MARIONA DIARIO 0.15 mg/0.03 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Mariona Diario 0.15 mg/0.03 mg film-coated tablets EFG

Desogestrel / Ethinylestradiol

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 having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive after a break of 4 weeks or more.
• Be alert and consult your doctor if you think you may have symptoms of a blood clot (see section 2 "Blood Clots (Thrombosis)").

Contents of the Package Leaflet:

1. What Mariona Diario is and what it is used for
2. What you need to know before you start taking Mariona Diario
3. How to take Mariona Diario
4. Possible side effects
5. Storage of Mariona Diario
6. Package contents and additional information

1. What Mariona Diario is and what it is used for

• This medication is a contraceptive and is used to prevent pregnancy.
• Each of the 21 active tablets, white in color, contains a small amount of two different female hormones, called desogestrel and ethinylestradiol.
• The 7 green tablets do not contain active ingredients and are called placebo tablets.
• Contraceptives that contain two hormones are called combined contraceptives.

2. What you need to know before starting to take Mariona

Do not take MarionaDaily

You should not use this medication if 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 Mariona Daily".

• If you have (or have ever had) a blood clot in a blood vessel of the legs (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs.
• If you know you have a disorder that affects blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden or antiphospholipid antibodies.
• If you need an operation or if you spend a lot of time without getting up (see section "Blood clots (thrombosis)").
• If you have ever had a heart attack or a stroke.
• If you have (or have ever had) angina pectoris (a condition that causes severe chest pain and can be the first sign of a heart attack) or a transient ischemic attack (TIA, temporary symptoms of stroke).
• If you have any of the following diseases that can increase your risk of forming a clot in the arteries:
• • Severe diabetes with blood vessel damage.
  • Very high blood pressure.
  • Very high levels of fat in the blood (cholesterol or triglycerides).
  • A condition called hyperhomocysteinemia.

• If you have (or have ever had) a type of migraine called "migraine with aura".
• If you have (or have had) pancreatitis (inflammation of the pancreas), along with high levels of fat in the blood.
• If you have jaundice (yellowing of the skin) or
• If you have (or have had) jaundice (yellowing of the skin) or a severe liver disease and your liver function has not yet normalized.
• If you have (or have had) a liver tumor.
• If you have (or have had) cancer that is influenced by sex hormones (such as breast cancer or cancer of the sex organs).
• If you have vaginal bleeding, whose cause is unknown.
• If you have abnormal growth of the endometrium.
• If you are allergic to ethinylestradiol or desogestrel or to any of the other components of this medication (included in section 6). This may manifest with itching, rash, or inflammation.
• If you are allergic to peanuts or soy.
• If you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also the section "Taking Mariona Daily with other medications").

If any of these circumstances occur for the first time while using this medication, stop taking it immediately and consult your doctor as soon as possible. In the meantime, use other non-hormonal contraceptive measures. See also "General considerations" at the beginning of section 2.

When to have special care with Mariona Daily

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

If the condition develops or worsens while you are using Mariona Daily, 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 seem to have heart rhythm disturbances or certain heart disorders
• If you have inflammation of the veins that are under the skin (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 suffer from epilepsy
• If you have high levels of fat in the blood (hypertriglyceridemia) or a known family history of this condition. Hypertriglyceridemia has been associated with a higher risk of developing pancreatitis (inflammation of the pancreas).
• if you need an operation or spend a lot of time without getting up (see section 2 "Blood clots (thrombosis)").
• if you have just given birth, you are at a higher risk of suffering from blood clots. You should ask your doctor when you can start taking this medication after childbirth.
• if any of your close relatives have or have had breast cancer
• if you have any 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 any disease that appeared for the first time during pregnancy or during previous use of sex hormones (e.g., hearing loss, a blood disease called porphyria, a skin rash with blisters during pregnancy (gestational herpes), a nervous disease in which involuntary movements appear (Sydenham's chorea).
• if you have or have had chloasma (skin discoloration, especially on the face or neck, also called "pregnancy spots"). In that case, avoid direct exposure to the sun or ultraviolet rays.
• if you experience symptoms of angioedema such as swelling of the face, tongue, and/or pharynx, and/or difficulty swallowing or urticaria along with difficulty breathing, contact your doctor immediately. Products containing estrogens may induce or worsen the symptoms of hereditary angioedema.

