Prospect: information for the patient

Drosiane Daily 0.03 mg/3 mg film-coated tablets EFG

etinilestradiol/drospirenona

Read this prospect carefully before starting to take this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people, even if they present the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, or pharmacist, even if they do not appear in this prospect. See section 4.

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

• They are one of the most reliable reversible contraceptive methods if used correctly.
• They slightly increase the risk of suffering a blood clot in the veins and arteries, especially in the first year or when restarting the 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 section2 “Blood clots”).

Drosiane Diario is a contraceptive and is used to prevent pregnancy.

Each of the 21 yellow tablets contains a small amount of two different female hormones, known as drospirenone and ethinyl estradiol.

The 7 white tablets do not contain active ingredients and are also known as placebo tablets.

Contraceptives that contain two hormones are known as combined contraceptives.

Do not take Drosiane Diario

You should not take Drosiane Diario 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:

• If you have (or have ever had) 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 standing up (see section “Blood Clots”),
• 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 may be the first sign of a heart attack) or a transient ischemic attack (TIA),
• 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 ever had) a type of migraine called “migraine with aura”,
• If you have (or have ever had) a liver disease and your liver function has not normalized yet,
• If your kidneys do not function well (renal failure),
• If you have (or have ever had) a tumor in the liver,
• If you have (or have ever had), or if you suspect that you have breast cancer or cancer of the reproductive organs,
• If you have vaginal bleeding, whose cause is unknown,
• If you are allergic to ethinylestradiol or drospirenone or to any of the other components of this medication (including in section 6). This may manifest as itching, rash, or inflammation.
• If you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir, glecaprevir/pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir (see also section “Other Medications and Drosiane Diario”).

Additional Information on Special Populations

Use in children

Drosiane Diario is not designed for use in women whose periods have not yet begun.

Warnings and Precautions

Consult your doctor or pharmacist before starting Drosiane Diario.

Inform your doctor if you are affected by any of the following conditions

In some situations, you need to be particularly careful during the use of Drosiane Diario or any other combined pill. Your doctor may regularly examine you. If the condition develops or worsens while you are using Drosiane Diario, you should also inform your doctor:

• If a close relative has or has had breast cancer,
• If you have liver disease or gallbladder disease,
• If you have diabetes,
• If you have depression,
• If you have inflammatory bowel disease (Crohn's disease or ulcerative colitis),
• 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 high levels of fat in the blood (hypertriglyceridemia) or known family history of this condition. Hypertriglyceridemia has been associated with an increased risk of pancreatitis (inflammation of the pancreas),
• If you need surgery or spend a lot of time without standing up (see section “Blood Clots”),
• If you are at higher risk of blood clots after giving birth. You should ask your doctor when you can start taking Drosiane Diario after delivery,
• If you have superficial thrombophlebitis (inflammation of the veins under the skin),
• If you have varicose veins,
• If you have epilepsy (see “Other Medications and Drosiane Diario”),
• 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, skin rash with blisters during pregnancy (herpes gestationalis), a nervous disorder in which involuntary movements occur (Sydenham's chorea)),
• If you have or have had melasma (a skin discoloration, especially on the face or neck, known as “pregnancy mask”). If so, avoid direct sunlight or ultraviolet light,
• If you experience symptoms of angioedema such as facial swelling, tongue, and/or throat swelling, and/or difficulty swallowing or urticaria with possible difficulty breathing, contact a doctor immediately. Products containing estrogens can cause or worsen the symptoms of hereditary and acquired angioedema.

BLOOD CLOTS

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

Blood clots can form:

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

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

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

HOW TO RECOGNIZE A BLOOD CLOT

Seek immediate medical attentionif you notice any of the following signs or symptoms:

BLOOD CLOTS IN A VEIN

What can happen if a blood clot forms in a vein?

• The use of combined hormonal contraceptives has been associated with an increased risk of blood clots in veins (venous thromboembolism). However, these 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 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 Drosiane Diario, 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 Drosiane Diario is small.

• Of every 10,000 women who do not use a combined hormonal contraceptive and who are not pregnant, about 2 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing levonorgestrel, noretisterone, or norgestimato, about 5-7 will develop a blood clot in a year.
• Of every 10,000 women who use a combined hormonal contraceptive containing drospirenone like Drosiane Diario, about 9-12 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 in a vein” below).

