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FEMICEPT 150/30 COATED TABLETS

Active substance(s): ETHINYLESTRADIOL / LEVONORGESTREL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol
150/30 microgram Coated tablets
(Levonorgestrel/Ethinylestradiol)
Important things to know about combined hormonal contraceptives (CHCs):
• They are one of the most reliable reversible methods of contraception if used
correctly.
• They slightly increase the risk of having a blood clot in the veins and arteries,
especially in the first year or when restarting a combined hormonal contraceptive
following a break of 4 or more weeks.
• Please be alert and see your doctor if you think you may have symptoms of a
blood clot (see section 2 “Blood clots”).
Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist or Nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may
harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist or Nurse. This
includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:

PACKAGE LEAFLET:
INFORMATION FOR THE USER
Femicept 150/30 Coated Tablets,
Levonorgestrel/Ethinylestradiol
150/30 microgram Coated tablets
(Levonorgestrel/Ethinylestradiol)

1. What Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30
microgram Coated tablets is and what it is used for
2. What you need to know before you take Femicept 150/30 Coated Tablets,
Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets
3. How to take Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol
150/30 microgram Coated tablets
4. Possible side effects
5. How to store Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol
150/30 microgram Coated tablets
6. Contents of the pack and other information
1. WHAT FEMICEPT 150/30 COATED TABLETS, LEVONORGESTREL/
ETHINYLESTRADIOL 150/30 MICROGRAM COATED TABLETS IS AND
WHAT IT IS USED FOR
Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram
Coated tablets are a combined oral contraceptive and belongs to a group of products
often referred to as “the Pill”. Femicept 150/30 Coated Tablets, Levonorgestrel/
Ethinylestradiol 150/30 microgram Coated tablets contains two hormones:
oestrogen (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. WHAT YOU NEED TO KNOW BEFORE YOU USE FEMICEPT 150/30
COATED TABLETS, LEVONORGESTREL/ETHINYLESTRADIOL 150/30
MICROGRAM COATED TABLETS
General notes
Before you start using Femicept 150/30 Coated Tablets, Levonorgestrel/
Ethinylestradiol 150/30 microgram Coated tablets you should read the information
on blood clots in section 2. It is particularly important to read the symptoms of a
blood clot – see Section 2 “Blood clots”.
Before you can begin taking Femicept 150/30 Coated Tablets, Levonorgestrel/
Ethinylestradiol 150/30 microgram Coated tablets, 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
Femicept Coated Tablets, or where the reliability of Femicept 150/30 Coated
Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets 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 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol
150/30 microgram Coated tablets alters the monthly changes of the cervical mucus.
Femicept Coated Tablets, like other hormonal contraceptives, does not protect
against HIV infection (AIDS) or any other sexually transmitted disease.
Do not take Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol
150/30 microgram Coated tablets
You should not use Femicept 150/30 Coated Tablets, Levonorgestrel/
Ethinylestradiol 150/30 microgram Coated tablets if you have any of the conditions
listed below. If you do have any of the conditions listed below, you must tell your
doctor. Your doctor will discuss with you what other form of birth control would be
more appropriate.
















If you are allergic to active substances or any of the other ingredients of Femicept
150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram
Coated tablets (listed in section 6).
If you have (or have ever had) a blood clot in a blood vessel of your legs (deep
vein thrombosis, DVT), your lungs (pulmonary embolus, PE) or other organs
If you know you have a disorder affecting your blood clotting – for instance,
protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V
Leiden or antiphospholipid antibodies
If you need an operation or if you are off your feet for a long time (see section
‘Blood clots’)
If you have ever had a heart attack or stroke
If you have (or have ever had) angina pectoris (a condition that causes severe
chest pain and may be a first sign of a heart attack) or transient ischaemic attack
(TIA – temporary stroke symptoms)
If you have any of the following diseases that may increase your risk of a clot in
the arteries:
- severe diabetes with blood vessel damage
- very high blood pressure
- a very high level of fat in the blood (cholesterol or triglycerides)
- a condition known as hyperhomocysteinaemia
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

If any of these conditions appear for the first time while using Femicept 150/30
Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets,
stop taking it at once and tell your doctor. In the meantime, use a non-hormonal
contraceptive. See also ‘General Notes’ in section 2 above.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Femicept 150/30 Coated
Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets.

