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

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

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

Desogestrel / ethinylestradiol

Important things you need to 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 developing a blood clot in veins and arteries, especially during 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)”).

Read the entire leaflet carefully before you start using the medicine. It contains important information of interest to you. Keep this leaflet. You may need to read it again. If you have any questions, consult your doctor or pharmacist. This medicine has been prescribed for you personally. Do not give it to others, even if they have the same symptoms as you, as it may harm them. If any of the side effects are serious or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Package leaflet:

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

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

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

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

General considerations Before starting to use this medicine, you should read the information about blood clots (thrombosis) in section 2. It is particularly important that you read about the symptoms of a blood clot (see section 2 “Blood clots (thrombosis)”). This leaflet describes several situations in which you should stop using Mariona Daily or in which the effectiveness of this medicine may be reduced. In such situations, you should avoid sexual intercourse or use additional non-hormonal contraceptive precautions, for example, condoms or another barrier method. Do not use the rhythm method or temperature method. These methods may not be reliable because this medicine alters the monthly changes in body temperature and cervical mucus. This medicine, like other hormonal contraceptives, does not protect against HIV (AIDS) or any other sexually transmitted disease.

Do not take MarionaDiario

You must not use this medicine 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 which other form of contraception would be more suitable. See also the section “When you must be especially careful with Mariona Diario”.

• If you have (or have ever had) a blood clot in a blood vessel in your legs (deep vein thrombosis, DVT), in your lungs (pulmonary embolism, PE), or in other organs.

• If you know you have a disorder affecting blood clotting: for example, protein C deficiency, protein S deficiency, antithrombin III deficiency, factor V Leiden, or antiphospholipid antibodies.

• If you require surgery or if you are going to be immobile for a long time (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 causing severe chest pain and may be the first sign of a heart attack) or a transient ischaemic attack (TIA, temporary stroke-like symptoms).

• If you have any of the following conditions that may increase your risk of developing a blood 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), together with high levels of fats 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 serious liver disease and your liver function has not yet returned to normal.

• If you have (or have had) a liver tumour.

• If you have (or have had) cancer that grows under the influence of sex hormones (such as breast cancer or cancer of the sex organs).

• If you have vaginal bleeding of unknown cause.

• If you have abnormal growth of the endometrium.

• If you are allergic to ethinylestradiol or desogestrel or to any of the other ingredients of this medicine (listed in section 6). This may present as itching, rash, or swelling.

• If you are allergic to peanuts or soya.

• If you have hepatitis C and are taking medicines containing ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Taking Mariona Diario with other medicines”).

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

When you must be especially careful with Mariona Diario

When should you consult your doctor? Seek urgent medical attention. If you notice possible signs of a blood clot which may indicate that 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 clot (thrombosis)” below). For a description of the symptoms of these serious side effects, see “How to recognize a blood clot”.

Inform your doctor if you have any of the following conditions.

If any of these conditions develop or worsen while you are using Mariona Diario, you must also inform your doctor.

• If you are a smoker
• If you have diabetes
• If you are overweight
• If you have high blood pressure
• If you have heart rhythm disorders or certain cardiac disorders
• If you have inflammation of the veins beneath the skin (superficial thrombophlebitis)
• If you have varicose veins
• If any of your close relatives have had thrombosis, heart attack, or stroke
• If you have migraine
• 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 an increased risk of pancreatitis (inflammation of the pancreas).
• If you require surgery or will be immobile for long periods (see section 2 “Blood clots (thrombosis)”).
• If you have recently given birth, you are at increased risk of blood clots. Ask your doctor when you can start taking this medicine after childbirth.
• If any close relative has had or has 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 affecting your natural defense system)
• If you have hemolytic uremic syndrome (HUS, a blood clotting disorder causing kidney failure)
• If you have sickle cell anemia (an inherited red blood cell disorder)
• If you have any condition that first occurred during pregnancy or during previous use of sex hormones (e.g., hearing loss, a blood disorder called porphyria, blistering rash during pregnancy (herpes gestationis), a nervous disorder characterized by involuntary movements (Sydenham's chorea))
• If you have ever had or currently have chloasma (skin discoloration, especially on the face or neck, also known as "pregnancy mask"). In such cases, avoid direct exposure to sunlight or ultraviolet rays.
• If you experience symptoms of angioedema such as swelling of the face, tongue and/or pharynx, and/or difficulty swallowing or hives along with difficulty breathing, contact your doctor immediately. Products containing estrogens may induce or worsen symptoms of hereditary angioedema.

