Package Leaflet: Information for the User

Microdiol 0.15mg/0.03mg tablets

desogestrel/etinilestradiol

Important things you should know about combined hormonal contraceptives (CHCs):

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of suffering a blood clot in veins and arteries, especially in the first year or when restarting use of a combined hormonal contraceptive after a pause of 4weeks or more.
• Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section2 “Blood Clots”).

Read this leaflet carefully before starting to take this medicine,because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• Ifyouexperienceadverse effects, consult your doctor or pharmacist,eveniftheyarenotlistedinthisleaflet.See section 4.

1.What is Microdiol tablets and for what it is used

2.What you need to know before starting to take Microdiol tablets

3.How to take Microdiol tablets

4.Adverse effects

5.Storage of Microdiol tablets

6.Contents of the pack and additional information

Microdiol belongs to a group of medicines called monophasic oral contraceptives (“Combined Pill”). All tablets in the pack contain the same combination of active ingredients.

Microdiol is indicated to prevent pregnancy.

General Considerations

Before starting to useMicrodiol, you must read the information about blood clots in section2. It is particularly important that you read the symptoms of a blood clot (see section2 “Blood Clots”).

Do not take Microdiol

You should not useMicrodiolif you have any of the conditions listed below. Inform your doctor if you have any of the conditions listed below. Your doctor will discuss with you what other form of contraception would be more suitable.See also the section“When to have special care with Microdiol”.

• If you have (or have had at any time)a blood clot in a vein in your leg (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE) or in other organs.
• If you know that you have a disorder that affects blood clotting: for example, proteinC deficiency, proteinS deficiency, antithrombinIII deficiency, factorV Leiden or antiphospholipid antibodies.
• If you need surgery or if you spend a lot of time without getting up (see section“Blood Clots”).
• If you have ever had a heart attack or a stroke.
• If you have (or have had at any time)angina pectoris (a condition that causes severe chest pain and may be the first sign of a heart attack) or a transient ischemic attack (TIA, symptoms of a stroke).
• If you have any of the following diseases that may increase your risk of forming a blood clot in your arteries:
• • Diabetes with severe vascular damage.
  • Very high blood pressure.
  • Very high levels of fat in your blood (cholesterol or triglycerides).
  • A condition called hyperhomocysteinemia.
• If you have (or have had at any time) a type of migraine called “migraine with aura”.
• If you have or have had pancreatitis, along with high levels of fat in your blood.
• If you have jaundice (yellowing of the skin) or severe liver disease.
• If you have or have had cancer that grows in response to sex hormones (for example, breast cancer or cancer of the reproductive organs).
• If you have or have had a tumor in the liver.
• If there is any unexplained vaginal bleeding.
• If you have abnormal growth of the internal lining of the uterus.
• If you are pregnant or think you may be pregnant.
• If you are allergic to desogestrel or ethinylestradiol or toany of the othercomponents ofthis medicine (listed in section 6).
• If you have hepatitis C and are taking medicines that contain ombitasvir/paritaprevir/ritonavir and dasabuviror glecaprevir/pibrentasvir(see also the section“Taking Microdiol with other medicines”).

If any of these circumstances occur for the first time while using the pill, do not take more and consult your doctor immediately. In the meantime, use non-hormonal contraceptive measures.

Warnings and Precautions

When to have special care with Microdiol

Before starting treatment with Microdiol

Inform your doctor if you suffer from any of the following conditions.

If the condition develops or worsens while usingMicrodiol, you should also inform your doctor.