When should you contact your doctor?
Seek urgent medical attention
- if you notice possible signs of a blood clot that may mean you are suffering from
a blood clot in the leg (i.e. deep vein thrombosis), a blood clot in the lung (i.e.
pulmonary embolism), a heart attack or a stroke (see ‘Blood clots` section below).
For a description of the symptoms of these serious side effects please go to “How
to recognize a blood clot”.
Tell your doctor if any of the following conditions apply to you.
If the condition develops, or gets worse while you are using Femicept 150/30
Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets,
you should also tell 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
• if you have elevated levels of fat in the blood (14)) or a positive family history for
this condition. Hypertriglyceridaemia has been associated with an increased risk of
developing pancreatitis (inflammation of the pancreas);
• if you need an operation, or you are off your feet for a long time (see in section 2
‘Blood clots ’);
• if you have just given birth you are at an increased risk of blood clots. You should
ask your doctor how soon after delivery you can start taking Femicept 150/30
Coated Tablets, Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated tablets;
• If you have an inflammation in the veins under the skin (superficial
thrombophlebitis);
• If you have varicose veins.
Blood clots
Using a combined hormonal contraceptive such as Femicept 150/30 Coated Tablets,
Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets increases your
risk of developing a blood clot compared with not using one. In rare cases a blood
clot can block vessels and cause serious problems.
Blood clots can develop:
• in veins (referred to as a ‘venous thrombosis’, ‘venous thromboembolism’ or
VTE);
• in the arteries (referred to as an ‘arterial thrombosis’, ‘arterial thromboembolism’
or ATE).
Recovery from blood clots is not always complete. Rarely, there may be serious
lasting effects or, very rarely, they may be fatal.
It is important to remember that the overall risk of having a harmful blood clot
due to Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30

microgram Coated tablets is small.
HOW TO RECOGNISE A BLOOD CLOT
Seek urgent medical attention if you notice any of the following signs or symptoms.
Are you experiencing any of these
signs?

What are you possibly suffering
frm?

• swelling of one leg or along a
vein in the leg or foot especially
when accompanied by:
• pain or tenderness in the
leg which may be felt only
when standing or walking
• increased warmth in the
affected leg
• change in colour of the skin
on the leg e.g. turning pale,
red or blue

Deep vein thrombosis

• sudden unexplained breathlessness
or rapid breathing
• sudden cough without an obvious
cause, which may bring up blood
• sharp chest pain which may
increase with deep breathing
• severe light headedness or
dizziness
• rapid or irregular heartbeat
• severe pain in your stomach

• chest pain, discomfort, pressure,
heaviness
• sensation of squeezing or fullness
in the chest, arm or below the
breastbone
• fullness, indigestion or choking
feeling
• upper body discomfort radiating
to the back, jaw, throat, arm and
stomach
• sweating, nausea, vomiting or
dizziness
• extreme weakness, anxiety, or
shortness of breath
• rapid or irregular heartbeats

Stroke

Pulmonary embolism

• swelling and slight blue
discolouration of an extremity
• severe pain in your stomach (acute
abdomen)

Blood clots blocking other blood
vessels.

BLOOD CLOTS IN A VEIN
What can happen if a blood clot forms in a vein?

The use of combined hormonal contraceptives has been connected with
an increase in the risk of blood clots in the vein (venous thrombosis). However,
these side effects are rare. Most frequently, they occur in the first year of use of a
combined hormonal contraceptive.

If a blood clot forms in a vein in the leg or foot it can cause a deep vein
thrombosis (DVT).

If a blood clot travels from the leg and lodges in the lung it can cause a
pulmonary embolism.