MarionaDailyand blood clots

BLOOD CLOTS (THROMBOSIS)

The use of a combined hormonal contraceptive like Mariona Daily increases your risk of suffering from 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 the veins (which is called "venous thrombosis", "venous thromboembolism" or VTE).
• In the arteries (which is called "arterial thrombosis", "arterial thromboembolism" or ATE).

Recovery from blood clots is not always complete. In rare cases, there can be serious long-term effects or, very rarely, they can be fatal.

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical attention if 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 the veins (venous thrombosis). 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 the leg or foot, it can cause deep vein thrombosis (DVT).
• If a blood clot moves from the leg and lodges in the lung, it can cause a pulmonary embolism.
• In very rare cases, a clot can form in a vein of another organ, such as the eye (retinal vein thrombosis)

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

The risk of having a blood clot in a vein is higher during the first year in which you take a combined hormonal contraceptive for the first time. The risk may also be higher if you start taking a combined hormonal contraceptive (the same medication or a different one) after an interruption 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 taking Mariona Daily, your risk of having a blood clot returns to normal within a few weeks.

What is the risk of having 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 having a blood clot in the leg or lung (DVT or PE) with this medication is small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and are not pregnant, about 2 will have a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive that contains levonorgestrel or norethisterone or norgestimate, about 5-7 will have a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive that contains desogestrel like Mariona Daily, between 9 and 12 women will have a blood clot in a year.
• The risk of having 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 having a blood clot with this medication is small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index or BMI over 30 kg/m2).
• If any of your close relatives have had a blood clot in the leg, lung, or other organ at a young age (i.e., before the age of 50). In this case, you may have a hereditary disorder of blood clotting.
• If you need an operation or if you spend a lot of time without getting up due to an injury or illness or if you have a leg in a cast. You may need to interrupt the use of this medication several weeks before surgery or while you have less mobility. If you need to interrupt the use of Mariona Daily, ask your doctor when you can start using it again.
• As you get older (especially over 35 years).
• If you have recently given birth.

The risk of having a blood clot increases with the number of conditions you have.

Long-distance flights (more than 4 hours) can temporarily increase the 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 suffer from any of the above conditions, even if you are not sure. Your doctor may decide to interrupt the use of this medication.

If any of the above conditions change while you are using Mariona Daily, for example, a close relative experiences a blood clot (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 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 to the use of this medication is very small, but it can increase:

• With age (over 35 years).
• If you smoke. When using a combined hormonal contraceptive like this medication, you are advised to quit smoking. If you are not able to quit smoking and 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 any of your close relatives have had a heart attack or stroke at a young age (less than 50 years). In this case, you may also be at higher risk of having a heart attack or stroke.
• If you or any of your close relatives have a high level of fat in the blood (cholesterol or triglycerides).
• If you have migraines, especially migraines with aura.
• If you have a heart problem (valve disorder, heart rhythm disturbance called atrial fibrillation).
• If you have diabetes.

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

If any of the above conditions change while you are using this medication, for example, you start smoking, a close relative experiences a blood clot (thrombosis) without a known cause, or you gain a lot of weight, inform your doctor.

The pill and cancer

It has been observed that breast cancer occurs slightly more frequently in women who use combined contraceptives, but it is not known if this is due to the treatment. For example, it may be that more tumors are detected in women who take combined contraceptives because they are examined by a doctor more frequently. The incidence of breast tumors decreases gradually after stopping the use of combined hormonal contraceptives. It is essential to undergo regular breast exams, and you should see your doctor if you notice any lump or changes in the nipples.