• If you are a smoker.
• If you are diabetic.
• If you are overweight.
• If you have high blood pressure.
• If you have heart rhythm disorders or certain heart diseases.
• If you have superficial thrombophlebitis.
• If you have varicose veins.
• If any of your close relatives have had thrombosis, heart attack or cerebral embolism.
• If you have migraines.
• If you have epilepsy.
• If you have high levels of fat in your blood (hypertriglyceridemia) or a family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas).
• If you need surgery or spend a lot of time without getting up (see section2 “Blood Clots”).
• If you have recently given birth, you are at greater risk of blood clots. Ask your doctor when you can start taking Microdiol after childbirth.
• If any of your close relatives have had breast cancer.
• 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 your natural defense system).
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder that causes kidney failure).
• If you have sickle cell anemia (a hereditary disease of red blood cells).
• If you have a disease that appeared or worsened during pregnancy or previous use of sex hormones (e.g. hearing loss, a metabolic disease called porphyria, a skin disease called herpes gestational or a disease called Sydenham's chorea).
• If you experience symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing, or urticaria possibly with difficulty breathing, contact your doctor immediately. Medicines containing estrogens can cause or worsen symptoms of hereditary and acquired angioedema.
• If you have or have had melasma (brown-yellow patches on the skin, particularly on the face); in this case, avoid intense sun exposure or ultraviolet radiation.

If any of the above situations occur for the first time, recur or worsen with treatment with the pill, consult your doctor, who may recommend that you stop taking the pill.

Microdiol, like all contraceptive pills, does not protect against HIV or any other sexually transmitted disease.

Once treatment with Microdiol has started

While taking the pill, your doctor will require you to undergo regular check-ups, usually once a year.

Contact your doctor as soon as possible in the following cases:

• if you notice possible signs of a blood clot that may mean you are suffering from a blood clot in your leg (deep vein thrombosis), a blood clot in your lungs (pulmonary embolism), a heart attack or a stroke (see section “Blood Clots” below).

For a description of the symptoms of these serious side effects, see “How to recognize a blood clot”.

• if you notice any change in your health, especially in any of the points mentioned in this leaflet (see also “When not to use Microdiol” and “What you need to know before starting to take Microdiol”); do not forget to mention the points related to your close relatives;
• if you find any lump in your breasts;
• if you experience symptoms of angioedema, such as facial swelling, tongue and/or throat swelling, and/or difficulty swallowing, or urticaria possibly with difficulty breathing (see also the section “When to have special care with Microdiol”);
• if you are going to take other medicines (see also “Taking Microdiol with other medicines”);
• if you need to be immobilized or are going to have surgery, as in these cases your risk of thrombosis temporarily increases; consult your doctor at least four weeks in advance;
• if you have unexplained vaginal bleeding;
• if you forget to take pills in the first week of the pack and have had sex in the sevendays beforehand;
• if you have severe diarrhea;
• if you have two consecutive missed periods or suspect you may be pregnant, do not start the next pack until your doctor tells you to.

BLOOD CLOTS

The use of a combined hormonal contraceptive like Microdiol increases your risk of suffering a blood clot compared to not using it. In rare cases, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• in veins (which is called “deep vein thrombosis”, “venous thromboembolism” or VTE).
• in arteries (which is called “arterial thrombosis”, “arterial thromboembolism” or ATE).

The recovery of blood clots is not always complete. In rare cases, there may be long-lasting or even fatal effects.

It is essential to remember that the overall risk of a harmful blood clot due to Microdiol is small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attentionif you notice any of the following signs or symptoms.

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 veins (venous thromboembolism). However, these side effects are rare. They occur more frequently in the first year of use of a combined hormonal contraceptive.
• If a blood clot forms in a vein in your leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot breaks loose from your leg and lodges in your lung, it can cause a pulmonary embolism (PE).
• In very rare cases, a blood clot can form in a vein in another organ, such as the eye (retinal vein thrombosis).

When is the risk of a blood clot in a vein higher?

The risk of a blood clot in a vein is higher during the first year of taking a combined hormonal contraceptive for the first time. The risk may be higher if you start taking a combined hormonal contraceptive again (the same medicine or a different medicine) after a break of 4 weeks or more.

After the first year, the risk decreases, but it is always slightly higher than if you were not taking a combined hormonal contraceptive.

When you stop takingMicrodiol, your risk of a blood clot returns to normal in a few weeks.

What is the risk of 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 a blood clot in your leg or lung (DVT or PE) withMicrodiolis small.

• Of every 10,000women who are not using a combined hormonal contraceptive and are not pregnant, 2 will develop a blood clot in a year.

• Of every 10,000women who are using a combined hormonal contraceptive that contains levonorgestrel or noretisterone or norgestimato, 5‑7women will develop a blood clot in a year.

