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MIBELLE 30 MICROGRAMS/150 MICROGRAMS FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Mibelle 30 micrograms/150 micrograms film-coated tablets
Ethinylestradiol, Levonorgestrel
Read all of this leaflet carefully before you start taking this medicine.
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Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

In this leaflet:
1. What Mibelle is and what it is used for
2. Before you take Mibelle
3. How to take Mibelle
4. Possible side effects
5. How to store Mibelle
6. Further information

1.

WHAT MIBELLE IS AND WHAT IT IS USED FOR

Mibelle is a combined oral contraceptive, here generally referred as “pill”. Combined oral contraceptives contain
two female types of hormone, estrogen and progestogen. When used as instructed you are very unlikely to become
pregnant.

2.

BEFORE YOU TAKE MIBELLE

General notes
Before you can begin taking Mibelle, your doctor will ask you some questions about your personal health and that
of your close relatives. The doctor will also measure your blood pressure and depending upon your personal
situation, may also carry out some other tests.
In this leaflet, several situations are described where you should stop using Mibelle, or where the reliability of
Mibelle may be decreased. In such situations you should either not have intercourse or you should take extra nonhormonal contraceptive precautions, e.g., use a condom, or another barrier method. Do not use rhythm or
temperature methods. These methods can be unreliable because Mibelle alters the monthly changes of the cervical
mucus.
Mibelle, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually
transmitted disease.

Do not take Mibelle if you




are allergic (hypersensitive) to any of the ingredients of Mibelle
if you have (or have had in the past) a blood clot (thrombosis) in a blood vessel of the leg, lung (embolus) or
other organs
If you have (or have had in the past) a heart attack or stroke













If you have (or have had in the past) a disease that can be a predictor of a heart attack (for example, angina
pectoris, which causes severe pain in the chest) or of a stroke (for example, a transient slight stroke with no
residual effects)
If you have a disease that may increase the risk of a thrombosis in the arteries. This applies to the following
diseases:
o Diabetes mellitus with damaged blood vessels
o Very high blood pressure
o A very high level of fat in the blood (cholesterol or triglycerides)
If you have a disturbance of blood clotting (for example, protein C deficiency)
If you have (had) a certain form of migraine (with so-called focal neurological symptoms)
If you have (had) an inflammation of the pancreas (pancreatitis)
If you have or have had in the past a liver disease and your liver function is still not normal
If you have or have had a tumour in the liver
If you have (had) or if you are suspected to having breast cancer or cancer of the genital organs
If you have any unexplained bleeding from the vagina
If you have absence of menstrual period and the cause is unknown.

Take special care with Mibelle
In some situations you need to take special care while using Mibelle or any other combined hormonal
contraceptive, and it may be necessary that you are regularly checked by your doctor. If any of the following
conditions applies to you, you must inform your doctor before starting to use Mibelle. Also if any of the following
conditions develops or worsens during the use of Mibelle you must consult your doctor.















If a close relative has or has had breast cancer
If you have a disease of the liver or the gallbladder
If you have diabetes
If you have depression
If you have Crohn’s disease or ulcerative colitis (inflammatory bowel disease)
If you have HUS (haemolytic uraemic syndrome; a blood disease that causes kidney damage)
If you have epilepsy (see “Taking other medicines”)
If you have SLE (systemic lupus erythematosus; a disease of the immune system)
If you have a disease that first appeared during pregnancy or earlier use of sex hormones (for Example,
hearing loss, porphyria (a disease of the blood), gestational herpes (skin rash with vesicles during
pregnancy), Sydenham’s chorea (a disease of the nerves in which sudden movements of the body occur)
If you have or have ever had chloasma (golden brown pigment patches, so called “pregnancy patches”,
especially on the face). If this is the case, avoid direct exposure to sunlight or ultraviolet light
If you have hereditary angioedema, products containing estrogens may induce or worsen symptoms of
angioedema. You should see your doctor immediately if you experience symptoms of angioedema such as
swollen face, tongue and/or pharynx and/or difficulty swallowing or hives together with difficulty
breathing
If a pre-existing high blood pressure condition worsens
If a pre-existing high level of fat in blood worsens.

Mibelle and thrombosis
Venous thrombosis

The use of any combination pill, including Mibelle, increases a woman’s risk of developing a venous thrombosis
(formation of a blood clot in vessels) compared with a woman who does not take any (contraceptive) pill.
The risk of venous thrombosis in users of combined pills increases:





with increasing age
if you are overweight
if one of your close relatives has had a blood clot (thrombosis) in the leg, lung, or other organ at a young age
if you must have an operation (surgery), any prolonged period of immobilization, or if you have had a serious
accident. It is important to tell your doctor in advance that you are using Mibelle as the treatment may have to
be stopped. Your doctor will tell you when to start again. This is usually about two weeks after you are back on
your feet.