In rare cases, benign liver tumors, and even more rarely, malignant liver tumors, have been reported in users of hormonal contraceptives. See your doctor if you suffer from severe abdominal pain.

The situation that most affects the risk of developing cervical cancer is the continued infection with the human papillomavirus (HPV). In women who use the contraceptive pill for many years, the possibility of developing cervical cancer is slightly higher. However,

It is not clear whether the contraceptive pill plays a direct role in this risk, or whether sexual habits and other factors (such as increased medical monitoring) do.

Psychiatric disorders

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

Other medications and Mariona Diario

Tell your doctor, pharmacist, or nurse if you are taking, have taken, or are going to take any other medication or herbal preparation in addition to this medication. Also, inform any other doctor or dentist who prescribes you another medication (or your pharmacist) that you are using Mariona Diario. They may indicate whether you need to take additional non-hormonal contraceptive precautions (e.g., condoms) and, if so, for how long you should use them, or whether you should modify the use of the other medication.

Do not take this medication if you have Hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir, as these medications may produce increases in liver test results (increase in liver enzyme ALT).

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

This medication can be used again approximately 2 weeks after the end of this treatment. See the section "Do not use Mariona Diario".

Some medications:

may cause this medication to lose its contraceptive effect or may cause unexpected bleeding.

These include:

• medications used in the treatment of:

or epilepsy (e.g., primidone, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, topiramate, felbamate)

or tuberculosis (e.g., rifampicin, rifabutin)

or HIV infections (e.g., ritonavir, nelfinavir, nevirapine, efavirenz)

or Hepatitis C virus infection (e.g., boceprevir, telaprevir)

or other infectious diseases (e.g., griseofulvin)

or high blood pressure in the blood vessels that carry blood to the lungs (bosentan)

or depressive mood disorders (the herbal medicine St. John's Wort).

If you are taking medications or herbal preparations that may make Mariona Diario less effective, you should also use a barrier contraceptive method. Since the effect of the other medication on this treatment may last up to 28 days after stopping the medication, during that time, it is necessary to use an additional barrier contraceptive method.

Mariona Diario may influence the effect of other medications, for example, those that contain:

• medications that contain cyclosporine
• the antiepileptic lamotrigine (this may lead to an increased frequency of seizures).

Mariona Diario with food and beverages

This medication can be taken with or without food, with some water if necessary.

Laboratory tests

If you need a blood test, inform your doctor or the laboratory staff that you are taking a contraceptive, as oral contraceptives may influence the results of some tests.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, you should not take Mariona Diario.If you become pregnant during treatment with this medication, you must stoptreatment immediately and contact your doctor. If you wish to become pregnant, you can stop treatment at any time (see also "If you want to stop Mariona Diario treatment").

Breastfeeding

In general, it is not recommended to take this medication during the breastfeeding period. If you want to take the contraceptive while breastfeeding, you should consult your doctor.

Driving and using machines

There is no information that suggests that the use of this medication has any effect on the ability to drive or use machinery.

Mariona Diario contains lactose and soybean oil

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains soybean oil. It should not be used in case of soy allergy.

Children and adolescents

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

When should you contact your doctor?

Periodic checks

While taking the pill, your doctor will require you to undergo periodic checks. Your personal situation will determine what checks should be performed and how often.

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 the leg (i.e., deep vein thrombosis), a blood clot in the lung (i.e., pulmonary embolism), a heart attack, or a stroke (see section "Blood clots (thrombosis)").
• To obtain a description of the symptoms of these serious side effects, see "How to recognize a blood clot".

3. How to Take Mariona Daily

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

When and How to Take the Tablets

Each blister pack contains 21 active white tablets and 7 green placebo tablets.

The two different types of colored Mariona tablets are placed in order. A pack contains 28 tablets.

Take one tablet every day, with some water if necessary. You can take the tablets with or without food, but every day at approximately the same time.