• Of every 10,000 women who are using a combined hormonal contraceptive that contains desogestrel, such asMicrodiol, 9‑12women will develop a blood clot in a year.

• The risk of a blood clot will depend on your personal history (see “Factors that increase your risk of a blood clot” below).

Factors that increase your risk of a blood clot in a vein

The risk of a blood clot is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (BMI of 30kg/m2or higher).
• If any of your close relatives have had a blood clot in a vein, lung, or other organ at a young age (i.e. before about 50years). You may have a hereditary disorder of blood clotting.
• If you need surgery or spend a lot of time without getting up due to an injury or illness or if you have your leg immobilized. You may need to stop usingMicrodiolfor several weeks before the operation or while you have less mobility. If you need to stop usingMicrodiolask your doctor when you can start using it again.
• With increasing age (especially over about 35years).
• If you have recently given birth.

The risk of a blood clot increases as you have more conditions.

Long flights (more than 4hours) may temporarily increase your risk of a blood clot, especially if you have any of the other risk factors listed.

It is essential to inform your doctor if you have any of the above conditions, even if you are unsure. Your doctor may decide that you need to stop usingMicrodiol.

If any of the above conditions change while you are usingMicrodiol, for example, a close relative experiences a thrombosis without a known cause or you gain a lot of weight, inform your doctor.

BLOOD CLOTS IN AN ARTERY

What can happen if a blood clot forms in an artery?

Like a blood clot in a vein, a blood clot in an artery can cause serious problems. For example, it can cause a heart attack or a stroke.

Factors that increase your risk of a blood clot in an artery

It is essential to note that the risk of a heart attack or stroke due toMicrodiolis very small, but it may increase:

• With age (over about 35years).
• If you smoke.
• If you are overweight.
• If you have high blood pressure.
• If any of your close relatives have had a heart attack or stroke at a young age (less than about 50years). You may also be at higher risk of a heart attack or stroke.
• If you have high levels of fat in your blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, heart rhythm disorder called atrial fibrillation).
• If you have diabetes.

If you have one or more of these conditions or if any of them are particularly severe, your risk of a blood clot may be increased even further.

If any of the above conditions change while you are usingMicrodiol, for example, you start smoking, a close relative experiences a thrombosis without a cause or you gain a lot of weight, inform your doctor.

Blood Pressure

If you have high blood pressure or any related disease (including certain kidney diseases), it is recommended that you use other contraceptive methods. If you decide to use hormonal contraceptives, you should monitor your blood pressure, but if it increases and cannot be controlled with medication, you should stop treatment.

Tumors

Cases of breast cancer have been observed in women who use contraceptive pills, with a slightly higher frequency than in women of the same age who do not use them. This slight increase in breast cancer diagnoses decreases gradually over the ten years following the discontinuation of treatment. It is not known whether this difference is due to the treatment with the pill. It may be that women who use contraceptive pills visit their doctor more frequently.

Rarely, cases of benign liver tumors and even more rarely malignant liver tumors have been reported in women using the contraceptive pill. This can cause internal bleeding, resulting in severe abdominal pain. If this occurs, you should contact your doctor immediately.

The situation that most affects the risk of cervical cancer is the continued infection with the human papillomavirus. In women who use the contraceptive pill for many years, the risk of cervical cancer is slightly higher. However, it is not clear whether the contraceptive pill plays a direct role in this risk or whether other factors (such as sexual habits and other factors) do.

Vaginal Bleeding

You may not have your “period” during the week of rest. If the pill has been taken correctly, it is very unlikely that you are pregnant. However, if you have two missed periods, you should consult your doctor as you will need to rule out pregnancy. If you have not taken the pill correctly and have a missed period, you should stop treatment and use a non-hormonal contraceptive method until pregnancy has been ruled out.

Microdiol may cause vaginal bleeding or spotting between periods. If this happens, continue taking Microdiol and if the bleeding continues after three cycles, consult your doctor immediately. Errors in pill use can also cause vaginal bleeding and spotting.

When you stop using Microdiol, you may experience irregular, light, or no bleeding, especially in the first three months and especially if your periods were irregular before starting hormone treatment.

