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MOONIA 75 MICROGRAMS FILM-COATED TABLETS

Active substance(s): DESOGESTREL

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the woman gets older. Therefore, the extra number of breast cancers diagnosed is higher if the
age until which the woman continues to take the Pill is higher. How long she takes the Pill is
less important.

PACKAGE LEAFLET: INFORMATION FOR THE USER

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. Likewise, 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.

Moonia 75 micrograms film-coated tablets
Desogestrel

The risk of breast cancer in users of progestogen-only pills like Moonia is believed to be similar
to that in women who use the Pill, but the evidence is less conclusive.

Desogestrel

Read all of this leaflet carefully before you start taking the medicine because it
contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It is not
suitable for all women, so you should not give it to anyone else as it may harm them.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.
What is in this leaflet:
1. What Moonia is and what it is used for
2. What you need to know before you take Moonia
3. How to take Moonia
4. Possible side effects
5. How to store Moonia
6. Contents of the pack and other information
1. WHAT MOONIA IS AND WHAT IT IS USED FOR
Moonia is used to prevent pregnancy.
Moonia contains a small amount of one type of female sex hormone, the progestogen
desogestrel. For this reason Moonia is called a progestogen-only-pill (POP).
Contrary to the combined pill, the POP does not contain an oestrogen hormone next to the
progestogen.
Most POPs work primarily by preventing the sperm cells from entering the womb but do not
always prevent the egg cell from ripening, which is the primary action of combined pills.
Moonia is distinct from POPs in having a dose that in most cases is high enough to prevent the
egg cell from ripening. As a result, Moonia provides high contraceptive efficacy. In contrast to
the combined pill, Moonia can be used by women who do not tolerate oestrogens and by
women who are breastfeeding.
A disadvantage is that vaginal bleeding may occur at irregular intervals during the use of
Moonia. You also may not have any bleeding at all.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MOONIA
Moonia, like other hormonal contraceptives, does not protect against HIV infection
(AIDS) or any other sexually transmitted disease.
Do not take Moonia
• If you are allergic to desogestrel or to any of the other ingredients of this medicine
(listed in section 6).
• If 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)).
• If you have or have had jaundice (yellowing of the skin) or severe liver disease and your liver
function is still not normal.
• If you have or are suspected to have a cancer that is sensitive to sex-steroids, such as certain
types of breast cancer.
• If you have any unexplained vaginal bleeding.
• If you are allergic to peanut or soya.
Tell you doctor before you start to use Moonia if any of these conditions apply to you. Your
doctor may advise you to use a non-hormonal method of birth control.
Consult your doctor immediately if any of these conditions appear for the first time while
using Moonia.
Warnings and precautions
Talk to your doctor or pharmacist before you start to use Moonia, if
• you have ever had cancer of the breast.
• you have liver cancer, since a possible effect of Moonia cannot be excluded.
• you have ever had a thrombosis.
• you have diabetes.
• you suffer from epilepsy (see section ‘Other medicines and Moonia’).
• you suffer from tuberculosis (see section ‘Other medicines and Moonia’).
• you have high blood pressure.
• you 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 Moonia 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.
Moonia and breast cancer
Regularly check your breasts and 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, the risk
gradually decreases, so that 10 years after stopping 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
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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 known whether the difference in
breast cancer risk is caused by the Pill. It may be that the women were examined more often,
so that the breast cancer is noticed earlier.
Moonia and thrombosis
See your doctor immediately; if you notice possible signs of a thrombosis (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”. As a result, fatal situations may occur. 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 Moonia, is believed to be lower than in users of Pills
that also contain oestrogens (combined Pills).
Children and adolescents
No clinical data on efficacy and safety are available in adolescents below 18 years.
Other medicines and Moonia
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. Some medicines may stop Moonia from working properly.
These include medicines used for the treatment of epilepsy (e.g. primidone, phenytoin,
carbamazepine, oxcarbazepine, felbamate and Phenobarbital) or tuberculosis (e.g. rifampicin),
HIV infections (e.g. ritonavir) or other infectious diseases (e.g. griseofulvin), stomach upset
(medical charcoal), depressive moods (the herbal remedy St John's wort).
Your doctor can tell you if you need to take additional contraceptive precautions and if so, for
how long.
Moonia 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 and breast-feeding
Pregnancy
Do not use Moonia if you are pregnant, or think you may be pregnant.
Breast-feeding
Moonia may be used while you are breast-feeding. Moonia does not influence the production
or the quality of breast milk. However, a small amount of the active substance of Moonia
passes over into the milk.
The health of children breast-fed for 7 months whose mothers were using Moonia has been
