Package Leaflet: Information for the user

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

Desogestrel / etinilestradiol

Important information 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 the veins and arteries, especially in the first year or when restarting use of a combined hormonal contraceptive after a pause 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)”).

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

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

3. How to take Mariona Diario

4. Possible side effects

5. Storage of Mariona Diario

6. Contents of the pack and additional information

• This medicationis 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, known as desogestrel and ethinylestradiol.
• The 7 green tablets, which do not contain active ingredients, are called placebo tablets.
• Contraceptives that contain two hormones are called combined contraceptives.

Do not take MarionaDiario

Do not usethis medicationif 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 Diario”.

• If you have (or have had at any time) a blood clot in a leg vein (deep vein thrombosis, DVT), in the lungs (pulmonary embolism, PE) or in other organs.
• If you know that 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 surgery 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 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, temporary symptoms of a stroke).
• If you have any of the following diseases that may increase your risk of forming a blood clot in the arteries:
• • Severe diabetes with vascular 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 had at any time) 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 cancer that grows in response to sex hormones (such as breast cancer or cancer of the reproductive organs).
• If you have vaginal bleeding, whose cause is unknown.
• If you have abnormal endometrial growth.
• If you are allergic to ethinylestradiol or desogestrel or to any of the other components of this medication (including in section6). This may manifest as 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 Diario 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. Meanwhile, use other non-hormonal contraceptive methods. See also “General Considerations” at the beginning of section 2.

When to have special care with Mariona Diario

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

Inform your doctor if the condition develops or worsens while using MarionaDiario, 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 appear to have alterations in heart rhythm or certain cardiac disorders
• If you have superficial phlebitis (inflammation of the veins under the skin)
• If you have varicose veins
• If any of your immediate family members have had thrombosis, heart attack or cerebral embolism.
• If you have migraines
• If you have epilepsy
• If you have high levels of fat in the blood (hypertriglyceridemia) or known family history of this condition. Hypertriglyceridemia has been associated with a higher risk of pancreatitis (inflammation of the pancreas).
• If you need surgery or spend a lot of time without getting up (see section 2 “Blood Clots (Thrombosis)”).
• If you are at greater risk of blood clots after giving birth. You should ask your doctor when you can start taking this medicationafter the birth.
• If any of your immediate family members have had breast cancer
• If you have liver disease 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 disorder of red blood cells).
• If you have any disease that appeared for the first time during pregnancy or during a previous use of sex hormones (for example, hearing loss, a blood disorder called porphyria, a skin rash with blisters during pregnancy (gestational herpes), a nervous disorder in which involuntary movements occur (Sydenham's chorea).
• If you have or have had melasma (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 facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria possibly with difficulty breathing, contact your doctor immediately. Estrogen-containing products can induce or worsen angioedema hereditary symptoms.

MarionaDiarioand Blood Clots

BLOOD CLOTS (TROMBOSIS)

The use of a combined hormonal contraceptive like MarionaDiarioincreases 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 MarionaDiariois small.

HOW TO RECOGNIZE A BLOOD CLOT

Seek urgent medical assistanceif 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 thrombosis). However, these adverse 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 may cause deep vein thrombosis (DVT).

• If a blood clot breaks loose from the leg and lodges in the lung, it may cause a pulmonary embolism.

• 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 in which you start taking a combined hormonal contraceptive for the first time. The risk may be higher also if you restart taking a combined hormonal contraceptive (the same medication or a different medication) 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 taking MarionaDiario, 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 the leg or lung (DVT or PE) with this medicationis small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, 2 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel or noretisterone or norgestimate, 5-7 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing desogestrel like MarionaDiario, between 9 and 12 women 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 with this medicationis small, but some conditions increase the risk. Your risk is higher:

• If you are overweight (body mass index or BMI above 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 about 50 years). You may have an inherited 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 interrupt the use of this medicationfor several weeks before the surgical procedure or while you have less mobility. If you need to interrupt the use of MarionaDiario, ask your doctor when you can start using it again.

• As you get older (especially above about 35 years).

• If you have given birth recently.

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

Flights (more than 4 hours) may 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 conditions above, even if you are unsure. Your doctor may decide that you need to interrupt the use of this medication.

If any of the conditions above change while you are using MarionaDiario, 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?

A blood clot in an artery can cause serious problems, such as 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 a stroke due to the use of this medicationis very small, but it may increase:

• With age (above about 35 years).