Mental Health Disorders

Some women who use hormonal contraceptives like Microdiol have reported depression or a depressed mood. Depression can be severe and sometimes may lead to suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

Children and Adolescents

There are no clinical data available on safety and efficacy in adolescents under 18 years old.

Other Medicines and Microdiol

Always inform your doctorabout any medicines or herbal remedies you are taking. Also inform any doctor or dentist (or pharmacist) who prescribes another medicine that you are using Microdiol. They can inform you if you need to use additional contraceptive measures (e.g. condoms) and, if necessary, for how long, or if you need to modify the use of the other medicine.

Some medicines:

• may affect the levels ofMicrodiolin the blood
• may make itless effective in preventing pregnancy
• may cause unexpected bleeding.

These include medicines used to treat:

• epilepsy (e.g. primidone, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, topiramate, felbamate);
• tuberculosis (e.g. rifampicin, rifabutin);
• infections with HIV (e.g. ritonavir, nelfinavir, nevirapine, efavirenz);
• infection with hepatitis C (e.g. boceprevir, telaprevir);
• other infectious diseases (e.g. griseofulvin);
• high blood pressure in the blood vessels that carry blood to the lungs (bosentan);
• mood disorders (St. John's Wort).

If you are taking medicines or herbal remedies that may make Microdiol less effective, you should also use a barrier contraceptive method. Since the effect of the other medicine on Microdiol may last for up to 28 days after stopping the medicine, you will need to use a barrier contraceptive method for that time, or modify the use of the other medicine.

Microdiol may affect the effect of other medicines, for example:

• medicines that contain ciclosporin
• the antiepileptic lamotrigine (this could lead to an increase in seizure frequency).

Do not take Microdiol if you have hepatitis C and are taking medicines that contain

ombitasvir/paritaprevir/ritonavir and dasabuviror glecaprevir/pibrentasvir, as this may cause increased liver enzyme levels (elevated ALT levels).

Your doctor will prescribe another type of contraceptive before starting treatment with these medicines.

Microdiol can be used again about 2 weeks after completing this treatment. See the section “Do not take Microdiol”.

Laboratory Tests

The use of hormonal contraceptives may affect the results of certain laboratory tests. If you are told to have any laboratory tests, inform your doctor that you are taking Microdiol.

Pregnancy and Breastfeeding

Microdiol should never be used by pregnant women or women who suspect they may be pregnant.

Generally, Microdiol is not recommended during breastfeeding. If you want to take the pill while breastfeeding, consult your doctor.

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and Operating Machinery

No effects have been observed.

Microdiol contains lactose

This medicine contains lactose. If your doctor has told you that you have a lactose intolerance, consult them before taking this medicine.

Follow exactly the administration instructions of this medication as indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

The Microdiol blister has 21 marked tablets with the days of the week. Take your tablet approximately at the same hour every day, with liquid if necessary.

Each time you start a new Microdiol blister, take the tablet from the top row, corresponding to the day of the week when you take it.

Follow the arrow direction until you finish the 21 tablets.tablets.

In the 7days that follow, you should not take Microdiol, during which a menstrual period (bleeding due to deprivation) will appear, which usually starts two or three days after the last Microdiol tablet. Continue with the next blister on the eighth day, even if you still have a menstrual period. In this way, you will always start the blisters on the same day of the week and have the menstrual period approximately on the same days every month.

Use in children and adolescents

No clinical data are available on safety and efficacy in adolescents under 18 years.

The first Microdiol blister

If you have not used hormonal contraception in the previous month.

Start taking Microdiol on the first day of the cycle, that is, the first day of menstruation. Microdiol will start acting immediately. You do not need to take additional contraceptive measures. You can also start on days 2 to 5 of your cycle, but in this case, make sure to use an additional contraceptive method (for example, a barrier method) while taking the first 7tablets of the first cycle. Do not use menstrual cycle-based methods or temperature methods, as these methods are not reliable while taking the pill.

Change from another combined hormonal contraceptive (combined oral contraceptive pill, vaginal ring, or transdermal patch).

