MERCILON 0.15 mg/0.02 mg Coated tablet

Зміст інструкції

1. Mercilon 0.15 mg + 0.02 mg tablets
   1. What is Mercilon and what is it used for
   2. Cosa deve sapere prima di prendere Mercilon
   3. How to take Mercilon
   4. Possible side effects
   5. How to store Mercilon
   6. Contents of the pack and other information

Mercilon 0.15 mg + 0.02 mg tablets

desogestrel/ethinylestradiol

Important things to know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible methods of contraception, if used correctly.
• They slightly increase the risk of blood clots forming in veins and arteries, especially during the first year of use or when restarting a combined hormonal contraceptive after a break of 4 or more weeks.
• Be careful and see a doctor if you think you have symptoms of a blood clot (see section 2 “Blood clots”).

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Mercilon is and what it is used for
• 2. What you need to know before you take Mercilon
• 3. How to take Mercilon
• 4. Possible side effects
• 5. How to store Mercilon
• 6. Contents of the pack and other information

1. What is Mercilon and what is it used for

Composition and type of pill
Mercilon is a combined oral contraceptive pill to be taken by mouth. Each tablet contains
a small amount of two different female hormones. These are desogestrel (a progestin) and
ethinylestradiol (an estrogen).
Due to its low hormone content, Mercilon is considered a low-dose oral contraceptive. Since all the tablets in the pack contain the same hormones in the
same dosage, Mercilon is considered a monophasic combined oral contraceptive.

Why use Mercilon
Mercilon is used to prevent pregnancy.
When used correctly (without forgetting any tablets) the possibility of pregnancy is very
low.

2. Cosa deve sapere prima di prendere Mercilon

Note generali
Before starting to take Mercilon, read the information on blood clots in section 2. It is particularly important that you read the symptoms of a blood clot (see section 2 “Blood clots”).

Do not take Mercilon
Do not take Mercilon if you have any of the conditions listed below. If you have any of the conditions listed below, talk to your doctor. Your doctor will discuss with you other contraceptive methods that may be more suitable for you.

• if you are allergic to the active ingredients or any of the other ingredients of this medicine (listed in section 6);
• if you have (or have ever had) a blood clot in a leg vein (deep vein thrombosis, DVT), in the lung (pulmonary embolism, PE) or in other organs;
• if you know you have a disorder that affects blood clotting, such as protein C deficiency, protein S deficiency, antithrombin-III deficiency, Factor V Leiden or antiphospholipid antibodies;
• if you are going to have surgery or if you will be bedridden for a long period (see “Blood clots”);
• if you have ever had a heart attack or stroke;
• if you have (or have ever had) angina pectoris (a condition that causes severe chest pain and may be a first sign of a heart attack) or a transient ischemic attack (TIA - symptoms of a temporary stroke);
• if you have one of the following diseases, which may increase the risk of blood clots forming in the arteries:
• severe diabetes with damage to blood vessels
• very high blood pressure
• very high levels of fats (cholesterol or triglycerides) in the blood
• a disease known as hyperhomocysteinemia
• if you have (or have ever had) a type of migraine called “migraine with aura”;
• if you suffer from or have suffered in the past from pancreatitis (inflammation of the pancreas) associated with high levels of fats in the blood;
• if you suffer from jaundice (yellowing of the skin) or a severe liver disease (of the liver);
• if you have or have ever had cancer that may grow under the influence of sex hormones (e.g. of the breast or genital organs);
• if you have or have ever had a liver tumor;
• if you have any type of vaginal bleeding of unknown origin;
• if you have endometrial hyperplasia (abnormal growth of the lining of the uterus);
• if you are pregnant or suspect you may be pregnant;
• if you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir (see also section “Other medicines and Mercilon”).

If any of these conditions occur for the first time during the use of the pill, stop taking it immediately and inform your doctor. In the meantime, use non-hormonal contraceptive methods. See also section “General notes”.

Warnings and precautions
Talk to your doctor or pharmacist before taking Mercilon.