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

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

• If you are overweight (body mass index (BMI) greater than 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). In this case, you may have a hereditary disorder of blood clotting.
• If you need surgery or spend a lot of time without standing up due to an injury or illness or if you have your leg immobilized. You may need to interrupt the use of Drosiane Diario for several weeks before the operation or while you have less mobility. If you need to interrupt the use of Drosiane Diario, ask your doctor when you can start using it again.
• With increasing age (especially above about 35 years).
• If you have given birth recently.

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

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

It is essential to inform your doctor if you have any of the conditions mentioned above, even if you are unsure. Your doctor may decide that you should interrupt the use of Drosiane Diario.

If any of the conditions mentioned above change while you are using Drosiane Diario, for example, a close relative experiences a blood clot without a known cause or you gain a lot of weight, inform your doctor.

BLOOD CLOTS IN AN ARTERY

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

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

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

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

• With age (above about 35 years),
• If you smoke.When using a combined hormonal contraceptive like Drosiane Diario, you are advised to quit smoking. If you are unable to quit smoking and are over 35 years old, your doctor may advise you to use a different type of contraception,
• If you are overweight,
• If you have high blood pressure,
• If any of your close relatives have had a heart attack or stroke at a young age (less than about 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 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, abnormal heart rhythm called atrial fibrillation),
• If you have diabetes.

If you have more than one 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 mentioned above change while you are using Drosiane Diario, for example, you start smoking, a close relative experiences a blood clot without a known cause, or you gain a lot of weight, inform your doctor.

Drosiane Diario and Cancer

Breast cancer has been detected more frequently in women taking combined hormonal contraceptives. However, this may be due to other causes, including sexually transmitted diseases.

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

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

Mental Health Disorders

Some women who use hormonal contraceptives like Drosiane Diario 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, consult your doctor for additional medical advice as soon as possible.

Spotting between periods

During the first few months of taking Drosiane Diario, you may experience unexpected bleeding (bleeding outside of the days of use of the placebo pills). If this bleeding persists beyond a few months or starts after a few months, your doctor should investigate the cause.

What to do if you do not have your period during the placebo days

If you have taken all the active yellow pills correctly, have not had intense vomiting or diarrhea, and have not taken other medications, it is very unlikely that you are pregnant.

If your expected period does not arrive in two consecutive instances, you may be pregnant. Consult your doctor immediately. Do not start the next pack until you are certain that you are not pregnant.

Other Medications and Drosiane Diario

• Some medications may affect the blood levels of Drosiane Diariolose its contraceptive effect, or may cause unexpected bleeding. This may occur with medications used to treat:

• Epilepsy (e.g., primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, felbamate, topiramate),
• Tuberculosis (e.g., rifampicin),
• Human immunodeficiency virus (HIV) and hepatitis C infections (called protease inhibitors and non-nucleoside reverse transcriptase inhibitors such as ritonavir, nevirapine, efavirenz),
• Fungal infections (e.g., griseofulvin, ketoconazole),
• Arthritis, osteoarthritis (etoricoxib),
• High blood pressure in the blood vessels of the lungs (bosentan),
• Herbal medicinal preparations.

• Drosiane Diario may affect the effect of other medications, for example,
• Medications containing ciclosporin,
• The antiepileptic lamotrigine (may lead to an increase in seizure frequency),
• Theophylline (used to treat respiratory problems),
• Tizanidine (used to treat muscle pain and/or muscle cramps).

Do not take Drosiane Diario if you have hepatitis C and are taking medications that contain ombitasvir/paritaprevir/ritonavir and dasabuvir,glecaprevir / pibrentasvir, or sofosbuvir/velpatasvir/voxilaprevir, as these medications may cause increases in liver function parameters in the blood (elevated liver enzyme ALT).

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

Drosiane Diario can be restarted approximately 2 weeks after completing this treatment. See section “Do not take Drosiane Diario”.

Taking Drosiane Diario with food and drinks

Drosiane Diario can be taken with or without food and 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 may affect the results of some tests.

Pregnancy, Lactation, and Fertility

If you are pregnant or breastfeeding, or if you suspect that you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

If you are pregnant, do not take this medication. If you become pregnant during treatment with Drosiane Diario, stop the treatment immediately and contact your doctor. If you want to become pregnant, you can stop taking Drosiane Diario at any time (see “If you want to stop taking Drosiane Diario”).

Lactation

Generally, it is not recommended to take Drosiane Diario during lactation. If you want to take the contraceptive while breastfeeding, consult your doctor.

Driving and Operating Machines

There is no information to suggest that the use of Drosiane Diario has any effect on your ability to drive or operate machines.

Drosiane Diario contains lactose and sodium.

If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet; this is, essentially “sodium-free”.