Very rarely a clot may form in a vein in another organ such as the eye (retinal
vein thrombosis).
Retinal vein thrombosis (blood clot in
the eye)

Heart attack

Ethinylestradiol 150/30 microgram Coated tablets, about 5-7 will develop a blood
clot in a year.
-
The risk of having a blood clot will vary according to your personal medical
history (see “Factors that increase your risk of a blood clot in a vein” below).
Risk of developing a blood clot in
a year

Sometimes the symptoms of
stroke can be brief with an almost
immediate and full recovery, but
you should still seek urgent medical
attention as you may be at risk of
another stroke.

If you are unsure, talk to a doctor
as some of these symptoms such as
coughing or being short of breath
may be mistaken for a milder
condition such as a respiratory tract
infection (e.g. a ‘common cold’).
Symptoms most commonly occur in
one eye:
• immediate loss of vision or
• painless blurring of vision which
can progress to loss of vision

• sudden weakness or numbness of
the face, arm or leg, especially on
one side of the body
• sudden confusion, trouble speaking
or understanding
• sudden trouble seeing in one or
both eyes
• sudden trouble walking, dizziness,
loss of balance or coordination
• sudden, severe or prolonged
headache with no known cause
• loss of consciousness or fainting
with or without seizure

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year of taking
a combined hormonal contraceptive for the first time. The risk may also be higher
if you restart taking a combined hormonal contraceptive (the same product or a
different product) after a break of 4 weeks or more.
After the first year, the risk gets smaller but is always slightly higher than if you
were not using a combined hormonal contraceptive.
When you stop Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol
150/30 microgram Coated tablets your risk of a blood clot returns to normal within
a few weeks.
What 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 (DVT or PE) with Femicept
150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated
tablets is small.
-
Out of 10,000 women who are not using any combined hormonal
contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
-
Out of 10,000 women who are using a combined hormonal contraceptive that
contains levonorgestrel, such as Femicept 150/30 Coated Tablets, Levonorgestrel/

Women who are not using a combined
hormonal pill and are not pregnant

About 2 out of 10,000 women

Women using a combined hormonal
contraceptive
pill
containing
levonorgestrel

About 5-7 out of 10,000 women

Women
using
Levonorgestrel

Not yet known

Ethinylestradiol/

Factors that increase your risk of a blood clot in a vein
The risk of a blood clot with Femicept 150/30 Coated Tablets, Levonorgestrel/
Ethinylestradiol 150/30 microgram Coated tablets is small but some conditions will
increase the risk. Your risk is higher:
• if you are very overweight (body mass index or BMI over 30kg/m2)
• if one of your immediate family has had a blood clot in the leg, lung or other
organ at a young age (e.g. below the age of about 50). In this case you could have a
hereditary blood clotting disorder
• if you need to have an operation, or if you are off your feet for a long time
because of an injury or illness, or you have your leg in a cast. The use of Femicept
150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated
tablets may need to be stopped several weeks before surgery or while you are
less mobile. If you need to stop Femicept 150/30 Coated Tablets, Levonorgestrel/
Ethinylestradiol 150/30 microgram Coated tablets ask your doctor when you can
start using it again.
• as you get older (particularly above about 35 years)
• if you gave birth less than a few weeks ago.
The risk of developing a blood clot increases the more conditions you have.
Air travel (>4 hours) may temporarily increase your risk of a blood clot, particularly
if you have some of the other factors listed
It is important to tell your doctor if any of these conditions apply to you, even if
you are unsure. Your doctor may decide that Femicept 150/30 Coated Tablets,
Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets need to be
stopped.