•If you smoke.You are advised to quit smoking when using a combined hormonal contraceptive like this medication. If you are unable 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 a stroke at a young age (less than about 50 years). You may also be at higher risk of a heart attack or a stroke.

• If you or any of your close relatives have high levels 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 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 conditions above 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

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

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

The situation that most affects the risk of developing cervical cancer (cervix) is the continued infection with the human papillomavirus (HPV). In women using 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 if other factors (such as sexual habits and other factors) do.

Mental disorders

Some women who use hormonal contraceptives like this medicationhave 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 MarionaDiario

Inform your doctor, pharmacist, or nurse if you are taking, have taken, or plan to take any other medication or herbal preparation in addition to this medication. Also, inform any other doctor or dentist who prescribes another medication (or your pharmacist) that you use MarionaDiario. They may advise you to take additional non-hormonal contraceptive precautions (for example, condoms) and, if so, for how long you should use them, or whether you should modify the use of the other medication.

Do not takethis medicationif you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir or glecaprevir/pibrentasvir or sofosbuvir/velpatasvir/voxilaprevir,since these medications can cause increases in liver enzyme test results (elevated ALT levels).

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

You can resume using this medication approximately 2 weeks after completing this treatment. See the section “Do not use Mariona Diario”.

Some medications:

may reduce the effectiveness of this medicationor may cause unexpected bleeding.

These include:

• medications used in the treatment of:

orepilepsy (for example: primidone, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, topiramate, felbamate)

ortuberculosis (for example: rifampicin, rifabutin)

orinfections with HIV (for example: ritonavir, nelfinavir, nevirapine, efavirenz)

or hepatitis C infection (for example: boceprevir, telaprevir)

or other infectious diseases (for example: griseofulvin)

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

ormood disorders (St. John's Wort).

If you are taking medications or herbal preparations that may reduce the effectiveness of Mariona Diario, you should also use a barrier contraceptive method. Since the effect of the other medication on this treatment may last for up to 28 days after stopping the medication, you will need to use a barrier contraceptive method during that time.

Mariona Diario may interact with other medications, for example, those containing:

• cyclosporine
• the antiepileptic lamotrigine (this may lead to an increase in seizure frequency).

MarionaDiariowith food and drinks

This medicationcan be taken with or without food, with a little 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 hormonal contraceptives can affect the results of some tests.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, do not take MarionaDiario.If you become pregnant while taking this medicationstop taking it immediately and contact your doctor. If you want to become pregnant, you can stop taking the medicationat any time (see also “If you want to stop taking MarionaDiario”).

Breastfeeding

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

Driving and operating machinery

There is no information to suggest that the use of this medicationaffects your ability to drive or operate machinery.

MarionaDiariocontains lactose and soy oil

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

This medication contains soy oil. Do not use it if you are allergic to soy.

Children and adolescents

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

When to contact your doctor?

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

When and how to take the tablets

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

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

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

Do not confuse the tablets: take a white tablet every day for the first 21 days, followed by a green tablet for the last 7 days. Then you must start taking a new package (21 white tablets and 7 green tablets). In this way, there is no break between two packages.

Due to the different composition of the tablets, you must 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 package.

Preparation of the blister

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

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

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

When can you start with the first package?If you have not taken any hormonal contraceptive in the previous month.

Start taking the tablets on the first day of the 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 the cycle, but you must use additional contraceptive methods (e.g., a condom) during the first 7 days.

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

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

In the case of using a vaginal ring or a transdermal patch, you must start taking the tablets on the same day as the 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 application of the patch or the vaginal ring would be due.

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

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

• Change from a progestin-only method (progestin-only pill, injection, implant, or progestin-releasing intrauterine device (IUD)).

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

• After an abortion.

Follow your doctor's recommendations.

• After giving birth

After giving birth, you can start taking this medication between 21 and 28 days later. If you start later, you must use one of the so-called barrier methods (e.g., a condom) during the first 7 days of taking Mariona. If, after giving birth, you have already had sexual intercourse before starting to take Mariona (again), you must make sure you are not pregnant or wait for your next menstrual period.

• If you are breastfeeding and want to start taking Mariona (again) after giving birth.

Read the section "Pregnancy and breastfeeding".

If you take more Mariona than you should

No serious cases of overdose of this medication have been reported.

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

Teenage girls may experience vaginal bleeding.

If you have taken too many Mariona tablets, or if you 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. Tel. 91 562 04 20 indicating the medication and the amount ingested.

