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DESOMONO 75 MICROGRAM FILM-COATED TABLETS

Active substance(s): DESOGESTREL

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FRONT

BACK
FPO

FPO

PACKAGE LEAFLET: INFORMATION FOR THE USER

3. HOW TO TAKE DESOMONO

Desomono 75 microgram film-coated tablets
Desogestrel

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you
are not sure.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

When and how to take the tablets?

!
Keep this leaflet. You may need to read it again.
The Desomono pack contains 28 tablets. Each day corresponds with one tablet. On the back of the blister you will see the
!
If you have any further questions, ask your doctor or pharmacist or nurse.
days of the week printed on the foil as well as arrows between each tablet. Every time you start a new pack of Desomono,
!
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of
take a tablet from the top row. Do not start with just any tablet. For example if you start on a Wednesday, you must take the
illness are the same as yours.

tablet from the top row marked (at the back) with Wed. Continue to take one tablet a day until the pack is empty, always

in this leaflet. See section 4.

already taken your 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 Desomono, but you must continue to take your tablets as
normal. When a pack is empty, you must start with a new pack of Desomono on the next day - thus without interruption
and without waiting for a bleed.

!
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed
following the direction indicated by the arrows. By looking at the back of your pack you can easily check if you have
What is in this leaflet:
1. What Desomono is and what it is used for
2. What you need to know before you take Desomono
3. How to take Desomono
4. Possible side effects
5. How to store Desomono
6. Contents of the pack and other information

Starting your first pack of Desomono

!
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 Desomono 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 example a condom) for the first 7 days of tablet-taking.

1. WHAT IS DESOMONO AND WHAT IS IT USED FOR
Desomono is used to prevent pregnancy. Desomono contains a small amount of one type of female sex hormone, the
progestogen desogestrel. For this reason Desomono is called a progestogen-only-pill (POP), or a mini-pill. Contrary to
the combined pill, the POP or mini-pill does not contain an oestrogen hormone next to the progestogen.

!
When changing from a combined pill, vaginal ring, or transdermal patch.
You can start taking Desomono 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 Desomono 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.

Most POPs or minipills 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. Desomono is distinct from other mini-pills in
having a dose that in most cases is high enough to prevent the egg cell from ripening. As a result, Desomono provides high
contraceptive efficacy.

You can also start at the last 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 example a condom) for the first 7 days of tablet-taking.

In contrast to the combined pill, Desomono 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 Desomono.
You also may not have any bleeding at all.

!
When changing from another progestogen-only pill (mini-pill).
You may stop taking it any day and start taking Desomono right away. You need not take extra contraceptive precautions.