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

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

The Drosiane Diario tablets of different colors are ordered. A blister contains 28 tablets.

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

Do not confuse the tablets:take a yellow tablet for the first 21 days and then a white tablet for the last 7 days. After that, you must start another blister immediately (21 yellow tablets and then 7 white tablets). Therefore, there is no interval between two blisters.

Since the composition of the tablets is different, you have to start the blister with the tablet from the top left corner and take the tablets every day. Follow the direction of the arrows in the blister to take the tablets in the correct order.

Preparation of the blister

To help you follow the order of taking, each package of Drosiane Diario contains 7 adhesive strips with the 7 days of the week. Choose the strip of the week that starts with the day you take the first tablet.

According to the day of the week when you are going to start taking the tablets, you should choose the corresponding adhesive strip, for example, if you start on Wednesday, take the one that indicates "WED" as the initial tablet. Then, you have to stick the corresponding strip on the top left corner of the package, in the "Start" position. In this way, there is a day of the week indicated above each tablet and you can check visually if you have taken a certain tablet. The arrows show the order in which you should take the tablets.

During the 7 days when you take placebo tablets (placebo days), menstruation (also called withdrawal bleeding) usually starts. Normally, menstruation starts the second or third day after you have taken the last active yellow tablet of Drosiane Diario. Once you have taken the last white tablet, you must start the next package, even if you have not finished bleeding. This means that you should start the next packageon the same day of the weekthat you started the previous one, and menstruation should occur during the same days every month.

Since the composition of the tablets is different, you have to start the blister with the tablet from the top left corner and take the tablets every day. Follow the direction of the arrows in the blister to take the tablets in the correct order.

When can you start with the first blister?

• If you have not taken any hormonal contraceptive in the previous month.

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

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

You can start taking Drosiane Diario preferably on the day after taking the last active tablet (the last tablet that contains active ingredients) of your previous contraceptive, but no later than the day after the days without tablets (or after the last inactive tablet of your previous contraceptive). When switching from a vaginal combined contraceptive ring or patch, follow your doctor's recommendations.

• Switching from a progestin-only method (only progestin pill, injection, implant, or IUD).

You can switch from the only progestin 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 having a child.

After having a child, you can start taking Drosiane Diario between 21 and 28 days. 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 Drosiane Diario.

If, after having a child, you have already had sex before starting to take Drosiane Diario (again), you must be sure you are not pregnant or wait for your next menstrual period.

• If you are breastfeeding and want to start taking Drosiane Diario (again) after having a child.

Read the "Breastfeeding" section.

Consult your doctor if you have doubts about when to start.

If you take more Drosiane Diario than you should

No serious cases of overdose of Drosiane Diario have been reported.

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 more Drosiane Diario tablets than you should, or if you discover that a child has taken them, consult your doctor or pharmacist immediately or go to the nearest hospital, immediately or call the Toxicological Information Service 91 562 04 20 indicating the medication and the amount used.

If you forgot to take Drosiane Diario

The last tablets of the4throwof the blister are placebo tablets. If you forgot one of these tablets, the contraceptive effect of Drosiane Diario is not lost. You must discard the forgotten placebo tablet.

If you forgot an active yellow tablet (tablets of the1st, 2nd, or 3rd row), you must follow the following steps:

• If you delayless 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 delaymore than 12 hoursin taking some tablets, the protection against pregnancy may decrease. The more tablets you have forgotten, the greater the risk of decreased protection against pregnancy.

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

• Forgetting more than one tablet from the blister

Consult your doctor.

• Forgetting a tablet during 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, e.g., a condom, during the next 7 days. If you had sex in the week before forgetting the tablet, you must know that there is a risk of pregnancy. In that case, consult your doctor.

• Forgetting a tablet during 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 during week 3

You can choose between two options:

Probably, you will experience spotting (drops or spots of blood) or bleeding during the use of the second package. Finish this second package by taking the 7 white placebo tablets of the 4th row. Then start the next package.

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

If you forgot to take a tablet from a package and you do not have menstruation during the placebo days, this may mean you are pregnant. In that case, you must go to your doctor before continuing with the next package.

What should you do in case of vomiting or intense diarrhea?

If you have vomiting in the 3-4 hours after taking a tablet or experience intense diarrhea, there is a risk that the active ingredients will not be fully absorbed by the body. This is similar to what happens when you forget a tablet. After vomiting or diarrhea, you must take a tablet from a spare package as soon as possible. If possible, take it before 12 hourshave passed since the usual hour when you take your contraceptive. If it is not possible or more than 12 hours have passed, follow the instructions in the "If you forgot to take Drosiane Diario" section.

