Vagifem 10mcg vaginal tablets 24

 

Package leaflet: Information for the user:
Feanolla 75 microgram film coated tablets
Desogestrel
Read all of this leaflet carefully before you start taking 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, pharmacist or Family Planning Nurse.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or Family Planning Nurse. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1.What Feanolla is and what it is used for
2.What you need to know before you take Feanolla
3.How to take Feanolla
4.Possible side effects
5.How to store Feanolla
6.Contents of the pack and other information
1.What Feanolla is and what it is used for
•Feanolla is used to prevent pregnancy.
•There are 2 main kinds of hormone contraceptive.
- The combined pill,
"The Pill", which contains 2 types of female sex hormone, an oestrogen
and a progestogen
- The progestogen-only pill, POP or mini-pill, which doesn't contain an oestrogen.
• Feanolla is a progestogen-only-pill (POP), or a
mini-pill.
• Feanolla contains a small amount of one type
of female sex hormone, the progestogen
desogestrel.
•Most POPs or minipills work primarily by
preventing the sperm cells from entering the
womb but they do not always prevent the egg
cell from ripening, which is the main way that
combined pills work.
•Feanolla is different from other mini-pills in having
a dose that in most cases prevents the egg cell
from ripening. As a result, Feanolla is a highly
effective contraceptive.
•In contrast to the combined pill, Feanolla can be
used by women who do not tolerate oestrogens
and by women who are breast feeding.
•A disadvantage is that vaginal bleeding may occur
at irregular intervals during the use of Feanolla. On
the other hand you may not have any bleeding at
all.
2.What you need to know before you take
Feanolla
Feanolla, like other hormonal contraceptives, does
not protect against HIV infection (AIDS) or any other
sexually transmitted disease.
Do not take Feanolla if:
• you are allergic to desogestrel or any of the other ingredients of this medicine (listed in section 6).
• you have a thrombosis. Thrombosis is the formation of a blood clot in a blood vessel (e.g. of the legs (deep venous thrombosis) or the lungs (pulmonary embolism)).
• you have or have had jaundice (yellowing of the skin) or severe liver disease and your liver is still not working normally.
• you have or if you are suspected of having a cancer that grows under the influence of sex-steroids, such as certain types of breast cancer.
• you have any unexplained vaginal bleeding.
If any of these conditions apply to you, tell your doctor before you start to use Feanolla. Your doctor may advise you to use a non-hormonal method of birth control. If any of these conditions appear for the
first time while using Feanolla, consult your doctor immediately.
Warnings and precautions:
Before you start Feanolla tell your doctor or family planning nurse, if you:
• have ever had breast cancer.
•have liver cancer, since a possible effect of Feanolla cannot be excluded.
• have ever had a thrombosis.
•have diabetes.
• suffer from epilepsy (See section ‘Other medicines and Feanolla').
•have tuberculosis (See section ‘Other medicines and Feanolla').
•have high blood pressure.
• have or have had chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face); if so avoid too much exposure to the sun or ultraviolet radiation.
When Feanolla is used in the presence of any of these conditions, you may need to be kept under close observation. Your doctor can explain what to do.
Breast cancer:
•It is important to regularly check your breasts and you should contact your doctor as soon as possible if you feel any lump in your breasts.
•Breast cancer has been found slightly more often in women who take the Pill than in women of the
same age who do not take the Pill. If women stop taking the Pill, this reduces the risk, so that 10
years after stopping the Pill, the risk is the same as for women who have never taken the Pill.
Breast cancer is rare under 40 years of age but the
risk increases as the woman gets older. Therefore,
the extra number of breast cancers diagnosed is
higher if a woman continues to take the Pill when she
is older. How long she takes the Pill is less important.
•In every 10,000 women who take the Pill for up to
5 years but stop taking it by the age of 20, there
would be less than 1 extra case of breast cancer
found up to 10 years after stopping, in addition to
the 4 cases normally diagnosed in this age group.
•In 10,000 women who take the Pill for up to 5
years but stop taking it by the age of 30, there
would be 5 extra cases in addition to the 44 cases
normally diagnosed.
•In 10,000 women who take the Pill for up to 5
years but stop taking it by the age of 40, there
would be 20 extra cases in addition to the 160
cases normally diagnosed.
The risk of breast cancer in users of progestogen-