You can start taking Microdiol the day after taking the last tablet of the current blister. This means that you do not need to leave a break. If your current preparation has inactive tablets, you can start Microdiol the day after the lastactivetablet (if unsure, consult your doctor or pharmacist). You can also start later, but never after the break of your current preparation (or after the last inactive tablet of your current preparation). If you are using a vaginal ring or a transdermal patch, start taking Microdiol preferably on the day of removal of the vaginal ring, or on the day when the patch should be removed. You can also start, but no later than the day when the next patch or vaginal ring application would be due.

If you have taken the pill, or used the vaginal ring or patch continuously and correctly and are sure you are not pregnant, you can also stop taking the pill, or remove the vaginal ring or patch on any day of your current cycle and start with Microdiol immediately.

If you follow these instructions, you do not need to use an additional contraceptive method.

Change from a progestin-only pill.

You can stop taking your current pill on any day and start taking Microdiol the next day at the same hour, but make sure to use an additional contraceptive method (for example, a barrier method) while taking the first 7tablets in case of sexual intercourse.

Change from an injectable, an implant, or an Intrauterine System (IUS) with progestin only.

Start using Microdiol at the time when you should receive the next injection, or on the day when the implant or IUS is removed, but make sure to use an additional contraceptive method (barrier method) while taking the first 7tablets, in case of sexual intercourse.

After childbirth.

If you have just given birth, your doctor may advise you to wait for your first normal menstrual period before starting with Microdiol. Sometimes it is possible to start earlier, but your doctor will advise you how. If you are breastfeeding and want to use Microdiol, discuss it first with your doctor.

After an abortion.

Consult your doctor.

You can stop Microdiol at any time. If you stop Microdiol because you want to become pregnant, it is generally recommended to wait until you have had your first natural menstrual period before trying to conceive, which will help you calculate the due date.

If you take more Microdiol than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

No serious effects have been reported for taking an excess of Microdiol tablets at one time. If you have taken several tablets at once, you may experience nausea, vomiting, or vaginal bleeding.

If you forget to take Microdiol

If more than 12 hours have passed since the usual hour, the reliability of the pill is maintained. Take the tablet as soon as you remember it and continue taking the next tablets at the usual hour.

If more than 12 hours have passed since the usual hour, the reliability of the pill may be reduced. The more consecutive tablets you have forgotten, the higher the risk of reduced efficacy. The risk of becoming pregnant is particularly higher if you forget the tablets at the beginning or end of the blister. Therefore, follow the recommendations that are outlined below (see also the diagram).

If you forget more than one tablet in a blister

Consult your doctor.

If you forget 1 tablet in the first week

Take the forgotten tablet as soon as you remember it (even if it means taking two tablets at once) and take the next tablets at the usual hour. Take additional contraceptive measures (barrier method) for the next 7days.

If you have had sexual intercourse in the previous week, there is a possibility that you may be pregnant. Inform your doctor immediately.

If you forget 1 tablet in the second week

Take the forgotten tablet as soon as you remember it (even if it means taking two tablets at once) and take the next tablets at the usual hour. The reliability of the pill is maintained, and you do not need to take additional contraceptive measures.

If you forget 1 tablet in the third week

You can choose one of the following options, without needing to take additional contraceptive measures.

1- Take the forgotten tablet as soon as you remember it (even if it means taking two tablets at once) and take the next tablets at the usual hour. Start the nextblisterthe next day after finishing the current blisterwithout leaving a break betweenblister. You may not have a menstrual period until the end of the secondblister, although you may have spotting or a small period while taking the tablets of the secondblister.

Or,

2- Stop taking the tablets of theblistercurrent, leave a break of a maximum of 7days (also count the day you forgot the tablet) and continue with the nextblister. Following this method, you can always start your nextblisteron the same day of the week as you do normally.

If you have forgotten tablets in ablisterand do not have the expected menstrual period in the first break, you may be pregnant.

Consult your doctor before starting the nextblister.

If you vomit or have intense diarrhea

If you vomit or have intense diarrhea in the 3 or 4 hours after taking your Microdiol tablet, it may be that the active principles are not fully absorbed, which is equivalent to forgetting a tablet. Therefore, follow the recommendations for a forgotten tablet.