Delay of menstrual period: what should you know?

Although it is not recommended, it is possible to delay your menstrual period if you do not take the white placebo tablets of the 4th row and start taking the tablets of a new package of Drosiane Diario until the end of this new package. You may experience spotting (drops or spots of blood) or bleeding during the use of the second package. Finish this second package by taking the 7 white placebo tablets of the 4th row. Then start the next package.

Before deciding to delay your menstrual period, ask your doctor.

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

If you take the tablets according to the instructions, your menstrual period will start duringthe placebo week. If you have to change that day, you can do it by reducing the placebo days - the days when you take the white placebo tablets (but never extending 7 days is the maximum!). For example, if you start the placebo days on Friday and want to change it to Tuesday (3 days earlier), you must start a new package 3 days earlier than usual. It is possible that you will not experience bleeding during these days. Then you may experience spotting or bleeding.

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

If you interrupt the treatment with Drosiane Diario

You can stop taking Drosiane Diario when you want. If you do not want to get pregnant, consult your doctor about other effective birth control methods. If you want to get pregnant, it is recommended that you stop taking Drosiane Diario and wait until your menstrual period before trying to get pregnant. This way, you can calculate your estimated due date more easily.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

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

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

Severe side effects

Contact your doctor immediately if you experience any of the following angioedema symptoms: facial swelling, tongue, and/or throat swelling and/or difficulty swallowing or potentially difficulty breathing (also see section “Warnings and precautions”).

The following side effects are related to the use of Drosiane Diario:

Common:may affect up to 1 in 10 people

• Menstrual changes, bleeding between periods, breast pain, breast tenderness, white vaginal discharge, and vaginal yeast infection,
• Headaches, changes in mood,
• Migraine,
• Nausea.

Uncommon:may affect up to 1 in 100 people

• Breast enlargement, changes in libido (sex interest),
• High blood pressure, low blood pressure,
• Vomiting, diarrhea,
• Acne, itching, skin rash, hair loss (alopecia),
• Vaginal infection,
• Fluid retention and changes in body weight.

Rare:may affect up to 1 in 1,000 people

• Allergic reactions (hypersensitivity), asthma,
• Auditory problems,
• Skin diseases: erythema nodosum (a skin disease characterized by the formation of painful, red nodules) or erythema multiforme (characterized by the appearance of a rash or skin eruption with red spots or ulcers),
• Mammary secretion,
• Detrimental 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 a stroke, known as a 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).

Unknown:The following side effects have also been reported, but their frequency cannot be estimated from the available data:

• Worsening of symptoms of hereditary and acquired angioedema.

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 prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://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 use this medication after the expiration date indicated on the packaging and blister after CAD/EXP: "The expiration date refers to the last day of that month.

This medication does not require special storage conditions

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

Composition of Drosiane Diario

A blister pack ofDrosiane Diariocontains 21 active yellow tablets in rows 1, 2, and 3, and 7 white placebo tablets in row 4.

Active Tablets:

Tablet core: lactose monohydrate, cornstarch, pregelatinized cornstarch, crospovidone, povidone, polisorbate 80, magnesium stearate.

Capsule coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, talc, and yellow iron oxide (E-172).

White Placebo Tablets:

Tablet core: anhydrous lactose, povidone, magnesium stearate.

Capsule coating: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, talc.

Appearance of the Product and Contents of the Package

The active tablets are yellow-coated, round tablets.

The placebo tablets are white-coated, round tablets.

Drosiane Diario is available in packages of 1, 2, 3, 6, and 13 blister packs, each containing 28 (21 active tablets and 7 placebo tablets).

Only some package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible Manufacturer

Laboratorios León Farma, S.A.

C/ La Vallina s/n

Polígono Industrial de Navatejera

24193 Villaquilambre, León

Spain

or

Lek Pharmaceutical d.d.

Verovskova 57

1526 Ljubljana

Slovenia

or

Salutas Pharma GmbH

Otto von Guericke Alle 1

39179 Barleben

Germany

This Medicinal Product is Authorized in the Member States of the European Economic Area with the Following Names:

Estonia:Marionelle 0.03 mg/3 mg õhukese polümeerikattega tabletid

Finland:Rubira 0.03 mg/3 mg kalvopäällysteiset tabletit

Norway:Rubira 3 mg/0.03 mg filmdrasjerte tabletter

Last Review Date of this Leaflet:December 2022

More detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.