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!
When changing from an injectable or implant or a progestogen-releasing intrauterine device (IUD).
Desomono, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually
Start using Desomono when your next injection is due or on the day that your implant or your IUD is removed. You need
transmitted disease.
not take extra contraceptive precautions.
Do not take Desomono
!
!
if you are allergic to desogestrel or any of the other ingredients of this medicine (listed in section 6).
After having a baby.
!
if you have a thrombosis. Thrombosis is the formation of a blood clot in a blood vessel (e.g. of the legs (deep venous
You can start Desomono between 21 to 28 days after the birth of your baby. If you start later, make sure you use during the
thrombosis) or the lungs (pulmonary embolism)).
first cycle an additional contraceptive method (barrier method) for the first 7 days of tablet-taking. However, if
!
if you have or have had jaundice (yellowing of the skin) or severe liver disease and your liver function is still not
intercourse has already occurred, pregnancy should be excluded before starting Desomono use. Additional information
normal.
for breast-feeding women can be found in “Pregnancy and breast-feeding” in section 2. Your doctor can also advise you.
!
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.
!
After a miscarriage or an abortion.
Tell your doctor before you start to use Desomono if any of these conditions apply to you. Your doctor may advise you
Your doctor will advise you.
to use a non-hormonal method of birth control.
If you forget to take Desomono
Consult your doctor immediately if any of these conditions appear for the first time while using Desomono.
!
If you are less than 12 hours late in taking a tablet, the reliability of Desomono is maintained.
Take the missed tablet as soon as you remember and take the next tablets at the usual times.
Warnings and precautions
Talk to your doctor or pharmacist before taking Desomono, if
!
If you are more than 12 hours late in taking any tablet, the reliability of Desomono may be reduced.
!
you have ever had breast cancer.
The more consecutive tablets you have missed, the higher the risk that the contraceptive efficacy is decreased. Take the
!
you have liver cancer, since a possible effect of Desomono cannot be excluded.
last missed tablet as soon as you remember and take the next tablets at the usual times. This means that you possibly take 2
!
you have ever had a thrombosis.
tablets on one day. Use an additional contraceptive method (barrier method, such as condoms) too for the next 7 days of
!
you have diabetes.
tablet-taking. If you missed one or more tablets in the first week of tablet-intake and had intercourse in the week before
!
you suffer from epilepsy (see section 2, Other medicines and Desomono).
missing the tablets, there is a possibility of becoming pregnant. Ask your doctor for advice.
!
you suffer from tuberculosis (see section 2, Other medicines and Desomono).
!
you have high blood pressure.
If you suffer from gastro-intestinal disturbances (e.g. vomiting, severe diarrhoea)
!
you have or have had chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face); if so,
Follow the advice for missed tablets in the section above. If you vomit or use medical charcoal within 3 - 4 hours after
avoid too much exposure to the sun or ultraviolet radiation.
taking your Desomono tablet or have severe diarrhoea, the active ingredient may not have been completely absorbed.
When Desomono 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.
If you take more Desomono than you should
There have been no reports of serious harmful effects from taking too many Desomono tablets at one time. Symptoms that
Breast cancer
may occur are nausea, vomiting and, in young girls, slight vaginal bleeding. For more information ask your doctor for
!
Regularly check your breasts and contact your doctor as soon as possible if you feel any lump in your breasts.
advice.
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
If you stop taking Desomono
same as for women who have never taken the Pill. Breast cancer is rare under 40 years of age but the risk increases as
You can stop taking Desomono whenever you want. From the day you stop you are no longer protected against
the woman gets older. Therefore, the extra number of breast cancers diagnosed is higher if the age until which the
pregnancy.
woman continues to take the Pill is higher. How long she takes the Pill is less important.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
!
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
4. POSSIBLE SIDE EFFECTS
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
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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.
Serious undesirable effects associated with the use of Desomono are described in the paragraphs “Breast cancer” and
“Thrombosis” in section 2 “What you need to know before you take Desomono”. Please read this section for additional
The risk of breast cancer in users of progestogen-only pills like Desomono is believed to be similar to that in women who
information and consult your doctor at once where appropriate.
use the Pill, but the evidence is less conclusive.
Vaginal bleeding may occur at irregular intervals during the use of Desomono. This may be just slight staining which may
Breast cancers found in women who take the Pill, seem less likely to have spread than breast cancers found in women
not even require a pad, or heavier bleeding, which looks rather like a scanty period and requires sanitary protection. You
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
may also not have any bleeding at all. The irregular bleedings are not a sign that the contraceptive protection of
women were examined more often, so that the breast cancer is noticed earlier.
Desomono is decreased. In general, you need not take any action; just continue to take Desomono. If, however, bleeding
is heavy or prolonged you should consult your doctor.
Thrombosis
See your doctor immediately, if you notice possible signs of a thrombosis (section 2, Contact your doctor)
Users of another desogestrel-only pill have reported the following side effects:
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 Desomono is believed to be
lower than in 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 Desomono
Tell your doctor or pharmacist or nurse if you are taking, have recently taken or might take any other medicine.