Do Not Confuse the Tablets: take one white tablet every day for the first 21 days, followed by one green tablet for the last 7 days. After that, you should start taking a new pack (21 white tablets and 7 green ones). This way, there is no break between two packs.

Due to the different composition of the tablets, it is necessary to start with the first tablet located in the top left corner and then take one tablet every day. To maintain the order, follow the direction of the arrows on the pack.

Preparing the Blister Pack

To help you follow the order of intake, each Mariona pack includes seven adhesive strips that have the 7 days of the week printed on them. Choose the strip of the week that starts with the day you take the first tablet. For example, if you start on a Wednesday, stick the one that says "WED" as the initial tablet.

Stick the weekly adhesive strip on the top of the blister pack where it says "Place the strip here", so that the first day is placed above the tablet marked with "1". This way, there is a day of the week indicated above each tablet and you can see if you have taken a particular tablet. The arrows show the order in which the tablets should be taken.

During the 7 days when you take the green placebo tablets (placebo days), menstruation (also called withdrawal bleeding) should occur. Usually, menstruation starts on the 2nd or 3rd day after taking the last active white Mariona tablet. Once you have taken the last green tablet, you should start the next pack, even if you have not finished your period. This means that you should start each pack on the same day of the weekthat you started the previous one, and that menstruation should occur during the same days every month.

If you take the medication as indicated, you will also be protected against pregnancy during the 7 days when you are taking the placebo tablets.

When Can You Start with the First Pack?If you have not taken any hormonal contraceptive in the previous month.

Start taking the tablets on the first day of your cycle (i.e., the first day of your menstruation). If you start treatment on the first day of your menstruation, you will be immediately protected against pregnancy. You can also start on days 2-5 of your cycle, but you must use additional contraceptive methods (e.g., a condom) during the first 7 days.

Changing from another combined hormonal contraceptive, vaginal ring, or patch.

You can start taking Mariona preferably the day after taking the last tablet of your current blister pack (the last one containing active substances) of your previous pill, but never after the break week of your previous contraceptive (or after taking the last inactive tablet of your current pill).

In the case of using a vaginal ring or transdermal patch, you should start taking the tablets on the same day you remove the vaginal ring or on the day you should remove the patch. You can also start, but no later than the day when the next application of the patch or ring 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 any day of your current cycle and start with Mariona Daily immediately.

If you follow these instructions, there is no need for an additional contraceptive method.

• Changing from a progestogen-only method (progestogen-only pill, injection, implant, or intrauterine device (IUD)).

You can change from the progestogen-only pill at any time (if it's an implant or IUD, on the day of its removal; if it's an injectable, when the next injection is due), but in all cases, it is recommended that you use additional contraceptive measures (e.g., a condom) during the first 7 days of taking the tablets.

• After an abortion.

Follow your doctor's recommendations.

• After having a child

After having a child, you can start taking this medication between 21 and 28 days later. If you start later, you must use a barrier method (e.g., a condom) during the first 7 days of using Mariona. If, after having a child, you have had sexual intercourse before starting to take Mariona again, you must ensure you are not pregnant or wait for your next menstrual period.

• If you are breastfeeding and want to start taking Mariona again after having a child.

Read the section "Pregnancy and Breastfeeding".

If You Take More Mariona Than You Should

No cases have been reported where an overdose of this medication has caused serious harm.

The symptoms that may appear if you take many tablets at once are nausea and vomiting.

Adolescent girls may experience vaginal bleeding.

If you have taken too many Mariona tablets, or discover that a child has taken them, consult your doctor or pharmacist.

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.

If You Forget to Take Mariona

The tablets in the fourthrow of the pack are placebo tablets. If you forget to take one of these tablets, you will not lose the contraceptive effect of the treatment. Discard the forgotten placebo tablet.