Note generali
of the pill or in which the effectiveness of the pill may be reduced. In these situations, you should not have sexual intercourse or you should use additional non-hormonal contraceptive precautions, such as using a condom or another barrier method. Do not use the rhythm or basal temperature methods. These methods may be unreliable because the pill alters the normal changes in temperature and cervical mucus that occur during the menstrual cycle.
When should you see a doctor?
See a doctor urgently

• if you notice possible signs of a blood clot that may indicate that you have a blood clot in the leg (deep vein thrombosis), a blood clot in the lung (pulmonary embolism), a heart attack or a stroke (see “Blood clots (thrombosis)”). For a description of the symptoms of these serious side effects, go to the section “How to recognize a blood clot”.

Mercilon, like all contraceptive pills, does not protect against infection with HIV (AIDS) or any other sexually transmitted disease.
Mercilon is not normally used to delay a period. However, if in exceptional cases, it is necessary to delay a period, contact your doctor.

Tell your doctor if any of the following applies to you.
If this condition occurs or worsens while you are using Mercilon, tell your doctor.

• if you smoke;
• if you have diabetes;
• if you are overweight;
• if you have high blood pressure;
• if you have a heart valve disorder or some heart rhythm disorders;
• if you have inflammation of the veins under the skin (superficial thrombophlebitis);
• if you have varicose veins;
• if you have a family history of thrombosis, heart attack or stroke;
• if you suffer from migraine;
• if you suffer from depression;
• if you suffer from epilepsy;
• if you have liver or gallbladder disease;
• if you have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease);
• if you have systemic lupus erythematosus (SLE, a disease that affects the body’s defense system);
• if you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure);
• if you have sickle cell anemia (an inherited red blood cell disease);
• if you have high levels of fats in your blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of developing pancreatitis (inflammation of the pancreas);
• if you are going to have surgery or if you will be bedridden for a long period (see section 2 “Blood clots”);
• if you have just given birth, your risk of developing blood clots is higher. Ask your doctor how long after giving birth you can start taking Mercilon;
• if any of your close relatives have had breast cancer;
• if you have disorders that have occurred for the first time or worsened during pregnancy or following previous hormone therapy (e.g. hearing loss, a disease called porphyria, a skin disease called herpes gestationis, a disease called Sydenham’s chorea);
• if you have or have ever had chloasma (brownish-yellow pigmented patches on the skin, especially on the face). If so, avoid excessive exposure to the sun or ultraviolet rays.

If any of the above conditions occur for the first time, recur or worsen during the use of the pill, consult your doctor.

Pill and thrombosis
BLOOD CLOTS
The use of a combined hormonal contraceptive like Mercilon causes an increased risk of developing a blood clot compared to not using one. In rare cases, a blood clot can block blood vessels and cause serious problems.
Blood clots can develop

• in the veins (a condition called “venous thrombosis”, “venous thromboembolism” or VTE)
• in the arteries (a condition called “arterial thrombosis”, “arterial thromboembolism” or ATE).

Recovery from blood clots is not always complete. Rarely, serious long-term effects can occur, or very rarely, these effects can be fatal.

It is important to remember that the overall risk of a harmful blood clot associated with Mercilon is low.
HOW TO RECOGNIZE A BLOOD CLOT
See a doctor immediately if you notice any of the following signs or symptoms.
Do you have any of these signs? What are you likely to be suffering from?

• swelling in one leg or along a vein in the leg or foot, especially if accompanied by:
• pain or tenderness in the leg that can be felt only when standing or walking
• increased feeling of warmth in the affected leg
• change in skin color of the leg, such as paleness, redness or bluish discoloration
• sudden shortness of breath or rapid breathing;
• sudden cough without an obvious cause, with possible blood production;
• sharp chest pain that may worsen when breathing deeply;
• severe dizziness or lightheadedness;
• rapid or irregular heartbeat;
• severe stomach pain.