Common
may affect up to 1 in 10 people
mood altered, depressed mood,
decreased sexual drive (libido)

Uncommon
may affect up to 1 in 100 people
infection of the vagina

headache
nausea
acne
breast pain, irregular or no
menstruation
increased body weight

difficulties in wearing contact lenses
vomiting
hair loss
painful menstruation, ovarian cyst

Rare
may affect up to 1 in 1,000 people
rash, hives, painful blue-red skin
lumps (erythema nodosum) (these
are skin conditions)

tiredness

Apart from these side effects, breast secretion may occur.

Some medicines:
Breakthrough bleeding and/or contraceptive failure may result from interactions of other drugs (enzyme inducers) with
!
can have an influence on the blood levels of Desomono.
hormonal contraceptives.
!
can make it less effective in preventing pregnancy.
!
can cause unexpected bleeding.
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.
These include medicines used for the treatment of:
!
epilepsy (e.g. primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, topiramate and phenobarbital);
Reporting of side effects
!
tuberculosis (e.g. rifampicin, rifabutin);
If you get any side effects, talk to your doctor, pharmacist or Family Planning Nurse. This includes any possible side
!
HIV infections (e.g. ritonavir, nelfinavir, nevirapine, efavirenz) ;
effects not listed in this leaflet. You can also report side effects via the national Yellow Card Scheme, Website:
!
Hepatitis C virus infection (e.g. boceprevir, telaprevir);
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side
!
or other infectious diseases (e.g. griseofulvin);
effects you can help provide more information on the safety of this medicine.
!
high blood pressure in the blood vessels of the lungs (bosentan);
!
depressive moods (the herbal remedy St. John's Wort);
5. HOW TO STORE DESOMONO
!
certain bacterial infections (e.g. clarithromycin, erythromycin);
!
fungal infections (e.g. ketoconazole, itraconazole, fluconazole) ;
Keep this medicine out of the sight and reach of children.
!
high blood pressure (hypertension), angina or certain heart rhythm disorders (e.g. diltiazem).

Desomono 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 Desomono if you are pregnant, or think you may be pregnant.

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Do not use this medicine after the expiry date which is stated on the carton label and blister foil after EXP. The expiry date
refers to the last day of that month.

Your doctor can tell you if you need to take additional contraceptive precautions and if so, for how long.
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2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DESOMONO

Do not store above 30°C.
Store in the original foil pouch to protect from moisture.
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.

Breast-feeding
Desomono may be used while you are breast-feeding. Desomono does not influence the production or the quality of
breast milk. However, a small amount of the active substance of Desomono passes over into the milk.
The health of children breast-fed for 7 months whose mothers were using Desomono 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
Desomono, please contact your doctor.
Driving and using machines
There are no indications of any effect of the use of Desomono on alertness and concentration.
Desomono contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this
medicine.
Regular Check-ups
When you are using Desomono, 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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Desomono contains
The active substance is Desogestrel.
Each film coated tablet contains 75 microgram desogestrel.
The other ingredients are alpha-tocopherol; maize starch; povidone; stearic acid; hypromellose; macrogol 400; titanium
dioxide (E 171); lactose monohydrate (see section 2).
What Desomono looks like and the contents of the pack
One blister pack of Desomono contains 28 biconvex, round, white film-coated tablets without break-marks. Each blister
is enclosed in an aluminium foil pouch.
Each carton contains 1, 3, 6 or 13 blister packs.
Not all pack sizes may be available.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
MedRx Licences Limited
9 St George's Yard,
Castle Street,
Farnham,
Surrey, GU9 7LW, UK

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);
Manufacturer:
!
you have a sudden, severe stomach ache or look jaundiced (possibly indicating liver problems);
Pharbil Waltrop GmbH
!
you feel a lump in your breast (possibly indicating breast cancer);
Im Wirrigen 25
!
you have a sudden or severe pain in the lower abdomen or stomach area (possibly indicating an ectopic
D-45731 Waltrop
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);
This medicinal product is authorised in the Member States of the EEA under the following names:
!
you have unusual, heavy vaginal bleeding;
UK: Desomono 75 microgram film-coated tablets
!
you suspect that you are pregnant.
This leaflet was last revised in September 2017.

