DESOMONO 75 MICROGRAM FILM-COATED TABLETS
Active substance(s): DESOGESTREL / DESOGESTREL / DESOGESTREL
Danya 75 microgram
MedRX Licenses Ltd
180 x 590 mm
Final Preparation Date For Submission: 17/06/2016
Packing Site Technical Approval:
Authority Approval Date:
Latest Implementation Deadline:
Print Proof Approval:
PACKAGE LEAFLET: INFORMATION FOR THE USER
Danya 75 microgram film-coated tablets
Read all of this leaflet carefully before youstart 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.
• 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. This includes any possible side effects not listed in this
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
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. BEFORE YOU TAKE DANYA
Danya, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually
Do not take Danya
• if you are allergic (hypersensitive) to the active substance 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
• 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.
Take special care with Danya
Tell your doctor before you start to use 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 “Taking other medicines”).
• you suffer from tuberculosis (see section “Taking other medicines”).
• 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.
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 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.
See your doctor immediately, if you notice possible signs of a thrombosis (see also “When should you contact your
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).
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines or herbal products,
including medicines obtained without a prescription.
Some medicines may stop Danya 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)
• 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.
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
Do not use Danya if you are pregnant, or think you may be pregnant.
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
Danya contains lactose (milk sugar). Please contact your doctor before taking Danya 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.
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
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
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
• 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 Breastfeeding” in section 2. Your doctor can also advise
• 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
If you stop taking Danya
You can stop taking Danya whenever you want. From the day you stop you are no longer protected against
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.
Serious undesirable effects associated with the use of Danya are described in the paragraphs “Breast cancer” and
“Thrombosis” in section 2 “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:
may affect up to 1 in 10 people
may affect up to 1 in 100 people
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)
difficulties in wearing contact lenses
breast pain, irregular or no
painful menstruation, ovarian cyst
increased body weight
Apart from these side effects, breast secretion 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or
5. HOW TO STORE DANYA
Keep out of the sight and reach of children.
Do not use Danya 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 30×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 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.
What Danya looks like and the content of the pack
One blister pack of Danya contains 28 biconvex, round, white film-coated tablets without break-marks.
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.
Pharbil Waltrop GmbH
Im Wirrigen 25
This leaflet was last revised in 06/2016.
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.