If you are unsure, tell your doctor as some of these symptoms such as cough or shortness of breath can be mistaken for a milder condition such as a respiratory infection (e.g. a “common cold”).
Pulmonary embolism
Symptoms that occur more frequently in one eye:

• sudden loss of vision or
• painless blurred vision that can progress to vision loss
• pain, discomfort, pressure or heaviness in the chest;
• feeling of squeezing or fullness in the chest, arm or below the breastbone;
• feeling of fullness, indigestion or choking;
• discomfort in the upper body, radiating to the back, jaw, throat, arms and stomach;
• sweating, nausea, vomiting or dizziness;
• extreme weakness, anxiety or shortness of breath;
• rapid or irregular heartbeat.

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

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in the veins (venous thromboembolism). However, these side effects are rare. In most cases, they occur in the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein in the leg or foot, it can cause a deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• Very rarely, the clot can form in another organ such as the eye (retinal vein thrombosis).

When is the risk of developing a blood clot in a vein highest?
The risk of developing a blood clot in a vein is highest during the first year you take a combined hormonal contraceptive for the first time. The risk may also be higher if you restart a combined hormonal contraceptive (the same medicine or a different medicine) after a break of 4 or more weeks.
After the first year, the risk decreases but is still slightly higher than if you were not using a combined hormonal contraceptive.
When you stop taking Mercilon, the risk of developing a blood clot returns to normal levels within a few weeks.

What is the risk of developing a blood clot?
The risk depends on your natural risk of VTE and the type of combined hormonal contraceptive you are taking.
The overall risk of developing a blood clot in the leg or lung (DVT or PE) with Mercilon is low.

• In 10,000 women who do not use any combined hormonal contraceptive and are not pregnant, about 2 will develop a blood clot in a year.
• In 10,000 women who use a combined hormonal contraceptive containing levonorgestrel,

noretisterone or norgestimate, about 5-7 will develop a blood clot in a year.

• In 10,000 women who use a combined hormonal contraceptive containing desogestrel, like Mercilon, about 9-12 will develop a blood clot in a year.
• The risk of a blood clot forming depends on your medical history (see “Factors that increase the risk of developing a blood clot”).

Factors that increase the risk of developing a blood clot in a vein
The risk of developing a blood clot with Mercilon is low but some conditions cause an
increase. Your risk is higher:

• if you are strongly overweight (body mass index or BMI greater than 30 kg/m²);
• if a close relative of yours has had a blood clot in a leg, in the lung or in another organ at a young age (under about 50 years). In this case you may have an inherited blood clotting disorder;
• if you need to undergo surgery or if you need to stay bedridden for a long period due to an injury or illness or if you have a leg in a cast. It may be necessary to stop taking Mercilon a few weeks before surgery or during the period when you are less mobile. If you need to stop taking Mercilon, ask your doctor when you can start taking it again;
• as you get older (especially over 35 years);
• if you have given birth less than a few weeks ago.

The risk of developing a blood clot increases when you have more than one of these
conditions.
Air travel (lasting > 4 hours) can temporarily increase the risk of a blood clot forming, especially if you have some of the other risk factors listed.
It is important that you inform your doctor if any of these conditions apply to you, even
if you are not sure. The doctor may decide to stop you from taking Mercilon.
If any of the above conditions change while you are using Mercilon, for example if a
close relative develops thrombosis for no known reason or if you gain a lot of weight, contact
your doctor.

BLOOD CLOTS IN AN ARTERY
What can happen if a blood clot forms in an artery?
Like blood clots in a vein, clots in an artery can cause serious problems, for
example, they can cause a heart attack or a stroke.

Factors that increase the risk of developing a blood clot in an artery
It is important to note that the risk of heart attack or stroke associated with the use of Mercilon is
very low but can increase:

• as you get older (over 35 years);
• if you smoke. When using a combined hormonal contraceptive like Mercilon it is advisable that you quit smoking. If you cannot quit smoking and you are over 35 years old, your doctor may advise you to use a different type of contraceptive;

• if you are overweight;
• if you have high blood pressure;
• if a close relative of yours has had a heart attack or stroke at a young age (under about 50 years). In this case you may also be at high risk of heart attack or stroke;
• if you, or a close relative, have high levels of fats in the blood (cholesterol or triglycerides);
• if you suffer from migraine, especially migraine with aura;
• if you have any heart problems (valve defect, a heart rhythm disorder called atrial fibrillation);
• if you have diabetes.