tablets, you are advised to stop smoking. If you are unable to stop smoking and are
older than 35 your doctor may advise you to use a different type of contraceptive
• if you are overweight
• if you have high blood pressure
• if a member of your immediate family has had a heart attack or stroke at a young
age (less than about 50). In this case you could also have a higher risk of having a
heart attack or stroke
• if you, or someone in your immediate family, have a high level of fat in the
blood (cholesterol or triglycerides)
• if you get migraines, especially migraines with aura
• if you have a problem with your heart (valve disorder, disturbance of the rhythm
called atrial fibrillation)
• if you have diabetes.
If you have more than one of these conditions or if any of them are particularly
severe the risk of developing a blood clot may be increased even more.
If any of the above conditions change while you are using Femicept 150/30 Coated
Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets, for
example you start smoking, a close family member experiences a thrombosis for no
known reason, or you gain a lot of weight, tell your doctor.
Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30
microgram Coated tablets and cancer
Breast cancer has been found slightly more often in women using combined pills,
but it is not known whether this is caused by the combined pills. For example, it
may be that tumours are found more in women on combined pills because they are
examined by the doctor more often. After stopping the combined pill, the increased
risk gradually reduces.
It is important to check your breasts regularly and you should contact your doctor if
you feel any lump.
You should also tell your doctor if a close relative has, or ever had breast cancer
(see section 2 “When to take special care with Femicept 150/30 Coated Tablets,
Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets”).
In rare cases, benign (noncancerous) liver tumours, and in even fewer cases
malignant (cancerous) liver tumours have been reported in pill users. Contact your
doctor if you have unusual severe abdominal pain.
Cervical cancer is caused by an infection with the human papilloma virus (HPV).
It has been reported to occur more often in women using the pill for a long time. It
is unknown if this finding is due to the use of hormonal contraceptives or to other
factors, such as difference in sexual behaviour.
Bleeding between periods

If any of the above conditions change while you are using Femicept 150/30 Coated
Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets, for
example a close family member experiences a thrombosis for no known reason, or
you gain a lot of weight, tell your doctor.

During the first few months that you are taking Femicept 150/30 Coated Tablets,
Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated tablets, 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.

BLOOD CLOTS IN AN ARTERY

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

What can happen if a blood clot forms in an artery?

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.

Like a blood clot in a vein, a clot in an artery can cause serious problems. For
example, it can cause a heart attack or a stroke.
Factors that increase your risk of a blood clot in an artery

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.

It is important to note that the risk of a heart attack or stroke from using Femicept
150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated
tablets is very small but can increase:

Other medicines and Femicept 150/30 Coated Tablets, Levonorgestrel/
Ethinylestradiol 150/30 microgram Coated tablets

• with increasing age (beyond about 35 years)
• if you smoke. When using a combined hormonal contraceptive like Femicept
150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated

Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including medicines obtained without a prescription and herbal
medicines.

Also tell any other doctor or dentist who prescribes another medicine (or
the dispensing pharmacist) that you use Femicept 150/30 Coated Tablets,
Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated tablets. They can tell
you if you need to take additional contraceptive precautions (barrier method)
and, if so, for how long.

150/30 microgram Coated tablets exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure. Take one tablet of Femicept 150/30
Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets
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.

Some medicines have an influence on the blood level of Femicept 150/30
Coated Tablets, Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated
tablets and can make it less effective in preventing pregnancy, or can cause
unexpected bleeding. These include medicines used for the treatment of:
– epilepsy (e.g. primidone, phenytoin, phenobarbital, carbamazepine,
oxcarbazepine, topiramate, felbamate);
– tuberculosis (e.g. rifampicin);
–HIVand Hepatitis C Virus infections (so-called protease inhibitors
and non-nucleoside reverse transcriptase inhibitors such as ritonavir,
nevirapine, efavirenz)
– other infections (griseofulvin)– high blood pressure in the blood vessels
in the lungs (bosentan).

The herbal product St. John’s wort may also stop Femicept 150/30 Coated
Tablets, Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated tablets
from working properly. If you want to use herbal products containing St.
John’s wort while you are already using Femicept 150/30 Coated Tablets,
Levonorgestrel/ Ethinylestradiol 150/30 microgram Coated tablets you
should consult your doctor first.