Mariona Diario and blood clots

BLOOD CLOTS (THROMBOSIS)

Using a combined hormonal contraceptive such as Mariona Diario increases your risk of developing a blood clot compared to not using one. Rarely, a blood clot can block blood vessels and cause serious problems.

Blood clots can form:

• In veins (called “venous thrombosis”, “venous thromboembolism” or VTE)
• In arteries (called “arterial thrombosis”, “arterial thromboembolism” or ATE)

Recovery from blood clots is not always complete. Rarely, there may be serious long-term effects, and very rarely, they may be fatal.

It is important to remember that the overall risk of a harmful blood clot due to Mariona Diario is small.

HOW TO RECOGNIZE A BLOOD CLOT

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

Are you experiencing any of these signs?	What might you be suffering from?
Swelling in one leg or foot, or along a vein in the leg or foot, especially when accompanied by: • Pain or tenderness in the leg, which may only be noticeable when standing or walking. • Increased warmth in the affected leg. • Skin discoloration of the leg, e.g., turning pale, red, or blue.	Deep vein thrombosis
Sudden shortness of breath without known cause or rapid breathing. • Sudden cough without clear cause, possibly producing blood. • Sharp chest pain that may worsen with deep breathing. • Severe dizziness or lightheadedness. • Rapid or irregular heartbeat. • Severe stomach pain. If in doubt, consult a doctor, as some of these symptoms such as cough or shortness of breath may be mistaken for a milder condition like a respiratory infection (e.g., the common cold).	Pulmonary embolism
Symptoms occurring more frequently in one eye: • Sudden loss of vision, or • Painless blurred vision, which may progress to vision loss.	Retinal vein thrombosis (blood clot in the eye).
Chest pain, discomfort, pressure, or heaviness. • A feeling of tightness or fullness in the chest, arm, or under the breastbone. • A sensation of fullness, indigestion, or suffocation. • Upper body discomfort radiating to the back, jaw, throat, arm, or stomach. • Sweating, nausea, vomiting, or dizziness. • Extreme weakness, anxiety, or shortness of breath. • Rapid or irregular heartbeat.	Heart attack
Sudden weakness or numbness of the face, arm, or leg, especially on one side of the body. • Sudden confusion, difficulty speaking or understanding speech. • Sudden vision problems in one or both eyes. • Sudden difficulty walking, dizziness, loss of balance or coordination. • Sudden, severe, or prolonged headache without known cause. • Loss of consciousness or fainting, with or without seizures. Sometimes stroke symptoms may be brief, with almost immediate and complete recovery, but you should still seek urgent medical attention as you may be at risk of another stroke.	Stroke
Swelling and slight bluish discoloration of a limb. • Severe stomach pain (acute abdomen).	Blood clots blocking other blood vessels.

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 during the first year of using a combined hormonal contraceptive.
• If a blood clot forms in a vein of the leg or foot, it may cause deep vein thrombosis (DVT).
• If a blood clot travels from the leg and lodges in the lung, it may cause a pulmonary embolism.
• Very rarely, a clot may form in a vein of another organ, such as the eye (retinal vein thrombosis).

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

The risk of developing 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 also be increased if you restart taking a combined hormonal contraceptive (the same medication or a different one) after a break of 4 weeks or more.

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

When you stop taking Mariona Diario, your risk of developing a blood clot returns to normal within a few weeks.

What is the risk of developing a blood clot?

The risk depends on your natural risk of venous thromboembolism (VTE) and the type of combined hormonal contraceptive you are taking.

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

• Among 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, norethisterone, or norgestimate, about 5–7 will develop a blood clot in one year.
• Among 10,000 women who use a combined hormonal contraceptive containing desogestrel, such as Mariona Diario, between 9 and 12 women will develop a blood clot in one year.
• Your risk of developing a blood clot will depend on your personal medical history (see “Factors that increase your risk of a blood clot” below).

