratory staff that you are taking birth control pills, as hormonal contraceptives may affect the results of some tests.
Other drugs and Leverette
Always tell your doctor prescribing Leverette if you are taking, have recently taken, or might take any other medicines, including herbal medicines. Also, tell other doctors or dentists who prescribe other medicines (or pharmacists) that you are using Leverette. They can tell you if you need to use additional contraceptives (eg condoms) and if this is the case for how long.
Do not use Leverette if you have hepatitis C and are being treated with medicines containing ombitasvir/paritaprevir / ritonavir, dasabuvir, glekaprevir / pibrentasvir and
sofosbuvir / velpatasvir / voxilaprevir as treatment with these products may lead to elevated liver function values (elevated levels of the liver enzyme ALT in the blood).
Your doctor will prescribe another type of contraceptive before you start treatment with any of these medicines.
Treatment with Leverette can be restarted approximately 2 weeks after the end of medication with the above medication. See the section “Do not take Leverette”.
Some medicines may affect the level of Leverette blood and make Leverette less effective in preventing pregnancy or may cause unexpected bleeding.
This applies, among other things
- drugs used to treat:
- epilepsy (eg primidone, phenytoin , barbiturates , carbamazepines, oxcarbazepines)
- 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, ketoconazole )
- arthritis , osteoarthritis (etoricoxib)
- high blood pressure in the pulmonary blood vessels ( bosentan )
- herbal medicine that contains St. John’s wort .
Leverette may affect the effectiveness of other medicines eg:
- medicines containing ciclosporin
- the epilepsy drug lamotrigine (this may lead to an increased number of epileptic seizures)
- theophylline (an asthma medicine )
- tizanidine, a muscle relaxant
Leverette with food, drink and alcohol
Leverette can be taken with or without food, if necessary with a small amount of water.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding8, 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 are pregnant do not take Leverette. If you become pregnant while taking Leverette, stop using the contraceptive pill immediately and consult a doctor. If you want to get pregnant, you can stop using the contraceptive pill at any time (see also “If you want to stop using Leverette”).
Breast-feeding
The use of Leverette is generally not recommended for breastfeeding women. If you want to take birth control pills while breastfeeding, consult a doctor.
Driving and using machines
There is no information to suggest that the use of Leverette 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. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Leverette contains excipients
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 Leverette.
How to use Leverette
Always take Leverette exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Remember to take Leverette according to the instructions as forgotten tablets may reduce the effect of the medicine.
When and how should Leverette be taken:
Each blister card contains 28 tablets: 21 yellow hormone tablets and 7 white placebo tablets.
The two different colored tablets are arranged in the order they are to be taken.
Take one tablet of Leverette daily, if necessary with a small amount of water. You should take the tablets at about the same time each day.
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 you should 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.
Preparation of the blister map
To help you stay organized, there are 7 sets of self-adhesive memory strips with 7 days of the week printed, for each blister card for Leverette. 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 “ONS”.
Attach the memory strip at the top of the tablet map, where “Place memory 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 a day of the week above each tablet and you can see if you have taken the tablet. The arrows show the order in which you should take the tablets.
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 Leverette. After taking the last white tablet, start with the following tablet chart the next day, 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 occurs on the same days each month.
If you use Leverette in this way, you are also protected against pregnancy during the 7 days when you are not taking hormone tablets.
When to start taking Leverette
- You have not used any hormonal contraceptive in the last monthStart taking Leverette on the first day of your menstrual cycle (ie on the first day of your period). If you start using Leverette on the first day of your period, you are immediately protected against pregnancy. You can also start on days 2-5 of the menstrual cycle, but then you must use another method of contraception (eg condoms) for the first 7 days.
- If you are switching from a combination pill , vaginal ring or patchYou can start taking Leverette preferably on the following day after the last active tablet (the last tablet containing the active substances) of the previous pill but no later than the day after the tablet-free days of the previous pill.When changing from a vaginal ring or patch, follow your doctor’s instructions.
