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LEVONORGESTREL/ETHINYLESTRADIOL 150/30 MICROGRAM COATED TABLETS

Active substance: LEVONORGESTREL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Femicept 150/30 Coated tablets



Levonorgestrel 150mcg / Ethinylestradiol 30mcg




Read all of this leaflet carefully before you start using this
medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, 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 Femicept is and what it is used for
2. Before you take Femicept
3. How to take Femicept
4. Possible side effects
5. How to store Femicept
6. Further information






1. WHAT FEMICEPT IS AND WHAT IT IS USED FOR
Femicept coated tablets are a combined oral contraceptive and
belongs to a group of products often referred to as “the Pill”.
Femicept contains two hormones: estrogen (Ethinylestradiol) and
progestogen (Levonorgestrel). These hormones prevent you from
getting pregnant, just as your natural hormones would prevent
you from conceiving again when you are already pregnant.
2. BEFORE YOU USE FEMICEPT

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

Femicept and thrombosis



Femicept, like other hormonal contraceptives, does not protect
against HIV infection (AIDS) or any other sexually transmitted
disease.

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).
















Take special care with Femicept
In some situations you need to take special care while using
Femicept 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 Femicept. Also is any of
the following conditions develops or worsens during the use of
Femicept 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 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 Femicept, 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 Femicept. They can tell
you if you need to take additional contraceptive precautions (for
example condoms) and if so, for how long.






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 Femicept 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 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 Femicept, 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 Femicept and tell your doctor immediately if
after taking Femicept 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

Femicept 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.

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Some medicines can make Femicept 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 (metoclopramid), and the herbal remedy St. John's
wort.
Femicept 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 you 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 Femicept you must stop
immediately and contact your doctor.
Ask your doctor or pharmacist for advice before taking any
medicine.
Breast feeding
Use of Femicept is generally not advisable when a woman is
breast feeding. If you want to take the pill while you are breastfeeding you should contact your doctor.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
Femicept does not have any known effect on your ability to drive
or use machines.
Important information about some of the ingredients of
Femicept
Femicept contains lactose and sucrose. If you have been told by
your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicine.
3. HOW TO TAKE FEMICEPT
Always take Femicept exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
Take one tablet of Femicept 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 tabletfree 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 Femicept tablet (that is, after the 7day 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.

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In this leaflet, several situations are described where you should
stop using Femicept, or where the reliability of Femicept may be
decreased. In such situations you should either not have
intercourse or you should take extra non-hormonal contraceptive
precautions, e.g., use a condom, or another barrier method. Do
not use rhythm or temperature methods. These methods can be
unreliable because Femicept alters the monthly changes of the
cervical mucus.

If you are allergic (hypersensitive) to any of the ingredients
of Femicept.
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

What you must do if no bleeding occurs in the gap week

The use of any combination pill, including Femicept, 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:



During the first few months that you are taking Femicept, 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.

Venous thrombosis

General notes
Before you can begin taking Femicept, 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.

Do not take Femicept if you

Bleeding between periods

If you use Femicept in this manner, you are also protected
against pregnancy during the 7 days that you are not taking a
tablet.

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.

Starting the first pack of Femicept

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 have not used a contraceptive with hormones in the
previous month.
Begin with Femicept on the first day of the cycle (that is the first
day of your menstruation). If you start Femicept on the first day
of your menstruation you are immediately protected against
pregnancy. You may also begin on day 2-5 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 Femicept 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 Femicept 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 Femicept use.
If, after having a baby, you have had intercourse before starting
Femicept (again), you must first be sure that you are not
pregnant or you must wait until the next menstrual bleed.

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.
Ask your doctor for advice
Several tablets
yes
forgotten in 1strip
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
• And finish strip

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

In
week 2

In
week 3

• Take the forgotten tablet and
• Finish the strip
• Take the forgotten tablet and
• Finish the strip
• Instead of gap week
• Go straight on next strip
or

Let your doctor advise you in case you are not sure when to start.

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 Femicept if
you & Take special care with Femicept). These include:
-

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 FEMICEPT
Keep out of the reach and sight of children.
Store below 25° C
Do not use Femicept after the expiry date which is stated on the
carton.
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. These measures will help to protect the
environment.
6. FURTHER INFORMATION

What must you do in the case of vomiting or severe diarrhoea
• If you are breastfeeding and want to start Femicept after having
a baby.
Read the section on “Breast feeding”.
If you take more Femicept than you should
There are no reports of serious harmful results of taking too
many Femicept 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 Femicept tablets, or you discover
that a child has taken some, ask your doctor or pharmacist for
advice.
If you forget to take Femicept
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.

Femicept contains
If you vomit within 3-4 hours of taking a tablet or you have
severe diarrhoea, there is a risk that the active substance 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 Femicept.

-

The active substances are Levonorgestrel (150µg) and
Ethinylestradiol (30µg)
The other ingredients are Lactose Monohydrate, Maize
Starch, Povidone K-25, Sucrose, Talc, Calcium carbonate,
Povidone K-90, Glycerin, Macrogol 6000, Titanium dioxide,
Magnesium Stearate, Carnauba Wax.

What Femicept looks like and contents of the pack
Delay of menstrual period: what must you know
Femicept tablets are white, circular, biconvex and sugar coated.
Even if not recommended, delay of your menstrual period
(withdrawal bleed) is possible by going straight on to a new strip
of Femicept 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

Each blister pack contains 21 tablets.
Femicept is sold in cartons of 1, 3, 6 or 13 blister packs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Famy Care Europe Ltd.
One Wood Street
London, EC2V 7WS
United Kingdom
Femicept is manufactured by:

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 Femicept
You can stop taking Femicept 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, Femicept can cause side effects, although not
everybody gets them.
Common side effects (affecting more than 1 in 100, but less than
1 in 10 women):
Mood swings, headache, abdominal pain (stomach ache), acne,

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Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow, Middlesex
HA1 4HF,
United Kingdom
OR
Wessling Hungary Kft
Fóti út 56., Budapest, 1047,
Hungary
This medicinal product is authorised in the Member States of
the EEA under the following names:
BE: Levonorgestrel – Ethinylestradiol Famy Care
DE : Glorianna 0,03 mg/0,15 mg überzogene Tabletten
FI, PL, NO: Oralcon
UK: Femicept & Levonorgestrel/Ethinylestradiol 150/30
microgram coated tablet
DK: Femicept
NL: Ethinylestradiol/Levonorgestrel Mylan 0,03/0,15 mg
HU: Oralcon 150mcg/30mcg Bevont tabletta
This leaflet was last approved in 01/2014

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

breast pain, weight gain, nausea

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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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