only pills like Feanolla is believed to be similar to that
in women who use the Pill, but the evidence is less
conclusive.
Breast cancers found in women who take the Pill,
seem less likely to have spread than breast cancers
found in women who do not take the Pill.
It is not certain whether the Pill causes the increased
risk of breast cancer. It may be that the women were
examined more often, so that the breast cancer is
noticed earlier.
Thrombosis:
See your doctor immediately if you notice possible
signs of athrombosis
(see also ‘Regular check-ups').
Thrombosis is the formation of a
blood clot
, which may block a blood vessel. A thrombosis sometimes
occurs in the deep veins of the legs (deep venous
thrombosis). If this clot breaks away from the
veins where it is formed, it may reach and block the
arteries of the lungs, causing a so-called "pulmonary
embolism". A pulmonary embolism can cause chest
pain, breathlessness, collapse or even death.
• Deep venous thrombosis is a rare occurrence. It
can develop whether or not you are taking the Pill.
It can also happen if you become pregnant.
The risk is higher in Pill-users than in non-users.
The risk with progestogen-only pills like Feanolla is
believed to be lower than in users of Pills that also
contain oestrogens (combined pills)
Other medicines and Feanolla
Tell your doctor, pharmacist, or Family Planning
Nurse if you are taking, have recently taken or might
take any other medicines or herbal products.This
includes medicines obtained without a prescription.
Some medicines may stop Feanolla from working
properly. These include medicines used for the
treatment of:
• epilepsy (e.g. primidone, phenytoin,
carbamazepine, oxcarbazepine, felbamate and
phenobarbital)
• tuberculosis (e.g. rifampicin)
• HIV infections (e.g. ritonavir), or other infectious
diseases (e.g. griseofulvin)
• stomache upset (medical charcoal)
• depressive moods (the herbal remedy St.
John'sWort).
Your doctor can tell you if you need to take additional
contraceptive precautions and if so, for how long.
Feanolla may also interfere with how certain
medicines work, causing either an increase in
effect (e.g. medicines containing cyclosporine) or a
decrease in effect.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
Pregnancy:
Do not use Feanolla if you are pregnant, or think you
may be pregnant.
Breast-feeding:
Feanolla may be used while you are breast-feeding.
Desogestrel does not influence the production or the
quality of breast milk. However, a small amount of
the active substance of Feanolla passes over into the
milk.
The health of children who were breast-fed for 7
months while their mothers were using desogestrel
has been studied up until they were 2½ years of age.
No effects on the growth and development of the
children were observed.
If you are breast feeding and want to use Feanolla,
please contact your doctor.
Fertility
There is no evidence to suggest any short or long
term infertility effects following the use of this
medicine. However, in patients receiving similaroral
contraceptive products, temporary infertility
after discontinuance of treatment has been seen
occasionally.
Driving and using machines:
Feanolla has no known effect on the ability to drive or
use machines
Feanolla contains lactose
Feanolla contains lactose (milk sugar). Please contact
your doctor before taking Feanolla if you have been
told by your doctor that you are intolerant to some
sugars.
Use in adolescents:
No clinical data on efficacy and safety are available in
adolescents below 18 years.
Regular Check-ups:
When you are using Feanolla, your doctor will tell
you to return for regular check-ups. In general, the
frequency and nature of these check-ups will depend
on your personal situation.
Contact your doctor as soon as possible if:
• you notice possible signs of a blood clot
(e.g. severe pain or swelling in either of your legs)
unexplained pains in the chest, breathlessness,
an unusual cough, especially when you cough up
blood)
• you have a sudden, severe stomach ache or
jaundice
(you may notice yellowing of the skin,
the whites of the eyes, or dark urine, possibly a
sign of
liver problems)
• you feel a lump in your breast
• you have a sudden or severe pain in the lower
abdomen or stomach area (possibly a sign of
an ectopic pregnancy - a pregnancy outside the
womb)
• you are to be immobilised or are to have surgery
(consult your doctor at least four weeks in
advance)
• you have unusual, heavy vaginal bleeding
• you suspect that you are pregnant
3. How to take Feanolla
Always take this medicine exactly as your doctor,
pharmacist or family planning nursehas told you.
Check with your doctor, pharmacist or family
planning nurse if you are not sure.
When and how to take the tablets
Each strip of Feanolla contains 28 tablets - 4 weeks
supply.
• Take your tablet each day at about the same
time. Swallow the tablet whole, with water.