If you have more than one of these conditions, or if one of them is particularly severe, the risk of
developing a blood clot may be even higher.
If any of the above conditions change while you are using Mercilon, for example if you start
smoking, if a close relative develops thrombosis for no known reason or if you gain a lot of
weight, contact your doctor.
Very rarely, a thrombosis can cause serious permanent disability or may be fatal.

Pill and cancer
Breast cancer is diagnosed with a slightly higher frequency in women
who use the pill compared to those who do not use it. This slight increase in risk disappears
gradually within 10 years after stopping use of the pill. It is not known whether the
pill is the cause of this difference. This may be due to the fact that women are visited
much more often and therefore cancer of the breast is more likely to be diagnosed earlier.
In women who use the pill, benign liver tumors have been observed in rare cases and even more
rarely malignant ones. These tumors can cause internal bleeding. Contact your doctor immediately
if you experience any severe abdominal pain.
Cervical cancer is caused by a human papillomavirus (HPV) infection. It is more
frequent in women who use the pill for a long time. It is not known whether this is due to the use of
hormonal contraceptives or sexual behavior or other factors (such as better control of the
cervix).

Psychiatric disorders
Some women who use hormonal contraceptives including Mercilon have reported depression or
low mood. Depression can be severe and sometimes can lead to suicidal thoughts. If you
experience changes in mood and depressive symptoms, seek medical advice as soon as possible.

Children and adolescents
There is no clinical data on efficacy and safety in adolescents under 18 years of
age.

Other medicines and Mercilon
Always inform your doctor about any medicines or herbal products you are already using. Also inform all other doctors or dentists (or the pharmacist) who prescribe other medicines that you are taking Mercilon, so that they can tell you if you need to use additional contraceptive precautions (for example a condom) and, if so, for how long, or if the use of another medicine you need should be modified.
Do not use Mercilon if you have hepatitis C and are taking medicines containing
ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir as these products may
cause increases in blood test values for liver function (increased liver enzymes ALT).
The doctor will prescribe you another type of contraceptive before starting treatment with these
medicines.
Mercilon can be resumed approximately 2 weeks after the end of such treatment. See
paragraph “Do not take Mercilon”.
Some medicines

• can affect the blood levels of Mercilon
• can determine a decrease in contraceptive efficacy
• can cause unexpected bleedingThese include medicines used for the treatment:
• of epilepsy (e.g., primidone, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, topiramate, felbamate);
• of tuberculosis (e.g., rifampicin, rifabutin);
• of HIV infection (e.g., ritonavir, nelfinavir, nevirapine, efavirenz);
• of hepatitis C virus infection (e.g., boceprevir, telaprevir);
• of other infectious diseases (e.g., griseofulvin);
• of high blood pressure in the blood vessels of the lungs (bosentan);
• of depressed mood (herbal remedy St. John's Wort).

If you are taking medicines or herbal products that may lead to a reduction
in the effectiveness of Mercilon, you must also use a barrier method of contraception. Because the effect of
other medicines on Mercilon can last up to 28 days after they are stopped, it is necessary
to use an additional barrier method of contraception for the entire period.
Mercilon can influencethe effect ofother medicines, e.g.

• medicines containing cyclosporine
• the antiepileptic lamotrigine (this may lead to an increase in the frequency of seizuresconvulsions).

Laboratory tests
If you need a blood test, tell your doctor or the laboratory that you are taking
the pill, as oral contraceptives can affect the results of some blood tests.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Mercilon must not be used by pregnant women or women who suspect they are pregnant. If you suspect
you are pregnant while taking Mercilon, you should stop treatment immediately
and contact your doctor as soon as possible.