If you forget to take an active white tablet from the 1st, 2nd, or 3rd row, you should follow these steps:

• If you are less than 12 hourslate in taking a tablet, the protection against pregnancy will not decrease. Take the tablet as soon as you remember and the following tablets at the usual time.
• If you are more than 12 hourslate in taking a tablet, the protection against pregnancy may be reduced. The more tablets you have forgotten, the higher the risk that this effect will decrease.

The risk of incomplete protection against pregnancy is maximum if you forget to take a tablet at the beginning or end of the pack. Therefore, you should take the following measures (see also the diagram below):

?Forgetting More Than One Tablet in the Pack

Consult your doctor.

?Forgetting a Tablet in Week 1

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at once. Continue taking the following tablets at the usual time and use additional precautions, such as a condom, for the next 7 days. If you have had sexual intercourse in the week before forgetting the tablet, you should know that there is a risk of pregnancy. In that case, consult your doctor.

?Forgetting a Tablet in Week 2

Take the forgotten tablet as soon as you remember, even if it means taking two tablets at once. Continue taking the following tablets at the usual time. The contraceptive protection will not decrease and you do not need to take additional precautions.

?Forgetting a Tablet in Week 3

You can choose between two options:

1. Take the forgotten tablet as soon as you remember, even if it means taking two tablets at once. Continue taking the following tablets at the usual time. Instead of taking the green placebo tablets from this pack, discard them and start the next pack.

You will probably have your period at the end of the second pack – during the intake of the green placebo tablets – although you may experience light bleeding or spotting during the intake of the second pack.

1. You can also stop taking the active white tablets and go directly to the 7 green placebo tablets (before taking the placebo tablets, you must note the day you forgot to take the tablet). If you want to start a new pack on the fixed day you always start, take the placebo tablets for less than 7 days.

If you follow one of these two recommendations, you will remain protected against pregnancy.

• If you have forgotten to take an active tablet (white) and do not have your period during the intake of the placebo tablets, this may mean that you are pregnant. In that case, you must consult your doctor before continuing with the next pack.

What to Do if You Have Gastrointestinal Disorders (e.g., Vomiting, Severe Diarrhea)

If you are sick (vomit) or have severe diarrhea, your body may not get the usual dose of hormones from the preparation. If you vomit within 3 or 4 hours after taking the pill, it is equivalent to forgetting a tablet. Therefore, follow the recommendations for a forgotten tablet. In case of severe diarrhea, consult your doctor.

Delayed Menstrual Period: What You Should Know

Although it is not recommended, you can delay your menstrual period if you do not take the green placebo tablets from the fourth row and start taking a new Mariona pack and finish it. You may experience light bleeding or spotting during the use of the second pack. Finish this second pack by taking the 7 green tablets from the 4th row. Then start with the new pack.

You should ask your doctor for advice before deciding to delay your menstrual period.

Changing the First Day of Your Menstrual Period: What You Should Know

If you take the tablets according to the instructions, your period will start during the placebo days. If you need to change this day, you can do so by reducing the placebo days (the days you take the green tablets) (but never increase them - 7 at most!). For example, if you start taking the placebo tablets on Fridays and want to change it to Tuesdays (3 days earlier), start a new pack 3 days earlier than usual. If you make the placebo period very short (e.g., 3 days or less), you may not experience bleeding during these days. Then you may experience light bleeding or spotting.

If you are not sure how to proceed, consult your doctor for advice.

If You Have Unexpected Bleeding

As with all pills, irregular vaginal bleeding (called spotting or intermenstrual bleeding) may occur between periods during the first few months. 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, worsens, or appears again, consult your doctor.

If You Do Not Have Your Menstrual Period

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

If you have two consecutive missed periods, you may be pregnant, so you must inform your doctor immediately. Do not start the next blister pack of the medication until your doctor has confirmed that you are not pregnant.

If You Stop Taking Mariona Daily

You can stop taking this medication whenever you want. If you do not want to become pregnant, consult your doctor about other effective birth control methods. If you want to become pregnant, stop taking the medication and wait for your menstruation before trying to become pregnant. This way, you will be able to calculate the estimated due date more easily.