If you forget to take Mariona

The tablets of thefourthrow of the package 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 of the1st, 2nd, or 3rd row, follow these steps:

• If you are lateless than 12 hoursin taking some tablets, the protection against pregnancy does not decrease. Take the tablet as soon as you remember and the subsequent tablets at the usual hour.
• If you are latemore than 12 hoursin taking some tablets, the protection against pregnancy may decrease. The more tablets you have forgotten, the greater the risk of reduced protection.

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

?Forgetting more than one tablet from the package

Consult your doctor.

?Forgetting a tablet in week 1

Take the forgotten tablet as soon as you remember, although this means you will have to take two tablets at once. Continue taking the subsequent tablets at the usual hour and useadditional precautions, for example, a condom, during 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, although this means you will have to take two tablets at once. Continue taking the subsequent tablets at the usual hour. The contraceptive protection does 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, although this means you will have to take two tablets at once. Continue taking the subsequent tablets at the usual hour. Instead of taking the green placebo tablets of this package, discard them and start a new package.

Probably you will experience bleeding during the use of the second package - during the taking of the green placebo tablets - although you may experience light bleeding or menstrual-like bleeding during the taking of the second package.

2. You can also interrupt the taking of active white tablets andpass 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 package on the day scheduled to start, take the placebo tabletsless 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 taking of placebo tablets, this may mean you are pregnant. In that case, you should consult your doctor before continuing with the next package.

What to do if you have gastrointestinal disorders (e.g., vomiting, intense diarrhea)

If you are sick (vomit) or have intense diarrhea, your body may not receive the usual dose of hormones from the preparation. If you vomit during the 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 intense diarrhea, consult your doctor.

Delay in menstrual period: what you should know

Although it is not recommended, you can delay your menstrual period if you do not take the placebo tablets, of green color, of the fourth row and start taking a new package of Mariona and finish it. You may experience bleeding during the use of the second package - during the taking of the green placebo tablets - although you may experience light bleeding or menstrual-like bleeding during the taking of the second package.

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

Change in the first day of your menstrual period: what you should know

If you take the tablets as indicated, your period will start duringthe placebo days. If you have to change this day, you can do so by reducing theplacebo days(the days when you take green placebo tablets). Never increase them - 7 at most!(but never increase - 7 at most!). For example, if you start taking the placebo tablets on Friday and want to change it to Tuesday (3 days earlier), start a new package 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 menstrual-like bleeding.

If you are unsure how to proceed, consult your doctor for advice.

If you experience 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 your 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 this medication as usual.

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

If you interrupt treatment withMariona Diario

You can stop taking this medication when 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 menstrual period before trying to become pregnant. In this way, you will be able to estimate your due date more easily.

Like all medicines, this medicinemay 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 change that you think may be due to this treatment, 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 section 2 “What you need to know before starting to use Mariona Diario”.

Contact your doctor immediately if you experience any of the following angioedema symptoms: swelling of the face, tongue, or pharynx and/or difficulty swallowing or urticaria along 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 medicine:

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

• depression
• mood changes
• headaches
• 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 of contact lenses
• skin changes (erythema nodosum (characterized by the appearance of painful red nodules), erythema multiforme (rash with redness or blisters))
• 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 or transient stroke-like symptoms, known as transient ischemic attack (TIA).
• Blood clots in the liver, stomach/intestine, kidneys, or eye.

The chances 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 the symptoms of a blood clot).

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 through the Spanish System for the Pharmacovigilance of Medicines for Human Use website:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 86°F (30°C). Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging, after ‘CAD’. The expiration date is the last day of the month indicated.

Do not usethe medicationif you observe a change in color, broken tablets or any 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 SIGREpoint at 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 MarionaDaily

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

Active white tablets

• The active principles are desogestrel and etinilestradiol. Each white tablet contains 0.15 mg of desogestrel and 0.03 mg of etinilestradiol.
• 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), polisorbate, 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), polisorbate, titanium dioxide (E171), aluminum FD & C Blue 2 (E132), yellow iron oxide (E172).

Appearance of MarionaDiarioand packaging content

• 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 packaging consists of 1, 3, 6, and 13 blisters, each containing 28 tablets.

Only some packaging sizes may be 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.España

This medicine is authorized in the member states of the European Economic Area with the following names:

Netherlands:Bryoronna 28 150/30 microgram, fimomhulde tabletten

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

This leaflet was last revised in: April 2024