studied up to 2.5 years of age. No effects on the growth and development of the children were
observed.
If you are breast-feeding and want to use Moonia, please contact your doctor.
Driving and using machines
There are no indications of any effect of the use of Moonia on alertness and concentration.
Moonia contains lactose (milk sugar) and soy bean oil.
If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.
If you are allergic to peanut or soya, do not use this medicinal product.
Regular check-ups
While you are using Moonia 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 have severe pain or swelling in either of your legs, unexplained pains in the chest,
breathlessness, an unusual cough, especially when you cough up blood (possibly
indicating a thrombosis).
• you have a sudden, severe stomach ache or look jaundiced (possibly indicating liver
problems);
• you feel a lump in your breast (possibly indicating breast cancer);
• you have a sudden or severe pain in the lower abdomen or stomach area (possibly
indicating an ectopic pregnancy, this is 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 MOONIA
Route of administration
Moonia is for oral use.
When and how you should take Moonia
The Moonia pack contains 28 tablets. The days of the week are printed in the blister and also
arrows are printed indicating the order to take the pills. Each day correspond with one tablet.
Every time you start a new pack of Moonia, 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 with ‘WED’ (Wednesday). Continue to take one tablet a day until the pack is empty,
always following the direction indicated by the arrows. By looking at the pill pack you can
easily check if you have already taken a tablet on a particular day. Take your tablet each day at
about the same time.
Swallow the tablet whole, with water. You may have some bleeding during the use of Moonia,
but you must continue to take your tablets as normal. When a pack is empty, you must start
with a new pack of Moonia on the next day – thus without interruption and without waiting
for a bleed.
When to start with the first strip Moonia
When no hormonal contraceptive has been used in the past month
Wait for your period to begin. On the first day of your period take the first Moonia tablet.
You need not take extra contraceptive precautions.
You may also start on days 2-5 of your cycle, but in that case make sure you also use an
additional contraceptive method (barrier method) for the first 7 days of tablet-taking.
When you change from a combined pill, vaginal ring, or transdermal patch
You can start taking Moonia on the day after you take the last tablet from the present Pill pack,
or on the last 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 Moonia
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, you need not take extra contraceptive
precautions.
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 contraceptive method (barrier method) for the first 7 days of tablet-taking.
When changing from another progestogen-only pill
You may stop taking it any day and start taking Moonia right away. You need not take extra
contraceptive precautions.
When changing from an injectable or implant or a progestogen-releasing intrauterine device
(IUD)
Start using Moonia when your next injection is due or on the day that your implant or your
IUD is removed. You need not take extra contraceptive precautions.
After having a baby
You can start Moonia between 21 and 28 days after the birth of your baby. If you start later,
make sure you use an additional contraceptive method (barrier method) until you have
completed the first 7 days of tablet-taking.
However, if intercourse has already occurred, pregnancy should be excluded before starting
Moonia use. Additional information for breast-feeding women can be found in 'Pregnancy
and Breast-feeding' in section 2. Your doctor can also advise you.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious undesirable effects associated with the use of Moonia are described in the sections
"Moonia and breast cancer" and "Moonia and thrombosis" in section 2 “What you need to
know before you take Moonia” Please read this section for additional information and consult
your doctor at once where appropriate.
Vaginal bleeding may occur at irregular intervals during the use of Moonia. This may be just
slight staining which may not even require a pad, or heavier bleeding, which looks rather like
a scanty period and requires sanitary protection. You may also not have any bleeding at all. The
irregular bleedings are not a sign that the contraceptive protection of Moonia is decreased. In
general, you need not take any action; just continue to take Moonia. If, however, bleeding is
heavy or prolonged you should consult your doctor.
Following side effects have been reported:
• Common (may affect up to 1 in 10 women):
mood changes, depressed mood, decreased sexual drive (libido), headache, nausea, acne,
breast pain, irregular or no menstruation, increased body weight.
• Uncommon (may affect up to 1 in 100 woman):
infection of the vagina, difficulties in wearing contact lenses, vomiting, hair loss, painful
menstruation, ovarian cyst, tiredness.
• Rare (may affect up to1 in 1,000 woman):
Skin conditions such as: rash, hives, painful blue-red skin lumps (erythema nodosum).
Apart from these side effects, breast secretion may occur.
You should see your doctor immediately if you experience symptoms of angioedema, such as
swollen face, tongue or pharynx; difficulty swallowing; or hives and difficulty breathing.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.
5. HOW TO STORE MOONIA
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use Moonia after the expiry date which is stated on the carton after ”Do not use after:”
or “EXP:” The Expiry date refers to the last day of that month.
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