	Risk of developing a blood clot in one year
Women who do not use a combined hormonal pill/patch/ring and who are not pregnant	About 2 out of 10,000 women
Women who use a combined oral contraceptive pill containing levonorgestrel, norethisterone, or norgestimate	About 5 - 7 out of 10,000 women
Women who use Mariona Diario	About 9 - 12 out of 10,000 women

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

The risk of having a blood clot with this medicine is small, but certain 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 has had a blood clot in the leg, lung, or another organ at a young age (i.e., before about 50 years). In this case, you might have an inherited blood clotting disorder.
• If you need surgery or if you are immobile for long periods due to injury or illness, or if your leg is in a cast. You may need to stop taking this medicine several weeks before surgery or while you are less mobile. If you need to stop taking Mariona Diario, ask your doctor when you can start taking it again.
• As you get older (especially above about 35 years of age).
• If you have given birth within the last few weeks.

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

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

It is important 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 taking this medicine.

If any of the above conditions change while you are using Mariona Diario—for example, if a close relative experiences a blood clot (thrombosis) without a known cause, or if 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 lead to a heart attack or stroke.

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

It is important to note that the risk of heart attack or stroke from using this medicine is very small, but it may increase:

• With age (especially above about 35 years).
• If you smoke. When using a combined hormonal contraceptive like this medicine, you are advised to stop smoking. If you cannot stop 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 a close relative has had a heart attack or stroke at a young age (under about 50 years). In this case, you may also have an increased risk of heart attack or stroke.
• If you or any of your close relatives have high levels of fat in the blood (cholesterol or triglycerides).
• If you suffer from migraines, especially migraines with aura.
• If you have a heart condition (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 developing a blood clot may be further increased.

If any of the above conditions change while you are using this medicine—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

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

Rarely, benign liver tumors and, even more rarely, malignant tumors have been reported in users of contraceptives. See your doctor if you experience sudden severe abdominal pain.

The factor most affecting the risk of cervical (cervix) cancer is persistent infection with human papillomavirus (HPV). In women who use the contraceptive pill for many years, the likelihood of cervical cancer is slightly higher. However, it is unclear whether the contraceptive pill plays a direct role in this risk, or whether sexual habits and other factors (such as more frequent medical check-ups) are responsible.

Psychiatric disorders

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

Other medicines and Mariona Diario

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or plan to take any other medicines or herbal preparations in addition to this medicine. Also inform any other doctor or dentist who prescribes another medicine (or your pharmacist) that you are using Mariona Diario. They may advise you whether you need to use additional non-hormonal contraceptive precautions (e.g., condoms), and if so, for how long, or whether you need to adjust the use of the other medicine.

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

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

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

Some medicines:

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

These include:

• Medicines used to treat:

  o Epilepsy (e.g.: primidone, phenytoin, phenobarbital, carbamazepine, oxcarbazepine, topiramate, felbamate)

  o Tuberculosis (e.g.: rifampicin, rifabutin)

  o HIV infection (e.g.: ritonavir, nelfinavir, nevirapine, efavirenz)

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

  o Other infectious diseases (e.g.: griseofulvin)

  o High blood pressure in the blood vessels leading to the lungs (bosentan)

  o Depressive mood disorders (the herbal remedy St. John's wort).

If you are taking medicines or herbal remedies that could reduce the effectiveness of Mariona Diario, you should also use a barrier contraceptive method. Since the effect of the other medicine on this treatment may last up to 28 days after stopping the medicine, a barrier contraceptive method must be used during that time.

Mariona Diario may influence the effect of other medicines, for example, those containing:

• Cyclosporine
• The antiepileptic lamotrigine (this may lead to an increased frequency of seizures).

Mariona Diario with food and drinks

This medicine can be taken with or without food, with some water if needed.

Laboratory tests

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

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, you must not take Mariona Diario. If you become pregnant during treatment with this medicine, you must stop treatment immediately and contact your doctor. If you wish to become pregnant, you may stop treatment at any time (see also “If you wish to stop treatment with Mariona Diario”).

Breastfeeding

Generally, it is not recommended to take this medicine during breastfeeding. If you wish to take a contraceptive while breastfeeding, you should consult your doctor.

Driving and use of machines

There is no information suggesting that the use of this medicine affects the ability to drive or operate machinery.

Mariona Diario contains lactose and soybean oil

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains soybean oil. It must not be used if you are allergic to soy.

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?

Regular check-ups

While taking the pill, your doctor will require you to undergo regular check-ups. Your personal situation will determine which checks are needed and how often they should be performed.