Arterial thrombosis
The use of combination pills has been connected with an increase of the risk of arterial thrombosis (obstruction of
an artery), for example, in the blood vessels of the heart (heart attack) or the brain (stroke).
The risk of arterial thrombosis in users of combined pills increases:







with increasing age
if you smoke you are strongly advised to stop smoking when you use Mibelle, especially if you are older than
35 years
if you have an increased fat content in your blood (cholesterol or triglycerides)
if you have high blood pressure
if you have migraine
if you have a problem with your heart (valve disorder, a disturbance of the heart rhythm).

Stop taking Mibelle and tell your doctor immediately if after taking Mibelle you notice possible signs of
thrombosis, such as













any unusual, severe or long-lasting headache or worsening of migraine
partial or complete blindness or double vision
sudden pain and/or swelling in one of your legs
sudden breathlessness
sudden cough without an obvious cause
sudden severe pain in the chest which may reach the left arm
difficulty in speaking or inability to speak
weakness, strange feeling, or numbness in any part of the body
a feeling of dizziness or spinning
collapse with or without focal seizure
motor disturbances
sudden severe abdominal pain.

Mibelle and cancer
Breast cancer has been observed slightly more often in women using combined pills, but it is not known whether
this is caused by the treatment. For example it may be that more tumours are detected in women on combined pills

because they are examined by their doctor more often. The occurrence of breast tumours becomes gradually less
after stopping the combination hormonal contraceptives. It is important to regularly check your breasts and you
should contact your doctor if you feel any lump.
In rare cases, benign liver tumours, and in even fewer cases malignant liver tumours have been reported in pill
users. Contact your doctor if you have unusual severe abdominal pain.

Bleeding between periods
During the first few months that you are taking Mibelle, you may have unexpected bleeding (bleeding outside the
gap week). If this bleeding lasts longer than a few months, or if it begins after some months, your doctor must
investigate the cause.
What you must do if no bleeding occurs in the gap week
If you have taken all the tablets correctly, have not had vomiting or severe diarrhoea and you have not taken any
other medicines, it is highly unlikely that you are pregnant.
If the expected bleeding does not happen twice in succession, you may be pregnant. Contact your doctor
immediately. Do not start the next strip until you are sure that you are not pregnant.
Taking other medicines
Always tell the doctor, who prescribes Mibelle, which medicines or herbal products you are already using. Also tell
any other doctor or dentist who prescribes another medicine (or the dispensing pharmacist) that you are using
Mibelle. They can tell you if you need to take additional contraceptive precautions (for example condoms) and if
so, for how long.




Some medicines can make Mibelle less effective in preventing pregnancy, or can cause unexpected bleeding.
They include medicines used for the treatment of epilepsy (e,g, primidone, phenytoin, barbiturates,
carbamazepine, oxcarbamazepine, topiramate, felbamate) and tuberculosis (e.g. rifampicin), or HIV infections
(ritonavir, nevirapine) or other infectious diseases (griseofulvin, penicillin, tetracycline), medicines that
increase the motility of your intestines (metoclopramide), and the herbal remedy St. John’s wort.
Mibelle may influence the effect of other medicines, e.g. medicines containing cyclosporin, or the anti-epileptic
lamotrigine (this could lead to an increased frequency of seizures).

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

Effect on laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that you are taking the pill, because oral
contraceptives can affect the results of some tests.

Pregnancy
If you become pregnant while taking Mibelle you must stop immediately and contact your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.

Breast feeding
Use of Mibelle is generally not advisable when a woman is breast feeding. If you want to take the pill while you are
breast-feeding you should contact your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Mibelle does not have any known effect on your ability to drive or use machines.

Important information about some of the ingredients of Mibelle
This medication contains lactose. If you have been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.

3.

HOW TO TAKE MIBELLE

Always take Mibelle exactly as your doctor has told you. You should check with your doctor or pharmacist if you
are not sure.
Take one tablet of Mibelle every day, if necessary with a small amount of water. You may take the tablets with or
without food, but you should take the tablets every day around the same time.
The strip contains 21 tablets. Next to each tablet is printed the day of the week that it should be taken. If, for
example you start on a Wednesday, take a tablet with “WED” next to it. Follow the direction of the arrow on the
strip until all 21 tablets have been taken.
Then take no tablets for 7 days. In the course of these 7 tablet-free days (otherwise called a stop or gap week)
bleeding should begin. This so-called “withdrawal bleeding” usually starts on the 2nd or 3rd day of the gap week.
On the 8th day after the last Mibelle tablet (that is, after the 7-day gap week), start the following strip, even if the
bleeding has not stopped. This means that you should start the following strip on the same day of the week and that
the withdrawal bleed should occur on the same days each month.
If you use Mibelle in this manner, you are also protected against pregnancy during the 7 days that you are not
taking a tablet.