In the case of intense diarrhea, consult your doctor.

If you want to change the day when your period starts

If you take the tablets as instructed, you will have your period approximately on the same day every 4 weeks. If you want to change it, you must shorten (never lengthen) the next break. For example, if your period usually starts on Friday and you want it to start on Tuesday in the future, that is, three days earlier, you must start the nextblisterthree days earlier than the day it started. If the break is too short, from1 to3 days, you may not have a menstrual period during the break and may have spotting or a small period during the nextblister.

If you have unexpected bleeding

As with all pills, you may experience irregular vaginal bleeding between periods during the first months (called spotting or intermenstrual bleeding). In this case, continue taking the tablets normally. This irregular vaginal bleeding usually disappears once your body has adapted to the pill, usually after three cycles.

If it continues, becomes more intense, or appears again, consult your doctor.

If you do not have a period

If you have taken all the tablets at the same hour and have not vomited, had intense diarrhea, or taken other medications, it is very unlikely that you are pregnant. Continue taking Microdiol as usual.

If you have two consecutive missed periods, you may be pregnant, so inform your doctor immediately. Do not start the nextblisterof Microdiol until your doctor has confirmed that you are not pregnant.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.If you experience any side effect, especially if it is severe and persistent, or if you have any health changes that you think may be due toMicrodiol, consult your doctor.

All women taking combined hormonal contraceptives are at a higher risk of developing blood clots in the veins (venous thromboembolism (VTE)) or blood clots in the arteries (arterial thromboembolism (ATE)). For more detailed information on the different risks of taking combined hormonal contraceptives, see section2 “What you need to know before starting to useMicrodiol”.

Contact your doctor immediately if you experience any of the following angioedema symptoms: swelling of the face, tongue, and/or throat, and/or difficulty swallowing, or urticariapossiblywith difficulty breathing (see also section2“What you need to knowbeforestarting totake Microdiol tablets”).

The side effects are listed below, classified by frequency according to the following criterion:

Frequent: (may affect up to1in 10 people).

Infrequent:(may affect up to1in 100 people).

Rare:(may affect up to1in 1,000people).

Frequent (may affect up to 1 in 10people):

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

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

• fluid retention
• decreased libido
• migraines
• vomiting, diarrhea
• skin rash, urticaria
• breast enlargement

Rare (may affect up to1in 1,000people):

• harmful blood clots in a vein or artery, for example:

The chances of having a blood clot may be higher if you have any other condition that increases this risk (see section2 for more information on conditions that increase the risk of blood clots and the symptoms of a blood clot).

• allergic reactions
• increased libido
• contact lens intolerance
• erythema nodosum, erythema multiforme (which are skin diseases)
• altered menstrual flow, breast secretion
• weight loss

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly to the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not store at a temperature above30 °C.

Store in the original packaging.

Do not usethis medicationafter the expiration date that appears on the packagingafter the abbreviation CAD. The expiration date is the last day of the month indicated.

Do not usethis medicationif you observe, for example, a change in color, broken tablets, or any other visible sign of deterioration.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Microdiol

• The active principles are: desogestrel and etinilestradiol. One tablet contains 0.15 mg of desogestrel and 0.03 mg of etinilestradiol.

• The other components are: Colloidal anhydrous silica, all- rac -alpha- ‑ tocopherol, lactose monohydrate, potato starch, povidone, and stearic acid.

Appearance of the product and contents of the packaging

The tablets are white, biconvex, round, and 6 mm in diameter. Each tablet bears a code marked, TR over 5 on one face and Organon and an asterisk on the opposite face.

Microdiol is presented in aluminum/PVC blisters of 21 tablets, conditioned in a laminated aluminum sealed over. The overwraps are packaged in boxes with 1x21 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Organon Salud, S.L.

Paseo de la Castellana, 77

28046 Madrid

Spain

Phone: 915911279

Responsible for manufacturing:

N.V. Organon

Kloosterstraat 6,

5349 AB, Oss,

Netherlands

Last review date of this leaflet: September 2022.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) ( http://www.aemps.gob.es/ )