Feanolla
75 microgram
film coated tablets

• Arrows are printed on the front of the strip, between
the tablets. The days of the week are printed on the
back of the strip. Each day corresponds with one
tablet.
• Every time you start a new strip of Feanolla, take
a tablet from the top row. Don't start with just any
tablet. For example if you start on a Wednesday,
you must take the tablet from the top row marked
(on the back) with WED.
• Continue to take one tablet every day until the pack
is empty, always following the direction indicated
by the arrows. By looking at the back of your pack
you can easily check if you have already taken
your tablet on a particular day.
• You may have some bleeding during the use of
Feanolla, (See Section 4 - Side Effects) but you
must continue to take your tablets as normal.
• When a strip is empty, you must start with a
new strip of Feanolla on the next day - without
interruption and without waiting for a bleed.
Starting your first pack of Feanolla
If you are not using hormonal contraception at
present (or in the past month)
Wait for your period to begin. On the first day of
your period take the first Feanolla tablet. Additional
contraceptive precautions are not necessary.
Ifyoutakeyourfirsttabletondays2to5ofyourperiod
use an additional barrier method of contraception for
the first 7 days of tablet-taking.
When you change from a combined pill (COC),
vaginal ring, or transdermal patch.
If you have
a tablet-, ring- or patch-free break
• You can also start at the latest the day following
the tablet-, ring-, patch-free break, or placebo
tablet interval, of your present contraceptive.
• If you follow these instructions, make sure
you use an additional barrier method of
contraception for the first 7 days of tablet-taking.
If you don't have
a tablet-, ring- or patch-free break
• Start taking Feanolla on the day after you take the
last tablet from the present Pill pack, or on the
day of removal of your vaginal ring or patch (this
means no tablet-, ring- or patch-free break).
• If your present Pill pack also contains inactive
tablets you can start Feanolla on the day after
taking the last active tablet (if you are not sure
which this is, ask your doctor or pharmacist).
• If you follow these instructions, additional
contraceptive precautions are not necessary.
When you change from another progestogen-only
pill (mini-pill)
Switch on any day from another mini pill. Additional
contraceptive precautions are not necessary.
When you change from an injection, implant or a
hormonal IUS
Start using Feanolla when your next injection is
due or on the day that your implant or you IUS is
removed. Additional contraceptive precautions are
not necessary.
After you have a baby:
You can start Feanolla between 21 to 28 days after the
birth of your baby.
If you start later, make sure that during the first cycle
you use an additional barrier method of contraception
for the first 7 days of tablet-taking. However, if you
have already had sex, check that you are not pregnant
before starting Feanolla. Information for breast-
feeding women can be found in section 2 "What
you need to know before you take Feanolla" in the
paragraph "Pregnancy, breast-feeding and fertility".
Your doctor can also advise you.
After a miscarriage or an abortion
Your doctor will advice you.
If you forget to take Feanolla
If you are
less than 12 hours late:
• Take the missed tablet as soon as you remember
and take the next one at the usual time.
Feanolla will still protect you from pregnancy.
If you are
more than 12 hours late:
• If you are more than 12 hours late in taking any
tablet,
you may not be completely protected
against pregnancy.
The more consecutive tablets
you have missed, the higher the risk that you
might fall pregnant.
• Take a tablet as soon as you remember and take
the next one at the usual time. This may mean
taking two in one day. This is not harmful. (If you
have forgotten more than one tablet you don't
need to take the earlier missed ones). Continue to
take your tablets as usual but you must also use
an extra method, such as a condom, for the
next 7
days .
• If you are more than 12 hours late taking your
tablet and have had sex it is safe to use
emergency contraception; please consult your pharmacist or
doctor.
• If you missed one or more tablets in the
very first week of tablet-intake and had intercourse in the
week before missing the tablets, you may fall
pregnant. Ask your doctor for advice.
If you vomit or use medical charcoal