Starting the first pack of Mibelle
• If you have not used a contraceptive with hormones in the previous month
Begin with Mibelle on the first day of the cycle (that is the first day of your menstruation). If you start Mibelle on
the first day of your menstruation you are immediately protected against pregnancy. You may also begin on day 25 of the cycle, but then you must use extra protective measures (for example, a condom) for the first 7 days.
• Changing from another combined hormonal contraceptive, or combined contraceptive, vaginal ring or patch

You can start Mibelle preferably on the day after the last active tablet (the last tablet containing the active
substance) of your previous pill, but at the latest on the day after the tablet-free days of your previous pill finish (or
after the last inactive tablet of your previous pill). When changing from a combined contraceptive vaginal ring or
patch, follow the advice of your doctor.
• Changing from a progestogen-only-method (progestogen-only pill, injection, implant or a progestogen-releasing
IUD)
You may switch any day from the progestogen-only pill (from an implant or the IUD on the day of its removal,
from an injectable when the next injection would be due) but in all of these cases you must use extra protective
measures (for example, a condom) for the first 7 days of tablet-taking.
• After a miscarriage
Follow the advice of your doctor.
• After having a baby
After having a baby, you can start Mibelle between 21 and 28 days later. If you start later than day 28, you must
use a so-called barrier method (for example, a condom) during the first seven days of Mibelle use.
If, after having a baby, you have had intercourse before starting Mibelle (again), you must first be sure that you are
not pregnant or you must wait until the next menstrual bleed.
Let your doctor advises you in case you are not sure when to start.
• If you are breastfeeding and want to start Mibelle after having a baby
Read the section on “Breast feeding”.

If you take more Mibelle than you should
There are no reports of serious harmful results of taking too many Mibelle tablets.
If you take several tablets at once then you may have symptoms of nausea or vomiting. Young girls may have
bleeding from the vagina.
If you have taken too many Mibelle tablets, or you discover that a child has taken some, ask your doctor or
pharmacist for advice.

If you forget to take Mibelle
If you are less than 12 hours late in taking your pill, the protection from pregnancy is not reduced. Take the tablet
as soon as you remember, and further pills again at the usual time.
If you are more than 12 hours late taking a tablet, the protection from pregnancy may be reduced. The greater the
number of tablets that you have forgotten, the greater is the risk that the protection from pregnancy is reduced.
The risk of incomplete protection against pregnancy is greatest if you forget a tablet at the beginning or the end of
the strip. Therefore, you should adhere to the following rules:
• More than one tablet forgotten in this strip
Contact your doctor.
• One tablet forgotten in week 1
Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same
time. Take the tablets again at the usual time and use extra precautions for the next 7 days, for example, a condom.

If you have had intercourse in the week before the oversight or you have forgotten to start a new strip after the
tablet-free period, you must realize that there is a risk of pregnancy. In that case, contact your doctor.
• One tablet forgotten in week 2
Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the same
time. Take the tablets again at the usual time. The protection from pregnancy is not reduced, given that you have
taken the tablets correctly in the previous 7 days, otherwise extra precaution should be used for the next 7 days.
• One tablet forgotten in week 3
You can choose between two possibilities:
1. Take the forgotten tablet as soon as you remember, even if that means that you have to take two tablets at the
same time. Take the tablets again at the usual time. Instead of the tablet-free period go straight on to the next strip.
Most likely, you will have a period (withdrawal bleed) at the end of the second strip but you may also have spotting
or breakthrough bleeding during the second strip.
2. You can also stop the strip and go directly to the tablet-free period of 7 days (record the day on which you
forgot your tablet). If you want to start a new strip on your fixed start day, make the tablet-free period less than 7
days.
If you follow either of these two recommendations, you will remain protected against pregnancy.
If you have forgotten any of the tablets in a strip, and you do not have bleeding in the first tablet-free period, this
may mean that you are pregnant. You must contact your doctor before you go on to the next strip.

Several tablets
forgotten in 1 strip.

Ask your doctor for advice.

yes

In week 1

Had sex in the previous week before forgetting?

no

• Take the forgotten tablet.
• Use a barrier method (condom) for the following 7 days.
• Finish the strip.

Only 1 tablet
forgotten (taken
more than 12 hours
late).

In week 2

• Take the forgotten tablet.
• Finish the strip.

• Take the forgotten tablet.
• Finish the strip.
• Instead of the gap week go straight on the next strip.

In week 3

or

• Stop the strip immediately.
• Begin the gap week (not longer than 7 days, including the
forgotten tablet)
• Then go on the next strip.