Breastfeeding
The use of Mercilon is not recommended during breastfeeding. If you wish to take the pill during
breastfeeding, you should consult your doctor.

Driving and using machines
Mercilon does not affect the ability to drive vehicles or use machines.

Mercilon contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking
this medicine.

When to contact your doctor
Periodic checks
While using the pill, your doctor will ask you to attend periodic check-up visits. In
general, you should have a check-up at least once a year.

Contact your doctor as soon as possible if:

• you notice any change in your state of health, especially with regard to

and “What you need to know before taking Mercilon”. Do not forget changes in the
state of health of your close family members);

• you feel a lump in your breast;
• you experience symptoms of angioedema such as swelling of the face, tongue and/or throat and/or difficulty swallowing or hives together with difficulty breathing;
• you need to use other medicines (see also paragraph “Other medicines and Mercilon”);
• you need to be immobilized or need to undergo surgery (inform your doctor at least 4 weeks before);
• you experience heavy and unusual vaginal bleeding;
• during the first week you forgot to take the tablets contained in the package and had sexual intercourse in the previous seven days;
• you suffer from severe diarrhea;
• you have not had your period for two consecutive cycles or suspect you are pregnant (do not start a new pack without first consulting your doctor).

Stop taking the tablets and go to your doctor immediately if you notice
possible signs of thrombosis such as:

• unusual cough;
• severe chest pain that may spread to the left arm;
• shortness of breath;
• unusual, severe or prolonged headache or a migraine attack;
• partial or total loss of vision or double vision;
• slurred speech or inability to speak;
• sudden changes in hearing, smell and taste;
• dizziness or fainting;
• weakness or numbness of any part of the body;
• severe abdominal pain;
• severe pain or swelling in a leg.

3. How to take Mercilon

Take this medicine always exactly as your doctor or pharmacist has told you. If
you have doubts, ask your doctor or pharmacist.

When and how to take the tablets
The pack of Mercilon contains 21 tablets, all marked with the day of the week
on which each one should be taken.
Take one tablet every day at about the same time, if necessary with a little water. Follow the
direction of the arrows until all 21 tablets have been taken.
Do not take any pills for the 7 days following.
Your period should appear during these 7 days (withdrawal bleeding). In
general it starts 2-3 days after taking the last Mercilon tablet.
Start the new pack on the eighth day, even if your period has not yet finished. By
doing so you will always start the new pack on the same day of the week and the withdrawal
bleeding will occur approximately on the same days of the week each month.

Use in children and adolescents
Clinical data on efficacy and safety in adolescents under 18 years of
age are not available.

How to start the first pack of Mercilon

• If you have not used any hormonal contraceptive pill in the previous month.Start taking Mercilon on the first day of your cycle, that is, the first day of your period, taking the tablet marked with that day of the week. Then continue in the order indicated by the arrows. Mercilon is effective immediately. You therefore do not need any additional contraceptive methods.

You can also start between the second and fifth day of your cycle, but in this case you must use an additional contraceptive method (barrier method) for the first 7 days of taking the tablets in
the first cycle.

• Switching from another combined hormonal contraceptive (combined oral contraceptive pill, vaginal ring or transdermal patch)You can start taking Mercilon the day after the last pill of the previous contraceptive (i.e. without observing any pill-free interval). If the previous contraceptive pack also contains inactive pills, you can take Mercilon the day after taking the last active pill (if in doubt, ask your doctor or pharmacist). You can also start later, but no later than the day after the pill-free interval (or the day after the last inactive pill) of the previous contraceptive. If you are using a vaginal ring or a transdermal patch, it is preferable to start taking Mercilon on the same day as removing the ring or patch. You can start, at the latest, on the day scheduled for the next application of the ring or patch.

If you have used the pill, patch or ring correctly and if you are sure you are not pregnant,
you can also stop taking the pill or removing the ring or patch on any day and
start using Mercilon immediately.
If you follow these instructions, you do not need to use additional contraceptive methods.