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

• If you notice possible signs of a blood clot, which may mean you are experiencing 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)”).
• For a description of the symptoms of these serious adverse 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 must not use Mariona Diario” and “What you need to know before starting Mariona Diario”); do not forget the points related to your immediate family members;
• If you find a lump in your breasts;
• If you experience symptoms of angioedema, such as swelling of the face, tongue and/or throat, and/or difficulty swallowing, or hives possibly with difficulty breathing (see also section “When must you take special care with Mariona Diario”);
• If you are going to take other medicines (see also “Taking Mariona Diario with other medicines”);
• If you are going to be immobile or undergo surgery, as the risk of thrombosis increases temporarily in these cases; consult your doctor at least four weeks in advance;
• If you have unusual and heavy vaginal bleeding;
• If you forget to take tablets in the first week of the pack and have had sexual intercourse in the previous seven days;
• If you have severe diarrhoea;
• If you miss two periods in a row or suspect you are pregnant, do not start the next pack until your doctor advises you to do so.

3. How to take Mariona Diario

Follow exactly the instructions for taking this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

When and how to take the tablets

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

The two different colored tablets in Mariona are arranged in order. One pack contains 28 tablets.

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

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

Because of the different composition of the tablets, you must start with the first tablet located in the top left corner and then take one tablet each day. To maintain the correct order, follow the direction of the arrows on the pack.

Preparing the blister pack

To help you keep track of your dosing schedule, each pack of Mariona includes seven adhesive strips printed with the seven days of the week. Choose the strip that starts with the day on which you take your first tablet. For example, if you start on Wednesday, apply the strip marked “WED” as your starting tablet.

Apply the weekly adhesive strip to the top of the blister pack where indicated “Place strip here”, so that the first day is positioned above the tablet marked “1”. This way, each tablet will have a corresponding day of the week indicated above it, allowing you to see whether 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), you should experience menstruation (also called withdrawal bleeding). Menstruation usually begins on the 2nd or 3rd day after taking the last active white tablet of Mariona. After taking the last green tablet, you should immediately start the next pack, even if your period has not finished. This means you should start each new pack on the same day of the week as you started the previous one, and your period should occur during the same days every month.

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

When to start the first pack?
If you have not used 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 period, you will be protected against pregnancy immediately. You may also start on days 2–5 of your cycle, but in this case you must use additional contraceptive methods (e.g., a condom) during the first 7 days.

Switching from another combined hormonal contraceptive, vaginal contraceptive ring, or transdermal contraceptive patch.

You may start taking Mariona preferably the day after taking the last active tablet (the last tablet containing active substances) of your current pill pack, but no later than the day after the pill-free interval of your previous contraceptive (or after taking the last inactive tablet of your current pill).

If you are using a vaginal ring or a transdermal patch, you should start taking the tablets on the same day the ring is removed or on the day the patch is due to be removed. You may also start, but no later than the day the next patch or ring application would have been due.

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

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

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

You may switch from the progestogen-only pill on any day (if using an implant or IUD, on the same day of removal; if using an injectable, on the day 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 tablet intake.

After an abortion.

Follow your doctor’s recommendations.

After childbirth.

After childbirth, you may start taking this medicine between 21 and 28 days postpartum. If you start later, you must use one of the so-called barrier methods (e.g., a condom) during the first 7 days of using Mariona. If, after childbirth, you have already had sexual intercourse before starting Mariona (again), you must ensure you are not pregnant or wait until your next menstrual period.

If you are breastfeeding and wish to start taking Mariona (again) after childbirth.

Please read the section “Pregnancy and breastfeeding”.

If you take more Mariona than you should

There have been no reported cases in which an overdose of this medicine has caused serious harm.

Symptoms that may occur if you take many tablets at once include nausea and vomiting.

Adolescent women may experience vaginal bleeding.

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

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Mariona

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

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

• If you are less than 12 hours late in taking a tablet, protection against pregnancy is not reduced. Take the tablet as soon as you remember, and take the following tablets at your usual time.
• If you are more than 12 hours late in taking a tablet, protection against pregnancy may be reduced. The more tablets you forget, the greater the risk that protection will decrease.

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

?Forgotten more than one tablet in the pack

Consult your doctor.