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Danya 75 microgram film-coated tablets
Desogestrel
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, please ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you. 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:
1. What Danya is and what it is used for
2. What you need to know before you take Danya
3. How to take Danya
4. Possible side effects
5. How to store Danya
6. Contents of the pack and other information
1. WHAT IS DANYA AND WHAT IS IT USED FOR
Danya is used to prevent pregnancy. Danya contains a small amount of one type of female sex hormone, the
progestogen desogestrel. For this reason Danya is called a progestogen-only-pill (POP), or a mini-pill. Contrary to the
combined pill, the POP or mini-pill does not contain an oestrogen hormone next to the progestogen.
Most POPs or minipills 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. Danya is distinct from other mini-pills in
having a dose that in most cases is high enough to prevent the egg cell from ripening. As a result, Danya provides high
contraceptive efficacy.
In contrast to the combined pill, Danya 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 Danya. You
also may not have any bleeding at all.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DANYA
Danya, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually
transmitted disease.
Do not take Danya
• if you are allergic to desogestrel or 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.
Tell your doctor before you start to use Danya 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 Danya.
Warnings and precautions
Talk to your doctor or pharmacist before taking Danya, if
• you have ever had breast cancer.
• you have liver cancer, since a possible effect of Danya cannot be excluded.
• you have ever had a thrombosis.
• you have diabetes.
• you suffer from epilepsy (see section 2 “Other medicines and Danya”).
• you suffer from tuberculosis (see section 2 “Other medicines and Danya”).
• 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 Danya 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
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 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.
• 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
than1 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.
The risk of breast cancer in users of progestogen-only pills like Danya 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 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.
Thrombosis
See your doctor immediately, if you notice possible signs of a thrombosis (see section 2 “Contact your doctor”)
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 Danya is believed to be lower
than in 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 Danya
Tell your doctor or pharmacist or nurse if you are taking, have recently taken or might take any other medicine.
Some medicines:
• can have an influence on the blood levels of Danya.
• can make it less effective in preventing pregnancy.
• can cause unexpected bleeding.
These include medicines used for the treatment of:
• epilepsy (e.g. primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, topiramate and phenobarbital);
• tuberculosis (e.g. rifampicin, rifabutin);
• HIV infections (e.g. ritonavir, nelfinavir, nevirapine, efavirenz);
• Hepatitis C virus infection (e.g. boceprevir, telaprevir);
• high blood pressure in the blood vessels of the lungs (bosentan);
• depressive moods (the herbal remedy St. John's Wort);
• certain bacterial infections (e.g. clarithromycin, erythromycin);
• fungal infections (e.g. ketoconazole, itraconazole, fluconazole);
• high blood pressure (hypertension), angina or certain heart rhythm disorders (e.g. diltiazem).
Your doctor can tell you if you need to take additional contraceptive precautions and if so, for how long.
Danya 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 Danya if you are pregnant, or think you may be pregnant.
Breast-feeding
Danya may be used while you are breast-feeding. Danya does not influence the production or the quality of breast milk.
However, a small amount of the active substance of Danya passes over into the milk.
The health of children breast-fed for 7 months whose mothers were using Danya 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 Danya, please contact your doctor.
Driving and using machines
There are no indications of any effect of the use of Danya on alertness and concentration.
Danya contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this
medicine.
Regular Check-ups
When you are using Danya, 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 DANYA
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if
you are not sure.
When and how to take the tablets?
The Danya pack contains 28 tablets. Each day corresponds with one tablet. On the back of the blister you will see the
days of the week printed on the foil as well as arrows between each tablet. Every time you start a new pack of Danya,
take a tablet from the top row. Do not start with just any tablet. For example if you start on a Wednesday, you must
take the tablet from the top row marked (at the back) with WED. Continue to take one tablet a 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. 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 Danya, but you must continue to take your
tablets as normal. When a pack is empty, you must start with a new pack of Danya on the next day - thus without
interruption and without waiting for a bleed.
Starting your first pack of Danya
• 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 Danya 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 example a condom) for the first 7 days of tablet-taking.
• When changing from a combined pill, vaginal ring, or transdermal patch.
You can start taking Danya 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 Danya 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 last 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 example a condom) for the first 7 days of tablet-taking.
• When changing from another progestogen-only pill (mini-pill).
You may stop taking it any day and start taking Danya 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 Danya 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 Danya between 21 to 28 days after the birth of your baby. If you start later, make sure you use during the
first cycle an additional contraceptive method (barrier method) for the first 7 days of tablet-taking. However, if
intercourse has already occurred, pregnancy should be excluded before starting Danya use. Additional information
for breast-feeding women can be found in “Pregnancy and Breast-feeding” in section 2. Your doctor can also advise
you.
• After a miscarriage or an abortion.
Your doctor will advise you.
If you forget to take Danya
• If you are less than 12 hours late in taking a tablet, the reliability of Danya is maintained.
Take the missed tablet as soon as you remember and take the next tablets at the usual times.
• If you are more than 12 hours late in taking any tablet, the reliability of Danya 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. This means that you possibly
take 2 tablets on one day. Use an additional contraceptive method (barrier method, such as condoms) 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 Danya tablet or have severe diarrhoea, the active ingredient may not have been completely absorbed.
If you take more Danya than you should
There have been no reports of serious harmful effects from taking too many Danya 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 Danya
You can stop taking Danya 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 medicine, ask your doctor or pharmacist.
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 Danya are described in the paragraphs “Breast cancer” and
“Thrombosis” in section 2 “What you need to know before you take Danya”. 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 Danya. 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
Danya is decreased. In general, you need not take any action; just continue to take Danya. If, however, bleeding is
heavy or prolonged you should consult your doctor.
Users of another desogestrel-only pill have reported the following side effects:
Common
may affect up to 1 in 10 people