After a miscarriage or a premature termination of pregnancy
Your doctor will advise you.

What Moonia contains
The active substance is: desogestrel (75 micrograms)

If you forget to take Moonia
If you are less than 12 hours late in taking a tablet, the reliability of Moonia is maintained.
Take the missed tablet as soon as you remember and take the next tablets at the usual times.

The other ingredients are: lactose monohydrate, maize starch, povidone K30,
RRR-α-tocopherol, soybean oil, silica, colloidal anhydrous, silica, colloidal hydrated,
stearic acid, hypromellose, polyethylene glycol, titanium dioxide (E 171)
(see also "Moonia contains lactose (milk sugar) and soy bean oil" in section 2).

If you are more than 12 hours late in taking any tablet, the reliability of Moonia may be
reduced. The more consecutive tablets you have missed, the higher the risk that the
contraceptive efficacy is decreased. Take the last missed tablet as soon as you remember and
take the next tablets at the usual times. Use an additional contraceptive method (barrier
method) too for the next 7 days of tablet-taking. If you missed one or more tablets in the first
week of tablet-intake and had intercourse in the week before missing the tablets, there is a
possibility of becoming pregnant. Ask your doctor for advice.
If you suffer from gastro-intestinal disturbances (e.g. vomiting, severe diarrhoea)
Follow the advice for missed tablets in the section above. If you vomit or use medical charcoal
within 3 - 4 hours after taking your Moonia tablet or have severe diarrhoea, the active
ingredient may not have been completely absorbed.
If you take more Moonia than you should
There are no mentions of seriously damaging results of taking too many Moonia pills
simultaneously. Should you have taken a number of pills simultaneously, you may suffer from
nausea, vomiting or vaginal blood loss. If you find out that a child has taken multiple pills,
contact immediately your doctor for advice.
If you stop taking Moonia
You can stop taking Moonia whenever you want. From the day you stop you are no longer
protected against pregnancy.

What Moonia looks like and content of the pack
One blister pack of Moonia contains 28 white round film-coated tablets (with a diameter of
about 5 mm). Each carton contains 1, 3 or 6 blisters.
Not all pack sizes may be available.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
STRAGEN UK Ltd
Castle Court
41 London Road
Reigate
Surrey RH2 9RJ
Phone: +44 (0)870 351 87 44
Email: info@stragenuk.com
Manufacturer
Laboratorios León Farma, S.A.
Pol. Ind. Navatejera.
C/ La Vallina s/n
24008 - Villaquilambre, León.
Spain
This leaflet was last revised in: 03/2015

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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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