- If you are switching from a progestagen-only contraceptive (mini- pill , injection , implant or progestagen-releasing intrauterine insert)You can change any day from the mini-pill (from an implant or progestagen-releasing intrauterine insert on the day it is removed, from injection when the next injection is to be given) but in any case, another contraceptive method (eg condom) used during the first 7 days you take tablets.
- After miscarriageFollow your doctor’s advice.
- After childbirthYou can start taking Leverette 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 intercourse has taken place after delivery and before you start taking Leverette (again), you should be sure that you are not pregnant or wait for your next period before using this medicine.
- When breastfeedingIf you are breast-feeding and want to start using Leverette (again) after giving birth, read the section “Pregnancy and breast-feeding”.
Ask your doctor if you are not sure when to start using Leverette.
If you use more Leverette than you should
There are no reports of serious side effects from taking too many Liver tablets.
If you take several tablets at once, you may experience symptoms of nausea and vomiting. Young girls may experience vaginal bleeding.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any side effects, especially if they are serious or persistent, or if your health changes and you think it may be due to Leverette, talk to your doctor.
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”).
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 when taking combined hormonal contraceptives, see section 2 “What you need to know before taking Leverette”.
Common side effects are (may affect up to 1 in 10 people):
- nausea
- abdominal pain
- weight gain
- headache
- Depression
- mood swings
- chest tightness
- chest pain
Less common side effects are (may affect up to 1 in 100 people):
- vomiting
- diarrhea
- fluid retention (accumulation of fluid in the body)
- migraine
- decreased sexual desire
- breast augmentation
- rash
- hives ( urticaria )
Rare side effects are (may affect up to 1 in 1000 people):
- contact lens intolerance (difficulty wearing contact lenses)
- hypersensitivity
- weight loss
- increased sexual desire
- fluid secretion from the breasts
- vaginal discharge
- a type of dermatitis that results in reddish, painful, sensitive lumps (erythema nodosum)
- a skin disease that causes red spots or wounds that resemble targets (erythema multiforme) – dangerous blood clots in a vein or artery , such as:
- in one leg or foot (ie DVT)
- in the lungs
- myocardial infarction
- stroke
- mini- stroke or transient stroke-like symptoms called transient ischemic attack ( TIA )
- blood clots in the liver, stomach / intestines, kidneys or eyes.
The risk of developing a blood clot may be higher if you have other conditions that increase this risk (see section 2 for more information on the conditions that increase the risk of blood clots and the symptoms of a blood clot).
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 (when the body attacks and damages its organs and tissues ), herpes in late pregnancy, Sydenhams KOREA ( rapid and involuntary body movements), hemolytic uremic syndrome (a condition that occurs after diarrhea caused by the bacterium E.coli), liver disease in the form of jaundice, problems with gallbladder or gallstones.
How to store Leverette
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
Content declaration
One tablet map contains 21 yellow active tablets on rows 1, 2, and 3 of the tablet map and 7 white placebo tablets on row 4.
Active tablets
- 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 K30, crospovidone type A and magnesium stearate.
Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol (3350), talc (E553b), and yellow iron oxide (E172).
Placebo tablets
- The placebo tablets do not contain any active substance.
- Other ingredients are:
Tablet core: lactose (anhydrous), povidone K30, and magnesium stearate.
Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc (E553b).
What the medicine looks like and contents of the pack
- Each tablet of Leverette contains 21 yellow film-coated tablets and 7 white film-coated tablets.
- The active tablets are yellow, round, with a diameter of 6 mm and an approximate thickness of less than 4 mm.
- The placebo tablets are white, round, with a diameter of 6 mm and an approximate thickness of less than 4 mm.
- Leverette is available in packs of 1, 3, 6 and 13 tablet tablets, each containing 28 tablets (21 active tablets and 7 placebo tablets). Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Exeltis Healthcare SL
Av. Miralcampo 7-Poligono Ind. Miralcampo
19200, Azuqueca de Henares – Guadalajara
Spain
Manufacturer
Laboratorios León Farma, SA
Polígono Industrial Navatejera, La Vallina S / N
24008 Navatejera (Leon) – Spain