• Switching from a progestin-only pill (mini-pill)You can stop taking the mini-pill on any day and start taking Mercilon the next day at the same time. However, if you have sexual intercourse, use an additional contraceptive method (barrier method) for the first 7 days of taking Mercilon.
• Switching from a progestin-only injectable contraceptive or implant orfrom a progestin-releasing intrauterine device (IUS)You can start taking Mercilon when the next injection is due or on the day the implant or IUS is removed. However, if you have sexual intercourse, use an additional contraceptive method (barrier method) for the first 7 days of taking Mercilon.
• After childbirthAfter having a baby, your doctor may tell you to wait until your first normal menstrual period before starting to use Mercilon. Sometimes it is possible to start earlier. Your doctor will give you instructions. If you are breastfeeding and want to use Mercilon, talk to your doctor first.
• After a spontaneous or induced abortionYour doctor will give you instructions.

If you take more Mercilon than you should
After taking many Mercilon tablets at once, no serious harmful effects have been reported. If you have taken more tablets at the same time, you may experience nausea, vomiting or
vaginal bleeding.

If you discover that a child has taken Mercilon, contact your doctor for instructions.

If you forget to take Mercilon
WHAT TO DO IF…
…you forget to take the tablets
If less than 12 hourshave passed since the usual time of taking, the reliability of the pill is
maintained. Take the forgotten tablet as soon as you remember and then take the subsequent
tablets as usual.
If more than 12 hourshave passed since the usual time of taking, the reliability of the pill may
be reduced. The more tablets you forget to take consecutively, the greater the
risk that the contraceptive effect is reduced.
The risk of pregnancy is particularly high if you forget the pills at the beginning and end of the
pack. Therefore, you must follow the instructions below (see also the diagram
below).

If you have forgotten to take more than one tablet from a pack
Contact your doctor for instructions.

If you have forgotten 1 tablet during the first week
Take the tablet as soon as you remember (even if this means taking two tablets
at the same time) and continue as usual. Use additional contraceptive methods
(barrier methods) for the next 7 days.
If you had sexual intercourse in the week before the missed pill, there is a possibility that you
may be pregnant. Contact your doctor immediately.

If you have forgotten 1 tablet during the second week
Take the tablet as soon as you remember (even if this means taking two tablets
at the same time) and continue as usual. The contraceptive safety of the pill is
maintained. No other additional contraceptive measures are necessary.

If you have forgotten 1 tablet during the third week
You can choose one of the following alternatives, without the need for additional contraceptive
precautions.

• 1. Take the forgotten tablet as soon as you remember (even if this means taking two tablets at the same time) and continue as usual. Start the new pack as soon as you have finished the current one, withoutan interval between the two packs. You may not experience withdrawal bleeding until the end of the second pack, but you may experience intermenstrual bleeding (spotting) or breakthrough bleeding during the second pack. or
• 2. Stop taking the tablets from the pack in use, observe an interval of 7 days or less ( including the day the pill was forgotten) and then continue with a new pack. If you choose this alternative, you can start the new pack on the same day of the week as you usually do. If you forget to take one or more tablets from a pack and your period does not occur during the first pill-free interval, you may be pregnant. In this case, you should contact your doctor before starting the new pack.

……if you suffer from gastrointestinal disorders (such as vomiting or severe diarrhea)
If you vomit or have severe diarrhea, the active ingredients of the Mercilon tablet may not be
fully absorbed. If you vomit within 3-4 hours of taking the tablet, this is similar to a forgotten pill. You must follow the instructions provided for
forgotten tablets. If you have severe diarrhea, contact your doctor.

.......if you want to postpone the start of your period
You can postpone the start of your period if you start taking tablets from a new
pack of Mercilon immediately after finishing the pack in use. You can continue with
the new pack for as long as you want, up to the end of the second pack. When
you want your period to start, stop taking the tablets. You may experience breakthrough bleeding or spotting during the use of
the second pack. Start the next pack after the usual 7-day pill-free interval.