4. Possible Side Effects

Like all medications, this medication can have side effects, although not all people experience them. If you experience any side effect, especially if it is severe and persistent, or have any change in health that you think may be due to this treatment, consult your doctor.

All women who take 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 section 2 "What you need to know before you start using Mariona Daily".

Contact your doctor immediately if you experience any of the following symptoms of angioedema: swelling of the face, tongue, or pharynx and/or difficulty swallowing or urticaria with difficulty breathing (see also the section "Warnings and Precautions".

The following is a list of possible side effects related to the use of this medication :

Common(may affect up to 1 in 10 women):

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

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

• fluid retention
• decreased libido
• migraine
• vomiting, diarrhea
• skin rash, breast enlargement.

Rare(may affect up to 1 in 1,000 women):

• hypersensitivity
• increased libido
• irritation when wearing contact lenses
• skin disorders (erythema nodosum (characterized by the appearance of painful red nodules), erythema multiforme (rash with redness or sores))
• vaginal discharge
• breast discharge
• weight loss
• harmful blood clots in a vein or artery, for example:
• In a leg or foot (i.e., DVT).
• In a lung (i.e., PE).
• Heart attack.
• Stroke.
• Mild stroke or temporary symptoms similar to those of a stroke, called a transient ischemic attack (TIA).
• Blood clots in the liver, stomach/intestine, kidneys, or eye.

The risk of having 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 symptoms of a blood clot).

Reporting Side Effects:

If you experience any 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 through the Spanish Pharmacovigilance System for Human Use website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Mariona Daily

Keep this medication out of sight and reach of children.

Do not store above 30°C. Keep in the original package to protect from light.

Do not use this medication after the expiration date that appears on the package, after "EXP". The expiration date is the last day of the month indicated.

Do not use the medication if you notice a color change, broken tablets, or any visible sign of deterioration.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need in the SIGRE collection point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Mariona CompositionDaily

Each blister pack contains 21 active white tablets in rows 1, 2, and 3, and 7 placebo green tablets in row 4.

Active White Tablets

• The active ingredients are desogestrel and ethinylestradiol. Each white tablet contains 0.15 mg of desogestrel and 0.03 mg of ethinylestradiol.
• The other components are: lactose monohydrate, cornstarch, povidone K-30 (E1201), d-alpha-tocopherol (E307), soybean oil, hydrated colloidal silica (E551), anhydrous colloidal silica (E551), stearic acid (E570), hypromellose 2910 (E464), triacetin (E1518), polysorbate, titanium dioxide (E171).

Placebo Green Tablets:

Lactose monohydrate, cornstarch, povidone K-30 (E1201), anhydrous colloidal silica (E551), magnesium stearate (E572), hypromellose 2910 (E464), triacetin (E1518), polysorbate, titanium dioxide (E171), aluminum lake FD & C Blue 2 (E132), yellow iron oxide (E172).

Appearance of MarionaDailyand Package Contents

• Each active film-coated tablet is white and round.
• Each placebo film-coated tablet is green and round.

Available in blisters of 28 tablets: 21 active white tablets and 7 placebo green tablets.

• The packages are available in 1, 3, 6, and 13 blisters, each containing 28 tablets.

It is possible that only some package sizes are marketed.

Marketing Authorization Holder

EXELTIS HEALTHCARE S.L.

Av.Miralcampo 7-Poligono Ind.Miralcampo, 19200,

Azuqueca de Henares, Guadalajara

Spain

Manufacturer

Laboratorios León Farma, S.A.

C/ La Vallina s/n, Pol. Ind. Navatejera.

24193 - Villaquilambre, León. Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands: Bryoronna 28 150/30 microgram, filmomhulde tabletten

Spain: Mariona daily 0.15 mg/0.03 mg, film-coated tablets EFG

This leaflet was last revised in: April 2024