If you vomit, or use medical charcoal within 3 - 4
hours after taking your Feanolla tablet or have severe
diarrhoea, the active ingredient may not have been
completely absorbed. Follow the advice for forgotten
tablets in the section above.
If you take more Feanolla than you should
There have been no reports of serious harmful effects
from taking too many desogestrel tablets at one time.
Symptoms that may occur are nausea, vomiting and
in young girls, slight vaginal bleeding.
For more information ask your doctor for advice.
If you stop taking Feanolla
You can stop taking Feanolla whenever you want.
From the day you stop you are no longer protected
against pregnancy.
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 medicinecan cause side
effects, although not everybody gets them.
Tell your doctor if you notice any unwanted effect,
especially if severe or persistent.
Serious side effects
associated with the use of
desogestrel are described in section 2 "What you
need to know before you take Feanolla". Please read
this section for additional information on ‘Breast
cancer' and ‘Thrombosis', and consult your doctor at
once where appropriate.
Vaginal bleeding may occur at irregular intervals
while using Feanolla. This may be just slight staining
which may not even require a pad, or heavier bleeding,
which looks rather like a scanty period. You may need
to use tampons or sanitary towels. You may also not
have any bleeding at all. Irregular bleeding is not a
sign that Feanolla is not working. In general, you need
not take any action; just continue to take Feanolla.
If bleeding is heavy or prolonged you should consult
your doctor.
How often are other possible side effects seen?
Common
(affecting less than 1 in 10 women)
•mood changes
•depressed mood
•decreased sexual drive (libido)
•headache
•nausea
•acne
•breast pain
•irregular or no periods
•weight increase.
Uncommon
(affecting less than 1 in 100 women)
• infection of the vagina
• difficulties in wearing contact lenses
• vomiting, hair loss
• painful periods
• ovarian cysts
• tiredness
Rare
(affecting less than 1 in 1000 women)
• skin conditions such as: rash, hives, painful blue-
red skin lumps (erythema nodosum)
• breast secretion or leakage may occur
You should see your doctor immediately if you
experience symptoms of angioedema, such as (i)
swollen face, tongue or pharynx, (ii) difficulty to
swallow, or (iii) hives and difficulties to breathe.
If you get any side effects, talk to your doctor,
pharmacist or family planning nurse. This includes
any possible side effects not listed in this leaflet.
5.How to store Feanolla
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the expiry date which
is printed on the carton and blister. The expiry date
refers to the last day of that month.
This medicinal product does not require any special
storage conditions.
Do not throw away any medicines via waste water or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help to protect the environment.
6.
Contents of the pack and other
information
What Feanolla contains
• The active substance is desogestrel. One (1)
film-coated tablet contains 75 micrograms of
desogestrel.
• The other ingredients are:
Tablet core: Lactose monohydrate, Allrac
αTocopherol (E307), Povidone K30, Silica colloidal
anhydrous, Talc (E553b), Maize starch, Stearic
acid, Magnesium stearate (E470b)
Film-coating: Hypromellose (HPMC2910, E464),
Titanium dioxide (E171), Macrogol 400 (PEG 400)
What Feanolla looks like and contents of the pack
Feanolla are white, round, biconvex, film-coated
tablets, plain on both the sides. Feanolla film-coated
tablets are packed in blister strips. Each blister
contains 28 tablets
Feanolla is available in packs of 28 (1x28), 84 (3x28)
and 168 (6x28) tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Lupin (Europe) Limited
Victoria Court
Bexton Road
Knutsford
Cheshire
WA16 0PF
United Kingdom
This medicinal product is authorised in the Member
States of the EEA under the following names:
Germany:
Feanolla 75 Mikrogramm
Filmtabletten
Italy:
Feanolla 75 microgrammi
compresse rivestite con film
Spain:
Feanolla 75 microgramos
comprimidos recubiertos con
película
United Kingdom: Feanolla 75 microgram film-
coated tablets
This leaflet was last revised in September 2014
Code No. MP/DRUGS/28/6/2010
ID#: 238713

 

 

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www.medicines.org.uk/emc/files/pil.5719.pdf

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