.......if you want to change the day your period starts
If you take the tablets correctly, you will have your period approximately on the same day every
4 weeks. If you want to change this day, you only need to shorten (never lengthen) the next
pill-free interval. For example, if your period usually comes on Friday and you want it to come on Tuesday in the future (3 days earlier), you must start the next
pack 3 days earlier than usual. If you shorten your pill-free interval considerably (for
example 3 days or less), you may not have bleeding during that interval. You may have
breakthrough bleeding or spotting during the use of the next pack.

……if you experience unexpected bleeding
With all oral contraceptives, you may experience irregular vaginal bleeding in the first few months of taking them (spotting or breakthrough bleeding) between periods. You may need to use pads, but you should continue to take the tablets normally. Usually
irregular bleeding disappears once the body has adjusted to the pill (usually after
about 3 months). Consult your doctor if the bleeding persists, becomes heavy or recurs at
intervals.

…..if your period does not occur
If you have taken all the tablets correctly and have not vomited or taken any other medicines, it is
very unlikely that you are pregnant. Continue taking Mercilon as
usual.
If your period does not occur for two consecutive times, you may be pregnant. Contact your doctor immediately. Do not start the new pack of Mercilon until
the doctor has ruled out pregnancy.

If you stop taking Mercilon
If you have any questions about using this medicine, ask your doctor or pharmacist.
You can stop taking Mercilon at any time. If you still want to avoid a
pregnancy, ask your doctor for advice on other methods of birth control.
If you want to stop taking Mercilon to become pregnant, you should wait for
your next natural period before trying to conceive. This will help you
establish when the baby is due.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any side effect, especially if severe or persistent, or if you notice any change in your health that you think might be due to Mercilon, inform your doctor.
A higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or
blood clots in the arteries (arterial thromboembolism (ATE)) is present in all women who
take combined hormonal contraceptives. For more detailed information on the different risks
associated with taking combined hormonal contraceptives, see section 2 “What you need to know
before taking Mercilon”.
Serious reactions associated with the use of the pill and their related symptoms are described in the sections “The pill and
thrombosis” and “The pill and cancer”.
Common (may affect up to 1 in 10 people):

• depressed mood, mood changes
• headache
• nausea, abdominal pain
• breast pain, breast tenderness
• weight gain.

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

• fluid retention
• decreased libido
• migraine
• vomiting, diarrhoea
• skin reactions, urticaria
• breast enlargement.

Rare (may affect more than 1 in 1,000 people):

• harmful blood clots in a vein or an artery, for example: o in a leg or foot (DVT) o in the lung (PE) o heart attack o stroke o mini-stroke o temporary symptoms similar to those of a stroke, known as a transient ischaemic attack (TIA) o blood clots in the liver, stomach/intestine, kidneys or eye. The possibility of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information on conditions that increase the risk of blood clots and the symptoms of a blood clot).
• hypersensitivity reactions
• increased libido
• intolerance to contact lenses
• erythema nodosum, erythema multiforme (skin diseases)
• nipple discharge, vaginal discharge
• weight loss.

Following the instructions contained in the package leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform
your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of
this medicine.

5. How to store Mercilon

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 30°C.
Do not freeze.
Store in the original packaging to protect the medicine from light and moisture.
Do not use this medicine after the expiry date which is stated on the pack after “Exp”.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice changes in the colour of the tablets, crumbling of the
tablets or any other visible sign of deterioration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Mercilon contains

• The active ingredients are: desogestrel (0.150 mg) and ethinylestradiol (0.020 mg).
• The other ingredients are: anhydrous colloidal silica, lactose monohydrate, potato starch, povidone, stearic acid, alpha-tocopherol.

Description of the appearance of Mercilon and contents of the pack
Mercilon is available in packs of 1, 3 or 6 blisters of 21 tablets, enclosed in an aluminum pouch and packaged in a carton.
The tablets are biconvex, round and 6 mm in diameter and identified with TR4 on one side and
Organon* on the other side.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Roma

Manufacturer
N.V. Organon, Kloosterstraat 6, 5349 AB Oss (Netherlands)