What must you do in the case of vomiting or severe diarrhoea
If you vomit within 3-4 hours of taking a tablet or you have severe diarrhoea, there is a risk that the active
substances in the pill are not fully adsorbed into your body. The situation is similar to if you forget a tablet. After
vomiting or diarrhoea, you must take another tablet from a reserve strip as soon as possible. If possible take it
within 12 hours of when you normally take your pill. If this is not possible or 12 hours have passed, you should
follow the advice given under ‘if you forget to take Mibelle.

Delay of menstrual period: what must you know
Even if not recommended, delay of your menstrual period (withdrawal bleed) is possible by going straight on to a
new strip of Mibelle instead of the tablet-free period, to the end of the second strip. You may experience spotting

(drops or flecks of blood) or breakthrough bleeding while using the second strip. After the usual tablet-free period
of 7 days, continue with the following strip.
You might ask your doctor for advice before deciding to delay your menstrual period

Change of the first day of your menstrual period: what you must know
If you take the tablets according to the instructions, then your menstrual period/withdrawal bleed will begin in the
tablet-free week. If you have to change this day, do this by making the tablet-free period shorter (but never longer!)
For example, if your tablet-free period begins on a Friday, and you want to change this to a Tuesday (3 days
earlier) you must start a new strip 3 days earlier than usual. If you make the tablet-free period very short (for
example, 3 days or less) then it may be that you do not have any bleeding during this tablet-free period. You may
then experience spotting (droplets or flecks of blood) or breakthrough bleeding.
If you are not sure how to proceed, contact your doctor for advice.

If you want to stop taking Mibelle
You can stop taking Mibelle whenever you want. If you do not want to become pregnant, ask you doctor for advice
about other reliable methods of birth control.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, Mibelle can cause side effects, although not everybody gets them.
Very common side effects (affecting more than 1 in 10 women): head ache
Common side effects (affecting more than 1 in 100, but less than 1 in 10 women):
Mood swings, depression, abdominal pain (stomach ache), breast pain, breast tenderness, weight gain, nausea, rash
Uncommon side effects (affecting more than 1 in 1000 but less than 1 in 100 women):
Vomiting, diarrhoea, fluid retention, migraine, decreased libido (interest in sex), breast enlargement, itchy red rush
of the skin (urticaria)
Rare side effects (affecting less than 1 in 1000 women):
Contact lens intolerance, allergic reactions, weight loss, increased libido (interest in sex, breast discharge, vaginal
discharge, allergic reactions which can sometimes be severe with swelling of the skin and/or mucous membranes
(erythema nodosum & eruthema multiforme)
Other serious side effects you should be aware off are also mentioned in section 2 of this leaflet (Do not take
Mibelle if you & Take special care with Mibelle). These include:
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Blood clot disorders
High blood pressure
Liver tumours
Swelling of the skin (angioedema)
Occurrence or deterioration of conditions such as: Crohn’s disease, epilepsy, migraine etc.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist

5.

HOW TO STORE MIBELLE

Keep out of the reach and sight of children.
Do not use Mibelle after the expiry date which is stated on the label and carton after Exp. The expiry date refers to
the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This measure helps to protect the environment.

6.

FURTHER INFORMATION

What Mibelle contains
The active substances are:
ethinylestradiol and levonorgestrel.
Each film-coated tablet contains 30 micrograms ethinylestradiol and 150 micrograms levonorgestrel.
The other ingredients are:
Tablet core:
Lactose monohydrate, maize starch, maltodextrin, sodium starch glycolate (type A), magnesium stearate.
Tablet coating:
Hypromellose, titanium dioxide (E171), macrogol 400, iron oxide red (E172), quinoline yellow, aluminium lake
(E104).

What Mibelle looks like and contents of the pack
Mibelle are round, yellow film-coated tablets.
Mibelle is available in packages containing:
1 blister, containing 21 film-coated tablets
3 blisters, each containing 21 film-coated tablets and
6 blisters, each containing 21 film-coated tablets.

Marketing Authorisation Holder and Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany

This medicinal product is authorised in the Member States of the EEA under the following names:
Belgium
Germany
United Kingdom
Netherlands
Austria
Poland
Slovak Republic
Czech Republic:

Levomin
Levomin
Mibelle
Ethinylestradiol/Levonorgestrel Sandoz 0,03/0,15 mg, filmomhulde tabletten
Levostrol 30 Mikrogramm/150 Mikrogramm Filmtabletten
Levomine
Levomin
Ethinylestradiol/Levonorgestrel mibe 30 mikrogramů/150 mikrogramů potahované tablety

This package leaflet was last approved in 03/2012.

Detailed information on this medicine is available on the web site of: UK/Medicines and Healthcare
products Regulatory Agency (MHRA).

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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