?Forgot a tablet in week 1

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the following tablets at your usual time and use additional precautions, such as a condom, during the next 7 days. If you have had sexual intercourse in the week before missing the tablet, be aware that there is a risk of pregnancy. In this case, consult your doctor.

?Forgot a tablet in week 2

Take the missed tablet as soon as you remember, even if this means taking two tablets at the same time. Continue taking the following tablets at your usual time. Your contraceptive protection is not reduced, and you do not need to take any additional precautions.

?Forgot a tablet in week 3

You have two options:

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

You will likely get 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 second pack.

2. Alternatively, you may interrupt the intake of the active white tablets and go directly to the 7 green placebo tablets (before taking the placebo tablets, you should note the day on which you missed the tablet). If you wish to start a new pack on your usual starting day, take fewer than 7 days of placebo tablets.

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

• If you have missed one or more active (white) tablets and do not get your period during the placebo tablet intake, this may indicate that you are pregnant. In this case, you must consult your doctor before starting the next pack.

What to do if you experience gastrointestinal disorders (e.g., vomiting, severe diarrhea)

If you are ill (vomiting) or have severe diarrhea, your body may not absorb the usual dose of hormones from the medication. If you vomit within 3 to 4 hours after taking a tablet, this is equivalent to missing a tablet. Therefore, follow the instructions for a missed tablet. In case of severe diarrhea, consult your doctor.

Delaying your menstrual period: what you should know

Although not recommended, you may delay your menstrual period by skipping the green placebo tablets in the fourth row and immediately starting a new pack of Mariona and completing it. You may experience light bleeding or spotting during the second pack. Finish this second pack by taking the 7 green tablets in the 4th row, then start the next pack.

You should seek advice from your doctor before deciding to delay your menstrual period.

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

If you take the tablets as directed, your period will begin during the placebo days. If you wish to change this day, you may do so by shortening the number of placebo days (the days when you take the green tablets) (but never extend them—maximum 7 days!). For example, if you usually start the placebo tablets on Fridays and wish to change to Tuesdays (3 days earlier), start the new pack 3 days earlier than usual. If you make the placebo period very short (e.g., 3 days or less), you may not have bleeding during these days. In this case, you may experience light bleeding or spotting later.

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

If you experience unexpected bleeding

As with all oral contraceptives, irregular vaginal bleeding between periods may occur during the first few months (this is called spotting or intermenstrual bleeding). In this case, continue taking the tablets as usual. This irregular vaginal bleeding usually stops once your body has adjusted to the pill, typically after three cycles. If it continues, becomes heavier, or recurs, consult your doctor.

If your period does not occur

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

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

If you stop treatment with Mariona Diario

You may stop taking this medicine at any time. If you do not wish to become pregnant, consult your doctor about other effective methods of contraception. If you wish to become pregnant, stop taking the medicine and wait for your menstruation before trying to conceive. This will allow you to calculate your estimated due date more easily.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. If you experience any adverse effect, especially if it is severe and persistent, or if you have any change in health that you think may be due to this treatment, consult your doctor.

All women who take combined hormonal contraceptives have an increased 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 associated with 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 symptoms of angioedema: swelling of the face, tongue or pharynx and/or difficulty swallowing, or hives together with difficulty breathing (see also section “Warnings and precautions”).

Listed below are possible adverse effects associated with the use of this medicine:

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

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

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

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

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

• hypersensitivity
• increased libido
• intolerance to contact lenses
• skin disorders (nodular erythema (characterized by painful red skin 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.
• Mini-stroke or temporary stroke-like symptoms, known as transient ischaemic attack (TIA).
• Blood clots in the liver, stomach/intestines, kidneys or eye.

The likelihood of developing a blood clot may be higher if you have any other condition that increases this risk (see section 2 for more information about conditions that increase the risk of blood clots and symptoms of a blood clot).

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mariona Diario

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

Do not store above 30°C. Store in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the container, after 'EXP'. The expiry date refers to the last day of the month indicated.

Do not use the medicine if you notice any change in colour, broken tablets, or any visible signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of MarionaDiario

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

White active tablets

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

Green placebo tablets:

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

Appearance of MarionaDiario and contents of the pack

• 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 white active tablets and 7 green placebo tablets.

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

Only some pack 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. 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, fimomhulde tabletten

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

This leaflet was last reviewed in: April 2024