Some medicines can increase the levels of the active substances of Femicept

150/30 Coated Tablets, Levonorgestrel/ Ethinylestradiol 150/30 microgram
Coated tablets in the blood. The effectiveness of the pill is maintained, but
tell your doctor if you are using anti-fungal medicines
containing ketoconazole.

Femicept 150/30 Coated Tablets, Levonorgestrel/ Ethinylestradiol 150/30
microgram Coated tablets may also interfere with the working of other
medicines – such as the anti-epileptic lamotrigine.
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, breast feeding and fertility
Pregnancy
If you become pregnant while taking Femicept 150/30 Coated Tablets,
Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets you must stop
immediately and contact your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Breast feeding
Use of Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30
microgram Coated tablets 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
Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram
Coated tablets does not have any known effect on your ability to drive or use
machines.
Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30
microgram Coated tablets 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.

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 Femicept 150/30 Coated Tablets, Levonorgestrel/
Ethinylestradiol 150/30 microgram Coated tablets (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 Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30
microgram Coated tablets 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 Femicept 150/30 Coated Tablets, Levonorgestrel/
Ethinylestradiol 150/30 microgram Coated tablets
• If you have not used a contraceptive with hormones in the previous month.
Begin with Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol
150/30 microgram Coated tablets on the first day of the cycle (that is the first day of
your menstruation). If you start Femicept 150/30 Coated Tablets, Levonorgestrel/
Ethinylestradiol 150/30 microgram Coated tablets 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 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol
150/30 microgram Coated tablets 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 or an abortion.
Follow the advice of your doctor.
• After having a baby.
After having a baby, you can start Femicept 150/30 Coated Tablets, Levonorgestrel/
Ethinylestradiol 150/30 microgram Coated tablets 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 150/30 Coated Tablets,
Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets use.

3. HOW TO TAKE FEMICEPT 150/30 COATED TABLETS,
LEVONORGESTREL/ ETHINYLESTRADIOL 150/30 MICROGRAM
COATED TABLETS

If, after having a baby, you have had intercourse before starting Levonorgestrel/
Ethinylestradiol 150/30 microgram Coated Tablets (again), you must first be sure
that you are not pregnant or you must wait until the next menstrual bleed.

Always take Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol

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

• If you are breastfeeding and want to start Femicept 150/30 Coated Tablets,
Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets after having a
baby.
Read the section on “Breast feeding”.

Ask your doctor for advice
Several tablets
forgotten in 1strip

yes
In
week 1

no

If you take more Femicept 150/30 Coated Tablets, Levonorgestrel/
Ethinylestradiol 150/30 microgram Coated tablets than you should
There are no reports of serious harmful results of taking too many Femicept 150/30
Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated 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 150/30 Coated Tablets, Levonorgestrel/
Ethinylestradiol 150/30 microgram Coated tablets, or you discover that a child has
taken some, ask your doctor or pharmacist for advice.
If you forget to take Femicept 150/30 Coated Tablets, Levonorgestrel/
Ethinylestradiol 150/30 microgram Coated tablets
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.

Had sex in the previous week
before forgetting?

• 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
• Stop the strip immediately
• Begin the gap week (not longer
than 7 days, including the
forgotten tablet )
• Then go to 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 substance in the pill are not fully absorbed 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 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram
Coated tablets.
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 Femicept 150/30 Coated Tablets,
Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets 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 stop taking Femicept 150/30 Coated Tablets, Levonorgestrel/
Ethinylestradiol 150/30 microgram Coated tablets
You can stop taking Femicept 150/30 Coated Tablets, Levonorgestrel/
Ethinylestradiol 150/30 microgram Coated tablets 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, this medicine can cause side effects, although not everybody
gets them. If you get any side effect, particularly if severe or persistent, or have any
change to your health that you think may be due to Femicept 150/30 Coated Tablets,
Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets, please talk to
your doctor.
An increased risk of blood clots in the veins (venous thromboembolism (VTE))
or blood clots in the arteries (arterial thromboembolism (ATE)) is present for all
women using combined hormonal contraceptives. For more detailed information
on the different risks from taking combined hormonal contraceptives please see
section 2 “What you need to know before you use Femicept 150/30 Coated Tablets,
Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets”.
Very common (may affect more than 1 in 10 people):