Uncommon
may affect up to 1 in 100 people

Rare
may affect up to 1 in 1,000 people

mood altered, depressed mood,
decreased sexual drive (libido)

infection of the vagina

rash, hives, painful blue-red skin
lumps (erythema nodosum) (these
are skin conditions)

headache

difficulties in wearing contact lenses

nausea

vomiting

acne

hair loss

breast pain, irregular or no
menstruation

painful menstruation, ovarian cyst

increased body weight

tiredness

Apart from these side effects, breast secretion may occur.
Breakthrough bleeding and/or contraceptive failure may result from interactions of other drugs (enzyme inducers) with
hormonal contraceptives.
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.
Reporting of side effects
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. You can also report side effects via the national Yellow Card Scheme,
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By
reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE DANYA
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 carton label and blister foil after EXP. The expiry
date refers to the last day of that month.
Do not store above 30ºC.
Store in the original foil pouch to protect from moisture.
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 Danya contains
The active substance is Desogestrel.
Each film coated tablet contains 75 microgram desogestrel.
The other ingredients are alpha-tocopherol; maize starch; povidone; stearic acid; hypromellose; macrogol 400;
titanium dioxide (E 171); lactose monohydrate (see section 2).
What Danya looks like and the contents of the pack
One blister pack of Danya contains 28 biconvex, round, white film-coated tablets without break-marks. Each blister is
enclosed in an aluminium foil pouch.
Each carton contains 1, 3, 6 or 13 blister packs.
Not all pack sizes may be available.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
MedRx Licences Limited
9 St George's Yard, Castle Street, Farnham, Surrey, GU9 7LW, UK.
Manufacturer:
Pharbil Waltrop GmbH
Im Wirrigen 25, D-45731 Waltrop
This medicinal product is authorised in the Member States of the EEA under the following names:
UK: Danya 75 microgram film-coated tablets
This leaflet was last revised in September 2017.
MXL0002/O/PIL/G1

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