acne

changes to menstrual periods (e.g. absence or irregularity)
Common (may affect up to 1 in 10 people):

decreased interest in sex; depression/depressed mood; mood changes

headache or migraine

feeling sick (nausea)

heavy menstrual periods; breast pain; pelvic pain

weight gain
Uncommon (may affect up to 1 in 100 people):

increased appetite; fluid retention (oedema)

hot flush

swollen abdomen

increased sweating; hair loss; itching; dry skin; oily skin

heaviness in limbs

regular but scanty periods; larger breasts; breast lump; milk production
while not pregnant; premenstrual syndrome; pain during intercourse; dryness in the
vagina or vulva; spasm of the uterus

irritability

increased liver enzymes
Rare (may affect up to 1 in 1,000 people):
• harmful blood clots in a vein or artery, for example:
o in a leg or foot (i.e., DVT)
o in a lung (i.e., PE)
o heart attack
o stroke
o mini-stroke or temporary stroke-like symptoms known as a transient ischaemic attack (TIA)
o blood clots in the liver, stomach/intestine, kidneys or eye.
The chance of having a blood clot may be higher if you have any other conditions
that increase this risk (See section 2 for more information on the conditions that
increase risk for blood clots and the symptoms of a blood clot.) decreased appetite

increased interest in sex

disturbance in attention

dry eye; contact lens intolerance

dry mouth

golden brown pigment patches, mostly in the face; excessive hair growth

vaginal smell; discomfort in the vagina or vulva

hunger

disease of the gallbladder
Allergic (hypersensitive) reactions have been reported in users of Femicept 150/30
Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets,
but the frequency cannot be estimated from the available data.
Further information on the possible side effect changes to menstrual periods
(e.g. absence or irregular) during the use of Femicept 150/30 Coated Tablets,

Levonorgestrel/Ethinylestradiol 150/30 microgram Coated tablets is described
in section 3 ‘HOW TO TAKE FEMICEPT 150/30 COATED TABLETS,
LEVONORGESTREL/ ETHINYLESTRADIOL 150/30 MICROGRAM COATED
TABLETS’.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes
any possible side effects not listed in this leaflet.
You can also report side effects directly via the yellow card system at www.mhra.
go.uk/yellowcard. By Reporting side effects you can help provide more information
on the safety of this medicine.
5. HOW TO STORE FEMICEPT 150/30 COATED TABLETS,
LEVONORGESTREL/ ETHINYLESTRADIOL 150/30 MICROGRAM
COATED TABLETS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister / carton
after ‘{EXP}’. The expiry date refers to the last day of that month Store below 25° C
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help protect the environment.
6. Contents of the pack and other information
What Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30
microgram Coated tablets contains
- The active substances are Levonorgestrel (150 mcg) and Ethinylestradiol (30 mcg)
- 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 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30
microgram Coated tablets looks like and contents of the pack
Femicept 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30 microgram
Coated tablets are white, circular, biconvex and sugar coated.
Each box contains 1, 3, 6 and 13 blisters of 21 tablets each.
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 150/30 Coated Tablets, Levonorgestrel/Ethinylestradiol 150/30
microgram Coated tablets is manufactured by:
Accord Healthcare Limited
Sage House, 319 Pinner Road,
North Harrow, Middlesex
HA1 4HF, United Kingdom
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:
DE: Glorianna 0,03 mg/0,15 mg überzogene Tabletten
NO: Oralcon
DK: Femicept

NL: Ethinylestradiol/Levonorgestrel Mylan 0,03/0,15 mg
UK: Levonorgestrel/Ethinylestradiol 150/30 microgram Coated Tablets
HU: Oralcon 150mcg/30mcg Bevont tabletta
This leaflet was last revised in 03/2016.

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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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